Final Updates and Additions

for

 

HERB CONTRAINDICATIONS AND DRUG INTERACTIONS, 3rd ed.

 

 

including extensive Appendices addressing

COMMON PROBLEMATIC CONDITIONS, MEDICationS AND NUTRITIONAL SUPPLEMENTS,

AND INFLUENCES ON pHASE i, ii & iii METABOLISM

with new Appendix on

botanicals AS COMPLEMENTARY ADJUNCTS WITH DRUGS

 

by Francis Brinker, N.D.

Copyright 2010

All rights reserved

Nothing from this document may be reproduced for sale or distribution in any form.

Last update July 13, 2010

 

Combining herbal use with medications should only be done after consultation with a knowledgeable physician. Preliminary research data on potentially beneficial combinations of herbals and drugs is provided to educate pharmacists and physicians and encourage further clinical research. Information provided in this book is not intended as recommending self treatment or to replace instructions provided by one’s own doctor or health care provider.

 

Introduction  +

The content on this site is presented to supplement the information found in the third edition of the book.  By this means the database can be enlarged, enhanced and updated without the user having to annually purchase a new printed edition largely containing information already provided in the previous edition or subscribing to an online updating service.  The format for this site is consistent with that found in the book, so that herbs and appendix categories can be easily accessed by the same arrangement as in the printed text. The page numbers for the updates indicate where in the book the associated information can be found, while additions are identified as "NEW." The added reference citations begin with 1100.  Citations for lower reference numbers are found in the book. Changes in scientific binomials and standardized common names used here are now based on the second edition of Herbs of Commerce (2000).

Since the information on this site presupposes familiarity with the content in the book, it must be understood in that context. The content on this site must be recognized as inadequate without access to what has been published in the 3rd edition.  However, abbreviated versions of prior referenced statements about the contraindications or the drug interactions are included at the beginning of an addition to identify the context of the addition. Listed below are important terms, abbreviations, and symbols used in the book and/or on this site, followed by a Table of those herbs and appendix sections to which additions have been made. 

Regarding herbal contraindications, many bridge the empirical vs. speculative designations, with greater evidence provided by one or the other, though a combination of factors often contribute. The method of determining such designations is imprecise, and what is described as a speculative contraindication for self-prescribing by the general public (the method employed for this text and web site) may in some cases be more accurately described as a precaution for an expert prescriber educated in botanical medicine (as indicated in other texts primarily intended for professional use). Potential risks from contraindications or adverse interactions can be uncertain in regard to the actual degree of risk due to conflicting evidence. For this reason, in such cases the inclusion of contradictory data in a separate indented paragraph prefixed with the word, “However,” has been used as a means of emphasing the equivocal nature of the extant evidence for some controversial contraindications or interactions.

            As stand-alone evidence of drug interactions with herbals, laboratory studies in vivo with animals in Category II. and/or with in vitro cell or tissue cultures in Category III. are insufficient to extrapolate the findings to humans with certainty. The reasons for this are many. For one, animals and their intestinal bacterial flora differ from humans in their abilities to digest, absorb, and/or metabolize the many different types of components found in any complex botanical preparation. Similar but distinct problems exists with in vitro laboratory studies utilizing cell organelles, cell cultures, tissues, or isolated organs. The systemic exposure of living tissues to complex solutions extracted from plants following intestinal absorption does not involve the same chemical content and proportions as is found in laboratory conditons where cells and tissues are exposed to the complete extract. Clinical case reports or case series appear to be of more real value in determining an herbal effect than extrapolating laboratory data to a clinical setting. In the absence or preferably in the context of controlled clinical studies, combining all types of preclinical evidence based on similar preparations facilitates a more complete and, hopefully, a more dependable assessment.

When herbal influence on drug pharmacokinetics is discussed, the term “bioavailability” is often used as a short-hand term to describe the total Area Under the concentration-time Curve (AUC). Though the total time that the drug concentration is monitored may vary from a few hours to a few days depending upon the study, this general term is applied to conveniently indicate when the overall average circulating serum level of the drug has been significantly altered.  Results reported here as "significant" are deemed so based on statistical significance demonstrated by a P value of < 0.05, at most. However, statistical significance in changes to biological markers does not guarantee a clinically significant effect when it comes to assessing therapeutic outcomes.

KEYS TO INTERPRETTING CONTENT IN THE BOOK AND AT THIS SITE

The following terms are used to describe the different means of determining botanical effects.

The categorization of I, II, III and IV is used to rank potential herb-drug interactions according to their probable pertinence based on the strongest degree of evidence available.

Where contradicting data exists for a particular item in any category, this is noted by an indentation, and the sentence will begin with the word, “However.”

I.          human studies – published research done on healthy individuals

            human clinical studies – published research from therapeutic trials on patients being treated for a condition

            empirical – traditional knowledge or consensus based on experience from extensive use

            human case reports – published individual responses to using herbal products

            human case series – published responses from several patients using a preparation of the same herb

II.        in animals (types listed) – laboratory tests using live animals (in vivo) and various modes of administering the herb or herbal component(s)

III.       ex vivo laboratory interaction finding on cells, tissue, or organs from animals or humans who were administered the herbal agent (as contrasted to in vivo when studies are done on the living organisms themselves)

            in vitro –laboratory interaction finding with cell or tissue samples from animals or humans

            speculative – using pharmacological evidence from in vitro research, animal studies, or human studies to infer probable or potential interactions or effects in humans

IV.       [dubious interactions] shown in brackets with the drugs underlined rather than in bold type are based on preliminary findings, speculation, inaccurate information, and/or false assumptions that have been contradicted by established evidence.

 

Abbreviations for the various modes of administration are used as follows:

            IM (intramuscular) – injected into a large skeletal muscle

            IP (intraperitoneal) – injected into the peritoneal cavity

            IV (intravenous) – injected into a vein

            PO (per os) – by mouth; orally or through a feeding tube; b.i.d. = 2x/day, t.i.d. = 3x/day

            SC (subcutaneous) – injected under the skin

 

ADDITIONAL INFORMATION BASED ON THE FOLLOWING IS AVAILABLE FOR THE LISTED HERBS AND APPENDICES:

+ denotes new contraindication(s) and/or interaction(s) not previously listed in the book for the herb

^ denotes new herb with contraindication(s) and/or interaction(s) in body of text or an entirely new appendix section

Ä denotes use of new standardized common name from second edition of Herbs of Commerce

 

If none of the above are present in the list below, elaborations have been made to information already included in the book.

An asterisk (*) in front of an herb’s scientific name denotes toxic effects from over-consumption of that herb or a major active component.

Where [CORRECTION:] appears before numbers or information in ALL CAPS, it denotes correction of an error found in the book.

 

HERBAL AGENTS – Contraindications and/or Drug Interactions

            The following list are those herbs that are either new or for which updates or new information has been added.

Agar  +

Agave  ^

Alfalfa  +

American ginseng  +

Andrographis  ^

Anise  +

Apricot  ^

Arjun  ^

Arnica  +

Artichoke  +

Ashwagandha  +

Asparagus  +

Astragalus 

Bacopa  ^

Barberry  +

Basil  +

Beebalm  ^

Beth root  ^

Bilberry

Birch +

Bitter melon  +

Bitter orange  +

Black chokeberry  ^

Black cohosh  +

Black cumin  ^

Black currant  ^

Bladder kelp  ^

Bladderwrack  +

Blue cohosh  +

Blue flag  ^

Blue vervain  ^

Bloodroot  +

Boldo  +

Borage +

Boswellia  ^

Bromelain  +

Burdock  +

Butcher's broom  ^

Butternut  ^

Cajeput  ^

Calendual  +

California spikenard  ^

Camphor bark  +

Caraway  ^

Cascara sagrada 

Cassia cinnamon  + Ä See Cassia

Cat’s claw  +

Cayenne 

Celandine +

Celery  +

Chamomile, German  +  Ä See Chamomile

Chamomile, Roman  Ä See Roman Chamomile

Chaste tree  +

Chickweed  ^

Chicory  +

Chinese cucumber  ^

Chinese skullcap  ^ Ä

Cinchona +

Cinnamon  +

Clove  +

Cocoa  +

Coffee

Comfrey +

Copaiba  ^

Coptis  ^

Cordyceps  +

Corydalis  ^

Cotton  +

Couch grass  Ä See Triticum. 

Cranberry  ^

Cranesbill  ^

Crucifers

Cumin  ^

Dan shen

Dandelion  +

Devil’s claw

Dill  +

Dog rose  ^

Dong quai  +

Dulse  +

Dyer’s broom  +

Eastern red cedar  ^

Eleuthero

Ephedra

Eucalyptus

European pennyroyal  ^

European vervain  ^

Evening primrose  +

False unicorn root  ^

Fennel  +

Fenugreek  +

Feverfew

Flax

Forsythia  ^

Fragrant angelica  ^

French maritime pine ^

Garlic +

Ginger +

Ginkgo

Ginseng   +  Ä See Asian ginseng

Goat’s rue  ^

Goldenrod  ^  Ä For Solidago virgaurea see European goldenrod. 

Goldenseal +

Gotu kola  +

Grapes  ^

Grapefruit  +

Guar gum   +

Guarana

Guggul  ^

Gurmar   +  Ä See Gymnema

Hawthorn  +

Henna  ^

Hops  +

Horse chestnut  +

Horseradish +

Horsetail  +

Iboga +

Inmortal ^

Ipecac +

Jamaica dogwood  +

Job’s tears  ^

Jujube seeds  ^

Kava +

Konjac

Kudzu  +

Kutaki  Ä

Lavender  Ä See English lavender.

Lemongrass  +

Licorice +

Life root

Lobelia +

Lomatium  ^

Lycium  ^

Maca  ^

Maitake  +

Makandi  +

Mangosteen  ^

Marijuana  + See Cannabis.

Marshmallow  +

Mate

Meadowsweet  +

Milk thistle  +

Muirapuama   ^ 

Mustard

Myrrh  +

Nard  ^

Neem  ^

Nutmeg  +

Oat  +

Ocotillo  ^

Olive  +

Orange  ^

Oregon grape  +

Osha  ^

Papain

Passion flower  +

Pennyroyal  Ä See American pennyroyal.

Peppermint  +

Periwinkle  Ä See Lesser periwinkle. 

Petasites  +

Plantain  Ä For Plantago lanceolata see English plantain. 

Pleurisy root +

Poke  ^

Pomegranate +

Prickly ash

Prickly pear

Psoralea  ^

Psyllium

Puncture vine  ^

Purslance  ^

Quassia (Jamaican)  ^

Quassia (Surinam)  ^

Queen Ann’s lace  Ä See Wild carrot

Raspberry   +

Red clover  +

Rehmania  +

Reishi  +

Rhatany  ^

Rhodiola  ^

Rhubarb, Chinese  Ä See Chinese rhubarb

Royal sun agaricus  ^

Sage  +

Schizandra  +

Scotch broom

Scouring rush ^

Sea buckthorn  ^

Senna +

Sesame  ^

Shepherd’s purse  +

Shrub aloe  ^

Small spikenard  ^

Soy  +

Spikenard  ^

St. John’s wort  +

Stevia  ^

Stinging nettles  +

Sweet annie  ^

Sweet clover

Szechuan lovage  ^

Szechuan pepper  ^

Tea  +

Tea tree  ^

Thuja  +

Thunder god vine  ^

Thyme +

Tobacco  +

Turkey tail  +

Turmeric  +

Tylophora  ^

Uva ursi

Valerian +

Vetiver  ^

Watercress  +

Wheat  ^

Wild cherry  Ä See Black cherry

Wild lettuce  +

Wild marjoram  See Oregano

Wild yam  +

Willow  +

Wintergreen  ^

Witch hazel  +

Wormwood  +

Yarrow  +

Yellow dock  ^

 

APPENDIX SECTIONS WITH NEW HERBALS, DATA OR SECTIONS ADDED:

Appendix A – Herbals To Be Used With Caution

A.2  Due To Potential Photosensitizing Effect

A.2.1 Carrot family

 

A.4  In Acute Inflammation of the Urinary Tract

A.4.1 Medicinal Plants Containing Urinary Irritants

A.4.2 Medicinal Plants Containing Soluble Oxalates

 

A.5  In Gastrointestinal Irritation

A.5.1  Herbals That Can Upset the GI Tract

 

A.6  In Hypothyroid Conditions or Euthyroid Goiter

A.6.2  Antigoitrogens

 

A. 7  Due to Potential Adverse Effects

            A.7.1  Herbals With Toxic Potential

 

Appendix B – Herbal/Drug Interactions

B.1 Modifying Intestinal Absorption of Medicines [AND PHASE III METABOLISM]

            B.1.1.b.i Selective Precipitation of Alkaloids and Minerals by Tannins

B.1.1.b.ii  Precipitation by Non-tannin Phenols

B.1.1.f Slows and/or Decreases Active Intestinal Transport by hPepT1 and/or Others

B.1.2.c Enhanced retention of Drugs by Inhibiting MRP1 or MRP2            ^

B.1.3  No Influence on Drug Absorption in Humans                         ^

B.1.3.a  No Effect on P-glycoprotein Efflux                                     ^

 

B.2  Potentiating Cardiotonic Medicines

B.2.2.b Potentiation by Kaliuretics and/or Diuretics

 

B.3  Potentiating Sedative or Tranquilizing Medicines

B.3.1 Hypnotic and/or Anxiolytic Drug Enhancement         

 

B.4  Modigying Blood Sugar in Insulin-Dependent Diabetics

B.4.1 Hypoglycemic Herbals

B.4.2  Antihyperglycemic Botanicals Enhancing Oral Hypoglycemic Drugs in Humans      ^

 

B.5  Modifying the Effects of Anticoagulants

B.5.1.c Warfarin or Heparin Metabolism Inhibitors and/or Anticoagulant Adjuvants

B.5.1.d Platelet Aggregation Inhibitors

B.5.1.e Fibrin Formation Inhibitors or Fibrinolysis Promoters

 

B.7  Modifying Enzyme Activities in Metabolic Conversions

B.7.1.a Modulation by Phase I &/or Phase II Enzymes &/or Other Clearance Factors

B.7.1.b Influence on Pregnane X Receptor (PXR)    ^

B.7.1.c Influence on Aryl hydrocarbon Receptor (AhR)       ^

B.7.2.a Influence on CYP 1A2 Metabolic Conversion of Substrates

B.7.2.b Influence on CYP 2E1 Metabolic Conversion of Substrates

B.7.2.c Influence on CYP 3A4 Metabolic Conversion of Substrates

B.7.2.d  Influence on CYP 2C9 Metabolic Conversion of Substrates           ^

B.7.2.e  Influence on CYP 2C19 Metabolic Conversion of Substrates         ^

B.7.2.f  Influence on CYP 2D6 Metabolic Conversion of Substrates           ^

B.7.3.a Influence on Glutathione S-Transferase Activity or its Isozyme Levels

B.7.3.b  Influence on Activity and/or Content of UDP-Glucuronosyltransferases [UGT]

B.7.3.c  Influence on NADPH-Quinone Reductase [QR] (DT-Diaphorase) Activity and/or Content

B.7.3.d  Influence on Epoxide Hydrolase (Epoxide Hydratase)[EH] Activity

B.7.4.a  Aromatase (CYP19) Conversion of Testosterone to 17b-Estradiol

B.7.4.b  5a-Reductase Conversion of Testosterone to Dihydrotestosterone

B.7.4.d  11b-Hydroxysteroid Dehydrogenase type 2 Conversion of Cortisol to Cortisone

B.7.4.e  17b-Hydroxysteroid Dehydrogenase types 1, 3 or 5 Conversion of Androstenedione to Testosterone

B.7.4.f  17b-Hydroxysteroid Dehydrogenase type 2 Conversion of Testosterone to Androstenedione or Estradiol to Estrone  ^

B.7.4.g  17b-Hydroxysteroid Dehydrogenase type 1 Conversion of Estrone to Estradiol  ^

B.7.4.h  3b-Hydroxysteroid Dehydrogenase type 1 or 2 Conversion of DHEA to Androstenedione and/or Pregnenolone to Progesterone  ^

B.7.5  Herbal Monoamine Oxidase –A &/or –B Inhibitors

 

Appendix C – Herbals Contraindicated for Mothers and Children

C.1 During Pregnancy

C.1.1  Herbals That May Impact the Uterus or Fetal Development

 

Appendix D – Vitamin/Mineral/Drug Interactions

D.1 Drug and Mineral Interactions with Vitamin Supplements 

D.1.5  Vitamin B6 (Pyridoxine, Pyridoxamine, Pyridoxal) / Drug Interactions

D.1.5.a  Vitamin B6-Rich Herb and Vegetable Sources        

D.1.7  Folic Acid / Drug Interactions

D.1.8  Vitamin C (Ascorbic Acid, Ascorbates) / Drug Interactions

D.1.10.a  Vitamin E-Rich Plant Sources

D.2  Drug and Vitamin Interactions with Mineral Supplements       

D.2.1  Calcium / Drug Interactions

D.2.1.a  Calcium-Rich Herb and Vegetable Sources

D.2.2.a  Copper-Rich Herb and Vegetable Sources  

            D.2.4  Iron (as Ferrous Sulfate) / Drug Interactions

D.2.4.a  Iron-Rich Herb and Vegetable Sources

D.2.5.a  Magnesium-Rich Herb and Vegetable Sources

D.2.6.a  Manganese-Rich Herb and Vegetable Sources

            D.2.7.a  Potassium-Rich Herb and Vegetable Sources

 

Appendix E – Herbals as Complementary Adjuncts with Medicines  ^

E.1. Potentially Beneficial Combinations of Herbals with Drugs   [formerly Addendum]  

E.2. Herbal Aids for Modifying Substance Abuse  ^

E.3  Complementing Treatment of Inflammations ^

E.4. Enhancing Chemotherapy and Chemoprevention or Reducing the Adverse Effects  ^

E.5. Herbals for Preventing and Healing Radiation Adverse Effects and/or Enhancing Radiotherapy or Photodynamic Therapy ^ 

E.6. Herbals and Anti-infectious Agents  ^

 

References

1100. – 2708.

 

 

Introduction

            There are many possible meanings of the word “herb.” Taken in its broadest medicinal sense, it commonly refers to all plants and/or plant parts. Traditionally, it has been applied to the above-ground part of non-woody plants, excluding their roots and/or rhizomes. The term is used in this text with this intended meaning, to describe the part of the plant used for many of the botanicals included herein. In the culinary arts an herb is distinguished from spices as referring primarily to aromatic leaves, in contrast to seeds, bark, or roots/rhizomes. In all of these cases, the word is intended to be understood as the whole part of the fresh or dried plant, characteristically including its fiber content.

            For the purposes of understanding the title of this book in all of its ramifications, the concept of “herb” incorporates chemically complex derivatives of all plant parts. This extended application of the term is in consideration of the majority of studies using only derivatives of the medicinal parts of plants. These extractives include, for example, juices, teas, tinctures, volatile oils, and other fractions that are physically or chemically removed from the fresh or dried plant parts. These preparations are more properly referred to as botanicals or “herbals”, the terms now employed in the text. Since these commercial derivatives are commonly consumed, it is important to acknowledge the specific forms used in studies when this is adequately described in published research.

By extension, major active components of the plants have been used to help understand the pharmacology of the extracts and whole herbs. Discussion of isolated phytochemicals should not be taken to imply that the pharmacology of a commonly used extract or herb is identical to that of a single compound that these may contain. Rather, the activity of an isolated compound is simply one contributing factor to the overall effect derived from using the extract or herb. The same case can be made in regard to a subfraction or even commonly used extracts, when compared to the whole herb itself. At each level of growing complexity (from isolate to subfraction to extract to herb) the influence of the isolate in relation to the overall effect diminishes both in quality and quantity.

Nevertheless, it remains useful to consider specific pharmacological research regarding the activity of isolates, subfractions, and extracts, when considering the effects of the herb itself. For this reason, research data from all of these forms are used as evidence in this book to help document the probability of specific outcomes. This remains a useful approach as long as it is understood that direct application of the findings for a specific preparation apply only to that preparation and dose; other correlations necessarily fall short.

The term “bioequivalence” is a relative concept, in that certain extractives or derivatives of an herb have more or less similarity to one another, depending on each one’s unique phytochemical content and proportions. Bioequivalency certainly cannot be assumed to strictly corrlate with an initial amount of plant material from which many variable preparations can be made. Though the inherent variability in content and complexity of “similar” preparations may be unsettling for the scientific purist, it should be no more uncomfortable than considering the fact that each person who uses a herb or its extract is also genetically and biochemically unique in their own peculiar response to the remedy. It is knowledge of the general similarities regarding pathophysiology, pharmacology and therapeutic responses in conjunction with an understanding of the individual distinctions between both preparations used and patients using them that comprise the challenging art of medical practice. These are facts that must be acknowledged and addressed in each case, to optimize the safety and efficacy of the intervention. The same relative significance can be applied to different quantities consumed of the exact same preparation. While an accepted therapeutic dose and duration can be completely safe, increasing its consumption in amount and/or length of use beyond its acknowledged safe limitations can lead to undesirable adverse effects. Therefore, in addition to characterizing the form used in scientific studies it is important to describe the dosage used.

In some cases, animal and in vitro evidence can provide either contradictory or supporting evidence to help assess the likelihood of interaction report(s) involving botanicals and drugs or in establishing mechanistic evidence for contraindication rationales.As stand-alone evidence, laboratory studies with animals (in vivo) and/or with cell cultures (in vitro) are insufficient to extrapolate the findings to oral dosing in humans. The reasons for this are many. Animals differ from one another and from humans in their abilities to digest, absorb, and/or metabolize the many different types of components found in any complex botanical preparation. Animal studies often utilize exaggerated doses to produce an effect that is more readily observed or measure biochemically, but this exposure also may not correlate with typical human dosage. In many animal studies on botanicals the use of injections helps to maintain a consistent and reliable dosage, but systemic bioavailability of the complete phytochemical complex does not accurately represent the partial systemic exposure that follows digestion and absorption with oral dosing in humans.

Similar but distinct problems exists with laboratory studies utilizing cell cultures or isolated organs. The exposure of living tissues to complex solutions extracted from plants following intestinal absorption does not involve the same content and proportion as is found in laboratory conditons where cells and tissues are exposed to the complete extract. The pre- and postabsorption conversion of various phytochemicals in the extract, potentially involving both activation and/or deactivation from digestion and metabolism, does not occur to nearly the same extent in cell monocultures and the nonreactive in vitro glass environment. The concentration tested in vitro also often greatly exceed tissue exposure in vivo. These issues call into question many of the so-called “mechanisms of actions” that supply the basis for theoretical indications, contraindications and interactions on which many speculate. In the case of these in vitro laboratory studies, more may be learned about potential mechanisms by studying the contribution of isolated components found in the herbs and/or extracts, so long as the particular isolate has been shown to absorbed systemically and is bioavailable in the sustained concentrations as tested in the lab. The only direct application of herb or extract in vitro lab data might be their local use on superficial tissues, i.e, the skin or mucosa, or on associated microbial growth on these surfaces.

 

 

HERBAL AGENTS –

Contraindications and Drug Interactions

AGAR                                                                                                p. 27

^          Gelidium spp. thallus

Drug Interactions

III.  +   1) May inhibit absorption of oral drugs such as aspirin, digitalis and other cardiac glycosides, antibiotics, and anticoagulants if administered concurrently (speculative)150

 

AGAVE                                                                                 NEW

     ^     Agave americana plant, juice

Contraindications

            1) Pregnancy (empirical)2 due to its emmenagogue and abortifacient effects (empirical)74

 

ALFALFA                                                                             p. 27

Medicago sativa plant

Drug Interactions

I.   +     2) A kidney transplant patient maintained on azathioprine and cyclosporin for 16 years suffered severe acute rejection after taking alfalfa and black cohosh (Cimicifuga racemosa) for 6 weeks, though serum cyclosporine levels were not altered. Anti-T-cell immunoglobulin and steroid helped control transplant rejection. Immunostimulation through T-cell activition by alfalfa’s l-canavanine is suspected as contributing to the kidney rejection (PO in human case report).1553

II.         1) CORRECTION: increase rate of metabolism of ETHOXYCOUMARIN in the liver by increasing the activity of hepatic microsomal mixed-function oxidase reactions (PO in mice)103

III. +    3) The cytotoxic effect of gemcitabine, a standard drug for pancreatic cancer, on pancreatic cancer cells was inhibited in the presence of coumestrol and genistein even when used at 2.5 times higher concentration (in vitro)1681

 

ALOE                                                                                     p. 29

            Aloe vera = Aloe barbadensis gel (not the dried sap)

Contraindications

     +     2) Allergic hypersensitivity to aloe preparations such as contact dermatitis (empirical).1890

     +     3) Pregnancy without professional advice (speculative) due to uterine stimulant, abortifacient, and/or teratogenic effects (in vitro, PO in rat study).1890

Drug Interactions

IV.  +   1) Following extensive bleeding in the surgical removal of a large hemangioma, this effect was attributed in part to a possible interaction between sevoflurane and the consumption of 4 tablets per day for two weeks of Aloe vera (PO in human case report). It was not known whether the aloe tablets were a whole herb product or contained an extract, nor were the tablets analyzed for constituent or to detect potential adulterants. Sevoflurance inhibits COX activity and TXA2, impairs platelets, and prolongs bleeding, while aloe was suspected of contributing by reducing prostaglandin synthesis.1785 This speculation was based on a study of a water extract and successive fractions with n-hexane, benzene, ethyl acetate, chloroform, acetone, and 96% ethanol from Aloe vera dried gel. Only the water extract of the gel reduced PGE2 production (in vitro).1786 

 

ALOES                                                                                  p. 29

            *Aloe vera, Aloe ferox, or Aloe perryi dried leaf latex or sap (not the gel)

Contraindications

            8) Do not take during intestinal obstruction due to stimulation of peristalsis by the anthroquinones (empirical).4,6,150,401

Causes of obstruction include stenosis and atony.1890

     +     13) Allergic hypersensitivity to aloe preparations such as contact dermatitis (empirical)1890

     +     14) Do not take if there is known dehydration due to depletion of water and electrolytes (empirical).1890

Drug Interactions

IV. +    1) Following extensive bleeding in the surgical removal of a large hemangioma, this effect was attributed in part to a possible interaction between sevoflurane and the consumption of 4 tablets per day for two weeks of Aloe vera (PO in human case report). It was not known whether the aloe tablets were a whole herb product or contained an extract, nor were the tablets analyzed for constituent or to detect potential adulterants. Sevoflurance inhibits COX activity and TXA2, impairs platelets, and prolongs bleeding, while aloe was suspected of contributing by reducing prostaglandin synthesis.1785 This speculation was based on a study of a water extract and successive fractions with n-hexane, benzene, ethyl acetate, chloroform, acetone, and 96% ethanol from Aloe vera dried gel. Only the water extract of the gel reduced PGE2 production (in vitro).1786 

 

AMERICAN GINSENG                                                     p. 30

Panax quinquefolius root

Contraindications

            1) Estrogenic activity, especially of alcoholic root extracts, may be present in large part due to zearalenone and its metabolites from Fusariam fungal contamination (in vitro).1695 In addition estrogen-independent stimulation of human breast cancer cell proliferation with the alcoholic extract (in vitro)1664 suggests that regular consumption of the root or its alcoholic extracts should be avoided in those with a history of breast cancer (speculative)

Drug Interactions

I.   +     1) 3 grams or more of the powdered root given prior to a glucose challenge reduced blood sugar levels in seven type 2 diabetics whose condition was being treated with sulfonylureas or a combination of these and metformin (PO in human study).1114

In 12 nondiabetic subjects 3 grams of the dried cultivated root tended to lower plasma glucose at 90 minutes during a 75-gram oral GTT, but the same dose of wild root raised blood sugar after 120 minutes (PO in human study).1713 From 3-9 grams of the ground root improved glucose tolerance following a 25 gram glucose challenge in 10 nondiabetics (PO in human study).1685 However, different batches of the root from the same supplier that differed in ginsenoside ratios were not consistent in reducing blood sugar of normal subjects under the same experiemental conditions (PO in human study).1596 Roots grown in Wisconsin have shown wide variability in total and individual ginsenoside content from those grown in Illinois.1714

A water extract of the root has been shown to significantly lower blood sugar, probably due to the activity of several glycans (IP in mice).1574

            An alcoholic extract of the berries at 150 mg/kg daily in diabetics also lowers fasting blood sugar and improves overall glucose tolerance while lowering body weight (IP in mice).1704

     +     2) 2 grams of encapsulated powdered root for 3 weeks in healthy subjects significantly reduced blood levels and anticoagulant effect of warfarin (PO in human study). The peak INR decreased along with peak plasma warfarin, compared to placebo.1600

II.  +     1) Hot water extract at 400 mg/100 gm given 10 minutes prior to ethanol delayed the effects of ethanol on the righting reflex and reduced its plasma levels, probably due to the additive effect of slowing of gastric emptying by alcohol and American ginseng extract or ginsenosides (PO in mice)1117

     +     2) The saponin fraction enhanced phenylephrine vasoconstrictor effect (in vitro)1550

III.       1) Standardized extract synergistically increased suppression of estrogen-dependent cancerous breast cells when combined with tamoxifen, cytoxan, doxorubicin, taxol and methotrexate (in vitro).981

Tumor inhibition may be due in part to the antiangiogenic activity of its predominant ginsenoside Rb1, the opposite effect associated with Rg1 (in vitro, SC in mice)1686 However, an alcoholic extract stimulated growth in the MCF-7 human breast cancer cell line (in vitro), though it showed no estrogenic activity in failing to induce transactivation of alpha- or beta-estrogen receptors (in vitro) or increase uterine weight after 4 days (PO in mice).1664

In 3 digoxin immunoassays, an aqueous American ginseng extract increased the digoxin measurement results for the fluorescence polarization immunoassay (in vitro). Using the microparticle enzyme immunoassay, this extract significantly lowered the serum digoxin measurement (in vitro). No effect was found on the measurement done by Tina-quant (in vitro).1995

 

AMERICAN PENNYROYAl [formerly PENNYROYAL]         p. 159

Ä         *Hedeoma pulegioides plant

 

ANDROGRAPHIS                                                               NEW

     ^      Andrographis paniculata plant

Contraindications

            1) Pregnancy due to its abortifacient effects (empirical),150 antifertility effect in females at high doses (in mice),777 and fetal damage (in animals)1890

            2) Gastric hyperacidity such as duodenal ulcers and esophageal reflux (empirical).1890

Drug Interactions

III.       1) Avoid long-term use with immunosuppressive drugs (speculative)1890 due to the activation of immunocompetent cells by its extract and component andrographolide (in vitro).1967

            2) Caution should be used when taking with antiplatelet or anticoagulant medications (speculative),1890 since it inhibits platelet aggregation after consumption by cardiovascular disease patients (ex vivo).404,1890

 

ANISE                                                                                    p. 31

            Pimpinella anisum seed/fruit

Contraindications

     +     3) CNS toxicity following consumption the tea, especially in nursing mothers and/or their breast fed infants (PO in human case reports)1141 

     +     4) Pregnancy (speculative)150 probably due to its estrogenic effects of its essential oil component anethole14 and the antagonism of testosterone and progesterone by anise seed oil (injected in rats)1312

 

APRICOT                                                                             NEW

     ^     Prunus armeniaca seed

            (Ch. xing ren)

Contraindications

            1) Self prescribing due to potential for adverse effects from cyanogenic glycosides (speculative)150

            2) Children due to increased vulnerability to toxic and lethal effects from cyanogenic glycosides (empirical)150

Drug Interactions

II.  +     1) The absorption of sulfasalazine was increased 2- to 4-fold when taken with apricot extract (PO in rats).2287

 

ARJUN                                                                                  NEW

     ^     Terminalia arjuna bark

            (Manipuri: Maiyokpha; Tamil: Marutu; Malayalam: Nirmarutu; Kannada: Nirmatti)

Drug Interactions

I.          1)  An extract given at 500 mg 3 times/day for 2 weeks improved symptoms of  patients with Class IV refractory chronic congestive heart failure compared to placebo, when given in a crossover design to 12 patients taking digoxin, along with the diuretic drugs furosemide, and spironolactone (PO in human clinical study). In addition, vasodilator prescriptions included  8 for enalapril, 3 for captopril, 1 for nifedipine, and 3 for isosorbide dinatrate. Antiarrhythmic medication amiodarone was used by 2 patients, while all were administered potassium supplements. In an open continuation of the trial for a mean of 24 months signs and symptoms continued improving for 2-3 months and were maintained throughout the study, while diuretic dosages were reduced for all and other doses were kept flexible. After 4 months 9 patients were at Class II and 3 at class III.2661

 

ARNICA                                                                                p. 31

            Arnica montana flowers

Contraindications

     +     6) Internally by nursing mothers and not applied topically to the nipple, due to potential toxicity to the infant (empirical).1890 

 

ARTICHOKE                                                                       p. 32

            Cynara solymus leaves

Contraindications

1) Allergic hypersensitivity to artichoke or other Asteracea [Compositae] family plants (empirical),6,17,401,777,1890

though the likelihood of globe artichoke preparations producing an allergic response is very low (empirical).1890

A man and a woman who handled artichokes in their occupations suffered seasonal allergic eruptions and urticaria, respectively, and tested positive to patch or skin prick tests, especially to the stem, leaves, and their fuzz (TP in human case reports).1974,1975

            2) Bile duct obstruction, due to its cholagogue effect (empirical)6,17,401,777,1890

and its choleretic activity as shown with a single 1.9 gram dose of its 4.5-5:1 strength extract (PO in human study).1270

Drug Interactions

III.       1) It may enhance cholesterol-lowering agents, due to additive effects (speculative).777 

Tablets with 450 mg of a 25-35:1 aqueous extract reduced total cholesterol, LDL cholesterol, and LDL/HDL ratio (PO in human clinical study).1271

 

ASHWAGANDHA                                                               p. 33

            Withania somnifera root

Drug Interactions

II.   +    2) After 10 days of using 100 mg/kg of a commercial root extract, tolerance to morphine analgesia was inhibited, and morphine dependence was blocked (PO in mice study), suggesting that it could be of use in opiate addiction1277 

      +    3) Leucopenia induced by cyclophosphamide was significantly reduced by ashwagandha methanolic extract (IP in mice). So, the intended cytotoxic activity of this chemotherapeutic agent and its efficacy in treating cancer may be diminished (speculative).1583

However, when 4/5 of the total ashwagandha root extract was combined with 1/5 Tinospora cordifolia stem extract or the alkaloid-free polar ashwagandha extract was given in cyclophosphamide-treated ascitic sarcoma, not only did the extracts provide myelo- and immuno-protective activity, but the drug’s antitumor activty was not altered when compared to cyclophosphamide given alone (PO in mice).2217

Also, 20 mg daily for 5 days of the methanolic extract was shown to reduce bladder damage caused by cyclophosphamide metabolites, one of the leading causes of adverse effects from this drug (IP in mice). Rather than severe inflammation and hemorrhage 4-48 hours after the drug, when given the extract the bladder morphology was normal, the elevated serum and urine protein levels were normalized, while the lowered liver and bladder glutathione levels were enhanced.1279

            However, the discontinuity effects caused by cyclophosphamide on the GI mucous membrane with bleeding spots in the lower esophagus and upper stomach were not affected by ashwagandha extract, suggesting the extract’s inability to protect against general cyclophosphamide cytotoxicity (PO in mice).1278

100 mg/kg root extract given for 15 days with cyclophosphamide, azathioprin and prednisolone prevented the myelosuppressive activity of these drugs by increasing the hemoglobin, red blood cell and platelet counts for all three groups, and the white blood cell count for the cyclophosphamide and prednisolone groups (PO in mice). The response was different for azathioprin and prednisolone than with cyclophosphamide in that it reflected more of a direct response of the immune system to ashwagandha, rather than indirect modulation or interference with the drug’s immunosuppressive action.1278

     +     4) Pretreatment with 100 mg/kg extract enhanced the antiepileptic effects of diazepam and clonazepam when convulsions were induced by lithium-pilocarpine model (PO in rats)1290

     +     5) Adverse effects such as orofacial dyskinesia and poor memory retention induced by reserpine and associated with brain lipid peroxidation have been reversed dose-dependently by chronic use of ashwagandha root extract (PO in rats).1855

     +     6) Increased levels of pertussis antibodies were detected after 100 mg/kg of a water extract was given daily for 15 days after receiving a Diphtheria, Pertussis, Tetanus [DPT] vaccine (PO in mice). When immunized animals were challenged on day 14 with intracerebral pertussis, morbidity and mortality were reduced in those that had been treated with the extract.2006

     +     7) A decrease in benzo(a)pyrene-induced lung tumor markers AHH, GGT, and LDH in the serum and lungs by paclitaxel was further decreased when ashwaganha ethanol extract 400 mg/kg once weekly for 4 weeks was added to paclitaxel treatment (PO in mice). Likewise, a further reduction of lung glycoprotein markers was also noted with the combination, compared with use of paclitaxel alone.2218

     +     8) Catalepsy induced by haloperidol was reduced dose-dependently when an ashwagandha water extract was given 30 minutes prior to haloperidol in the acute study and for 6 days prior in the chronic study (PO in mice). The reduction in catalepsy was correlated with superoxide dismutase levels in the brain, indicating that the antioxidant activity of the extract could have contributed to its effect.2295

            9) In 3 digoxin immunoassays, 3 liquid hydroalcoholic extracts were fed to animals, and the serum was tested and produced significant false positive apparent digoxin concentrations (PO in mice). These results were confirmed for digoxin with fluorescence polarization immunoassay but not for carbamazepine, phenytoin, phenobarbital, valproic acid, procainamide, N-acetyl procainamide, theophylline, gentamicin, tobramycin, acetaminophen, or salicylate (in vitro).2665 A 60-65% ethanolic ashwagandha extract increased the digoxin measurement results for the fluorescence polarization immunoassay (in vitro). Using the microparticle enzyme immunoassay, this extract significantly lowered the serum digoxin measurement (in vitro). No effect was found on the measurement done by Tina-quant (in vitro).1995

 

asian GINSENG   [Formerly GINSENG.]                       p. 107

            Panax ginseng root

Contraindications

            1) High blood pressure (empirical, human case report)150,361,404,777  

However, 200 mg of a ginseng extract standardized to 4% ginsensosides reduced diastolic blood pressure 2 hours after ingestion.1298

2) Acute asthma (empirical)404,777,1308

or other inflammation (empirical)1308

3) Acute infections404,777

accompanied by fever (empirical)1308

            4) Excessive menstruation or nose bleeds (empirical)777

due to platelet aggregation inhibition by ginsenoside Rg1 (in vitro)1196 and ginseng lipophilic fraction (in vitro, ex vivo), and prolonged time of fibrinogen conversion to fibrin (ex vivo) following a 25 mg dose of the lipophilic fraction (PO in rats)1194 

However, 10 adults taking a proprietary Asian ginseng product at the manufacturer’s recommended dose for 2 weeks had no increase in coagulation time in ADP and epinephrine assays of intrinsic and extrinsic platelet function, respectively (ex vivo), but the product was not analyzed for its phytochemical content.2262

     +     5) Headaches, palpitations or strong pulse, or insomnia since ginseng can cause these in some people (empirical)1308

     +     6) Anxiety, nervousness or emotional imbalance due to its enhancement of the sympathetic nervous system (speculative),1308 or in those with clinical affective disorders such as major depression who may experience a manic state (PO in human case report)27,560,1461

     +     7) Pregnancy due to possible estrogenic effects (speculative)1308

            Estrogenic activity, especially of alcoholic extracts, may be present in large part due to zearalenone and its metabolites from Fusariam fungal contamination (in vitro).1695

            One study of 88 pregnant women suggested an increase risk of adverse fetal outcome (PO in human study).1509

            Ginsenoside Rb1 at concentrations of 30-50 mcg/ml increased teratogenic effects in whole rat embryos (in vitro),1485 results with uncertain implications for women taking the whole root or complex extracts in typical doses.

     +     8) Brittle type 1 diabetes (speculative)893 because of the hypoglycemic effect in diabetic patients (PO in human clinical study),109 probably due to the glycans of ginseng roots known as panaxans (IP in mice)567-569 and/or ginsenoside Rb2 that lowered blood sugar in diabetics (IP in rats).72

                        However, the anti-hyperglycemic activity was not confirmed as a hypoglycemic effect, since doses ranging from 1 to 9 grams of powdered root in a randomized, multiple-crossover design did not significantly affect plasma glucose or insulin following an oral glucose tolerance test (PO in human study). Rather, the 2-hour plasma glucose was significantly higher in pooled results.1612 Also, effects in 12 nondiabetic subjects on 75-gram oral glucose tolerance test responses to 3 grams of dried root varied according the type of ginseng. The dried whole root was found to raise plasma glucose, whereas Asian-red ginseng steam-treated root had no effect (PO in human study).1713 Compound K, the main gut bacterial metabolite of protopanaxadiols, enhances glucose transport rate, while the major protopanaxatriol Rg1 inhibits glucose transport across intestinal cells (in vitro) These act by modulating the sodium/glucose cotransporter 1 gene expression (in vitro).2043

            An alcoholic extract of the berries at 150 mg/kg daily in diabetics also lowers fasting blood sugar and improves overall glucose tolerance while lowering body weight and plasma cholesterol levels (IP in mice). The antihyperglycemic activity, but not the anti-obesity effect, is due in large part to ginsenoside Re.1705

     +     9) Use at least one week, and definitely in the 24 hours, prior to surgery due to short term potential for hypoglycemia and long term potential for decreased coagulation leading to hemorrhage (speculative).1309,1310 The hypoglycemic effect appears to be due to the glycans of ginseng roots known as panaxans (IP in mice).567-569 Diminished coagulation may be attributed to panaxynol, ginseng lipophilic fraction, and some ginsenosides’s antiplatelet activity (in vitro410,565,1194, 1196 and lipophilic fraction ex vivo1194), and prolonging time of fibrinogen conversion to fibrin by ginsenoside Ro (in vitro)565 and ginseng lipophilic fraction (ex vivo) following a 25 mg dose of the lipophilic fraction (PO in rats),1194 and the potent platelet activating factor antagonism of several ginsenosides (in vitro).718 

However, 10 adults taking a proprietary Asian ginseng product at the manufacturer’s recommended dose for 2 weeks had no increase in coagulation time in ADP and epinephrine assays of intrinsic and extrinsic platelet function, respectively (ex vivo), but the product was not analyzed for its phytochemical content.2262

Drug Interactions

I.          1) Caffeine with large amounts of “ginseng” led to hypertension, nervousness, diarrhea, skin eruptions and insomnia in 14 subjects (PO in human case series).108

Caffeine metabolism by CYP 1A2 was not affected when 1.5 gm of ginseng standardized to 5% ginsensosides was consumed daily for 4 weeks. CYP 2D6, 2E1, and 3A4 were also unaffected (PO in human study).1328

3) Phenelzine produced manic-like symptoms with the use of ginseng (human case reports).26,27

However, the “Natrol High” product that supposedly contained Asian ginseng in one report26 actually contained the generically- and phytochemically-distinct eleuthero or “Siberian ginseng” (Eleutherococcus senticosus) as part of a combination product. Positive identification of ginseng and its causality in the other report was not established. This interaction was still assessed as possible due to the evidence in latter report, while the former was described as unevaluable based upon its inadequate data.1239 

     +     5) When 5.4 gm of red Korean ginseng were taken daily with zidovudine by HIV-1 infected patients for 4-6 years, it effectively maintained their CD4+ T cell counts and delayed development of resistance mutations to zidovudine (PO in human clinical study).1335 In addition to zidovudine, red ginseng use with nucleoside reverse transcriptase inhibitor (NRTI) didanosine lowered resistance mutations, but not for lamivudine, and no multinucleoside drug resistance mutations were detected (PO in human clinical study).1336

     +     6) Following surgical removal of stage III gastric cancer in 42 patients, 4.5 grams daily of red ginseng powder doubled 5-year and overall survival rates and improved CD3 and CD4 levels compared to placebo, while patients were also given chemotherapy with 5-fluorouracil and cisplatin (PO in human clinical study).1382

     +     7) 200 mg daily of the standardized extract G 115 given 4 weeks prior and 8 weeks after a polyvalent influenza vaccine resulted in significantly fewer cases of influenza and the common cold during the 8 weeks following vaccination than in the group receiving placebo. The antibody titers and natural killer cell activity were also much higher in those receiving the extract, along with no significant differences in adverse effects (PO in human clinical study).408

     +     8) 200 mg/day of uncharacterized "ginseng" for 18 days inhibited metabolism of CYP 3A4 substrate nifedipine, as indicated by increased peak plasma concentration of 29% (PO in humans).1728

However, daily doses for 28 days of 1.5 gm Asian ginseng standardized to 5% ginsenosides failed to alter the metabolism of CYP 3A4 substrate midazolam in humans (PO in human study).1328 Likewise, 200 mg/day for 14 days of ginseng extract standardized to 4% ginsenosides failed to alter cortisol metabolism in 20 subjects (PO in human study).1811 

      +    9) A woman treated for major depression with clomipramine and haloperidol became manic with the use of 300 mg/day of a ginseng root extract (PO in human case report).1461

Clomipramine is a substrates for CYP 2D6, while haloperidol is a substrate for CYP 3A4. A daily dose of 1.5 grams of an Asian ginseng product standardized to 5% ginsenosides inhibited metabolism of the substrate debrisoquin CYP 2D6 by 7% and an uncharacteried product inhibited CYP 3A4 as shown by increasing the peak plasma concentration of substrate nifedipine by 29% (PO in human studies),1728,1808 though standardized ginseng extracts with other 3A4 substrates showed no altered bioavailability (PO in human studies).1328,1811

            10) [Previously III.2.] Warfarin anticoagulant activity was reduced as the INR fell from 3.1 to 1.4 following several weeks of taking ginseng extract G 115 capsules 3 times daily (PO in speculative human case report). Two weeks after the extract was discontinued, the INR returned to 3.3.110

Nonetheless, in a diabetic man with aortic valve prosthesis, a thrombus interfered with the artificial leaflets valve in conjunction with a reduction of INR to 1.4 in spite of increasing warfarin dosage, following use of an undisclosed commercial ginseng product used at an unreported dose for an indefinite time (PO in human case report).1986

However, a study of 25 ischemic stroke patients given warfarin with or without 1.5 grams/day of an 11:1 aqueous ginseng extract for 2 weeks did not result in any differences in INR or prothrombin time between the two groups (PO in human clinical study).2326 When 1 gram solid Korean red ginseng aqueous extract daily was given for 6 weeks to patients using warfarin, there were no significant changes in INR after 3 or 6 weeks, compared to placebo (PO in human clinical trial).2625 Furthermore, an open-label 3-way crossover randomized trial with 12 healthy subjects found that ginseng extract daily providing 53.6 mg ginsenosides derived from 3 grams of the root given 7 days before and after a single warfarin dose does not affect warfarin clearance, INR, or platelet aggregation (PO in human study).1578 In this study the apparent clearance was increased by 14%, but this seems unlikely to have clinical significance (speculative).2016

     +     11) A randomized, double-blind, crossover trial using Korean ginseng rootlets in capsules at doses of 2 grams 3 times daily before meals for 12 weeks in 19 patients with well-controlled diabetes type 2 treated with diet plus hypoglycemic drugs alone or in combination in 14, including sulfonylurea in 10, metformin in 9, rosiglitazone in 2, and acarbose in 1; this resulted in reduction in oral glucose tolerance test indices by 8-11% and plasma insulin by 33-38% (PO in human clinical study). It also increased insulin sensitivity indices by 33% compared to placebo. The rootlets had total ginsenoside concentration of 1.92% with content of protopanaxadiols Rb1 0.48%, Rc 0.29%, and Rb2 0.25%, along with protopanaxatriols Rg1 0.51% and Rf 0.23%.2042 

Ginseng extract’s anti-hyperglycemic effect was shown in non-insulin-dependent diabetic patients when 200 mg daily was given orally for 8 weeks (PO in human clinical study).109 Ginseng extract G115 at single doses of 200 mg and 400 mg reduced fasting blood glucose levels in 30 healthy young adults after 60, 90 and 120 minutes (PO in human study).2153

However, the anti-hyperglycemic activity was not confirmed as a hypoglycemic effect in healthy subjects, since doses ranging from 1 to 9 grams of powdered root in a randomized, multiple-crossover design did not significantly affect plasma glucose or insulin following an oral glucose tolerance test (PO in human study). Rather, the 2-hour plasma glucose was significantly higher in pooled results.1612 When given with a 25-gram glucose drink to 27 healthy subjects, 200 mg of G115 actually raised blood sugar levels after 1 hour but had no effect after 2 hours, compared to controls (PO in human study).2153 Also, effects on 75-gram oral glucose tolerance test responses in 12 nondiabetic subjects given 3 grams of dried root varied according the type of ginseng. The dried whole root was found to raise plasma glucose, whereas Asian-red ginseng steam-treated root had no effect (PO in human study).1713 Compound K, the main gut bacterial metabolite of protopanaxadiols, enhances glucose transport rate, while the major protopanaxatriol Rg1 inhibits glucose transport across intestinal cells (in vitro) These act by modulating the sodium/glucose cotransporter 1 gene expression (in vitro).2043

II.  +     3) Extract G115 increased intestinal clearance of the active metabolite albendazole sulfoxide (IV in rats)1711

     +     4) An acidic polysaccharide fraction of red ginseng, derived from the marc following 85% ethanol extraction, combined with paclitaxel increased life span with transplanted sarcoma 180 by 29-43% at 25 mg/kg and reduced B16 melanoma tumor weight by 76% at 100 mg/kg, compared to the results from using paclitaxel alone (IP in mice)1721

       +   5) The use of the 5 grams/day of the root as a decoction for 30 days along with doxorubicin (adriamycin) given by intraperitoneal injection over a 2-week period reduced the physical and biochemical signs of heart failure associated with the drug (PO in rats).2257

III. +    1) Insulin dosage may need adjusting (speculative) because of ginseng extract’s hypoglycemic effect in diabetic patients (PO in human clinical study).109

                Effects in 12 nondiabetic subjects on 75-gram oral glucose tolerance test responses to 3 grams of dried root varied according the type of ginseng and the protopanaxadiol to protopanaxatriol ratio. The dried whole root was found to raise plasma glucose, whereas Asian-red ginseng steam-treated root had no effect (PO in human study). The Asian-red protopanaxadiol content and ratio were greater.1713

            A randomized study found that while 6 grams Korean red ginseng root body and water extract were ineffective in reducing glycemia from a 50-gram glucose tolerance test, the rootlets were effective (PO in human study). A dose of 2 grams of rootlets was found to be equally effective, and the ginsenoside Rb1 was identified as the sole predictor of effects on postprandial glucose.1977

                        However, another study with 27 young healthy subjects showed that the extract G115 at single 200 mg doses lowered fasting blood sugar from 60-120 minutes compared to placebo, but when given with a drink containing 25 grams of glucose it raised blood glucose levels more than when glucose was given alone (PO in human study).2018

            An ethanolic extract of ginseng berries that differed in ginsenoside proportions had an even greater anti-hyperglycemic and anti-obesity effects than the root extract (IP in mice).1597 The alcoholic extract of the berries at 150 mg/kg daily in diabetics also lowers fasting blood sugar and improves overall glucose tolerance while lowering body weight and plasma cholesterol levels (IP in mice). The antihyperglycemic activity, but not the anti-obesity effect, is due in large part to ginsenoside Re.1705

2) [See IV. 2)]

     +     The synergistic cytotoxic effect of the chemotherapy drug mitomycin C combined with ginseng component panaxytriol was shown on gastric carcinoma MK-1 cells (in vitro).1712

3) [Formerly IV. 1)] Using 5 digoxin immunoassays on 2 liquid Asian ginseng extracts and 1 capsule, one liquid increased the digoxin concentration results only for the fluorescence polarization immunoassay (in vitro, ex vivo with rats, ex vivo with humans). Using the microparticle enzyme immunoassay, the liquid extract significantly lowered the serum digoxin measurement (ex vivo with humans).1352,1995 

IV.       1) [See III. 3]

 

ASPARAGUS                                                                       p. 34

            Asparagus racemosus root

Drug Interactions

II.  +     1) Increased levels of pertussis antibodies were detected after 100 mg/kg of a water extract was given daily for 15 days after receiving a Diphtheria, Pertussis, Tetanus [DPT] vaccine (PO in mice). When immunized animals were challenged on day 14 with intracerebral pertussis, morbidity and mortality were reduced in those that had been treated with the extract.2006

 

ASTRAGALUS                                                                    p. 34

            Astragalus membranaceus root

Contraindications

     +     2) Allergic hypersensitiviy or autoimmune conditions, since they may be aggravated due to immunostimulating polysaccharides (speculative).409

     +     3) Following organ transplantation due to immunostimulating polysaccharides (speculative).409

Drug Interactions

I.          1) The effects of recombinant interferon-a1 were therapeutically enhanced with an astragalus preparation that improved the outcome in chronic viral cervicitis associated with human papillomavirus type 16 and herpes simplex virus type 2 (human clinical study).2359

     +     2) A meta-analysis compiled 34 randomized trials that combined astragalus herbal formulas with chemotherapy regimens based on cisplatin for non-small-cell lung cancer in 2,815 patients. The data showed that chemotherapy plus oral astragalus formulas such as Jin Fu Kang, or Ai Di Zhu She Ye injections containing astragalus used 8 studies, improved outcomes versus chemotherapy alone (PO or IV in human clinical studies). Seven studies (529 patients) showed reduced risk of death after 6 months, twelve (940 patients) after 12 months, nine (768 patients) after 24 months, and six (556 patients) after 36 months. One of the studies reducing this risk from 12-36 months used astragalus alone, rather than in a formula. Tumor response rate favored the combination with herbs in 29 of 30 studies reporting this data, including two with astragalus alone. Karnofsky performance status was stabilized or improved in one study with astragalus alone, two studies with Jin Fu Kang, four studies with Ai Di Zhu She Ye, and five studies with other astragalus formulas, totaling 1,095 patients.1851 Astragalus decoction enhanced immune function by increasing proliferation of spleen cells, increasing B cell IgG production, enhanced induction of cytoxic T cells, and increased macrophage cytokine production of IL-6 and TNF (in vitro).1852

II.         2) The hydroalcoholic extract induced Th cells and enhanced antibody response following use of cyclophosphamide (IP in mice).599

A partially purified fraction completely reversed immunosuppression induced by cyclophosphamide (IV in rats).1504

Another fraction of the water extract of the roots was shown after 6 days to increase proliferation of colony-forming unit-fibroblast proliferation and improve bone marrow stromal cell survival, its production of IL-6, and expression of mRNA and bcl-2 protein, which helps promote blood cell formation after cyclophosphamide myelosuppression (IP in mice).2212

            So, if cyclophosphamide is being used for treatment of lymphomas or leukemias or to prevent graft rejection, concurrent use of astragalus could have an undesirable antagonistic effect to the immunosuppression.

 

BACOPA                                                                               new

     ^     Bacopa monniera = Herpestis monniera whole plant

            (Brahmi; Ind.: Brahmi Patra)

Drug Interactions

II.         1) Both cold aqueous infusion and 95% alcoholic extract potentiated sleep induced by pentobarbital, though the water extract was much more active (IP in rats)1291

            2) Dried alcoholic extract at 40 mg/kg prevented increased lipid peroxidation and decreased antioxidant enzymes in liver caused by morphine when the two were given concurrently (PO in rats).1661 In addition, prior exposure of intestinal ileum to the alcoholic extract before exposure to morphine reduced the subsequent naloxone-induced contraction of the ileal tissue (in vitro), suggesting a possible use in reducing morphine withdrawal symptoms.1662

            3) After using phenytoin for 7 days cognitive deficit demonstrated in a passive avoidance task was reversed by 40 mg/kg dried alcoholic extract given concurrently for the next 7 days (PO in mice), suggesting possible use to prevent this adverse drug effect. Acquisition and retention of memory were also improved, and phenytoin's anticonvulsant activity was not affected.1663

 

BARBERRY                                                                                     p. 35

            *Berberis vulgaris root bark

Contraindications

     +     9) Do not use in nursing mothers without professional advice (speculative), since berberine is passed through the breast milk to the infant1890 and displacement by berberine of bilirubin from serum albumen which may lead to kernicterus (IP in rats).1092

Drug Interactions

I.   +     3) Berberine 1.2 grams daily, given as tablets to 79 congestive heart failure patients on ACE inhibitors along with digoxin in 76, nitrates in 71, and diuretics / spironolactone in 77, significantly increased left ventricular ejection fraction and exercise capacity, improved dyspnea-fatigue index, and reduced frequency of ventricular premature complexes compared with 77 patients using only comparable conventional medications. The mortality of the berberine group decreased significantly as well, and there were no apparent side effects (PO in human clinical study).1457 In 56 congestive heart failure patients on loop diuretics and ACE inhibitors, including 51 using digoxin and 46 on nitrates, the significant increases in left ventricular ejection fraction and decreases in ventricular premature beats from baseline from 1.2 grams of berberine daily was also significant better when plasma berberine concentrations were higher versus lower than 0.11 mg/L (PO in human clinical study).2639

     +     4) Berberine at 0.6 grams daily for 3 months increased previously stabilized cyclosporin A trough blood concentrations by 90% in 52 renal transplant patients, and when given for 12 days to 6 transplant patients increased the cyclosporine bioavailability by 35% (PO in human clinical study), likely by inhibition of CYP 3A4 (speculative).2281

     +     5)  The combination of 500 mg berberine 3 times daily for 3 months in 43 patients with poorly-controlled type 2 diabetes together with one or more of their regular oral hypoglycemic medications including sulfonylureas in 28, metformin in 20 acarbose in 15, and/or insulin in 10 resulted in lower fasting and postprandial blood sugar from week 1 through week 12 (PO in human clinical study). Fasting plasma insulin was also lowered by 28% and an index of insulin resistance by 45% of those on medications, while total cholesterol and LDL were likewise reduced. In 31 newly diagnosed type 2 diabetics to whom 15 were given the same dose of berberine and 16 used 500 mg metformin 3 times daily, berberine’s hypoglycemic effect was similar to that of metformin on fasting and postprandial blood glucose, as well as reducing glycosylated hemoglobin and plasma triglycerides (PO in human clinical study). Transient gastrointestinal adverse effects were experienced by 35% of the patients, or 20 in total.2315

II.         1) The antitumor constituent berbamine (20 mg/kg once daily for 7 days) significantly enhanced antitumor activity of cyclophosphamide against Walker tumor (IP in rats).398

When the alkaloid component berberine was given once or twice at doses of 50, 100, or 200 mg/kg before cyclophosphamide injection, it significantly reduced the chemotherapy adverse effect of bladder hemorrhage in a dose-dependent manner (IP in rats).2570 

2) Berberine administered prior to pentobarbital increased the induced sleeping time (IP in mice)1032

A single 4 mg/kg dose of berberine prolonged pentobarbital sleeping time and increased strychnine toxicity (PO in rats)1215

      +     3) Pre-treatment with 4 mg/kg berberine prevented a rise in serum levels of liver enzymes from excessive acetaminophen, suggesting protection from its toxic effects (PO in rats). Use of this dose three times every six hours following a toxic dose of acetominophen reduced liver damage.1215

     +     4) Berberine at 100 mg/kg enhanced the anxiolytic effects of buspirone and ritanserin but did not interact with diazepine (PO in mice).2668

III.       3) Berberine increased efflux of rhodamine 123 and paclitaxel by inducing P-glycoprotein and thereby reducing the retention and concentration of these drugs in human hepatoma and digestive tract cancer cells, respectively (in vitro)1045,1046

     +     4) Studies in human liver-derived cells with berberine was found to have an additive effect with lovastatin by increasing LDL receptor mRNA expression (in vitro). This statin did not reduce this effect of berberine, indicating a different mechanism of action (in vitro). In 63 high-cholesterol subjects taking 1.0 grams berberine HCl daily for 3 months, serum cholesterol was reduced 18%, LDL cholestreol 20%, and triglycerides 28%, compared to those using placebo (PO in human study). In the 32 who were taking no other medication or herbs, cholesterol was reduced 29%, LDL cholesterol 25%, and triglycerides 35%. HDL cholesterol was unaffected, and berberine was well tolerated. Berberine was found to have a dose-dependent cholesterol-lowering effect (in hamsters).1656 

    +      5) Do not combine with phenylbutazone or other drugs that displace protein binding of bilirubin (speculative),1890 since displacement by berberine of bilirubin from serum albumen which can lead to kernicterus (IP in rats).1092

 

BASIL                                                                                    p. 37

            Ocimum basilicum plant

Drug Interactions

III.   +  1) Alkaline aqueous extracts of basil were shown to potentiate insulin activity in glucose metabolism (in vitro).1464

 

BEEBALM                                                                            NEW

     ^      Monarda spp. plant

(Oswego tea, mountain balm/ wild begamot; horsemint; spotted beebalm)

Contraindications

            1) Pregnancy due to the emmenagogue and uterine stimulant activity (empirical)150

                                                 

BETH ROOT                                                                                    NEW

^          Trillium erectum root

            (birth root, purple trillium, wakerobin)

Contraindications

            1) Pregnancy due to emmenagogue activity (empirical)150

            2) Stomach or intestinal irritation due to its irritant properties (empirical)150

 

BILBERRY                                                                           p. 38

            Vaccinium myrtillus fruit

Drug Interactions

II.         1) CORRECTION: anti-ulcer activity demonstrated by its 25% ANTHOCYANIDIN extract was shown by one of its aglycone components (PO in rats).624

III.       1) Warfarin and antiplatelet drugs may be enhanced at high doses (speculative).777,1890

            CORRECTION: The prostaglandin modulation by the anthocyanosides enhances antiaggregatory processes (in vitro;1084,1086 EX VIVO AFTER PO in rats,684,1086). A daily dose of 480 mg of an extract containing anthocyanosides (equivalent to 120 mg daily of anthocyanidins) led to decreased platelet aggregation after 30 days that decreased further after 60 days (EX VIVO AFTER PO in humans).1085

On the other hand bilberry anthocyanins tended to reduce retinal hemorrhage due to anticoagulant therapy (in humans) and the extract reduced post-surgical bleeding complications (empirical).1316

BIRCH                                                                                   p. 38

            Betula pendula = Betula alba leaves or bark

Drug Interactions

I.    +    1) Warfarin potentiation was determined with 11 patients who concurrently used ointment containing methyl salicylate, the primary component of birch bark oil. All of the patients had unusually high INRs after extensive topical use of the ointment, based on patient history and salicylate blood levels. One had GI bleeding, 2 were bruising, and 3 had other bleeding events (topically in human case reports).1392 Several other cases with the same etiology resulted in significant bleeding problems requiring plasma infusion or temporary cessation of warfarin intake in 2 cases. A similar case with simply an elevated INR of 12.2 occurred after applying a low-dose methyl salicylate gel to both knees for 8 days (topically in human case reports).714,1393,1394 Another case of local application to arthritic knees for two weeks increased the INR to 6.1 and resulted in multiple bruising.1426 Still another warfarin case had bleeding and a doubled prothrombin time after using large amounts of methyl salicylate over arthritic joints (topical in case reports).1427 The methyl salicylate may affect vitamin K metabolism or displace warfarin from protein binding sites (speculative).1394

 

BITTER MELON                                                                p. 39

            Momordica charantia fruit and its juice

Contraindications

     +     2) Brittle type 1 diabetes (speculative)893 due to hypoglycemic effects in normal and diabetic animals (PO in rats)746-749 and in healthy and diabetic humans when using the cooked fruit, juice or extract (PO in human studies)34,35,745

Drug Interactions

II.  +     1) A combination of 500 mg/kg daily each of bitter melon dried juice and an Ayurvedic preparation of zinc (Jasad Bhasma) reduced fasting blood sugar and increased the hypoglycemic effect of 250 and 500 mg/kg tolbutamide (PO in rabbits)1544

However, in a study with type 2 diabetics using oral hypoglycemic drugs who were given 2 capsules of fruit and seed extract 3 times daily, no change in glycosylated hemoglobin or fasting blood sugar was seen after 3 months when compared to placebo (PO in human clinical study).2275

 

BITTER ORANGE                                                              p. 40

            Citrus aurantium fruit, peel, or juice

            (Port.: laranja-amarga, laranja-azeda, laranja-cavalo; Ch.: zhi shi; Jap.: kijitsu; Kor.: chisil)

Contraindications

     +     4) Avoid juice in severe high blood pressure, rapid heart rate, and narrow-angle glaucoma due to its content of the adrenergic synephrine (speculative).1421 A single 900 mg dose of a dried fruit extract standardized to 6% synephrine significantly raised systolic and diastolic blood pressures and heart rate (PO in human study).1867

However, in other tests with the dried fruit extract standardized to 6% synephrine, a single dose of 450 mg did not raise blood pressure (PO in human study).1866 Also, 8 oz. did not affect blood pressure or heart rate in normal subjects (PO in human study)1421

Drug Interactions

I.          1) The juice consumed by 11 subjects at a dose of 200 ml increased dextromethorphan bioavailability both by inhibiting intestinal CYP 3A and affecting an intestinal transport protein (PO in human study).2666

II.   +    1) Essential oil from the peel at 0.5-1.0 gm/kg increased the sleeping time induced by pentobarbital (PO in mice).1626

      +    2) In a crossover study 200 ml of decoction of 20 gm of the fruit increased the maximum concentration of cyclosporine by 64% and resulted in acute toxicity in 1 of 5 subjects (PO in swine).2028 Enhanced absorption of cyclosporine may occur due to the inhibition of CYP 3A4, as shown by a 40% reduction following consumption of 8 oz. of the juice (PO in human study).1031

However, an uncharacterized bitter orange product lacking the CYP3A4-inducing compound 6,7-dihydroxybergamottin failed to alter bioavailability of 3A4 substrate midazolam in 12 subjects after 4 weeks (PO in human study).1589

III. +    1) Use of the juice with monoamine oxidase inhibitors (MAOIs) should be avoided (speculative) due to its content of the synephrine (speculative), even though 8 oz. did not cause adrenergic cardiovascular effects in normal subjects (PO in human study)1421

     +     2) Use of the juice with drug substrates of CYP3A4 may lead to their enhanced absorption due to the reduction of this isozyme by 40% following consumption of 8 oz. of the juice (PO in human study).1031

However, an uncharacterized bitter orange product lacking the CYP 3A4-inducing compound 6,7-dihydroxybergamottin failed to alter bioavailability of 3A4 substrate midazolam in 12 subjects after 4 weeks (PO in human study).1589

     +     3) Consumption of the juice with decongestant cold preparations (presumably containing pseudoephedrine, an alkaloid similar to synephrine in the juice) should be avoided (speculative).1421

 

BLACK CHERRY [formerly WILD CHERRY]                p. 198

Ä         *Prunus serotina bark

 

BLACK COHOSH                                                               p. 40

            *Actaea racemosa  = Cimicifuga racemosa roots/rhizome

Contraindications

1) Avoid in pregnancy during the first trimester2

due to its emmenagogue possible uterine stimulating effect (speculative).2141

However, only low-level evidence is available that indicates the need to use it with caution and rigorous high-quality studies with humans are needed to better determine its safety in pregnancy.2141

            2) Black cohosh preparations are inappropriate for use with nursing mothers150,777,1890

due to its possible hormonal effects (speculative).2141

However, only low-level evidence is available that indicates the need to use it with caution and rigorous high-quality studies with humans are needed to better determine its safety in lactation.2141

3) Estrogen-dependent tumors including some breast cancer due to potential estrogenic activity (speculative).777

However, black cohosh and its ethanolic and isopropenolic extracts were found to significantly reduce breast cancer risk a case-control study involving 949 breast cancer cases and 1524 controls, whether cancers were of estrogen receptor-postitive or -negative status (PO in human study).2114 In 61 menopausal women taking 80 mg daily of black cohosh extract containing 2.4% 23-epi-27-deoxyactein, including 45 who used the extract the full 24 weeks, no significant effect on estrogenic markers in the serum or on cellular mophology in nipple aspirate fluid was detected (PO in human clinical study).2494 In addition, animals with transplanted breast cancer and with their ovaries removed were given either synthetic estrogen (mestranol) positive control, two different doses of an isopropanolic extract of black cohosh, or the vehicle negative control daily for 6 weeks. Only those receiving mestranol had enhanced cancer growth at the end of the study (PO in rats).1383

Also, the isopropanolic extract inhibited cell proliferation in a human breast adenocarcinoma test system (MCF-7) and inhibited estrogen-induced growth of this system (in vitro).1384 The liquid ethanolic extract failed to induce proliferation of the MCF-7 human breast cancer cell line or transactivation of either human alpha- or beta-receptor (in vitro) or increased uterine weight after 4 days (PO in mice).1664 Both the isopropanolic and ethanolic extracts were shown to dose-dependently inhibit growth and induce apoptosis of both estrogen receptor-positive MCF-7 and estrogen receptor-negative MDA-MB231 breast cancer cells (in vitro). The effective concentrations were lower for the isopropanolic extract.1719 Unlike tamoxifen that stimulates estrogen endometrial adenocarcinoma tumor growth, the isopropanolic extract did not increase this growth or metastasis to lymph nodes or lungs in rats when given alone or combined with tamoxifen (PO in rats).1697 Black cohosh as a 40% 2-propanol extract binds to serotonin receptors of the hypothalamus (in vitro), which, rather than any estrogenic activity, may explain its reduction of hot flashes (speculative).2031 The black cohosh 40% isopropanolic extract at 40 mg per day for 12 weeks was shown to have no effect on estrogen concentrations or luteinizing hormone [LH] pulsatility in postmenopausal women (PO in human clinical study). Nonetheless, with naloxone blockade it did suppress LH pulsatility especially during sleep, and its m-opioid receptor binding ranged from 10-61% across brain regions involved with emotional and cognitive functioning.2495

     +     4) Signs or symptoms indicative of liver dysfunction such as tiredness, loss of appetite, yellowing of skin or eyes, dark urine, or severe upper stomach pain with nausea and vomiting after using black cohosh products are reasons for its discontinuation and avoidance in these individuals (empirical), due to its association with nearly 3 dozen hepatotoxicity cases in Europe plus 8 published case reports.1901

Fulminant liver failure in two women in their 50s followed use of 500-1000 mg/day of black cohosh root for 5-8 months (PO in human case reports). Both had high bilirubin, aminotransferases, Alk Phos, and INR, when other probable causes were screened out.1902,1903 One of the women drank 2 glasses of wine daily as a probable contributing factor; she had fatigue, weight loss, and upper right abdominal tenderness. Two weeks after her exam she developed encephalopathy and died from hemorrhage during transplantation surgery on day 39. Both autoimmune and drug-induced liver damage were deemed probable after analysis.1902 The other had jaundice, dark urine and light stools; 1 week after prednisone treatment for possible autoimmune hepatitis, her aminotransferase levels improved but INR increased. She developed encephalopathy from the acute hepatitis and underwent a successful liver transplantation. Temporal association with long-term black cohosh use prior to this acute episode was the only evidence implicating it as a causative factor.1903

A 57 year-old woman taking 6 other medications for over 2 years used black cohosh tablets of unknown brand or dose for 1 week prior to developing fatigue and lethargy; she saw a doctor 2 weeks later (PO in human case report).Her anti-nuclear antibody titer and liver biopsy suggested autoimmune hepatitis. Symptoms resolved in two weeks after withdrawing black cohosh and tapering steroids. Liver function tests were normal at nine weeks. After 4 months symptoms and signs recurred, but steroid treatment had rapid success.1909

However, problems with these reports include a lack of analytical verification of the product contents, insufficient exclusion of other potential causes, and an implausible proposed mechanism.1905,1906 An assessment by the European Medicines Agency concluded that, of 42 patients suspected of severe hepatotoxicity related to black cohosh use, only 16 were sufficiently documented and in only 4 ot these was the causality possible or probable.1901 A diagnostic algorithm applied to these 4 patients that utilized conventional causality assessment factors allowed an objective analysis of the data to show that 1 patient was not assessable and the other 3 were unrelated to drug use, including black cohosh. In 2 cases the steroid therapy possibly augmented the hepatotoxicity that was finally established as herpetic hepatitis, leading to transplantation is both cases and the death of one.2490 The steroid therapy employed in these cases was effective only in one that was finally diagnosed as autoimmune hepatitis.1909 In a 12-month study of 22 peri- or postmenopausal women using a 128 mg daily of a dry extract made with a 75% ethanol solvent and standardized to7.3 mg triterpene glycosides, no elevation of liver function tests for ALP, ALT, or AST showed significant elevation compaired to 22 similar women in the placebo group. (PO in human clinical study).2596

Other cases associated with hepatotoxic effects did not document such high or prolonged dosage. A 47 year-old woman who used a black cohosh product for one week developed jaundice and elevated aminotransferases, but fibrosis from her liver biopsy is indicative of months of hepatotoxin exposure. She required a liver transplant after two weeks (PO in human case report). Another hepatotoxicity case with a 43-year-old woman involved use of a multi-herb preparation (skullcap, valerian, black cohosh, passionflower, dong quai, hops, oat, chasteberry) with potential adulterants (PO in human case report).1904 Hepatotoxicity associated with black cohosh fluid extract in a 52-year-old women with jaundice from acute liver failure showed low serum albumin and high serum bilirubin, Alk Phos, ALT, and GGT, along with an elevated INR of 3.0. She had taken a mixture of fluid extracts for 3 months but had ceased their use 4 weeks prior. A week after examiniation she developed hepatic encephalopathy and herpato-renal failure, requiring a liver transplantation.1908

However, in the latter case the 200 ml bottles containing the combination of 1:1 fluid extracts that she used had 80 ml of ground ivy (Nepeta hederacea) but only 20 ml of black cohosh.1907 The ground ivy’s pulegone, a well recognized hepatotoxin, was the most likely cause of liver failure in this case.1908 In a review of the total 69 known distinct hepatotoxicity cases from the European Medicines Agency [36 cases], other published case reports [11 cases], and others reported in a USP study [22 cases], an updated structured quantitiative scale for causality found that 68 had an excluded, unlikely, unrelated, or unassessable causality for black cohosh; the only 1 possibly case with causality was complicated by multiple confounding factors (case series review).2597 

5) A group of infertile women receiving the fertility drug clomiphene citrate were divided into 60 who also recieved 120 mg per day of black cohosh extract BNO 1055 for 12 days and 59 who did not prior to HCG injection and timed intercourse (PO in human clinical study). Those receiving the extract had higher estrodiol and LH concentrations and significantly higher serum progesterone, endometrial thickness and pregnancy rate.2704 In a similar study with 134 fertility patients, the half who received the same dosage of extract had significantly more rapid follicular maturation, thicker endometrium, and higher estradiol concentration at the time of the HCG injection, and a higher luteal-phase progesterone level compared the the half who instead received 100 mcg ethinyl estradiol for 12 days  (PO in human clinical study). While clinical pregnancy rates were not significantly different, the extract group did have a higher rate [14% versuse 21%].2705

Drug Interactions

I.   +     1) Use of 50 mg black cohosh extract daily along with 150 mg of soy extract containing 40% isoflavones (60 mg daily) and 100 mg dong quai extract daily for 24 weeks by 49 menstrual migraine patients significantly reduced the number of doses of triptans and analgesics after 20-24 weeks compared to placebo (PO in human clinical study)1422

     +     2) Solid black cohosh extract obtained with 58% ethanol (CR BNO 1055), corresponding to 20 mg of the root, was given by randomization for one year with 20 mg tamoxifen in daily oral doses with premenopausal breast cancer survivors (PO in human clinical study). About 74% of those using only tamoxifen had severe hot flushes, compared with only 24% of those combining it with the extract. Nearly half of the tamoxifen plus extract group were free of hot flushes, the most frequent adverse effect of tamoxifen.1655 Alone, both the hydroethanolic and hydropropanolic extracts of the rhizome inhibited cell proliferation in a human breast adenocarcinoma test system (MCF-7) and inhibited estrogen-induced growth of this system (in vitro).1384,1556 The isopropanolic extract alone significantly inhibited estrogen-deprived cell growth and with tamoxifen further enhanced inhibition of the breast adenocarcinoma proliferation (in vitro).1384 Unlike tamoxifen that stimulates estrogen endometrial adenocarcinoma tumor growth, the isopropanolic extract did not increase this growth or metastasis to lymph nodes or lungs in rats when given alone or combined with tamoxifen (PO in rats).1697  Black cohosh as a 40% 2-propanol extract binds to serotonin receptors of the hypothalamus (in vitro), which, rather than any estrogenic activity, may explain its reduction of hot flashes (speculative).2031  

When tested for estrogen-dependent gene transcription in two types of estrogen alpha-receptor cells, the isopropanolic extract was shown to be both non-estrogenic and anti-estrogenic (in vitro). The ethanolic extract activity differed in terms of active extract concentration, and in one of the alpha-receptor cell assays the ethanolic extract, though non-estrogenic, was not anti-estrogenic (in vitro).1556

III.       1) [FORMER: See IV. 1) ]

     +     Increased cytotoxicity of doxorubicin was noted only when EMT6 nonestrogen-dependent mouse breast cancer cells were exposed to a concentration representing 2.5 times or more of the recommended dose of a commercial 50% ethanolic liquid extract standardized to 3% triterpene glycosides (in vitro). Two different commercial hydroalcoholic liquid extracts had similar, though less potent, cytotoxicity-enhancing effects after exposure to the 3 extracts at 100 times the concentration expected from the recommended black cohosh extract dose (in vitro). At this high concentration a less potent effect of enhancing doxetaxel cytoxicity was found with the initial extract, while the same extract and dose reduced the cytoxicity of cisplatin (in vitro). No interactive effects were found with 4-hydroperoxy-cyclophosphamide or radiation even at the high extract dose (in vitro).1736

IV.       [formerly III. 1) ] 1) Estrogen replacement therapy may lead to estrogen excess due to phytoestrogen content of black cohosh (speculative)893

However, when the 40% isopropanolic extract given to perimenopausal and postmenopausal women in daily doses derived from 39 mg or 127.3 mg of the dried root were used to assess estrogenic activity, the lack of changes in vaginal cells indicated a nonestrogenic effect. Likewise, no significant changes in serum hormone levels relevant to sexual function were noted (PO in human study).1558 A dried 58% aqueous/ethanolic extract in daily doses corresponding to 40 mg of the rhizome was compared to 0.6 mg of conjugated estrogens and placebo in a study with 62 menopausal women. The extract was as beneficial as the estrogens for menopausal symptoms and on serum markers of bone metabolism. While the estrogens and extract increased vaginal cell growth similarly, only the estrogens increased uterine endometrial thickness. Black cohosh hydroalcoholic extract therefore has demonstrated selective estrogen receptor modulator (SERM) activity for bones and the vagina without affecting the uterus (PO in human study).1559 Black cohosh contains SERM compounds that primarily interact with the estrogen beta-receptors and affect hypothalamus, bone, liver, brain, and arteries, but the components did not interact with estrogen alpha-receptors of the uterus (in rats).1557 The liquid ethanolic extract failed to induce proliferation of the MCF-7 human breast cancer cell line or transactivation of either human alpha- or beta-receptor (in vitro) or increased uterine weight after 4 days (PO in mice).1664 When tested for estrogen-dependent gene transcription in two types of estrogen alpha-receptor cells, the isopropanolic extract was shown to be both non-estrogenic and anti-estrogenic (in vitro). The ethanolic extract activity differed in terms of active extract concentration, and in one of the alpha-receptor cell assays the ethanolic extract, though non-estrogenic, was not anti-estrogenic (in vitro).1556 Black cohosh as a 40% 2-propanol extract binds to serotonin receptors of the hypothalamus (in vitro), which, rather than any estrogenic activity, may explain its reduction of hot flashes (speculative).2031 The black cohosh 40% isopropanolic extract at 40 mg per day for 12 weeks was shown to have no effect on estrogen concentrations or luteinizing hormone [LH] pulsatility in postmenopausal women (PO in human clinical study). Nonetheless, with naloxone blockade it did suppress LH pulsatility especially during sleep, and its m-opioid receptor binding ranged from 10-61% across brain regions involved with emotional and cognitive functioning.2495    

 

BLACK CUMIN                                                                  NEW

^          Nigella sativa seed

Drug Interactions

I.          1) Chemical war victims from inhalation of mustard gas reliant on inhaled and oral salbutamol and corticosteroids required less of these drugs except for the inhaled corticosteroids after 2 months of taking an aqueous extract of black cumin than controls who did not, yet the respiratory symptoms/wheezing and pulmonary function of those using the black cumin extract was still significantly better than controls (PO in human clinical study).2489

II.         1) Nephrotoxicity from cisplatin was ameliorated by the main active seed oil component thymoquinone when it was given 5 days before and after the chemotherapy drug at 4 and 8 mg/kg daily (PO in rats and mice, respectively). The antitumor activity of cisplatin for Ehrlich ascites carcinoma was enhance by thymoquinone at 8 mg/kg daily (PO in mice).2615

 

BLACK CURRANT                                                                        NEW

^          Ribes nigrum seed oil

[Due to their content of gamma linolenic acid (GLA), the oil from black currant seeds is similar in activity to borage seed oil and evening primrose oil. See EVENING PRIMROSE.]

Drug Interactions

I.          1) Rheumatoid arthritis patients using corticosteroids &/or NSAIDs added 10.5 gm black currant seed oil containing 2 gm GLA (20 subjects) or placebo soybean oil (14 subjects) for 6 months. Those treated at the end had significantly improved joint tenderness count and tenderness score with no adverse effects; 2 cases of nausea occurred in the placebo group. Four patients in the treatment group and 11 receiving placebo were also maintained on steady doses of second-line anti-rheumatic drugs, particularly methotrexate, hydroxychloroquine, or gold salts (PO in human clinical study).1399

            2) Faster clinical response to tamoxifen was achieved when gamma linolenic acid as found in black currant seed oil was given to 38 patients with estrogen-dependent breast cancer (PO in human clinical study).589

III.       1) Due to a decrease in plasma heparin-neutralizing activity and platelet aggregation inhibition associated with prostaglandin PGE1 that is formed from metabolism of dihomo-gamma-linolenic acid (PO in human study),681,693 a component formed from GLA in black currant seed oil, heparin may be potentiated (speculation)

 

BLACK PEPPER                                                                p. 41

            Piper nigrum fruit

Drug Interactions

I.          1) Phenytoin was more rapidly and more completely absorbed and eliminated more slowly in 5 males when taken with 20 mg of the component piperine (PO in human study).205

            A single 20 mg dose of piperine in 2 groups of 10 men receiving 300 mg or 400 mg daily of phenytoin increased mean plasma drug concentration and bioavailability (PO in human study).1943

     +     4) Piperine dose of 20 mg increased serum concentrations of curcumin after 0.25-1.0 hours and increased bioavailability by 2000% (PO in human study).1533 

            Piperine content of black pepper ranges from about 5-7%.1586

II.  +     5) Increased anti-nociceptive and anti-inflammatory activity from nimesulide was achieved when 100 mg was combined with 60 mg piperine from black pepper (PO in mice). This was apparently due to reduced metabolic breakdown of nimesulide.1821

     +     6) Decreased absorption and anti-inflammatory effect of diclofenac sodium was observed when it was combined with trikatu, a 1:1:1 mixture of black pepper, long pepper and ginger (PO in rabbits and rats).2003 Since the drug was mixed with the herbs in solution prior to administration, the interaction may have been chemical in nature, rather than biological (speculative).

     +     7) Reduced absorption, peak concentration, and bioavailability of isoniazid resulted for 4 hours when it was given together with 500 mg/kg trikatu, a 1:1:1 mixture of dried fruits of black pepper, long pepper and dried rhizomes of ginger providing 10 mg/kg of the alkaloid piperine (PO in rabbits). This may be due to a decrease in gastric emptying time (speculative).2005

     +     8) Increased absorption and peak concentration of indomethicin after 4 hours was achieved when it was given together with 500 mg/kg trikatu, a 1:1:1 mixture of dried fruits of black pepper, long pepper and dried rhizomes of ginger (PO in rabbits). The pharmacokinetic effect may have been due to an increased GI blood flow (speculative), but was not due to change in indomethicin metabolism.2004

III. +    3) Increased membrane transport of the drugs digoxin and cyclosporine (in vitro) by piperine inhibition of P-glycoprotein may lead to increased bioavailability.1820

      +    4) Reduced metabolism of verapamil by piperine inhibition of CYP3A4 (in vitro) may lead to increased bioavailability.1820 Bisalkaloid components called dipiperamides A, B, and C inhibit CYP3A4 metabolism of nifedipine and act much more potently than piperine (in vitro).1822 

 

BLADDER KELP                                                                p. 43

            Nereocystis luetkeana thallus

Contraindications

     +     4) Large amounts during pregnancy due to potential development of infantile goiter (empirical)150

 

BLADDERWRACK                                                                        p. 43

            Fucus vesiculosus thallus

Drug Interactions

III.       1) Interactions may occur with thyroid replacement medication like thyroxine or hyperthyroid drugs like  carbimazole (speculative) due to its natural iodine content.1890

            2) Do not combine with iodine-containing drugs like amiodarone or bneziodarone, since there is a greater risk of causing iodine-induce thyrotoxicosis with these drugs (speculative).1890

 

BLOODROOT                                                                      p. 44

            *Sanguinaria canadensis rhizome

Contraindications

      +    3) Hiatal hernia, esophageal varices, stomach ulcer or peptic ulcer due to aggravation and/or potential hemorrhage from emetic effect if bloodroot is taken in excessive doses (speculative)150

Drug Interactions

III. +    1) Do not take large doses after recent consumption of central nervous system stimulants, due to the emetic action potentially inducing convulsions (speculative).150

      +    2) Do not take large doses after recent consumption of central nervous system sedatives, due to the emetic action potentially inducing aspiration pneumonitis (speculative).150

 

BLUE COHOSH

            *Caulophyllum thalictroides root

Contraindications

            1) Pregnancy prior to labor, due to its emmenagogue and abortifacient effects (empirical)2,6,,7,10,74,150

and potential embryotoxic and teratogenic effects from its extracts and alkaloids (in animals).2,1890

     +     2) Not to be used by fertile women trying to conceive or nursing mothers (speculative), due to the potential for teratogenicity in the embryos or toxicity in the infants, respectively.1890

 

BLUE FLAG                                                                        NEW

     ^      *Iris versicolor, Iris virginica roots/rhizome

(flag lily, iris liver lily, poison flag, snake lily, sweet flag, water flag, wild iris; Fr.: fleur-de-lis)

Contraindications

            1) Pregnancy (speculative)150 due to its potential toxicity (empirical)2,150

Drug Interactions

III.       1) Do not take large doses after recent consumption of central nervous system stimulants, due to the emetic action potentially inducing convulsions (speculative).150

            2) Do not take large doses after recent consumption of central nervous system sedatives, due to the emetic action potentially inducing aspiration pneumonitis (speculative).150

 

BLUE VERVAIN                                                                 NEW

     ^      Verbena hastata plant

(American vervain, false vervain, Indian hyssop, purvain, Simpler’s joy, traveler’s joy, vervain, wild hyssop)

Contraindications

            1) Pregnancy (speculative)2,150 due to its emmenagogue effect in early pregnancy (empirical)2

 

BOLDO                                                                                  p. 45

            Peumus boldus leaves

Contraindications

     +     8) Pregnancy or with nursing mothers due to possible toxic effects in the fetus from boldine (PO in rats) or in infants from the essential oil components, respectively.1890

     +     9) Avoid prolonged use (speculative), due to possible toxic effects from the essential oil components.1890

Drug Interactions

     +     1) A woman stabilized on warfarin developed an elevated INR after several weeks of using a capsule of fenugreek before meals and 10 drops of boldo extract after meals. Her INR returned to the normal range after stopping the herbal products but became elevated again after resuming their use (PO in human case study). It may be that warfarin metabolism was reduced or the serum protein bond of warfarin was modified (speculative).1489

 

BORAGE                                                                              p. 46

            *Borago officinalis plant

BORAGE SEED OIL  

[Borage seed oil does not contain toxic pyrrolizidine alkaloids6,150 but has separate effects and interactions due to its gamma linolenic acid (GLA) content similar to black currant seed oil and evening primrose oil. See EVENING PRIMROSE.]

Drug Interactions

I.          1) In a 6-month randomized, double-blind, placebo-controlled (RPCDB) trial with 37 rheumatoid arthritis (RA) patients, 7.2 ml borage seed oil (1.4 gm GLA) or cottonseed oil placebo was given daily in addition to stable doses of NSAIDs and corticosteroids. Those receiving GLA had significant reductions in number of tender joints (36%), tender joint score (45%), swollen joint count (28%), and swollen joint score (41%). The placebo group was unchanged or grew worse (PO in human clinical study).1401 In a second RPCDB trial using daily placebo sunflower seed oil or 2.8 gm GLA derived from borage seed oil, 56 RA patients on stable amounts of NSAIDs, corticosteroids and second-line anti-rheumatic drugs received the GLA for the first six months and/or the second six months. After the first half year, 14 of 22 in the GLA group had at least a 25% improvement in the four measures, while 4 of 19 using placebo improved this much. When all received GLA in the second half year, 16 of 21 in the original GLA group had this degree of response over baseline, while the placebo/GLA group also improved. Three months after the end of the trial, the GLA group had a smaller increase in 3 of the 4 measures (PO in human clinical study).1402

III.       1) Due to a decrease in plasma heparin-neutralizing activity and platelet aggregation inhibition associated with prostaglandin PGE1 that is formed from metabolism of dihomo-gamma-linolenic acid (PO in human study),681,693 a component formed from GLA in borage seed oil, heparin may be potentiated (speculation)

 

BROMELAIN                                                                       p. 47

            Ananas comosus extract from fruit, stem

Contraindications

            1) Allergic hypersensitivity to bromelain (empirical)17

A worker who handled bromelain for 10 years developed rhinitis and asthma that could be induced by both 0.03 mg of inhaled bromelain and 190 grams of ingested pineapple (human case report). Cross-reactivity with bromelain by skin and RAST tests occurred with 5 of 6 workers sensitized to airborne papain, and 2 of the 6 had immediate asthmatic reactions (human clinical study).1275 Cross-sensitivity shown by RAST inhibition suggested bromelain, papain, wheat flour, rye flour, grass pollen and birch pollen possess more or less similar or identical antigenically active regions (in vitro),1276 corresponding to positive skin tests to bromelain in 2 of 60 asthmatics and positive RAST tests to bromelain in 8 of 60 asthmatics not exposed to airborne sources of this protease (in vitro).1275

            2) bile duct obstruction6,17,401,777

due to its choleretic activity as shown with a single 1.9 gram dose of its 4.5-5:1 strength extract (PO in human study)1270

Drug Interactions

I.          1) Bromelain at 20 mg/kg increased cerebrospinal fluid levels of penicillin injected intramuscularly 4 hours later (per duodenum in rabbits).1111

            3) Potentiates bleeding with anticoagulants (PO in case report), [CORRECTION]31

probably due to inhibition of platelet aggregation shown with 30 mg/kg (IV in rats)1110, increased fibrinolytic activity shown with 25 mg/kg (enterally in rats),1110 and increased prothrombin time shown with 5 mg/kg (PO in rabbits)1110

                                However, following doses of 40 mg four times daily for one week the coagulation and bleeding times were not changed, and the prothrombin time was only slightly increased (PO in human study).1253

            4) Increases blister fluid concentration of tetracycline in 18 males (PO in human study)1112

     +     5) In a randomized, placebo-controlled, double blind trial following episiotomy for childbirth, 160 patients required aspirin or aspirin with codeine or propoxyphene HCl for the pain; half received an additional 2 tablets of bromelain (50,000 RU/tablet) 4 times daily for 3 days, beginning 4 hours after delivery. For the bromelain group the responses were considered good or excellent in 90%, compared to 44% of these responses for the placebo group, a highly significant difference. While 75%-78% of each group received asprin or aspirin/propoxyphene, 14% more in the placebo group received the aspirin/codeine (PO in human clinical study).1405

However, in treating osteoarthritis of the knee, a randomized, double-blind controlled trial found that the 14 patients using bromelain as an adjuvant with conventional and/or alternative medications had not better outcomes based on symptom scores than 17 who used placebo (PO in human clinical trials). Those who recently or currently used corticosteroids were excluded from this trial.2152 Also, in a case of combining with NSAID use for rheumatoid arthritis, a 76-year-old woman developed ecchymosis on her forearms when she used bromelain with naproxen (PO in human case report).2126

6) In another placebo-controlled, double-blind study 59 patients were given 2 tablets of bromelain 4 times daily for 2 days prior to cataract surgery, and for the 5 days following. In addition to local cortisone for all, those on bromelain and the 52 placebo patients also received oral aspirin and propoxyphene for pain as needed. On the seventh postoperative day there was significant reduction of lid edema, conjunctival hyperemia, and conjunctival edema in the bromelain group compared to placebo. Operative complications included mild hemorrhage in 13 bromelain patients and 6 placebo patients (PO in human clinical trial).1406

II.   +    1) Increased concentration of the antibiotic cefazolin in bronchial secretions when given at 100 mg/kg (PO in rats)1110

      +    2) Increases blood and urine levels of the antibiotic ethambutol (in rabbits)1112

      +    3) Increases duration of sleeping time when given prior to pentobarbital (IP in mice)1112

III.       1) May enhance cholesterol-lowering agents (speculative).777 

Tablets with 450 mg of a 25-35:1 aqueous extract reduced total cholesterol, LDL cholesterol, and LDL/HDL ratio (PO in human clinical study)1271

 

BUCHU                                                                                 p. 48

            *Agathosma betulina = Barosma betulina leaves

Contraindications

            4) Nursing mothers (speculative), since the essential oil may pass through the breast milk to the infant with unforeseen consequences.1890

 

BURDOCK                                                                           p. 50

            Arctium lappa root

Contraindications

            1) Allergic hypersensitivity to the root (human case reports).662

Some even suggest avoiding if there is known hypersensitivity to other Compositae family plants (speculative).1890

Drug Interactions

II.   +    1) Freeze-dried water extract of burdock root at 300 mg/kg decreased SGOT, SGPT, and malondialdehyde levels caused by liver damage from acetaminophen. The decrease in glutathione and cytochrome P450 in the liver caused by acetaminophen was reduced by burdock extract (PO in mice)1404 The freeze-dried decoction of burdock at 100 mg/kg reduces edema from injected carrageenan (SC in rats) and decreases liver toxicity of CCl4 at this dose (IP in rats). This extract has radical scavenging activity (in vitro).1407

 

BUTCHER’S BROOM                                                        NEW

     ^     Ruscus aculeatus roots and rhizome

            (box holly)

Contraindications

            1) Broken skin or ulcerated skin, due to the irritant effect of the saponins (speculative).1890 

 

BUTTERNUT                                                                      NEW

     ^      *Juglans cinerea bark

(lemon walnut, oil nut, white walnut)

Contraindications

            1) Pregnancy (speculative) since large doses may cause a cathartic action150

 

CAJEPUT                                                                             NEW

     ^     Melaleuca leucodendron = Melaleuca cajeputi leaf oil

            (white tea tree, broad-leaved tea tree, paper-barked tea tree, swamp tea tree, white-wood)

Drug Interactions

I.          1) Component 1,8-cineole (eucalyptol) induces hepatic microsomal mixed-function oxidase enzyme induction (in rats), resulting in increased clearance of aminopyrine with aerosol inhalation of eucalyptol 10 min. daily for 10 days (human study).28

II.         1) Pentobarbital, zoxazolamine, and amphetamine given 24 hours after an aerosol exposure to 1,8-cineole for 2-10 min/day for 4 days were effective for a reduced length of time (in rats).28

 

cALENDULA                                                                      p.52

            Calendula officinalis flowers

Contraindications

     +     2) Allergic hypersensitivity to calendula or allergies to other members of the Asteraceae family (empirical).1890

 

CALIFORNIA POPPY                                                       p.52

            Eschscholtzia californica herb

Contraindications

     +     2) Nursing mothers (speculative) without professional advice.1890

 

CALIFORNIA SPIKENARD                                             NEW

     ^     Aralia californica rhizome and roots

Contraindications

            1) Pregnancy (speculative)150 probably due to its similarity to the related species and known emmenagogues Aralia nudicaulis and A.racemosa, known as  small spikenard and spikenard, respectively (empirical)1125

 

CAMPHOR BARK                                                              p. 53

            Cinnamomum camphora = Laurus camphora bark oil 

Contraindications

            5) Epilepsy (empirical), since its rapid absorption through the skin and mucus membranes in small doses can result in CNS overstimulation and seizures (empirical).400

            6) During fever (empirical),400 due to potential CNS toxicity (empirical).2

 

CANNABIS [Formerly MARIJUANA.]                              p. 142

            *Cannabis sativa leaves and tops

Contraindications

            2) Avoid in those with a history of schizophrenia, since psychotic symptoms may be induced with consumption (empirical).2,627,629

Cannabis use increases the risk of incidence of psychosic symptoms in the young, stronger effects in those predisposed to psychosis, and a poor prognosis for those with established psychotic disorder (human study).1372,1737

3) Heavy, prolonged use

may cause psychological dependance and physical withdrawal (human studies)1198 and increased risk of depressive symptoms including consideration of suicide and experiencing loss of ordinary pleasure (human study).1229

      +    6) Daily heavy use due to reversible cognitive deficits detectable for at least 7 days after quitting (PO in human study),1197 as well as impairments in memory and attention (human study)1272 and decrements even after 28 days abstinence in neurocognitive performance (human study)1146

Drug Interactions

I.          2) Vomiting induced by chemotherapy including cyclophosphamide, doxorubicin, cisplatin, procarbazine, methotrexate, dacarbazine and streptozocin was relieved by cannabis in 78% of the patients (inhaled in human clinical study).1078

One incident of lethal ischemic stroke was associated with cisplatin-based chemotherapy and cannabis inhalation (human case report). Ischemic strokes have occurred at least 15 times with cisplatin use alone and a few times following cannabis inhalation.1346 

 

CARAWAY                                                                          NEW

     ^      Carum carvi seeds

Contraindications

            1) Allergic hypersensitivity to similar plants in carrot (Apiaceae) family (speculative)10

 

CASCARA SAGRADa                                                      p. 53

            *Frangula purshiana = Rhamnus purshiana aged bark [NOTE: new scientific name]

 

CASSIA [formerly CASSIA CINNAMON]                                    p. 55

            Cinnamomum cassia = Cinnamomum aromaticum bark  [See also Cinnamon.]

Contraindications

            1) Large doses in pregnancy150,401

due to potential hepatotoxicity of its extremely high coumarin content (speculative)2231,2248

Drug Interactions

I.     +   1) In 60 men and women with type 2 diabetes using sulpholylureas such as glibenclamide, when either 1, 3, or 6 grams of cassia cinnamon or placebos was given daily for 40 days, all three cassia doses reduced fasting glucose along with trigyceride, LDL cholesterol, and total cholesterol (PO in human clinical study).1592 A 9:1 aqueous extract at a dose of 336 mg/day for 4 months significantly reduced serum glucose in type 2 diabetics with poor glycemic control, though 77% were already taking non-insulin oral hypoglycemics including sulphonylureas, metformin, glinides, glitazones, and their combinations (PO in human clinical study).1900 One gram daily of cassia powder randomized to type 2 diabetics with blood sugar poorly controlled by oral hypoglycemics and/or insulin had a significant reduction in hemoglobin A1C after 90 days compared to  controls (PO in human clinical study).2603

However, in a study involving 25 postmenopausal women with type 2 diabetes, all but 4 of whom were taking metformin, sulphonylureas and/or thiazolidinediones, 1.5 grams daily of cassia cinnamon taken for 6 weeks had no effect on fasting blood sugar or lipids or insulin sensitivity or glucose tolerance (PO in human clinical study). This disparate result may have been due to use of a different geographic source of cassia, since the bioactive components have not been identified to establish an effective profile.2139 Similarly, 60 patients in a randomized, double-blind trial were given 500 mg encapsulated cassia powder or placebo twice daily for 3 months while ¾ were also taking metformin and over 1/3 were using thiazoledinedione (PO in human clinical study). No reduction in fasting glucose, insulin levels or glycosylated hemoglobin were found.2237

Cassia cinnamon powder given to 7 healthy males at a dose of 5 grams, either with or 12 hours prior to an oral glucose tolerance test, resulted in a reduction of total plasma glucose and improved insulin sensitivity (PO in human study).2567 Taken with a meal, 6 grams of cassia cinnamon lowered postprandial glucose and slowed gastric emptying in 14 healthy subjects (PO in human study).2294

However, in 15 healthy subjects, a single dose of 1 or 3 grams of cassia cinnamon failed to significantly alter postprandial blood glucose, glucose-dependent insulinotropic polypeptide or ghrelin response, gastric emptying, or satiety, though 3 grams did significantly lower changes in glucagon-like peptide 1 response and maximum concentration, the insulin response at 60 minutes, and total serum insulin for 120 minutes postprandially (PO in human study).2531

III.  +   2) Alkaline aqueous extracts of cassia cinnamon were show to greatly potentiate insulin activity (in vitro).1464 This is likely due to enhanced insulin signaling in skeletal muscle as shown with freeze-dried cassia hot water extract (PO in rats).1762

However, in a placebo-controlled study with 72 type 1 diabetes adolescents, after consuming a 1-gram dose of cinnamon powder daily for 90 days no differences were found in total daily insulin intake, number of hypoglycemic episodes, glycated hemoglobin (A1C), or change in A1C between the cinnamon and placebo groups (PO in human clinical study). Unfortunately, the authors did not characterize the type of cinnamon (Cinnamomum spp.) by species name.2108  Giving 3 grams Cassia cinnamon with rice pudding significantly lowered the insulin response at 60 minutes, and total serum insulin for 120 minutes postprandially (PO in human study).2531

Cassia bark aqueous extract increased insulin release from insulin-secreting cells in a dose-dependent manner by 144-182% (in vitro). The extract and the bark significantly increased plasma insulin in animals, the bark for 1-2 hours and the extract for 1-4 hours. Cassia cinnamon bark and extract were more effective than cinnamon (C. zeylanicum) extract (PO in rats). Only after glucose consumption did the extract reduce blood glucose (PO in rats).1763 The bark reportedly lowers blood sugar in normal animals due to cinnamaldehyde effects (PO in animal studies).319  Moreover, water-soluble polyphenol polymers of A type doubly linked procyanidin oligomers of catechins and/or epicatechins increased insulin-dependent glucose metabolism 20-fold (in vitro).1659

     +     3) Essential oil from cassia with its strong antifungal effect against Candida albicans potentiated amphotericin B by reducing the required concentration to inhibit candida (in vitro).1856

 

CAT’S CLAW                                                                      p. 57

            Uncaria tomentosa bark

Contraindications

            2) Avoid in pregnancy (empirical)701,1487,1890 and in women attempting conception (empirical),1890

due to traditional use as a contraceptive (empirical)150,1890 and the increased risk of fetal malformation or damage (PO in mice).1890

     +     4) Long-term use in autoimmune disorders should be avoided until further information is available (speculative).1487

            A patient with systemic lupus erythematosus taking 4 capsules of cat's claw daily developed acute renal failure after several months; urinalysis results gradually returned to normal after the supplement was discontinued (PO in human case report).  The herb was not positively identified and the dose weight was not given.2667

However, 60 mg aqueous-acid extract of root with pentacyclic oxindole alkaloids used for a year by rheumatoid arthritis patients taking taking disease-modifying medication and anti-inflammatory drugs led to a reduced number of painful and swollen joints compared to baseline (PO in human clinical study).1321

5) Caution is advised for use of the chemotype with tetracyclic oxindole alkaloids prior to surgery or by those with bleeding disorders (speculative) due to the inhibition of platelet aggregation by the alkaloid rhynchophylline.2667

Drug Interactions

I.    +    1) Water soluble extract with 8-10% active carboy alkyl esters but free of oxindole alkaloids given in 350 mg tablets twice daily enhanced immune response to 23 valent pneumococcal vaccine by elevating lymphocyte/neutrophil ratios in blood and reducing decay in 12 serotype antibody titers at 5 months with no adverse effects (PO in human study)1240

      +    2) 60 mg aqueous-acid extract of root with pentacyclic oxindole alkaloids (14.7 mg/g)used for a year or 28 weeks with 40 rheumatoid arthritis patients on sulfasalazine or hydroxychloroquine treatment for at least 6 months previously showed a reduced number of painful and swollen joints compared to baseline. In the first 24-week (placebo) phase the extract group had fewer painful joints than the placebo group. The steroid prednisolone  was used by 38% of the participants; use of NSAIDs was also allowed.1321

II.  +     1) Intestinal ulceration by indomethacin was reduced by aqueous extract of cat’s claw (PO in rats).597

This same concentration of cat’s claw decoction in drinking water given for 3 days prior to a toxic dose of indomethacin (20 mg/kg) caused a protective effect that greatly reduced the extent of erosion to the stomach lining (PO in rats). Anti-inflammatory and anti-oxidant effects of this cat’s claw bark extract were both demonstrated as well (in vitro).1389 The protective effect against indomethacin-induced stomach damage was due to its suppression of NF-kB activation (PO in rats).1784

      +    2) Avoid use with antihypertensives, since its rhynchophylline alkaloids may lower blood pressure further (speculative)1487

III. +    3) Use of preparations standardized to pentacyclic oxindole alkaloids concurrently with immunosuppressants should be avoided to prevent antagonistic effects (speculative).1890  

      +    4) Caution is advised for use of the chemotype with tetracyclic oxindole alkaloids together with warfarin or other anticoagulants (speculative) due to the inhibition of platelet aggregation by the alkaloid rhynchophylline.2667

 

CAYENNE                                                                            p. 57

            *Capsicum frutescens fruit

Drug Interactions

I.          1) 20 gm of powdered chili (containing 9.56 mg capsaicin, a concentration of 478 ppm) reduced gastric mucosal damage from aspirin (PO in human study).211

At 10-30 mg/kg capsaicin aggravated the damage caused by aspirin (PO in rats).1120

II.         3) Prevention of ethanol/acid-induced ulcers was shown by giving 3-30 mg/kg of capsaicin (PO in rats).522

Dilute capsaicin at 0.1 mcg/kg protected the stomach from mucosal damage by ethanol. At 10-30 mg/kg capsaicin aggravated the damage caused by ethanol (PO in rats).1120

 

CELANDINE                                                                                   p. 59

            *Chelidonium majus root and plant

Contraindications

      +    9) Idiosyncratic hepatotoxic reaction after using celandine, since mild to severe acute hepatitis occurred in 10 patients following its consumption (PO in human case reports).  These cases were independent of dose and commercial preparation (5 different manufacturers of celandine products, including of two herbal combinations) and had long and variable latent periods (1-9 months). Recovery was complete 2-6 months after discontinuation of celandine, but hepatitis recurred in the one patient who re-introduced it after release from the hospital.1142 These observations implicate celandine involvement in a case of hepatotoxicity in a patient who used a different herbal combination containing celandine (PO in human case report).1143

     +     10) Nursing mothers, and only preparations of the leaves may be used, but after first receiving professional advice due to the potential for causing liver problems (speculative)1890 

      +    11) Prolonged use (speculative), due to its potential toxicity (empirical)1890

Drug Interactions

III.  +   1) Chelerythrine, a major alkaloid component, enhanced the retention of rhodamine 123 in human breast cells by inhibiting its efflux mediated by P-glycoprotein (in vitro)1034

            2) May aggravate hepatotoxic reactions to anesthetics, steroids, estrogen, or chlorpromazine (speculative), due to its own liver stimulant and toxic effects (empirical)1890

 

CELERY                                                                               p. 60

            Apium graveolens seeds (fruit) or stalks

Contraindications

     +     5) Not to be used by nursing mothers without professional advice (speculative).1890

Drug Interactions

I.   +     2) Compared to a basal diet with no vegetables, after eating for 6 days a diet with the umbelliferous vegetables 110 gm (0.75 cup) frozen carrots, 100 gm (1.25 cup) fresh grated parsnips, 50 gm (0.5 cup) celery, 5 gm (3 Tbs) parsley and 0.5 gm (1 tsp) dill daily, 36 subjects had a significantly decreased rate of caffeine metabolism (PO in human study)1634  

     +     3) Use of celery seed reduced serum concentrations of thyroxine in two patients (PO in human case reports)1890

 

CHAMOMILE [formerly CHAMOMILE, GERMAN]      p. 61

            Matricaria recutita = Matricaria chamomilla plant or flowers

Contraindications

            3) Allergic hypersensitivity (human case reports, human clinical studies)4,663,666

An enema containing an oily extract of chamomile flowers given during labor resulted in an anaphylactic response and cesarean delivery with severe asphyxia in the newborn which died the following day (human case report)1144 In 14 patients allergic to either chamomile or spices and weeds and with a positive skin-prick test to chamomile, 10 had a history of immediate-type reaction to chamomile, 11 were sensitized to mugwort and 8 to birch tree pollen based on RAST, while 4 showed IgE binding to high molecular weight chamomile protein allergens (in vitro).1740 A man developed acute eczema on his forearms and hands after washing and applying compresses of chamomile and Roman chamomile tea (topically in human case report). In patch tests he was shown to be sensitive to both of the teas and their mix, a Roman chamomile extract, yarrow, tansy, and feverfew extracts, and a sesquiterpene lactone mix. The chamomile sesquiterpene lactone desacetyl matricarin likely contributed to his reaction.1742 

Drug Interactions

I.     +   1) Non-heme iron absorption is reduced with consumption of the tea prepared with 3 grams per cup (PO in human study) likely due to its flavonoid content1246

       +   2) From 10-15 drops of a flower extract in 4 oz of water and used as a thorough mouth rinse 3 times daily prevented and/or effectively treated oral mucositis from systemic chemotherapy in 78 cancer patients treated with L-asparginase, cisplatin, cyclophosphamide, cytosine arabinoside, daunorubicin, doxorubicin, 5-fluorouracil, methotrexate, and/or vincristine (TP in human clinical study). It also prevented oral mucositis in 19 of 20 head and neck cancer patients treated locally with radiation.2541 

Oral ulcers and mucositis from overdose of methotrexate resolved within 2 weeks following use of 20 ml of a 1:125 chamomile infusion used as a gargle 4 times daily (local in human case report).1803

3) [Formerly IV.1).] One woman on warfarin had pelvic ecchymoses and increased INR of 7.9 from 3.6 five days earlier, after drinking several cups daily of chamomile made with a teaspoon of dried leaves and applying a lotion containing a chamomile preparation (PO in human case report).1876 

However, such a response could also have occurred if she drank grapefruit juice with here co-medication amiodarone, though she denied in general any change in her diet in the prior days.1876

Chamomile has been identified as potentiating warfarin due to its coumarin content (speculative)893-895 that consists of the coumarin derivatives herniarin and umbelliferone.897-899 Though chamomile and herniarin (7-methoxycoumarin) are reported to have hemostatic activity,691 and umbelliferone (7-hydroxycoumarin) shows no evidence of anticoagulant effects,690,847,848 both herniarin and umbelliferone strongly inhibit rabbit platelet aggregation in platelet-rich plasma induced by collagen and arachidonic acid, while umbelliferone likewise strongly inhibits aggregation induced by ADP and platelet-activating factor (in vitro).2497 Chamomile contains the flavonoid apigenin which also has been shown to inhibit platelet aggregation (in vitro).420,1015

II.         2) Chamomile oil reduced the reduction of ACTH by diazepam in normal animals (inhaled in rats). 625

Apigenin acts as a strong ligand to central benzodiazepine receptors (in vitro).1554 Unlike diazepam, the anxiolytic effect of apigenin does not lead to amnesia of learning tasks but slightly enhances retention (IP in rats)1555

     +     3) After being consumed for 4 weeks, a 2% tea made from the flowers reduced the metabolism of the analgesic CYP 1A2 substrate phenacetin by liver microsomes to 39% of normal (PO in rats)1608

     +     4) Chamomile extract standardized to apigenin and given with morphine twice daily for 7 days reduced the morphine dependence as well as its withdrawal syndrome after naloxone was administered (IP in rats). The effect appeared to be due to prevention of increased plasma cAMP.2014

 

 

CHAMOMILE, ROMAN [now ROMAN CHAMOMILE] p. 62

            Chamaemelum nobile = Anthemis nobilis flowers and plant

 

CHAPARRAL                                                                      p. 63

            Larrea tridentata leaves

Contraindications

     +     6) Pregnancy due to its use as an abortifacient and contraceptive agent (empirical).1890

 

CHASTE TREE                                                                   p. 64

            Vitex agnus-castus berries

Contraindications

     +     4) Depression associated with reduced estrogen levels (PO in human case report)1503

Drug Interactions

I.   +     1) The essential oil may potentiate the activity of progesterone drugs, resulting in breakthrough bleeding (PO in clinical study)1503

III.       1) Chaste tree may interfer with the efficacy of progesterone drugs such as birth control pills (speculative) or disrupt hormone replacement therarpy due to its additive progesterone effect (speculative), especially of the essential oil derived from the berries and leaves (PO in clinical study).1503

However, some cases combining the essential oil with estrogen in menopause appeared successful.1503

            2) Dopamine antagonists may be weakened (speculative) due to its dopaminergic effects (in vitro,1565 in animals,17,401,777,1565 PO in human clinical study1770).

3) Neuroleptic medications like thioridazine may reduce chaste tree activity (speculative),1503 as shown by the antagonism of haloperidol to the dopamine-induced prolactin inhibition from chaste tree ethanolic extract (in vitro).700 

 

CHICKWEED                                                                      NEW

     ^     Stellaria media herb

            (adder’s mouth, Indian chickweed, satin flower, starwort, tongue-grass, winterweed)

Contraindications

            1) Allergic hypersensitivity to topical use of this plant (empirical).1890

 

CHICORY                                                                             p. 64

            Cichorium intybus root

Drug Interactions

II.    +   1) Inulin and its short-chain fructan obtained by partial enzymatic hydrolysis from chicory inulin given at 15 grams daily beginning seven days before liver tumor transplantation both potentiated in an additive or synergistic manner the therapeutic effects of 5-fluorouracil, doxorubicin, cyclophosphamide, vincristine sulfate, methotrexate, and cytarabine given IP in subtherapeutic doses 48 hours after transplantation (PO in mice).1115 This may be due to their prebiotic effect of enhancing bifidobacterial colon flora, lowering colon pH, enhancing mineral bioavailability, and/or reducing de novo hepatic synthesis of fats (speculative).1255

 

CHINESE CUCUMBER                                                     NEW

     ^     Trichosanthes kirilowii root

            (Chinese snakegourd)

Contraindications

            1) Pregnancy due to its abortifacient effects (empirical)150

 

CHINESE RHUBARB [formerly RHUBARB, CHINESE]           p. 168

Ä         *Rheum officinale, *Rheum palmatum root

 

CHINESE SKULLCAP [formerly Baikal skullcap]                        NEW

Ä         Scutellaria baicalensis root

            (Baikal skullcap; Ch.: huang qin)

Drug Interactions

II.   +    1) A decoction in doses of 1 and 2 gm/kg given just before oral administration of cyclosporine reduced its maximum serum concentration by 63% and 80% and the total absorption by 55% and 82%, respectively, compared to water. In contrast, the root flavonoid components baicalin and baicalein given alone at 112 mcmol/kg elevated the cyclosporine peak 408% and 88% and the total absorption by 685% and 150%, respectively. When the cyclosporine was given IV, there was no change in bioavailability when the decoction was given orally. So the decoction reduced cyclosporine absorption and should not be used concurrently (PO in rats).1572

      +    2) Its component baicalin reduced weight loss, anorexia, and diarrhea resulting from intake of irinotecan (PO in rats). Also, less damage accurred to the intestinal mucosa, and the damage healed more rapidly. Two Kampo formulas contain Chinese skullcap produced similar effects (PO in rats).1828 One of these formulas, Hangeshasin-To, was also shown to alleviate diarrhea from irinotecan given for non-small-cell lung cancer when compared to placebo, given to 18 subjects at 7.5 grams daily (PO in human clinical study).1829 Both methanol eluate fractions III (68 mg/kg) and IV (63 mg/kg) of Hangeshasin-To helped reduce diarrhea induced by castor oil (PO in human study). The main component of fraction III was baicalin in Chinese skullcap.1830

      +    3) Liver damage from acetaminophen as indicated by transaminase leverls and hepatic necrosis was significantly prevented by 300 mg/kg of the flavone component baicalin (PO in mice). Acetaminophen-induced mortality was reduced from 43% to 0%, apparently due to inhibition of acetaminophen bioactivation by CYP 2E1.1891

      +    4) an extract ameliorated the myelotoxicity of the cytostatic chemotherapy drugs cyclophosphamide and 5-fluorouracil, as well as helping to decrease tumor cell viability (in mice and rats).2207

III. +    1) Absorption of rhodamine 123 was reduced across both the jejunum and ileum from rats by the root decoction (in vitro)1572

 

CHOKEBERRY                                                                   NEW

            Aronina melanocarpa fruit

            (aronia, black chokeberry, wild chokeberry)

Drug Interactions

I.          1) An extract of the fruit with about 25% anthocyanins, 9% phenolic acids, and 50% monomeric and oligomeric procyanidins was given at 255 mg daily to 22 myocardial infarction patients who had been on the statin drugs simvastatin and atorvastatin for at least 6 months, while an equal number of similar patients were given placebo in a double-blind trial (PO in human clinical study). In addition, 77% of those in the study were taking aspirin and 52% were using ACE inhibitors. Compared to those given placebo with their medications, those receiving the extract had significantly lowered diastolic and systolic blood pressure, C-reactive protein, IL-6, adhesion molecules, oxidized LDL, and F2-isoprostane measurements and higher adiponectin. These changes indicate reduced oxidative stress and inflammatory response and a lower risk for further ischemic heart disease.2675 A total of 250 ml daily of the fruit juice high in polymeric procyanidins, phenolic acids, and glycosides of quercetin and cyanidin were taken for 6 weeks, stopped for 6 weeks, then taken again for another 6 weeks by 35 hypercholesterolemic men who were not taking medications for their condition; after the second 6-week juice intake there were significant decreases in mean serum total cholesterol, LDL cholesterol, and triglycerides and increases in mean changes in brachial artery diameter, flow mediated dilatation, and serum nitric oxide levels (PO in human clinical study).2708

II.         1) When given before indomethacin subcutaneous injections, the fruit juice reduced the number and area of damage to the stomach lining compared to controls, due to an increase in gastric mucus production and reduced oxidative stress (PO in rats).1983 Likewise, the methanol extract of the fruit at 2 gm/kg protected the gastric mucosa from damage by ethanol by reducing the damaged area to >30% of that in the control group (PO in rats). The red pigment fraction with 3 main components including cyaniding 3-O-beta-glucoside demonstrated radical-scavenging activity (in vitro).1984  

 

CINCHONA                                                                          p. 65

            *Cinchona spp. bark

Drug Interactions

III.  +   5) Inhibition of glutatithione S-transferase conjugation of ethacrynic acid and 1,3-gis(2-chloroethyl)-1-nitrosurea (BCNU) by quinine and/or quinidine (in vitro) could lead greater tumor cell retention and increased efficacy of BCNU as an anticancer agent1547

 

CINNAMON                                                                         p. 66

            *Cinnamomum verum = Cinnamomum zeylanicum bark  [See also Cassia.]

Drug Interactions

III.   +  1) Alkaline aqueous extracts of cinnamon and a concentrated fraction were shown to greatly potentiate insulin activity (in vitro).1462-1465

A methylhydroxychalcone polymer from this cinnamon fraction stimulates glucose uptake and glycogen synthesis similar to insulin. When combined with insulin, together these compounds had greater than additive activity (in vitro).1466 Water-soluble polyphenol polymers of A type doubly linked procyanidin oligomers of catechins and/or epicatechins increased insulin-dependent glucose metabolism 20-fold (in vitro).1659 Cinnamon bark aqueous extract significantly increased plasma insulin in animals after 1 hour. Cassia bark (C. cassia) and extract were more effective than cinnamon extract (PO in rats). The extract did not reduce normal blood glucose.1763 

However, in a placebo-controlled study with 72 type 1 diabetes adolescents, after consuming a 1-gram dose of cinnamon powder daily for 90 days no differences were found in total daily insulin intake, number of hypoglycemic episodes, glycated hemoglobin (A1C), or change in A1C between the cinnamon and placebo groups (PO in human clinical study).2108 When 6 grams of cinnamon were given with 300 grams of rice to healthy subjects, it delayed gastric emptying and reduced postprandial blood glucose (PO in human study).2294 Unfortunately, in these studies the authors did not characterize the type of cinnamon (Cinnamomum spp.) by species name.2108,2294 A water extract had no effect on blood sugar in normal or streptozotocin-induced diabetes (PO in rats).1467

 

CLOVE                                                                                  p. 66

            Syzygium aromaticum buds

Contraindications

    +      1) Allergic hypersensitivity to eugenol (speculative)10

Drug Interactions

III.       1) Anticoagulants (speculative),777

            including warfarin and heparin may be potentiated, as well as aspirin (speculative)400

      +    3) Alkaline aqueous extracts of clove were shown to potentiate insulin activity in glucose metabolism (in vitro).1462,1464 Cloves have been shown to reduce blood sugar in streptozotocin-diabetic animals, but not in those that have normal function (PO in animal studies).319

      +    4) Essential oil should not be used with acetaminophen [paracetamol] (speculative), due to the potential hepatotoxicity of its eugenol content400

 

COCOA                                                                                 p. 67

            Theobroma cacao seed

Drug Interactions

I.     +   2) Non-heme iron absorption is diminished by 5 grams of cocoa in a cup of hot water due to the polyphenol content (PO in human study)1246

            3) When cocoa that supplied 963 mg flavanols daily was given to 41 fully medicated type 2 diabetics with 76% on oral hypoglycemic drugs, 24% on insulin, 81% on antiplatelet drugs, 76% on statins, 71% on beta blockers, and 67% on ACE inhibitors, flow-mediated dilation increased initially as after 30 days was 30% over baseline (PO in human clinical study). Though this appears to reverse vascular dysfunction by increasing nitric oxide synthesis, the glycemic control, heart rate, and blood pressure were unaffected.2600

 

COFFEE                                                                                p. 67

            *Coffea arabica seeds

Contraindications

3) Consumption of large amount daily should be avoided in pregnancy (speculative).150,401

A study of 2,714 women who delivered live infants in which coffee was the main source of caffeine in the first month (38% of all women) and seventh month (35%) found that > 300 mg caffeine daily was not associated with growth retardation (PO in human study).1966 However, a prospective study of 18,478 singleton pregnancies found the risk of stillbirth is increased by those who drink 8 cups of coffee or more daily during pregnancy, compaired to those who drink none (PO in human study).1486

In an evaluation of 2,291 mothers caffeine consumption was found to reduce average birth weight. This was considered significant for those who consumed more than 600 mg of caffeine daily, approximately equivalent to six 10-ounce cups of coffee (PO in human study).1568

However, a prospective study of 873 women found no association between caffeine consumption, primarily from coffee, at any amount and birth weight, gestational age at delivery, or birth weight standardized for gestational age (PO in human study).1672

            5) Heart disorders and cardiovascular disease due to caffeine increasing heart rate and arrhythmias (empirical)8,10

            In a study of risk of nonfatal myocardial infarction (heart attack) based on coffee consumption and CYP1A2 genotype, it was shown that those with only the allele *1A for rapid caffeine metabolism have a somewhat reduced risk of heart attack with coffee consumption, while those carriers of the allele *1F for slow caffeine metabolism have an increasingly greater risk of myocardial infarction with coffee consumption greater than 11 cup/day (PO in human clinical study).1925

Caffeine at a dose of 250 mg acutely increased aortic stiffness in 20 healthy subjects, leading to increased blood pressure centrally and to a lesser extent peripherally (PO in human study). These effects may impact cardiovascular risk (speculative).1569 However, a study of 155,594 women over 12 years found no linear association with coffee or caffeine consumption and hypertension (PO in human study).1859

6) Psychological disorders (speculative) since caffeine can aggravate depression or induce anxiety neurosis.8

In a dose-dependent manner coffe consumption increased state anxiety in men but not in women (PO in human study).1494

            7) Glaucoma (speculative),150

since it increases intraocular pressure in glaucoma patients 60-90 minutes after drinking caffeinated coffee, as compared to decaffeinated coffee (PO in human clinical study)1359

Drug Interactions

I.          2) Increased weight loss occurs due to a reduction of body fat along with side effects of agitation, tremors, and insomnia, when caffeine is combined with ephedrine (PO in human clinical study).19

            When 25 mg ephedrine was taken with 200 mg caffeine, systolic blood pressure, heart rate, and glucose, insulin and lactate concentrations were all raised (PO in human study). Taken alone, ephedrine increased heart rate, glucose, and insulin, and caffeine increase systolic blood pressure. No pharmacokinetic interaction was found.1665

     +     14) Methotrexate efficacy for reducing the joint pain and morning stiffness of rheumatoid arthritis was diminished for those consuming 260 mg of caffeine daily on average, compared to those who consumed an average of only 90 mg daily (PO in human clinical study), probably due to methylxanthines like caffeine acting as adenosine receptor antagonists while methotrexate increases adenosine.1495

     +     15) A study over 13.6 years of 26,556 Finnish men with no history of strokes who smoked 5 or more tobacco cigarettes daily showed the consumption of 8 or more cups of coffee daily significantly reduced the risk of strokes by cerebral infarction (PO in human study).2300

 

COLA                                                                                                p. 71

            Cola nitida, Cola acuminata seed

Contraindications

            3) High blood pressure (speculative), since caffeine increases the secretion of epinephrine and norepinephrine.150

                        However, a study of 155,594 women over 12 years found no linear association with coffee or caffeine consumption and hypertension, but consumption of sugared or diet cola was associated with high blood pressure (PO in human study).1859

            5) Pregnancy (speculative), since caffeine crosses the placenta and has been weakly associated with fetal loss, low birth weight and premature deliveries in humans.8

However, a study of 2,714 women who delivered live infants in which soda was consumed in the first month by 30% of the women found that > 300 mg caffeine daily from all sources was not associated with growth retardation (PO in human study).1966

Drug Interactions

I.          2) Increased weight loss due to a reduction of body fat as well as side effects of agitation, tremors, and insomnia when caffeine is combined with ephedrine (PO in human clinical study)19

            When 25 mg ephedrine was taken with 200 mg caffeine, systolic blood pressure, heart rate, and glucose, insulin and lactate concentrations were all raised (PO in human study). Taken alone, ephedrine increased heart rate, glucose, and insulin, and caffeine increase systolic blood pressure. No pharmacokinetic interaction was found. Oral contraceptives prolonged caffeine elimination.1665

Similar results occur when cola nut and ephedra are used together to provide 90 mg of ephedrine alkaloids and 192 mg of caffeine daily (PO in human study).1307

     +     13) Methotrexate efficacy for reducing the joint pain and morning stiffness of rheumatoid arthritis was diminished for those consuming 260 mg of caffeine daily on average, compared to those who consumed an average of only 90 mg daily (PO in human clinical study), probably due to methylxanthines like caffeine acting as adenosine receptor antagonists while methotrexate increases adenosine.1495

 

COMFREY                                                                           p. 75

            *Symphytum officinale root/leaves

Contraindications

1) Internal use due to development of hepatic veno-occlusive disease (human case reports)17,150,236,237,590

The belief that all internal comfrey use poses an inappropriate risk has been challenged on the basis of empirical experience and inadequate scientific investigation (speculative).1355

3) Avoid any use during pregnancy (speculative)150,401

due to fetal hepatotoxicity resulting from transferral from mother of toxic pyrrolizidine alkaloids similar to those in comfrey (injected in rats38 and PO in human case report144)

            4) Avoid any use by nursing mothers (speculative)150,401

due to infant hepatotoxicity resulting from transferral from mother of toxic pyrrolizidine alkaloids similar to those in comfrey (PO in rats)38

     +     7) In infants due to their increased susceptibility to the toxicity of pyrrolizidine alkaloids for even less than a week, whereas older children are affected after several months (empirical),1311 such as a 13 year old boy suffering veno-occlusive disease of the liver from consuming unknown quantities of comfrey root and then a tea made from its leaves for several years (PO in human case report)237

 

COPAIBA                                                                             NEW

     ^     *Copaiba langsdorffii, Copaiba spp. oleoresin

            (capivi, balsam of copaiba, balsam capivi)

Contraindications

            1) Internal use with inflamed urinary tract, especially in acute gonorrhea, due to its irritate volatiles excreted in the urine (empirical)2,5

 

COPTIS                                                                                 NEW

     ^     Coptis chinensis and Coptis groenlandica rhizomes

            (Chinese goldthread; Ch: huang lian) and (goldthread, canker root)

Contraindications

            1) Pregnancy due to emmenogogue effect of the herb2,150 and uterine stimulant activity of the alkaloid berberine (empirical)74,150

            2) Jaundice in newborns from (speculative) due to the displacement by berberine of bilirubin from serum albumen which may lead to kernicterus (IP in rats)1092 

Drug Interactions

I.          1) 0.2% berberine effectively eliminated inclusion bodies of Chlamydia trachomatis when used as eye drops to treat trachoma patients in conjunction with local sulphacetamide solution which alleviated clinical symptoms alone but did not eliminate this organism (locally in human clinical study)577

     +     2) Berberine 1.2 grams daily, given as tablets to 79 congestive heart failure patients on ACE inhibitors along with digoxin in 76, nitrates in 71, and diuretics / spironolactone in 77, significantly increased left ventricular ejection fraction and exercise capacity, improved dyspnea-fatigue index, and reduced frequency of ventricular premature complexes compared with 77 patients using only comparable conventional medications. The mortality of the berberine group decreased significantly as well, and there were no apparent side effects (PO in human clinical study).1457 In 56 congestive heart failure patients on loop diuretics and ACE inhibitors, including 51 using digoxin and 46 on nitrates, the significant increases in left ventricular ejection fraction and decreases in ventricular premature beats from baseline from 1.2 grams of berberine daily was also significant better when plasma berberine concentrations were higher versus lower than 0.11 mg/L (PO in human clinical study).2639

     +     3) Berberine at 0.6 grams daily for 3 months increased previously stabilized cyclosporin A trough blood concentrations by 90% in 52 renal transplant patients, and when given for 12 days to 6 transplant patients increased the cyclosporine bioavailability by 35% (PO in human clinical study), likely by inhibition of CYP 3A4 (speculative).2281

     +     4) The combination of 500 mg berberine 3 times daily for 3 months in 43 patients with poorly-controlled type 2 diabetes together with one or more of their regular oral hypoglycemic medications including sulfonylureas in 28, metformin in 20 acarbose in 15, and/or insulin in 10 resulted in lower fasting and postprandial blood sugar from week 1 through week 12 (PO in human clinical study). Fasting plasma insulin was also lowered by 28% and an index of insulin resistance by 45% of those on medications, while total cholesterol and LDL were likewise reduced. In 31 newly diagnosed type 2 diabetics to whom 15 were given the same dose of berberine and 16 used 500 mg metformin 3 times daily, berberine’s hypoglycemic effect was similar to that of metformin on fasting and postprandial blood glucose, as well as reducing glycosylated hemoglobin and plasma triglycerides (PO in human clinical study). Transient gastrointestinal adverse effects were experienced by 35% of the patients, or 20 in total.2315

II.         1) Berberine administered prior to pentobarbital increased the induced sleeping time (IP in mice)1032

A single 4 mg/kg dose of berberine prolonged pentobarbital sleeping time and increased strychnine toxicity (PO in rats)1215

            2) pre-treatment with 4 mg/kg berberine prevented a rise in serum levels of liver enzymes from excessive acetaminophen, suggesting protection from its toxic effects (PO in rats). Use of this dose three times every six hours following a toxic dose of acetominophen reduced liver damage.1215

     +     3) When the alkaloid component berberine was given once or twice at doses of 50, 100, or 200 mg/kg before cyclophosphamide injection, it significantly reduced the chemotherapy adverse effect of bladder hemorrhage in a dose-dependent manner (IP in rats).2570 

     +     4) Berberine at 100 mg/kg enhanced the anxiolytic effects of buspirone and ritanserin but did not interact with diazepine (PO in mice).2668

III.       1) An aqueous solution of berberine induced susceptibility of three strains of enteric bacteria to penicillin and 13 strains to chloromycetin which had previously been unaffected by these antibiotics (in vitro).578

      +    2) Berberine increased efflux of rhodamine 123 and paclitaxel by inducing P-glycoprotein and thereby reducing the retention and concentration of these drugs in human hepatoma and digestive tract cancer cells, respectively (in vitro)1045,1046

     +     3) It may have an additive effect with statins (speculative), since studies in human liver-derived cells with berberine extracted from coptis was found to increase LDL receptor mRNA expression (in vitro). Lovastatin did not reduce the effects of berberine that stabilized mRNA of the LDL receptor after transcription (in vitro), indicating a different mechanism of action (in vitro). In 63 high-cholesterol subjects taking 1.0 grams berberine HCl daily for 3 months, serum cholesterol was reduced 18%, LDL cholestreol 20%, and triglycerides 28%, compared to those using placebo (PO in human study). In the 32 who were taking no other medication or herbs, cholesterol was reduced 29%, LDL cholesterol 25%, and triglycerides 35%. HDL cholesterol was unaffected, and berberine was well tolerated. Berberine was found to have a dose-dependent cholesterol-lowering effect (in hamsters).1656 

 

CORDYCEPS                                                                       p. 76

            Cordyceps sinensis mycelium

Drug Interactions

I.          2) Fermented mycelial product improved clinical outcomes following cyclosporin A use in 30 kidney transplants (PO in human clinical study).598

            In 69 kidney transplant patients receiving cyclosporin, those 30 given 3 grams cordyceps concurrently had less nephrotoxicity compared to the 39 receiving placebo, based on serum creatinine and urea levels (PO in human clinical study).1804

 

CORYDALIS                                                                        NEW

     ^      Corydalis yanhusuo = Corydalis ambigua rhizome

            (Ch.: yan hu suo)

Contraindications

            1) Pregnancy due to its emmenagogue and uterine stimulant effects (empirical)150,404 due to its emmenagogue and uterine stimulant effects (empirical)150 and embryotoxicity (PO in rats)404  

 

COTTON                                                                               p. 76

            Gossypium herbaceum  = Gossypium indicum and Gossypium hirsutum fresh root bark

            (Levant cotton, Indian cotton; Ger.: Indische baumwollstaude; Fr.: cotonnier de l’Inde; Sp.: algodon) and (American Upland cotton)

Contraindications

            3) Self-prescribing since medical supervision is required (empirical)7 and Upland cotton root bark contains 1.2% gossypol1168 with its potential for adverse effects6 including hypokalemia with use of 20-50 mg gossypol daily for up to twelve months (PO in human studies)1169,1170 that is not controlled by potassium supplementation or use of a potassium blocker (PO in human studies)1170,1171

     +     4) Prolonged use in men may cause sterility150 since Upland cotton root bark contains 1.2% gossypol1168 and gossypol has been shown to be an effective male antifertility drug (PO in human study).1169 Also, hypokalemia occurs with use of 20-50 mg gossypol daily for 12 months (PO in human study).1169

Drug Interactions

III. +    1) Accelerated coagulation was shown with 0.5 ml/kg of an acetone-alcohol root extract (IV in dogs), which also increased prothrombin in the blood of rats,1172 so use with anticoagulants such as warfarin should be avoided (speculative)

     +     2) Since upland cotton root bark contains 1.2% gossypol1168 with its potential for hypokalemia with use of 20-50 mg gossypol daily for up to twelve months (PO in human studies)1169,1170 that is not controlled by potassium supplementation or use of the potassium blocker triamterene (PO in human studies),1170,1171 it may potentiate the activity of antiarrhythmic drugs and cardiac glycosides such as those in Adonis, Convallaria, Urginea, Helleborus, Strophanthusand Digitalis (speculative)

 

COUCH GRASS [now TRITICUM]                                               p. 77

            Elymus repens = Agropyron repens roots, rhizomes and short stems

 

CRANBERRY                                                                      NEW

     ^     Vaccinium macrocarpon fruit

            (craneberry)

Contraindications

II.  +     1) One liter of cranberry juice given daily for 7 days to 12 normal subjects and 12 formers of calcium oxalate stones to assess the risk of developing urinary stones (PO in human study). There were not differences between the two groups, but an increased urinary saturation of calcium oxalate of 18% and reduced pH was found in the combined groups. The risk of calcium oxalate stone formation is increased (speculative), whereas the risk of brushite stones is decreased. By comparison, cranberry cocktail contains only 27% juice.1997

Drug Interactions

I.          1) Initially, a brief report on5 individuals suggested cranberry juice may increase the effects of warfarin.1764 These included a case of fatal internal hemorrhage in a man in his 70s with an INR (International Normalized Ratio) initially reported to be >50.1483,1764  This elderly man had been taking a stable warfarin dosage for 4 years along with digoxin and phenytoin but suffered a deadly hemorrhage marked by melena after he consumed about 300-400 ml of cranberry juice daily for 6 weeks (PO in human case report). He had eaten almost no solid food for 2 weeks prior to his death, but continued his medication and the juice. On admission to a hospital just hours before dying his status included: INR >15, hemoglobin 5 g/dl, an immeasurable prothrombin time, and blood pressure 70/40 mmHG. Autopsy revealed 950 ml of fluid with blood in his pericardial sac, extensive bruising on his limbs, and blood throughout his gut from erosive pan-gastritis.2508

However, the fatal case was dismissed by some as due to an almost complete lack of other nutrition including competing vitamin K as well as prior 7-day use of the antibiotic cephalexin which can alter the intestinal flora and vitamin K biosynthesis.1765,2510 In brief anecdotes about another 6 potential interactions of warfarin with cranberry juice, 4 had INR increases, 2 had unstable INRs, and in 1 the INR decreased (PO in human case reports).1483,1764 After a 2-week lead-in for patients with stable warfarin INRs of 1.7-3.3 over the prior 8 weeks, a randomized double-blind trial with 16 subjects taking placebo and 14 using 9 oz cranberry juice daily for 2 weeks found no differences in INR or R- or S-warfarin peak levels during the lead-in or treatment phases. Plasma levels of warfarin were the same for both enantiomers in both groups at corresponding times. The mean INR was identical for both groups on day 15 at the end of the intervention. Only on day 11 was the INR of the cranberry group significantly higher. For the 14 subjects taking cranberry juice, 4 developed slightly higher INRs and 1 had a low INR, while 4 of 16 in the placebo groups had slightly higher INRs.2512 At least 30% of patients using warfarin are commonly outside of the normal therapeutic range.1765 

Nonetheless, a 71-year-old man taking warfarin sustained an INR of 2-3 for 3 months prior to using 24 oz cranberry juice daily for 2 weeks; he developed blood in his sputum and stools, low hemoglobin, a prothrombin time >120 seconds, and an INR of >18 (PO in human case report). After a blood transfusion and stopping warfarin and cranberry juice, bleeding was controlled in 1 day. His INR was 7 the next day and 2.6 in another 3 days.2505 A 78-year-old man taking a stable warfarin dose for about 6 years had never had an INR >3.0 before drinking a half gallon of cranberry/apple juice in the week prior to registering an INR of 6.45, but no bleeding was reported (PO in human case report). After adjusting warfarin dosage and refraining from cranberry juice, the INR decreased to 3.39 and normalized after 2 weeks.2506 A 75-year-old man taking a stable dose of warfarin for 10 months with INRs from 2-3 registered an INR of 4.8 a week after Thanksgiving, but no bruising or bleeding had occurred (PO in human case report). He reported consuming about 113 gm of cranberry sauce over the prior week. After discontinuing the cranberry sauce and stopping warfarin for 2 days, the INR returned to 2.2 within a week.2507

            However, cranberry juice does not inhibit the CYP 2C9 isozyme involved in metabolism of the more potent S-warfarin, since the 2C9 substrate flurbiprofen was not affected by exposure to cranberry juice (in vitro) or after 8 oz cranberry juice was consumed twice, the evening before and morning of the flubiprofen dose (PO in human study).1947 R-warfarin may be metabolized by CYPs 1A2 or 3A4, but 10 healthy subjects consuming 200 ml of cranberry juice or water three times daily for 5 days before and 5 days after taking 10 mg R,S-warfarin caused no changes in bioavailability for either warfarin isomer (PO in human study). Other CYP 1A2 and 3A4 substrates were also unaffected. The combination with the juice did not alter hemodynamics, but the low warfarin dose makes this observation tentative.2316

Taking 25 mg warfarin alone once as a baseline, following a 2-week washout 12 healthy males of ages 18-34 years took 1 gm of cranberry extract 3 times daily for 2 weeks; the same dose of warfarin was given again and the cranberry extract continued for a third week (PO in human study). The daily extract dose was derived from 57 gm of dried fruit. No changes in baseline INR or platelet aggregation were found after 2 weeks of cranberry extract alone. The protein binding and pharmacokinetics of the S- and R-warfarin enantiomers were not affected by use of the extract, neither for subjects with wild nor with variant CYP2C9 genotypes. On the other hand, the pharmacodynamic effect of warfarin combined with the extract, shown by a 30% increased area under the INR-time curve, was significant both statistically and clinically. A mean decrease in the estimated S-warfarin effective dose was shown when the extract was taken compared to control. This decrease was significant for the 8 subjects with a vitamin K epoxide reductase subunit 1 gene [VKORC1] variant, but not for the 4 subjects with the wild-type VKORC1. No bleeding or INR readings above 4 resulted. The strength of these findings is limited by the small sample sizes for the genotypes.2509

The United Kingdom’s Committee on Safety of Medicines has alerted clinicians of a potential interaction and advised patients to avoid concurrent use of warfarin with cranberry juice. It appears that ingestion of large volumes of juice destabilize the therapy, whereas small amounts are not expected to cause a serious interaction, though patients should be counseled and monitored.2510 An earlier pharmacodynamic investigation of 7 subjects on warfarin for 3 months did not find prothrombin time or INR changes when 250 ml of cranberry juice cocktail or placebo was given for 7 days, followed by a crossover after a 7-day washout, though the short time and small sample size limits the findings (PO in human study). The authors suggest that elimination of up to 250 ml [1 cup] cranberry juice cocktail daily should not be required if INRs are closely followed.2511 In a systematic review of the 9 unpublished and 6 published cases of potential interactions of cranberry juice with warfarin, 2 were found to be "probable" and 4 "possible" interactions on the Naranjo validation scale.2698

2) In 16 subjects consuming 3 glasses of 240 ml double-strength cranberry juice prior to a single dose of midazolam, its bioavailability was significantly reduced but not its half-life (PO in human study). This was indicative of inhibition of intestinal, but not hepatic, first-pass metabolism. The juice used was the only 1 of 5 commercial cranberry juice samples tested at 0.05% that showed significant inhibitory effects on metabolism of midazolam by CYP3A (in vitro).2699

            However, in prior trials no inhibition was shown in 10 subjects by 200 ml cranberry juice 3 times daily for 10 days with midazolam given on day 5 (PO in human study)2316 or when a single 240 ml glass of juice was taken with one dose of the CYP3A substrate cyclosporine by 12 health subjects (PO in human study). 2021

2) When 16 healthy volunteers consumed 3 glasses with 240 ml of double-strength cranberry juice prior to a single dose of midazolam, its bioavailability, but not its half-life, was significantly increased (PO in human study). This was indicative of inhibition of intestinal, but not hepatic, first-pass metabolism. The juice used was the only 1 of 5 commercial cranberry juice samples tested at 0.05% that showed significant inhibitory effects on metabolism of midazolam by CYP3A (in vitro).2699

                However, in prior studies no inhibition was shown by cranberry juice with midazolam (PO in humans) 2316 or with CYP3A substrate cyclosporine (PO in humans). 2021

III.       1) In human multiple myeloma cells the triterpenoid component ursolic acid increased the apoptotic effects of thalidomide from 20% to 70% and enhanced this activity of bortezomib from 25% to 80% (in vitro).2428

 

CRANESBILL                                                                     NEW

     ^     Geranium maculatum root

            (American cranesbill, spotted cranesbill, spotted geranium, alum root, crowfoot, wild cranesbill, wild geranium)

Contraindications

II.         1) GI inflammation and ulceration (speculative),1890 due to its tannin content.232,1890 However, cranesbill has been traditionally used as part of a formula with demulcents for treating gastric ulcers, especially when bleeding (empirical).1

            2) Iron deficiency anemia and malnutrition (speculative) due to tannin content that binds metal ions and thiamine1890 and reduces iron absorption when taken concurrently (PO in human study).1246

            3) Constipation (speculative) due to the high tannin content that produces an astringent effect.1890

            4) Prolonged use (speculative) due to its tannin content.1890

Drug Interactions

III.       1) Due to its tannin content, it should not be taken concurrently with oral thiamine, metal ions like iron and zinc, or alkaloids because of probable precipitation in the gut leading to reduced absorption (speculative) as is suggested by studies combining tea with metal ions or thiamine (in humans), tannins with thiamine (in animals), and tannins with alkaloids (in vitro).1890  

 

CRATAEVA                                                                                     NEW

     ^     Crataeva nurvala and Crataeva religiosa bark

Contraindications

II.         1) Pregnancy (speculative) without professional advice, due to its known antifertility and fetotoxic effects (in animals) and potential mutagenic and goitrogenic activity from its glucosinolate content.1890

 

CRUCIFERs                                                                                    p. 77

            Brassica spp heads or leaves

Drug Interactions

            1) Anticoagulant effect of warfarin may be inhibited or rendered ineffective by regular consumption of broccoli, brussels sprouts (PO in human case reports)32,33,303,304

       However, the glucosinolate metabolite indole-3-carbinol formed after maceration of cabbage, broccoli and Brussels sprouts, etc., also has both antiplatelet activity associated with inhibiting both fibrinogen binding to platelet surface glycoprotein receptor and the formation of TXB2 and PGE2 (in vitro) and has shown antithrombotic effects (PO in mice).2224 

3) Increased caffeine metabolic rate was shown after consuming 500-600 gm daily of cruciferous vegetables (PO in human studies).620,801

Compared to a basal diet with no vegetables, 36 subjects after eating for 6 days a diet containing 16 gm (0.5 cup) fresh radish sprouts, 150 gm (1 cup) frozen cauliflower, 200 gm (2 cups) frozen broccoli, and 70 gm (1 cup) fresh cabbage daily, had a significantly greater rate of caffeine metabolism by CYP 1A2 (PO in human study).1634 The juice of 2 cultivars of both Brussels sprouts and red cabbage both induced CYP 1A2 and UGT when raw or cooked, but Brussels sprouts had greater activity associated with its 2-3-fold greater glucosinolate content (PO in rats).1987

            4) Consuming 500 gm/day of broccoli, healthy subjects had increased estrone metabolism, due to increased CYP1A2 and other cytochrome P450 enzymes (PO in human study).620

With every 10 gm/day increase in crucifer consumption by 34 postmenopausal women, the 2-hydroxyestrone:16alpha-hydroxyestrone [2:16] ratio increases 0.08 (PO in human study). Increasing the 2:16 ratio is associated with reducing breast cancer risk.2516 400 mg daily for 2 months of I3C by 5 obese premenopausal women also increased the 2-hydroxyestrone:estratriol ratio, another indicator of lowered breast cancer risk (PO in human study).2517  Consumption of the cruciferous derivative indole-3-carbinol increased the detoxifying 2-hydroxylation of estradiol by over 50% (PO in rats, PO in human study).798,803

Indole-3-carbinol also reduces estrogen receptor-alpha expression by 50% a 100 mcM concentration in MCF-7 human breast cancer cells, while its metabolic dimmer has a comparable effect at 5 mcM (in vitro).1979

 

CUMIN                                                                                  NEW

      ^    Cuminum cyminum seeds

Drug Interactions

II.         1)  An aqueous extract, its concentrated fraction and an isolated flavonoid glycoside designated CC-I were all capable of increasing the oral bioavailability of the anti-turberculosis drug rifampicin (PO in rats). In gut sac studies CC-I increased the rate of mucosal-to-serosal transfer of rifampicin (in vitro). This can serve a therapeutic advantage since rifampicin has notoriously poor oral bioavailability.2296

 

DAN SHEN                                                                           p. 78

            Salvia miltiorrhiza roots

Drug Interactions

I.          1) Anticoagulants404 are enhanced due to reduced coagulation with extended use of the decoction (PO in human case reports);202,444,715

antithrombin III-like effects could augment the action of heparin (speculative).1238

II.   +    1) The chemotherapeutic drug doxorubicin (adriamycin) given intraperitoneally over a 2-week period caused less heart and liver damage when a freeze-dried powder of decoction of the roots was given along with it for 30 days (PO in rats). The extract was more effective at 100 mg/kg than 20 mg/kg, especially in preventing cardiotoxicity.2256 

III. +    2) Dan shen extract added to digoxin pools from patients resulted in false elevations (positive interference) for digoxin in the fluorescence polarization immunoassay (in vitro)1353,1386 and false reductions (negative interference) in the microparticle enzyme immunoassay (in vitro).1353 Unlike eleuthero and Asian ginseng interference, false positives and/or negatives can be avoided by monitoring free digoxin concentration.1352,1353,1386 The amount of interference varied with different brands of danshen products (in vitro).1386 

 

DANDELION                                                                       p. 79

            Taraxacum officinale = Taraxacum dens-leonis roots and leaves

Drug Interactions

II.   +    1) After being consumed for 4 weeks, a 2% tea made from the roots reduced the metabolism of the CYP 1A2 substrate phenacetin by liver microsomes to 15% of normal (PO in rats). It also reduced the activity of CYP 2E to 48% that of controls, while increasing phase II UDP-glucuronosul transferase activity by 244%.1608

 

DEVIL’S CLAW                                                                  p. 80

            Harpagophytum procumbens roots and tubers

Contraindications

            3) Avoid use except with caution in hyperacidity and esophageal reflux (speculative), due the the gastric stimulation effect of bitters (empirical).1890

Drug Interactions

I.          1) Purpura developed with the use of devil’s claw in combination with warfarin in one case (PO in human case report).614

However, this report has been described as unevaluable based upon report inadequacies.1239

     +     2) In 227 patients with hip, knee, or back pain associated with osteoarthritis, the use of nonsteroidal anti-inflammatory drugs (NSAIDs) including diclofenac, metamizol, aspirin, ibuprofen, naproxen, propyphenazon, clecoxib, acemetacin, ketoprofen, indomethacin, piroxicam, and rofecoxib was reduced with concurrent use of a standardized extract containing a daily dose of 60 mg harpagoside in this open trial (PO in human clinical study). Those with back pain required more medication, but their requirement decreased more than the other groups over 8 weeks of extract use.1368

            Devil’s claw extract with harpagoside has a dose-dependent analgesic effect (PO in human clinical study)1413 but lacks the biochemical effect on arachidonic acid metabolism typical of NSAIDs (PO in human study).1414

A dose of 2 gm/kg of an uncharacterized devil’s claw preparation lacked both anti-inflammatory and prostaglandin synthetase inhibiting activity (PO in rats),1415 even though 50-800 mg/kg of an aqueous extract of the secondary root produced significant analgesic and anti-inflammatory effects (IP in mice and rats, respectively).1743 Likewise, a 60% ethanolic 4:1 extract in water produced analgesic and anti-inflammatory effects in acute and chronic treatment with 25, 50 and/or 100 mg/kg (injected in rats).2001

     +     3) A randomized, double-blind comparative study with 100 mg daily of the analgesic diacerhein and 2.6 gm cryoground devil’s claw powder was carried out for 4 months with 122 patients with osteoarthritis of the knee and hip. Both diclofenac and the analgesic acetaminophen with caffeine were also allowed and their intake monitored. Pain reduction was equivalent for the two treatments, but those taking the devil’s claw had less adverse effects (diarrhea in 8% vs. 27%) and were using significantly less NSAID and analgesic at the end (PO in human clinical study).1411

            A 4-week RPCDB study of 118 chronic low back pain patients used 2.4 gm daily of a 2.5:1 devil’s claw tuber extract (with 50 mg harpagoside total) along with the analgesic tramadol. The use of tramadol by the extract and placebo groups was same, but at the end 9 of 51 in the extract group were pain-free compared to 1 of 54 in the placebo group. No adverse effects were noted (PO in human clinical study).1412 

                In an 8-week single-group open-label study with 259 general rheumatic disorder patients 960 mg of extract tablets from dried tincture was used daily, along with concomitant medications by 94% including analgesics by 154 of these subjects or 69% at baseline. Along with improved quality of life scores, significant reductions in pain scores were found for the hand, wrist, elbow, shoulder, hip, knee and back. Of those using the analgesics, after 8 weeks 26% had stopped taking them and 45% had decreased their dosage, while 17% used the same dosage and 9% increased the analgesic dosage. Tolerability was rated good by 87%; possible or probable adverse events were reported by 17%, most of which were gastrointestinal complaints, though no serious side effects were reported.2259

            However, some are of the opinion that use with powerful prescription analagesics should be approached with caution (speculative).1890

 

DILL                                                                                      p. 81

            Anethum graveolens fruit

Contraindications

     +     3) Allergic hypersensitivity to similar plants in carrot (Apiaceae) family (empirical)10

 

DOG ROSE

            Rosa canina fruit, petals

            (rose hip, brier hip, brier rose, dogberry, eglantine gall, hip rose, hip tree, hogseed, sweet brier, wild brier, witches’ brier)

Drug Interactions

I.          1) Five grams daily of standardized rose hip powder given randomly for 4 months to 48 osteoarthritis patients, of whom 23 were taking NSAIDs and 14 used acetaminophen, resulted in signicantly decreased joint pain compared to 48 taking placebo and comparable medications, and signicantly reduced NSAID use compared to baseline (PO in human clinical study). Reduction of acetaminophen was not significant.2564 In another randomized double-blind study in which 80 osteoarthritis patients used 5 grams of the same powder for 3 months in a crossover study design, 36 on prescription NSAIDs were told to maintain their use and dose; those who took placebo first had significantly reduced joint pain and use of analgesic rescue medications including acetaminophen and tramadol compared to baseline (PO in human clinical trial). Those who used the rose hop powder first showed no significant changes in pain, stiffness or rescue medications from baseline, presumably due to a strong carryover effect from the rose hip powder. Overall, there was a significant decrease in rescue medication from the first 2 weeks of active treatment compared to the last 2 weeks of the 3-month treatment.2565 In a very similar crossover study with 80 osteoarthritis patients using the same treatment and duration and advising those 28 on NSAIDS to maintain their dosage but encouraging all to reduce acetaminophen [n=39] and tramadol or codeine [n=16] analgesic rescue medications after 3 weeks of blinded active or placebo treatment in each crossover phase, joint pain was significantly reduced by rose hip powder after 3 weeks and rescue medication use was significantly reduced during the active treatment phase, including an acetaminophen reduction of 40%. After 3 months the stiffness, activities of daily living, and patient’s global assessment of disease severity were all significantly improved.2566

III.       1) The ethyl acetate extract of the petals increased the efficacy of b-lactam antibiotics including oxacillin, ampicillin, benzylpenicillin, or tetracycline against multi-drug resistant/methicillin-resistant Staph. aureus (in vitro). This was at least partially due to the component tellimagrandin I that increased oxacillin and tetracycline inhibition of methicillin-sensitive and multi-drug resistant Staph. aureus (in vitro). The extract and its isolate both inhibited protein binding of the antibiotics by these Staph. aureus strains.2351

However, the extract did not enhance the anti-Staph. effects of fosfomycin, erythromycin, or kanamycin with multi-drug resistant Staph. aureus strains or with ofloxacin and methicillin-resistant Staph. aureus (in vitro).2351 

 

DONG QUAI                                                                                    p. 81

            Angelica sinensis root

Drug Interactions

I.          1) Use concurrently with warfarin increased prothrombin time and doubled international normalized ratio (INR) (PO in human case report).616

            Another patient who used warfarin for 10 years began having widespread bruising along with an INR of 10 after one month of using dong quai (PO in human case report). After six days she was discharged as well.1230

2) Use of 100 mg dong quai extract daily along with 150 mg of soy extract containing 40% isoflavones (60 mg daily) and 50 mg black cohosh extract daily for 24 weeks by 49 menstrual migraine patients significantly reduced the number of doses of triptans and analgesics after 20-24 weeks compared to placebo (PO in human clinical study)1422

II.  +     1) An extract with 95% polysaccharides precipitated with 75% ethanol from a dong quai decoction dose-dependently prevented gastric mucosal damage from ethanol and indomethacin.  The effective dose was 10 mg/kg; 30 mg/kg had a protective effect that lasted at least 12 hours (IP in rats).1101

     +     2) Giving a water extract of the root at 15 g/kg daily for 4 weeks, prior to IV doxorubicin 15 mg/kg weekly, reduced the cardiotoxicity by improving heart performance,  preventing loss of myofibrils, and improving arrhythmias and conduction abnormalities, compared with water placebo (PO in mice). Mortality was also reduced. The antitumor activity of doxorubicin was not compromised by the root extract (in vitro).2672

     +     3) A polysaccharide fraction was shown to offset the leukopenia and gastroduodenal mucosal cytotoxicity induced by cyclophosphamide by promoting white blood cell recovery and increasing blood vessel number and cell proliferation in the gut tissues and by reversing the down-regulation of vascular endothelial growth factor in the stomach mucosa (SC in mice).2677

IV.       [1) It has been suggested that use with estrogen replacement therapy be avoided due to the supposed phytoestrogen content of dong quai (speculative).893

However, dong quai has shown no estrogenic activity in tests (in vitro, in rats, PO in mice, PO in human study).846,923,924,1664

Nonetheless, its alcoholic extract was shown to stimulate growth in the MCF-7 human breast cancer cell line independent of estrogenic activity (in vitro)1664]

 

DULSE                                                                                  p. 82

            Rhodymenia palmetta = Palmaria palmata thallus

Contraindications

     +     3) Large amounts during pregnancy due to potential development of infantile goiter (empirical)150

 

DYER’S BROOM                                                                p. 83

            Genista tinctoria plant and flower

Contraindications

     +     3) Hiatal hernia, esophageal varices, stomach ulcer or peptic ulcer due to aggravation and/or potential hemorrhage from emetic effect if bloodroot is taken in excessive doses (speculative)150

Drug Interactions

III. +    1) Do not take large doses after recent consumption of central nervous system stimulants, due to the emetic action potentially inducing convulsions (speculative).150

      +    2) Do not take large doses after recent consumption of central nervous system sedatives, due to the emetic action potentially inducing aspiration pneumonitis (speculative).150

 

EASTERN RED CEDAR                                                   NEW

      ^    *Juniperus virginiana berries and leaves

Contraindications

            1) Pregnancy (speculative)2,150 due to potential for adverse effects (empirical)2

 

ECHINACEA                                                                                   p. 83

            Echinacea angustifolia, Echinacea pallida, Echinacea purpurea roots

            Echinacea purpurea herb juice

Contraindications

            2) “In principle,” avoid in progressive systemic conditions such as leukosis4,17 (speculative).

Arabinogalactan-proteins from E. pallida roots increased murine spleen cell proliferation (in vitro).2150

5) For E. pallida and E. angustifolia herbs and roots, autoimmune disorders (speculative).4

E. angustifolia hydroalcoholic root extract was shown to increase antigen-specific IgG production but not IgM during weeks 2-4 of 6-week use (PO in rats).1176 Arabinogalactan-proteins from E. pallida roots increased IgM production of mouse lymphocytes (in vitro).2150

However, high doses (250 mg/kg) of high-alcohol root extracts of a combination of E. purpurea, E. angustifolia, and E. pallida failed to raise antibody levels to the same KLH antigen in female rats after two weeks. High and low (50 mg/kg) doses of a commercial 1:4 echinacea (unspecified “dried herb”) glycerin/water extract likewise had no effect on antibody production in male rats, but high doses decreased antibody production in females.1750

A 32-year-old man suffered a severe case of thrombotic thrombocytopenic purpura following a week of E. pallida hydroalcoholic extract use (PO in human case report). After transfusions and plasmapheresis for over a month, along with a variety of medications, the patient recovered completely.2694

A single case of sudden onset of Sjogren’s syndrome was associated with two weeks prior use of echinacea and other herbs. However, no causal evidence and no characterization or positive identification of the echinacea product were provided, so the association in this case is entirely speculative (PO in human case report). 1430

A case of pemphigus vulgaris controlled for 3 years (completely for 1 year) with prednisone, azathioprine, and/or dapsone had a severe acute exacerbation within a week after beginning daily supplementation with an uncharacterized echinacea product for an upper respiratory infection for the first time. He developed blisters on his trunk, head and oral mucosa, the latter an entirely new location. After discontinuing the echinacea, only partial control was achieved with the 3-drug combination (PO in human case report).1682

A 45-year-old male developed acute cholestatic autoimmune hepatitis with positive IgG levels after taking 1.5 gm/day of uncharacterized echinacea root tablets for about a month (PO in human case report). After stopping the echinacea consumption upon admission, the transaminases and cholestatic enzyme levels spontaneously decreased, and within a month all lab values were normal except for anti-smooth muscle antibodies.2147

However, though a temporal association existed, no causal evidence and no characterization or positive identification of the echinacea product were provided in these cases.1430,1682,2147,2694 

6) HIV infection or AIDS (speculative) for E. angustifolia and E. pallida roots or herbs.4,17

            Tumor necrosis factor-alpha (TNF-a) and other cytokines were not significantly altered after mitogenic stimulation in leukocytes taken from 23 tumor patients after a 4-week oral exposure to 3 ml daily of a combination extract made with 40% Echinacea angustifolia, 40% Eupatorium perfoliatum, and 20% Thuja occidentalis (PO in human study).  However, this dose of Echinacea is well below typical therapeutic exposure. Plant parts utilized were not specified, though the product is described as a spagyric extract combining three mother tinctures.1147

            While extracts of E. purpurea herb, root, and E. angustifolia root all increased production of the cytokines IL-1, IL-8, IL-10, and TNF-alpha in cell cultures after 6 hours (in vitro), giving  a combination of these extracts at 1.5 grams/day for 2.3 days decreased IL-1, IL-8, and TNF-alpha while increasing the antiviral cytokine interferon-alpha (PO in human study).1521  

7) Allergic hypersensitivity,777,1244 to aerial parts777,1244,1890 including to plants in the Asteraceae family, (empirical),777,1890  resulting mainly in contact dermatitis,1890 but anaphylaxis can follow internal exposure (PO in human case report).265,1244

Anaphylaxis, two acute asthma attacks, and a severe general rash in another patient has occurred from using internally either echinacea tablets, tea, or tincture (PO in human case reports). Of 26 other adverse reactions reported using one of six brands of these three forms, 26 suggested allergic responses, and half of these were in atopic disease patients. Four were anaphylactic, 12 had acute asthma, and 10 suffered urticaria/angioedema. Of 100 other atopic patients tested, only 3 had used echinacea, but 20% reacted to skin prick testing with aqueous or glycerinated extracts of echinacea, while 90% reacted strongly to grass pollens (topically human study).1244

Using dried E. purpurea juice in 200 children ages 2-11 years, 7.1% developed rashed compared to 2.7% of the 207 who used placebo (PO in human clinical study).1684

One individual suffering 4 episodes of erythema nodosum had used an echinacea product each time for flu-like prodromal symptoms (PO in human case report). Though a temporal association existed, no causal evidence was provided and no characterization or positive identification of the echinacea product was provided.1683

     +     8) Patients with organ transplants should avoid prolonged use echinacea preparations (speculative).1890

E. angustifolia hydroalcoholic root extract was shown to increase antigen-specific IgG production but not IgM during weeks 2-4 of 6-week use (PO in rats).1176 At doses of 0.4 and 0.8 ml/kg, daily use of a 1:4 extract of E. purpurea leaves, stem and flowers in 50% glycerin amd water enhanced IgM antibody-forming cell response (PO in mice). At 0.6 mg/kg the effect was significant at day 4 but not at day 8.2149 Arabinogalactan-proteins from E. pallida roots increased murine spleen cell proliferation and IgM production of mouse lymphocytes (in vitro).2150

However, though extracts of E. purpurea herb, root, and E. angustifolia root all increased production of the cytokines IL-1, IL-8, IL-10, and TNF-alpha in cell cultures after 6 hours (in vitro), giving  a combination of these extracts at 1.5 grams/day for 2.3 days decreased IL-1, IL-8, and TNF-alpha while increasing only the antiviral cytokine interferon-alpha (PO in human study).1521 Also, high doses (250 mg/kg) of high-alcohol root extracts of either E. purpurea or a combination of E. purpurea, E. angustifolia, and E. pallida failed to raise antibody levels to the same KLH antigen in female rats after two weeks. High and low (50 mg/kg) doses of a commercial 1:4 echinacea “dried herb” glycerin/water extract likewise had no effect on antibody production in male rats, but high doses decreased antibody production in females.1750

Drug Interactions

I.   +     2) E. purpurea root at 1.6 gm/day for 8 days both increased the clearance and reduced bioavailability of midazolam (IV in human study) but did not alter its clearance when the drug was given to 12 subjects (PO in human study). These results may suggest that the root extract components in the gut inhibit intestinal CYP3A while those absorbed induce liver CYP3A.1588 Likewise, when an E. purpurea whole plant extract was given in a 1.6 gram daily dose to 12 healthy subjects for 28 days, no significant effect on oral midazolam was detected (PO in human study).1589

                        However, tincture of E. purpurea roots was a strong CYP3A4 inhibitor, moreso than a tincture of the tops, but a E. angustifolia root tincture was the most potent (in vitro).840 A tea made from a mixture of E. purpurea and E. angustifolia tops, E. purpurea root extract, and spearmint and lemon grass leaves also inhibited CYP3A4 (in vitro).1577 The inhibition of CYP3A4 by different Echinacea species and types of preparations corresponded to their relative alkamide content, but CYP1A2 inhibition found with E. purpurea whole fresh plant extract did not (in vitro).2610 Alkamides from root extracts of E. purpurea and E. angustifolia are well absorbed, whereas caffeic acid conjugates are not (PO in human study).1968 Alkamides in E. pallida roots are in minute amounts and are isobutylamides of the type found in E. purpurea.2293 The enteric versus hepatic effects may be due to the fact that phytochemical exposure is different for each; this could help explain why the in-vitro studies of the entire phytochemical complex mimics the enteric rather than the hepatic in-vivo results.

      +    3) Echinacea purpurea root extract at 1.6 gm/day for 8 days reduced oral clearance of caffeine and tolbutamide when the drugs were given orally to 12 subjects, suggesting the root inhibits CYP1A2 and 2C9, respectively (PO in human study).1588

However, the clearance of the CYP 2C9 substrate tolbutamide was not considered clinically relevant because the 90% confidence interval for the geometric mean ratio of treatment over control phases was between 0.8-1.25 (PO in human study).1588 Also, when an E. purpurea whole plant extract was given in a 1.6 gram daily dose to 12 healthy subjects for 28 days, no significant effect on caffeine was detected (PO in human study),1589 suggesting that the active phytochemical content of the root differs from that of the whole plant in its effect on CYP 1A2. Isolated alkamides inhibited CYPs 2C19, 2D6, and 3A4, but not CYP 1A2 (in vitro).2610

     +     4) The use of 150 mg twice daily of an E. purpurea extract together for 9 months with desamethazone for 21 patients with anterior uveitis and oral prednisone for 11 patients with intermediate uveitis was compared with 10 and 9 patients, respectively, treated with these steroids alone (PO in human clinical study).  The primary difference in outcomes was that the patients initially using the echinacea extract with steroids were able to successfully remain off steroids for an average of 209 and 146 days, respectively, at the end of the test period, compared to 121 and 87 days, respectively, for those initially on steroids alone.2199

II.   +    1) Placebo, 10 mg/kg levamisole, or 360 mg/kg of a 70% ethanolic extract of E. purpurea dried aerial parts was given on the 10th day of gestation with phenytoin and 12 hours later (IP in mice). The teratogenic incidense of phenytoin-induced cleft palate in fetal mice by the 19th day of gestation was reduced from 16% with placebo to 5.3% by levamisole and 3.2% by the echinacea extract due to their immune-enhancing properties. The mean weight and length of fetuses were also enhanced by levamisole and the extract.2202

III.       1) Echinacea may offset or minimize the effects of immunosuppressive drugs (speculative).777,893

            Transplant patients who use these drugs should take echinacea preparations only for short-term use (speculative).1890

            However, at doses of 0.4 and 0.8 ml/kg, daily use of a 1:4 extract of E. purpurea leaves, stem and flowers in 50% glycerin amd water enhanced IgM antibody-forming cell response, and at 0.6 mg/kg the effect was significant at day 4 but not at day 8 (PO in mice).2149

E. angustifolia hydroalcoholic root extract was shown to increase antigen-specific IgG production but not IgM during weeks 2-4 of 6-week use (PO in rats).1176

While extracts of E. purpurea, E. angustifolia, and  E. pallida all increased production of the cytokines IL-1, IL-8, IL-10, and TNF-alpha in cell cultures after 6 hours (in vitro), giving  a combination of these extracts at 1.5 grams/day for 2.3 days actually decreased IL-1, IL-8, and TNF-alpha while increasing the antiviral cytokine interferon-alpha (PO in human study).1521 Also, high doses (250 mg/kg) of high-alcohol root extracts of either E. purpurea or a combination of E. purpurea, E. angustifolia, and E. pallida failed to raise antibody levels to the same KLH antigen in female rats after two weeks. High and low (50 mg/kg) doses of a commercial 1:4 echinacea “dried herb” glycerin/water extract likewise had no effect on antibody production in male rats, but high doses decreased antibody production in females.1750   

IV.       [1) Supposed hepatotoxic effects suggested that echinacea should not be used with known hepatotoxic drugs (speculation)893,896]

There have been seven cases of hepatitis anonymously reported in Australia that were suspected to be due to echinacea, though these reports were not confirmed.1244

 

ELECAMPANE                                                                   p. 85

            Inula helenium root

Contraindications

     +     2) Nursing mothers (speculative)150 due to potential toxicity (empirical)2

     +     3) Pregnancy (speculative)2,150 due to potential toxicity (empirical)2

 

ELEUTHERO                                                                      p. 86

            Eleutherococcus senticosus = Acanthopanax senticosus root

Contraindications

            2) Prolonged use without periodic breaks every one to three months (speculative)150

            Suspending use is likely based on the need to assess the response and health status and to determine the value of continuing as before, adjusting the dose, or stopping its use (empirical). It also may help avoid developing tolerance to the beneficial influences of the herb (speculative).

Drug Interactions

II.         1) Eleuthero increased the effect of hexobarbital (IP in mice), possibly due to inhibition of its metabolic breakdown (in vitro).111 Hexobarbital is typically metabolized by CYP 2C19.

III. +    1) Due to hypoglycemic effects of the aqueous extract (IP in mice)116 insulin dosage may need adjusting when consuming the tea (speculative).

However, 3 gram of root in 12 healthy subjects actually raised plasma glucose in a 75-gram oral glucose tolerance test after 90 minutes (PO in human study).1713 

2) [Formerly IV. 1)] It was reported that eleutherosides were associated with falsely elevated digoxin levels in the absence of toxic effects, presumably due to a digoxin assay interaction (ex vivo with human). Though the capsules were analysed and found negative for digitoid content, the identity of the contents was not established as eleuthero, referred to as Siberian ginseng.907 

            Using 5 digoxin immunoassays on 1 liquid eleuthero extract and 2 eleuthero extract capsules, the liquid and one of the capsules increased the digoxin concentration test results only for the fluorescence polarization immunoassay (in vitro, ex vivo with rats, ex vivo with humans).1352,1995 This increase occurred at at concentrations from 10-50 mcl/ml for the liquid extract, while the microparticle enzyme immunoassay showed reduced results, but only at 50 mcl/ml, and no change occurred with the Tina-quant (in vitro).1995  

However, the modest interference does not account for the great elevation noted in the prior case report, which may have been due to adulteration.1352 Also, and most importantly, 10 digitalized patients in a double-blind study who were given 300 mg daily of a dry eleuthero extract for 8 weeks did not show an alteration in blood digoxin levels compared to 10 given placebo, and no adverse effects were seen in either group (PO in human clinical study).2086 

 

ENGLISH LAVENDER [formerly LAVENDER]                         p. 129

Ä         Lavandula angustifolia = Lavandula officinalis = Lavandula vera flowers

Contraindications

     +     2) Cross-reactivity in those who have allergic hypersensitivity to other members of the mint family (Labiatae) such as oregano (Origanum vulgare) or thyme (Thymus vulgaris) may result in contact allergy to lavender (speculative), especially its oil.1890

     +     3) Skin exposure in prepubertal boys to cosmetic products with lavender essential oil scent including lotions, soap, shampoo and hair gel was associated with gynecomastia in 3 cases (TP in human case reports). Cell culture tests showed the oil has both estrogenic and antiandrogenic activity (in vitro).2025

However, neither the product names employed in the reported cases nor a listing of their ingredients with potential chemical hormone disrupters were disclosed, nor were the products tested for positive botanical identity or adulteration. A lack of empirical observation of estrogenic type effects for this traditional herb also challenges conclusions based on isolated cases and in vitro results (speculative). Since the condition in such boys is uncommon and 3 cases were reported in a short period of time from the same clinic, factors such as environmental influences should also be ruled out (speculative).2143  In at least one of the cases that noted only the use of lavender-scented soap and lotions,2025 it is possible the product may have not have contained true essential oil of lavender but only a cheaper lavender fragrance with synthetic aromatic chemicals, as is typical in some cosmetic products.

Drug Interactions

I.   +     1) In a 4-week randomized, double-blind trial with 45 patients with mild to moderate depression, 100 mg/day of imipramine combined with 60 drops daily of a 1:5 strength English lavender tincture (50% alcohol) was more effective and faster acting than when imipramine was used alone (PO in human clinical study).1387

 

ENGLISH PLANTAIN [formerly included with PLANTAIN] p. 162

Ä         Plantago lanceolata leaves

            (lance-leaf plantain, ribwort, buckhorn, chimney-sweeps, headsman, snake plantain, ribgrass, ripple grass, soldier’s herb)

Contraindications

            1) Avoid use in profuse catarrh or congestion of mucous membranes in respiratory conditions (empirical),777 since its mucilage may exaggerate the effect of the mucosal discharge.

 

EPHEDRA                                                                            p. 87

            *Ephedra sinica = Ephedra vulgaris, Ephedra equisetina, Ephedra intermedia;

            (Chinese ephedra, Chinese jointfir; Ch.: ma huang)

Ephedra distachya; Ephedra gerardiana stems

(European jointfir; Indian jointfir)

            [NOTE: American ephedra, such as Ephedra nevadensis, contains little or no alkaloids, so the Contraindications and Drug Interactions for Ephedra are not relevant for American species.150]

Contraindications

    +      21) At least 24 hours prior to surgery due to cardiovascular risks (speculative)1309

    +      22) Pre-existing psychiatric conditions due to the occurrence of 57 serious adverse psychiatric events including psychosis, severe depression, mania, hallucination, sleep disturbance, and suicidal ideation following ephedra supplement use, in which 2/3 involved patients who had preexisting conditions and/or were using medications or illicit substances (PO in human case reports).1863

Drug Interactions

I.          1) Weight loss and agitation, tremors, and insomnia, may occur when ephedrine is combined with caffeine (PO in mice, PO in human clinical study)18,19,20,305

When 25 mg ephedrine was taken with 200 mg caffeine, systolic blood pressure, heart rate, and glucose, insulin and lactate concentrations were all raised (PO in human study). Taken alone, ephedrine increased heart rate, glucose, and insulin, and caffeine increase systolic blood pressure. No pharmacokinetic interactions were found.1665

Similar results occur when ephedra with 24 mg ephedrine alkaloids is taken 3 times daily with a herbal caffeine source such as guarana containing 80 mg caffeine (PO in human clinical study)1173 or kola nut and ephedra are used together to provide 90 mg of ephedrine alkaloids and 192 mg of caffeine daily (PO in human study).1307 8 healthy subjects given a single dose (2 capsules) of a formula with guarana (200 mg caffeine) and ephedra (20 mg alkaloids) had a significantly increased systolic blood pressure after 90 minutes and increased heart rate after 6 hours. Though the kinetics of the caffeine and ephedrine alkaloids were comparable to similar drugs formulations, one subject with a high urine pH had longer ephedra alkaloid half-lives, and two subjects on oral contraceptives had longer caffeine half-lives (PO in human study).1356

In a double-blind, randomized, crossover trial 15 healthy subjects were given a single dose of the commercial product Metabolife 356, a proprietary blend of 728 mg that contained 12 mg of ephedra extract, 40 mg of guarana seed with caffeine, and unspecified amounts of 8 other herbs and 2 bee products, along with vitamin E, magnesium, zinc, and chromium. After taking the product subjects had significantly higher systemic blood pressure and extended QT intervals on their ECGs than after taking placebo. All reported nonspecific adverse events including jitteriness and queasiness after using the product but not after taking placebo. There were one case each of tachycardia, hand tremor and premature ventricular complexes after taking the product (PO in human study).1610

A case of congestive heart failure (CHF) and a case of myopericarditis were assessed as possibly related to ephedra after the young male subjects had used one or two products containing ephedra extract combined with caffeine over the course of 2 years (PO in human case reports). The doses and frequency of the products used were undetermined. Both smoked tobacco, and the CHF patient smoked marijuana and drank beer several times per week. The CHF patient died after 6 weeks, but the myopericarditis patient was stabilized with medication.1611

     +     11) Psychogenic drugs due to the occurrence of 57 serious adverse psychiatric events including psychosis, severe depression, mania, hallucination, sleep disturbance, and suicidal ideation following ephedra supplement use, in which 2/3 involved patients who had preexisting conditions and/or were using medications or illicit substances (PO in human case reports).1863

III.  +  4) Pargyline, isoniazid, and furazolidone (speculative) since they reduce inactivation of norepinephrine and dopamine, while ephedrine promotes the release of these neurotransmitters1493 

 

EUCALYPTUS                                                                    p. 91

            Eucalyptus spp. leaves

Drug Interactions

II.         2) Mixed-function oxidase induction by the leaves increased the toxicity of plants containing pyrrolizidine alkaloids such as Senecio jacobaea (PO in rats).36

The pyrrolizidine alkaloid senecionine from Senecio jacobaea, tansy ragwort, has been shown to be both bioactivated to its toxic form and detoxified to its N-oxide form by cytochrome P450 isozyme 3A4 (in vitro).1183 However, S. jacobaea chronic toxicity was not increased when fed together with St. John's wort, a known CYP 3A4 inducer (PO in rats).1653

 

eUROPEAN GOLDENROD [formerly GOLDENROD] p. 109

Ä         Solidago virgaurea plant

Contraindications

            1) Allergic hypersensitivity to goldenrod or similar plants in the Asteracea [Compositae] family (empirical). Contact dermatitis after either oral or topical exposure has occurred.1890

            One man had 5 days of generalized itchy eczema that began 6 days after use of a goldenrod fluid extract (PO in human case report). Patch tests were postitive for the fluid extract and the stronger goldenrod dilutions, and mildly positive for the Compositae plants tansy and yarrow.1976

 

EUROPEAN PENNYROYAL                                           NEW

    ^      Mentha pulegium plant

            (pennyroyal)

Contraindications

            1) Pregnancy due to its emmenagogue and uterine stimulant effects (empirical)7,150 and abortifacient activity secondary to the hepatotoxicity of its volatile oil component pulegone (empirical)2

            2) Nursing mothers, due to the toxicity of its component pulegone (empirical).1890

            3) Essential oil for internal use, due to its hepatotoxicity (empirical).1890

 

eUROPEAN VERVAIN                                                     NEW

     ^      Verbena officinalis plant

(Enchanter’s plant, herb of the cross, holy herb, Juno’s tears, pigeon’s grass, pigeonweed, simpler’s joy, vervain; Ger.: eisenkraut; Fr.: verveine)

Contraindications

            1) Pregnancy (speculative)2,150 due to its emmenagogue effect in early pregnancy (empirical)7,74

 

EVENING PRIMROSE                                                      p. 92

            Oenothera biennis seed oil

Drug Interactions

I.    +    3) When eight multiple sclerosis patients were given 2.4 ml of evening primrose oil (EPO) daily, only three showed improvement on their disability score, while four of six given the same amount of oil with 0.5 mg colchicine twice daily improved the disability score. Manual dexterity was enhanced overall in both groups (PO in human clinical study).1148

     +     4) 6-month double-blind trial involving 40 rheumatoid arthritis (RA) patients with upper GI lesions due to NSAIDs used 6 gm daily of EPO (540 mg of gamma linolenic acid, or GLA) or equal amount of “placebo” olive oil. NSAIDs were not stopped, but 3 in each group reduced their dose. EPO subjects had reduced morning stiffness after 3 months, while the olive oil group had reduced pain scores after 6 months (PO in human clinical study).1400 A study of 49 rheumatoid arthritis patients who used only NSAIDs to control symptoms determined the effects of EPO alone (GLA 540 mg/day) and combined with fish oil GLA 450 mg/day with EPA 240 mg/day) in comparison to placebo. After a year EPO improved symptoms in at least 93% with and without the fish oil versus 30% on placebo. In addition, 73% and 80% using EPO or EPO/fish oil, respectively, lowered or stopped NSAID use, compared to 30% on placebo (PO in human clinical study).1537 In a 3-month trial with 18 RA patients not using NSAIDs, 20 ml daily of EPO or olive oil daily reduced prostaglandin E2 and increased thromboxane B2 in both groups. These results were associated with a good therapeutic response, but no significant clinical improvement was found (PO in human clinical study). Acetaminophen was allowed for pain when necessary, and the antirheumatic drugs such as hydroxychloroquine and IM gold were continued at unchanged doses.1403

 

FALSE UNICORN ROOT                                                  NEW

^          Chamaelirium luteum rhizome

            (helonias)

Contraindications

            1) Pregnancy due to emmenagogue activity and GI irritant properties (empirical)150

            2) Stomach or intestinal irritation due to its irritant properties (empirical)150,1890 caused by its rich 9.5% saponin content including chamaelirin.1890

            3) Caution is urged when used by patients with pre-existing cholestasis (speculative).1890

 

FENNEL                                                                               p. 93

            Foeniculum vulgare fruit

Contraindications

            1) Pregnancy due to the emmenagogue effect (empirical),2,4,14,17,74,401

due to the phytoestrogenic activity as shown by the acetone extract of its seeds (in rats)1313

     +     6) CNS toxicity following consumption the tea, especially in nursing mothers and/or their breast fed infants (PO in human case reports)1141 

 

FENUGREEK                                                                      p. 93

            Trigonella foenum-graecum seed

Contraindications

2) Brittle diabetes (speculative),893

100 grams of defatted seed powder daily for 10 days lowered blood sugar and reduced by 54% the urinary glucose excretion in type 1 diabetics (PO in human clinical study).1646

A hypoglycemic effect is likewise found in type 2 diabetics (PO in human studies).1360,1645

Both aqueous and methanolic extracts of the seeds have hypoglycemic activity (PO in mice), suggesting that the active compounds are polar in nature.2253 A single-dose of dialysed aqueous extract at 15 mg/kg body weight reduced glucose in diabetics after 90 minutes and increased hepatic glucokinase and hexokinase, similar to insulin (IP in mice). Glucose tolerance increased while insulin levels were reduced in normal subjects (IP in mice).2525 

Drug Interactions

I.     +   1) In a double-blind study 2 capsules twice daily of a fenugreek seed hydroalcoholic extract taken by 12 newly diagnosed type 2 diabetes patients (10 using the oral hypoglycemic drugs sulfonylurea, biguanides, or both) resulted after 2 months in significantly decreased HbA1c levels, lower fasting and 2-hour postprandial insulin levels, and increased insulin sensitivity compared to 13 patients receivng placebo, of which 10 used the oral hypoglycemic drugs, also (PO in human clinical study).1360 Hypoglycemic activity was also shown in non-insulin dependent diabetes melitus type 2 with 100 grams defatted seed powder for 10 days with 10-15 patients (PO in human clinical studies),1645,1646

            2) [Formerly IV. 1) ]A woman stabilized on warfarin developed an elevated INR after several weeks of using a capsule of fenugreek before meals and 10 drops of boldo extract after meals. Her INR returned to the normal range after stopping the herbal products but became elevated again after resuming their use (PO in human case study). It may be that warfarin metabolism was reduced or the serum protein bond of warfarin was modified (speculative).1489 Boldine, an alkaloid in boldo (Peumos boldus), inhibits platelet aggregation by arachidonic acid and collagen, probably due to inhibition of thromboxane A2 (in vitro).1532

3) [Formerly II. 1] In 10 type 1 diabetics on insulin, 100 grams of defatted seed powder daily for 10 days lowered blood sugar and reduced by 54% the urinary glucose excretion (PO in human clinical study),1646 suggesting that it could lead to hypoglycemia in some who do not adjust insulin dosage (speculative).

A dialysed aqueous extract at 15 mg/kg body weight for 5 days reduced hyperglycemia in diabetics from days 5-15 (IP in mice). A single-dose of this extract also reduced glucose in diabetics after 90 minutes and increased hepatic glucokinase and hexokinase similar to insulin (IP in mice). Glucose tolerance increased while insulin levels were reduced in normal subjects (IP in mice).2525 The components coumarin and trigonelline have been shown to be partially responsible for hypoglycemic effects (PO in rats).128 Both aqueous and methanolic extracts of the seeds have hypoglycemic activity (PO in mice), suggesting that the active compounds are polar in nature.2253 The fenugreek component 4-hydroxyisoleucine has been shown to increase glucose-induced insulin release without interacting with other agonists of insulin secretion such as tolbutamide and glyceraldehydes, thus demonstrating a novel insulinotropic activity (in vitro).1507

II.         1) [See I. 3)]

   +       2) Consumption of 4 ml of a 1% aqueous extract of fenugreek seeds concurrently with ethanol for 60 days reduced liver and brain damage compared with use of alcohol alone, as indicated by serum enzymes and histopathological examinations (PO in rats). The aqueous extract has antioxidant potential inliver cells comparable to vitamin E and glutathione (in vitro).1484

III.       2) It may enhance cholesterol-lowering agents due to additive effects (speculative).777

100 grams of defatted seed powder for 10 days reduced total, LDL, and VLDL cholesterol and triglyceride levels in 10-15 patients (PO in human clinical studies).1645,1646

In a double-blind study 2 capsules twice daily for 2 months of a fenugreek seed hydroalcoholic extract by 12 type 2 diabetes patients, of which 10 used the oral hypoglycemic drugs, resulted in lower triglyceride levels compared to baseline, but not in the placebo group (PO in human clinical study).1360

            3) When human chronic myelogenous leukemia [KBM-5] cells were exposed to the saponin component diosgenin at 10 mM together with paclitaxel or doxorubicin, the cytotoxic effect of these agents were synergistically increased (in vitro). Diosgensin alone was equivalent in cytotoxicity to each of there chemotherapeutic agents in this cell culture (in vitro).2429

 

FEVERFEW                                                                                     p. 95

            Tanacetum parthenium = Chrysanthemum partheniumplant

Contraindications

            3) Allergic hypersensitivity to feverfew or other Asteraceae plants428,777

In 300 subjects chewing fresh feverfew leaves, 11.3% experienced mouth ulcers. This has also been experienced following systemic exposure from consuming tablets. Some had swollen lips and inflammation throughout their mouths, possibly due to the local effects of the sesquiterpene lactones (empirical).1351

Drug Interactions

III. +    2) The combination of feverfew component parthenolide with the NSAID sulindac inhibited the cell growth in pancreatic cancer cells synergistically in two lines and additively in one line (in vitro). The combination lowered the threshold for apoptosis, increased IkB-a protein, and decreased NF-kB DNA binding and transcriptional activities compared to their use as single agents.1844

     +     3) The feverfew component parthenolide and its combinaton with the antiestrogen fulvestrant both inhibited antiestrogen-resistant breast cancer cell growth (in vitro). The combination resulted in a 4-fold synergistic growth reduction and restored fulvestrant-induced apoptosis, apparently due to NFkB inhibition in the drug-resistant cells.1845

     +     4) The combination of feverfew component parthenolide with the anticancer agent paclitaxel increased the paclitaxel-induced apoptosis of MDA-MB-231 breast cancer cells by inhibiting NF-kB, thus mimicking IkBa.(in vitro).1846 The growth of MCF-7 breast cancer cells was inhibited by parthenolide, which also enhaced paclitaxel effectiveness against these cells (in vitro). It was observed that parthenolide stimulated tubulin assembly activity and altered the microtubule network and nuclear morphology when combined with paclitaxel (in vitro).1847

 

FLAX                                                                                                 p. 96

            Linum usitatissimum = Linum humile seeds

Contraindications

      +    7) Manic or hypomanic responses to high doses (75-120 ml daily) of flax seed oil used in open-label in management of schizophrenia and to lower doses effective for depressive expressions of bipolar disorder (PO in case report series)1496,1497 suggest that it should be avoided in mania patients (speculative).

Drug Interactions

II.   +    1) The combination of 10% flaxseed in the diet for 6 weeks with tamoxifen, given to groups with estrogen-dependent human breast cancer cell MCF-7 implants along with high estrogen and low estradiol supplementation, caused a greater reduction in tumor regression than tamoxifen alone by 50% vs 41% with high estrogen and by >53% compared to only tamoxifen with low estrogen (PO in mice).2240 When either 5%, or 10% flaxseed in the diet for 8 weeks was given to those with MCF-7 tumors, high estrogen, and tamoxifen, the tumor growth inhibition compared to the tamoxifen-only control was 48% and 43%, respectively (PO in mice). Flaxseed 10% diet with no tamoxifen gave 38% tumor inhibition and was similar to tamoxifen alone. The reduced tumor growth was caused by decreased cell proliferation and increased cell apoptosis.2241 Under the same conditions except without estrogen supplementation, the 5% and 10% flaxseed diets for 16 weeks reduced tumor size by over 90% compared to controls, while with tamoxifen alone only a 6% reduction was achieved. Tamoxifen with 10% flaxseed diet decreased tumor growth by 55%, along with decreased expression of cyclin D1, estrogen receptor a, insulin-like growth factor 1 receptor and human epidermal growth factor receptor 2 in both flaxseed groups (PO in mice).2242 In addition a 10% flaxseed diet with a 20% soy protein diet reduced MCF-7 tumor growth to size of controls, whereas the soy diet alone caused an increase in turmor size (PO in mice).2243

The effect of flaxseed may be due at least partially to the inhibition of the estrogen-generating enzyme aromatase by metabolites of its lignin secoisolariciresinol diglycoside (in vitro).913,914 This enzyme inhibition may explain the reduction in serum concentration of 17 b-estradiol and estrone compared to controls following flaxseed feeding of 5 or 10 grams to 28 postmenopausal women for 7 weeks in a crossover trial, compared to the basal diet with no flaxseed (PO in human study).2244

The flaxseed lignin metabolites enterodiol and enterolactone also reduced the breast cancer cell adhesion, migration, and invasion of 2 estrogen-negative cell lines, MDA-MB-435 and MDA-MB-231, dose-dependently alone and in combination with tamoxifen (in vitro).2245

III. +    1) When consuming significant quantities of the seeds with medications, the seed mucilage coats GI mucosa and retards absorption of oral drugs (speculative)4,6,17,150,344,401

such as aspirin, digitalis and other cardiac glycosides, antibiotics, and anticoagulants if administered concurrently (speculative),150 and may inhibit iron absorption (speculative).1890

 

FORSYTHIA                                                                        NEW

     ^     Forsythia suspense fruit

            (golden bells; Ch.: lian qiao)

Contraindications

            1) Pregnancy due to its emmenagogue and uterine stimulant effects (empirical)150

 

FRAGRANT ANGELICA                                                 NEW

     ^     Angelica dahurica root

            (Ch.: bai zhi)

Drug Interactions

II.         1) At 1 gm/kg dose of the root extract the CYP450 metabolism of tolbutamide (2C9), bufuralol (2D6), nifedipine (3A4) and diazepam (2C11, 2D1, 3A2) was inhibited. Likewise, the hydroxylation of testosterone by 3 separate enzymes was inhibited. Diazepam availability was not affected when it was administered IV, but increased 4 times when diazepam was administered orally (PO in rats).1632 Furanocoumarins from fragrant angelica, Angelica japonica (hamaudo) root, and other umbelliferous medicinals were shown to inhibit CYP 3A (in vitro).1637

 

FRANKINCENSE                                                                           NEW

     ^     Boswellia serrata resin

            (Indian frankincense, Indian olibanum, Salai guggal)

Contraindications

            1) Allergic hypersensitivity to Boswellia species, since contact dermatitis may result (empirical).1890

Drug Interactions

I.          1) In 3 groups with osteoarthritis of the knee, the number of those taking placebo who used ibuprofen as a rescue medication was 16.7% more than subjects using 100 mg/day of extract with 30% 3-O-acetyl-11-keto-beta-boswellic acid, but outcomes were still significantly better in the extract group; the placebo users of ibuprofen were 72.2% more than those taking 250 mg extract daily, yet the higher extract dose group had the greatest efficacy in relieving pain and improving physical function (PO in human clinical study).2483 In a review of 11 published trials using a standardized extract of the gum resin to treat rheumatoid arthritis, a considerable reduction of NSAID [nonsteroidal anti-inflammatory drug] intake was often shown during the course of treatment (PO in clinical studies).1534

II.         1) The gum resin extract H15 at 34.2 mg/kg and its component acetyl-11-keto-b-boswellic acid at 3.4 or 5.1 mg/kg reduced tissue injury, inflammatory features, and leukocyte adhesion to epithelial cells in ileitis induced by SC indomethacin (PO in rats).2662

 

FRENCH MARITIME PINE                                             NEW

            Pinus pinaster = Pinus maritima bark fraction

            (Pycnogenol®)

Drug Interactions

I.          1) The polyphenol fraction used by 28 hypertensive subjects at 100 mg daily for 12 weeks allowed for significant reduction of nifedipine dosage for treating hypertension compared to subjects receiving placebo (PO in human clinical study). Heart rate, lab findings, and the rate of adverse effects (all mild and transient) did not differ significantly between the two groups.1623

            In addition, early evidence of reduced renal function and blood flow associated with hypertension and leading to the development of kidney damage was diminished when 150 mg of Pycnogenol daily was combined with the ACE inhibitor drug ramipril in 29 pateints with high blood pressure, moreso than used of ramipril alone by 26 hypertesive patients (PO in human clinical study).2683

            2) The use of 50 mg of the special standardized extract Pycnogenol 3 times daily with meals for 3 months by patients with osteoarthritis of the knee using concurrent NSAIDs and/or analgesics led to a significant reduction in inflammation and pain scores over time and less use of these drugs, compared to baseline and placebo (PO in human clinical study).2324 A dose of 100 mg Pycnogenol daily in 77 patients with osteoarthritis of the knee recused NSAID us by 58%, compared to a 1% reduction by 77 patients taking placebo (PO in human clinical study). Gastrointestinal complications were thereby reduced by 63% versus 3% for placebo. There was also a 54% reduction in non-NSAID medications with Pycnogenol, compared to 11% for placebo. After 3 months the number and duration of hospitalizations and the symptoms scores, walking distance, and foot edema were significantly improved in the Pycnogenol group over the control group.2526

            3) Pycnogenol given at 150 mg daily for 2 months beginning the day after the first cycle of chemotherapy for solid tumors with 5-fluorouracil, cisplatin with gemicitabine or 5-fluorouracil, or CCNU with vinblastine, led to a reduction in adverse effects, especially nausea, vomiting, diarrhea, and weight loss, compared to controls (PO in human clinical trial). Other improvements in those taking Pycnogenol were seen with cognitive impairment, cardiotoxicity, neutropenia, and thrombotic episodes induced by chemotherapy. Less days of hospitalization were required, and less medications to treat the adverse effects of chemotherapy were consumed by those given Pycnogenol. Equivalent results were found with Pycnogenol given to patients receiving only radiotherapy for similar solid tumors.2523

Pycnogenol given for 13 days at 50-200 mg/kg with injection of the chemotherapy drug cyclophosphamide on days 8, 9, and 10 significantly decreased the reduction in hemoglobin and red blood cells and the inhibition of DNA synthesis in the thymus induced by drug (PO in mice). When doxorubicin was given every other day during 13 days of Pycnogenol daily doses of 50-150 mg/kg, the Pycnogenol significantly reduced the elevation in creatine phosphokinase and decreased heart rate induced by doxorubicin (PO in mice). No effect was found with Pycnogenol on the antitumor effect of doxorubicin or cyclophosphamide against S180 tumors (PO in mice).2522

4) The use of 100 mg daily of Pycnogenol by 30 subjects with allergic rhinitis to birch pollen for at least 3 weeks prior to seasonal exposure to this allergen led to only 36.7% relying on antihistamines as a rescue medication through the allergy season, compared to 50% of the 30 taking a matching placebo (PO in human clinical study). For those 8 taking Pycnogenol >7 weeks, only 1 required this additional drug use, as opposed to 5 of the 10 taking placebo over the same time period. Compared to placebo, hay fever nasal and eye symptoms were lower in those taking the extract for 5 weeks or more. The birch specific IgE titer was increased only 19.4% in the Pycnogenol group but 31.9% in the placebo group.2706 

III.       1) 150 mg of the polyphenol fraction taken 3 times daily for 4 weeks improved microcirculation, myocardial ischemia, and reduced platelet adhesion and aggregation in 26 coronary arterey disease patients not using anticoagulants or aspirin, compared to 25 patients taking placebo (PO in human clinical study).1570 After single doses of 100-120 mg of the bark polyphenol fraction, the enhanced platelet reactivity of 22 heavy German smokers and 19 American smokers who were not using anticoagulants or aspirin was normalized, similar to 500 mg of aspirin for the control group. Aspirin significantly increased bleeding time, though the polyphenol fraction did not (PO in human studies).1571 Though these platelet effects may safely reduce the risk of cardiovascular disease, especially coronary thrombosis for smokers, they may increase the risk of hemorrhage for patients who simultaneously use anticoagulants like warfarin or antiplatelet drugs like aspirin (speculative).

However, a study compared the effect on platelet aggregation and TxB2 levels following daily use of 200 mg of the extracted polyphenol fraction in 19 smokers with non-smokers using the extract. The study found the extract lowered these factors from hyperactive pretreatment levels in smokers to the normal level of non-smokers after 8 weeks of treatment (PO in human study). There was no change in platelet aggregation or TxB2 levels in non-smokers using the extract.2022 These results together indicate a low risk of increasing hemorrhage in either smokers or non-smokers (speculative). 

 

GARLIC                                                                                p. 99

            *Allium sativum bulbs

Contraindications

2) Excessive use should be avoided in early pregnancy (speculative).2

Prolonged and high doses of fresh garlic or products high in allicin should not be taken during pregnancy (speculative),1890 since a single dose of aqueous garlic extract at 25 mg/kg inhibits thrombin-induced platelet synthesis of the pro-aggregating thromboxane-A2 breakdown product, thromboxane-B2, with maximum effect after 6 hours of 64% inhibition (IV in rabbits).1108 A clove of garlic of about 3 grams daily for 16 weeks lowers serum thromboxane B2 by 90% (PO in human study).1707

3) Low thyroid function (speculative)2

since both fresh garlic homogenate and vinyldithiin components decrease T3 and T4 levels after 6-12 hours, serum TSH levels are lowered, and pituitary and thyroidial secretions are reduced (PO in rats).1224, 1234

            4) Heavy consumption prior to surgery (PO in human case reports)131,738

[CORRECTION] This results from increased fibrinolytic activity and DECREASED human platelet aggregation after oral consumption of garlic oil (ex vivo).279,280,286

For this reason garlic use should be discontinued at least 7 days before surgery, particularly if a person is at risk for excessive bleeding (speculative).1309,1310

A single dose of aqueous garlic extract at 25 mg/kg inhibits thrombin-induced platelet synthesis of the pro-aggregating thromboxane-A2 breakdown product, thromboxane-B2, with maximum effect after 6 hours of 64% inhibition.  This led to a significant recovery after 24 hours to 14% inhibition which was more complete after 72 hours at 11% inhibition (IV in rabbits).1108 About 3 grams of fresh garlic daily for 4 weeks lowers serum thromboxane B2 by 20%, but after 16 weeks it was reduced by 90% (PO in human study).1707 Antiplatelet activity has been shown for aged garlic extract (in vitro).1879 An aqueous extract of raw garlic is more potent than boiled garlic for inhibiting platelet aggregation (in vitro),1708 but boiling or oven-heating at 200oC for only 3 minutes did not affect platelet inhibition (in vitro).2038

However, compared to raw garlic activity, 6 minutes of boiling or oven-heating at 200oC suppressed antiaggregation activity with uncrushed garlic, and 10 minutes completely suppressed this effect for crushed garlic (in vitro).2038 Also, inhibition of platelet cyclooxygenase is achieved with aqueous extract of raw but not boiled garlic (in vitro).1709 In addition, 10 adults taking a proprietary garlic product at the manufacturer’s recommended dose for 2 weeks had no increase in coagulation time in ADP and epinephrine assays of intrinsic and extrinsic platelet function, respectively (ex vivo), but the product was not analyzed for its phytochemical content.2262 

     +     6) Brittle type 1 diabetes (speculative)893 due to the hypoglycemic effects of garlic, its juice or ether extract (PO in rats and rabbits)133,538,539 and its activity shown in healthy humans with 800 mg daily of garlic powder for over 4 weeks reducing blood glucose by 11.6% (PO in human study)956

     +     7) Allergic hypersensitivity in rare cases with frequent contact (empirical),17,401 typically in the form of contact dermatitis from the juice leading to blistering (empirical)10

     +     8) Prolonged application externally on unprotected skin may lead to chemical burn as occurred on the dorsum of the feet of a 17-month-old infant when no oil was applied and a >50% fresh garlic poultice was used on the feet for 8 hours (human case report). The child later patch-tested negative for allergic sensitivity to garlic.1746

Drug Interactions

I.          1) Taking garlic pearls or tablets reported doubled the INR of two patients stabilized on warfarin (PO in human case reports),451

though these events have been described as unevaluable based upon report inadequacies.1239

About 3 grams of fresh garlic daily for 4 weeks lowers serum thromboxane B2 by 20%, but after 16 weeks it was reduced by 90% (PO in human study).1707 Compared to raw garlic activity, boiling or oven-heating at 200oC for 3 minutes did not affect platelet inhibition (in vitro).2038

However, 6 minutes of either suppressed antiaggregation activity with uncrushed garlic, and 10 minutes completely suppressed this effect for crushed garlic (in vitro).2038

Also, 10 ml daily for 12 weeks of aged garlic extract found no evidence of hemorrhage in 22 patients using warfarin (PO in human clinical study),1878 even though antiplatelet activity has been shown for aged garlic extract (in vitro).1879 Aged garlic extract is active in reducing adherence to fibrinogen at 2.4-7.2 grams per day but only at the 7.2 gm/day in tests employing ADP, collagen, and von Willebrand factor (ex vivo).2037

Likewise, an enteric-coated garlic tablet derived from 2 gm of fresh garlic with 3.7 mg allicin per tablet was given twice daily for 3 weeks to 12 healthy subjects; when a single 25 mg dose of racemic warfarin was given after 2 weeks, no change in INR was detected over the next week (PO in human study).  Also, no effect on platelet aggregation was found, nor was the bioavailability of warfarin isomers affected as reflected by the plasma concentration-time profiles, indicating a lack of effect on CYP 2C9.2509

     +     2) Ten healthy people taking a caplet of garlic twice daily for three weeks had a reduction in plasma content of the CYP 3A4 substrate and HIV protease inhibitor saquinavir of just over 50% (PO in human study). After a 10-day washout period the saquinavir levels were still about 35% less than baseline.1210

However, subsequent testing in 14 healthy volunteers showed that 1.8 grams of a standardized garlic extract twice daily for 14 days did not impact the metabolism of the 3A4 substrate alprazolam or the 2D6 substrate dextromethorphan (PO in human study).1456 CYP 3A4 substrate midazolam was also unaffected by garlic oil (PO in human study).1328 These results implicate the possible induction of P-glycoprotein by garlic (speculative).

However, fresh and aged garlic extracts had a moderate effect on inhibiting P-glycoprotein (in vitro).1594

     +     3) Chlorzoxazone metabolism by CYP 2E1 was inhibited with consumption of 500 mg of garlic oil 3 times daily for 28 days in 12 healthy subjects; enhanced sedation from the drug was noted after garlic oil use.

However, CYP isozymes 1A2, 2D6, and 3A4 were unaffected by the garlic oil (PO in human study).1328,1808 A component of garlic oil, diallyl sulphide, given at 0.2 mg/kg was shown to reduce CYP2E1 activity by inhibiting chorzoxazone metabolism (PO in human study). The dose was roughly equivalent to the diallyl sulphide found in 15 cloves of garlic, though it was not equivalent to 15 cloves due to the many other active components in garlic.1717

     +     4) Aged garlic extract at 4 ml daily for 1 year inhibited the rate of coronary calcification of plaques in patients with coronary artery disease using maintenance doses of statins and aspirin (PO in human clinical trial).1772 In a randomized, placebo-controlled crossover study, the flow mediated endothelium-dependent dilation in the brachial artery, following two weeks of 2.4 grams aged garlic extract daily, improved in men with coronary artery disease who were using statins and aspirin concurrently (PO in human clinical study).1857

     +     5) A topical garlic gel applied twice daily for 3 months by 12 men and 8 women, along with a topical corticosteroid cream containing 0.1% betamethasone valerate for local treatment of balding areas of scalp, resulted in good results for 95% (TP in human clinical study). Size of patches and the number of total and terminal hairs in the areas were monitored. The response to the drug with garlic was significantly better than for 10 men and 10 women who used only the topical drug.2260

II.         1) Fresh garlic at 5 gm/kg prevented hepatotoxicity from acetaminophen and was partially protective at 0.5 gm/kg (PO in mice). 540

A single 500 mg/kg dose of diallyl sulfide depresses hepatic cytochrome P450 and aminopyrine N-demethylase activities (IP in rats), but 50 mg/kg for 5 days increased these activities (IP in rats).1362 Diallyl sulfone, a metabolite of diallyl sulfide, given in doses as low as 5 mg/kg prevented acetaminophen depletion of glutathione in the liver (PO in mice). At 25 mg/kg it completely protected from hepatotoxicity.1816

However, 16 subjects given 10 ml of aged garlic extract daily for 12 weeks caused no effect on CYP 2E1 metabolism of acetaminophen (PO in human study). The extract used minced garlic incubated in 15-20% alcohol for 8-12 months and had as its major constituent S-allyl-L-cyseine, but very little diallyl sulfide.1815

       +   3) Aged garlic extract as 2% of the diet for 4-5 days when giving methotrexate or 5-fluorouracil protected the intestines from damage (PO in rats).1262

            Severity of jejunal damage by methotrexate was reduced, as were increases in tissue MDA and plasma lactate by 250 mg/kg of the aged extract given to 40 subjects for 7 days (PO in rats).1865 

            Epithelial cells from the rat ileum were protected from methotrexate-induced apoptosis by 0.5% aged garlic extract (in vitro).1881 

       +   4) Raw garlic extracts and derivatives allicin and diallyl disulfide protected the gastric mucosa of rats from damage by 100% ethanol (PO in animal study)1263

       +   5) Aged garlic extract WG-1 given in doses of 0.05 ml six times weekly helped protect animals from doxorubicin toxicity to the heart muscle when it was given 3 times weekly for 40 days (IP in mice)1273

       +   6) Dried powedered leaves of garlic as 2% of the diet for 7 days,1911 or its components diallyl disulfide1912 or diallyl sulfide1913 at 50 mg/kg/day for 4 days, all reduced the kidney toxicity from injections of the antibiotic gentamicin, based on preventing the decrease the manganese superoxide dismutase and glutathione peroxidase and thereby preventing necrosis and oxidative changes in the kidney (PO in rats).1911-3 Aged garlic extract at 2.4 ml/kg/day for 6 days1914 and its component S-allylcysteine at 250 mg/kg/day for 5 days1915 likewise prevented kidney toxicity by gentamicin in the same manner (IP in rats).1914-5 Neither garlic powder extract or its components diallyl sulfide and diallyl disulfide nor aged garlic extract or its component S-allylcysteine interfered with the antibiotic activity of gentamicin against E. coli (in vitro).1910

III.       1) Insulin dose may require adjusting (speculative)

due to 800 mg daily of garlic powder reducing blood glucose by 11.6% (PO in human study).956

2) Prolonged and high doses of fresh garlic or products high in allicin should not be taken with antiplatelet drugs (speculative).1890 About 3 grams of fresh garlic daily for 4 weeks lowers serum thromboxane B2 by 20%, but after 16 weeks it was reduced by 90% (PO in human study).1707 Antithrombotic activity of garlic aqueous extract appears to be due in part to the inhibition of thromboxane B2 synthesis (IV in rabbits).1108 An aqueous extract of raw garlic is more potent than boiled garlic for inhibiting platelet aggregation ( in vitro).1708 Compared to raw garlic activity, boiling or oven-heating at 200oC for 3 minutes did not affect platelet inhibition, but 6 minutes of either suppressed antiaggregation activity with uncrushed garlic, and 10 minutes completely suppressed this effect for crushed garlic (in vitro).2038

     +     3) Mashed and freeze-dried fresh garlic, in concentrations corresponding to one clove in an empty stomach, and its major antibacterial derivative, allicin, both synergistically lowered the minimum inhibitory concentration of vancomycin against vancomycin-resistant Enterococcus spp. from 32-256 mcg/ml to 0.5-16 mcg/ml (in vitro)1560

     +     4) The essential oil and its isolate allicin enhanced the effectiveness of the antifungal drug ketoconazole against Trichophyton rubrum, T. erinacei, and T. soudanense (in vitro).2364 

IV.       [Formerly III. 2). 1). may enhance the effects of cholesterol-lowering agents due to additive effects (speculative).777

                        However, a 6-month study with 192 adults that used doses of fresh garlic, powdered garlic, and an aged garlic extract that were approximately equivalent to 4 grams of garlic for 6 days weekly found no significant effects on LDL-cholesterol, HDL-cholesterol, triglyceride levels or the ratio of total cholesterol to HDL-cholesterol compared to placebo (PO in human study).2034 ]

 

GINGER                                                                               p. 101

            Zingiber officinale rhizome

Contraindications

1) pregnancy150 due to its emmenagogue344 and abortifacient effects (empirical)74 and increased embryonic loss when consumed regularly as a tea (PO in rats).1157

It has therefore been stated that ginger should not be used for morning sickness401 when taken in large amounts.2

However, 250 mg four times daily of the powder root significantly reduced the number of vomiting episodes and the severity of nausea in 28 of 32 compared to 10 of 35 taking the placebo with no adverse outcome detected with the pregnancy (PO in human clinical study).1158

A placebo-controlled study with 26 subjects in the first trimester using ginger syrup representative of 1 gm ginger daily showed a reduction of nausea and vomiting with no apparent adverse effects (PO in human clinical study)1369

3) large doses prior to surgery to avoid risk of hemorrhage (speculative),428 possibly at least one week before elective surgery (speculative)1310

       However, a ginger product dose equivalent to 3.6 grams of the rhizome daily was given for one week and no change was detected in INR or platelet aggregation (PO in ex vivo human study).1774 At 100 mg/kg for 4 days an ethanolic extract of the dried rhizomes had no impact on whole blood clotting time, prothrombin time, or activated partial thromboplastin time (PO in rats).1174

            4) occupational allergic contact dermatitis due to regular, repeated exposure (empirical)777

            as well as topical application in patients with allergic hypersensitivity (empirical)777

     +     5) Use only with expert advice in the case of peptic ulcers (speculative).1890

                        However, 500 mg/kg of ginger spray dried extract significantly reduced gastric mucosal damage from 70% ethanol by inhibiting reduction of deep corpus mucin content (PO in rats).498 The protection against hydrochloric acid and/or ethanol is due in part to 6-gingesulfonic acid, zingiberene, 6-gingerol and 6-shagaol (PO in rats).504,505,507 Ginger ethanolic extract at 500 mg/kg likewise inhibited ulcer formation induced by 80% ethanol, indomethacin, and aspirin (PO in rats).506

Drug Interactions

I.    +    3) Six Danish rheumatoid arthritis patients using NSAIDs with little or no benefit found symptomatic relief from pain, swelling, morning stiffness, and restricted joint movement after adding 5 grams fresh or 0.5-1 gram powdered ginger daily. They stopped taking the NSAIDs yet remained improved with no side effects after 3 months (PO in human cases).1408 An open study of 28 patients with rheumatoid arthritis, 18 with osteoarthritis, and 10 with muscular discomfort using powdered ginger (from 0.5-1 to 2-4 gm per day, ave. 1-2 gm) from 3 months to 2.5 years found marked relief of pain and swelling was produced in 74% and 59% of rheumatoid patients, respectively. Good pain relief occurred for 55% of osteoarthritis patients, while 50% had marked reduction of swelling (PO in human study).1410 In subjects with knee osteoarthritis of whom 34% were using oral analgesics and 38% were using oral NSAIDs [nonsteroidal anti-inflammatory drugs], lower extremity massage 6 times within 3 weeks with 1% ginger oil and 0.5% orange oi in olive oil had significantly improvement in pain, stiffness, and function from baseline, whereas those receiving only olive oil massage or no massage showed no improvement (TP in human clinical study).2484

     +     4) A RPCDB 6-week study with 261 osteoarthritis patients used 2 capsules of extract EV.EXT77 (each containing 255 mg representing 2.5-4.0 gm dried ginger and 0.5-1.5 gm dried Alpinia galanga [galangal] ). In addition, acetaminophen was allowed for pain and was equal for the two groups. Reduced pain on standing after using the extract was significantly better than for placebo, and stiffness and pain after walking were also improved by the extract. Withdrawal rate due to adverse events was 13% in the extract group and 5% for placebo (PO in human clinical study).1409

However, in a RPCDB crossover study a 510 mg standardized Chinese ginger extract EV.ext-33 was compared with 1.2 gm ibuprofen daily when used for 3 weeks each by 56 osteoarthritis patients. As a rescue drug, acetaminophen was allowed up to 3 gm daily. For visual analogue scale of pain and Lequesne-index, as well as limiting acetaminophen use, the efficacy ranking was ibuprofen > ginger extract > placebo. While ibuprofen was significantly better than the other two using these criteria, the ginger extract was not significantly better than placebo. The frequency of adverse effects, mainly GI complaints, diminished in the same listed order (PO in human clinical study).1420

     +     5) One gram of ginger prior to chemotherapy and repeated six hours after completely controlled nausea and vomiting in patients receiving cyclophosphamide by 62% and 68%, respectively (PO in human clinical study). This was equivalent to injections of the antiemetic drug metoclopramide but significantly less effective than ondnasetron injections. The percentage of subjects obtaining partial or complete control of nausea and vomiting was equivalent for all three.1598

When combined with a high-protein meal 1 gram of ginger twice daily beginning a day after chemotherapy and continuing for 3 days helped reduce delayed nausea, its frequency, and the use of antiemetic medications compared to controls (PO in human clinical study). Chemotherapy in this group consisted single drugs or 2-drug combinations of cyclophosphamide, doxorubicin, epirubicin, etoposide, gemcitabine, navalbine, and/or paclitaxel. There was no benefit from ginger when used with regular protein meal under the same circumstances.2513

     +     6) Regular intake of dried ginger and tea made from ginger powder was associated with nosebleed and an increase in international normalized ration [INR] to > 10 in a woman who was on long-term phenprocoumon therapy (PO in human case report). She previously had a stable INR in the therapeutic range of 2.0-3.0. Partial prothrombine time [PPT] was also prolonged to 84.4 seconds, well beyond the normal range < 35 seconds. After giving vitamin K to counteract the phenprocoumon, both INR and PPT normalized, and the patient was stabilized on the same drug dose and advised to refrain from ginger intake.2087

     +     7)  In a prospective longitudinal 16-week study of 171 adults prescribed warfarin for anticoagulation who recorded bleeding events and risk factor exposures in a diary, garlic was identified as independently associated with an increased risk of self-reported bleeding, especially bruising beyond what is considered typical with warfarin (PO in human study). Seven bleeds associated with ginger during 25 weeks of total use among all patients were recorded.2206

However, no elevation of increased INR with was documented when ginger use was combined with warfarin, and no ginger doses were reported (PO in human study).2206 A ginger product dose equivalent to 3.6 grams of the rhizome daily was given for one week after and prior to single doses of warfarin, and no change in warfarin pharmacokinetics or protein binding was found 12 healthy males (PO in human study), nor was there detected any alteration in INR or platelet aggregation (ex vivo).1774  At 100 mg/kg for 4 days an ethanolic extract of the dried rhizomes given before 1 dose of warfarin had no impact on whole blood clotting time, prothrombin time, or activated partial thromboplastin time, when compared to warfarin alone (PO in rats).1174

     +     8)  With 10 healthy subjects taking ginger 1 gram daily for a week, it reduced platelet aggrevation by 35-38% depending on whether the inducing agent was collagen, ADP, or epinephrine (ex vivo in PO human study). Combined with 10 mg of nifedipine for a week in these healthy subjects, the same ginger dose increased inhibition of platelet aggregation to 69-80% from the 20-23% inhibition when nifedipine was given alone (ex vivo in PO human study). Combined with nifedipine for a week in hypertensive subjects with higher baselin platelet aggregation, the platelet inhibition was 61-64%, compared to 19-22% with nifedipine alone (ex vivo in PO human study). The effects of ginger were equivalent to those of 75 mg aspirin given daily for a week (ex vivo in PO human study). The synergistic effect on platelets could be useful as a prophylactic measure in hypertensive patients at high risk for cardiovascular and cerebrovascular complications (speculative).2312

     +     9) In a randomized crossover study with 48 gynecologic cancer patients receiving cisplatin therapy along with metoclpramide 8 times the first day, 1 gram daily of ginger for the first 5 days after chemotherapy was as effective in controlling nausea and vomiting as was continuing for 5 days the standard drug metoclopramide which was more associated with restlessness (PO in human clinical study).2534

            Vomiting induced by cisplatin was prevented by acetone and 50% ethanolic extracts at doses of 25-200 mg/kg (PO in dogs).1162 Delayed gastric emptying caused by cisplatin was reversed by 50% ethanolic extract at 500 mg/kg, acetone extract at 200-500 mg/kg, and juice of ginger at 2-4 ml/kg given 30 minutes before cisplatin (PO in rats).1156

     +     10) Patients consuming methoxsalen (8-methoxypsoralen) for photopheresis treatment of cutaneous T-cell lymphoma experienced on average 1/3 as much nausea after taking 1.59 grams of ginger 30 minutes prior than without using it (PO in human clinical study). Ten of 11 patients maintained therapeutic methoxsalen levels after using ginger; connective tissue disease may account for poor methoxsalen absorption by the one patient.2535 

     +     7) When given 3 days before and 3 days after chemotherapy together with 5HT3 receptor antagonist antiemetics (ondansetron or granisetron) on the day of chemotherapy, 0.5-1.5 grams of ginger significantly reduced nausea greater than the antiemetic drug alone (PO in human clinical study).2585

III.       1) See IV. 2).

IV.       [Formerly, III. 1) ] [2) An ethanol extract of dried ginger rhizomes had no effect on coagulation parameters or changes in coagulation induced by warfarin when given in doses of 100 mg/kg (PO in rats).1174

Ginger extract tablet derived from 0.4 grams of rhizome powder were given in doses of 3 tablets three times daily for a week, followed by a single dose of warfarin (PO in human study). No changes were observed in R- or S-warfarin kinetics including protein binding, nor was any alteration of INR detected following ginger extract use.1774 One week is unlikely to be sufficient for cytochrome P450 induction that might reduce warfarin bioavailability. Continuing ginger extract use for another week, no change in INR or platelet aggregation ex vivo were detected from using the daily extractive of 3.6 gram of ginger alone (PO in human study).1774

            Only extremely large doses of ginger beyond its normal therapeutic use of 2-4 gm daily appear to increase the risk of further reducing coagulation when taken with anticoagulants, and no such incidences have been documented in animals or humans.]

 

GINKGO                                                                               p. 103

            Ginkgo biloba leaves

Contraindications

1) Allergic hypersensitivity of the skin or gastrointesitinal tract to ginkgo or its preparations which are rare (empirical).17,344,401

What has been described as fruit ginkgolic acid cross-reactions in ivy-sensitive individuals may actually be irritative and/or allergic reactions to cardanols, decarboxylation products of ginkgolic acids that may be produced in solution (topically in guinea-pigs).1266 Injection of 2 mg of a 60% hydro-alcoholic extract and a concentrated fraction with 24.6% ginkgolic acids produced a significant lymphoproliferative reaction in the local lymph node (subplantar in mice). A heptane fraction that contained no ginkgolic acids or cardanols and one that had 49.1% ginkgolic acids also produced significant reactions.1267

2) Bleeding disorders428 due to potential association with hemorrhage as reported after chronic (6-month or 2-year) daily use of 120-160 mg ginkgo extract (human case reports).195,525,1190,1191,1449

A systematic review of 12 case reports of ginkgo products associated with hemorrhage found that the likelihood of causality were in 10 case possible, while one case was unevaluable and only one case involving a drug interaction was likely caused by ginkgo extract.1727 Another case and a systematic review of 15 published cases associated ginkgo with bleeding episodes. Other risk factors were identified in 13 of the cases, but in 6 reports the bleeding did not recur after the ginkgo was stopped. This incident involved a 73-year-old man with multiple spontaneous bleeds that stopped when he discontinued his 6-month, 75 mg/day dose of ginkgo extract standardized to 27% flavone glycosides and 10% terpene lactones (PO in human case report). After a 6-week washout lab tests for bleeding parameters were normal, e.g., bleeding time 5.5 minutes. After 10 weeks back on the same dose he had occasional ecchymoses and a bleeding time elevated to >15 minutes.1916

A couple of poorly-documented cases illustrate the uncertainty in a number adverse incidences in which ginkgo is suspected of contributing to bleeding events. A 78-year-old woman with age-related macular disease took an unspecified amount of ginkgo with fish oil and other supplements for 4 months and developed preretinal and subretinal hemorrhage, and in the following month a dense vitreous hemorrhage appeared (PO in human case report). After stopping ginkgo use, the vitreous hemorrhage gradually resolved.2320 A 59-year-old man also suffered a vitreous hemorrhage during ginkgo use of undocumented amount and duration, subsequent to a subphrenic hematoma following a liver transplant (PO in human case report). Though ginkgo use began before the transplantation, no bleeding problems occurred during the procedure; also, 81 mg of aspirin were given daily after the transplant. No bleeding episodes were noted after ginkgo cessation.2321

While ginkgolide B can prevent and embolize PAF-induced thrombi (in vitro), several ginkgo extracts and ginkgolide B reduce PAF-induced thrombus formation (IV in guinea pigs).1380

However, a PAF-induced aggregation of human platelets requires a concentration of 100 times or more greater than is achieved in the plasma by normal therapeutic doses of 120-240 mg of a 50:1 concentrated ginkgo extract (in vitro).1747 A database of bleeding episodes among 320,644 German patients indicated that EGb 761 does not increase the risk of bleeding episodes when taken with or without anticoagulant or antiplatelet drugs (PO in human study).2117 Also, 10 adults taking a proprietary ginkgo product at the manufacturer’s recommended dose for 2 weeks had no increase in coagulation time in ADP and epinephrine assays of intrinsic and extrinsic platelet function, respectively (ex vivo), but the product was not analyzed for its phytochemical content.2262 

In 21 of 28 healthy midage (ave. 43) subjects and 16 of 19 midage (ave. 54) patients with type 2 diabetes mellitus, taking 120 mg of standardized ginkgo extract for 3 months significantly reduced collagen-mediated, but not PAF-mediated, platelet aggregation (PO in human study).1381 A randomized, placebo-controlled, double blind crossover trial used 120 mg daily of the extract EGb 761 with 12 healthy subjects for 3 months, with the result of COX-1 inhibition decreasing production of thromboxane B2, a promoter of platelet aggregation, after taking the extract (ex vivo). When the extract was added to platelet-rich plasma, platelet aggregation and thromboxane B2 were both inhibited (in vitro).1848 

However, in 32 healthy young males, taking ginkgo extract EGb761 for 2 weeks at 120, 240 or 480 mg daily hemostasis, coagulation and fibrinolysis were not significantly altered (PO in human study).1455 Furthermore, 40 subjects aged 65-79 years taking 120 mg Egb-761 daily for 7 days had no change in bleeding or coagulation parameters (PO in human study).1833

Type 2 diabetics using 240 mg EGb 761 daily for 3 months had significantly decreased fibrinogen levels and blood viscosity compared to baseline values (PO in human study).1759 Also, 25 subjects from age 60-70 taking 80 mg daily of a standardized dry extract had reduced blood viscosity compared to 23 men of the same age taking placebo (PO in human study).1526 Blood viscosity decreased after 6 months in 25 men when taking EGb761 at 80 mg/day, compared to placebo (PO in human study). The decrease was progressive for the first 90 days, but not during the second 90 days.2297

3) Use before elective surgery (speculative)428,703 for at least 36 hours1309 or up to one week.1310,1782

A rare retrobulbar hemorrhage following injection of local anesthetic prior to cataract surgery was associated with daily use of 120 mg ginkgo extract for two years (PO in human case report).1488

On the first night after an unspecified ambulatory surgery, disseminated bleeding in the operative field occurred in a 75-year-old woman who had taken 80 mg daily for 2 years of a 35-67:1 ginkgo concentrated extract (PO in human case report). Platelet count, coagulation factors, and prothrombin time were normal, but platelet aggregation to collagen was decreased, though normal with ADP, epinephrine, and ristocetin (in vitro). Bleeding times, also known as closure times, were prolonged with ADP and epinephrine (in vitro). After being advised and stopping extract use, 10 days later the platelet aggregation and closure times were normal.2322

Following a total hip arthroplasty in a 77-year-old woman, persistent bloody/serous discharge 3 weeks after aspirin was stopped was connected with the ongoing use of 120 mg daily of ginkgo extract, though no clotting cascade abnormalities were identified (PO in human case report). Following the ginkgo extract withdrawal, the oozing gradually reduced until it was dry 5.5 weeks later.2318 In another total hip arthroplasty, a 65-year-old man had acute postoperative wound hemorrhage associated with preoperative use of 2 tablespoons daily of a liquid herbal extract from ginkgo and 4 other herbs: Piper longum, Tylophora indica, Marrubium vulgare, Cetraria islandica (PO in human case report). After a 4-unit transfusion the bleeding stopped after 8 hours, and the patient was discharged on the fifth postoperative day.2319

A 59-year-old man suffered a subphrenic hematoma with ginkgo use of undocumented amount and duration, following a liver transplant (PO in human case report). Though ginkgo use began before the transplantation, no bleeding problems occurred during the procedure; also, 81 mg of aspirin were given daily after the transplant. This was followed by a vitreous hemorrhage 3 weeks later. No bleeding episodes were noted after ginkgo cessation.2321

Recently, two incidences of bilateral hematomas following a rhytidoplasty or blepharoplasty occurred after chronic use of 160 mg ginkgo extract daily (PO in human case reports).1782

A case report of spontaneous bleeding and a systematic review of 15 published cases associated ginkgo with bleeding episodes. Other risk factors were identified in 13 of the cases, but in 6 reports the bleeding did not recur after the ginkgo was stopped.1916

A systematic review of 12 case reports of ginkgo products associated with hemorrhage found that the likelihood of causality were in 10 case possible, while one case was unevaluable and only one case involving a drug interaction was likely caused by ginkgo extract.1727 A database of bleeding episodes among 320,644 German patients indicated that EGb 761 does not increase the risk of bleeding episodes when taken with or without anticoagulant or antiplatelet drugs (PO in human study).2117

25 subjects from age 60-70 taking 80 mg daily of a standardized dry extract had reduced blood viscosity compared to 23 men of the same age taking placebo (PO in human study).1526

A randomized, placebo-controlled, double blind crossover trial used 120 mg daily of the extract Egb 761 with 12 healthy subjects for 3 months, with the result of COX-1 inhibition decreasing production of thromboxane B2, a promoter of platelet aggregation, after taking the extract (ex vivo). When the extract was added to platelet-rich plasma, platelet aggregation and thromboxane B2 were both inhibited (in vitro).1848

However, in 32 healthy young males taking ginkgo extract EGb761 for 2 weeks at 120, 240 or 480 mg daily hemostasis, coagulation, and fibrinolysis were not significantly altered (PO in human study).1455  In addition, 40 subjects aged 65-79 years taking 120 mg Egb-761 daily for 7 days had no change in bleeding or coagulation parameters (PO in human study).1833 Type 2 diabetics using 240 mg Egb 761 daily for 3 months had significantly decreased fibrinogen levels and blood viscosity compared to baseline values (PO in human study).1759 Also, 10 adults taking a proprietary ginkgo product at the manufacturer’s recommended dose for 2 weeks had no increase in coagulation time in ADP and epinephrine assays of intrinsic and extrinsic platelet function, respectively (ex vivo), but the product was not analyzed for its phytochemical content.2262    

While ginkgolide B can prevent and embolize PAF-induced thrombi (in vitro), several ginkgo extracts and ginkgolide B reduce PAF-induced thrombus formation (IV in guinea pigs).1380

However, a PAF-induced aggregation of human platelets requires a concentration of 100 times or more greater than is achieved in the plasma by normal therapeutic doses of 120-240 mg of a 50:1 concentrated ginkgo extract (in vitro).1747 In 21 of 28 healthy midage (ave. 43) subjects and 16 of 19 midage (ave. 54) patients with type 2 diabetes mellitus, taking 120 mg of standardized ginkgo extract for 3 months significantly reduced collagen-mediated, but not PAF-mediated, platelet aggregation (PO in human study).1381

     +     4) Patients possibly predisposed to seizures should be avoided or done cautiously (speculative). At least seven anecdotal reports have been submitted to the FDA’s Special Nutritionals Adverse Event Monitoring System by the general public concerning claims of ginkgo-linked seizures, though most follow use of multi-ingredient products.  Apparently, no follow-up medical reports have documented these or other such claims appearing on several other online forums; neither has ginkgo identity nor plant part been confirmed in these cases. 1105

Drug Interactions

I.          1) A A50:1 concentrated extract induced bleeding following chronic use of aspirin (PO in human case report).194

Following a total hip arthroplasty in a 77-year-old woman, persistent bloody/serous discharge continued for 10 days, at which time aspirin use was stopped (PO in human case report). Then 3 weeks later, the continued oozing was associated with the continuing use of 120 mg daily of ginkgo extract, though no clotting cascade abnormalities were identified. Following the ginkgo extract withdrawal, the oozing gradually reduced until it was dry 5.5 weeks later.2318 A 59-year-old man suffered a subphrenic hematoma with ginkgo use of undocumented amount and duration following a liver transplant; 81 mg of aspirin were given daily after the transplant, and though ginkgo use began before the transplantation, no bleeding problems occurred during the procedure (PO in human case report). This was followed by a vitreous hemorrhage 3 weeks later. No bleeding episodes were noted after ginkgo cessation.2321

However, in a randomized double-blind study of 67 peripheral arterial disease patients taking 325 mg of aspirin daily, compared to placebo the addition of 300 mg/day for 4 weeks of EGb 761 made no difference in platelet function analysis or platelet aggregation induced by the agonists epinephrine, collagen or ristocetin (ex vivo).2229

Use should be avoided with anticoagulants.401,415,416,777,893 including heparin, and antiplatelet drugs including NSAIDs (speculative).893 [For warfarin, see IV. 1).]

            However, a database of bleeding episodes among 320,644 German patients indicated that EGb 761 does not increase the risk of bleeding episodes when taken with or without anticoagulant or antiplatelet drugs (PO in human study).2117 A systematic review of 12 case reports of ginkgo products associated with hemorrhage found that only the case involving the ibuprofen interaction was likely caused by ginkgo extract.1727 This case involved 2.5 years use of 80 mg daily of a 50:1 ginkgo extract and resulted in a fatal intracerebral hemorrhage when 600 mg of the NSAID ibuprofen daily was introduced for 4 weeks (PO in human case report).1432

A randomized, placebo-controlled, double blind crossover trial used 120 mg daily of the extract EGb 761 with 12 healthy subjects for 3 months, with the result of COX-1 inhibition decreasing production of thromboxane B2, a promoter of platelet aggregation, after taking the extract (ex vivo). When the extract was added to platelet-rich plasma, platelet aggregation and thromboxane B2 were both inhibited (in vitro).1848 While ginkgolide B can prevent and embolize PAF-induced thrombi (in vitro), several ginkgo extracts and ginkgolide B reduce PAF-induced thrombus formation (IV in guinea pigs).1380

Type 2 diabetics using 240 mg EGb 761 daily for 3 months had significantly decreased fibrinogen levels and blood viscosity compared to baseline values (PO in human study).1759  Also, 23 subjects from age 60-70 taking 80 mg of a standardized dry ginkgo extract daily for 8 months had reduced blood viscosity compared to 25 men of the same age taking placebo (PO in human study).1526 In 21 of 28 healthy midage (ave. 43) subjects and 16 of 19 midage (ave. 54) patients with type 2 diabetes mellitus, taking 120 mg of standardized ginkgo extract for 3 months significantly reduced collagen-mediated, but not PAF-mediated, platelet aggregation (PO in human study).1381

However, in 32 healthy young males taking ginkgo extract EGb761 for 2 weeks at 120, 240 or 480 mg daily, hemostasis, coagulation and fibrinolysis were not significantly altered (PO in human study).1455  Furthermore, 40 subjects aged 65-79 years taking 120 mg EGb-761 daily for 7 days had no change in bleeding or coagulation parameters (PO in human study).1833 A PAF-induced aggregation of human platelets requires a concentration of 100 times or more greater than is achieved in the plasma by normal therapeutic doses of 120-240 mg of a 50:1 concentrated ginkgo extract (in vitro).1747

2) ginkgo leaf extract offset sexual dysfunction following antidepressant use.

A placebo-controlled double blind study with 37 patients involved 36 using SSRIs; half were given 120 mg ginkgo extract EGb 761 daily fo 2 weeks, 160 mg for the next 2 weeks, and finally 240 mg daily for 4 weeks. The ginkgo and placebo both showed significant improvement over baseline performance at some point. Comparing the two showed placebo to be better in one of 9 categories with no significant difference in the others (PO in human clinical study).1318

4) Ginkgolide B helped prevent rejection of kidney transplants when used with cyclosporine (IV in  human clinical study).527 

A ginkgo product given at 240 mg daily did not alter digoxin pharmacokinetics in 8 healthy subjects (PO in human study),1477 so an effect on cyclosporine absorption is unlikely, since both digoxin and cyclosporin are P-glycoprotein substrates.

5) Ginkgo extract taken with trazodone resulted in a coma (PO in human case report).1058 

Trazodone is metabolized by CYP 3A4, but standardized ginkgo extract given at 240 mg daily for 4 weeks did not alter midazolam metabolism by 3A4. Likewise, isozymes 1A2, 2D6, and 3E1 were not affected by ginkgo extract (PO in human study),1328 though the extract as 0.5% of the diet caused induction of CYPs 1A1, 1A2, 2B, 2C9, 2E1, 3A4, and GST (PO in rats). The induced isozymes had all returned to normal levels within 2 weeks, including the increased CYP 3A4 metabolism of testosterone after 1 week.1952 

Likewise, ginkgo extract at 90 mg/day for 30 days in 14 subjects did not alter the metabolism of CYP3A4 substrate donepezil after prolonged therapeutic use (PO in human clinical study).1824   

6) Patient taking a thiazide diuretic had an increase in blood pressure after she took ginkgo for a week (PO in human case report).614 This report has been described as unevaluable based upon report inadequacies.1239 

A clinical survey identified a 66-year-old man whose hypertension was exacerbated when the hydrochlorothiazide that he was taking was combined with a ginkgo product (PO in human case report).2126

     +     7) [previously considered as part of Drug Interactions IV. 1)] Two elderly epilepsy patients who had been stabilized on anticonvulsant therapy with sodium valproate without a seizure for 1.5 and 2.0 years experienced 3 to 4 seizures within two weeks of beginning use of 120 mg daily of ginkgo extract (PO in human case reports). After two days of being off the ginkgo extract, no more seizures occurred over the next 18 and 4 months, respectively. The mechanism of this interaction has not been established, nor have the responsible components.1247

     +     8) Ginkgo standardized extract LI 1370 given at 240 mg/day with trimipramine to 8 patients with major depression for 4 weeks improved sleep patterns by reducing awakenings and increasing sleep efficiency compared with trimipramine given alone to 8 patients (PO in human clinical study). Discontinuation of the ginkgo extract reversed the effects.1317 

     +     9) Ginkgo leaf extract EGb 761 given to 56 refractory schizophrenia patients at a dose of 360 mg/day together with haloperidol increased the effectiveness and reduced the extrapyramidal side effects of the medication compared to 53 given placebo, probably due to the free radical scavenging effects provided by the complex spectrum of active substances in the ginkgo extract (PO in human clinical study)1281 A group of 109 schizophrenic subjects given haloperidol with either 360 mg ginkgo extract daily or placebo had low CD3+, CD4+, and IL-2-secreting T cell subsets and a low CD4/CD8 ratio at baseline, but those receiving ginkgo for 12 weeks increased these subsets and ratio and lowered SOD compared to baseline and placebo (PO in human clinical study). There was also a significant correlation with a lower score on the Brief Psychiatric Ratio Scale and use of ginkgo but not placebo, indicating that ginkgo both improved immune function and psychiatric outcome when used with haloperidol.2113

     +     10) 120 mg daily of ginkgo extract EGb 761 taken by type II (non-insulin-dependent) diabetics reduced oral glucose tolerance test plasma insulin and increased the blood glucose levels during this test in patients who were taking the oral hypoglycemic agents metformin, troglitazone, glipizide, and glyburide (glibenclamide) (PO in human clinical study)1323

However, a single 120 mg/day dose for 3 months of a ginkgo extract standardized to appear similar to EGb 761 decreased glycated hemoglobin concentrations in 20 type II diabetics using 500 mg/day metformin, though it did not affect glucose or insulin concentrations (PO in human clinical study). Metformin pharmacokinetics were not affected at a dose of 500 mg or less, though its excretion was decreased by the ginkgo extract combined with 850 mg metformin.1978

In addition, when 360 mg/day of ginkgo extract EGb 761 was taken for 28 days by 10 healthy males, it reduced the bioavailability of CYP 2C9 substrate tolbutamide by 16% and attenuated its effect on lowering blood glucose (PO in human study).2015

Tolbutamide and CYP 2C9 substrate diclofenac were not affected by 240 mg ginkgo extract for 8 days (PO in human study),2011 not did it alter metabolism of CYP 2C9 substrates S-warfarin after 7 days (PO in human study)1774 or flurbiprofen after 2 days (PO in human study),1842 but these studies were not sufficiently long to determine potential induction of this isozyme to reduce the availability of these drugs. Glipizide and glyburide are also CYP 2C9 substrates.

    +      11) Ginkgo extract EGb761 given in doses of 280 mg/day to 12 Chinese subjects significantly decreased omeprazole bioavailability by inducing its metabolism by CYP 2C19, and it also reduced the urinary excretion of its major metabolite (PO in human study).1617,2301 Among this ethnic group with CYP 2C19 genetic polymorphism, the 7 poor metabolizers had a significantly greater increase in hydroxylation of the drug than the 5 heterozygous and 6 homozygous extensive metabolizers, though all three genotypes showed significant induction of this isozyme. The conversion of omeprazole by CYP 3A4 to omeprazole sulfone was not affected, nor was the conversion by this isozyme of cortisol to 6b-hydroxycortisol enhanced by ginkgo extract.2301  

     +     12) Following treatment of colorectal cancer patients with 5-fluorouracil, 32 with advanced cases were treated every 3 weeks with 350 mg EGb 761 followed by 5-fluorouracil for 6 days for each course (IV in human clinical study). After two courses the disease progressed in 22, was stable in 8, and responded partially in 2. Of the 22, the disease progressed further in 17 after two courses, in 2 after three courses, and in the other 3 after four courses, similar to other second line treatments. EGb761 was well tolerated, and median survial was 9.5 months. Good benefit-risk ratio with improvement in some, despite 5-fluorouracil failure, suggests application as a first-line treatment.1669

     +     13) 120 mg/day of uncharacterized ginkgo for 18 days inhibited metabolism of CYP 3A4 substrate nifedipine as indicated by an increase in peak plasma concentrations of 53% (PO in humans).1728

     +     14) A dose of 360 mg/day of EGb 761 increased bioavailability of CYP 3A4 substrate midazolam by 25% and decreased its oral clearance by 26% (PO in humans study).2015

However, daily doses for 28 days of 240 mg ginkgo standardized to 24% flavone glycosides and 6% terpene lactones failed to alter the metabolism of CYP 3A4 substrate midazolam (PO in humans).1328 In addition, 240 mg daily for 14 days of ginkgo extract slightly decrease alprazolam availability, suggesting CYP 3A4 induction (PO in human study).1840  

            15) While consumption of a single standardized extract dose had no effect on talinolol pharmacokinetics, taking  360 mg extract daily for 14 days significantly increased the drug bioavailability, likely due to inhibition of P-glycoprotein or another efflux protein (PO in human study).2680

     +     16) EGb761 at 280 mg twice daily for 12 days in 12 healthy Chinese subjects significantly increased metabolism of a single dose of CYP 2C19 substrate mephenytoin by a mean of 8.6%, though it ranged from 0.6% to 30.4% (PO in human study). In the same study the CYP 2E1 substrate chlorzoxazone showed a mean change of 15.0%.2302 Ginkgo extract as 0.5% of the diet was shown to induce this isozyme. Recovery from CYP2E1 induction occurs within 2 weeks (PO in rats).1952 

          However, in other studies normal therapeutic doses did not produce this effect with chlorzoxazone (PO in humans).1328,1808

II.  +     2) EGb 761 96 mg/kg for 8 days increased social contact in animals given an injection of diazepam more than diazepam alone, even though EGb 761 by itself had diminished social contact (PO in rats)1268

      +    3) The antiplatelet drug ticlopidine was as effective inhibiting platelet aggregation ex vivo in a small dose of 50 mg/kg/day combined with ginkgo extract EGb761 at 40 mg/kg/day as with a large dose of 200 mg/kg/day alone (PO in rats and mice). The combination increased bleeding time by 150% and improved recovery in acute thrombosis.1090

It has been suggested that caution be used when combining ginkgo products with antiplatelet drugs (speculative).1890 A daily dose of 80 mg of a 50:1 concentrated extract was associated with spontaneous bleeding, following chronic (3-year) use by a 70-year-old man of aspirin as an antiplatelet drug (PO in human case report).194

      +    4) Compared to controls, administering the extract at 100 mg/kg daily for 5 days decreased the bioavailability of the CYP 1A2 substrate theophylline by 38% when the drug was given intravenously and by 40% when it was given orally (PO in rats). The only significant effect with 10 mg/kg extract dose was an increase in total theophylline clearance, independent of route. The normal human dose is less than 5 mg/kg daily.2278

            5) Compared to animals given 600 mg/kg of amikacin daily for 2 weeks, those also given EGb761 at 100 mg/kg/day over the same period plus an additional week had increased ototoxicity (PO in rats). Those receiving only the EGb761 had no change in auditory measurements. Other aminoglycoside antibiotics may have a similar interaction with ginkgo extract (speculative).2654 The normal human dose is less than 5 mg/kg daily.2278

III.       2) [Formerly IV. 1)] Ginkgo may diminish the effectiveness of anticonvulsants [See I. 7) above.] or potentiate seizures with medications like tricyclic antidepressants that reduce the seizure threshold (speculative).893 

At least seven anecdotal reports submitted to the FDA’s Special Nutritionals Adverse Event Monitoring System by the general public concerning claims of ginkgo-linked seizures, though most follow use of multi-ingredient products. Similar claims appear on several other online forums; but ginkgo identity and plant part have not been confirmed in these cases. Still, the recommendation is made that ginkgo (leaf? leaf extract? seeds?) use with medicines known to incite seizures should be avoided or done cautiously (speculative).1105 Convulsions occurred twice in a 36-year-old woman after eating 70-80 ginkgo nuts/seeds (PO in human case report).1106 

However, no convulsions occurred after administration of the anticonvulsants phenobarbital and later carbamazepine.  The convulsive effect seems to be due to high ginkgotoxin content in the nuts interfering with vitamin B6 activity as a cofactor of glutamate decarboxylase, resulting in decreased GABA levels in the brain and loss of GABAergic inhibition of convulsions.1106 In contrast the bilobalide in the leaves has been shown to suppress glutamatergic toxic convulsions (IP in rats).1107

IV.  +      [1) [Previously in I.1).] Warfarin use stabilized for 5 years with a 78-year-old woman resulted in intracerebral hemorrhage with the addition of ginkgo for 2 months (human case report).524

A Danish randomized, placebo-controlled, double-blind cross-over trial with 24 patients found that 100 mg of a ginkgo product used for 4 weeks did not alter the effective warfarin dosage required to maintain an INR between 2.0-4.0 (PO in human study). Unfortunately, the report failed to identify the type of ginkgo product as to whether it was the leaf, a native leaf extract, or a concentrated standardized extract.1433 In addition, ginkgo standardized extract EGb761 tablets derived from 2 grams of leaf powder were given in doses of 2 tablets three times daily for a week, followed by a single dose of warfarin (PO in human study). No changes were observed in R- or S-warfarin metabolism by CYPs 1A2 or 2C9, respectively, or alterations in warfarin protein binding, nor was any alteration of INR detected following ginkgo extract use. Continuing ginkgo extract use for another week, no change in INR or platelet aggregation (ex vivo) were detected from using the daily extractive of 12 gram of ginkgo alone (PO in human study).1774 Likewise, no effect was found in the pharmacokinetics of other CYP 2C9 drug substrates including flurbiprofen, diclofenac and tolbutamide (PO in human studies).1842,2011 While a lab study did show ginkgo extract inhibited warfarin metabolism (in vitro),2011 the extract as 0.5% of the diet caused induction of CYP 2C9 metabolism of S-warfarin (PO in rats). The isozyme level returned to normal within a week.1952 CYP 2C9 induction would increase the tendency to clot, not bleed.

A systematic review of 12 case reports of ginkgo products associated with hemorrhage found that the likelihood of causality were in 10 cases possible, while one case was unevaluable and only the case involving the ibuprofen interaction was likely caused by ginkgo extract.1727 Also, a database of bleeding episodes among 320,644 German patients indicated that EGb 761 does not increase the risk of bleeding episodes when taken with or without anticoagulant or antiplatelet drugs (PO in human study).2117 Furthermore, 40 subjects aged 65-79 years taking 120 mg EGb-761 daily for 7 days had no change in bleeding or coagulation parameters (PO in human study).1833

 

GINSENG      [Now ASIAN GINSENG.]                           p. 107

            Panax ginseng root

 

GOAT’S RUE                                                                       NEW

            Galega officinalis herb

            (French lilac)

Drug Interactions

III.       1) Blood glucose may be reduced in those stabilized on insulin or hypoglycemic drugs (speculative),1890 based on the hypoglycemic effect of its seeds (PO in animals).127,954,1868 

and a decoction of the herb equivalent to the 12.5 grams dry weight of the herb per kg body weight (PO in mice).2252   

 

GOLDENROD [now eUROPEAN GOLDENROD]        p. 109

Solidago virgaurea plant

 

GOLDENROD

     ^     Solidago canadensis and Solidago gigantean herb     NEW

            (Fr.: gerbe d’or) and (Ger.: riesengoldrute)

Contraindications

            1) Chronic kidney disorder unless a medical practitioner has been consulted (speculative)6,150 to assess the nature and seriousness of the condition

 

GOLDENSEAL                                                                    p. 110

            *Hydrastis canadensis roots/rhizome

Contraindications

4) High blood pressure (speculative)777

However, a 0.2 mg/kg/min rate of berberine infusion caused a significant decrease in peripheral vascular resistance and systemic arterial pressure (IV in human clinical study).1367

Drug Interactions

I.    +    2) Berberine 1.2 grams daily, given as tablets to 79 congestive heart failure patients on ACE inhibitors along with digoxin in 76, nitrates in 71, and diuretics / spironolactone in 77, significantly increased left ventricular ejection fraction and exercise capacity, improved dyspnea-fatigue index, and reduced frequency of ventricular premature complexes compared with 77 patients using only comparable conventional medications. The mortality of the berberine group decreased significantly as well, and there were no apparent side effects (PO in human clinical study).1457 In 56 congestive heart failure patients on loop diuretics and ACE inhibitors, including 51 using digoxin and 46 on nitrates, the significant increases in left ventricular ejection fraction and decreases in ventricular premature beats from baseline from 1.2 grams of berberine daily was also significant better when plasma berberine concentrations were higher versus lower than 0.11 mg/L (PO in human clinical study).2639

     +     3) 2.7 gram daily of goldenseal extract given for 28 days inhibited metabolism of CYP3A4 substrate midazolam by 40% in 12 healthy subjects (PO in human study).1807 Also, 3.97 gram of the root extract delivering 132 mg hydrastine and 77 mg berberine per day for 14 days significantly reduced midazolam bioavailability in 16 healthy subjects (PO in human study).2501

Goldenseal tincture and its herb tea were the strongest CYP 3A4 inhibitors tested in vitro of the 21 herb extracts840 and 20 herb and black teas.1577

However, 2.28 grams of the root given daily to 10 healthy volunteers for 14 days failed to affect the pharmacokinetics of CYP 3A4 substrate indinavir (PO in human study).1700 

     +     4) Berberine at 0.6 grams daily for 3 months increased previously stabilized cyclosporin A trough blood concentrations by 90% in 52 renal transplant patients, and when given for 12 days to 6 transplant patients increased the cyclosporine bioavailability by 35% (PO in human clinical study), likely by inhibition of CYP 3A4 (speculative).2281

However, 2.28 grams of the root given daily to 10 healthy volunteers for 14 days failed to affect the pharmacokinetics of CYP 3A4 substrate indinavir (PO in human study).1700

     +     5) The combination of 500 mg berberine 3 times daily for 3 months in 43 patients with poorly-controlled type 2 diabetes together with one or more of their regular oral hypoglycemic medications including sulfonylureas in 28, metformin in 20 acarbose in 15, and/or insulin in 10 resulted in lower fasting and postprandial blood sugar from week 1 through week 12 (PO in human clinical study). Fasting plasma insulin was also lowered by 28% and an index of insulin resistance by 45% of those on medications, while total cholesterol and LDL were likewise reduced. In 31 newly diagnosed type 2 diabetics to whom 15 were given the same dose of berberine and 16 used 500 mg metformin 3 times daily, berberine’s hypoglycemic effect was similar to that of metformin on fasting and postprandial blood glucose, as well as reducing glycosylated hemoglobin and plasma triglycerides (PO in human clinical study). Transient gastrointestinal adverse effects were experienced by 35% of the patients, or 20 in total.2315

     +     6) The use of 900 mg goldenseal root extract 3 times/day for 28 days in 12 volunteers resulted in about a 40% inhibition of CYP 2D6 metabolism of debrisoquin (PO in human study).1807 With 18 volunteers taking 1.1 gm of the root extract containing 44 mg hydrastine and 25.6 mg berberine 3 times daily for 14 days, the debrisoquin metabolism was inhibited by about 50%, as determined by 8-hour debrisoquine urinary recovery ratios (PO in human study).2502

II.  +     1) Pre-treatment with 4 mg/kg berberine prevented a rise in serum levels of liver enzymes from excessive acetaminophen, suggesting protection from its toxic effects (PO in rats). Use of this dose three times every six hours following a toxic dose of acetominophen reduced liver damage.1215

            2) Berberine administered prior to pentobarbital increased the induced sleeping time (IP in mice).1032

A single 4 mg/kg dose of berberine prolonged pentobarbital sleeping time and increased strychnine toxicity (PO in rats).1215

     +     3) When the alkaloid component berberine was given once or twice at doses of 50, 100, or 200 mg/kg before cyclophosphamide injection, it significantly reduced the chemotherapy adverse effect of bladder hemorrhage in a dose-dependent manner (IP in rats).2570 

     +     4) Berberine at 100 mg/kg enhanced the anxiolytic effects of buspirone and ritanserin but did not interact with diazepine (PO in mice).2668

III. +    4) Studies in human liver-derived cells with berberine was found to have an additive effect with lovastatin by increasing LDL receptor mRNA expression (in vitro). This statin did not reduce this effect of berberine, indicating a different mechanism of action (in vitro). In 63 high-cholesterol subjects taking 1.0 grams berberine HCl daily for 3 months, serum cholesterol was reduced 18%, LDL cholestreol 20%, and triglycerides 28%, compared to those using placebo (PO in human study). In the 32 who were taking no other medication or herbs, cholesterol was reduced 29%, LDL cholesterol 25%, and triglycerides 35%. HDL cholesterol was unaffected, and berberine was well tolerated. Berberine was found to have a dose-dependent cholesterol-lowering effect (in hamsters).1656 

     +     5) It could have an additive effects with drugs like phenylbutazone that displace protein binding of bilirubin (speculative),1890 since the displacement by berberine of bilirubin from serum albumen has been demonstrated (IP in rats).1092

     +     6) Berberine increased efflux of paclitaxel (taxol) by inducing P-glycoprotein1046 and thereby potentially reduces its retention and concentration in human hepatoma or digestive tract cancer cells (in vitro).1045,1046 Goldenseal extract components, berberine and hydrastine, were shown to act as substrates for P-glycoprotein (in vitro).2145  

However, a study with the P-glycoprotein probe drug digoxin in 20 subjects found that 3.2 grams daily for 14 days of an extract of goldenseal containing 3.25% isoquinoline alkaloids failed to alter the bioavailability of digoxin (PO in human study).2082  

 

GOTU KOLA                                                                       p. 111

            Centella asiatica = Hydrocotyle asiatica plant

Contraindications

            2) Allergic hypersensitivity resulting in contact dermatitis by using topical medications containing the extract (human case reports)1185,1186

Drug Interactions

II.   +    1) Aqueous extract at a 50 mg/kg dose increased the sleeping time induced by pentobarbital (IP in mice),1201 so barbiturates may be enhanced (speculative)

 

GRAPES                                                                   NEW

   ^       Vitis spp. seeds

Drug Interactions

II.         1) Pica induced by the chemotherapy agent cisplatin was significantly reduced by 3 different grape seed extracts made from different varieties or species of grapes at a dose of 10 mg/kg, but the percentage reduction correlated dose-dependently with the variable polyphenol content of the 3 products (IP in rats).1877

 

GRAPEFRUIT                                                                     p. 111

            Citrus paradisi fruit/juice; seed extract

Drug Interactions

I.          1) Juice consumed concurrently increases bioavailability of many calcium antagonists777

Use with verapamil also resulted in prolongation of the PR intervals in subjects (PO in human study).1304 Several studies noted that the small inhibition of verapamil metabolism by grapefruit juice did not appear to be clinically significant (PO in human studies).1161,1333 Nonetheless, when a 42-year-old woman accidentally took 2 additional verapamil tablets in addition to her 120 mg tablet daily after having consumed 3-4 liters of grapefruit juice during the prior 7 days, she presented with palpitations, a complete heart block with ventricular escape rhythm of 34 beats/minute, systolic blood pressure of 56 mm/Hg, hypoxic respiratory failure, and metabolic acidosis (PO in human case report).2584

The absorption of other calcium channel blockers is also increased. Six healthy men drinking 300 ml grapefruit juice 30 minutes before taking nicardipine increased the average oral drug bioavailability and increased their heart rates 1-2 hours after dosing, compared to taking the drug after consuming 300 ml water (PO in human study).2099 When 10 healthy males took diltiazem with 250 ml of grapefruit juice or water, the juice increased the drug bioavailability but did not affect blood pressure or heart rate (PO in human study).2100

However, furanocoumarin-free juice did not alter felodipine pharmacokinetics compared with grapefruit juice that did not have the furanocoumarins removed (PO in human study). Other CYP 3A4 substrates will likely also not have altered metabolism if the furanocoumarins are removed from the juice (speculative).1862

2)  When 240 ml of grapefruit juice is consumed with terfenadine, or in some individuals even two hours after its consumption, it increases the bioavailability of the drug (PO in human study).1980

     +     3) After using simvastatin for more than two years with no problems, a 40-year-old woman over 10 days gradually developed muscle weakness in her lower extremities secondary to statin-associated rhabdomyolysis for which she was hospitalized. Fourteen days prior she had begun eating one grapefruit daily (PO in human case report).1575 When 200 ml of water or juice were taken for 3.3 days before simvastatin, the juice increased bioavailability 3.6-fold and simvastatin acid 3.3-fold, while the peak concentrations were increased 3.9- and 4.3-fold, respectively (PO in human study).2046 In an animal study, 200 mg/kg of simvastatin resulted in 50% survival after 10 days, but when 20 mg/kg were given with 5 ml/kg grapefruit juice no signs of toxicity were observed after 4 weeks (PO in rats). This suggests that the pharmacokinetic changes following a single dose of simvastatin do not necessarily carry over to pharmacodynamic changes with repeated doses,2255 but the interspecies differences may have contributed to the lack of effect.

When 16 healthy subjects were given 8 oz grapefruit juice or water for breakfast for 3 days and then given lovastatin on the last evening, the bioavailability and maximum concentration of the statins was increased 30-40% (PO in human study).2049

In two groups of studies with 12 and 10 subjects that compared the effects of water and grapefruit juice, given at 200 ml [double-strength] or 250 ml, respectively, 3 times daily for 2.3 days, on both atorvastatin and pravastatin, the bioavailability of atorvastatin acid was increased 2.5- or 1.4-fold, respectively, but no change was found in pravastatin pharmacokinetics (PO in human studies).2047,2048

Another statin drug whose bioavailability is increased by grapefruit or its juice is cerivastain.1161

4) increased plasma concentration of cyclosporine (PO in human studies),320,483 probably due in part to inhibition of P-glycoprotien efflux (PO in human study).1031

When 8 oz of grapefruit juice were given to 10 renal transplant patients on steady state cyclosporine A dosing and results compared to the effects of 8 oz of water, the grapefruit juice was shown to increase drug exposure and delay absorption without changing the peak concentration (PO in human clinical study).1988

However, increased excretion, due to enhancement of P-gp efflux of cyclosporine in kidney cells (in vitro), may offset increased absorption somewhat.1036 Pharmacokinetic studies with a single dose of digoxin showed no significant change of serum levels from P-glycoprotein inhibition from 0-48 hours with 4 doses of 220 ml grapefruit juice consumed before and during the first 12 hours. Though a 9% increase in digoxin occurred from 0-4 and 0-24 hours, no change in digoxin clearance from the kidneys occurred during these intervals (PO in human study).1216

5) CORRECTION - Caffeine metabolism is inhibited when 300 ml of [CORRECTION] GRAPEFRUIT JUICE was drunk one half hour before and every six hours following 167 mg caffeine ingestion in 5 gram instant coffee by 12 subjects (PO in human study). Area under curve and caffeine half-life were increased while oral caffeine clearance was decreased. Caffeine metabolites were not identified. [CORRECTION] NARINGENIN inhibits CYP1A2 conversion of caffeine to paraxanthine (in vitro).852

7) Fexofenadine bioavailability was reduced two thirds when taken with grapefruit juice (PO in human study).1097

While 300 ml juice reduced the bioavailability and peak plasma concentration to 58% and 53% of control values, respectively, 1.2 liters of juice reduced these parameters to 36% and 33%.1757 When 240 ml of double-strength grapefruit juice was taken three times daily for 2 2/3 days, and fexofenadine dose was taken with, and then followed by, the last final two doses, the total absorption and maximum serum concentration were reduced by 30% (PO in human sudy).1919 Even a single 300 ml dose of grapefruit juice taken with oral fexafenadine or 2 hours before, but not 4 hours before, reduced its oral bioavailability in 12 healthy subjects by 52% and 38%, respectively (PO in human study).2304

The reduced uptake is due to inhibiting intestinal organic anion transporting polypeptide (OATP) 1A2,1097,1757 not to inducing P-glycoprotein efflux (in vitro).1097 The grapefruit flavonoid naringin inhibits the OATP1A2 transport of fexofenadine (in vitro). Based on comparative testing in 12 subjects of 300 ml juice, an equivalent amount of naringin in water, and a low-naringin furanocoumarin fraction of the juice, the reduced bioavailability of fexofenadine by 55-57%, 75%, and 96%, respectively, appears to be due largely to naringin (PO in humans).2305

     +     8) A man maintained on HIV protease inhibitors indinavir, stavudine and lamivudine (CYP 3A substrates and inhibitors) and co-medicated for depression with fluoxetine and trazodone began to experience serotonin syndrome after increasing grapefruit consumption from one to three grapefruit daily (PO in human case report). Advised to discontinue the grapefruit, his symptoms resolved within one month.1231

     +     9) Conversion of sildenafil to N-desmethylsildenafil by CYP3A4 was reduced when 500 ml grapefruit juice was taken in the hour before the drug by 24 men, resulting in a 23% increase in plasma sildenafil and a 15 minute delay in reaching the maximum plasma concentration (PO in human study)1274

     +     10) 250 ml of grapefruit juice also increases bioavailability of other oral drugs320  

including praziquantel,1300 amiodarone, carbamazepine, clomipramine, and tacrolimus (PO in human studies)1161,1333 due mostly to inhibition of metabolism by cytochrome P450 3A4 enzymes in the gastrointestinal tract by furanocoumarins like dihydroxybegamottin as shown with midazolam (in vitro).476 Inhibited metabolism of calcium antagonists such as nifedipine and felodipine by dihydroxybegamottin and grapefruit flavonoids, respectively, has also been show in liver microsomes (in vitro).475,1454 The CYP3A4 inhibition from a single dose of 300 ml of juice is complete withing 3 days, with a recovery half-life of 23 hours (PO in human study).1454

     +     11) 100 ml of grapefruit juice decreases the bioavailability of oral etoposide by 26% when given to 6 subjects and compared to its oral consumption without grapefruit juice (PO in human study). No certain mechanistic explanation was offered.1329

     +     12) Comparing the consumption of 240 mg of water or reconstituted grapefruit juice three times daily for 5 days on the absorption of a single 1.0 mg oral dose of digoxin significantly increased absorption lag time with the juice but no differences were found in digoxin maximum concentration, area under the curve (AUC), elimination half-life, or renal clearance.1434

However, the juice reduced the maximum digoxin concentration, absorption rate, and AUC among subjects with a T allele compared to CC homozygotes. Since digoxin is a P-glycoprotein substrate, but not a CYP 3A4 substrate, the inhibition of P-glycoprotein by grapefruit juice appears to be not generally important but may impact individuals (PO in human study).1434 

     +     13) Combining large amounts of grapefruit juice with the quinine from excessive tonic water intake was suspected as the cause of torsad de pointes, resulting in convulsive syncope in a diabetic woman with polydipsia (PO in human case report). This combination was proposed as a probable cause of increasing her QT interval since quinine’s optical isomer quinidine prolongs the QT interval, and other research shows the grapefruit flavonoid naringen increases quinine availability (PO in rats).1452

However, grapefruit juice failed in research with10 subjects to significantly alter the bioavailability of oral quinine which is metabolized by liver CYP 3A4 (PO in human study),1453 and naringin failed to inhibit CYP3A activity in rat liver microsomes (in vitro).1450 The inhibition of CYP3A4 occurs in the intestines, but not in the liver (PO in human study), and in human liver microsomes CYP3A4 inhibition is due largely to the juice component dihroxybergamottin (in vitro).1454

     +     14) 350 ml of fresh frozen grapefruit juice taken by six healthy male subjects increased the total absorption and maximum serum concentration of artemether, while reducing the time required to reach this peak, but this did not influence ECG results (PO in human study).1506 Another antimalarial drug, primaquine, has increased bioavailability in 10 male and 10 female subjects when taken orally with 300 ml of grapefruit juice made from concentrate (PO in human study).1917

However, taking this medication with bread and butter caused a similar increase, as shown by the maximum serum concentration and total absorption.1917

A third antimalarial drug, halofantrine, was given to 6 men and 6 women with either 250 ml of water, orange juice, or grapefruit juice after use for 4 days at 250 ml/day (PO in human study). Besides grapefruit juice increasing halofantrine peak plasma concentration and the total absorption in comparison to water or orange juice, it also increased the halofantrine-induced QT interval prolongation, increasing the risk of fatal ventricular arrhythmia. Therefore, grapefruit juice is contraindicated while using halfantine.1918

            15) Consumption by 25 subjects of a single 300 ml glass of regular grapefruit juice 2 hours before midazolam led to a significant increase in the drug's bioavailability and peak plasma concentration. A single glass could increase bioavailability of midazolam if taken 1-2 days, but not 3 days, prior (PO in human study).1624 When 16 healthy subjects were given 8 oz grapefruit juice or water for breakfast for 3 days and then given midazolam on the last evening, the bioavailability of midazolam increased 2.4-fold (PO in human study).2049

A single 200 ml dose of juice increased bioavailability and peak plasma concentration of triazolam in a random crossover trial, while 3 doses of juice daily for three days increased bioavailability even more along with increasing the drug half-life and its pharmacodynamic effects in 12 subjects (PO in human study).2051

            However, in separate single-dose studies with either 10 mg of midazolam or 0.25 mg of triazolom in 12-15 healthy students given water or 300 ml grapefruit juice or 750 mg erythromycin in 6 subjects as a positive control of CYP3A inhibition, post-treatment psychomotor function tests showed the addition of grapefruit only with midazolam significantly increased only digit symbol substitution [DSS] impairment compared to water (PO in human study). On the other hand erythromycin use led to greater impairment in both DSS and letter substitution than water or grapefruit, and much higher plasma values of midazolam, whereas grapefruit led to only slightly higher plasma midazolam values than water. The single oral dose of grapefruit juice therefore had no important interactions with either doses of midazolam or triazolam in healthy young subjects.2697

Another benzodiazepine drup increased after grapefruit juice consumption is diazepam.1333

     +     16)  A dose of 200 ml of juce 3 times daily for 2.3 days, followed by two more doses after consuming buspirone, led to a 4.3-fold increase in peak plasma concentration and a 9.2-fold increase in bioavailability compared to water in the randomized, crossover design, along with an increase in subjective drug activity among the 10 subjects (PO in human study).2052

     +     17) Compaed to water, after 3 doses daily of 200 ml of juice in 10 healthy subjects for 2.3 days followed by a cisapride dose and 2 more juice doses, the peak drug concentration and its bioavailability were increased by 81 % and 144%, respectively (PO in human study). The time of peak concentration and elimination half-life were also delayed, though no differences in QTc interval could be found by ECG.2053 After a single 250 ml dose of juice in 12 healthy men, the peak cisapride concentration and bioavailability were increased168% and 151%, respectively, but the time for maximum concentration and the apparent elimination half-life was not affected (PO in human study).1731

     +     18) Ineffective results with clomipramine in children and adolescents with obsessive-compulsive disorder and excessive CYP3A demethylation led to use of 250 ml grapefruit juice with each dose of  the drug to lower the ratio of blood levels of metabolite to drug (PO in case studies). While this combination was effective in raising trough levels of clomipramine and reducing the ratio, the clinical effect was variable, apparently depending upon individual metabolic differences.2589

     +     19) Taking 250 ml of grapefruit juice 3 hours before and with a dose of sildenafil led to increased bioavailability by 23% and somewhat delayed absorption in 24 healthy white males (PO in human study). The maximum plasma concentration was delayed by 15 minutes on average, but this peak plasma concentration was not increased. Even though grapefruit juice used concurrently will not usually increase the risk of  sildenafil adverse effects, due to interindividual variability it appears advisable to avoid this combination.2590

     +     20) Use of 200 ml grapefruit juice a half hour before and then with a dose of methadone in 8 patients led to an average 17% increased bioavailability for both enantiomers of the drug during the next 24 hours (PO in human clinical study). The peak level increased similarly and the apparent clearance decreased, but no symptoms of overmedication were detected by clinicians or patients. Nonetheless, due to variability among patients, grapefruit juice intake is not recommended with methadone, especially when beginning this treatment.2591

     +     21)  Taking 250 ml of grapefruit juice 3 time daily for 5 days and then with sertraline on day 6 led to significant increases in average peak concentration and bioavailability of the drug (PO in humans study).2592

     +     22) While one 300 ml glass of grapefruit juice significantly reduced nonmetabolized single-dose talinolol bioavailability, peak concentration, and urinary excretion 56-57% in 24 healthy subjects, 900 ml/day for 6 days also reduced these parameters 44-65% (PO in human study). MDR1 RNA and P-glycoprotein levels in duodenal biopsies of 3 subjects showed no changes, and 3 MDR1 genotypes did not alter the pharmacokinetics.2619

     +         23) The juice consumed by 11 subjects at a dose of 200 ml increased dextromethorphan bioavailability both by inhibiting intestinal CYP 3A and affecting an intestinal transport protein (PO in human study).2666

III. +    1) grapefruit juice increased the efflux of P-glycoprotein substrates losartan and vinblastine from kidney cells, thus speeding their elimination from these cells (in vitro),1036 but inhibited the P-glycoprotein efflux of digoxin,2029 saquinavir and vinblastine from colon and/or intestinal cells, thus enhancing their retention (in vitro).1029,1030,2026 

The inhibition of vinblastine efflux from colon cells was due to furanocoumarins including dihydroxybergamottin, begamottin, bergaptol, and bergapten (in vitro). Of these furanocoumarins, only bergaptol did not also inhibit human liver CYP3A4 (in vitro).1358 P-glycoprotein efflux of vincristine, rhodamine-123, and fexofenadine was also inhibited by an ethyl acetate extract of grapefruit juice (in vitro)1627,2026 and its components dihydroxybergamottin and begamottin (in vitro). This resulted in a 3-fold increase of vincristine in some leukemia cells (in vitro).1627

      +    2) The conversion of testosterone to 6beta-hydroxytestosterone by CYP 3A activity was inhibited by fresh-squeezed juice and a juice extract with no naringin, but was not inhibited by a solution of naringin of the same concentration as it occurs in the fresh juice (in vitro)1450

      +    3) The OATP transporter protein substrates estrone and glibenclamide have reduced uptake in kidney cells via OATP-B in the presence of 5% grapefruit juice and at 10 mM concentrations of several of its flavonoids and furanocoumarins (in vitro).1922

IV. +    [1) The consumption of grapefruit seeds extracts as an antimicrobial agent for 3 days was associated with an incidence of increased INR in 2 patients stabilized on warfarin, one of whom experienced a subcutaneous hematoma (PO in human case reports). When this product and 2 other European “grapefruit seed extract” products were compared to an actual seed extract for content and CYP influence, none of the 3 were found to contain seed components, but all yielded the undeclared synthetic preservative benzethonium chloride. The 3 commercial “extract” products and benzethonium chloride all were shown to inhibit CYP 2C9 (in vitro), thus accounting for the increased INR values associated with probable inhibition of warfarin metabolism.2225]

Benzethonium chloride was identified in both liquid and solid commercial American grapefruit seed extracts.2226 Several batches of another commercial extract revealed a content of 22% of the synthetic antimicrobial preservative agent benzalkonium chloride.2227 In another assay of 1 powdered and 8 liquid commercial grapefruit seed extracts, 4 contained benzethonium chloride and 3 contained benzalkonium chloride along with smaller amounts of other preservatives including 4-hydroxybenzoic acid esters, benzoic acid, and salicylic acid.2228 The benzalkonium chloride was shown to inhibit CYP 2C9 similar to benzethonium chloride (in vitro).2225 So, while common adulterants of grapefruit seed extract likely inhibit warfarin metabolism and increase risk of hemorrhage, this effect has not been demonstrated for authentic grapefruit seed extract.]

 

GUAR GUM                                                                                     p. 113

            Cyamopsis tetragonolobus seeds

Drug Interactions

I.          1) Insulin doses for 3 of 6 diabetic patients required reduction after using 25 grams of guar gum daily for 5-7 days lowered urinary glucose excretion  (PO in human clinical study)730

Also, in 3 subjects with type 1 diabetes 16 grams of guar gum plus 10 grams of pectin reduced the rise in blood glucose between 1-2 hours after the test meal. Likewise, in and 8 subjects with type 2 diabetes blood glucsose decreased after 30-90 minutes and insulin levels were reduced from 30-120 minutes (PO in human clinical study).958

A hot water extract of the seeds and green fruit was also hypoglycemic at 20 mg/kg in normal subjects as well as at 40 mg/kg in diabetic subjects that were resistant to tolubutamide, indicating a extra-pancreatic action for the guar (PO in rabbits).957 

2) Guar gum may inhibit absorption of oral drugs such as aspirin, digitalis and other cardiac glycosides, antibiotics, and anticoagulants if administered concurrently (speculative).150

     +     7)  When 10 healthy women were given at weekly intervals glyburide with either 5 grams of guar gum in 200 ml of tap water or with tap water only, after receiving the guar the effects of glyburide were increased (PO in human study). The enhanced effects were increases in serum insulin and C-peptide after 0.75-1.0 hours and decreases in serum glucose after 0.75-1.5 hours. Hypoglycemic sensations were reported by some subjects after 3 hours, but these were reversed with sweetened beverages.2148

 

GUARANA                                                                           p. 114

            Paullinia cupana seeds

Contraindications

            3) Heart disorders (speculative) due to caffeine increasing heart rate or exacerbating arrhythmias (empirical).8

Caffeine at a dose of 250 mg acutely increased aortic stiffness in 20 healthy subjects, leading to increased blood pressure centrally and to a lesser extent peripherally (PO in human study). These effects may impact cardiovascular risk (speculative).1569 Guarana extract with 150 mg of caffeine plus black tea extract yielding 120 mg raised systolic blood pressure and resting metabolic rate 2 hours after a single dose in 16 healthy male subjects (PO in human study).1973

However, a study of 155,594 women over 12 years found no linear association with caffeine consumption and hypertension (PO in human study).1859

            6) Pregnancy (speculative) since caffeine has been associated with fetal loss, low birth weight and premature deliveries.8

In an evaluation of 2,291 mothers caffeine consumption was found to reduce average birth weight. This was considered significant for those who consumed more than 600 mg of caffeine daily (PO in human study).1568

However, a prospective study of 873 women found no association between caffeine consumption at any amount and birth weight, gestational age at delivery, or birth weight standardized for gestational age (PO in human study).1672

Drug Interactions

I.          1) Guarana as a source of 40 mg of caffeine per tablet containing an herbal mixture including ephedra having 12 mg of ephedrine-like alkaloids per tablet was shown to promote short-term fat loss and weight loss when two tablets were taken before meals three times daily (PO in human clinical trial).1173 8 healthy subjects given a single dose (2 capsules) of a formula with guarana (200 mg caffeine) and ephedra (20 mg alkaloids) had a significantly increased systolic blood pressure after 90 minutes and increased heart rate after 6 hours. Though the kinetics of the caffeine and ephedrine alkaloids were comparable to similar drugs formulations, one subject with a high urine pH had longer ephedra alkaloid half-lives, and two subjects on oral contraceptives had longer caffeine half-lives (PO in human study).1356

In a double-blind, randomized, crossover trial 15 healthy subjects were given a single dose of the commercial product Metabolife 356, a proprietary blend of 728 mg that contained 40 mg of guarana seed with caffeine, 12 mg of ephedra extract, and unspecified amounts of 8 other herbs and 2 bee products, along with vitamin E, magnesium, zinc, and chromium. After taking the product subjects had significantly higher systemic blood pressure and extended QT intervals on their ECGs than after taking placebo. All reported nonspecific adverse events including jitteriness and queasiness after using the product but not after taking placebo. There were one case each of tachycardia, hand tremor and premature ventricular complexes after taking the product (PO in human study).1610

            When 25 mg ephedrine was taken with 200 mg caffeine, systolic blood pressure, heart rate, and glucose, insulin and lactate concentrations were all raised (PO in human study). Taken alone, ephedrine increased heart rate, glucose, and insulin, and caffeine increase systolic blood pressure. No pharmacokinetic interaction was found. Oral contraceptives prolonged caffeine elimination.1665

     +     12) Methotrexate efficacy for reducing the joint pain and morning stiffness of rheumatoid arthritis was diminished for those consuming 260 mg of caffeine daily on average, compared to those who consumed an average of only 90 mg daily (PO in human clinical study), probably due to methylxanthines like caffeine acting as adenosine receptor antagonists while methotrexate increases adenosine.1495

 

GUGGUL                                                                              NEW

     ^     Commiphora mukul gum resin

Contraindications

            1) Pregnancy due to its emmenagogue and uterine stimulant effects (empirical)74,150 and its use as an abortifacient (empirical)74

            2) Nursing mothers (speculative) unless following professional advice, due to its allergic potential.1890

            3) Hyperthyroidism may be adversely affected (speculative),1890  due to increase in T3 found with 0.2 gm/kg guggul extract daily for 15 days (PO in mice).1981

            When 750 mg guggul extract daily was given as part of a formula in a double-blind randomized study on obesity, the serum throid hormone status of the 3 subjects tested showed no clear trends of change for T3, T4, or TSH from baseline to week 6, though 2 of 3 had an 8-10% increase in T3 (PO in human clinical study).2109

The antihyperthyroid drug effect of carbimazole was counteracted by guggulsterones (in chickens).1890 Likewise, the hypothyroid effect of propylthiourasil was counteracted when guggul extract with 3.8% guggulsterones was given in doses of 200 mg/kg daily for 14 days (PO in mice). The extract also decreased liver lipid-peroxidation induced by the drug.2110

            4) Caution in coagulation disorders, due to increase fibrinolytic activity and reduced platelet adhesiveness associated with its nonpolar fraction (PO in human study).1890

Drug Interactions

I.          1) A single dose of 1 gram guggulipid in 10 volunteers in a randomized crossover study reduced the bioavailability of single dose of propranolol and of diltiazem in 7 subjects (PO in human study). This may result in clinically reduced efficacy or no response for these CYP 3A4 substrates (speculative).1701 The probable mechanism of induction of CYP 3A4 is the activation of the pregnane X receptor by guggulsterone (in vitro).1636 However, it is improbable that a single dose would immediately induce a CYP isozyme, so binding of the drugs in the intestinal lumen to reduce absorption seems more likely (speculative).

II.         1) The antihyperthyroid drug effects of carbimazole involving decreased iodine uptake were counteracted by guggulsterones (in chickens).1890

            Likewise, the hypothyroid effect of propylthiourasil was counteracted when guggul extract with 3.8% guggulsterones was given in doses of 200 mg/kg daily for 14 days (PO in mice). The extract also decreased liver lipid-peroxidation induced by the drug.2110

            When 750 mg guggul extract daily was given as part of a formula in a double-blind randomized study on obesity, the serum throid hormone status of the 3 subjects tested showed no clear trends of change for T3, T4, or TSH from baseline to week 6, though 2 of 3 had an 8-10% increase in T3 (PO in human clinical study).2109 In addition 0.2 gm/kg guggul extract daily for 15 days increased T3 (PO in mice).1981 

 

GURMAR [now GYMNEMA]                                            p. 117

            Gymnema sylvestre leaves

GYMNEMA [formerly GURMAR]                                     p. 117

Ä         Gymnema sylvestre leaves

Contraindications

     +     1) Brittle type 1 diabetes (speculative)893 due to reduced insulin requirements in insulin-dependent diabetics when given 400 mg/day of a water-soluble acidic fraction of the ethanol extract (PO in human clinical study)357 resulting in part from increased insulin levels (PO in human clinical studies).359 This correlates with the hypoglycemic effect produced by the dried leaf powder (PO in rabbits and rats).355,356

 

HAWTHORN                                                                       p. 118

            Crataegus spp. leaves/flowers/fruit

Drug Interactions

I.          1) Crataegus extract enhanced cardiac glycoside drug digoxin in cardiac and coronary insufficiencies (perlingual in human clinical trial).395

            When compared by matched pairs technique to NYHA class II patients on chemical-synthetic drugs only, those class II using only hawthorn extract WS 1442 or the extract in addition to cardiac glycosides such as digoxin had significantly less fatigue, stress dyspnea, and palpitations (PO in human clinical study). The hawthorn extract cohort required significantly fewer cardiac glycosides [18% vs. 37%].2238

            Concurrent use with cardiac glycosides theoretically might potentiate their toxicity (speculative).895 In a randomize, double-blind placebo controlled trial with 120 ampulatory patients 18 years of age or older with NYHA class II-III chronic heart failure, no symptomatic or functional benefits were found by adding 900 mg of hawthorn exract WS 1442 daily to standard medications (angiotensin II receptor blockers, ACE inhibitors,  diuretics, beta-blockers, and/or digoxin) for 6 months, though left ventricular ejection fraction was better with the extract than placebo (PO in human clinical trial). There were not more cardiac adverse events in the hawthorn group, though there was a significantly greater number of patients with any adverse events.2669

However, the so-called SPICE trial, in which 2681 congestive heart failure patients were randomised to either WS 1442 or placebo, included 56% of subjects taking digitalis and nitrites, and 22% on antiarrhythmics [mostly amiodarone]. No drug interaction adverse effects or adjuvant effects were detected (PO in human clinical study).2493 In a pharmacokinetic test to assess whether hawthorn flavonoids affect P-glycoprotein and digoxin uptake, no interference was found during 3 weeks of digoxin use with hawthorn (C. oxyacantha) leaf and flower extract WS 1442. Also, ECG PR interval, heart rate, and blood pressure were not affected (PO in human study).1442

        +    2) Concentrated extract WS 1442 at a daily dose of 1800 mg combined with diuretic drugs triamterene and hydrochlorothiazide increased exercise tolerance and reduced adverse effects compared with using the diuretics alone for NYHA class III heart failure (PO in human clinical study).1303 In a similar study patients with NYHA class II heart failure also increased exercise tolerance from using the extract LI 132, compared to placebo, while some were allowed to continue established diuretic therapy unchanged (PO in human clinical study).1095 When compared by matched pairs technique to NYHA class II patients on chemcal-synthetic drugs only, those class II using only hawthorn extract WS 1442 or the extract in addition to cardiac glycosides such as digoxin had significantly less fatigue, stress dyspnea, and palpitations (PO in human clinical study). The hawthorn extract cohort used significantly fewer cardiac glycosides [18% vs. 37%], as well as significantly less ACE-inhibitors [36% vs. 54%], beta-blockers [22% vs. 33%], and diuretics [49% vs. 61%].2238

                        HOWEVER, the so-called SPICE trial, in which 2681 congestive heart failure patients were randomised to either WS 1442 or placebo, included 85% of subjects taking diuretics [39% spironolactone] and 83% receiving ACE-inhibitors, as well as 64% of subjects taking beta-blockers, 56% of subjects taking digitalis and nitrites, and 22% on antiarrhythmics, but no adjuvant effects were detected (PO in human clinical study).2493 Also, in a randomize, double-blind placebo controlled trial with 120 ampulatory patients 18 years of age or older with NYHA class II-III chronic heart failure, no symptomatic or functional benefits were found by adding 900 mg of hawthorn exract WS 1442 daily to standard medications (angiotensin II receptor blockers, ACE inhibitors,  diuretics, beta-blockers, and/or digoxin) for 6 months, though left ventricular ejection fraction was better with the extract than placebo (PO in human clinical trial). There were not more cardiac adverse events in the hawthorn group, though there was a significantly greater number of patients with any adverse events.2669

3) [Formerly III.2).] May have additive effects with antihypertensives (speculative)777

Of hypertensive diabetics taking antihypertensive medications, the 39 given 1.2 grams daily of the 3:1 hawthorn flower extract LI 132 twice daily, of which 19 used ACE inhibitors, 10 took diuretics, 6 were on beta-blockers, and 8 consumed calcium channel blockers, had a significant reduction in mean diastolic blood pressure compared to 40 patients on placebo using these drugs in equivalent proportion (PO in human clinical study). No adverse herb-drug reactions were found.2239 When compared by matched pairs technique to NYHA class II patients on chemical-synthetic drugs only, those class II using hawthorn extract WS 1442 required significantly fewer beta-blockers [22% vs. 33%] (PO in human clinical study).2238

However, the so-called SPICE trial, in which 2681 congestive heart failure patients were randomised to either WS 1442 or placebo, included 64% of subjects taking beta-blockers [about one half carvedilol and almost one third metoprolol] as well as 85% on diuretics, 83% receiving ACE-inhibitors, 56% of subjects taking digitalis and nitrites, and 22% on antiarrhythmics. No drug interactions were detected (PO in human clinical study).2493

III. +    3) Additive effects with the coronary vasodilators theophylline, caffeine, papaverine, sodium nitrate, adenosine, epinephrine (in vitro)156

IV. +    [1) sedative activity of hawthorn was presumed on the basis of its oligomeric procyanidins increasing sleep induced by hexobarbital (IP in mice).1102  This supposed observed sedative hypnotic effect suggested that hawthorn may potentiate CNS depressant effects of anesthetic agents such as barbiturates, benzodiazepines and opioids (speculative).1103 However, the pain induced by intraperitoneal injection or injection of nonsedative tannins results in similar sedated behavior as observed for phenolic fractions of hawthorn. This modified behavior can be abolished by simultaneous administration of aspirin for relief of the consequent pain (IP in mice).1104]

 

HENNA                                                                                 NEW

     ^     Lawsonia inermis leaves

            (alcanna, Egyptian privet, Jamaica mignonette, migonette tree, reseda)

Contraindications

            1) Pregnancy due to its internal use as an abortifacient (empirical)150

            2) Internal use (speculative)150 probably due to most henna products being combinations intended for external use only as hair coloring agents (speculative).

However, 2-week before and during exposure by procarcinogens, use of 200 mg and 400 mg doses of an 80% ethanolic extract of the fresh leaf led to increase in antioxidant and phase II metabolic enzymes and reduction in LDH and of skin and forestomach tumors induced by procarcinogens (topically and PO in mice). When used alone, these internal doses did not cause any visible changes attributed to liver, lung or kidney toxicity or alteration in liver phase I enzyme activity.1960

 

HOPS                                                                                                 p. 119

            (Humulus lupulus) strobiles

Contraindications

     +     3) Nursing mothers should not use hops without professional advice, since the infant may experience a sedating effect (speculative).1890

Drug Interactions

I.          3) Prepared as a 5:1 45% methanolic valerian extract in combination with a 6:1 hops extract, 2 and 6 tablets of this mixture reduced or inhibited, respectively, the stimulant effect of a single 200 mg dose of caffeine (PO in human study)1658

II.         1) Sedative activity of a hop extract (100-500 mg/kg) dose-dependently increases the sleeping time induced by the barbiturate drug pentobarbital (IP in mice).57

            This dose-dependent effect was confirmed with a CO2 extract and with the alpha-acid fraction of this extract, each beginning at a dose of 10 mg/kg (PO in rats).2198

     +     2) Increased sleeping time with the narcotic ketamine was induced by hops extracts and fractions at different doses depending on the component contents (PO in mice). The full CO2 extract from a “Perle” variety harvested in 1999 was effective at 200 mg/kg, whereas when this extract was enriched by about 1/3 with the pure oil the effective dose was 100 mg/kg. Equivalent doses for this extract’s oil fraction with small amounts of bitter acids was 50 mg/kg, while the pure oil required 100 mg/kg. The equivalent doses of humulone fraction with alpha-bitter acids andlupulone fraction with beta-bitter acids were 25 and 200 mg/kg, respectively. A soft resin fraction was inactive, but a combination of the hop oil and alpha- and beta-bitter acid fractions was similar to the oil-enriched CO2 extract.2197

To test whether the combination effects were due to an impact on ketamine metabolism pharmacokinetics, increases in sleeping time with ether by the “Perle 99” CO­­2 extract, the pure oil, and the lupulone showed the results were due instead to pharmacodynamic sedative effects (PO in mice).2197

III. +    2) The beta-acid lupulone and xanthohumol enhanced the antibacterial activity of polymyxin B, tobramycin, and ciprofloxacin against all Gram-positive and some Gram-negative bacteria tested (in vitro).2274

 

HORSE CHESTNUT                                                           p. 120

            *Aesculus hippocastanum bark or seeds

Contraindications

     +     3) Kidney insufficiency or liver dysfunction due to inadequate clearance of escin (speculative)1371

     +     4) Children due to the potential for toxicity, based on 2 cases of renal failure in children and 2 cases of tubulonephrosis in adults following escin therapy (speculative)1370

      +    5) Pregnancy or with nursing mothers without professional advice (speculative), reportedly due to lack of fetal weight gain when very high doses of extract were given (PO in rabbits).1890

Drug Interactions

III. +    2) Hypoglycemic drugs such as sulfonylureas, insulin or metformin may have an additive effect with horse chestnut seed extract (speculative)1370 since 200 mg/kg has hypoglycemic effects in a glucose tolerance test and 100 mg/kg of escins Ia, Ib, IIa, and IIb have significant hypoglycemic activity (PO in rats)338

     +     3) Protein-bound drugs1370,1371 such as phenytoin, warfarin or amiodarone (speculative)1370 since escin binds to plasma protein (speculative)1371

 

HORSERADISH                                                                  p. 120

            Armoracia rusticana = Cochlearia armoracia fresh root

Contraindications

     +     1) Stomach ulcers or intestinal ulcers (empirical) 6,17,401,777 or stomach inflammation due to the membrane irritating effect on the mucosa150

 

HORSETAIL                                                                                    p. 121

            *Equisetum spp. plant

Contraindications

      +    4) The species E. hyemale in pregnancy (empirical)150

 

IBOGA                                                                                   p. 122

            *Tabernanthe iboga root bark

Drug Interactions

I.        1) Acute decreases in intravenous self-administered morphine intake were dose-dependent (2.5-80 mg/kg) with the iboga alkaloids ibogaine, tabernanthine, R-coronaridine, R-ibogamine, and desethylcoronaridine and lasted for at least a day, and for several days for some alkaloids, especially R-ibogamine (IP in rats).  Tremors induced by ibogaine and other alkaloids were inconsequential with R-coronaridine and R-ibogamine, both of which also decreased dopamine in the striatum and nucleus accumbaens (NA).1126 An alkaloidal analogue of ibogaine, 18-methoxycoronaridine, reduced IV morphine self-administration and attenuated signs of opioid withdrawal with no apparent toxicity (IV in rats). This compound is a potent antagonist at 3a4beta nicotinic receptors.1459 

Decreased dopamine in the striatum, NA, and frontal cortex and decreased serotonin in the striatum followed 40 mg/kg ibogaine (IP in rats).1127 This dose reduced morphine stimulatory effects1127 and signs of morphine withdrawal (IP in rats).1128 The reduced morphine-induced locomotor stimulation was greater when there had been prior morphine exposure (in rats).1129 Ibogaine is an agonist for the mu opioid receptor (in vitro).1130

Noribogaine, an ibogaine metabolite, also reduces dopamine levels, morphine self-administration, and morphine’s locomotor stimulant effect but did not induce tremors (in rats).1131

II.   +  1) Acute decreases in intravenous self-administered cocaine intake were dose-dependent (2.5-80 mg/kg) with the iboga alkaloids ibogaine, tabernanthine, R-coronaridine, R-ibogamine, and desethylcoronaridine and lasted for at least a day, and for several days for some alkaloids, especially R-ibogamine which also decreased dopamine in the striatum and nucleus accumbaens (IP in rats).1126 An alkaloidal analogue of ibogaine, 18-methoxycoronaridine, reduced IV cocaine, methamphetamine, and nicotine self-administration with no apparent toxicity (IV in rats). This compound is a potent antagonist at 3alpha4beta nicotinic receptors.1459 In addition to decreased dopamine in the striatum and frontal cortex, decreased serotonin in the striatum followed 50 mg/kg ibogaine (IP in rats).1132 Ibogaine blocks cocaine-induced serotonin transmission which is modulated by kappa-opiod receptors; serotonin transmission in turn modulates dopamine release (in vitro).1133 Administration of 40 mg/kg of ibogaine once or twice reduced self-administered cocaine consumption for at least 2-5 days (IP in mice and rats).1134,1135 A greater reduction of cocaine intake followed administration of 40 mg/kg ibogaine once weekly for 3 weeks (IP in rats).1135

Noribogaine, an ibogaine metabolite, also reduces dopamine levels and cocaine self-administration but did not induce tremors (in rats).1131

Ibogaine involves 5-hydroxytryptamine(2) agonist activity (in rats)1136 and improves memory retrieval (in rats) that may be of importance in combating addictions (speculative).1137 Purkinje cell degeneration in the cerebellum from a toxic dose of 100 mg/kg ibogaine does not occur with therapeutic doses of 40 mg/kg (in rats) and so is not responsible for anti-addictive effects.1138

      +    2) Ibogaine at single doses of 10, 30, or 60 mg/kg reduced alcohol (ethanol) intake (IP in rats), as did subchronic dosing with 60 mg/kg (PO in rats), though it was ineffective subcutaneously.1139 Ibogaine has N-methyl-D-aspartate (NMDA) antagonistic actions (in vitro) associated with attenuation of multiple addictions.1140 An alkaloidal analogue of ibogaine, 18-methoxycoronaridine, reduced oral alcohol self-administration with no apparent toxicity (IV in rats). This compound is a potent antagonist at 3alpha4beta nicotinic receptors.1459 

      +    3) Ibogaine increases brain levels of amphetamine when given prior to the drug, possibly due to a hepatic drug-drug interaction (IP in rats).1471 Pretreatment with ibogaine increases the stimulatory motor effects of amphetamine at various doses of the drug (IP in rats).1472 Locomotor stimulation by amphetamine was decreased by 40 mg/kg ibogaine given 18 hours prior, likely due to its decrease in striatal dopamine levels that are increased by amphetamine (IP in mice). The interspecies differences were confirmed when the same dose and timing of ibogaine again resulted in a further increase in locomotor stimulation from amphetamine (IP in rats).1551

 

INMORTAL                                                                         NEW

     ^     Asclepias asperula = Asclepias capricornu root

Contraindications

            1) Pregnancy (empirical)150 due to its emmenagogue, oxytocic, and abortifacient effects (empirical)75  

 

IPECAC                                                                                p. 123

            *Cephaelis ipecacuanha root/rhizome

Contraindications  

            2) Petroleum distillate poisoning777 due to aspirational pneumonitis (empirical)2

[CORRECTION] though the risk appears less with emesis than with gastric lavage, especially if emesis is done under medical supervision (empirical)150

            6) Extended use as an emetic for over 3-4 days [CORRECTION: not PROLONGED USE for more than a month] can produce dehydration and severe electrolyte imbalances, and muscular cramping (empirical)150

            12) Drowsiness or reduced conciousness (empirical)2

or sedation due to risk of aspiration of stomach contents (empirical)150

     +     14) Hiatal hernia, esophageal varices, stomach ulcer or peptic ulcer due to aggravation and/or potential hemorrhage from emetic effect if bloodroot is taken in excessive doses (speculative)150

     +     15) High blood pressure150 due to the muscular exertion produced by inducing vomiting with ipecac (speculation)

Drug Interactions

III. +    1) Do not take large doses after recent consumption of central nervous system stimulants, due to the emetic action potentially inducing convulsions (speculative).150

      +    2) Do not take large doses after recent consumption of central nervous system sedatives, due to the emetic action potentially inducing aspiration pneumonitis (speculative).150

 

JAMAICA DOGWOOD                                                      p. 124

            *Piscidia erythrina = Piscidia piscipula bark

Contraindications

     +     3) Avoid in pregnancy (speculative), due to fetal malformation or irreversible damage from its rotenone content (PO in rats).1890

     +     4) Do not use in bradycardia (low heart rate) or cardiac insufficiency (speculative), due to rotenone impairing heart contractile force and lowering blood pressure (in animals).1890

     +     5) Avoid use by nursing mothers without professional advice, due to potential toxicity for infant (speculative).1890

Drug Interactions

III.       1) Do not use concurrently with powerful analgesics (speculative), due to potential additive effects.1890

 

JOB’S TEARS                                                                      NEW

     ^     Coix lacryma-jobi seeds

            (Ch.: yi yi ren)

Contraindications

            1) Pregnancy (empirical)150 due to uterine stimulant component palmitic acid as shown in lab studies74 

 

JUJUBE SEEDS                                                                   NEW

      ^     Ziziphus spinosa seeds

            (Ch.: suan zao ren)

Contraindications

            1) Pregnancy  due to its emmenagogue and uterine stimulant effects (empirical)150

 

KAVA                                                                                    p. 125

            *Piper methysticum root and rhizomes

            (kava pepper, kawa pepper, maori kava; S. Pacific: ava, gea, gi, kao, kawa, kew, malohu, maluk, meruk, milik, sakau, tonga, yagona, yangona, yaqona, yongona; Ger.: kawapfeffer, wurzelstock)

[FOR MORE INFORMATION ON KAVA, KAVALACTONES (PYRONES), AND POTENTIAL ADVERSE EFFECTS ON THE LIVER, SEE www.eclecticherb.com/kava]

Contraindications

            3) Do not use in endogenous depression to avoid potentiating suicidal tendencies (speculative).6,17,401,777

However, an aqueous extract of peeled roots was shown to acutely decrease scores on a depression rating scale after 1 week, while also reducing scores on 2 anxiety assessments in a placebo-controlled crossover study (PO in human clinical study).2575 With professional supervision, its use may be considered in this condition with caution (speculative).1890

4) Avoid operating a motor vehicle following excessive use due to impaired driving ability (PO in news reports).244,728

A study of kava drinkers compared 11 who had consumed kava beverage in the previous 24 hours made on average from 205 grams of powder to a group of 17 who had not drank the beverage for at least one week. The intoxicated group was found to have ataxia, tremors, sedation, eyelid spasm, and elevated GGT and ALP liver enzymes. They also had problems performing complex visual search tasks, but complex cognitive functions were normal. Saccade impairment indicates disrupted GABAerbic and cerebellar functions (PO in human study).1480

5) Regular prolonged use is suspected of contributing to the risk of adverse effects on the liver. One proposal is to limit daily use to no more than four weeks (speculative).1232

     +     6) Parkinson’s disease due to its aggravation by the dopamine antagonist properties of kavalactone-containing extract (PO in human case report) 316 and since concentrated kava concentrated extracts including WS1490 led to involuntary muscle movements in three people as bingeing on its traditional water extract did in another (PO in human case reports).316,1149 Another case of sudden, severe, and persistent Parkinsonism associated with 65 mg/day kava concentrated extract for 10 days appeared related to a genetic predisposition due to the presence of essential tremor in other family members (PO in human case report).1264

     +     7) Consumption of kava products should be avoided in individuals with jaundice or past liver disorders (speculative). A total of 24 cases of liver toxicity associated with kavalactone-concentrated extracts have been reported in Germany, including five in Switzerland. In 18 cases drugs with known or potential liver toxicity were also used.1232 A review of pre-clinical hepatotoxicity studies on kava and the 19 suspected German cases revealed that in only one was a probable causal relationship established.1476 In hepatotoxicity cases after kavalactone extract use, one patient has died and three required liver transplants. No association with liver damage has been reported in South Pacific islands where consumption of kava as a beverage is an important aspect of the traditional culture.1232 An aqueous extract of peeled roots was shown to acutely decrease scores on anxiety assessments in a placebo-controlled crossover study with no clinical signs of hepatotoxicity in 37 subjects (PO in human clinical study).2575

However, a critical analysis of 26 reported hepatotoxicity cases associated with kava ethanolic and acetonic extracts concluded that the clinical patterns indicated idiosyncratic reactions of the metabolic type, rather than predictable hepatotoxicity (PO in human case series).2327 Another possible cause of liver damage associated with use of concentrated kava preparation is an immunologically mediated idiosyncratic mechanism (speculative).1445,1607

Consumption of 3-4 capsules daily for two months of an acetone extract standardized to total kavalactones (WS1490 with 70 mg lactones per capsule) led to fulminant toxic hepatitis that required a liver transplant in a person who had not previously taken drugs or consumed alcohol (PO in human case report). Three capsules daily is the maximum recommended dose for this product.1150 One patient used the maximum recommended dose of WS1490 for three weeks followed by consumption of 60 grams of alcohol, resulting in acute toxic hepatitis. Use of the concentrated extract was stopped, and liver enzyme levels returned to normal within 8 weeks. T-lymphocyte reactivity to the extract suggested an immune-mediated reaction. In addition, like 9% of the local Swiss population, the patient showed poor metabolism by cytochrome P450 (CYP) 2D6 (PO in human case study).1211

German medical literature also reports overuse of an ethanolic concentrated extract of kava standardized to 120 mg total kava lactones (intake 480 mg lactones/day for over a year) was the probable cause of toxic hepatitis in another woman who required a liver transplant (PO in human case report).1159 Use of an ethanolic extract with 60 mg total kava lactones consumed daily induced hepatitis in a woman who had previously experienced acute hepatitis with elevated GPT while using the extract, but she recovered fully within four months when the kava extract was withdrawn (PO in human case report).1151 At high concentrations of 50 mcg/ml and above both acetonic and methanolic extracts of the dried root with 81.4-81.6% kavalactones, respectively, showed lactate dehydrogenase (LDH) leakage from hepatocytes after only 1.0-5.5 hours of exposure (in vitro).2222

However, estimates of hepatocyte exposure to extract concentration from normal dosing is only about 2-10 mcg/g tissue (speculation).2222 Also, giving an ethanolic root extract with 47.4% kavalactones at a dose of 73 mg/kg kavalactones daily for 3-6 months produced no signs of liver toxicity (PO in rats).1957 Piperidine alkaloids present in the basal stem peelings, including pipermethystine, may be hepatotoxic based on cytotoxicity demonstrated in hepatic cells unaffected by several kavalactones (in vitro). These peelings were formerly waste products but may have been used prior to hepatoxicity cases in manufacturing extracts.1500,1787

Two women in their 50s from Oceania consuming kava tea prepared from the dried root (one used 4 cups daily with approximately 18 grams of kavalactones/week) developed jaundice after 4-5 weeks. They had highly elevated levels of transaminases and total bilirubin. They did not consume alcohol, were negative for acute viral hepatitis, and were not poor CYP 2D6 metabolizers. Symptoms and lab results returned to normal after 3 months of eliminating kava tea consumption.  The assessment was possible kava allergenic idiosyncrasy (PO in human case reports). Further assessment of regular heavy kava tea consumers (about 32 grams of kavalactones/week) found most had elevated GGT and dry skin but no liver disease. Four who reduced their kava consumption had normal skin and GGT levels after one month (PO in human study).1445

However, on the island of Pohnpei it is estimated that the dose of kavalactones per sitting (drinking about 8 cups over 5 hours) was 2.4 grams, with no obvious liver damage occurring as a result (PO in field study).1499 With abusive kava tea consumption equivalent to using an average of 310-440 grams of dried root weekly for years, only gamma-glutamyl transferase (GGT) plasma enzyme levels indicative of liver damage were greatly elevated in an Australian aborigine population (PO in human study). Prior to this group being introduced to using the water extract of kava, they had previously abused alcohol.1160 Water extracts given at daily doses of 200 or 500 mg/kg for 2 or 4 weeks failed to cause elevations of 3 enzymes (ALT, ALP, LDH) that indicate liver damage, but instead reduced these enzyme levels. Malondialdehyde levels were increased but not significantly, when compared to placebo (in rats).1528

Inhibition of CYP isozymes 1A2, 2C9, 2C19, 2D6, 3A4, and 4A9/11 by kava extract, largely involving inhibition of CYP 2C9, 2C19, 2D6, and 3A4 by the kavalactones desmethoxyyangonin, dihydromethysticin. and methysticin but not kavain (in vitro), may contribute to increased circulating levels of hepatotoxins when cultivars such as “tudei” that are high in these two kavalactones are used (speculative).1327 The tudei cultivar is traditionally only used in mixtures, due to its potent effect that causes intoxication for “two days." HPLC assays on lots of the commercial acetonic extract from the period of 1999/2000 reveal that the kavalactone profile of one of the three lots tested was “a typical ‘tudey’ quality, a ‘no-drink’ kava type.”2286 Also, extracts made with acetone, ethanol or methanol inhibit CYPs 1A2, 2C9, 2C19, and 3A4 much more than a water extract (in vitro).1733

Another studied confirmed kavalactone inhibition of CYP 3A4 (in vitro).1475 Metabolites of kavalactones do not appear to have enhanced toxicity, since cells transfected with human CYP 1A1,1A2, 2A6, 2E1, and 3A4 and epoxide hydrolase were not more affected than cells without these enzymes when exposed to dried kava root ethanolic extract or the kavalactones methysticin, yangonin, and desmethoxyyangonin (in vitro).1643

However, 6-phenylhexenone (6-PHO), a highly reactive metabolite of kavain and dihydrokavain has been identified in the urine of 2 subjects given dried kava root (PO in human study). Such metabolites are not necessarily hepatotoxic themselves and usually require an adjuvant. This 6-PHO may also be formed during the processing of the root (speculative). 1781

Pipermethystine, an alkaloid present in the formerly discarded basal stem peelings, may be hepatotoxic based on cytotoxicity demonstrated in hepatic cells that were unaffected by several kavalactones (in vitro).1787 A methanolic extract of the leaves with 1.34% pipermethystine was shown in concentrations as low as 10 mcg/ml to increase the concentration of oxidized glutathione and decrease the ratio of reduced to oxidized glutathione in hepatic cells, while methanolic and acetonic extracts of the roots did not do so even at concentrations up to 150 mcg/ml (in vitro). The pipermethistine content of the root extracts was around 0.01%.2222 Piperidine alkaloids including pipermethystine are present in the basal stem peelings. These peelings were formerly waste products but may have been used prior to hepatoxicity cases in manufacturing extracts.1500,1787

A combination product with 60 mg kavalactones along with 50 mg Passiflora incarnata and 100 mg Scutellaria lateriflora taken three times daily was associated with acute liver failure and death in a 56-year-old Australian woman (PO in human case report). While analysis confirmed the kava and passionflower content, the Scutellaria (skullcap) ingredient could not be identified. Rather, a third unknown component was detected.1513 

However, hepatotoxicity has been reported in a number of cases where patients in Great Britain supposedly used products containing skullcap that may have been misidentified (PO in human case reports).1514 Some wholesale suppliers in Great Britain had provided Teucrium species in place of skullcap.1515 Teucrium chaemaedrys (germander) has been shown to cause hepatotoxicity in at least seven instances in France (PO in human case reports)1516 and two in Canada (PO in human case reports),1517 in addition to a case of fatal hepatitis (PO in human case report).1518 The American Scutellariea lateriflora is sometimes known as “blue skullcap” to distinguish it from “pink skullcap,” the American species Teucrium canadense (wild germander). This spurious skullcap Teucrium spp. may responsible for some cases of hepatitis based on misidentification as Scutellaria, due to similar common names of American “skullcap” species.1519 Teucrium and Scutellaria spp. can be readily distinguished based on their HPLC phytochemical profiles.1520

8) at least 24 hours and possibly one week prior to surgery (speculative)1309,1310 due to the potential for interaction with intra- and postoperative medications (speculative)1310 including the sedative effects of anesthetics (speculative)1309,1715

Drug Interactions

I.          2) Alprazolam, a benzodiazepine, may have been enhanced by the use of a kava product (human case report).137

This report has been described as unevaluable based upon report inadequacies.1239

            However, the man in the case report was taking cimetidine along with the alprazolam,137 and cimetidine is a known CYP3A4 inhibitor of alprazolam metabolism,2501 while kava does not inhibit CYP3A4 metabolism of midazolam (PO in human studies).1807,2501

Also, concurrent use of kava extract with 240 mg kavalactones daily and bromazepam at 9 mg/day reportedly did not cause adverse effects on mental performance and well-being more than the benzodiazepine alone (PO in human study).1890 Kavalactone-concentrated extract WS 1490, gradually increased from 50 mg to 300 mg over one week as benzodiazepine doses were tapered off over two weeks, was given as a monotherapy for three weeks to 40 non-psychotic anxiety patients. Following the pretreatment with alprazolam or lorazepam, bromazepam or oxazepam, WS 1490 efficacy was better than placebo and tolerance was as good (PO in human clinical study).1212

Inhibition of cytochrome P450 (CYP) isozyme 3A4 by kava extract involving the kavalactones desmethoxyyangonin, dihydromethysticin, and methysticin (in vitro) may contribute to increased circulating levels of benzodiazepines (speculative).1327

            However, in human hepatocytes kava was shown to induce CYP 3A4 mRNA via pregnane X receptor (in vitro).1696

            3) Sedation, cogntion, co-ordination, and intoxication increased when kava was taken with alcohol (PO in human study).1025 

Kava products should be avoided in individuals who consume alcohol on a regular basis (speculative).1232 It is also recommended that alcohol should be avoided with long-term kava beverage intake, especially in high doses, to minimize the risk of hepatic damage (speculative).2140

With abusive kava tea consumption equivalent to using an average of 310-440 grams of dried root weekly for years, gamma-glutamyl transferase plasma enzyme levels indicative of liver damage were greatly elevated in an Australian aborigine population (PO in human study). However, prior to this group being introduced to beverage kava, they had previously abused alcohol.1160

One patient used the maximum recommended dose of the kavalactone-concentrated extract WS1490 for three weeks with no incident. Two months later another three-week course of WS1490 use was followed by consumption of 60 grams of alcohol, resulting in acute toxic hepatitis. Use of the concentrated extract was stopped, and liver enzyme levels returned to normal within 8 weeks (PO in human case study).1211

     +     4) 1 gram root extract twice daily for 28 days inhibited metabolism of the CYP2E1 substrate chlorzoxazone by 40%, but not substrates for CYP 1A2, 2D6 or 3A4 (PO in human study).1807 Kava root preparations and its various isolated kavalactones 1733 have been shown to be in vitro inhibitors of CYP 1A2, 2C9, 2C19, 2D6, and 3A4 substrate metabolism,1327,1475,1577 but 2E1 was unaffected.1327

II.         1) Extract and lactones increased sleeping time from pentobarbital (in mice).510 

            Inhibition of cytochrome P450 isozyme 2C9 by kava extract involving the kavalactones desmethoxyyangonin, dihydromethysticin, and methysticin (in vitro) may contribute to increased circulating levels of barbiturates in general (speculative).1327

      +    3) Hypermotility induced by amphetamine was reduced by both kava resin and a lactone-free aqueous fraction of kava extract (IP in mice)1152

III.       1) Psychopharmacological agents such as sedatives may be enhanced by the extract (speculative),6,17,401

Prolonged sedation may result when combined with intra- and postoperative medications (speculative)1310,1715 including the sedative effects of anesthetics (speculative)1309,1715 and anesthetic induction drugs like benzodiazepines or opioids (speculative)1715 

2) Kavalactone products equivalent to those associated with adverse effects on the liver should be avoided in individuals taking any liver-toxic drugs (speculative). A total of 24 cases of liver toxicity associated with kavalactone-concentrated extracts have been reported in Germany and 5 in Switzerland. In 18 cases drugs with known or potential liver toxicity were also used. No association with liver damage has been reported in South Pacific islands where consumption of kava as a beverage is an important aspect of the traditional culture.1232

However, a critical analysis of 26 reported hepatotoxicity cases associated with kava ethanolic and acetonic extracts concluded that the clinical patterns indicated idiosyncratic reactions of the metabolic type, rather than predictable hepatotoxicity (PO in human case series).2327

One patient used the maximum recommended dose of WS1490 for three weeks followed by consumption of 60 grams of alcohol, resulting in acute toxic hepatitis. Use of the concentrated extract was stopped, and liver enzyme levels returned to normal within 8 weeks. T-lymphocyte reactivity to the extract suggested an immune-mediated reaction. In addition, the patient showed poor metabolism by cytochrome P450 2D6 (PO in human case study).1211

Two women in their 50s from Oceania consuming kava tea prepared from the dried root (one used about 18 grams of kavalactones/week) developed jaundice after 4-5 weeks. They had highly elevated levels of transaminases and total bilirubin. One woman had taken phenobarbital, lisinopril, and fenofibrate for months or years which she then discontinued. They did not consume alcohol, were not poor CYP 2D6 metabolizers, and returned to normal after 3 months of eliminating kava tea consumption. The 3 drugs were restarted without incident.  The assessment was possible kava allergenic idiosyncrasy (PO in human case reports). Further assessment of regular heavy kava tea consumers (about 32 grams of kavalactones/week) found most had elevated GGT and dry skin but no liver disease. Four who reduced their kava consumption had normal skin and GGT levels after one month (PO in human study).1445 It is recommended that medications with hepatotoxic potential should be avoided with long-term kava beverage intake in high doses to minimize the risk of hepatic damage (speculative), even though elevated GGT is the only associated significant lab deviation from normal (PO in human study).2140

Co-medication with kava preparations and other herbs and/or synthetic drugs is considered a risk factor for hepatotoxicity (speculative).2594 A 14-year-old female developed hepatic failure and required a liver transplant after using a combination product with 100 mg kava extract, 100 mg chamomile (Matricaria chamomilla) extract, and 50 mg St. John’s wort (Hypericum perforatum) extract twice daily for 4 months, as well as ibuprofen (PO in human case report). She developed nausea and vomiting for 8 days prior to becoming jaundiced. When he was admitted to the hospital 2 days later, she had elevated bilirubin and transaminases, and 8 days later her excised liver showed fulminant hepatitis with total hepatocyte necrosis. Her recovery was complete after liver transplant.2595

In addition, a combination product with 60 mg kavalactones along with 50 mg Passiflora incarnata and 100 mg Scutellaria lateriflora taken three times daily was associated with acute liver failure and death in a 56-year-old Australian woman (PO in human case report). While analysis confirmed the kava and passionflower content, the Scutellaria (skullcap) ingredient could not be identified. Rather, a third unknown component was detected.1513 Hepatotoxicity has been reported in a number of cases where patients in Great Britain supposedly used products containing skullcap that may have been misidentified (PO in human case reports).1514 Some wholesale suppliers in Great Britain had provided Teucrium species in place of skullcap.1515 Teucrium chaemaedrys (germander) has been shown to cause hepatotoxicity in at least seven instances in France (PO in human case reports)1516 and two in Canada (PO in human case reports),1517 in addition to a case of fatal hepatitis (PO in human case report).1518 The American Scutellariea lateriflora is sometimes known as “blue skullcap” to distinguish it from “pink skullcap,” the American species Teucrium canadense (wild germander). This spurious skullcap Teucrium spp. may responsible for some cases of hepatitis based on misidentification as Scutellaria, due to similar common names of American “skullcap” species.1519 Teucrium spp and Scutellaria spp can be readily distinguished based on their HPLC phytochemical profiles.1520

Giving an ethanolic root extract with 47.4% kavalactones at a dose of 73 mg/kg kavalactones daily for 3-6 months produced no signs of liver toxicity (PO in rats).1957 Pipermethystine, an alkaloid present in the formerly discarded basal stem peelings, may be hepatotoxic based on cytotoxicity demonstrated in hepatic cells that were unaffected by several kavalactones (in vitro).1787 6-phenylhexenone (6-PHO), a highly reactive metabolite of kavain and dihydrokavain has been identified in the urine of 2 subjects given dried kava root (PO in human study). This 6-PHO may also be formed during the processing of the root (speculative).1781

However, such metabolites are not necessarily hepatotoxic themselves and usually require an adjuvant.1781

Inhibition of cytochrome P450 (CYP) isozymes 1A2, 2C9, 2C19, 2D6, 3A4, and 4A9/11 by kava extract (in vitro) largely involved inhibition of CYP 2C9, 2C19, 2D6, and 3A4 by the kavalactones desmethoxyyangonin, dihydromethysticin. and methysticin but not kavain. This may contribute to increased circulating levels of hepatotoxins when cultivars such as “tudei” that are high in these two kavalactones are used (speculative).1327 Another studied confirmed kavalactone inhibition of CYP 3A4 (in vitro).1475 On the other hand, in human hepatocytes kava was shown to induce CYP 3A4 mRNA via pregnane X receptor (in vitro).1696 Inhibition in-vitro isozyme studies are notoriously unreliable when compaired to results from human studies, especially for CYP3A4.

     +     3) the kavalactone kavain relaxes arterial constrictions caused by phenylephrine due to its inhibition of calcium channels in the smooth muscles (in vitro)1527

 

KHELLA                                                                               p. 128

            *Ammi visnaga fruit

Contraindications

2) Ultraviolet light or solarium therapy due to photosensitization (empirical)10

 

KONJAC                                                                               p. 128

Amorphophallus konjac tuber

Drug Interactions

I.          2) Diabetics given 3.6-7.2 grams of konjac mannan had insulin or hypoglycemic drugs reduced or withdrawn (PO in human clinical study)729

            In 22 diabetic subjects using insulin (1) or glinbenclamide (13), metformin (15), glipizide (7), or acarbose (1) as single and/or combination oral hypoglycemic drugs, 4.5 grams daily of konjac powder with 80% glucomannan for 28 days lowered fasting glucose and blood lipid levels including plasma cholesterol, LDL-cholesterol, total/HDL cholesterol ratio and apolipotrotein B (PO in human clinical study). Without taking lipid-lowering medication, they also had increased fecal concentrations of neutral sterol and bile acids. Triglycerides, HDL-cholesterol, and postprandial glucose were not changed.1666

 

KUDZU                                                                                 p. 129

Pueraria lobata root

Drug Interactions

I.          1) Physicians used kudzu root to treat alcohol abusers; 80% no longer experienced alcohol craving (empirical).546

In a placebo-controlled double-blind crossover trial 14 heavy beer drinkers (11 males) given 1 gram three times daily for a week of kudzu extract with 19% puerarin, 4% daidzin and 2% daidzein significantly reduced beer intake during a 1.5 hour session (PO in human study). The total volume and the size of each sip decreased.1726

However, when 2.4 grams of an uncharacterized kudzu extract was given in a double-blind study of 38 alcoholic patients there appeared to be no reduction in alcohol craving or sobriety for those who received the extract (PO in human clinical study).1491

An isoflavone from kudzu, puerarin, decreases alcohol consumption when given chronically, gradually producing greater suppression of alcohol intake (PO in animals).1470 Puerarin increased locomotor activity and social interaction  that were otherwise reduced by withdrawal from 7% alcohol used in the diet for 17 days, similar to flumazenil. Puerarin showed other anxiolytic effects consistent with it being a weak benzodiazepine site antagonist (IP in rats).1460

II.  +     1) The simulataneous administration of the decoction at 2 gm/kg and higher with the chemotherapy and antirheumatic drug methotrexate led to its increased bioavailability and increase in mortality (PO in rats). This may be due to its interference with multi-drug resistant proteins or organic anion transporter proteins (speculative).2269

 

KUTAKI                                                                               NEW

Ä         Picrorhiza kurroa root

(picrorhiza; Ind.: kutki, katuka)

Contraindications

            1) Due to the emmenogogue and abortifacient effects (empirical),74 picrorrhiza should be avoided in large amounts in pregnancy

Drug Interactions

II.         1) The ethanol extract at 80 mg/kg for 15 days protected against myocardial infarction induced by isoproterenol (PO in rats).1214

2) The ethanol extract at 100 mg/kg for 10 days protected against stomach ulceration induced by a mixture of hydrochloric acid (HCl) and ethanol (PO in rats).1213

3) The freeze-dried methanolic extract given at 20 mg/kg for 3 days reduced ulcer indices by 45% in ulcerations induced by indomethacin, compared to no treatment (PO in mice). After 3 days the extract reduced levels of thiobarbituric acid reactive substances by 33% and increased mucin by 42%, epidermal growth factor by 149%, mucosal PGE2 by 21%, and COX-1 and –2 expression by 27% and 19%, respectively.2276

 

LAVENDER [now ENGLISH LAVENDER]                    p. 129

Lavandula angustifolia = Lavandula officinalis = Lavandula vera flowers

 

LEMONGRASS                                                                   p. 130

            Cymbopogon citratus plant

Contraindications

      +    3) Pregnancy due to its emmenagogue and/or uterine stimulant effects (empirical)150

 

LESSER PERIWINKLE [formerly PERIWINKLE]         p. 161

Ä         Vinca minor plant

 

LICORICE                                                                            p. 131

      +    * Glycyrrhiza glabra or Glycyrrhiza uralensis root/rhizome

            (G. uralensis = Chinese licorice; Ch: gan cao)

Contraindications

            1) High blood pressure344,401 due to hypertension caused by its overuse (PO in human case report)1379,2578

Increase in blood pressure after 1 week from 500 mg/day of glycyrrhizic acid is greatest in salt-sensitive individuals (PO in human study)1667

Eating 100 grams of licorice candy daily led to increased systolic blood pressure in a normotensive population of 30 subjects (PO in human study). The 13 women had increased systolic and diastolic blood pressure after consuming only 50 grams of licorice daily.2120

2) Low blood potassium4,150,401 due to diminished serum potassium associated with over-consumption of licorice (PO in human case reports) 1379,2578

Eating 100 grams of licorice candy daily led to decreased plasma potassium in 30 subjects (PO in human study).2120

Eating 250-500 grams of licorice candy daily for several years led to hypokalemia with ventricular fibrillation and hypertension (PO in human case report).2578

Eating 750 grams/day for 2 weeks led to progressive tetraparesis, flaccid paresis in all limbs, with a massive hypokalemia of 1.13 mmol/L in a 54-year-old woman who had just stopped smoking (PO in human case report).2279

3) Prolonged use150 for more than 4-6 weeks due to resulting hypertension, hypokalemia, and edema (empirical)4,6

A woman with a history of chronic hypokalemia developed a 5-month progressive weakness of her neck, so holding up her head became difficult. Supplementing potassium raised her serum level and gradually improved her condition. She had used to Chinese herbal medications containing licorice for over 10 years, and potassium levels did not normalize until the licorice ingestion was discontinued. Potassium supplementation was stopped, and full neck extension was regained in about 2 months (PO in human case report).1468 

4) Pregnancy2,4,6,17,401

            Women consuming more than 500 mg of glycyrrhizin per week were more likely to give birth earlier (PO in human study),1163 though not necessarily (PO in human study).2616 This heavy glycerrhizin exposure is associated with preterm (<37 weeks gestation) and especially early preterm (<34 weeks) delivery (PO in human study).1385

The inhibition of placental 11-beta-hydroxysteroid dehydrogenase by glycerrhizin following dose-related consumption of licorice in pregnancy in amounts >500 mg/week causes significant diminishment of verbal and visuospatial skills and narrative memory in the children by age 8 years (PO in human study). Also, these children show significant increases in problems with attention, aggression, and rule-breaking, apprarently due to overexposure to glucocorticoids in the womb.2616

            5) Chronic hepatitis (empirical)6,401

However, limited success is claimed in treating chronic hepatitis B with a combination therapy involving glycyrrhizin withdrawal and interferon-beta (PO in human clinical study)1989 and in preventing liver carcinogenesis in those with chronic hepatitis C with glycyrrhizin combined with cysteine and glycine (IV in human clinical study).1990 Those 72 of 115 chronic hepatitis C patients receiving 40 mg glycyrrhizin in the combination therapy 6 times weekly for 4 weeks that showed ALT lowering continued on an additional 22 weeks to see if results were sustained at different dosing frequencies (IV in human clinical study). 60% of those who had continued the 6 times weekly injections maintained lower ALT, compared to only 24% and 9% of those who had 3 times and once weekly injections, respectively. Those treated for 26 weeks had improvement of the physical functioning scale of the quality of life assessment and higher overall scores compared to those who stopped at 4 weeks.2121

10) men with decreased libido or other sexual dysfunction since licorice extract given to 7 men in doses containing 0.5 gram glycyrrhizin significantly reduced serum testosterone (PO in human study).888

However, a follow-up study repeating the same daily 0.5 gram dose of glycyrrhizin with 20 men found the salivary testosterone reduction to be an insignificant 9.5%. Using another source of licorice but the same glycyrrhizin dose again in 11 men and 10 women showed the salivary testosterone was not decreased significantly in either, though the salivary cortisol increased significantly in both (PO in human study).1261

     +     11) Nursing mothers (speculative)150 due to potential influence of hormone metabolism in infant (speculative)

Drug Interactions

I.          4) Licorice extract given to men at 7 grams daily (0.5 gram glycyrrhizin) reduced their serum testosterone (PO in human study).888

            Licorice root extract at 3.1 or 6.3 gm/kg or glycyrrhizin at 240 or 480 mg/kg significantly induced the activity of 5-6 types of testosterone hydroxylase (PO in mice).1630,1650

            7) Additive increase of potassium loss can occur even with small amounts when taken along with laxatives (human case report).541

Myoclonus due to metabolic alkalosis occured with an antacid powder with licorice was used with sennoside (PO in human case report).1690

II.  +     4) Glycyrrhizin inhibits the metabolic conversion of dexamethasone (PO in rats). This is likely due to its inhibition of the catalytic enzyme 11b-hydroxysteroid dehydrogenase.983 

     +     5) Enhanced metabolis breakdown of S-warfarin was induced by 500 mg/kg of an aqueous extract equivalent to 3 gm/kg dried root (PO in rats) evidently through activation of pregnane X receptor as shown by an ethanolic extract of G. uralensis (in vitro).1926

III. +    3) [Prior III. 3) added to I. 2).] Glycyrrhizin inhibited Herpes varicella-zoster virus replication in an additive or synergistic manner with anti-herpes drugs acyclovir, adenine arabinoside, bromovinyldeoxyuridine, phosphonoformate, and beta-interferon (in vitro).1826

     +     4) Avoid use with antihypertensives due to antagonism (speculative),777 due to hypertension caused by its overuse (PO in human case reports)215,275,344,401,573,1379 and the sodium and fluid retention caused by its saponin glycyrrhizin, also called glycyrrhizic acid.4,6,150 Increase in blood pressure after 1 week from 500mg/day of glycyrrhizic acid is greatest in salt-sensitive individuals (PO in human study).1667

     +     5) Hepatotoxicity induced by clinically relevant micromolar concentrations of azathioprine, as indicated by reduced cell viability and GSH depletion, was reduced by an aqueous extract of licorice and its component glycyrrhizic acid (in vitro).1953

 

LIFE ROOT                                                                          p. 136

            *Senecio aureus plant

Contraindications

                5) Avoid internal use, since pyrrolizidine alkaloid content (speculative),2 including senecionine,24,333 can lead to fatality (PO in human case report).144

The pyrrolizidine alkaloid senecionine from Senecio jabobaea has been shown to be both bioactivated to its toxic form and detoxified to its N-oxide form by cytochrome P450 isozyme 3A4 (in vitro).1183

 

LINDEN FLOWER                                                             NEW

     ^     Tilia cordata flowers

            (lime blossom, tilia)

Contraindications

            1) Avoid in allergic hypersensitivity for those rare individuals who are reactive to this plant (empirical).1890

Drug Interactions

I.          1) The absorption of iron was reduced by 52% when an infusion of 3 grams in 300 ml was given concurrently with ferric chloride (PO in human study). This was likely due to the content of monomeric flavonoids in the preparation that bind iron in the gut lumen.1246

 

LOBELIA                                                                              p. 136

            *Lobelia inflata plant or seeds

Contraindications

     +     12) Hiatal hernia, esophageal varices, stomach ulcer or peptic ulcer due to aggravation and/or potential hemorrhage from emetic effect if bloodroot is taken in excessive doses (speculative)150

Drug Interactions

II.   +    1) Lobeline alkaloid reduces hyperactivity due to amphetamine, while it inhibits this and drug discrimination and self-administration of methamphetamine (in rats). Lobeline reduces amphetamine-induced relase of dopamine (in vitro), while lacking its own addiction liability from self-adminstration (in rats).1602

III. +    1) Do not take large doses after recent consumption of central nervous system stimulants, due to the emetic action potentially inducing convulsions (speculative).150

      +    2) Do not take large doses after recent consumption of central nervous system sedatives, due to the emetic action potentially inducing aspiration pneumonitis (speculative).150

 

LOMATIUM                                                                         NEW

     ^     Lomatium dissectum root

            (Indian balsam, cough root, lace-leaved leptotaenia; Am. Ind: doza (Washoe), toh-sah-ah (Paiute), toh-sup (Shoshone) )

Contraindications

            1) Pregnancy (speculative)150 possibly due to the uterine relaxant effects of its coumarin component columbianin (in vitro) or the toxic effects of its oil fraction (IP and SC in mice)3

            2) Due to content of potentially phototoxic furocoumarins3 and skin rash that can occur with internal use,150 ultraviolet light and solarium therapy should be avoided (speculative)

 

LONG PEPPER                                                                   p. 138

            Piper longum fruit

Drug Interactions

I.          1) Phenytoin was absorbed more rapidly and more completely and eliminated more slowly in 5 males when taken with 20 mg of the component piperine (PO in human study).205

            A single 20 mg dose of piperine in 2 groups of 10 men receiving 300 mg or 400 mg daily of phenytoin increase mean plasma drug concentration and bioavailability (PO in human study).1943

     +     4) Piperine dose of 20 mg increased serum concentrations of curcumin after 0.25-1.0 hours and increased bioavailability by 2000% (PO in human study).1533

II.  +     5) Increased anti-nociceptive and anti-inflammatory activity from nimesulide was achieved when 100 mg was combined with 60 mg piperine from long pepper (PO in mice). This was apparently due to reduced metabolic breakdown of nimesulide.1821

     +     6) Decreased absorption and anti-inflammatory effect of diclofenac sodium was observed when it was combined with the trikatu combination of long pepper, black pepper and ginger (PO in rabbits and rats).2003 Since the drug was mixed with the herbs in solution prior to administration, the interaction may have been chemical in nature, rather than biological (speculative).

     +     7) Reduced absorption, peak concentration, and bioavailability of isoniazid resulted for 4 hours when it was given together with 500 mg/kg trikatu, a 1:1:1 mixture of dried fruits of black pepper, long pepper and dried rhizomes of ginger providing 10 mg/kg of the alkaloid piperine (PO in rabbits). This may be due to a decrease in gastric emptying time (speculative).2005

     +     8) Increased absorption and peak concentration of indomethicin after 4 hours was achieved when it was given together with 500 mg/kg trikatu, a 1:1:1 mixture of dried fruits of black pepper, long pepper and dried rhizomes of ginger (PO in rabbits). The pharmacokinetic effect may have been due to an increased GI blood flow (speculative), but was not due to change in indomethicin metabolism.2004

 

LYCIUM                                                                               NEW

     ^     Lycium barbarum, Lycium chinense berry and root bark

            (matrimony vine, wolfberry; Ch.: gou qi zi (berry), di gu pi (root bark) )

Contraindications

            1) Pregnancy (empirical)150 due to its abortifacient activity and the emmenagogue effect associated with the fruit (empirical)74

 

MACA                                                                                   NEW

^          Lepidium meyenii root

            (Peruvian ginseng)

Drug Interactions

I.          1) In a randomized double-blind dose-finding 12-week trial involving 14 women and 2 men with sexual dysfunction resulting from use of SSRIs [selective serotonin re-uptake inhibitors: escitalopram, citalopram, sertraline, venlafaxine, fluoxetine, paroxetine, duloxetine, or fluvoxamine] to treat depression, 9 taking 3 gr/day of maca had increased sexual function scores, whereas the 7 on 1.5 gr/day did not (PO in human clinical trial). The 16 in both dosing groups combined showed an increase scores for libido.2486

 

MAITAKE                                                                            p. 140

            Grifola frondosa mushroom fruiting bodies

Drug Interactions

I.    +    1) Six type II diabetes mellitus patients using the oral hypoglycemic agents glyburide, glipizide, or metformin further lowered their fasting blood glucose 30-63% after 2-4 weeks by taking 500 mg of whole maitake mushroom powder in caplets three time daily in an open-label trial (PO in human clinical trial)1609

III.  +   1) Maitake beta-glucan fraction potentiates the cytotoxicity of carmustine (BCNU) against prostate cancer cells, apparently by enhancing inhibition of the detoxifying enzyme glyoxalase I (in vitro)1511

 

MAKANDI                                                                            p. 141

            Coleus forskohlii root

Drug Interactions

III.       1) An additive effect could occur with epinephrine and/or theophylline (speculative), since these drugs are like forskohlin in that it has positive inotropic action (in vitro),1991,1992 increases heart rate (in vitro), and induces vasodilation (intraarterially in dogs). Yet, unlike epinephrine, forskohlin has neither direct nor indirect sympathomimetic activity (in vitro, IV in dogs), nor does it block phosphodiesterase significantly (in vitro) like theophylline.1991

            2) Disruption of predictable effects from digoxin could occur (speculative), since it shares positive inotropic activity with forskohlin, but the effect on potassium-sodium-ATPase is different. In addition, forskohlin increases heart rate (in vitro, IV in dogs), while digoxin reduces it.1991

 

MANGOSTEEN                                                                   NEW

     ^     Garcinia mangostana stem bark

Drug Interactions

III.       1) The component a-mangostin is synergistic with gentamicin for inhibiting vancomycin resistant Enterococci and with vancomycin for inhibiting methicillin resistant Staphylococcus aureus (in vitro). The a-mangostin inhibits 5 strains of the resistant Enterococci and 9 strains of the resistant S. aureus (in vitro).1771

 

MARIJUANA                        [now CANNABIS.]                           p. 142

            Cannabis sativa leaves and tops

 

MARJORAM             [now SWEET MARJORAM]          p. 143

            Majorana hortensis leaves

 

MARSHMALLOW                                                              p. 143

            Althaea officinalis root

Drug Interactions

I.          1) Giving 20 drops of an extract from 40 mg of marshmallow 3 times daily for 4 weeks reduced the incidence of coughs induced by ACE inhibitors compared to placebo in a group of 60 hypertensives (PO in human clinical study).2273

II.         1) Aqueous extract of roots potentiates andi-inflammatory activity of dexamethasone when skin is exposed to tetrahydofurfurylic alcohol or ultraviolet radition (topically in rabbits)1258

 

MATE                                                                                    p. 144

            Ilex paraguayensis leaves

Contraindications

            3) Heart disorders (speculative) due to caffeine increasing heart rate or exacerbating arrhythmias (empirical).8

Caffeine at a dose of 250 mg acutely increased aortic stiffness in 20 healthy subjects, leading to increased blood pressure centrally and to a lesser extent peripherally (PO in human study). These effects may impact cardiovascular risk (speculative).1569 However, a study of 155,594 women over 12 years found no linear association with caffeine consumption and hypertension (PO in human study).1859

            6) Pregnancy (speculative) since caffeine has been associated with fetal loss, low birth weight and premature deliveries.8

In an evaluation of 2,291 mothers caffeine consumption was found to reduce average birth weight. This was considered significant for those who consumed more than 600 mg of caffeine daily (PO in human study).1568

However, a prospective study of 873 women found no association between caffeine consumption at any amount and birth weight, gestational age at delivery, or birth weight standardized for gestational age (PO in human study).1672 In addition, though those consuming mate daily during the entire pregnancy appeared to have a 30% increase in the risk of small for gestational age births, after controlling for confounders there was no significant association of this risk with daily mate drinking (PO in human study).1827

     +     8) Daily use of very hot mate tea and/or consumption of one liter or more daily leads to a 2 to 3-fold increased risk of developing esophageal cancer (PO in human study)1443

Drug Interactions

I.          1) Increased weight loss due to a reduction of body fat as well as side effects of agitation, tremors, and insomnia when caffeine is combined with ephedrine (PO in human clinical study)19

            When 25 mg ephedrine was taken with 200 mg caffeine, systolic blood pressure, heart rate, and glucose, insulin and lactate concentrations were all raised (PO in human study). Taken alone, ephedrine increased heart rate, glucose, and insulin, and caffeine increase systolic blood pressure. No pharmacokinetic interaction was found. Oral contraceptives prolonged caffeine elimination.1665

In tests using various anti-obesity herbs including mate, guarana, tea, and ephedra, only mate extract reduced the respiratory quotient, indicative of a rise in fat oxidation (PO in human study)1423

     +     12) Methotrexate efficacy for reducing the joint pain and morning stiffness of rheumatoid arthritis was diminished for those consuming 260 mg of caffeine daily on average, compared to those who consumed an average of only 90 mg daily (PO in human clinical study), probably due to methylxanthines like caffeine acting as adenosine receptor antagonists while methotrexate increases adenosine.1495

     +     13) Consumption of 330 ml of infusions made with 16.5 g green or 6.6 g roasted mate 3 times daily for 40 days significantly enhanced the reduction of LDL cholesterol by statins (simvastatin, atorvastatin, lovastatin) 10% after 20 days and 13.1% after 40 days in 30 hypercholesterolemic subjects (PO in human clinical study). Significant LDL-cholesterol reductions without statins after 40 days were 8.7% for 15 normolipemics and 8.6% for 57 dyslipemics.2605

 

MAYAPPLE [now PODOPHYLLUM]                              p. 147

 

MEADOWSWEET                                                              p. 148  

            Filipendula ulmaria = Spiraea ulmaria flowers

Contraindications

            2) Avoid in pregnancy (speculative), due to aqueous infusion increasing force and tone of uterine muscle from animals (in vitro) and also because of fetal toxicity from 400mg/kg salicylaldehyde (SC in pregnant rats), though this dose exceeds normal therapeutic use. Do not use during pregnancy without professional advice.1890

            3) Do not use in constipation (speculative), due to its high tannin content that has an astringent effect on fluid secretions in bowels (empirical).1890

            4) Avoid in iron-deficiency anemia and malnutrition (speculative), due to its tannin content that can reduce absorption (empirical).1890

Drug Interactions

I.          1) Do not take concurrently with iron or other metal ion supplements, with thiamine, or with alkaloid medications, due to the tannin content than can bind these compounds (empirical). There should be at least a 2-hour separation between their consumption.1890

 

MILK THISTLE                                                                  p. 149

            Silybum marianum seeds

Contraindications

     +     1) Avoid in pregnancy (speculative)2 due to the emmenagogue effect of its seeds and root (empirical).74

However, the milk thistle seed extract silymarin was safely used as a dose of 210 mg three times daily by 6 women with cholestasis of pregnancy for 15  days (PO in human clinical study).190

     +     2) A woman in Australia who suffered nausea, vomiting, colicky pain, diarrhea, weakness and collapse over a two-month period while using a commercial milk thistle preparation. She recovered completely after she stopped taking the product, but suffered a violent reaction a few weeks later after taking another capsule (PO in human case report). This resembled one other report of a woman who had nausea, abdominal pains, listlessness, and insomnia after taking a milk thistle product. These were considered probable idiosyncratic reactions.752 They may be due to allergic hypersensitivity (speculative).

Drug Interactions

I.          2) Silymarin given to alcohol cirrhosis patients reduced the mortality rate compared to controls (PO in human clinical studies)495,1256 and use following ethanol liver damage helps normalize lab indices for transaminases (human clinical studies).119,1257

     +     4) Given with tacrine, 420 mg/day of silymarin reduced the gastrointestinal and cholinergic side effects of the drug compared with placebo, without interfering with tacrine’s effect on cognitive performance (PO in human clinical study)1260

      +        5) When used concurrently with insulin in alcoholic cirrhotis patients with noninsulin-dependent diabetes mellitus, 600 mg silymarin daily for 4 months significantly decreased fasting and mean glucose levels, daily glucosuria and glucosinated hemoglobin levels, fasting insulin and average insulin requirements. The control group had increased fasting insulin and stable insulin requirements (PO in human clinical study).1438

    +      6) After 800 mg silymarin was given with methotrexate and 6-mercaptopurine chemotherapy, liver aminotransferase levels normalized in 34-year-old woman with promyelocytic leukemia with no therapy interruptions and no reported adverse effects. During prior 18-month period of chemotherapy, treatment course had been interrupted repeatedly by dose modifications for hepatotoxicity.1795 The reduction of hepatotoxicity appears to be due to antioxidant and free radical scavenging properties1123 and includes replenishing mitochondrial glutathione (in vitro).1124

Silymarin abolishes the enhanced hepatotoxicity of CYP 2E1 substrate methotrexate after the toxicity is increased 2 to 3 times by 2E1 inducers acetaminophen and ethanol, respectively (in vitro).1124 Silymarin seemed to induce carbon tetrachloride metabolism by CYP 2E1 in one study (in vitro).1082

However, an uncharacterized milk thistle product failed to alter metabolism of 2E1 substrate chlorzoxazone in 12 subjects after 4 weeks (PO in human study).1589 Another study found no evidence of an interaction of silymarin or silybin with CYP 2E1 substrates carbon tetrachloride, acetaminophen, or NDMA (in vitro).1123 

While CYP 2E1 hydroxylation of p-nitrophenol was inhibited by silybin, silydianin, and silychristin at 10 mcm concentrations or greater (in vitro), this was not considered therapeutically relevant because concentrations of these flavonolignans in the body do not exceed 0.5 mcm.1398

     +     7) When tested with Pgp and CYP 2C9/3A4 substrate metronidazole in 12 healthy subjects, 140 mg silymarin daily for 9 days increased drug substrate clearance, while reducing the half-life, bioavailability, and urinary excretion of the drug and its active metabolite (PO in human study).1948

However, when given to treat giardia infections alone or with 3.5 mg/kg silymarin once daily, the drug was at least as effective with silymarin after 7-14 days but side effects were less (PO in dogs). With silymarin, metronidazole did not cause poor appetite or vomiting and the body weight was not reduced, compared to the drug alone. Also, serum GOT, GPT, and ammonia were increased while total protein, albumin, and the number of red and white blood cells were decreased with the drug alone but not the combination.2267

In spite of silymarin inhibiting Pgp efflux of substrates daunomycin, doxorubicin, digoxin, and vinblastine in vitro,1562,1837 Pgp induction is the probable cause, since silymarin does not modulate CYP 3A4 in humans1374,1431,1718,1589 and has an inhibitory effect on CYP 2C9 in vitro.1297 The Pgp substrate digoxin in 16 healthy humans together with 440 mg silymarin in 900 mg standardized extract daily for 14 days did not significantly alter the drug bioavailability, but there was a tendency toward reducing digoxin levels, suggesting potential Pgp induction.1806

     +     8) Silymarin 200 mg tablets given 3 times daily to 25 type II diabetic patients taking the oral hypoglycemic drugs metformin and glibenclamide significantly decreased glycosylated hemoglobin, fasting blood sugar, total cholesterol, LDL, triglycerides, and SGOT and SGPT levels, compared to 26 type II diabetics taking the drugs with a placebo (PO in human clinical study).2041

     +     9) A standardized extract with phosphatidylcholine in 240 mg capsules with 80 mg of silibinin or placebo was given to 50 children with acute lymphoblastic leukemia for 28 days,, at doses of silibinin ranging from 80 mg to 320 mg daily based on weight and concurrent with the chemotherapy drugs dexamethasone, 6-mercaptopurine, methotrexate, prednisone, thioguanine, vincristine; the liver toxicity from the drugs with the extract had lower levels of aminotransferases that was significant for AST and trending lower for ALT after 56 days compared to placebo (PO in human clinical study). [When the capsules were independently measured there weight was 282 mg with 97 mg silibinin.]2650

     +     10)  In a study with 59 b-thalassemia major patients treated with the iron chelator desferrioxamine, 29 who also received 140 mg of silymarin t.i.d. for 3 months had lower liver alkaline phosphatase and higher red blood cell glutathione levels than those who received placebo (PO in human clinical study). There was no significant difference between transferrin levels in the 2 groups.2702

II.         2) Prevention by silybin of hepatotoxicity from acetaminophen was associated with protection from glutathione depletion and lipid peroxidation (IV in rats).117

Exposing kidney cells to silybin before or after acetaminophen (paracetamol) prevented or lessened cell damage (in vitro).1621

4) Silybin helps prevent kidney damage from the nephrotoxic anti-tumor agent cisplatin when given at doses of 200 mg/kg (IV in rats)186,187 Exposing kidney cells to silybin before or after cisplatin prevented or lessened cell damage (in vitro).1621

            The use of silybin proved synergistic at 1.0 mcM with cisplatin in human ovarian cancer cells and cisplatin-resistant ovarian cancer cells (in vitro) 1619,1620 and at 100 mcM in estrogen-dependent MCF-7 and estrogen–independent MDA-MB468 breast cancer cells with either cisplatin or carboplatin (in vitro).1796  This anti-tumor enhancement trend with human ovarian cancer cells was similar when using a silybin phospholipid complex IdB 1016 (silipide) at 450 mg/kg for 4 days with cisplatin. The derivative silipide was found to be antiangiogenic when given by itself (PO in mice).1620

5) Silybin protects the exocrine secretions of the pancreas from the toxicity of cyclosporin A (IP in rats).496

This is probably not associated with reducing bioavailability due to induction of P-glycoprotein or CYP 3A4, since in two separate studies, milk thistle extract was given at doses of 153 mg or 173 mg silymarin 3 times daily for 2 or 3 weeks, respectively, did not inhibit 3A4 metabolism of substrate indinavir which is a substrate of both P-glycoprotein and CYP 3A4 (PO in human trial),1374,1431 and an uncharacterized milk thistle product failed to alter bioavailability of 3A4 substrate midazolam after 4 weeks (PO in human study).1589

     +     6) Milk thistle seed infusion reduces liver damage from methoxsalen when given 24 hours and 2 hours before the drug, as indicated by SGOT serum levels (PO in mice)1334

     +     7) Silybin suppresses human non-small-cell lung cancer xenographs in mice and enhances doxorubicin effects against this carcinomoma, while reducing this drug’s adverse effects (PO in mice). Both decreased cell proliferation and vasculature and increased apoptosis, while further enhancing these effects when combined (in vivo, in vitro). These effects involved NFkB signaling.1835 Silybin at 0.1 mcM proved synergistic with doxorubicin in doxorubicin-resistant breast cancer cells (in vitro) 1619 and at 100 mcM in estrogen-dependent MCF-7 and estrogen–independent MDA-MB468 breast cancer cells sensitive to doxorubicin (in vitro).1796 In addition, silybin at 100 mcM synergized with doxorubicin to induce apoptosis and inhibit prostate cancer cell growth for hormone-insensitive cells and inhibit growth in androgen-dependent human prostate cancer cells (in vitro).1834 Silymarin was found to inhibit P-glycoprotein removal of the chemotherapeutic agent doxorubicin from breast cancer cell lines (in vitro).1562 Silymarin and its flavonolignan components, especially silydianin, protected rat heart muscle cells from doxorubicin-induced damage (in vitro).1836 

III.   +  1) Silymarin inhibits P-glycoprotein removal of daunomycin in breast cancer cell lines (in vitro).1562

     +     2) While metabolism of erythromycin by CYP 3A4 was not siginificantly inhibited by silybin, 3A4 oxidation of denitronifedipine was clearly inhibited in a mostly non-competitive fashion (in vitro).1297 The conversion of testosterone by CYP 3A4 was also inhbited by silymarin (in vitro).1293 While 3A4 oxidation of nifedipine was inhibited by silybin, silydianin, and silychristin at 10 mcm concentrations or greater (in vitro), this was not considered therapeutically relevant because concentrations of these flavonolignans in the plasma do not exceed 0.5 mcm.1398 Iron-binding activity of silybin (in vitro)1761 may be responsible for isozyme inhibition in vitro.1639

     +     3) S(-)-warfarin 7-hydroxilation by CYP 2C9 was competitively inhibited by silybin (in vitro)1297

     +     4) Exposing kidney cells to silybin before or after vincristine prevented or lessened cell damage (in vitro).1621

     +     5) Silymarin with the toxic antiarrhythmic agent amiodarone increased the splenocyte proliferation, compared to amiodarone alone reducing it (in vitro). The conjugated dienes in liver tissue raised by amiodarone were lowered when silymarin was combined with the drug (in vitro).1817 Since silymarin does not attenuate the antiarrhythmic cardiac effect of amiodarone after daily use for 4 weeks (PO in mice), the combination may be useful to ameliorate its toxicity.1818

 

MUIRAPUAMA                                                                   NEW

^          Ptychopetalum olacoides roots

Drug Interactions

II.         1) Hydroalcoholic extract at 200 mg/kg potentiated the lethal effects of yohimbine (IP in mice).1116

            2) Hydroalcoholic extract at 50 mg/kg reversed the ptosis induced by reserpine (IP in mice).1116

            3) Hydroalcoholic extract at 60 mg/kg attenuated the stereotypy induced by apomorphine (IP in mice).1116

 

MUSTARD                                                                           p. 151

            Brassica alba, Brassica juncea and Brassica nigra (sometimes Sinapis spp.) seed

            [CORRECTION] (white mustard, Chinese mustard and black mustard, RESPECTIVELY)

 

MYRRH                                                                                 p. 152

            Commiphora myrrha, Commiphora molmol gum-resin

Contraindications

            3) Arterial excitement, since large doses can accelerate the pulse (empirical).5

However, 4 mg/kg of an aqueous extract reportedly reduced the heart rate by 14% in anesthetized subjects (IV in rats). Likewise, the systemic arterial blood pressure was acutely lowered by 20%. Both effects were blocked by atropine, indicative of a cholinergic mechanism.1890

     +     6) Allergic hypersensitivity, since contact allergy has been reported (TP in humans)1890

     +     7) Nursing mothers without professional advice (speculative).1890

     +     8) Prolonged use (speculative), due to reported increase in contact allergy with continued exposure in atopic subjects (TP in human study).1890

 

NARD                                                                                    NEW

     ^     Nardostachys jatamansi roots/rhizome

            (spikenard, jatamansi)

Contraindications

            1) Pregnancy due to its emmenagogue and uterine stimulant effects (empirical)150

Drug Interactions

II.         1) Its component valeranone prolongs sleep induced by 100 mg/kg of the barbiturate  hexobarbital (PO in animals).1061

 

NEEM                                                                                    NEW

^          Azadirachta indica leaves

Drug Interactions

II.         1) Pretreatment weekly for 4 weeks with a saline leaf extract reduced leucopenia and neutropenia while increasing tumor growth inhibition and survivability from carcinoma treatment with cyclophosphamide (injections in mice).1958

            2) Pretreatment with 2.5 or 24 mg/kg aqueous extracts of the bark or leaves, respectively, reduced gastric lesions induced by indomethacin by 75-85% (IP in rats). This is due in part to free-radical scavenging by the extracts preventing oxidative damage to gastric mucous membrane and to their antisecretory effects by which gastric acid secretion was reduced by 50% at 2.0-2.7 mg/kg for the bark extract and 3.7 mg/kg for the leaf extract (IP in rats).2518,2519 The extracts not only prevented mucosal DNA damage (in vitro),2518,2519 but the bark extract also blocked indomethacin-induced apoptosis of gastric mucosa by inhibiting the decrease in cytochrome-c release and caspase-3 activation. 2521 Freeze-dried powder of the bark aqueous extract at 30 mg twice daily for 10 days decreased gastric acid secretion by 77%, and at 30-60 mg twice daily healed cases of esophageal and gastric ulcers after 6 weeks and almost completely healed 6 cases of duodenal ulcers after 10 weeks (PO in human clinical study).2520

 

NONI                                                                                     NEW

^          Morinda citrifolia fruit

Drug Interactions

II.   +    1) Precipitates collected after adding ethanol to the juice, when given with suboptimal doses of adriamycin, cisplatin, 5-fluorouracil, or vincristine for Lewis lung peritoneal carcinomatosis, increased the number of survivors and life span significantly (IP in mice).1758

 

NUTMEG                                                                              p. 153

            *Myristica fragrans seeds

Drug Interactions

III.  +   2) Alkaline aqueous extracts of nutmeg were shown to potentiate insulin activity in glucose metabolism (in vitro).1464

 

OAT                                                                                       p. 154

            Avena sativa fresh plant/seeds or bran

Drug Interactions

I.    +    3) Consumption of 50-100 grams daily of oat bran by two patients taking lovastatin resulted in elevated LDL that decreased again after oat bran was withdrawn (PO in human case reports). Similar results were found with 3 patients using 15 grams of pectin daily (PO in case reports).1841

 

OCOTILLO                                                                           NEW

     ^     Fouquieria splendens stem

            (candle flower, coach whip, slimwood, flaming sword, wolf’s candles, desert candlewood, Joseph’s staff; Am. Ind.: moelhok (Pima); Mex.: albarda)

Contraindications

            1) Pregnancy (speculative)150 due to its emmenagogue effects (empirical)1314

 

OLIVE                                                                                   p. 155

            Olea europaea fruit oil

Drug Interactions

I.    +    1) Consumption of 3-4 spoonsful of extra virgin olive oil daily for 6 months compared to safflower oil in a crossover study led to significant reductions in the use of antihypertensive medicines like atenolol, nifedipine, lisinopril, doxazosin, and hydrochlorothiazide (PO in human clinical study).1773

 

ORANGE                                                                              NEW

     ^     Citrus sinensis fruit

(sweet orange)

Drug Interactions

Ia.        1) The reductions in fexofenadine bioavailability and maximum concentration were 69% and 67%, respectively, when taken with orange juice by 10 healthy subjects, compared to consuming it with water (PO in human study). Consumption of 1.2 liters of orange juice in a 3-hour period should be avoided with concurrent fexofenadine use. The reduced uptake is due to inhibiting intestinal organic anion transporting polypeptide (OATP) 1A2, not to inducing P-glycoprotein efflux (in vitro).1097 The flavonoid hesperdin is one orange component that appears to be at least partially responsible for this inhibition of OATP1A2 (in vitro).2305 

            2) After 10 healthy subjected ingested 200 ml juice or water 3 times daily for 2.7 days in a randomized crossover format, celiprolol maximum concentration, bioavailability, and excretion were reduced by 89%, 83%, and 77%, respectively, following consumption of the juice (PO in human study).1582

However, no blood pressure and heart rate changes were detected when drinking the juice, compared to consuming water, before taking celiprolol (PO in human study).1582

            3) When 8 male and 8 female subjects ingested 750 ml of juice over 4 hours, the maximum concentration and bioavailability of ivermectin was reduced compared to consuming water, and no differences were noted between P-glycoprotein genotypes (PO in human study).1628 

            4) When 200 ml of water or orange juice made from concentrate were consumed 3 times daily for 3.7 days in a randomized crossover design, the juice led to decreased peak concentration and bioavailability of atenolol by 49% and 40%, respectively (PO in human study).2045

 

OREGANO   [formerly wild marjoram]                    p. 200

            Origanum vulgare plant

Contraindications

            1) Excessive use should be avoided in pregnancy2 due to its emmenagogue and abortifacient effects (empirical)74

     +     2) Avoid topical use on hypersensitive, diseased or damaged skin (empirical)400

     +     3) Topically for children under age 2 (empirical)400 

     +     4) Over 1% concentration on mucous membranes (empirical)400

 

OREGON GRAPE                                                               p. 155

            Mahonia spp. root bark

Contraindications

      +    8) Avoid use by nursing mothers without professional advice (speculative),1890 due to displacement by berberine of bilirubin from serum albumen which may lead to kernicterus (IP in rats).1092,1890

Drug Interactions

I.    +    3) Berberine 1.2 grams daily, given as tablets to 79 congestive heart failure patients on ACE inhibitors along with digoxin in 76, nitrates in 71, and diuretics / spironolactone in 77, significantly increased left ventricular ejection fraction and exercise capacity, improved dyspnea-fatigue index, and reduced frequency of ventricular premature complexes compared with 77 patients using only comparable conventional medications. The mortality of the berberine group decreased significantly as well, and there were no apparent side effects (PO in human clinical study).1457 In 56 congestive heart failure patients on loop diuretics and ACE inhibitors, including 51 using digoxin and 46 on nitrates, the significant increases in left ventricular ejection fraction and decreases in ventricular premature beats from baseline from 1.2 grams of berberine daily was also significant better when plasma berberine concentrations were higher versus lower than 0.11 mg/L (PO in human clinical study).2639

     +     4) Berberine at 0.6 grams daily for 3 months increased previously stabilized cyclosporin A trough blood concentrations by 90% in 52 renal transplant patients, and when given for 12 days to 6 transplant patients increased the cyclosporine bioavailability by 35% (PO in human clinical study), likely by inhibition of CYP 3A4 (speculative).2281

     +     5) The combination of 500 mg berberine 3 times daily for 3 months in 43 patients with poorly-controlled type 2 diabetes together with one or more of their regular oral hypoglycemic medications including sulfonylureas in 28, metformin in 20 acarbose in 15, and/or insulin in 10 resulted in lower fasting and postprandial blood sugar from week 1 through week 12 (PO in human clinical study). Fasting plasma insulin was also lowered by 28% and an index of insulin resistance by 45% of those on medications, while total cholesterol and LDL were likewise reduced. In 31 newly diagnosed type 2 diabetics to whom 15 were given the same dose of berberine and 16 used 500 mg metformin 3 times daily, berberine’s hypoglycemic effect was similar to that of metformin on fasting and postprandial blood glucose, as well as reducing glycosylated hemoglobin and plasma triglycerides (PO in human clinical study). Transient gastrointestinal adverse effects were experienced by 35% of the patients, or 20 in total.2315

II.         1) The antitumor constituent berbamine (20 mg/kg once daily for 7 days) significantly enhanced antitumor activity of cyclophosphamide against Walker tumor (IP in rats).398

When the alkaloid component berberine was given once or twice at doses of 50, 100, or 200 mg/kg before cyclophosphamide injection, it significantly reduced the chemotherapy adverse effect of bladder hemorrhage in a dose-dependent manner (IP in rats).2570 

     +     2) Berberine administered prior to pentobarbital increased the induced sleeping time (IP in mice)1032

A single 4 mg/kg dose of berberine prolonged pentobarbital sleeping time and increased strychnine toxicity (PO in rats)1215

     +     3) Pre-treatment with 4 mg/kg berberine prevented a rise in serum levels of liver enzymes from excessive acetaminophen, suggesting protection from its toxic effects (PO in rats). Use of this dose three times every six hours following a toxic dose of acetominophen reduced liver damage.1215

     +     4) Berberine at 100 mg/kg enhanced the anxiolytic effects of buspirone and ritanserin but did not interact with diazepine (PO in mice).2668

III.       3) Berberine increased efflux of rhodamine 123 and paclitaxel by inducing P-glycoprotein and thereby reducing the retention and concentration of these drugs in human hepatoma and digestive tract cancer cells, respectively (in vitro)1045,1046

     +     4) Studies in human liver-derived cells with berberine was found to have an additive effect with lovastatin by increasing LDL receptor mRNA expression (in vitro). This statin did not reduce this effect of berberine, indicating a different mechanism of action (in vitro). In 63 high-cholesterol subjects taking 1.0 grams berberine HCl daily for 3 months, serum cholesterol was reduced 18%, LDL cholestreol 20%, and triglycerides 28%, compared to those using placebo (PO in human study). In the 32 who were taking no other medication or herbs, cholesterol was reduced 29%, LDL cholesterol 25%, and triglycerides 35%. HDL cholesterol was unaffected, and berberine was well tolerated. Berberine was found to have a dose-dependent cholesterol-lowering effect (in hamsters).1656 

     +     5) Avoid use with drugs that displace the protein binding of bilirubin such as phenylbutazone (speculative).1890

 

OSHA                                                                                     NEW

     ^     Ligusticum porterii root

            (Porter’s lovage, Colorado cough root, Indian parsley, bear medicine; Mex.: chuchupate)

Contraindications

            1) pregnancy150 due to its emmenagogue and abortifacient effects (empirical)75  

 

PAPAIN                                                                                 p. 156

Carica papaya extract from unripe fruit

Contraindications

            1) Allergic hypersensitivity401 to chymopapain can lead to anaphylaxis (empirical).24

Cross-reactivity with bromelain by skin and RAST tests occurred with 5 of 6 workers sensitized to airborne papain, and 2 of the 6 had immediate asthmatic reactions (human clinical study).1275 Cross-sensitivity shown by RAST inhibition suggested bromelain, papain, wheat flour, rye flour, grass pollen and birch pollen possess more or less similar or identical antigenically active regions (in vitro).1276

Drug Interactions

I.          1) Papain increases warfarin anticoagulation effects if used concurrently (PO in human case report).143,614

However, this report has been described as unevaluable based upon report inadequacies.1239

 

PASSION FLOWER                                                            p. 158

            Passiflora incarnata plant

Drug Interactions

I.    +    2) A dose of 60 drops daily of an undefined extract in combination with clonidine reduced the mental symptoms and improved total withdrawal scores compared to using clonidine alone in assisting opiate withdrawal for 65 male opiate addicts (PO in human clinical trial)1192

            A 10 mg/kg dose of the benzoflavone fraction of a methanol extract delayed tolerance to morphine analgesic effect and reduced withdrawal symptom after chronic morphine treatment (PO in mice).1541

II.         1) A passion flower methanolic fraction at 100-200 mg/kg (IP in mice)2299 or hydroethanolic extract at 65-250 mg/kg (IP in mice)516,2196 potentiates pentobarbital sleeping time.

      +    2) The benzoflavone fraction of a methanol extract significantly prevented ethanol (alchohol) withdrawal anxiety when giving with addictive doses twice daily or as a single dose following ethanol addiction (PO in mice). The multiple daily doses were more effective than the single dose, and the effect was dose dependent using 10, 20 or 50 mg/kg benzoflavone.1751

                        However, in samples of passion flower grown in India, Italy, and France, the previously described benzoflavone was found only in the one grown in Italy and only in trace amounts (in vitro), inadequate to serve as an active marker (speculative).2700

     +     3) The benzoflavone fraction of a passion flower dried aerial parts methanol extract significantly prevented nicotine withdrawal jumps when given with addictive nicotine doses four times daily for 14 days or as a single dose following nicotine addiction (SC in mice). The multiple daily doses were more effective than the single dose, and the multiple doses inhibiting withdrawal were 10 or 20 mg/kg benzoflavone while the effective acute dose was 20 mg/kg. Normal ambulatory behavior and performance in the swimming endurance test and prevention of weight loss were also observed following benzoflavone use.1752

                        However, in samples of passion flower grown in India, Italy, and France, the previously described benzoflavone was found only in the one grown in Italy and only in trace amounts (in vitro), inadequate to serve as an active marker (speculative).2700

     +     4) The benzoflavone fraction of a methanol extract of passion flower dried aerial parts significantly prevented changes in ambulatory behavior following benzodiazepine withdrawal when given with addictive doses of 20 mg/kg of diazepam daily for 21 days (PO in mice). The efficacy was dose dependent using 10, 50, or 100 mg/kg benzoflavone, the highest dose being the most effective. These doses given alone caused no change in normal ambulatory behavior following withdrawal.1753

                        However, in samples of passion flower grown in India, Italy, and France, the previously described benzoflavone was found only in the one grown in Italy and only in trace amounts (in vitro), inadequate to serve as an active marker (speculative).2700

     +     5) The benzoflavone fraction of a methanol extract of passion flower dried aerial parts at 10 or 20 mg/kg doses significantly prevented the cannabinoid THC tolerance and dependence, as well as withdrawal paw tremors and head shakes after receiving a cannabinoid-receptor antagonist, when given with addictive THC doses twice daily (PO in mice). A single dose of 20 mg/kg benzoflavone also reduced severe paw tremors and head shakes from THC withdrawal after receiving a cannabinoid-receptor antagonist (PO in mice).1754

                        However, in samples of passion flower grown in India, Italy, and France, the previously described benzoflavone was found only in the one grown in Italy and only in trace amounts (in vitro), inadequate to serve as an active marker (speculative).2700

 

PENNYROYAl [now AMERICAN PENNYROYAL]    p. 159

            *Hedeoma pulegioides plant

 

PEPPERMINT                                                                     p. 160

Mentha piperita leaves

Contraindications

     +     6) Avoid essential oil in nursing mothers without professional advice (speculative), due to concerns that it may reduce milk secretions.1890

     +     7) Avoid oral exposure in those with contact sensitivity reactions to peppermint oil or its component menthol, especially when resulting in mouth ulcers (empirical)1890

Drug Interactions

I.    +    1) Non-heme iron absorption is reduced with consumption of the tea prepared with 3 grams per cup (PO in human study) likely due to its flavonoid content1246

      +    2) Peppermint oil fraction dose of 600 mg increase bioavailability and peak plasma concentration of oral felodipine by 140% in 9 males and 3 females, all healthy subjects, similar to grapefruit juice (PO in human study). This was presumably due to inhibition of CYP3A4 (in vitro).1756

                        However, menthol in successive doses of 100, 50, 25 and 25 mg at the beginning and after 2, 5, and 7 hours, respectively, had no affect on pharmacokinetics or pharmacodynamics of a single oral dose of felodipine in a study with 10 females and one male (PO human study).2307

     +     3) When 6-10 menthol cough drops were used daily for 4 days or 3 weeks, beginning 2 or 4 weeks after instituting warfarin therapy, respectively, the therapeutic INR levels were significantly reduced (PO in human case reports). In one case the INR returned to normal after stopping the drops and increasing warfarin, then returning to the original dose,2643 while the other case was normalized by withdrawing the cough drops, and later lowering warfarin dosage.2642

                        However, reduced INR is suggestive of induction of CYPs 2C9, 1A2, and/or 3A4, but menthol has been shown to have no effect on the CYP1A2 probe caffeine (PO in human study).2308 Though peppermint oil inhibits metabolism of the 3A4 substrates cyclosporine (PO in rats)1755 and felodipine (PO in human study),1756 menthol has shown no effect felodipine (PO in human study).2307 Though this suggests that menthol induces CYP2C9, only these 2 cases exist out of the many of people who use warfarin and other CYP2C9 substrates simultaneously with mentholated cough drops, indicating extremely rare and likely idiosyncratic responses, if menthol is involved at all.

II.   +    1) Cardiotoxicity from doxorubicin, a widely used antitumor agent, was reduced by luteolin (PO in mice),1282  a component of peppermint also responsible for the antimutagenic effect of water extracts of this fresh herb (in vitro) and also fresh thyme (Thymus vulgaris) and sage (Salvia officinalis).1283

      +    2) After being consumed for 4 weeks, a 2% tea made from the leaves reduced the metabolism of phenacetin by liver microsomes to 24% of normal (PO in rats). It also reduced the activity of CYP 2E to 60% that of controls.1608 

      +    3) The peppermint oil fraction at 50 and 100 mg/kg increased 25 mg/kg cyclosporine peak plasma concentration and bioavailability by 2-3 times (PO in rats). The amounts given were greater than humans doses of 2-10 mg/kg cyclosporine and 17 mg/kg peppermint oil, but the blood levels of cyclosporine and the ratio of doses were similar to those found wih humans.1755

III.   +  1) Peppermint oil fraction and its components menthol and menthyl acetate caused reversible but nonmechanism-based inhibition of the CYP3A4 metabolism of nifedipine in human liver microsomes (in vitro).1756

            2) Due to its tannin content, it may reduce absorption of metal ions, thiamine or alkaloids when taken concurrently (speculative).1890

 

PERIWINKLE [now LESSER PERIWINKLE]                p. 161

Ä         Vinca minor plant

 

PETASITES                                                                         p. 162

            Petasites hybridus = Petasites officinalis root

Drug Interactions

I.     +   1) A standardized CO­2 extract with a minimum of 15% petasins was given for 2 months in doses from 50-150 mg daily, depending on age, to children and adults with asthma concurrently treated with inhaled corticosteroids (28%), short-acting beta-agonists (53%), and other medications (69%) and found to decrease number, duration, and severity of asthma attacks (PO in human clinical study). More than 40% of those using asthma medications reduced their intake, including 43% of those using steroids (avg. 16% reduction) and 48% using beta-agonists (avg. 13% reduction).1660

 

PLANTAIN [Plantago lanceolata now ENGLISH PLANTAIN] p. 162

            Plantago major leaves

Drug Interactions

II.  +     1) An official Russian preparation of the sap reduced the acute toxic effect on the gut mucosa from 5-fluorouracil used to treat Ehrlich ascites tumors. The DNA of the tumore cells also declined more drastically when the plantain sap was used with 5-fluorouracil than by using the chemotherapy alone (PO in mice).1525

 

PLEURISY ROOT                                                               p. 163

            *Asclepias tuberosa root

Contraindications

     +     2) Hiatal hernia, esophageal varices, stomach ulcer or peptic ulcer due to aggravation and/or potential hemorrhage from emetic effect if bloodroot is taken in excessive doses (speculative)150

Drug Interactions

II.    +   2) Do not take large doses after recent consumption of central nervous system stimulants, due to the emetic action potentially inducing convulsions (speculative).150

      +    3) Do not take large doses after recent consumption of central nervous system sedatives, due to the emetic action potentially inducing aspiration pneumonitis (speculative).150

 

POKE                                                                                     NEW

     ^     *Phytolacca decandra = Phytolacca americana root

            (pokeweed, coakum, garget, inkberry, pigeon berry, red weed, scoke)

Contraindications

I.          1) Pregnancy, due to its uterine stimulant activity (in animals)74 and abortifacient and toxic effects (empirical).2,1890

            2) Stomach irritation or intestinal irritation, due to its saponins’ irritant and purgative effects,1890 especially when fresh (empirical).2,5,7,1890

            3) Broken skin or skin ulcers, due to its irritant properties of its saponins, especially when fresh (empirical).1890

However, the hydroalcoholic extract of the root has been applied locally in glycerin to fissures and varicose or ulcerations of the legs (empirical). A poultice of the bruised fresh leaves or their dried juice has also been used as a local treatment for indolent ulcers (empirical).5

            4) Contact with eyes, due to the local irritant effects of its saponins (empirical).1890

II.         1) Nursing mothers, due to its potential toxicity (speculative). Since it is used for the topical treatment of mastitis, local application to the nipple should be avoided if nursing.1890

            2) Lymphocytic leukemia (speculative), due to mitogenic effects, especially of the fresh plant parts or liquid extracts (empirical).1890

            3) Exceeding recommended dose or extended use over 6 months (speculative), due to its potential of causing emesis, purgation, or other toxic effects (empirical).1890

Drug Interactions

III.       1) Avoid use with immunosuppressant drugs (speculative), due to poke’s mitogenic effects (empirical).1890

 

POMEGRANATE                                                               p. 163

            Punica granatum fruit juice

Drug Interactions

I.   +     1) Ten carotid artery stenosis patients, 6 on ACE inhibitors, 2 on beta-blockers and 2 on calcium channel blockers, had significant reductions in systolic blood pressure after consuming 50 ml/day of pomegranate juice with about 124 mg polyphenols, reconstituted from frozen concentrate (PO in human clinical study). Systolic blood pressure measurements were lowered by 7% after 1 month, and 10-12% after 3-12 months of daily use compaired to baseline values. No dialstolic blood pressure lowering found, and five who continued the juice for 3 years had no further systolic reduction. Nine placebo control patients with the same drug use pattern had no significant blood pressure changes in one year.1693 In a prior study with ten hypertensive patients, 8 on the ACE inhibitors enalapril or ramipril and 2 on calcium channel blockers, 50 ml of pomegranate juice with 1.5 mmol polyphenols daily resulted in a reduction of serum angiotensin converting enzyme (ACE) activity by 36% and a 5% reduction in systolic blood pressure (PO in human clinical study). This is probably not due to increased serum levels of ACE inhibitors because CYP 3A4 is only minimally inhibited by pomegranate juice.1694

            2) A man using ezetimibe daily and rosuvastatin every other day for 17 months to control familial hypercholesterolemia developed rhabdomyolysis 3 weeks after beginning to drink 200 ml of pomegranate juice twice weekly (PO in human case report). He had greatly elevated creatine kinase levels that returned to normal 10 days after stopping the drugs and the juice. However, prior to statin treatment he had elevated creatinine kinase, and taking atorvastatin and simvastatin previously caused myalgia. All 3 statins additionally increased the creatine kinase levels. Unlike atorvastatin and simvastatin that are metabolized by CYP 3A4, rosuvastatin is metabolized by CYP 2C9 and 2C19.1982

Though pomegranate juice has been shown to inhibit CYP 3A (PO in rats,1920 in vitro1920,1923), there is no data concerning its effect on other isozymes or P-glycoprotein or on CYP 3A4 in humans.

II. +      1) After 2 ml of pomegranate fruit juice was administered, carbamazepine was given by gastric intubation after 1 hour and its total absorption and maximum concentration were increased by 1.45 times, the same extent as when an equivalent dose of grapefruit juice is given (PO in rats). Pomegranate juice at 25 ml or 5% v.v was shown to inhibit CYP 3A almost completely, reducing the metabolism of carbamazepine to only 1.8% (in vitro).1920

III.+     1) Pomegranate juice strongly inhibited the metabolism of the CYP 3A substrate midazolam (in vitro).1923

     +     2) A methanol extract of the fruit in combination with chloramphenicol, gentamicin, ampicillin, tetracycline, or oxacillin increased the efficacy of the antibiotics against methicillin-resistant and methicillin-sensitive Staph. aureus (in vitro). This was apparently due to inhibition of the NorA efflux transporter protein, since the extract likewise increased the efficacy of nalidixic acid (in vitro).2355

IV.       [2)  A woman was stabilized on warfarin dosage for 5 months while consuming pomegranate juice 2-3 times/week (PO in human case report) . She began to have subtherapeutic INRs for 4 months after skipping a couple of doses, but returned to normal dosing and INRs. After referral to an anticoagulation clinic, she stopped the juice and had 2 normal INRs, but then 2 subnormal INRs though any potential CYP inhibition by the juice would have been eliminated. Another dose increase resulted in normal INRs. 2602 Pomegranate juice does inhibit CYP3A (in vitro,1920,1923,2123,2213 in rats1920).

       However, 2 doses of 8 oz juice each given about 12 hrs and 1 hr prior to CYP3A substrate midazolam had no effect on IV or oral midazolam clearance (PO in human study).2213 ]

 

PRICKLY ASH                                                                    p. 164

            Zanthoxylum americanum = Xanthoxylum americanum

     ^     and Zanthoxylum clava-herculis = Xanthoxylum clava-herculis bark

            (northern prickly ash) and (southern prickly ash, Hercule’s club)

 

PRICKLY PEAR                                                                 p. 164

            Opuntia spp. stems

Drug Interactions

I.          1) Blood sugar for a diabetic using chlorpropamide improved with prickly pear sap of Opuntia streptacantha (PO in human case report).952

A unidentified species of prickly pear also lowered blood sugar when 100 gm were given before meals to diabetics receiving tolbutamide at stable doses (PO in human study).945

Opuntia lindheimeri aqueous protein extract when given with feed had a time- and dose-dependent hypoglycemic effect in diabetics but not in non-diabetics (PO in pigs).1451

The ethanolic extract of O. megacantha leaf lowered plasma glucose concentrations in both streptozotocin-diabetic and non-diabetic animals, but  those receiving the extract had higher plasma urea and creatinine concentrations and reduced plasma sodium, possibly indicative of kidney toxicity (PO in rats).1228

In a clinical survey in which 17 patients reported using uncharacterized prickly pear pads [nopal] with metformin and 10 with glyburide, 5 were reported to have mild hypoglycemic symptoms when the nopal was used with a combination of metformin and glyburide, while 2 others had hypoglycemic symptoms when it was taken only with metformin (PO in human case series).2126

II.         1) After 7 weeks of an off-white powder of a proprietary purified extract of O. fuliginosa stems being given daily to streptozotocin-induced diabetic rats at a dose of 1 mg/kg body weight 8 hours after insulin treatment, normal glycemic and glycated hemoglobin levels resulted  (PO in rats). At week 8 the insulin was suspended but the extract was continued for 7 more weeks, and normoglycemia was maintained.2695

            2) The freeze-dried powder from pads with epidermis and glochids removed was prepared by mixing 20 grams in 100 ml water and given in doses of 1 gram per kilogram before or after the 90% ethanol (PO in rats). Ethanol given alone caused widespread gastric hyperemia and thickened lesions with an ulcer index (UI) of 8.24, but the pad pre-treatment significantly reduced hyperemia and lesions to near-normal with a UI of 1.48, while post-ethanolic treatment also significantly decreased the UI to 3.25.2696 

 

PSORALEA                                                                                      NEW

     ^     Cullen corylifolia = Psoralea corylifolia seed

            (scurfy pea; Ch.: bu gu zhi)

Contraindications

            1) Pregnancy due to its potential purgative and abortifacient effects (empirical)150

            2) Excessive sunlight and ultraviolet light or solarium therapy due to its phototoxic furocoumarin component (empirical)150

 

PSYLLIUM                                                                           p. 165

            Plantago psyllium = Plantago afra and Plantago ovata = Plantago ispaghula seed or seed husk

Contraindications

    +      4) Allergic hypersensitivity following psyllium use, due to the risk of anaphylaxis (empirical)1890

Drug Interactions

I.    +    3) Taking 6.0 grams of psyllium husk in water three times daily with orlistat reduced the percentage of patients experiencing gastrointestinal side effects from 71% to 29%, including the most troubling symptoms of flatulence and fecal incontinence associated with the increased intestinal fat load from the lipase inhibitor drug that were 2-6 times more common without psyllium use (PO in human clinical study)1193

      +    4) Psyllium reduced glucose absorption 12.2% and maximum glucose concentration in the blood by 10% while taken with sulfonylurea medication glibenclamide compared to using the medication alone. In addition, significant decreases in total and LDL cholesterol and uric acid also occurred (PO in human clinical study).1448

     +     5) When 68 patients with high cholesterol used 10 mg or 20 mg of simvastatin with placebo or 10 mg with 15 gm psyllium daily for 12 weeks, after 8 weeks LDL cholesterol was lowered by the psyllium and drug combination more than the 10 mg and as much as 20 mg of the drug (PO in human clinical study). Similar results were found for total cholesterol and apolipoprotein B, but no changes in HDL cholesterol or triglycerides occurred.1735

III. +    1) Psyllium may inhibit absorption of oral drugs (speculative)4,6,17,401

such as aspirin, digitalis and other cardiac glycosides, antibiotics, and anticoagulants if administered concurrently (speculative).150

 

PULSATILLA                                                                      p.166

            Anemone pulsatilla, Anemone pratensis herb

Drug Interactions

III. +    1) Avoid combining with powerful analgesics (speculative), especially long-term, due to possible additive effects.1890 

 

PUNCTURE VINE                                                              NEW

     ^     Tribulus terrestris herb

            (goat’s head, bullhead, burnut, little caltrop, terror of the earth; Sp. torrito)

Contraindications

            1) Pregnancy except under professional advice (speculative), due to reported fetotoxic effects (PO and IV in animals).1890

            2) Nursing mothers except under professional advice (speculative).1890

 

PURSLANE                                                                                      NEW

     ^     Portulaca oleracea plant

            (Arab.: humdeh)

Contraindications

            1) Pregnancy (empirical)150 due in part to uterine stimulation shown with an extract of 6 gm dry plant (injected in humans)1315

            2) History of kidney stones (speculative) due to its content of up to 1.7% oxalic acid150

 

QUASSIA (JAMAICAN)                                                    NEW

     ^     Picrasma excelsa bark, wood, root

            (bitter ash, bitter wood)

Contraindications

            1) Pregnancy due to its stomach mucosal irritation that can lead to vomiting (empirical)150

 

QUASSIA (SURINAM)                                                       NEW

     ^     Quassia amara bark, wood, root

Contraindications

            1) Pregnancy due to its stomach mucosal irritation that can lead to vomiting (empirical)150

 

QUEEN ANN’S LACE (See WILD CARROT.)

 

RASPBERRY                                                                       p. 167

            Rubus idaeus leaves

Contraindications

            1) Pregnancy with a history of precipitate labor (empirical)147
In a retrospective record review of 57 women who used raspberry leaf products during pregnancy compared to 51 random controls, no differences in safety or efficacy outcomes were found (PO in human clinical study). Infant outcomes measured were gestation duration, 5-minute Apgar, and transferral for care. Labor outcomes considered were length of labor stages, medical augmentation, epidural need, evidence of meconium, and normal delivery percentage.  Dosages for ¾ of the 56% who consumed the tea ranged from 1-3 cups daily, while over 2/5 of the 40% using tablets took six daily; 3.5% combined tea, tablets, and/or tincture.  Use began for 13% from 8-28 weeks, for 59% from 30-34 weeks, and for 28% after 35 weeks.1118 In 96 women in Australia given two 400 mg tablets daily of a 3:1 strength extract from 32 weeks gestation until labor, no adverse effects were found compared to controls. The second stage of labor was shortened by ten minutes, and forceps deliveries were reduced from 30% to 19% (PO in human clinical study).1177
However, it is raspberry leaf tea, not an uncharacterized solid extract, that is the form commonly used by nurse-midwives in America as a uterine tonic (practice survey).1344

     +     2) Iron-deficiency anemia, malnutrition and constipation (speculative), due to the high tannin content that produces an astringent effect.1890 

Drug Interactions

III. +    1) Due to its tannin content, it may reduce absorption of metal ions, thiamine or alkaloids when taken concurrently (speculative).1890

 

RED CLOVER                                                                     p.167

                Trifolium pratense

Drug Interactions

 III. +   2) The major isoflavone component biochanin A was found to inhibit P-glycoprotein removal of daunomycin and the chemotherapeutic agent doxorubicin from breast cancer cell lines (in vitro)1562

 IV.      [1) It has been suggested that anticoagulant  drugs such as warfarin may be potentiated due to the anticoagulant effects of the coumarin content of red clover (speculative).894,895

The prodrug coumarin is also present in red clover, along with the derivative umbelliferone (7-hydroxycoumarin).1769

However, in a preliminary report on using “approximately 400 mg/d” of a standardized extract with 29.4% total isoflavones, none of 17 potential coumarins were detected at levels greater than 0.3% by weight. Only 5 including coumestrol and scopoletin were detected in even trace amounts. Prothrombin time levels in 6 women taking this extract for one month showed no changes from baseline in any of the women (PO in human clinical study).1769 The final report on the 378 mg/day dose of an ethanolic extract of the aerial parts standardized to 117 mg isoflavones given to 22 peri- or postmenopausal women showed no significant change in prothrombin time after 1 month compared to 22 similar subjects given placebo (PO in human clinical study).2596]

 

REHMANNIA                                                                      p.168

            Rehmannia glutinosa root

Contraindications

2) Uncured rehmania in pregnancy in traditional Chinese medicine patterns of deficient blood, deficient spleen or deficient stomach (empirical). It should not be used in pregnancy without professional advice (speculative).1890

 

REISHI                                                                                  p. 168

            Ganoderma lucidum fruiting body

Contraindications

       +   1) Organ transplants in which patients must use immunosuppressive agents due to potential immune enhancement (speculative)1122

       +   2) Autoimmune disorders due to potential immune enhancement (speculative)1122

Drug Interactions

I.     +   1) Potentiates the sedative effects of reserpine and chlorpromazine (empirical)1122

       +   2) Antagonizes the stimulant effect of amphetamines (empirical)1122

       +   3) Increased the sleeping time induced by barbital and pentobarbital (human clinical studies)1122 [However, see II. 2).]

III.  +   1) If anticoagulants are used, consult with health care provider before taking reishi (speculative)1122 due to potential anti-platelet activity of its adenosisn-containing water extract (in vitro)418

       +   2) Lovastatin and other cholesterol-lowering medications may be potentiated (speculative) due to reishi’s inhibitory action on HMG-CoA reductase1122

       +   3) Immunosuppressants due to potential immune enhancement (speculative) and because reishi polysaccharides have been shown to antagonize the immunosuppression caused by morphine (in vitro, in animals)1122

 

RHATANY                                                                             NEW

   ^       Krameria triandra root

(Ratanhia)

Drug Interactions

I.          1) The use of a rhatany extract mouthwash and toothgel 3 times daily for 4 weeks by 32 women while undergoing chemotherapy druing the first week with carboplatin, cyclophosphamide, epirubicin, and/or taxol resulted in only 16% developing a mild mucositis (PO in human clinical study). The oral symptoms that developed during the week of chemotherapy were markedly improved three weeks later. Plaque and gingival indices were also reduced, compared to baseline. 2314

 

RHODIOLA                                                                          NEW

   ^       Rhodiola rosea root

            (golden root, Arctic root, roseroot)

Drug Interactions

II.         1) Cyclophosphamide antitumor and antimetastasis effects on Ehrlich ascites tumor and Lewis lung carcinoma were enhanced when combine with 0.5 ml/kg rhodiola extract daily for 7 days, while the hematotoxicity to leucocytes and myelokariocytes was reduced (PO in mice)1549

            2) Antimetastatic activity of adriamycin was unimpaired and its hepatotoxicity was greatly reduced when combined with rhodiola extract (in mice).1563

 

RHUBARB, CHINESE [now CHINESE RHUBARB]     p. 168

            *Rheum officinale, *Rheum palmatum root

 

ROMAN CHAMOMILE [formerly CHAMOMILE, ROMAN] p. 62

            Chamaemelum nobile = Anthemis nobilis flowers and plant

Contraindications

2) Allergic hypersensitivity skin reactions occur in 20% of those tested(topically in human study)64

Two women who used a chamomile ointment on their nipples while breastfeeding developed severe bilateral eczema on the nipples and areolae (topically in human case reports). Both had 3+ positive reactions to chamomile oil patch tests.1741 A man developed acute eczema on his forearms and hands after washing and applying compresses of chamomile and Roman chamomile tea (topically in human case report). In patch tests he was shown to be sensitive to both of these teas and their mix, a Roman chamomile extract, yarrow, tansy, and feverfew extracts, and a sesquiterpene lactone mix. The Roman chamomile sesquiterpene lactone nobilin likely contributed to his reaction.1742 

 

ROSEMARY                                                                        p. 170

            Rosmarinus officinalis leaves

Drug Interactions

I.          1) A decrease in nonheme iron absorption by 21% was shown in 14 women after consumption of rosemary extract (PO in human study). This was likely due to the phenolic components carnosol, carnosic acid and rosmarinic acid, whose total content in the extract given with test meals was 32.7 mg.1993 Therefore, it is best to avoid concurrent consumption of iron and rosemary preparations rich in phenolic compounds.1890

III.       2) In human multiple myeloma cells the triterpenoid component ursolic acid increased the apoptotic effects of thalidomide from 20% to 70% and enhanced this activity of bortezomib from 25% to 80% (in vitro).2428

 

ROYAL SUN AGARICUS                                                 NEW

     ^     Agaricus blazei mycelia or mushroom

            (sun mushroom, Brazilian sun-mushroom; Br.: cogumelo do sol, cogumelo piedade, cogumelo de deus; Jap.: himematsutake, kawariharatake, agarikusutake; Ch.: ji song rong)

Drug Interactions

I.          1) In a study with gynecological cancer patients (61 cervical, 35 ovarian, and 4 endometrial), one dose three times daily of an uncharacterized royal sun agaricus extract was combined with chemotherapy in 29 using carboplatin and etoposide and in 10 using carboplatin and taxol and compared to placebo in 39 and 22 patients using these combinations without the extract, respectively. Those taking the extract had fewer adverse effects from the therapy, such as loss of appetite, hair loss, emotional lability, and general weakness (PO in human clinical study).1850

            2) A 500 mg capsule of extract from the mushrooms or placebo was given 3 times daily for 12 weeks to 60 adult Chinese type 2 diabetic patients who had been taking gliclazide and metformin for at least 6 months (PO in human clinical study). Those 29 receiving the extract had improved insulin resistance compared to the placebo group, based on lowered HOMA-IR index and increased plasma adiponectic concentration.2215

 

SAGE                                                                                     p. 171

            *Salvia officinalis leaves

Contraindications

     +     3) Nursing mothers, unless the intent is to help stop milk flow (empirical).1890

Drug Interactions

II. +      1) Cardiotoxicity from doxorubicin, a widely used antitumor agent, was reduced by luteolin (PO in mice),1282  a component of sage also responsible for the antimutagenic effect of water extracts of this fresh herb and also fresh thyme and peppermint (in vitro).1283

 

SAW PALMETTO                                                               p. 173

            Serenoa repens fruit

Contraindications

     +     1) Avoid a few weeks prior to surgery and use with caution for those with hemostatic disorders (speculative), due to a severe intraoperative hemorrhage that occurred in association with use of the hexane extract (PO in human case report).1724

However, 10 adults taking a proprietary saw palmetto product at the manufacturer’s recommended dose for 2 weeks had no increase in coagulation time in ADP and epinephrine assays of intrinsic and extrinsic platelet function, respectively (ex vivo), but the product was not analyzed for its phytochemical content.2262

Drug Interactions

III.   +  3) Use of a formula with saw palmetto extract, pumpkin seed (Cucurbita pepo) extract, and 10 mg of vitamin E results in an increase INR of 2.1 in one case and and INR increase of 1.0 in a man using warfarin (PO in human case reports). The increases were largely attributed to the vitamin E.1725 Nonetheles, other anticoagulants should also be used with caution with the extract (speculative), due to a severe intraoperative hemorrhage that occurred in association with use of the hexane extract (PO in human case report).1724

 

SCHISANDRA                                                                     p. 173

            Schisandra chinensis fruit

Contraindications

     +     1) Pregnancy due to its uterine stimulant effects (empirical),404

            except to assist childbirth such as by inducing labor (empirical).1890

     +     2) Early stages of cough or rash (empirical), based on excessive heat patterns in traditional Chinese medicine energetics.1890

Drug Interactions

II.         1) Schizandra given at 50 mg/kg 30 minutes before pentobarbital reduced sleeping time of this barbiturate by 41% (IP in mice).1236

                        However, an ethanol fraction of the fruit of another species, S. sphenanthera, dose-dependently reduced sleep latency and increased sleeping time induced by pentobarbital (PO in mice).2074

     +     3) Enhanced metabolic breakdown of S-warfarin was induced by 500 mg/kg of an aqueous extract equivalent to 3 gm/kg dried fruit (PO in rats), evidently through activation of pregnane X receptor as shown by an ethanolic extract of schisandra (in vitro).1926

 

SCOTCH BROOm                                                               p. 174

            *Cytisus scoparius = Sarothamnus scoparius

Contraindications

            6) Avoid self-prescribing since only under the supervision of a qualified expert can its safe use be expected (empirical).150

From 6-10% of Caucasians down to 1% or less of east Asians are poor CYP 2D6 metabolizers that have an impaired ability to eliminate sparteine, leading to a potentially toxic outcome (human studies).1566

Drug Interactions

I.          1) Quinidine and haloperidol inhibit the CYP 2D6 metabolism of the component sparteine (PO in human studies).657-659

            Other clinically relevant CYP 2D6 inhibitors include amiodarone, chlorpheniramine, cimetidine, clomipramine, fluoxetine, methadone, paroxetine, and ritonavir (in vitro, animal and/or human studies).1567

 

SCOURING RUSH                                                              NEW

     ^     Equisetum hyemale plant

            (rough horsetail; Ch.: mu zei)

Contraindications

            1) Prolonged use due to thiaminase activity of plants (in vitro; PO in horses).182

            2) Pregnancy (empirical)150

Drug Interactions

II.         1) Herb thiaminase content causes breakdown of thiamine (in vitro; PO in horses)2,150,182

III.       1) Digitalis and its cardiac glycosides and others heart tonic herbs containing similar compounds such as Adonis, Apocynum, Convallaria, Urginea,2,6 Helleborus, and Strophanthus (speculative) since they can become more toxic due to the loss of potassium2 associated with the diuretic effect of horsetail (PO in mice)12

 

SEA BUCKTHORN                                                                        NEW

     ^     Hippophae rhamnoides fruit

            (sea berry, swallow thorn, Siberian pineapple)

Drug Interactions

II.         1) Pretreatment with 1 ml/kg hexane fruit extract greatly reduced ulceration produced by indomethacin, much better than the antiulcer drug misoprostol (PO in rats).1959

 

SENNA                                                                                  p. 175

            *Cassia spp= Senna spp. leaves or pods

Contraindications

II.         1) Avoid in pregnancy,4,17,150 due to potentially mutagenic and genotoxic anthraquinones (in vitro).6,844

                        However, a case-controlled population-based comparison of 22,843 congenital abnormalities found 2.2% of mothers had senna treatment with a dose Of 10-30 mg (mode 20 mg), while of 38,151 controls with no congential abnormalities 2.5% of mothers had used senna (PO in human study). No association was found with senna use and a higher risk in the offspring of women using senna for constipation during pregnancy.2655

Drug Interactions

      +    4) Laxative effect caused by 7.2 grams of psyllium daily was effective in increasing stool dry weight and frequency in 48% of 42 constipated adults, compared to 63% when 6.5 grams of psyllium were combined with 1.5 grams of senna daily (PO in human clinical study)1473

 

SESAME                                                                               NEW

      ^    Sesamum indicum seed oil

Drug Interactions

            1) When used exclusively in place of other oils in cooking and salads for 45 days by 40 hypertensive diabetic men and women taking as medications the beta-blocker atenolol and oral hypoglycemic drug glibenclamide, sesame oil reduced systolic and diastolic blood pressures, but these rose when other oils were substituted (PO in human clinical study). Also reduced by the sesame oil were body weight and girth, and plasma levels of sodium, glucose, glycosylated hemoglobin, LDL-cholesterol, and triglycerides. Antioxidant and potassium levels were increased during the 45 days of using about 35 grams of sesame oil daily.2050 

 

SHEPHERD’S PURSE                                                        p. 177

            Capsella bursa-pastoris herb

Contraindications

     +     2) Nursing mothers without professional advice, due to its glucosinolates that can taint the milk, reportedly caused adverse effects in newborns drinking milk from goats fed glucosinolates (empirical).1890

 

SHRUB ALOE                                                                      NEW

     ^     Aloe arborescens (= Aloe perfoliata)

            (tree aloe, Krantz aloe, candelabra aloe)

Drug Interactions

Ia.        1) A trial with chemotherapy drugs given with or without shrub aloe extract at 30 ml/day to treat metastatic solid tumors, including vinorelbine or cisplatin and etoposide for lung cancer, oxaliplatin and 5-fluorouracil for colorectal cancer, 5-fluorouracil for gastric cancer, and gemcitabine for pancreatic cancer, found the chemotherapy/extract combination significantly improved tumor regression and increased 3-year survival from 5% to 19% (PO in human clinical study). Use of the extract also was associated with significantly greater average lymphocyte counts and significantly less fatigue. Of those taking vinorelbine alone 71% had constipation, but only 18% of those also using the extract were constipated.2611

 

SILK TREE                                                                                      NEW

     ^     Albizia julibrissin bark

            (mimosa tree; Ch.: he huan pi)

Contraindications

            1) Pregnancy due to its emmenagogue and uterine stimulant effects (speculative)150

 

SMALL SPIKENARD                                                        NEW

     ^     Aralia nudicaulis rhizome

            (false sarsaparilla, wild sarsaparilla, rabbit’s root, wild licorice)

Contraindications

            1) Pregnancy (speculative)150 due to its emmenagogue effect (empirical)1125

 

SOY                                                                                        p. 177

            Glycine max beans

Contraindications

            1) Iodine-deficiency thyroid conditions such as nontoxic goiter (empirical)970

                        However, the concentration of thyroxine (T4) and the free thyroxine index were actually elevated, though not to clinically levels, when 56 mg of isoflavones in 40 grams of soy protein was taken daily for 3-6 months by 73 post-menopausal women, while thyroid stimulating hormone (TSH) concentration was higher with 90 mg soy protein isoflavones during this time (PO in human clinical study).1251 A study with 38 postmenopausal women not on hormone replacement therapy supplemented them with 150 mcg of iodine daily. In randomized, double-blind fashion, 21 received 90 mg of soy isoflavones daily for six months, but this did not alter TSH, T4, or T3 levels when compared to those on placebo (PO in human study).1680 

2) Allergic hypersensitivity to soy including soy-based formulas for infants who respond with enterocolitis typified by diarrhea with fecal blood and vomiting (PO in human clinical study).1546 Young children with cow’s milk allergy in addition to soy allergy have the greatest clinical response to soy exposure (PO in clinical studies),1546,1548 with immediate reactions elicited by very small doses and late reactions requiring higher repeated doses.1548

     +     3) Extensive long term continual use of concentrated isoflavones from soy, since 5 years, though not 3 years, of taking 150 mg soy isoflavones per day was associated with endometrial hyperplasia in 3.4% of postmenopausal women (PO in human study)1616

Drug Interactions

I.          1) Oral thyroxine doses to infants had to be reduced after discontinuation of soy-based formula (PO in human case reports).934 The isoflavones are absorbed by infants fed soy protein-based formula (PO in human study).978

In contrast, the concentration of thyroxine and the free thyroxine index were elevated when 56 mg of isoflavones in 40 grams of soy protein was taken daily for 3-6 months by 73 post-menopausal women, while thyroid stimulating hormone concentration was higher with 90 mg soy protein isoflavones during this time (PO in human clinical study).1251

     +     2) Use of 16 oz. soy milk daily for 4 weeks while taking warfarin led to a diminished INR value indicating reduced anticoagulation. Withdrawal of soy milk for 2 weeks led to a return of therapeutic coagulation values (PO in human case report).1347

However, soy protein that was either isoflavone-rich or -poor failed to produce an effect on coagulation and fibrinolytic factors after 24 weeks when each was used by 24 perimenopausal women, compared to baseline or 21 subjects taking whey protein (PO in human clinical study).1523

     +     3) Use of 150 mg of soy extract daily containing 40% isoflavones (60 mg daily) along with 100 mg dong quai extract and 50 mg black cohosh extract for 24 weeks by 49 menstrual migraine patients significantly reduced the number of doses of triptans and analgesics after 20-24 weeks compared to placebo (PO in human clinical study)1422

II.  +     1) Soybean meal or concentrate as the sole protein source taken 14 days prior and 7 days after methotrexate injection completely alleviated the anorexia and diarrhea associated with receiving the drug, along with preventing the intestinal necrosis observed when using a casein-based diet. Soybean fiber and isolate also provided some positive results. Methotrexate plasma levels were similar with all diets, as were the resultant depressed white blood cell counts (PO in rats).1545

     +     2) Increased apoptosis in prostate cancer tissue with docetaxel or cisplatin occurred when they combined with genistein, apparently due to an abrogation of the induction of NF-kB by the genistein (in vitro, PO in mice).1961,1962 Similar effects were found when genistein was combined with docatxel or cisplatin in cancer cells of the breast, lung, and pancreas (in vitro),1961 and with cisplatin in human malignant melanoma cells, though the mechanism in the latter appears to be suppression of anit-apoptotic proteins (in vitro).1963

III. +    2) The cytotoxic effect of gemcitabine, a standard drug for pancreatic cancer, on pancreatic cancer cells was inhibited in the presence of genistein even when used at 2.5 times higher concentration (in vitro)1681  

     +     3) Increased apoptosis in tumor cells, apparently due to an abrogation of the induction of NF-kB by the genistein, were found when genistein was combined with doxorubicin in cancer cell cultures of the prostate, breast, lung, and pancreas (in vitro).1961

     +     4) 3  dysplastic and 3 malignant breast cell lines showed inhibition of cell proliferation that was synergistic and additive, respectively, when exposed to the combination of tamoxifen with genistein continuously for 72 hours in comparison with the dose-dependent inhibition caused by genistein alone (in vitro). The effects were not modulated by the presence of estrogen receptors.2128 

     +     5) In a culture of colon cancer cells the apoptotic effect induced by 5-fluorouracil was increased by genistein, while the COX-2 up-regulation and increased prostaglandin secretion caused by the drug were abolished by the addition of genistein (in vitro).2129

 

SPIKENARD                                                                        NEW

     ^     Aralia racemosa rhizome

            (American spikenard, Indian root, life-of-man, nard, spignet)

Contraindications

            1) Pregnancy (speculative)150 due to its emmenagogue effect (empirical)1125 except for prior to labor to facilitate childbirth (empirical)7

                                              

ST. JOHN’S WORT                                                             p. 178

            Hypericum perforatum plant

Contraindications

     +     1) Pregnancy3 due to its emmenagogue1125 and abortifacient effects (empirical) and its uterine stimulant action (in vitro or in animals).74

In prospective, observational, controlled study of women in Canada to investigate the teratogenic potential of substances during pregnancy, 54 women who used St. John’s wort tablets at an average dose of 615 mg/day were compared with 56 women using pharmaceutical antidepressants and 56 women not exposed to any known teratogens (PO in human study). The groups were matched by gestational age, maternal age, and number of prior pregnancies, and the St. John’s wort group had more spontaneous abortions, 20.3% versus 12.5% and 8.9%, and more malformations, 5% versus 4% and 0%, compared to the pharmaceutical- and non-antidepressant groups, respectively.2622

However, no significant differences were found between the groups in the number of spontaneous abortions or malformations, suggesting some evidence of fetal safety. In addition, the small sample sizes of the groups may exaggerate these percentages, and the malformation rate for St. John’s wort group is within the 3-5% range expected in the general population.2622

At least caution is warranted,2115 since 100 mg/kg of the extract its induction of metabolic isozymes and transporter proteins in the mother and their reduction in the fetus (PO in rats) may lead to a disruption of hormonal concentrations and/or toxicity (speculative).1944 A 100 mg/kg dose of the extract during the entire prenatal period caused kidney and liver damage in the newborn (PO in rats).1945 

2) Prior to extensive exposure to sunlight,6 therapeutic ultraviolet light or solarium therapy (speculative)4,6,777

Acute polyneuropathy following consumption of 500 mg/day of powdered whole St. John’s wort occurred on areas exposed to the sun, though the skin was not burned. Pain resulted from mild mechanical stimulation only on the exposed areas, but disappeared gradually over two months following withdrawal of the herb use (PO in human case report).1175 

Skin reactions from radiotherapy in a 65-year-old man recurred as radiation recall dermatitis with later use of St. John's wort extract (PO in human case report).2656

While St. John’s wort extract and hypericin were both shown to have dose-dependent phototoxicity, the extract flavonoid component quercetrin helps reduce the phototoxicity (in vitro), indicating the extract is probably less phototoxic than an equivalent amount of hypericin that it contains (speculative).1332

Of special concern is exposure of the eyes to intense sunlight while using St. John’s wort due to photooxidation of alpha-crystallin of the lens by hypericin (in vitro) that could lead to the formation of cataracts (speculative).1378

            3) Endogenous depression24 or as sole therapy for psychotic symptoms or suicidal risk (speculative)777

A recent study showed 900-1200 mg daily of St. John’s wort extract was not effective in the treatment of major depression (PO in human clinical study).1113 The much publishized failure in treating major depression with St. John’s wort extract by the Hypericum Depression Trial Study Group in 2002 was complicated by the fact that the standard medication sertraline also failed to improve the primary outcome measures in this trial.1337

     +     4) Prior to surgery due to potential for interactions with some anesthetic agents (speculative).428,940,941,1309 (See drug interactions I.10 below.)

A woman using tablets of standardized St. John’s wort for about 3 months in doses of  one gram three times daily had delayed emergence from general anesthesia following surgery (PO in human case report). It is considered wise to discontinue St. John’s wort at least five days prior, based on known pharmacokinetics of hyperforin and hypericin.1289

St. John’s wort should be discontinued at least 5 days prior to surgery (speculative).and should be avoided postoperatively in organ transplant patients and those requiring oral anticoagulation.1309 (See drug interactions I.6 and I.8 below.)

However, 10 adults taking a proprietary St. John’s wort product at the manufacturer’s recommended dose for 2 weeks had no increase in coagulation time in ADP and epinephrine assays of intrinsic and extrinsic platelet function, respectively (ex vivo), but the product was not analyzed for its phytochemical content.2262

     +     5) A history of hypomania, mania or bipolar disorder since two cases of mania have been associated with use of 900 mg daily of standardized St. John’s wort extract in subjects with prior manic histories (PO in human case reports)1189 Another two cases of hypomania were associated with its use for 6 weeks and 3 months, though the dose and form of the products were unreported (PO in human case reports).1265 In cases of mania induced by St. John’s wort, one woman with depression stopped her medications and became over-active after using 900 mg daily for 3 weeks, while a man with bipolar II disorder self-medicating with 900 mg/day also experienced extreme manic behavior after two months (PO in human case reports). Reducing the dosage to 300 mg/day in both cases caused a reversion to depression.1269

     +     6) It should be avoided without professional advice and used with caution by nursing mothers (speculative),1890 since an increased incidence of infant side effects like colic,drowsiness, and lethargy can occur when the mother uses the botanical (PO in human study).1971

However, a prospective, observational cohort study with 33 breastfeeding women using St. John’s wort preparations on average 705 mg/day for 1.5 months, starting at 4.2 months postpartum found no statistical differences in reported decreases in milk production compared to controls, nor were there differences in infant weight during the first year (PO in human study). The average duration of infant exposure to the herbal products was 2.1 months.1946

Drug Interactions

I.          1) Incidences of serotonin syndrome from combining St. John’s wort with the antidepresssants nefazodone1022 and trazodone611 and the selective serotonin reuptake inhibitor (SSRI) sertraline1022 have been reported (human case reports).

The hospitalization for loss of consciousness and an epileptic fit of a 28-year-old woman who was taking 60 mg/day of the SSRI fluoxetine for 1 year and uncharacterized St. John’s wort for a month was complicated by her use of eletriptan for the 3 days prior to treat a recurring migraine (PO in human case report). On admission myoglobin was elevated. Fluoxetine dose was reduced to 20 mg/day, eletriptan was continued, and St. John’s wort was discontinued. Myalgias and serum myoglobin continued to increase for a few days, so both drugs were also discontinued. When discharged 10 days later, she had normal blood indices and no myalgias.2626 In a 42-year-old woman receiving 20 mg b.i.d. fluoxetine with 20 mg b.i.d. buspirone for major depression, hypomania characterized by anxiety, insomnia, and panic developed when she began taking  uncharacterized St. John’s wort extract, Ginkgo biloba extract, and melatonin for several weeks (PO in human case report). After discontinuation of the nonprescription items, the anxiety diminished and behavior improved over the next several months.2628

A 19-yea-old man with a cough treated by an unknown OTC cold medicine, and who was attempting to self-detoxify from ecstasy [MDMA] use, took 200-250 mg of tryptophan for 2 days along with several St. John’s wort tablets and developed symptoms typical for serotonin syndrome (PO in human case report). Tryptophan combined with monoamine oxidase inhibitor antidepressants was associated with the first reported cases of serotonin syndrome. Dextromethorphan in some cold products can also increase serotonin levels. His symptoms included confusion, agitation, anxiety, hypertehermia, flushing, sweating, rapid breathing and heart rate, restlessness, tremor, and ataxia, but lab tests were normal. After treatment with fluids, a cooling blanket and the sedative lorazepam, his symptoms resolved, and he was discharged.2632

3) Theophylline dose required increasing when standardized St. John’s wort was used for 2 months by a woman (PO in human case report). Theophylline is metabolized by the enzyme CYP 1A2.435

However, no change in theophylline plasma levels were found when 12 healthy Japanese males took 900 mg daily of a St. John’s wort extract standardized to 0.3% hypericin in a 15-day randomized, open-labeled, crossover study (PO in human study). A tendency for one of the major metabolites to increase proportionally to the total excreted in the urine was the only change noted. Duration may be a factor.1585 Likewise, no increased metabolism by CYP 1A2 of caffeine was found in a study of 12 Chinese men using the same dose (PO in human study).1584

Combining data from both genders resulted in no inducing effect on caffeine metabolism by CYP 1A2 found with oral use of 900 mg extract of St. John’s wort standardized to 0.3% hypericin for 14 days in 5 women and 7 men (PO in human study)1217 and either a moderate or no inducing effect after 28 days with the same dose in 6 men and 6 women (PO in human studies),1328,1808 as well as no effect by 240 mg of 0.4% hypericin extract after 10 days (PO in human study).1775

Nonetheless, another study using caffeine found no effect in 8 men but significantly increased metabolic ratios in 8 women, when results were separated by gender (PO in human study).1838 Therefore, CYP 1A2 induction by St. John’s wort preparations may be gender specific (speculative).

Paradoxically, the constituents I3,II8-biapigenin and quercetin inhibit CYP 1A2 (in vitro).1522 The unreliability of inhibitory test tube results using constituents in predicting herb and extract effects in humans is thereby demonstrated.

            4) St. John’s wort for 14 days reduced the HIV proteinase inhibitor indinavir, due in part to CYP 3A4 induction (PO in human study).436

Hyperforin acts as a potent ligand for activating the steroid X receptor [pregnane X receptor] (in vitro) that in turn regulates expression of CYP3A4.1002,1288

Indinavir is also a substrate for P-glycoprotein, an efflux drug transporter induced by St. John’s wort.1969 Hyperforin daily dosage correlated well with P-glycoprotein induction, hypericins and total flavonoid dosage did not (PO in human study).1343 Hyperforin and quercetin in nanomolar concentrations increase transport activity of Pgp (in vitro).1720

5) Extract after 10 days reduced the peak digoxin AUC by 25% (PO in human study).437

18 subjects were given 300 mg tablets 3 times daily for 14 days of extract WS 5572, each tablet standardized to contain 9 mg hyperforin [but assayed as containing 8 mg], that was comparable in significantly reducing digoxin bioavailability to rifampin, a known P-glycoprotein inducer (PO in human study).2504 

Different St. John’s wort dosages and formulations used with digoxin for 14 days vary in their influence on its bioavailability (PO in human study). While 900 mg daily of the extract LI160 (80% methanol extact of 4-7:1 strength, standardized to 0.3% hypericins) reduced digoxin bioavailability described as 24-hour-area-under-curve (AUC) by 25% compared to placebo, 4 grams daily of the encapsulated herb powder reduced digoxin AUC by 27%, and 2 grams encapsulated powder decreased AUC by 18%. Hyperforin dosage was similar between the extract and 4 grams of powder at 29 and 21 mg/day, respectively. Using daily either  0.5-1.0 gram of the same powdered herb, or 2 grams of a different powder, 2 cups of the tea each made with 1.75 grams herb, 1.2 grams of the encapsulated oil 0.075:1 strength extract, 20 ml fresh juice, or 500 mg of Ze117 that is a 5:1 strength 50% ethanolic extract, all with low hyperforin doses from 0-5.3 mg/day, caused no significant change in AUC or trough levels when compared to placebo. Whereas hyperforin dosage correlated well with P-glycoprotein induction, hypericins and total flavonoid dosage did not.1343 Ze 117, with low hyperforin, 0.2% hypericins, and 0.35% quercetin, has shown year-long safety and efficacy for mild to moderate depression (PO in human clinical trial).2576 Furthermore, a 240 mg/day dose of a 1.5% hyperforin extract providing a daily hyperforin dose of 3.5 mg failed to significantly reduce steady state digoxin levels in the blood after 10 days of concurrent dosing (PO in human study).1775 The extract LI 160 at 1 mcg/ml and its components hyperforin and quercetin in nanomolar concentrations increase transport activity of Pgp (in vitro).1720

            St. John’s wort extract LI 160 given at 900 mg daily for 14 days decreased AUC of a single dose of digoxin by 18% by increasing duodenal P-glycoprotein 1.4-fold, duodenal CYP3A4 1.5-fold, and hepatic CYP 3A4 1.4-fold (PO in human study). The LI 160 extract given at 1000 mg/kg daily for 14 days increases intestinal P-glycoprotein 3.8-fold and hepatic CYP3A2 2.5-fold (PO in rat study).1350

6) St. John’s wort extract (0.3% hypericin) 300 mg three times daily for three weeks resulted in a decrease in the concentration of the immunosuppressant drug cyclosporine in a heart transplant patient (PO in human case report).  Endomyocardial biopsy indicated acute transplant rejection.438 Two kidney transplant cases with serum cyclosporin reduction to subtherapeutic levels, including one case resulting in organ rejection, were scored as probable interactions since 300-900 mg daily of standardized St. Johns wort extract had been used for 1-6 months prior (PO in human case reports).1248,1601 Dozens of other cases reportedly had a lowering of serum cyclosporine while using St. John’s wort (PO in human case reports),602,612,1187,1249 although several of these reports have been described as unevaluable based upon report inadequacies.1239 A model of interaction based on rate of induction and elimination half-life of cyclosporine detoxicating proteins indicates that dosage regimens need to be carefully monitored for 2 weeks at the beginning of St. John’s wort introduction and for 2 weeks after its cessation.1924

Eleven renal transplant patients receiving cyclopsonin A were given 600 mg St. John’s wort extract for 14 days. After 2 weeks the bioavailability of cyclosporin was significantly reduced by over 40%, and its average dose required increasing from 2.7 mg/day to 4.2 mg/ day to maintain therapeutic levels (PO in human trial). Potentially nephrotoxic metabolites of cyclosporin increased with the elevated dosage.1377  A study of 12 days with 21 healthy subjects using 900 mg daily of the extract LI 160 standardized to 0.3% total hypericins found a greater increase in cyclosporine clearance after oral administration by 1.9-fold (PO in human study).1590 In a crossover study with 10 renal transplant patients using cyclosporine, one group received 900 mg/day for 14 days of an extract with 4.7% hyperforin content and the other group received an extract with less than 0.1% hyperforin. The high hyperforin extract led to significantly less cyclosporine bioavailability, peak concentration and plasma concentration at the end of 12 days requiring an increased daily dose, whereas the low hyperforin caused no changes in cyclosporine parameters (PO in human clinical study).1691

7) Breakthrough bleeding occurred in 3 women in Switzerland using ethinylestradiol and desogestrel with St. John’s wort (PO in human case reports)602 and in Sweden with women using oral contraceptives with St. John’s wort for one week in 5 cases (PO in human case reports).603

However, these reports have been described as unevaluable based upon report inadequacies.1239

In a randomized controlled trial with 18 females taking low-dose contraceptives with 0.02 mg ethinylestradiol and 0.15 mg desogestrel, intracyclic bleeding increased significantly, estradiol increased in those with enlarged follicle-like structures, and the concentration of the active progestin metabolite 3-ketodesogestrel was significantly reduced (PO in human study).1505 In addition, 9 reports of unplanned pregnancies from Sweden and Great Britain have occurred in association with using St. John’s wort concurrently with oral contraceptives (PO in case reports).1330

However, when LI160 was taken with ethinylestradiol and desogestrel, no evidence of ovulation or of altered ethinylestradiol metabolism was found (PO in human study).1505 Likewise, 500 mg/day of the solid ethanolic extract Ze 117, containing 0.13% hyperforin that provided 0.65 mg daily for 14 days, did not significantly alter the pharmacokinetics of ethinylestradiol or desogestrel/3-ketodesogestrel in low-dose contraceptive pills used by 16 healthy females (PO in human study).2569 Ze 117, with 0.2% hypericins and 0.35% quercetin, has shown year-long safety and efficacy for mild to moderate depression (PO in human clinical trial).2576

A low-dose oral contraceptive with 20 mcg ethinylestradiol and 1 mg norethindrone (norethisterone) was given to 16 women for 2 successive 28-day cycles before 900 mg/day of a St. Johns wort preparation was combined with the contraceptives on the next 2 cycles (PO in human study). The St. John’s wort was standardized and verified to contain 0.3% hypericin and 3.7% hyperforin. By the third week of the second combination cycle the bioavailability of both drugs had been reduced 13-15% with increased breakthrough bleeding and evidence of follicle growth. Whereas physical and hormonal indicators showed one probable ovulation during the first 2 weeks, after St. John’s wort introduction there was evidence of 3 probable and 3 possible ovulations among the 16 women.1802

An open study with 12 healthy females given the oral contraceptive combination of 0.035 mg ethinylestradiol and 1 mg norethindrone for three months introduced 900 mg of St. John’s wort during the second and third months. The half-life of ethinylestradiol was reduced. Clearance of norethindrone was increased in the third month when 7 of the 12 had breakthrough bleeding, compared to 2 of 12 in the first month. CYP 3A activity in the intestines, but not in the liver, also increased from the first to the third month (PO in human studies).1524,1809 Lower serum 3-ketodesogestrel and norethindrone are probably due to its enhanced metabolism by induction of CYP 3A4. This suggests caution when using St. John’s wort products with oral contraceptives (speculative).1505,1524 

8) A total of 7 patients had a lower INR while using St. John’s wort while on warfarin (PO in human case reports).603

However, this report has been described as unevaluable based upon report inadequacies.1239

An open-label 3-way crossover randomized trial with 12 healthy subjects showed that St. John's wort standardized extract, daily providing 37.5 mg hyperforin and 2.5 mg hypericin derived from 3 grams flowering tops, when given 14 days before and 7 days after a single 25 mg dose of racemic warfarin significantly increased both R- and S-warfarin apparent clearance (PO in human study). S-warfarin, the active isomer, is metabolized by the CYP 2C9. R-warfarin, the less active isomer, is metabolized by the CYPs 1A2 and 3A4.1578 In this study the extract increased apparent clearance by 39%.2016 

However, no effect on the CYP 2C9 metabolism of tolbutamide after 10 or 14 days was found with oral use of 240 mg or 900 mg of extracts of St. John’s wort standardized to 0.4% or 0.3% hypericin, respectively (PO in human studies).1217,1775 Likewise, no changes in metabolism of the CYP 2C9 substrates S(+)- or R(-)-ibuprofen stereoisomers were found after 21 days use of 0.03% hypericin-standardized St. John’s wort extract at 900 mgs daily in 8 males (PO in human study).2079

The extract and constituents hyperforin, hypericin, and I3,II8-biapigenin are potent inhibitors of CYP 2C9, while I3,II8-biapigenin and quercetin inhibit CYP 1A2 (in vitro).1522 The unreliability of inhibitory test tube results using constituents in predicting herb and extract effects in humans is thereby demonstrated.

9) Oral anticoagulant phenprocoumon had a reduced plasma concentration after ingesting St. John’s wort extract daily (PO in human study).605

Phenprocoumon is metabolized by CYP 2C9,1167 but no effect on metabolism of tolbutamide by 2C9 after 10 or 14 days was found with oral use of 240 mg or 900 mg of extracts of St. John’s wort standardized to 0.4% or 0.3% hypericin, respectively (PO in human studies).1217,1775 Likewise, no changes in metabolism of the CYP 2C9 substrates S(+)- or R(-)-ibuprofen stereoisomers were found after 21 days use of 0.03% hypericin-standardized St. John’s wort extract at 900 mgs daily in 8 males (PO in human study).2079

However, S-warfarin metabolism, apparently by the CYP 2C9, was shown to be increased by St. John's wort extract, also (PO in human study).1578 The extract1522 and constituents hyperforin, hypericin, and I3,II8-biapigenin are potent inhibitors of CYP 2C9 (in vitro),1522 which would be expected to raise phenprocoumon levels.

10) 21-year-old woman using 3 grams daily of standardized St. John’s wort for 3 months was slow to emerge from general anesthesia induced with fentanyl and propofol and maintained with sevoflurane and nitrous oxide. Eight hours later she had recovered (PO in human case report).1289

11) The benzodiazepine drug midazolam blood levels were reduced by 60% when the drug was given orally after 12 days of taking 900 mg/day of St. John’s wort (PO in human study). Midazolam is a specific substrate for CYP 3A4.1096 A single 900 mg dose of St. John’s wort extract standardized to 0.3% hypericin had no effect on oral midazolam given to 12 healthy subjects. However, after 2 weeks of 900 mg extract daily, serum levels of midazolam were reduced by >50% when midazolam was given orally and by 20% when medazolam was given IV (PO in human study).1217 Another study of 12 days with 21 subjects using 900 mg daily of the extract LI 160 standardized to 0.3% total hypericins also found a greater increase in midazolam clearance after administration orally (2.7-fold) than by IV dosing (1.5-fold) (PO in  human study).1590 Other reports noted St. John’s wort extract 900 mg/day for 50 days increased clearance only when midazolam was taken orally, not when systemically (PO and IV in human studies).1524,1809 900 mg daily for 28 days of an extract that delivered 4.8 mg hyperforin per day induced midazolam metabolism by 141%, when measured as a single timepoint phenotypic metabolic ratio (PO in human study).1808 In a 10-day study 900 mg of a St. John’s wort preparation significantly reduced midazolam bioavailability and increased its systemic clearance similarly among 5 subjects in each of 6 ethnic groups: White, Black, Hispanic, Mayla, Indian, and Chinese. The induction of CYP 3A4 was greater in the intestines than in the liver (PO in human study).1613 

Midazolam metabolism by CYP 3A4 was also induced by hypericin-standardized St. John’s wort in 12 healthy subjects after using 300 mg 3 times daily for 28 days (PO in human study).1328

However, when 1 gram/day of St. John’s wort herb providing only 0.06 mg total hyperforins, 0.6 mg total hypericins, and 17.8 mg total flavonoids was given daily for 14 days to 20 healthy men, the bioavailability of midazolam was significantly but mildly reduced by 11% and apparent oral clearance increased by 22% compared to baseline, though other pharmacokinetic factors such as maximum concentration and half-life were no significantly changed (PO in human study). Since 90% confidence intervals of all pharmacokinetic parameters were within no-effects limits, the mild induction of CYP 3A by the low hyperforin content of this herb was not considered clinically relevant.2598 When 42 men took 1 of 6 other St. John’s wort preparations for 14 days, these also reduced midazolam bioavailability compared to baseline based on their hyperforin content: e.g., 79% by 900 mg of LI 160 with 41 mg/day hyperforin, 48% by 2.7 grams of St. John’s wort powder tablets with 12 mg/day hyperforin, and 21% by 2.7 grams of powder tablets with 0.13 mg/day hyperforin (PO in human study). The bioavailability of midazolam correlated with the hyperforin dose and significantly with flavonoid dose  but not with hypericin dose.2599

The related drug alprazolam is another CYP 3A4 substrate that showed increased clearance and decreased bioavailability when 900 mg daily St. John’s wort extract LI 160 was given for 2 weeks prior and concurrently to 12 healthy subjects (PO in human study).1478

However, no effect on alprazolam metabolism occurred with 240 mg daily of an extract that delivered only 3.5 mg hyperforin per day for 10 days (PO in human study).1775 This extract, Ze 117 with 0.2% hypericins and 0.35% quercetin, has shown year-long safety and efficacy for mild to moderate depression (PO in human clinical trial).2576 So adequate hyperforin dosage and duration are both necessary factors for inducing CYP 3A4, but hyperforin is not essential for an antidepressant effect.

The constituents hyperforin, hypericin, and I3,II8-biapigenin are potent inhibitors of CYP 3A4 (in vitro).1522 The unreliability of inhibitory test tube results using constituents in predicting herb and extract effects in humans is thereby demonstrated.

In a randomized, placebo-controlled, double-blind, crossover trial 900 mg daily of an extract standardized to 0.3% hypericin was given for 14 days to 13 healthy subjects and reduced the bioavailability of a single dose of the benzodiazepine quazepam (PO in human study). While reducing drug concentrations, the sedative drug effect was not altered pharmacodynamically by St. John’s wort with its distinct measurable psychomotor effect.1819

     +     12) [previously III. 1)] Oral clearance of the HIV non-nucleoside reverse transcriptase inhibitor nevirapine, a substrate of P-glycoprotien, is increased with concurrent use of St. John’s wort which should therefore be avoided. Five male HIV patients aged 34-53 were treated with nevirapine while concurrently using SJW for several months. No forms or doses of St. John’s wort were specified. Nevirapine plasma concentrations were reduced with St. John’s wort intake compared with prior values. Oral clearance was increased 35% when taking St. John’s wort preparations (PO in human clinical study).1188

     +     13) After safely taking 2 tablets of St. John’s wort with 1 tablet of valerian daily for six months for her depression and migraines, a woman was hospitalized with delirium, rapid breathing, rapid heart rate, and mild hypertension following the additional use of loperamide for diarrhea (PO in human case report). The patient recovered in two days after naltrexone was given to counteract the drug. A MAO-inhibitor reaction was theorized, possibly in conjunction with loperamide-induced delirium.1227

     +     14) 300 mg of LI 160 taken three times daily for two weeks prior to administering single doses of simvastatin and pravastatin to 8 healthy males each resulted in lower plasma levels of simvastatin and its active metabolite, simvastatin hydroxy acid, but pravastatin plasma concentration was not influenced (PO in human study). Simvastatin is a substrate of P-glycoprotein and CYP3A4 in the intestinal wall and liver, but pravastatin is not a substrate for P-glycoprotein or CYP3A4.1250

            In a controlled, randomized, crossover trial with a 4-week run-in, 16 hypercholesterolemia patients on a stable dose of atorvastatin received 600 mg daily of a commercial St. John’s wort product and a multivitamin control for 4 weeks each (PO in human clinical study). After the botanical use period, the serum LDL cholesterol level was increased compared to the control. Atorvastatin is a CYP 3A4 substrate, but its levels were not monitored.2200

     +     15) A woman with bipolar I disorder experienced psychotic mania after taking St. John’s wort at an unknown dose for two weeks together with maintainence doses of lithium, clonazepam and olanzapine (PO in human case report)1269

     +     16) Chlorzoxazone metabolism by CYP 2E1 was enhanced by hypericin-standardized St. John’s wort in 12 healthy subjects after using 300 mg 3 times daily for 28 days (PO in human study).1328 In 12 healthy elderly subjects, the metabolism of chlorzoxazone was increased by 28% (PO in human study).1808

     +     17) A single 900 mg dose of St. John’s wort inhibited intestinal P-glycoprotein, increased the maximum plasma concentration of fexofenadine by 45%, and decreased its oral clearance by 20%. Compared to a single dose, 2 weeks of using 300 mg St. John’s wort three times daily reversed this effect and decreased fexofenadine maximum plasma concentration by 35% and increased its oral clearance by 47%, but there was no difference from baseline when compared to no St. John’s wort treatment (PO in human study).1331

However, a study of 12 days with 21 subjects using 900 mg daily of the extract LI 160 standardized to 0.3% total hypericins found a greater increase in fexofenadine clearance after oral administration by 1.6-fold (PO in human study).1590

            In a 10-day study 900 mg of a St. John’s wort preparation significantly increased fexofenadine oral clearance similarly among 5 subjects in each of 6 ethnic groups: White, Black, Hispanic, Malay, Indian, and Chinese (PO in human study).1613 

     +     18) 5 cancer patients receiving 900 mg daily of a St. John’s wort product together with the CYP 3A4 substrate irinotecan (CPT-11) in a randomized, unblinded crossover study had a reduction in plasma levels of its active metabolite SN-38 by 42% and a decrease of its detoxified metabolite APC (PO in human clinical study).1342

However, the authors suggest that induction of irinotecan metabolism resulting in lower levels of the active metabolite SN-38 and inactive APC may be due to prior metabolic induction of CYP 3A4 by the comedication dexamethasone, leading to other inactive metabolites (speculative).1342 Otherwise, inducing CYP 3A4 with either dexamethasone or St. John’s wort would be expected to lead to an increase of APC (speculative).

St. John’s wort extract LI-160 given at 400 mg/kg reduced the bioavailability of SN-38 glucuronide after 3 days of pretreatment and SN-38 after 14 days of pre-treatment, whereas SN-38 glucuronide bioavailability tended to rise after 2 weeks (PO in rats).2163 Ethanolic extract of St. John’s wort at a concentration of5 mcg/ml decreased SN-38 glucuronidation in rat hepatic microsomes but increased its glucuronidation in rat hepatoma cells (in vitro).2165 Both early and late-onset diarrhea were reduced when the extract was combined with irinotecan, and decreases in neutropils, lymphocytes and platelets were also lessened (PO in rats).2163 Besides decreasing intestinal apoptosis from irinotecan on days 5-11, the same dose of the extract for 8 days led to reduced production of pro-inflammatory cytokines TNF-alpha mRNA during the same time period (PO in rats).2164

     +     19) A patient on the immunosuppressant drug tacrolimus after a kidney transplant had lower blood levels of this drug a month after taking 600 mg daily of a St. John’s wort extract. Tacrolimus levels returned to the previous range after stopping use of the herb extract (PO in human case report).1349 Ten renal transplant patients receiving tacrolimus and mycophenolic acid were subjected to 600 mg St. John’s wort extract for 14 days. After 2 weeks the bioavailability of tacrolimus was significantly reduced. The average tacrolimus dose required an increase from 4.5 mg/day to 8.0 mg/ day to maintain therapeutic levels (PO in human trial). Mycophenolate mofetil kinetics were unaffected.1376  Ten healthy volunteers received tacrolimus, a substrate for CYP 3A4 and P-glycoprotien, prior to and during a course of  St. John’s wort 900 mg daily for 18 days. St. John’s wort reduced AUC and increased oral clearance, probably due to induction of both CYP 3A4 and P-glycoprotein.1552

     +     20) In 6 strong CYP2C19 metabolizers, but not in 6 poor metabolizers, 900 mg daily for 14 days of St. John’s wort extract containing 4% hyperforin and 0.3% hypericin increased metabolism of mephenytoin significantly (PO in human study).1584

However, when 3 different St. John’s wort extract products were tested they inhibited CYP2C19 (in vitro).1593 St. John’s wort appears to inhibit CYP 2C19 in the first 10 hours but induce this isozyme after 15 days of use (PO in human study).1839 

     +     21) St. John's wort standardized extract at 900 mg/day given for 14-47 days to 4 patients on methadone resulted in a 19%-60% (median 47%) decrease in methadone plasma concentration to dose ratios (PO in human clinical trial). Methadone is a substrate of P-glycoprotein and CYP 3A4. Two patients reported opioid withdrawal-like symptoms.1641 

     +     22) St. John's wort 900 mg daily for 2 weeks in 10 healthy subjects reduced the maximum concentration of a single dose of imatinib mesylate by29%, its half-life by 21%, and its bioavailability by 32% (PO in human study). Coadministration may compromise the drug's clinical efficacy which is both dose and concentration dependent.1668 Twelve healthy subjects taking 900 mg/day for two weeks of extract LI160 increased clearance of a single dose of imatinib by 43% compared to baseline, while its metabolite was increased significantly. Half-life and maximum concentration were significantly decreased and bioavailability reduced by 30% (PO in human study). Imatinib is metabolized by CYP3A4, and metabolite N-desmethyl-imatinib is active in vitro.1692

     +     23) 900 mg of extract with 0.3% hypericins and at least 4% hyperforin given daily to 12 men for 14 days reduced the peak plasma concentration and bioavailability of a single dose of omeprazole by 38% (PO in human study). Induction of isozymes increased both CYP 2C19 metabolite 5-hydroxyomeprazole and CYP 3A4 metabolite omeprazole sulfone.1674

     +     24) 900 mg of extract with 3-6% hyperforin given daily for 14 days to 8 males reduced the biavailability of the R- and S-enantimers of verapamil by 51% and 63%, respectively, due to first-pass CYP 3A4 metabolism, most likely in the gut (PO in human study).1675

     +     25) In 22 healthy subjects 900 mg/day for 18 days reduced nifedipine peak concentration by 53% 0.5 hour after a single dose (PO in human study).1728 When 10 healthy subjects were given a St. John’s wort preparation standardized to 0.3% hypericin and 5% hyperforin at a dose of 900 mg/day for 14 days, followed by a single dose of the calcium channel blocker drug nifedipine, the drug’s maximum plasma concentration and bioavailability were significantly reduced (PO in human study). Consequently, the maximum plasma concentration and bioavailability of the metabolite dehydronifedipine were significantly increased.2623

     +     26) When 900 mg LI 160 daily was given 16 men and the CYP 3A4 and 2C19 substrate voriconazole was taken after 1 day, bioavailability was increased 22% in the first 10 hours, but after giving the extract LI 160 for 15 days, the voriconazole 10-hour bioavailability was reduced 43% (PO in human study).1839 Initial inhibition of metabolism followed by induction could be due to the influence of different active components (speculative);2621 its components quercetin,1854 I3,II8-biapigenin, hyperforin,1522 and hypericin840,1522,1854 all inhibited CYP 3A4 in vitro, while CYP 3A4 induction occurs primarily through hyperforin activation of pregnane X receptor (in vitro). 1002,1288,1703

     +     27) The administration of 900 mg/day of the extract for 12 days to 9 subjects caused a significant decrease in peak serum concentration and bioavailability of orally-administered talinolol due to induction of P-glycoprotein (PO in human study).1972

     +     28) A 58-year-old woman who had taken 300 mg of a St. John’s wort preparation once daily for several years began taking bupropion for 4 days when she developed oro-facial dystonia on the right side of her face (PO in human case report). These episodic spasms occurred every 3-4 minutes and lasted about 45 seconds, during which her eyes would roll back and she could not communicate. Between attacks she was normal. She was treated with parenteral chlorpheniramine, procyclidine and diazepam which lengthened the spasm-free intervals but otherwise had no effect. She was released after 1 week and later given solium valproate with little effect; carbamazepine later produced some response. The dystonia became less frequent over 5 months and completely resolved, so all medications were gradually withdrawn with no dystonia recurrence. It was recommended not to combine St. John’s wort and bupropion use.2280

     +     29) In a 49-year-old man with recurrent depression and secondary sexual dysfunction from sertraline treatment that recurred when St. John’s wort was used in its stead, sildenafil was found to alleviate the impotency (PO in human case report).2084

     +     30) St. John’s wort extract LI 160 given at 900 mg daily for 14 days increased demethylation of erythromycin 1.44-fold, indicating an induction of CYP 3A4 (PO in human study).1350

     +     31) Use for 2 months of tablets containing an extract derived from 2 grams dry herb, standardized to 1 mg hypericin and combined with 250 mg typrosine and 25 mg magnesium, by a 27-year-old woman taking buspirone for 4 months resulted in nervous and hyperactive symptoms associated with serotonin syndrome (PO in human case report). After tapering off the St. John’s wort product, these symptoms disappeared within a week.2627 In a 42-year-old woman receiving 20 mg b.i.d. fluoxetine with 20 mg b.i.d. buspirone for major depression, hypomania characterized by anxiety, insomnia, and panic developed when she began taking  uncharacterized St. John’s wort extract, Ginkgo biloba extract, and melatonin for several weeks (PO in human case report). After discontinuation of the nonprescription items, the anxiety diminished and behavior improved over the next several months.2628

     +     32) In 5 HIV-1 patients taking the non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine and 2 nucleoside analogue reverse transcriptase inhibitors for over a year, St. John’s wort was also used for several months and was associated with a significant 35% increase in oral clearance (PO in case series). Since this could result in antiretroviral resistance and possibly treatment failure, it is recommended that concurrent use of of St. John’s wort and nevirapine be avoided.2629

     +     33) After 12 healthy subjects were given a single dose of ivabradine followed by 300 mg t.i.d. of a commercial St. John’s wort extract for 14 days, the subsequent metabolism of another dose of ivabradine and its main active metabolite after the 2 weeks was increased as indicated by significantly less bioavailability and lower maximum plasma concentration of the drug and its active metabolite than at baseline (PO in human study).2630

     +     34) The ingestion of a single 80 mg dose of gliclazide before and after 15 days of 300 mg t.i.d. LI 160 extract resulted in significantly lower bioavailability if all but 4 of 21 subjects, independent of their CYP2C9 genotypes (PO in human study). The gliclazide clearance was increased and its half-life decreased following 2-week use of the extract, but insulin and glucose levels were unaffected when 75 grams of glucose was given a half hour after the oral hypoglycemic drug.2624

However, though gliclazide is metabolized by CYP 2C9,2624 no effects on the metabolism of the oral hypoglycemic tolbutamide by CYP 2C9 were found with long-term oral use of 900 mg standardized extract of St. John’s wort daily (PO in human study).1217 Likewise, no changes in metabolism of the CYP 2C9 substrates S(+)- or R(-)-ibuprofen stereoisomers were found after 21 days use of 0.03% hypericin-standardized St. John’s wort extract at 900 mgs daily in 8 males (PO in human study).2079 

A single dose of the oral hypoglycemic drug and CYP 2C8 substrate rosiglitazone was found in 27 subjects to have significantly reduced bioavailability and increased clearance after daily use of 900 mg of an uncharacterized St. John’s wort product, independent of the CYP 2C8 genotype (PO in human study).2635

     +     35) After two weeks of giving the tricyclic antidepressant drug amitriptyline to 12 patients with depression, combining it with 900 mg/day of extract LI160 for two weeks led to a significant decrease in bioavailability, peak and trough plasma concentrations, and urinary excretion of amitriptyline and most of its metabolites (PO in human clinical study). The effect seems to be largely due to induction of P-glycoprotein, though CYP 3A4 and 2C19 may be involved. Amitriptyline did not significantly affect the metabolism of the hypericins or hyperforin, nor did individual cytochrome P450 genotypes affect theses outcomes at the end of the four weeks.1614

     +     36) A 59-year-old man whose elevated total cholesterol and LDL-cholesterol were being contolled by rosuvastatin took 300 mg St. John’s wort b.i.d. for 4 months; the lipid levels were re-elevated on a routine test (PO in human case report). After refraining for 4 months from the herbal product that also contained 80 mg rosemary (Rosmarinus officinalis) and 40 mg spirulina, his blood lipids had returned to prior treatment levels.2631

However, rosuvastatin is not a substrate for CYP 3A4 or P-gp, and only 10% is metabolized hepatically by CYPs 2C9 and 2C19 that are also induced by St. John’s wort.2631 Other factors may have contributed to this case, since rosuvastatin bioavailability can be reduced by a several drugs including aluminum and magnesium antacids or erythromycin, according to its pharmacokinetic profile.

     +     37) Of 20 women undergoing breast cancer treatment assessment with a photodiagnostic utilizing d-aminolevulinic acid [ALA] to induce protoporphyrin IX, 19 did not suffer photoxic reactions but the 1 using a St. John’s wort extract had a burning rash and severe swelling on the face, neck and hands (PO in case report). Only light-exposed body parts were affected, and she was not previously photosensitive or allergic. After 3 days of corticosteroid treatment, her skin peeled and recovery was complete. On testing the ALA with and without the St. John’s wort preparation on human keratinocyte cells, a synergistic effect of light sensitization was demonstrated with the 2 photosensitizing agents (in vitro).2633

II.         1) Extract enhanced sleeping time from alcohol and antagonized the effects of reserpine (PO in mice),51 though a secondary source reports that, in terms of cognitive abilities, no interaction was observed with alcohol and St. John’s wort in a human trial.1890

A St. John’s wort 0.3% hypericin extract in doses that did not affect general behavior or food intake reduced the amount of ethanol intake in alcohol-preferring rats offered 10% ethanol for 2-10 hours. The extract did not alter the absorption or metabolism of ethanol (PO in rats).1479 St. John’s wort extracts, especially those with high hyperforin content, reduce voluntary alcohol intake when used in chronic treatments (PO in rats)1470 A comparitive study of a St. John’s wort methanolic extract with 0.3% hypericin and 3.8% hyperforin with a carbon dioxide extract with neglible hypericin and 24.3% hyperforin found the higher hyperforin extract reduced the ethanol intake over a 2-hour exposure period about 8 times more. At higher doses of hyperforin the blood-alcohol level was also reduced. The neurochemical mechanism for reducing alcohol appears to be different than the antidepressant effect (PO in rats).1480 Tests using the extract with 3.8% hyperforin found antidepressant-type activity involved alpha-receptors and some serotonergic neurotransmission, but blocking these effects did not alter the reduction in ethanol consumption (PO in rats).1481 Giving GABAA,B receptor blockers likewise did not alter ethanol-intake reduction when using the extract with 24.3% hyperforin, indicating that St. John’s wort GABA agonist effects are not responsible for reducing ethanol cravings in alcohol-preferring rats (PO in rats).1482

      +    2) Ethanol extract prolonged the time it took for sleep to be induced by pentobarbital and also reduced muscle relaxant effect of diazepam (IP in mice).1338

      +    3) Combining hypericin with the chemotherapy drug temozolomide enhanced the antiglioma effects (in mice). In human glioblastoma multiforme cell line the apoptosis-stimulation and growth-inhibition induced by temozolomide was greatly increased by hypericin (in vitro).2657

III.       1) Due to concern over potentially-enhanced metabolism of drug substrates of CYP3A4 by St. John’s wort, it should not be used concomitantly with other crucial drugs that have a potential for interaction due to metabolism by these pathways (speculative).1330

            The component hyperforin acts as a potent ligand for activating the steroid X receptor or pregnane X receptor (in vitro) that in turn regulates expression of CYP3A4.1288,2127

     +     6) Drugs that have a potential for reduction due to increased metabolism by pathways induced by St. John’s wort include anti-cancer drugs such as etoposide (speculative).1003,1330 Induction of P-glycoprotein is associated with resistance to anthracyclines, vincristine, vinblastine, epipodophyllotoxins, taxanes, and they may be reduced by hypericin (speculative).1498 In addition, hypericin has been shown to antagonize the inhibitory activity of etoposide and amsacrine against topoisomerase II (in vitro)1348 and likewise may inhibit dactinomycin activity (speculative).1498

     +     7) At clinically relevant, low concentrations both St. John’s wort and hypericin caused significant induction of P-glycoprotein in intestinal cells and reduced absorption of rhodamine 123 (in vitro).1366

8) Inducement of exogenous steroid metabolism (speculative) was suggested by enhanced 6-beta-hydroxycortisol urinary excretory rate relative to cortisol excretion in 48 volunteers given 1800 mg daily for 2 weeks (PO in human study).1595 Hyperforin is the extract component that acts as a potent ligand for activating the steroid X receptor or pregnane X receptor (in vitro) that in turn regulates expression of CYP3A4.1002,1288,2127

            However, after giving 900 mg daily for 4 weeks of an extract standardized to 0.3% hypericin and a “minimum” of 4% hyperforin to 8 male adults, the pharmacokinetics of a single dose of prednisone and its metabolite prednisolone were not altered compared to baseline values (PO in human study).2216

 

STEVIA                                                                                 NEW

     ^     Stevia rebaudiana leaves

Drug Interactions

II.         1) Stevioside reduced insulin resistance in noninsulin-dependent diabetic animals and increased the blood sugar-lowering effects of tolbutamide (PO in rats). The component stevioside lowers blood glucose levels in diabetic rats when given twice daily, reduces the rise in glucose in normal rats during a glucose tolerance test, and slows gluconeogenesis (PO in rats).1783

 

STINGING NETTLE                                                          p. 184

            Urtica dioica leaf

Contraindications

     +     4) Brittle diabetes (speculative)893,2250 due to the hypoglycemic effect shown in animals (PO in rabbits)89,319

            An increased insulin secretion has been shown with an active fraction of the leaf decoction (in vitro, IP in rats).2251

However, both the herb decoction and its 80% ethanolic extract increased blood sugar levels when given at doses equivalent to 25 grams of dry herb per kg body weight 2 hours prior to a 5 mg/kg dextrose feeding (PO in mice).2252

Drug Interactions

II. +      1) Pretreatment with 50-200 mg/kg of a freeze-dried water extract of nettle reduced ulcer formation by 61-72% when 70% ethanol was given orally (PO in rats).2071

 

SWEET ANNIE                                                                   NEW

     ^      Artemisia annua plant

(Chinese wormwood, annual wormwood; Ch.: qing hao)

Contraindications

            1) Pregnancy (speculative)150,404 due to potential teratogenicity of the component artemisinin (speculative)404

Drug Interactions

I.          1) Artimisinin given at 250 mg/day to 14 subjects for for 9 days and 500 mg on day 10 induced N-demethylation of mephenytoin probably by CYPs 2B6 and 2C19 (PO in human study).1512 Artimisinin also induced its own metabolism, likely by the same mechanism.1512

            2) Artimisinin given at 500 mg/day to 9 subjects for for 7 days increased the metabolism and reduced the bioavailability of omeprazole by inducing CYP 2C19 (PO in human study).1931

 

SWEET CLOVER                                                               p. 185

            *Melilotus officinalis plant

Drug Interactions

I.          1) With woodruff and tonka beans providing additional coumarin, added to bromelain, induced a hemorrhagic diathesis (human case report) probably from conversion of coumarin  by mold (speculative).31

Coumarin alone does not influence coagulation, clotting factors, or fibrinolysis (PO in human study).1738

 

SZECHUAN LOVAGE                                                       NEW

     ^     Ligusticum chuanxiong = Ligusticum wallichii rhizome

            (Ch.: chuan xiong)

Contraindications

            1) Pregnancy (empirical)150

 

SZECHUAN PEPPER                                                         NEW

     ^     Zanthoxylum simulans, Zanthoxylum bungeanum, Zanthoxylum schinifolium fruit rind

            (Ch.: chuan jiao)

Contraindications

            1) Pregnancy (empirical)150

 

TEA                                                                                        p. 186

Camellia sinensis leaves

Contraindications

            2) Duodenal ulcers (speculative) possibly due to increased gastric acid secretion after large doses of caffeine,8

though a water extract of black tea at 2 gm/kg body weight did not significantly increase total gastric acid but reduced acid, ulcer incidence, and ulcer number induced by aspirin, inodmethacin, ethanol, reserpine, and cold restraint stress (PO in rats)492 

            3) Heart disorders (speculative) due to caffeine increasing heart rate or exacerbating arrhythmias (empirical).8

Caffeine at a dose of 250 mg acutely increased aortic stiffness in 20 healthy subjects, leading to increased blood pressure centrally and to a lesser extent peripherally (PO in human study). These effects may impact cardiovascular risk (speculative).1569 However, a study of 155,594 women over 12 years found no linear association with caffeine consumption and hypertension (PO in human study).1859

5) Prolonged use of fermented black tea (speculative)150 due partly to calcium and magnesium loss with potential for osteoporosis (SC in rats, PO in human studies)150,753, 774,780

Guarana extract with 150 mg of caffeine plus black tea extract yielding 120 mg raised systolic blood pressure and resting metabolic rate 2 hours after a single dose in 16 healthy male subjects (PO in human study).1973

However, an epidemiological survey of 497 men and 540 women over age 30 found 502 were habitual tea drinkers (91% consuming oolong or green tea) for 10 years on average. Compared with the non-habitual tea drinkers, those whose habitual use was from 6-10 years had higher lumbar spine bone mineral density, and habitual tea consumers over 10 years had the highest bone mineral density in all measured regions (PO in human study).1469

            6) Pregnancy (speculative) since caffeine has been associated with fetal loss, low birth weight and premature deliveries.8

In an evaluation of 2,291 mothers caffeine consumption was found to reduce average birth weight. This was considered significant for those who consumed more than 600 mg of caffeine daily (PO in human study).1568 However, a study of 2,714 women who delivered live infants in which tea was consumed in the first month by 25% of the women found that > 300 mg caffeine daily from all sources was not associated with growth retardation (PO in human study).1966

However, a prospective study of 873 women found no association between caffeine consumption at any amount and birth weight, gestational age at delivery, or birth weight standardized for gestational age (PO in human study).1672

     +     9) A concentrated aqueous-ethanolic extract of green tea associated with at least 13 cases of hepatitis in 12 women and 1 man from France and Spain leading to increases in liver enzymes and total and direct bilirubin, after taking it from 9 days to 5 months (PO in human case reports).1508,1579,1580,2328,2577 Causality was determined on the Naranjo scale as possible in 11 cases and probable in 2 cases.2577 Viral serologies tested negative in 8 cases, while one positive rechallenge and 8 positive dechallenges occurred (PO in human case reports). Resolution occurred after discontinuance in 12 cases; 1 requiring liver transplantation was complicated by concurrent alcohol and drug use.1508,1951,2577 This 48-year-old woman who drank 30 gm of alcohol daily for 10 years took 4 capsules per day of an a hydroalcoholic extract of green tea leaves for 6 weeks before developing stomach pain, fatigue, and then jaundice, dark urine and pale stools (PO in human case report). She stopped taking the extract and other medication but took 1 gm of acetaminophen on the day the jaundice began. Two weeks later she was admitted to the hospital for liver insufficiency. After a biopsy showed necrosis and fatty liver and fibrosis, she was given a liver transplant. The causative factors were likely additive.1951 In a clinical study on obesity of this tea extract AR25, an ethanolic dry extract standardized to 25% catechins, one person in 70 subjects had an increase of liver enzymes after using four capsules containing a total of 375 mg catechins daily for three months (PO in human clinical study).1345

Different products with concentrated green tea extracts, some combined with other ingredients have also been associated with hepatotoxicity, including at least 4 cases involving an aqueous extract.2577 A 37-year-old woman with acute liver toxicity for 10 days with jaundice and nausea had used a weight lost supplement for 4 months containing green tea extract, magnolia extract, epimedium extract, b-sitosterol, calcium, chromium, and vanadium (PO in case report). She had greatly elevated liver enzymes but recovered when the product was withdrawn, but it recurred when it was re-introduced, and she recovered again after a second withdrawal period.2328 Two men 27 and 30 years of age developed jaundice, fatigue and elevated liver enzymes after 5 days or 4 weeks of using 9 tablets daily of a combination weight loss product with green tea extract along with Garcinia cambogia, Gymnema sylvestre leaf extract, willow bark extract, guarana extract, and caffeine, glucomannan, a-lipoic acid, L-carnatine, calcium, chromium, and potassium (PO in human case reports). Both recovered within 1-2 months after withdrawal, but the evidence is not definitive nor a causative ingredient certain.2329

However, dilute liquid infusion of green tea leaves commonly consumed as a beverage are not implicated in liver toxicity cases.2577 Also, a systematic review on green tea, extract, and/or catechin consumption and liver disease revealed that of 10 human trials published, 8 found a significant protective effect against various liver diseases, though 2 only showed a partial tendency (PO in human clinical studies). Four showed a positive attenuation of liver disease, and these all were based on intake of aqueous infusions of green tea.2496

     +     10) Beriberi or any thiamine deficiency, since fermented tea leaves when chewed by 20 volunteers aged 18-40 years caused thiamine deficiency even when 10 mg/day of thiamine was supplemented (PO in human study). When black tea was drunk it also created a thiamine deficiency, but this was counteracted when 10 mg/day of thiamine was supplemented in 20 children aged 15-17 years (PO in human study).2023  When 3-week-old weanlings were given 1:50 w/v black tea to drink and compared with others given water, those receiving the tea had a progressive drop in brain levels of total thiamine after 2 weeks, reaching 60% after 14 weeks (PO in rats). No further decline in brain thiamine was found from 14 to 24 weeks, but activities of ketoglutarate and pyruvate dehydrogenase dropped by 65% during this period.2075

Drug Interactions

I.          1) Reduced absorption of iron (PO in human study).382,434

Nonheme-iron absorption is reduced by 70% with consumption of only 20 mg of tea polyphenols available in a dilution of black tea to 5%, while the addition of milk had little effect on tea inhibiting iron absorption (PO in human study).1246 Iron absorption is only affected by tea when they are consumed together, probably due to the formation of iron complexes with tannins in the gut (PO in rats).1145 The green tea catechin epigallocatechin gallate in a doses of 150 mg and 300 mg taken concurrently with iron reduced its absorption by !4% and 27%, respectively (PO in human study). Though the effect of the higher dose was significant, it was substantially less than the reduced iron absorption associated with concurrent consumption of black tea.1749 

Nonheme iron absorption was also reduced by 28% in 10 women after consumption of green tea extract (PO in human study). This was likely due to the phenolic components containing epicatechin and galloyl moieties, whose total content in the extract given with test meals was 37.3 mg.1993

3) Increased weight loss occurs due to a reduction of body fat, along with side effects of agitation, tremors, and insomnia, when caffeine is combined with ephedrine (PO in human clinical study).19

When 25 mg ephedrine was taken with 200 mg caffeine, systolic blood pressure, heart rate, and glucose, insulin and lactate concentrations were all raised (PO in human study). Taken alone, ephedrine increased heart rate, glucose, and insulin, and caffeine increase systolic blood pressure. No pharmacokinetic interaction was found. Oral contraceptives prolonged caffeine elimination.1665

An 80% ethanolic dry extract of green tea AR25 standardized to 25% catechins inhibited lipases and stimulated thermogenesis (in vitro). After 3 months of using AR25 with 375 mg catechines (270 mg EGCG) daily, body weight and waist circumference decreased about 4.5% in obese patients in open trial. One of the 70 patients had increased transaminases, a possible indication of liver insult (PO in human clinical study).1345 

However, this ethanolic green tea extract has been associated with cases of liver disorders in France and Spain after taking it from 9 days to 5 months. One positive rechallenge and 8 positive dechallenges occurred (PO in human case reports).1508,1579,1580

     +     15) Methotrexate efficacy for reducing the joint pain and morning stiffness of rheumatoid arthritis was diminished for those consuming 260 mg of caffeine daily on average, compared to those who consumed an average of only 90 mg daily (PO in human clinical study), probably due to methylxanthines like caffeine acting as adenosine receptor antagonists while methotrexate increases adenosine.1495

However, 80% ethanolic extract of green tea with 5-10% caffeine inhibited multidrug resistance-associated protein 2 (MRP2) removal of methotrexate from kidney cells (in vitro). MRP2 function was not affected by caffeine alone.1776

     +     16) Fermented tea leaves when chewed by 20 volunteers aged 18-40 years caused thiamine deficiency even when 10 mg/day of thiamine was supplemented (PO in human study). When black tea was drunk it also created a thiamine deficiency, but this was counteracted when 10 mg/day of thiamine was supplemented in 20 children aged 15-17 years (PO in human study).2023 

Also, when 3-week-old weanlings were given 1:50 w/v black tea to drink and compared with others given water, those receiving the tea had a progressive drop in brain levels of total thiamine after 2 weeks, reaching 60% after 14 weeks (PO in rats). No further decline in brain thiamine was found from 14 to 24 weeks, but activities of ketoglutarate and pyruvate dehydrogenase dropped by 65% during this period.2075

     +     17) A study over 13.6 years of 26,556 Finnish men with no history of strokes who smoked 5 or more tobacco cigarettes daily showed the consumption of 2 or more cups of tea daily significantly reduced the risk of strokes by cerebral infarction (PO in human study).2300

II.         2) In another study theanine also enhanced the inhibition by doxorubicin of hepatic metastasis of ovarian sarcoma (IP in mice). The doxorubicin concentration was increased 1.4-fold in ovarian sarcoma cells because theanine inhibited its efflux (in vitro).1245

In addition to the effect of theanine, doxorubicin concentration in Ehrlich ascites carcinoma cells was also significantly enhanced by the green tea components epigallocatechin gallate, cyaniding, dephinidin, and caffeine (in vitro). The inhibitory ratio in P388 leukemia cells was significantly increased along with a reduction in tumor weight when theanine at 10 mg/kg/day was combined with doxorubicin (IP in mice).1604 Theanine at 10 mg/kg/day for 4 days likewise induced the antitumor activity of idarubicin against P388 even at subtherapeutic doses (IP in mice) by doubling its concentration in tumor cells (in vitro), while reducing idarubicin toxicity to leukocytes and bone marrow cells (IP in mice).1605 In addition theanine inhibited pirarubicin efflux from M5076 ovarian sarcoma cells while increasing its concentration by 1.3-fold in the tumor and improved the therapeutic efficacy as determined by tumor weight (IP in mice).1606

     +     4) Green tea extract increased apoptosis in estrogen-receptor(ER)-positive breast tumor tissue when combined with tamoxifen compared to tamoxifen alone; the combinations also decreased MCF-7 graft tumor size and suppressed angiogenesis more than either agent alone (PO in mice). The extract decreased the ER-alpha levels in tumors (in vitro, PO in mice) and increased inhibitory effect of  tamoxifen on proliferation of the ER-positive human breast cancer cell lines ZR75 and T47D, while blocking ER-dependent transcripton (in vitro).2039 

The induction of apoptosis of human lung cancer cells by epigallocatechin gallate [EGCG] was synergistically enhanced by tamoxifen, as well as epicatechin from green tea (in vitro). Epicatechin also increased the apoptotic effects of epigallocatechin and epicatechin gallate, indicating that it is more beneficial to consume all of the catechins in green tea than to use one like EGCG in isolation (speculative).2133 

     +     5) The green tea constituent EGCG [epigallocatechin gallate] was shown to neutralize the antitumor effects of bortezomib against multiple myeloma (in vivo). In addition, green tea extract and several of its polyphenolic components, especially EGCG, blocked the cytotoxic effect of this proteasome inhibitor in multiple myeloma and glioblastoma cells (in vitro). The chemical antagonism of EGCG was also demonstrated against other boronic acid-based proteasome inhibitors including MG-262 and PS-IX (in vitro), but not MG-132, PS-I, or nelfinavir (in vitro) which lack the boronic acid moiety.2485 

                        However, the systemic concentration required to inhibit bortezomib activity can only be achieve by ingesting concentrated EGCG in a fasting state (PO in humans), not by drinking brewed green tea (speculative).2690 In addition, another study showed EGCG and bortezomib are synergistic for inhibiting cell proliferation and inducing apoptosis in the multiple myeloma cell line KM3 (in vitro).2691

III.  +   3) Freeze-dried water extract of Japanese sencha green tea was found to reverse resistance to methicillin of a resistant strain of Staphylococcus aureus and reduce resistance to benzylpenicillin of S. aureua that produce b-lactamase (in vitro). No synergy was found with the extract and penicillin-resistant gonococci, pneumococci, or Hemophilus influenza.1439 Green tea extract reduced the minimum inhibitory concentration of all b-lactam antibiotics (benzylpenicillin, oxacillin, ampicillin, cefmetazole, imipenem), but not other types of antibiotics, that were tested against four methicillin-resistant strains of S. aureus, but not a methicillin-sensitive strain (in vitro). Catechins found in green tea including epigallocatechin, epigallocatechin gallate, and especially epicatechin gallate reduced the minimum inhibitory concentration for oxacillin in these four strains (in vitro).1531

      +    4) Alkaline aqueous extracts of black and green tea were shown to potentiate insulin activity in glucose metabolism (in vitro).1464 Tea was also effective in lowering blood sugar in normal, streptozotocin- and alloxan-diabetic animals (PO in animal studies).319

      +    5) Green tea polyphenolic fraction inhibited P-glycoprotein leading to increase retention of rhodamine-123 in ovary cells, while the isolated phenolic component epigallocatechin gallate produced this effect with vinblastine in intestinal cells (in vitro)1561

     +     6) Induction of apoptosis of human lung cancer cells by epigallocatechin gallate [EGCG] was synergistically enhanced by sulindac, as well as epicatechin from green tea (in vitro). Epicatechin also increased the apoptotic effects of epigallocatechin and epicatechin gallate, indicating that it is more beneficial to consume all of the catechins in green tea than to use one like EGCG in isolation (speculative).2133 

 

TEA TREE                                                                           NEW

     ^     Melaleuca alternifolia leaf oil

Contraindications

            1) Allergic hypersensitivity to tea tree oil or its components including limonene, alpha-terpinene, aromadendrene, terpinene-4-ol, and/or eucalyptol as shown with external application (human study, human case report),672,673,1424 with internal use (PO in human case report),673 or by inhalation (human case report)1425

Drug Interactions

I.          1) Component 1,8-cineole (eucalyptol) induces hepatic microsomal mixed-function oxidase enzyme induction (in rats), resulting in increased clearance of aminopyrine with aerosol inhalation of eucalyptol 10 min. daily for 10 days (human study).28

II.         1) Pentobarbital, zoxazolamine, and amphetamine given 24 hours after an aerosol exposure to 1,8-cineole for 2-10 min/day for 4 days were effective for a reduced length of time (in rats).28

 

THUJA                                                                                  p. 190

            Thuja occindentalis leaves

            (American arborvitae, eastern white cedar, northern white cedar; Am. Ind.: hackmatack; Czech.: zerav zapadni; Dan.: livsta; Fr.: thuya d’occident; Ger.: amerikanischer lebensbaum, heckenthuja, lebensbaumItal.: thuia; Russ.: tuja; Swed.: livstrad)

Contraindications

     +     4) Nursing mothers (speculative), due to the potential toxicity of its essential oil (empirical)1890

 

THUNDER GOD VINE                                                      NEW

     ^     *Tripterygium wilfordii peeled root

            (Ch.: lu fan teng, chi hsueh teng, koikema, lei gong teng, lei ling ting, lei kung teng, mang cao)

Contraindications

            1) Pregnancy due to severe brain anomalies after use by mother in early pregnancy (empirical)1416

Drug Interactions

            1) A standardized ethyl acetate extract of the peeled roots was given at increasing does to 10 rheumatoid arthritis patients who were using NSAIDs; 8 were also taking prednisone at stable doses. Six of the 10 had improvement at 180 mg, and 8 of 9 had improved clinical and laboratory findings at doses over 360 mg. Adverse effects included 8 cases of dyspepsia, 2 with nausea, and 2 with diarrhea, 6 other GI complaints, plus diastolic hypertension (PO in human clinical study).1417 A PCDB study with 35 rheumatoid arthritis patients used standardized ethanol ethyl acetate extract in doses of 180 or 360 mg/day for 20 weeks. Thirty of the subjects were using stable doses of NSAIDs, and 21 were taking prednisone. After 4 weeks 0% on placebo, 40% on the low dose, and 80% on the high dose met the criteria for clinical response. Adverse effects were minor and occurred in 4 on placebo and in 11 using extracts, with diarrhea in 7 and nausea in 3 the most common extract problems (PO in human clinical study).1418  In a third study with 121 rheumatoid arthritis patients, 60 were randomized to receive 180 mg daily of the extract while 61 were given sulfasalazine; 17 of each were on stable doses of prednisone, and others were using stable NSAID doses (PO in human clinical study). Although only about half finished the trial after 24 weeks, subjects receiving extracts had a significantly better response than for sulfasalazine based on American College of Rheumatology criteria, as well as significantly greater IL-6 decreases and similar adverse event profiles.2606 Glycosides from the extract inhibit PGE2 production by synovial cells and COX-2 mRNA expression, similar to dexamethasone, but did not act as glucocorticoid agonists or directly inhibit COX-2 like NSAIDs (in vitro).1419

 

THYME                                                                                 p. 191

            *Thymus spp. leaves

Contraindications

      +    2) Allergic hypersensitivity following thyme or other mint family (Lamiaceae), due to the risk of anaphylaxis (empirical)1890

Drug Interactions

II.  +     1) Cardiotoxicity from doxorubicin, a widely used antitumor agent, was reduced by luteolin (PO in mice),1282  a component of thyme also responsible for the antimutagenic effect of water extracts of this fresh herb and also fresh sage and peppermint (in vitro)1283

III. +    1) The essential oil from plants of thymol chemotype enhanced the antifungal activity of amphotericin B against Candida albicans (in vitro).2365 

 

TOBACCO                                                                            p. 191

            *Nicotiana tabacum leaves

Drug Interactions

(The following are based on smoking tobacco. Smokers may require a higher initial therapeutic dose of drugs that are CYP 1A2 substrates; likewise, a 10% daily dosage reduction of these drugs is recommended until the fourth day after abrupt cessation of smoking, such as in hospitalized patients. This is independent of nicotine replacement.2211)

I.          2) Smoking speeds the elimination of alprazolam up to 50%,2211 and caffeine2008 that has an increased 56% clearance (in human studies).2211

            Smoking lowers blood levels of tricyclic antidepressants such as antipyrine (in human studies)81,345,2008 but the clinical importance has not been established.2211

3) Bioavailability of chlorpromazine is reduced by 36%, while its serum concentration decreases 25% (in human study), possibly resulting in diminished sedation (speculative).2211 Also, tacrine serum concentrations are three-fold lower, and its half-life is reduced by half, while haloperidol clearance increasing by 44% and serum concentrations decrease 70%  (in human studies).2211

4) Insulin effect is reduced345 probably due to the vasocontrictive of nicotine (speculative).2211

            However, inhaled insulin has greatly increased systemic exposure in smokers, with greater maximum concentrations of 3-5 fold and bioavailability 2-3 fold greater (in human studies).2211

Also, the high blood pressure medication propranolol, a beta-blocker with an increased clearance of 77%, is less effective (in human clinical studies), probably due to the vasocontrictive and/or stimulant effects of nicotine (speculative).2211

6) Smoking increases the risk of clots, strokes and heart attack in women over age 30 who use oral contraceptives (human clinical studies).81,345

Use in women over 35 years of age on hormonal contraceptives of any type is contraindicated due to increased risk of serious cardiovascular adverse effects (human studies).2211

7) For heparin, besides an pharmacokinetic increase in clearance and decrease in half-life, there is pharmacodynamic antagonism since smoking has prothrombotic effects (IH in human studies). Therefore, an increased dosage is usually desirable (speculative).2211

8) The asthma drug theophylline has an increased clearance of 58%-100% and a decreased half-life of 36% (human clinical studies).2211

      +    10) Analgesic effect of opioid drugs propoxyphene and pentazocine are reduced, due at least in part to their increased metabolism by 15-20% and 40%, respectively (IH in human studies).2211

      +    11) Metabolism of verapamil occurs more rapidly leading to lower serum levels and maximum concentration (PO in human clinical study).1304

      +    12) Smoking increases the CYP 1A2 metabolism of the selective serotonin reuptake inhibitor (SSRI) fluvoxamine with a 24% increased clearance, plasma concentrations decreased by 32%, and bioavailability 31% less (IH in human study).2211

      +    13) Psychotropic olanzapine drug metabolism by CYP 1A2 is increased by smoking, with a 98% increased clearance and serum concentrations decreased by 12% (IH in human study).2211

      +    14) Smoking decreases the half-life of the antiarrhythmic drug mexiletine by 36% and increase its clearance by 25% due to enhanced oxidation and glucuronidation (IH in human studies). Another antiarrhythmic medicine, flecainide, has 61% increased clearance and 25% decreased trough serum concentration that may require an increase in dosage for smokers (IH in human study).2211

     +     15) CYP 1A2 metabolism induced by smoking decreases clozapine plasma concentrations by 18% (in human study).2211

     +     16) A study over 13.6 years of 26,556 Finnish men with no history of strokes who smoked 5 or more tobacco cigarettes daily showed the consumption of 8 or more cups of coffee or 2 or more cups of tea daily significantly reduced the risk of strokes by cerebral infarction (PO in human study).2300

     +     17) Tobacco smokers taking the antiplatelet prodrug clopidogrel had lower platelet aggregation and glycoprotein IIb/IIIa expression than nonsmokers using the prodrug (IH in human clinical study). Since clopidogrel is metabolized by CYP 1A2 to it activate form, induction of this isozyme by tobacco smoke increases the drug effect.2306

     +     18) Nicotine is more slowly metabolized when consumed with menthol in mentholated tobacco smoke (IH in human study).2309 Reservoir formation for the carcinogenic benzo[a]pyrene and NNK found in tobacco smoke is increased in mucosal (esophageal) cells by menthol (in vitro),2310 possibly helping to explain the elevated esophageal squamous cell carcinoma and lung cancer rates in African Americans, since a greater percentage of cigarette smokers in this ethnic group use mentholated cigarettes (75%) than in white smokers (10-15%).2309,2310

            Also, in a smoking cessation study with 265 African Americans receiving bupropion, 60.3% non-menthol cigarette smokers were abstinent after 6 weeks compared with only a 36.2% abstinence rate for mentholated cigarette smokers (PO in human clinical study).2311

III. +    1) Inhaled corticosteroids may have reduced efficacy in asthma patients who smoke tobacco (speculative).2211

 

TRITICUM [formerly COUCH GRASS]                          p. 77

Ä         Elymus repens = Agropyron repens roots, rhizomes and short stems

 

TURKEY TAIL                                                                   p. 193

            Trametes versicolor = Coriolus versicolor mycelia extracts

Contraindications

            1) Autoimmune diseases or bone marrow transplant due to immune enhancing effects (speculative)1375

Drug Interactions

I.   +     6) 137 randomized patients who received 3 grams/day of PSK along with tegafur/uracil for 2 years or until tumor recurrence, beginning two weeks following surgery and bolus doses of mitomycin C for Stage II and II colorectal cancer, had decreased recurrence, especially lung metastases, as well as reduced mortality and increased 5-year disease-free survival (PO in human clinical studies).2537 They also had reduced immunosuppressive acidic protein [IAP] and increased natural killer [NK] cells for the first year, compared to 68 tegafur/uracil chemotherapy-only controls (PO in human clinical studies). Among those receiving PSK with IAP values < 500 mcg/ml the 5-year disease-free rate was significantly better than for controls, as it was for those on PSK with NK cell populations >8% 3 months after surgery. Also, the overall survival rate was significantly better than controls for those receiving PSK with IAP values < 500 mcg/ml.2536

     +     7) Of 520 gastric cancer patients treated with mitomycin C on the day of surgical resection and with futraful for 1 year, PSK at 3 g/day was given to 264 who showed a significant increase in 5-year survival [71.7% for PSK vs. 58.5% for controls] (PO in human clinical study).2538

However, when only futraful was given to 406 patients after gastric cancer surgery for 3 months with two months rest, and PSK was given at 3 g/day to 198 of these during the rest period, there was no significant difference between the groups though those taking PSK tended to show increase 5-year survival [71.3% for PSK vs. 63.6% for controls] (PO in human clinical study).2538

III.       1) Immunosuppressants may be counteracted by turkey tail decoctions or dried extract due to stimulation of various immunocompetent cells (speculative)1375 as has been shown with PSP in animals (PO in rats).1091

 

TURMERIC                                                                                     p. 194

            Curcuma aromatica, Curcuma longa = Curcuma domestica root

Contraindications

            1) Avoid in bile duct obstruction (empirical).4,6,17,150,1890

This is due to curcumin’s cholagogue activity, since a 50% contraction of the gall bladder was produced with a 40 mg dose of curcumin in 12 healthy subjects (PO in human study).2194

            2) Do not use in cases of gallstones unless a physician has first been consulted (speculative).4,17,150,1890

This is because of curcumin’s cholagogue effect, since a 50% contraction of the gall bladder was produced with a 40 mg dose of curcumin in 12 healthy subjects (PO in human study).2194

Drug Interactions

I.          1) Curcumin at a dose of 550 mg twice daily for 1 month and then 3 times daily for another month was used in 5 ulcerative proctitis patients receiving 5-aminosalicylic acid locally with sulfasalazine, prednisone, or azothiopine internally (PO in human clinical study). All 5 improved as 2 eliminated, 2 reduced, and 1 left unchanged their conventional medications. One of those who reduced the drugs completely stopped using prednisone.2195

            2) In a group of 5 with Chrohn’s disease, 4 improved from using 1080 mg  curcumin daily for a month and 1440 mg per day for another month along with 6-methylprednisone in 3 patients or with budesonide in 1 subject (PO in human clinical study). All four of these improved, whereas the patient with no medication aside from curcumin withdrew due to worsening fistula.2195

            3) When 43 ulcerative colitis patients received 1 gram curcumin after both breakfast and supper along with daily sulfasalazine or mesalamine for 6 months, 4.65% relapsed compared with a 20.51% relapse in 39 patients receiving only the drugs (PO in human clinical study). The clinical activity index and endoscopic index determined at entry and every 2 months were improved significantly with concurrent curcumin use.2674

II.  +     2) Curcumin at 25-50 mg/kg both prevented and corrected the reduction of bile flow and biliary bilirubin excretion induced by cyclosporine due to the choleretic effects of curcumin, but failed to alter the reduction of cholesterol by the drug (IV in rats). Only at the highest dose did curcumin temporarily increase cholesterol excretion after 60 or 90 minutes. Curcumin did not significantly affect the biliary excretion of cyclosporine or its metabolites.1119

     +     3) Curcumin at 25 mg/kg following 4 weeks prophylaxis with a melanoma protein immune preparation resulted in a substantial inhibition of melanoma growth that was not reduced by either intervention given separately (IP in mice). The immune response and median survival time were also significantly improved by the combination in comparison to their individual effects.1635

     +     4) Curcumin reduced cardiotoxicity of the antitumor antibiotic drug adriamycin when given at 200 mg/kg doses for 7 days prior and 2 days after a single toxic drug injection (IP in rats). Curcumin prevented ECG abnormalities and rises in creatinine and LDH induced by adriamycin, and it reduced the rise in lipid peroxide and catalase. Glutathione levels and glutathione peroxidase activity were increased by curcumin.2019

     +     5) A human breast cancer model showed curcumin as 2.5% of the diet significantly inhibited tumor regression by cyclophosphamide (PO in mice). This was due to a reduction in generation of reactive oxygen species and activation of the JNK pathway. Breast cancer patients receiving chemotherapy should avoid curcumin supplementation (speculative).2020

III.+     2) Alkaline aqueous extracts of turmeric were shown to potentiate insulin activity in glucose metabolism (in vitro).1462,1464

     +     3) The antitumor apoptosis effects on breast cancer cells MCF-7, MDA-MB-231 and BT-474 by camptothecin, mechlorethamine and doxorubicin, respectively, were inhibited by curcumin by upt to 70% (in vitro). This was due to a reduction in generation of reactive oxygen species and activation of the JNK pathway.2020

However, curcumin further inhibited cell growth and increased apoptotic effects in an additive or sub-additive fashion with doxorubicin on a hepatic cancer cell culture (in vitro). This appeared to be due in part to generation of free radicals, but it was mainly dependent on caspase-9 and -3 activation.2134

     +     4) Curcumin further inhibited cell growth and increased apoptotic effects in a synergistic manner with the antitumor agent cisplatin on a hepatic cancer cell culture, compared to the effects of cisplatin alone (in vitro). This appeared to be due in part to generation of free radicals, but it was mainly dependent on caspase-9 and -3 activation.2134

     +     5) Curcumin was shown to enhance the cytotoxic effect of the chemotherapeutic agent vinorelbine on human squamous cell lung carcinoma H520 cells (in vitro). Curcumin augmented caspase-9 and -3 activation and induced 24% apoptosis, while vinorelbine resulted in 38% apoptosis, but together they induced 61%. By acting as an adjuvant chemothery agent (in vitro), cucurmin could benefit elderly lung cancer patients with poor response or adverse effects from standard doses of vinorelbine (speculative).2135

     +     6) Curcumin at a sub-inhibitory concentration of 500 mcg/disc enhanced the antibacterial activities of cefixime, cephotaxime, tetracycline, and vancomycin against Staphylococcus aureus by 52.6%, 24.9%,24.4%, and 26.5%, respectively (in vitro).2673

       However, when combined with nalidixic acid, this same curcumin concentration antagonized the antibacterial effect against this Staph. aureus strain (in vitro).2673

 

TYLOPHORA                                                                      NEW

^          *Tylophora indica leaves

            (Indian lobelia, Indian ipecac)

Contraindications

            1) Pregnancy, due to potential abortifacient and fetotoxic effects from its potent pharmacological activity (empirical)1890

            2) Nursing mothers (speculative), due to its potential toxicity (empirical),1890 and immunosuppressive effects of its alkaloids on cellular immune responses (in vitro, PO in rats)1994

 

UVA URSI                                                                            p. 195

            Arctostaphylos uva-ursi leaves

Contraindications

1) Pregnancy (empirical)17,24,150,401,777,1890 due to the possibility of fetotoxicity (in animals).1890

2) Prolonged use unless consulting with a physician.6,150 due to its tannin content1890

A woman who consumed uva ursi tea regularly for 3 years developed bull’s-eye maculopathy (PO in human case reports). This was likely due to the inhibition of melanin synthesis, since the uva ursi component arbutin is metabolized to hydroquinone which is known to inhibit the enzyme tyrosine kinase involved in synthesizing melanin.1603

     +     7) GI ulceration (speculative),1890 since its excessive use can lead to stomach distress (empirical)7 due to its tannin content232,1890

     +     8) Iron deficiency anemia and malnutrition (speculative) due to tannin content that binds metal ions and thiamine1890 and reduces iron absorption when taken concurrently (PO in human study)1246

     +     9) Constipation (speculative) due to the high tannin content that produces an astringent effect1890

Drug Interactions

II.         1) 50% methanolic extract (100 mg/kg) and its component arbutin both enhanced the anti-inflammatory effect of subcutaneous prednisolone when administered simulaneously for picryl chloride-induced contact dermatitis due to additive therapeutic effects (PO in mice)399 [CORRECTION: CATEGORY II, NOT III. 2).]

III.   +     2) A 60% methanol extract of uva ursi and its component, corilagin, were shown to increase the effectiveness of the b-lactam antibiotics such as oxacillin and cefmetazole against Staphylococcus aureus strains that are resistant to methacillin (in vitro) Corilagin, a glucose conjugation of ellagic acid and gallic acid, also dramatically increased the efficacy of other b-lactams including imipenem, benzylpenicillin, streptomycin, and tetracycline (in vitro).1340

     +     3) Due to its tannin content, it should not be taken concurrently with oral thiamine, metal ions like iron and zinc, or alkaloids because of probable precipitation in the gut leading to reduced absorption (speculative), as is suggested by studies combining tea with metal ions or thiamine (in humans), tannins with thiamine (in animals), and tannins with alkaloids (in vitro).1890

 

VALERIAN                                                                          p. 196

            *Valeriana officinalis root/rhizome

Contraindications

            1) Nursing mothers without professional advice or for prolonged duration (speculative), due to possible reduction of vigilance (empirical)1890

            2) Children under 3 years of age, especially for prolonged duration (speculative), due to sedative effect on nervous system (empirical)1890

Drug Interactions

I.    +    2) After safely taking 2 tablets of St. John’s wort with 1 tablet of valerian daily for six months for her depression and migraines, a woman was hospitalized with delirium, rapid breathing, rapid heart rate, and mild hypertension following the additional use of loperamide for diarrhea (PO in human case report). The patient recovered in two days after naltrexone was given to counteract the opioid drug. A MAO-inhibitor reaction was theorized, possibly in conjunction with loperamide-induced delirium.1227

     +     3) Prepared as a 5:1 45% methanolic valerian extract in combination with a 6:1 hops extract, 2 and 6 tablets of this mixture reduced or inhibited, respectively, the stimulant effect of a single 200 mg dose of caffeine (PO in human study)1658

     +     4) A solid extract, made using 70% ethanol as a solvent and yielding 1.1% valerenic acids including 0.54% valerenic acid, given at night in 1 gram doses for 14 days to12 healthy subjects increased the maximum concentration of a single dose of the CYP3A4 substrate alprazolam compared to baseline exposure (PO in human study).1676  

However, the time to reach the maximum and the bioavailability were unaffected, and the small though significant change is unlikely to alter clinical responses.1676 Also, 375 mg daily for 28 days of valerian root extract had no effect on CYP3A4 substrate midazolam in another study with 12 men and women.1807 Single valerian extracts have been shown to be moderate to mild CYP3A4 inhibitors (in vitro).840,1593 Inhibition of CYP3A4 can be found with valerian extracts made with either water, 70% ethanol, or acetonitrile and is independent of the relative content of valerenic acids (in vitro).1748

II.         1) Component valerenic acid increases sleep induced by pentobarbital (IP in mice)52  Valeranone has also been shown to prolong barbiturate sleeping time (in animals).1061

            2) dried aqueous extract (2 mg/kg) increases thiopental sleeping time in (PO in mice).123

The valerian component hesperidin increased thiopental-induced sleep in doses of 2-4 mg/kg. The slightly increased thiopental sleep from 2 mg/kg hesperidin and greatly increased with the addition of 1 mg/kg of 6-methylapigenin, another flavonoid component of valerian (IP in rats).1529

     +     3) The monthly intramuscular injection of haloperidol and daily consumption of 1% valerian tincture, correlating to daily doses of 200-250 mg/kg of the root, were given both separately or combined for twelve weeks to groups of 12 animals, as was placebos, while liver and kidneys were monitored (PO in rats). While neither alone affected lipid peroxidation levels or production of marker reactive species, when combined they increased both of these in the liver. Their concurrent use also inhibited liver d-aminolevulinate dehydratase and increased its reactivation index, considered markers of oxidative stress, unlike use of the single agents.2285

     +     4) The aqueous, methanolic, and choloform extracts of the rhizome decreased the naloxone-induced jumping associated with the withdrawal of morphine (IP in mice). This suggests that the rhizome could be useful in palliating the morphine withdrawal syndrome (speculative).2678

 

VETIVER                                                                             NEW

     ^     Vetiveria zizanioides root

            (khus-khus, cuscus)

Contraindications

            1) Pregnancy (empirical)150 due to its abortifacient effects and emmenagogue and uterine stimulant activities (empirical)74,150

 

WILD CHERRY [now BLACK CHERRY]                                   p. 198

            *Prunus serotina bark

 

WATERCRESS                                                                   p. 198

            Nasturtium officinale plant

Drug Interactions

     +     1) A single ingestion of 50 gm of watercress by 10 volunteers increased the bioavailability of the CYP 2E1 substrate chlorzoxazone by increasing the AUC by 56% and its half-life by 53% (PO in human study).1642 

     +     2) A single ingestion of 50 gm of watercress by 10 volunteers in a crossover trial 10 hours before acetaminophen decreased the oxidation of the CYP 2E1 drug substrate by 52% and the total and peak of its oxidized NAPQI toxin metabolite by 28% and 21%, respectively (PO in human study). The 24-hour urinary excretion of the toxin metabolite was also reduced. The combined use of watercress with this drug could lead to a decrease in acetaminophen-associated hepatotoxicity (speculative).2009

 

WHEAT                                                                                 NEW

     ^     Triticum vulgare fermented germ

            (Avemar®)

Drug Interactions

Ia.        1) In an open-label pilot study a standardized extract of fermented wheat germ given for 12 months to 15 female rheumatoid arthritis patients using disease-modifying antirheumatic drugs (5 methrexate, 3 cyclosporine, 1 chloroquine, 1 sulfasalazine)  and/or corticosteroids (6 methylprednisolone, 3 prednisolone, 1 triamcinolone, 1 dexamethasone) was associated with significant improvement in baseline values of morning stiffness and other measures after both 6 and 12 months (PO in human clinical study). Steroid doses were reduced in 5 of 11 patients at 6 months and 4 of 11 after 12 months. Antirheumatic drugs were reduced in 3 of 10 during the entire study. Both types of drugs were increase in 1 patient each after 12 months.2032

            2) In an open-label pilot study use of the fermented wheat germ standardized extract MSC, when taken with cytotoxic chemotherapy drugs by children and compared to controls in 11 pairs of patients matched by diagnosis, stage of cancer, age and gender, reduced febrile neutropenic events from 46 among controls to 30 in the MSC group (PO in human clinical study). Types of cancer involved were Ewing sarcoma, cerebral PNET, osteosarcoma, hepatoblastoma, and mesenchymal chondrosarcoma. The number of pairs using specific cytotoxic drugs included 9 carboplatin, 4 cisplatin, 3 cyclophosphamide, 6 dactinomycin, 11 doxorubicin, 6 epirubicin, 7 etoposide, 10 ifosfamide, 3 methotrexate, and 7 vincristine. The follow-up, patients with central venous catheters, preventive counterneutropenic interventions, number of chemotherapy cycles, and type and dosage of antibiotics and antipyretics did not differ significantly between the groups.2036

In addition 66 patients with colorectal cancer were given 9 grams of the extract once daily for over 6 months following “curative” surgery, along with standard chemotherapy [65.2%] and/or radiation [27.3%], and compared to 104 control patients treated with chemotherapy [51%] and/or radiotherapy [53.8%] alone (PO in human clinical study). Those receiving the extract had significantly less progression as shown by new recurrences [3% vs 17.3%], new metastases [7.6% vs 23.1%], and deaths [12.1% vs 31.7%], and significantly better progression-free and overall survival probability.2247

            3) Following surgery for stage III melanoma, the random addition of standardized extract of fermented wheat germ to treatment with dacarbazine in 19 patients for 12 months led to a 54.5% 1-year relapse free survival rate, compared to 38.9% in 23 patients who received only dacarbazine (PO in human clinical study). Time to progression with the extract was 8.9 months, compared to 4.2 months without the extract.2246

 

wILD cARROT (formerly QUEEN ANN’S LACE)         p. 166

            Daucus carota seeds or roots

Contraindications

3) Avoid in diabetes mellitus due to its diuretic effect (speculative)777

and the hypoglycemic effect of a decoction of the roots equivalent to the 25 grams dry weight of root per kg body weight (PO in mice).2252 

 

WILD GINGER                                                                   p. 198

            *Asarum canadense root/rhizome

Contraindications

            3) Avoid prolonged use due to toxic and potentially carcinogenic effects of its components aristolochic acid and beta-asarone (speculative).150

Enzyme activation from the nitroreduction of aristolochic acid by microsomal CYP1A1 and CYP1A2 or by cytosolic xanthine oxidase and DT-diaphorase leads to adduct formation and mutagenesis (in vitro). The powerful nephrotoxic and carcinogenic effects of aristolochic acid has led to the recommendation that all botanical products containing this compound should be banned from the world wide market.1357

 

WILD LETTUCE                                                                p. 199

            Lactuca virosa leaves

Contraindications

     +     1) Allergic hypersensitivity to members of the Compositae family [Asteraceae] (empirical).1890

 

WILD MARJORAM [now OREGANO]                             p. 200

 

WILD YAM

            Dioscorea villosa root                                                             p. 200

Drug Interactions

III.       1) When human chronic myelogenous leukemia [KBM-5] cells were exposed to the saponin component diosgenin at 10 mM together with paclitaxel or doxorubicin, the cytotoxic effect of these agents were synergistically increased (in vitro). Diosgensin alone was equivalent in cytotoxicity to each of there chemotherapeutic agents in this cell culture (in vitro).2429

 

WILLOW                                                                              p. 200

            Salix spp. bark and leaves

Contraindications

            1) Allergic hypersensitivity to salicylates (empirical)4,150,401

Anaphylaxis occurred in a woman with aspirin allergy after taking a weight loss supplement containing willow bark (PO in human case report).1428 Salicylic acid is derived from absorbed saligenin which is an intestinal metabolite of the salicin found in numerous willow species.1429

     +     3) Nursing mothers unless following professional advice (speculative).1890

     +     4) Due to its tannin content of 8-20%, willow bark should not be taken in constipation, iron-deficiency anemia, or malnutrition (speculative).1890

      +    5) Due to its high tannin content, prolonged use should be avoided (speculative).1890

Drug Interactions

I.   +     1) In 210 patients with chronic low back pain allowed to use 400 mg of the analgesic tramadol daily, a placebo or daily doses of a willow bark extract providing 120 mg or 240 mg of salicin for 4 weeks resulted in no pain during the last week for 6%, 21%, and 39%, respectively  (PO in human clinical study)769

However, one source warns against combining willow bark prepartions with powerful analgesics (speculative).1890

     +     2) An open post-marketing surveillance study of low back pain patients assessed 112 using 240 mg salicin in a willow bark extract, 115 using 120 mg salicin in the extract and 224 who used neither; all patients were allowed conventional therapies including acetaminophen (paracetamol), NSAIDs, acupuncture, TENS, or physical therapy. After 4 weeks those pain-free accounted for 40% of the high dose salicin group. 19% of the low dose group, and only 8% of the control group (PO in human clinical study).1390.

However, one source warns against combining willow bark prepartions with powerful analgesics (speculative).1890

III.       1) May enhance the effects of salicylates (speculative)401

The analgesic effect from using the extract and the metabolic derivatives of its salicin component in a placebo-controlled study using 240 mg daily for 2 weeks of salicin in a standardized bark extract reduced the pain score in 39 patients by 14% compared to 2% for 39 placebo patients (PO in human clinical study).1391 

            2) [Formerly IV. 1) ] Salicylates in willow may increase the risk of bleeding if used with warfarin (speculative),894,1890,1899 since a study found induced platelet aggregation in 19 subjects was 61% when given 240 mg salicin/day in willow bark extract, compared to 78% for 15 subjects receiving placebo (PO in human study). This willow extract effect was mild compared to 100 mg aspirin for which induced aggregation was only 13%).1996 

            3) Due to its high tannin content of 8-20%, it should be taken separately from oral metal ion supplements, thiamine, and herbs or medications containing alkaloids (speculative).1890

 

WILLOW-HERB                                                                 NEW

     ^     Epilopbium spp. herb

Contraindications

II.         1) Due to its tannin content, willow-herb should not be taken in constipation, iron-deficiency anemia, or malnutrition (speculative).1890

            2) Due to its high tannin content, prolonged use should be avoided (speculative).1890

Drug Interactions

III.       1) Due to its high tannin content, it should be taken separately from oral metal ion supplements, thiamine, and herbs or medications containing alkaloids (speculative).1890

 

WINTERGREEN                                                                NEW

     ^     Gaultheria procumbens leaves

Contraindications

1) Allergic hypersensitivity to salicylates (speculative)150

Drug Interactions

I.    +    1) Warfarin potentiation was determined with 11 patients who concurrently used ointment containing methylsalicylate, the primary component of wintergreen oil. All of the patients had unusually high INRs after extensive topical use of the ointment, based on patient history and salicylate blood levels. One had GI bleeding, 2 were bruising, and 3 had other bleeding events (topically in human case reports).1392 Several other cases with the same etiology resulted in significant bleeding problems requiring plasma infusion or temporary cessation of warfarin intake in 2 cases. A similar case with simply an elevated INR of 12.2 occurred after applying a low-dose methylsalicylate gel to both knees for 8 days (topically in human case reports).714,1393,1394 Another case of local application to arthritic knees for two weeks increased the INR to 6.1 and resulted in multiple bruising. Still another warfarin case had bleeding and a doubled prothrombin time after using large amounts of methyl salicylate over arthritic joints (topical in case reports).1426,1427 The methylsalicylate may affect vitamin K metabolism or displace warfarin from protein binding sites (speculative).1394

 

WITCH HAZEL                                                                   p. 201

            Hamamelis virginiana leaves, bark

Drug Interactions

III.       1) Inhibition of the absorption of minerals and B vitamins (speculative)777

by forming insoluble tannate precipitates such as occurs with elemental iron and also plant drug alkaloids, resulting in their inactivation (speculative)151

    +      2) Alkaline aqueous extracts of witch hazel bark were shown to potentiate insulin activity in glucose metabolism (in vitro)1464

 

WORMWOOD                                                                     p. 202

            Artemisia absinthium herb

Contraindications

            1) Pregnancy (empirical)2,150,1890

            The use probably of the oil to induce abortion has reportedly resulted in toxic effects or death with high doses (empirical)1890

2) Stomach ulcers or duodenal ulcers (empirical)6,777

     +     or expressions of stomach hyperacidity (empirical)1890

     +     4) Allergic hypersensitivity to wormwood or other members of the Composite family [Asteraceae] (empirical)1890

     +     5) Nursing mothers (speculative), due to the potential toxicity of the essential oil with its thujone (empirical)1890

Drug Interactions

I.  +      1) In 20 patients with Crohn’s disease 500 mg of wormwood herb 3 times daily for 10 weeks for 8 weeks allowed a steady tapering of prednisone until withdrawal after 8 weeks with improvement of symptoms in 18 and remission in 13, though restarting the corticosteroids was necessary in 2 (PO in clinical study). Remissions persisted until the end of the observation period 10 weeks after the steroids and wormwood were discontinued. In 20 Crohn’s patients on placebo the symptoms increased and steroids needed to be restarted in 16 after the 8-week tapering period. Besides previously stable steroids use, prior stable doses of 5-aminosalicylates (mesalamine) and/or methotrexate and/or azathioprine were allowed to be continued as concomitant medications by both groups until the end of the observation period.2201 In a randomized, placebo-controlled study those 10 subjects with Crohn's disease using 750 mg the same powdered wormwood herb product 3 times daily for 6 weeks, in conjuntion with steady use of 5-aminosalicylates, azathioprine, methotrexate and/or steroids, had TNF-a levels that were significantly reduced, but not the 10 controls on standard medication only (PO in human clinical study). Score reductions in Crohn's Disease Activity Index and Hamilton's Depression Scale showed respective decreases of 30% or 70 points by 8 and ≥50% by 6 of those treated with wormwood, compared to 2 and 1 controls, respectively, who responded similarly.2692

 

YARROW                                                                             p. 203

            Achillea millefolium herb

Contraindications

     +     3) High doses should be avoided by nursing mothers who should not otherwise use it unless following professional advice (speculative)1890

 

YELLOW DOCK                                                                   NEW

     ^     Rumex crispus root

            (curled dock, narrow dock, sour dock, garden patience)

Contraindications

            1) Intestinal obstruction, due to its laxative effect (empirical).1890

            2) Nursing mothers, unless following professional advice (speculative).1890

Drug Interactions

III.       1) Used excessively, yellow dock may exacerbate potassium depletion caused by thiazide diuretics or licorice (speculative)1890

 

ZEDOARY                                                                            NEW

     ^     Curcuma zedoaria rhizome

            (Ch.: e zhu)

Contraindications

            1) Pregnancy (empirical)150 due to its abortifacient effects (empirical)74

 

                                                                                                                                                                                                           

 


Appendix A

HERBALS TO BE USED WITH CAUTION

 

A. 1  Due To Potential Allergic Response

(Based on references 10,17,400,401,1185, 1186, 1890,2261)

 

A.1.1  Aster Family                                                                                                                           p. 209

Calendula flowers (Calendula officinalis)

Costus root (Saussurea costus) 

Wild lettuce leaves (Lactuca virosa)

A.1.3  Other Plant Families                                                                                                              p. 210

Aloes dried leaf latex *(Aloe spp.)

Bay leaf oil (Laurus nobilis)

Boswellia resin (Boswellia serrata)

Chaparral leaves (Larrea tridentata) 

Chickweed herb (Stellaria media)

Cocoa seed (Theobroma cacao)

Garlic clove juice (Allium sativum)

Gotu kola leaves (Centella asiatica = Hydrocotyle asiatica)

Lavender flower (Lavandula officinalis)

Linden flowers (Tilia cordata)

Myrrh gum resin (Commiphora molmol)

Star anise fruit (Illicium verum)

Vervain leaf oil (Verbena officinalis)

A.1.4 Salicylate-Containing Plants                                                                                                              p. 211

Cranberry fruit (Vaccinium macrocarpon)

 

A. 2  Due To Potential Photosensitizing Effect

For example, an oral Angelica dahurica preparation was found as effective as 8-methoxypsoralen when combined with phototherapy for treating psoriasis, along with milder side effects.

(Based on reference 2220, 2223)

A.2.1  Carrot Family                                                                                                                         p. 211

Anise seed (Pimpinella anisum)

Fragrant angelica (Angelica dahurica)

 

A.4  In Acute Inflammation of the Urinary Tract

Some herbs have been used to reduce calcium oxalate stone formation, and a decoction of Herniaria hirsuta aerial herb has been shown to decrease the size of oxalate crystals and inhibit their aggregation.1887 

(Based on reference 150, 1341,1886,1887,2323.)

A.4.1 Medicinal Plants Containing Urinary Irritants                                                                    p. 215

Grindelia plant (Grindelia robusta, Grindelia squarrosa)

 

A.4.2 Medicinal Plants Containing Soluble Oxalates    (g/100 g)2644                                             p. 216

Amaranth leaf (Amaranthus hypochondriacus)                                   1.09

Beet leaves (Beta vulgaris)                                                      0.61

Chives leaves (Allium schoenoprasum)                                               1.48

Parsley leaves (Petroselinum sativum)                                                 1.70

Purslane leaves (Portulaca oleracea)                                      1.31

Spinach leaves (Spinacea oleracea)                                        0.97

Star fruit sour juice (Averrhoa carambola)

Turmeric rhizome (Curcuma longa)

 

A.5  In Gastrointestinal Irritation

Herbal agents that could aggravate inflammation of the alimentary tract include mucosal irritants (I) that act locally, bitters (B) that increase gastric mucosal and gall bladder secretions

(Based on reference 150.)

A.5.1  Herbals That Can Upset the GI Tract                                                                                 p. 218

 

Cranesbill root (Geranium maculatum) I

Grindelia herb (Grindelia robusta, Grindelia squarrosa) I, B

 

A.6  In Hypothyroid Conditions or Euthyroid Goiter

[B.1.1.c  High intake of iodine-containing foods and/or herbs can help to neutralize the anti-thyroid effects of cruciferous goitrogens. High iodine intake from a low-iodine content seaweed (Alaria esculenta) resulted in elevated serum TSH but not T4 or T3 elevations.2234 ]

(Based on reference 1234.)

A.6.2  Antigoitrogens                                                                                                                                    p. 222

Garlic cloves (Allium sativum)

 

A. 7  Due to Potential Adverse Effects                                               

Since most of these plants are not commercially available or commonly utilized, only those among the most familiar appear in the main portion of this text (#).  Adverse effects, contraindications and antagonistic drug interactions (as antidotes) for most of the potentially toxic plants of the Euro-American traditions can be found in reference 2 (The Toxicology of Botanical Medicines).

(Based on reference 1357, 1890.)

A.7.1  Herbals With Toxic Potential                                                                                                            p. 223

Asarum roots/rhizome *(Asarum spp.)

Tylophora *( Tylophora indica) leaves

Virginia snakeroot rhizomes *(Aristolochia serpentaria)  

Wild ginger rhizome *(Asarum canadense) #

                                                                                                                                                                                               

Appendix B

HERBAL-DRUG INTERACTIONS

 

B.1  Modifying Intestinal Absorption of Medicines and Phase III Metabolism           p. 227

Since tannins (polymerized polyphenol mixtures) precipitate alkaloids and metal ions, it stands to reason that the tannin content would determine the extent of precipitation. This has been shown with tea, since higher concentrations of tea reduce non-heme iron (iron sources other than hemoglobin from blood) absorption more than lower concentrations, even though as little as 20 mg tea tannins reduced iron absorption by almost 70%.1246 Tannins are common throughout the plant kingdom, but plants with high tannin levels act as astringents.777 Herbs containing enough tannins to produce a noticeable astringent effect would likely casue extensive precipitation when taken simultaneously with alkaloids and divalent cations. For example, astringent herbs should be eliminated from concurrent use if a patient is not responding to iron therapy, since these inhibit iron absorption. However, even herbs with non-polymerized phenols including monomeric flavonoids (from peppermint, European pennyroyal, vervain, small-leaved linden, and chamomile, in order of diminishing effects) and phenolic acids (coffee) have been shown to reduce iron absorption when taken simultaneously. From 20-50 mg total polyphenols can reduce non-heme iron absorption by 50-70%, while 100-400 mg polyphenols reduces it by 60-90%.1246 However, even black tea with its known high tannin content and astringency does not prevent adequate iron absorption when used concurrently if the mineral is provided in high doses383 or when iron is provided as part of the hemoglobin (“heme”) molecule as is found in meat products.434 In addition, tea does not affect iron absorption when they are consumed separately.1145

Evidence has been growing that the activity of P-glycoprotein (Pgp), also know as multidrug resisance protein 1 (MDR1), in cells of the intestinal mucosa in humans is a major factor in reducing the absorption of some drugs. Pgp is a cell membrane transport protein that pumps certain hydrophobic substrates, including some carcinogens, out of cells. Stimulating Pgp by botanical flavonols such as kaempferol, quercetin and galangin may be a means of chemoprevention in cases of concurrent exposure to carcinogenic substances such as 7,12-dimethylbenz(a)-anthracene.2104 Glutathione is required as a cofactor. Inducing its activity or increasing its content by inducing the MDR1 gene in enterocytes reduces absorption of particular drugs. Since absorption is an organ as well as an intestinal mucosal event, agents in the lists below that affect the transport proteins in cells of tissues other than the intestinal tract will also have those tissues designated in parentheses. When Pgp enhancement is associated with only a single isolated component (c) from a particular plant part, the plant part is given this letter designation.

Pgp and similar efflux pumps designated multidrug resistance-associated proteins (MRP-1 to MRP-9) such as MRP-1 and 2 move metabolized conjugates from liver cells into the bile, while others remove glucuronidated drugs from kidney cells for excretion into the urine. MRP-1 and -3 also efflux drugs and their conjugates from other organs into the blood. This efflux activity is now being designated by scientists as “Phase III” drug detoxification. The enhancement or inhibition of these proteins before or following metabolism further impacts the bioavailability of drug substrates. Both Pgp and MRP-2 efflux drugs from intestinal cells into the gut lumen. It is unclear at this time what impact MRP-1 has on intestinal absorption of drugs. Decreasing MRP content in the human intestinal cells can impact intestinal absorption of xenobiotics. The inhibition of Pgp and MRP-2 will enhance the retention of selective drugs that would otherwise be expelled from cells by these transporter systems. This has been demonstrated for several plant parts or isolated polyphenolic components (pc).

The organic anion transporting polypeptide (OATP) also mediates drug uptake at the intestinal level. OATP-1A2 (OATP-A) is predominantly expressed in the brain rather than the intestine, whereas OATP-2B1 (OATP-B) is more like involved with aiding in intestinal absorption. Several common fruit juices have been shown to inhibit this mediator, thereby reducing absorption of specific drugs from the gut. Human oligopeptide transporter 1 (hPepT1) and other transporters are expressed on the brush border membrane of the intestinal mucosa and transports some drugs such as beta-lactam antibiotics. This action can be slowed (s) or decreased (d).

Drugs or minerals whose absorption has been shown to be affected by a specific herb, its extract, or its featured component are indicated and referenced following the herbs in the lists below. These medications are in bold type when the documented effects result from concurrent oral ingestion by humans and italicized for equivalent animal studies.

 (Based on references 1145, 1246, 1250, 1331, 1350, 1366, 1533, 1552, 1561, 1562, 2060, 2641.)

 

B.1.1 Slowed and/or Reduced Absorption by Herbal Components

 

B.1.1.b.i  Selective Precipitation of Alkaloids and Minerals by Tannins                          p. 231

Cassia cinnamon bark (Cinnamomum cassia)

English plantain leaves (Plantago lanceolata)

Plantain leaves (Plantago major)

St. John’s wort tops (Hypericum perforatum)

Stinging nettle leaves (Urtica dioica)

Willow-herb herb (Epilobium spp.)

B.1.1.b.ii  Precipitation by Non-tannin Phenols                                                                             NEW

Chamomile flowers (Matricaria recutita)iron1246

Coffee seeds (Coffea arabica)iron1246

European pennyroyal plant (Mentha pulegium) – iron1246

Green tea leaves (Camellia sinensis) – iron1993

Rosemary leaves (Rosmarinus officinalis) – iron1993

Small-leaved linden flower (Tilia cordata) – iron1246 

Peppermint leaves (Mentha piperita) – iron1246

Vervain leaves (Verbena officinalis) – iron1246

B.1.1.c  Potential Precipitation of Alkaloids by Iodine from Sea Herbals                                    p. 232

Arame kelp (Eisenia bicyclis = Ecklonia bicyclis)

Hiziki seaweed (Hizikia fusiformes) [high in inorganic arsenic]

Sea palm kelp (Postelsia palmaeformis)

B.1.1.d  Selective Efflux of Drugs by Inducing P-Glycoprotein                                                   p. 232

[Note: rhodamine-123 is a fluorescent dye used as a marker of influence on P-gp.]

China root c (Alpinia officinarum) – doxorubicin [adriamycin] (colon)1026 

Goldenseal root (Hydrastis canadensis) – verapamil (baculovirus)2145 [See Note 3.]

Grapefruit fruit/juice (Citrus paradisi) – #digoxin, # vinblastine, *fexofenadine1036

Kutaki rhizome/roots c picroside I (Picrorrhiza kurroa) – (jejunum)2649 

Milk thistle seeds pc slymarin (Silybum marianum) – metronidazole (intestine)1948 [See Note 1.]

St. John’s wort tops (Hypericum perforatum)^amitriptyline (intestine),1614 digoxin (intestine),437,1350,2504 fexofenadine (intestine),1590,1613 simvastatin (intestine),1250 tacrolimus (intestine),1552 talinolol (intestine),1972 digoxin (intestine),1350 rhodamine 123 (intestine)1366

# - also shown to not induce P-glycoprotein in vitro1097

* - May be due to inhibition of OATP.1097

^ - Only when providing a daily hyperforin dose greater than 5 mg.1343,1775

B.1.1.e  Selective Inhibition of Absorption likely by Inhibiting OATP-A and/or OATP-B        p. 233

Banaba leaf (Lagerstroemia speciosa) – estrone (kidney - B)1883 

Bilberry fruit (Vaccinium myrtillus) – estrone (kidney - B)1883

Black cohosh root (Cimicifuga racemosa) – estrone (kidney - B)1883 

Echinacea purpurea flowers/leaves (Echinacea purpurea) – estrone (kidney - B)1883 

Eleuthero root (Eleutherococcus senticosus) – estrone (kidney - B)1883 

Ginkgo leaves &/or pc flavonol glycosides (Ginkgo biloba) – estrone, glibenclamide (kidney - B)1883 

Grape seed (Vitis vinifera) – estrone (kidney - B)1883 

Grapefruit fruit juice (Citrus paradisi) – estrone (kidney- B),1922 fexofenadine (intestine - 1A2),1097,2304 glibenclamide (kidney- B),1922 acebutolol,2054 celiprolol,1581 fexofenadine1097,1919,2304,2305 [See Note 2.]

Tea green leaves &/or pc catechins (Camellia sinensis) – estrone, glibenclamide (kidney - B)1883 

Mulberry leaf (Morus alba) – estrone (kidney - B)1883 

Orange fruit juice (Citrus sinensis) – estrone (kidney- B),1922 fexofenadine (intestine - A),1097 glibenclamide (kidney- B),1922 fexofenadine,1097 celiprolol,1582 ivermectin1628

Soy bean (Glycine max) – estrone (kidney - B)1883 

Notes

1. Though inhibiting Pgp efflux of substrates daunomycin, doxorubicin, digoxin, and vinblastine in vitro,1562,1837 when tested with the Pgp substrate digoxin in 16 healthy humans 440 mg silymarin in 900 mg standardized extract daily for 14 days did not significantly alter the drug bioavailability. There was a tendency toward reducing digoxin levels, suggesting potential Pgp induction.1806 When tested with Pgp and CYP 2C9/3A4 substrate metronidazole in 12 healthy humans, 140 mg silymarin daily for 9 days increased drug substrate clearance, while reducing the half-life, bioavailability, and urinary excretion of the drug and its active metabolite.1948 Pgp induction is the probable cause, since silymarin does not modulate CYP 3A4 in humans1374,1431,1718,1589 and has an inhibitory effect on CYP 2C9 in vitro.1297

2. Though acting as an OATP-B inhibitor of glibenclamide in vitro,1922 grapefruit juice failed to affect its pharmacodynamics in humans.2055 Like the orange flavonoid hesperidin, the grapefruit flavonoid naringin inhibits the OATP1A2 transport of fexofenadine in vitro. Based on comparative testing of the juice, naringin, and a low-naringin juice fraction, naringin appears to be primarily responsible for the reduced bioavailability of fexofenadine in humans as well.2305

3. A study in humans with the Pgp probe drug digoxin in 20 subjects found that 3.2 grams daily for 14 days of an extract of goldenseal containing 3.25% isoquinoline alkaloids failed to alter the bioavailability of digoxin, though the maximum concentration was actually increased by 14%.2082

B.1.1.f  Slows and/or Decreases Active Intestinal Transport by hPepT1 and/or Others

Cranberry fruit juice (Vaccinium macrocarpon) – amoxicillin (s)2618

Grapefruit fruit juice (Citrus paradisi) talinolol  (d)2619

 

B.1.2 Enhancement of Absorption

 

B.1.2.a  General Enhancement by Pungent Herbs                                                                                    p. 233

Black pepper fruit (Piper nigrum) curcumin1533

Long pepper fruit (Piper longum) curcumin1533

B.1.2.b Selective Retention of Drugs by Inhibiting P-glycoprotein                                                          p. 233

[Probes: rhodamine-123 is a fluorescent dye used as a marker of influence on P-gp; calcein acetyoxymethyl ester (calcein-AM) also serves as a marker substrate.]

Apple fruit pc phloretin (Malus domestica) – daunomycin, doxorubicin [adriamycin] (breast)1562

Asian ginseng root, ginsenosides and/or pc kaempferol (Panax ginseng) – doxorubicin (leukemia),2103 colchicine (fibroblast),2103 daunorubicin (myelogenous leukemia),1744,2102 doxorubicin [adriamycin] (myelogenous leukemia, fibroblast),1744,2103 etoposide (fibroblast),2103 rhodamine-123 (lymphoma,1739 fibroblast2103), ritonavir (intestine),1854 vincristine (fibroblast)2103

Barberry bark c berbamine/berberine (Berberis spp.) – rhodamine-123 (brain capillary endothelium)2105

Bitter orange fruit/juice (Citrus aurantium) dextromethorphan (intestine)2666

Black cohosh (Cimicifuga racemosa) – digoxin (intestine)1587 [See Note 1.]

Black pepper fruit c piperine (Piper nigrum) – digoxin, cyclosporin A1820

Cannabis leaf c tetrahydrocannabinol and/or cannabidiol (Cannabis sativa) - rhodamine 123 (colon, kidney;2651 T lymphoblast [prolonged exposure]2652), doxorubicin (colon, kidney),2651 vinblastine (T lymphoblast [prolonged exposure])2652

Cayenne fruit c capsaicin (Capsicum frutescens) – digoxin2620

Chaste tree c agnuside (Vitex agnus-castus) – (jejunum)2649 

Cranberry fruit/juice pc quercetin (Vaccinium macrocarpon) – rhodamine 123 (breast)2132

Crucifers like Brussels sprouts & cabbage glucobrassicin/I3C (Brassica oleracea) – vinblastine, vincristine (liver MDR1)2174

Echinacea roots (Echinacea spp.) – calcein-AM2693 

Echinacea whole plant, roots (Echinacea spp.) – digoxin (intestine)1587 [no effect: digoxin 2504]

Echinacea flowers/leaves (Echinacea purpurea) – digoxin (intestine)2607

Feverfew (Tanacetum parthenium) – digoxin (intestine)1587

Fig fruit pc morin (Ficus carica) – daunomycin, doxorubicin [adriamycin] (breast)1562

Frankincense resin and c keto-boswellic acids (Boswellia serrata) – calcein-AM (lymphocyte)2663

Garlic clove c allicin (Allium sativum)ritonavir (intestine)1854

Ginkgo leaves (Ginkgo biloba) – digoxin (intestine),2608 talinolol (intestine)2680

Grapefruit fruit/juice (Citrus paradisi) – dextromethorphan (intestine),2666 digoxin (colon),2029 fexofenadine, rhodamine 123 (intestine),2026 saquinavir (intestine,2026 colon2044), talinolol (colon),2255 vinblastine (colon),1358,2044 vincristine (myelogenic cells)1627

Kudzu plant pc genistein (Pueraria lobata) – daunorubicin (breast), rhaodamine 123 (fibroblast)2066

Kutaki rhizome/roots c picroside II (Picrorrhiza kurroa) – (jejunum)2649 

Long pepper fruit c piperine (Piper longum) – digoxin, cyclosporin A1820

Milk thistle seeds pc silymarin (Silybum marianum) – daunomycin, doxorubicin, digoxin, vinblastine1562,1837  [See Note 3.]

Mulberry twigs pc morin (Morus alba) – daunomycin, doxorubicin [adriamycin] (breast)1562

Onion bulbs pc quercetin (Allium cepa) – rhodamine 123 (breast)2132

Orange fruit/juice (Citrus sinensis) – fexofenadine, rhodamine 123 (intestine),2026 saquinavir (intestine,2026 colon2044), vinblastine (colon),2044 vincristine (myelogenic cells)1627

Oregon grape root bark c berbamine/berberine (Mahonia spp.) – rhodamine-123 (brain capillary endothelium)2105

Pomelo fruit and pericarp (Citrus grandis) – digoxin (colon)2029 [See Note 2.]

Red clover flowers pc biochanin A (Trifolium pratense) – daunomycin, doxorubicin [adriamycin] (breast),1562 digoxin, vinblastine (intestine)1837

Schisandra fruit lignans (Schisandra chinensis) – digoxin, rhodamine-123 (intestinal)2101

Soy beans pc genistein (Glycine max) – daunorubicin (breast), rhaodamine 123 (fibroblast)2066

St. John’s wort tops, pc quercetin, and/or c hypericin (Hypericum perforatum) – fexofenadine (intestine with single dose),1331 digoxin (intestine),1587 ritonavir (intestine)1854

Tea leaves pc quercetin (Camellia sinensis) – rhodamine 123 (breast)2132

Tea green leaf pc catechins (Camellia sinensis) – (jejunum),2649  doxorubicin [adriamycin] (breast),2172 rhodamine-123 (ovary),1561 tetrofosmin (breast),2172 vinblastine (intestine)1561

Turmeric root pc curcumin (Curcuma longa) – rhodamine-123 (liver),1564 (T lymphoblast),2652 (stomach),2184 and (cervix),1853,2173 vinblastine (cervix),1853,2173,2185 vincristine (stomach),2184 calcein-AM, bodipy-FL-vinblastine (cervix)1853 

Valerian (Valeriana officinalis) – digoxin (intestine)1587

Wormseed seed c santonin (Artimisia maritima) – (jejunum)2649

B.1.2.c Enhanced retention of Drugs by Inhibiting MRPs                                                                       NEW

Apricot fruit (Prunus armeniaca) – sulfasalazine (ileum), sulfasalazine (rat)2287

Fig fruit pc morin (Ficus carica) – daunomycin, vinblastine (pancreas MRP1) 1805

Grapefruit fruit (Citrus paradisi) – saquinavir, vinblastine (kidney MRP2) 2044

Kudzu plant pc genistein (Pueraria lobata) – daunorubicin (breast)2066

Milk thistle fruit pc silymarin (Silybum marianum) – daunomycin, vinblastine (pancreas MRP1) 1805

Mulberry twigs pc morin (Morus alba) – daunomycin, vinblastine (pancreas MRP1) 1805

Orange fruit (Citrus sinensis) – saquinavir, vinblastine (kidney MRP2) 2044  

Pineapple (Ananas comosus) – sulfasalazine (ileum), sulfasalazine (rat)2287

Red clover flowers pc biochanin A (Trifolium pratense) – vinblastine (pancreas MRP1) 1805  

Soy beans pc genistein (Glycine max) – daunorubicin (breast)2066

Tea green leaves (Camellia sinensis) – methotrexate (kidney MRP2) 1776

Notes

1. When tested with the Pgp substrate digoxin in 16 healthy humans, black cohosh extract at 40 mg daily for 14 days had no Pgp effect,1806 though it is an inhibitor in vitro.1587

2. When tested with the Pgp substrate digoxin in human colon carcinoma Caco-2 cell culture in vitro, pomelo fruit juice inhibited Pgp,2029 but the ethyl acetate extract of the juice failed to inhibit Pgp in vitro in pig kidney LLC-PK1 epithelial cells transfected with human MDR1  DNA to over-express human Pgp.2030

3. Silymarin inhibits Pgp efflux of substrates in vitro.1562,1837 However, when tested with the Pgp substrate digoxin in 16 healthy humans 440 mg silymarin in 900 mg standardized extract daily for 14 days did not significantly alter the drug bioavailability. There was a tendency toward reducing digoxin levels, suggesting potential Pgp induction.1806

 

B.1.3  No Influence on Drug Absorption in Humans                                                                    NEW

 

B.1.3.a  No Effect on P-glycoprotein Efflux

Black cohosh extract (Cimicifuga racemosa) – digoxin1806

Goldenseal root extract (Hydrastis canadensis) – digoxin2082

Kava rhizome extract (Piper methysticum) – digoxin2082

Milk thistle 80% silymarin fraction (Silybum marianum) – digoxin1806

 

B.2  Potentiating Cardiotonic Medicines                                           

Cardiovascular drugs as exemplified by digoxin are one of the major classes of prescription medications with implications of significant risk when combined with certain botanicals, particularly St. John’s wort tops effects on digoxin, verapamil, and statin absorption and/or metabolism.2277 Other mechanisms are associated with different botanicals that can also increase the risk of interfering with expected outcomes from digoxin and similar cardiotonic drugs.

Some plants contain steroidal cardiac glycosides similar to those contained in or derived from digitalis. By their additive effects, such glycosides can produce cardiac toxicity when used with digitalis glycosides such as digoxin, digitoxin, or similar medicines. Other medicinal plants that can induce toxic effects of digitaloid glycosides, such as fibrillations, include those that cause a decrease in serum potassium levels. 

(Based on references 1168-1171)

 

B.2.2 Increased Potassium Excretion

 

B.2.2.b Potentiation by Kaliuretics and/or Diuretics                                             p. 235

Cotton root bark (Gossypium herbaceum, Gossypium hirsutum)

Scouring rush plant *(Equisetum hyemale)

 

B.3  Potentiating Sedative or Tranquilizing Medicines

Sedative agents account for one of the four most common classes of prescription medications involved in over 90% of the cases with potential interactions, though actual incidences appear uncommon.2272 A number of plant extracts and some of their components such as flavonoids have been shown to prolong the hypnotic effect of ethanol (E), barbiturates (B), or other (O) hypnotics in animals and /or act as agonist ligands at the benzodiazepine-GABA receptor complex (BDZ) in vitro. Some have sedative and/or anxiolytic effects on their own or when combined with anxiolytics (A), suggesting an additive effect when combined with other tranquilizing drugs.

(Based on references 1100, 1109, 1201, 1222, 1254, 1291, 1510, 1529, 1530, 1626)

 

B.3.1  Hypnotic and/or Anxiolytic Drug Enhancement                                           p. 236

Bacopa leaves (Bacopa monniera) B1222, 1291

Bitter orange peel (Citrus aurantiumi) B1626

Bromelain pineapple stem extract (Ananas comosus) B1112

Chinese skullcap root (Scutellaria baicalensis) BDZ,1100,1109 A, O2209

European elder flower and berry (Sambucus nigra) B1651

Gotu kola leaves (Centella asiatica) B1201

Hops strobiles (Humulus lupulus)  B,2198 O2197

Hornamo morado plant (Valeriana adscendens) B1510

Indian valerian roots/rhizomes (Valerian wallichii) Bc,1529 BDZc1530

Jujube seeds (Ziziphus spinosa) B1254

Kava rhizome (Piper methysticum)  B2196

Passion flower leaves (Passiflora incarnata)  B2196,2299

Schisandra fruit (Schisandra chinensis, S. sphenanthera) B695,2074 

Skullcap herb (Scutellaria lateriflora)1894 A, O2209

                                                                         

B.4  Modifying Blood Sugar In Insulin-Dependent Diabetics and NIDDM

Antidiabetic agents are one of the common classes of prescription medications with implications of significant risk when combined with botanicals, one of the four that account over 90% of the cases with potential interactions, though actual incidences appear uncommon.2272,2277 Botanicals that lower blood sugar can have dire consequences in type I insulin-dependent diabetes if the use of these agents results in hypoglycemic shock. The following have been shown to reduce blood sugar when the herb (h) or its juice (j) or other extracts (e) or components (c) are taken orally.  This hypoglycemic or antihyperglycemic effect in humans is designated in bold and is indicated as having been demonstrated in diabetics of undetermined type (db), type I (t1), type II (t2), or in healthy (hl) individuals.

Potentially beneficial in type II non-insulin dependent diabetes mellitus (NIDDM), antihyperglycemic herbs when used with oral hypoglycemic drugs together have been shown to further reduce blood sugar in type II diabetes in humans.

 

B.4.1  Hypoglycemic Herbs                                                                                        p. 238

Acacia seeds (Acacia spp.)1868

Allspice fruit (Pimenta officinalis)319,1464

American ginseng root (Panax quinquefolius)1574,1685h(t2)1114

Andrographis plant (Andrographis paniculata)1868

Anemarrhena rhizome (Anemarrhena asphodeloides)1870

Balloon flower root (Platycodon grandiflorum)1869

Banaba leaves (Lagerstroemia speciosa)2282e(t2)2283

Barberry root bark (Berberis vulgaris) – c(t2)2315

Bay leaves (Laurus nobilis)319,1462,1464

Bilberry leaves (Vaccinium myrtillus)1871

Biophytum plant (Biophytum sensitivum)1868

Black cumin seed (Nigella sativa)1868

Caiapo root (Ipomoea batatas) – h(t2)1252,1647

Cassia (Cinnamomum cassia) – h(t2)1592,1900,2603 [neg h(t2)2139,2237] 

Cayenne fruit (Capsicum frutescens)1706

Cissus stem (Cissus rotundifolia)1868

Chinese mustard seed (Brassica juncea)1437

Chirata plant (Swertia chirayita)1437

Cidra chayote immature fruit (Cucurbita ficifolia)1868,2579j(t2)1209

Cinnamon bark (Cinnamomum verum)1763

Clove buds (Syzygium aromaticum)319,1462,1464  

Cocoa seed (Theobroma cacao)2119

Cola de caballo aerial plant (Equisetum myriochaetum)2580e(t2)1305

Coptis root (Coptis spp.) – c(t2)2315 

Coriander seeds (Coriandrum sativum)1868,1873

Cowitch seeds (Mucuna pruriens)1436,1437

Cuajilote roots, branch, fruit (Parmentiera edulis= P. aculeata)1868

Curry leaf leaves (Murraya koeingii) – h(t2)1437

Desert wormwood aerial plant (Artemisia herb-alba)1868e(db)1888,1889 

Detarium seeds (Detarium senegalense)1868

Fenugreek seeds (Trigonella foenum-graecum)1868,2236,2253,2525h(t2),1645 h(t1)1645

French maritime pine bark (Pinus pinaster) – e(t2)1760

Goat’s rue seeds and herb (Galega officinalis)1868,2252

Goldenseal root (Hydrastis canadensis) – c(t2)2315

Guarumbo leaves (Cecropia obtusifolia)1868,2579e(t2)1884

Guayacan bark (Acosmium panamense syn. Sweetia panamensis)2579

Hibiscus flowers (Hibiscus rosa-sinensis)1437

Holy fruit leaf (Aegle marmelose)1657

Horehound leaf (Marrubium vulgare) – e(t2)1884

Ivy gourd herb (Coccinia indica = C.cordifolia = C. grandis)2236e(t2)2235

Jambolan seeds (Syzygium cumini = Eugenia jambolana)1437,1868,2000

Japanese senega root (Polygala senega v. latifolia)1868

Kino heartwood (Pterocarpus marsupium)1868e(t2)1437,1965

Kisni leaf (Bridelia ferruginea)1868

Lotus rhizome (Nelumbo nucifera)1544

Maitake mushroom fruiting body (Grifola frondosa)1618h(t2)1609

Mango leaf (Mangifera indica)1868,1874

Margosa leaves (Azadirechta indica)1657

Marula leaves (Sclerocarya birrea)1868

Maturi roots, stems (Psacalium decompositum)1868

Mulberry leaves (Morus spp.)1868h(t2)1872

Oregon grape bark (Mahonia aquifolium) – c(t2)2315

Palo santo leaves (Agarista mexicana)2579

Pomegranate flowers, seeds (Punica granatum)1657

Poterium root bark (Poterium spinosum)1868

Prickly pear stems (Opuntia spp.)1228,1868

Queen Ann’s lace roots (Daucus carota)2252

Rhazya leaves (Rhazya stricta)1964

Sage herb (Salvia officinalis)2271

Sesame seed oil (Sesamum indicum) – e(t2)2050 

Spirulina algae (Spirulina spp.) – h(t2)1208

Stevia leaves (Stevia rebaudiana)1783

Taranome shoots, bark (Aralia elata)1868

Tarragon herb (Artemisia dracunculus)2118

Tea (green, oolong, and black) leaves (Camellia sinensis)319,1464,1576,2284 [neg e(t2)2330]

Walnut leaves (Juglans regia)2252

Zygophyllum aerial parts (Zygophyllum gaetulum)1868e(t2)1882

 

B.4.2  Antihyperglycemic Botanicals Enhancing Oral Hypoglycemic Drugs in Humans                       NEW

Aloe leaf juice (Aloe vera) – glyburide122

American ginseng root (Panax quinquefolium) – sulfonylureas, sulfonylureas/metformin1114

Asian ginseng rootlets (Panax ginseng) – acarbose, metformin, rosiglitazone, and/or sulfonylurea2042

Barberry root bark (Berberis vulgaris) – sulfonylureas, metformin, acarbose, and/or insulin2315

Bitter melon fruit (Momordica charantia) – chlorpropamide360

Cassia bark extract (Cinnamomum cassia)2603glinides, glitazones, metformin, and/or sulphonlyureas1900 including glyburide (glibenclamide)1592

Coptis root (Coptis spp.) – sulfonylureas, metformin, acarbose, and/or insulin2315

Goldenseal root (Hydrastis canadensis) – sulfonylureas, metformin, acarbose, and/or insulin2315

Guar seed gum (Cyamopsis tetragonolobus) – metformin,431 glyburide (glibenclamide)2148

Gymnema leaves (Gymnema sylvestre) – glyburide, tolbutamide359

Konjac tuber (Amorphophallus konjac) –glyburide,430,1666 glipizide, and/or metformin1666

Oregon grape root, bark (Mahonia aquifolium) – sulfonylureas, metformin, acarbose, and/or insulin2315

Prickly pear pads (Opuntia spp.) – chlorpropamide,952 glyburide,950,951,2126 metformin,2126 tolbutamide945,950

Psyllium seed husks (Plantago ovata) – sulfonylureas1448

 

B.5  Modifying the Effects of Anticoagulants                                                       

Potential problems involving the use of herbs with anticoagulants may include plants that contain the parent compound coumarin as a pro-drug. Coumarin itself does not affect coagulation, clotting factors, or fibrinolysis.1738 However, when converted by fungus or molds (Aspergillus spp., Penicillium spp. or Mucor spp.) to 4-hydroxycoumarins due to inadequate drying and/or improper storage, these coumarin derivatives can have an effect equivalent to pharmaceutical anticoagulants. In contrast, coumarin derivatives found in plants and referred to generically as coumarins are not ordinarily prothrombopenic anticoagulants. However, some natural coumarins that are found in plants, such as esculetin and osthole, in large amounts can possibly reduce coagulation due to anti-platelet aggregation effects.

Simultaneous consumption of several herbs with warfarin in vivo in animal lab studies (italicized) or in humans (bold) has been associated with a reduction in the metabolism and/or enhancement of the effect of warfarin (W), leading to increased risk of hemorrhage. Decreased plasma neutralization of heparin (H) has also been documented. The research on most of these herbs is limited to studies using platelet-rich plasma in vitro (I) to test an extract/fraction (e) or one or more isolated components (c). For example, a high oral dose of scopoletin (60 mcg/kg body weight) has been shown to increase the bleeding time in guinea pigs by 2-38%.2499 Scopoletin, like other botanical coumarin derivatives umbelliferone, 4-hydroxycoumarin, scoparone, and esculetin, has shown anti-platelet activity in platelet-rich plasma in vitro.2497 The research methodology used is significant, since isolated coumarin derivatives from several plants have shown much greater anti-platelet effects in platelet suspensions than in whole blood and platelet-rich plasma.1542 Under most circumstance, however, in vitro evidence on high concentrations of extracts or isolated constituents is not a reliable means to determine the potential risk of consuming therapeutic quantities of herbs or their extracts or components, but such research mainly serve as a means of examining a possible mechanism of action for an effect demonstrated in vivo. 

For a few herbs research studies using internal consumption of the herbs (h) or extracts by humans or animals have shown antiplatelet effects when the blood is drawn and tested with platelet-aggregating compounds ex vivo (E). This is a more reliable indicator for clinically relevant effects. In vivo (V) studies in animals test an herbal agent given orally for its enhancement of bleeding time or protective effects against a clot-inducing agent.  Further substantiation of increased hemorrhagic potential can be based on case reports (CR) or human studies (HS) findings that best document increased bleeding tendencies. Since they are the most pertinent, in vivo and ex vivo findings, human case reports, and human studies appear as bold in the lists below. If seemingly contradicting negative [neg] findings have been documented in people or animals for botanicals with anticoagulent or antiplatelet potential, this is likewise documented.

Antithrombotic agents are one of the common classes of prescription medications with implications of significant risk when combined with botanicals, one of the four that account over 90% of the cases with potential interactions, though actual incidences appear uncommon.2272,2277 When possible, the consumption of large therapeutic doses of herbs that potentiate bleeding should be discontinued 2 weeks before elective surgery. Likewise, anticoagulants like warfarin (Coumadin®) and platelet inhibitors such as aspirin and their combination with similar herbs should be avoided. Otherwise, presurgical coagulation testing and close monitoring are recommended.972

 

B.5.1  Increasing Potential for Hemorrhage

 

B.5.1.a  Additive Effect Due To Content of Potential Prothrombinopenic Components                       p. 244

Chinese skullcap root (Scutellaria baicalensis) Ic1237

Pau d’arco bark (Tabebuia avellanedae) Ic623

 

B.5.1.c  Warfarin or Heparin Metabolism Inhibitors and/or Anticoagulant Adjuvants                        p. 245

Birch bark oil (Betula lenta, Betula pendula) Wc714,1392-1394,1426,1427  [moved from B.5.1.d.]

Boldo leaf (Peumos boldus) We1489

Dong quai root (Angelica sinensis) Wh1230

Fenugreek seeds (Trigonella foenum-graecum) Wh1489

Garlic cloves (Allium sativum) neg HSe (aged garlic 10 ml/day chronic)1878

Ginger rhizome (Zingiber officinale) Wh,2206 neg We,1774 neg We1174

Lycium fruit (Lycium barbarum) We1768

Mango fruit (Mangifera indica) W1299

Wintergreen leaf oil (Gaultheria procumbens) Wc714,1392-1394,1426,1427 [moved from B.5.1.d.]

 

B.5.1.d  Platelet Aggregation &/or Adhesion Inhibitors                                                                p. 245

Asian ginseng root (Panax ginseng) Ic,1196 Ie,1194 Ee1194

Boldo leaf (Peumos boldus) Ic1532

Broccoli flower buds (Brassica oleracea v. italica) Ic, Vc2224

Bromelain from stem (Ananas comosus) CRe2126

Brussels sprouts buds (Brassica oleracea v. gemmifera) Ic, Vc2224

Cabbage leaves (Brassica oleracea v. capitata) Ic, Vc2224

Capillary artemisia herb (Artemisia capillaris) Ie,2497 Ic2497,2498

Cassava tuber (Manihot esculenta) Ic2497-2499

Cayenne fruit (Capsicum spp.) Ic2270

Chamomile (Matricaria recutita) CRe,1876 Ic420,1015,2497

Cocoa seed (Theobroma cacao) HSh1447

French maritime pine bark (Pinus pinaster) He1570,1571

Garlic cloves (Allium sativum) Ie(aged),1879 Ih,2038 Ee (aged)2037

Ginger rhizome (Zingiber officinale) Eh (1 gm daily for 1 week),2312  CRh/e,2087 neg Ve1174

Ginkgo leaves (Ginkgo biloba) Ee,2322 CRe1190,1191,2322

Japanese honeysuckle flowers (Lonicera japonica) Ic1543

Pipsissewa leaves (Chimaphila umbellata) Ic1502

Prickly pear pulp (Opuntia spp.) HSh1644

Pyrola whole herb (Pyrola spp.) Ie1502

Stinging nettle leaves (Urtica dioica) Ie, Ic1648

Sugar cane polycosanol (Saccharum officinarum) HS1864

Tarragon leaves (Artemisia dracunculus) Ie2205

Tomato fruit (Lycopersicon esculentum) Ee2081

Wasabi roots (Wasabia japonica) Ic,1689 Ec1877

Willow bark (Salix spp.) HSe1996

Yin chen hao herb (Artemisia scoparia) – Ic2497

 

B.5.1.e  Fibrin Formation Inhibitors or Fibrinolysis Promoters                                       p. 246

Asian ginseng root (Panax ginseng) Ee1194

Bromelain from fruit and stem (Ananas comosus) Ee1110

 

B.5.2  Increasing Potential for Coagulation

 

B.5.2.a  Warfarin Antagonism by Plants High in Vitamin K                                                       p. 247

Amaranth leaf (Amaranthus hypochondriacus)1339

Chard leaves (Beta vulgaris v. cicla)1339

Chives leaves (Allium schoenoprasum)1339 

Cilantro leaves (Coriandrum sativum)1339

Endive leaves (Cichorium endivia)1339 

Onion green tops (Allium cepa)1339

Peppermint leaves (Mentha piperita)1339

Purslane leaves (Portulaca oleracea)1339

 

B.5.2.b  Warfarin Antagonism by Inducing Its Metabolism and/or Modifying Its Effect         p. 247

Soy bean (Glycine max) CR1347

St. John’s wort herb (Hypericum perforatum) HS1578 

 

B.5.2.c  Herbs that May Accelerate Coagulation with Internal Use                                             p. 248

Black walnut hulls/leaves (Juglans nigra) Ec1243

Cotton root bark (Gossypium herbaceum, Gossypium hirsutum) Ee1172

Raspberry leaves (Rubus idaeus) Ec1243

Scouring rush plant (Equisetum hyemale) I11

 

 

B.7.  Modifying Enzyme Activities in Metabolic Conversions

The value of in vitro studies is highly questionable for inhibitory studies on CYP isozymes. This is due not only to the changes in botanical and extract content to which these isozymes are exposed in vivo due to variable breakdown, absorption, and bioavailability, especially in the liver. A major drawback in exposing proteinaceous isozymes to botanical extracts in vitro is the tannin content of the botanical preparation that leads to binding and structural transformation of the protein, rendering it inactive (inhibited).1638 Consequently, any tannin-containing preparation is likely to appear inhibitory in vitro though these components will not have the same effect in vivo where the intracellular isozymes will not come in contact with tannins. In addition, inhibition can occur due to a failure to reduce native ferric isozymes to ferrous or reducing binding of the oxygen to the ferrous iron, or interference with the transfer of oxygen from the ferrous ion to the substrate.1639 It has been shown that not only tannins, but other polyphenolic components such as monomeric flavonoids and phenolic acids of herbal preparations, inhibit the ferric iron absorbption in the gut,1246 suggestive of binding to this form and interferring with its absorption (facilitated in the ferrous form). This interference with iron apparently can occur with exposure of non-tannin polyphenols. These factors contribute to the concern that techniques of in vitro screening for potential isozyme inhibitory drug interactions lack adequate validation for in vivo and clinical extrapolation.1640 

Whole plant and complex extract studies are necessary to accurately describe the effect observed with normal use. The testing of “herb” effects on metabolic conversions both in vitro and in vivo almost never involves use of the whole powdered herb. In vitro evaluation requires extraction of the herb for adequate cellular and enzymatic exposure. In vivo tests, whether human (in bold) or animal (in italics), also involves dosing in forms that are typically derivatives of the whole herb as either liquid or solid extracts or fractions. There are many different types of extracts for each herb, and these vary in composition and activity. However, each separate form cannot be individually designated in this table format. They are simply described by the name of the herb (which is capitalized). The specific form used, whether powdered herb or extract, may be described in the main body of the text for the drug interaction listed under that herb. Where reduced chemical fractions or isolated derivatives (indicated with small letters) are used, the description of the fraction or isolated constituent is given below along with the herb(s) from which is it is typically obtained.

One major means of inducing drug metabolism is by gene activation via the nuclear pregnane X receptor (PXR) that regulates phase I (e.g., CYPs 2B6, 2C9, 2C19, 2E, 3A), Phase II enzymes (e.g., GSTs, UGTs, STs) and phase III drug transporter proteins (Pgp, MRP-2, OATP).1926-1928,2085 For example, the activation of PXR in human liver cells in vitro by St. John’s wort extract1002 and its major active component hyperforin1703 indicates the probable mechanism as an inducer of CYP 3A4, CYP 2C9, and P-glycoprotein1926 which is born out for St. John’s wort in human studies.1350,1578,1590,1613

Another nuclear receptor gene activator that impacts xenobiotic metabolism is the constitutive androstane receptor (CAR). CAR regulates mainly CYP 2B but is also involved in expression of CYPs 2C9 and 3A, phase II UGT 1A1, and phase III MDR-1. The hepatic nuclear factor 4a determines the liver’s PXR and CAR induction of CYP 3A4. One example of influence on CAR is guggulsterone in guggul (Commiphora mukul) resin that has been shown to repress CYP 2B10 by inhibiting CAR, as well as acting as an antagonist of the nuclear gene activator farnesoid X receptor.2111,2112 Other nuclear gene activators include retinoid X receptor and vitamin D receptor, the latter contributing to the induction of CYPs 2B6, 2C9, and 3A4. These nuclear gene activators are important components of bile acid detoxification by CYP 3A4, while bile acids themselves are PXR inducers that cause induction of CYP 3A4.1928,2085 The CYP 3A4-induction effect of bile acids has important implications for herbs that have choleretic (bile-producing) activity, versus those that have only cholagogues (bile-releasing) activity, if the choleretic effect is associated increased bile salt production and not simply a increase in bile water content.

            Aryl hydrocarbon receptor (AhR) is a cytosolic ligand-dependent inducible transcription factor that exists in most cell and tissue types in the body. When formed into a ligand-receptor complex, it accumulates in the nucleus to activate the genes that produce CYPs 1A1, 1A2, 1B1, and phase II conjugating enzymes GST, UGT, and QR. Since consumption of herbs, vegetables and fruit provide phytochemicals in micromolar quantities sufficient to antagonize or activate the AhR signaling pathway, this is an important aspect to assess in the context of a multifaceted influence on detoxification pathways. AhR is sometimes referred to as the dioxin receptor, and those agents that inhibit receptor binding may be useful in preventing toxicity from synthetic environmental contaminants that are the strongest ligands such as polychlorinated dibenzo-p-dioxins and halogenated aromatic hydrocarbons and other toxins including dibenzofurans, biphenyls, and polycyclic aromatic hydrocarbons such as benzo[a]pyrene and dibenz[a,h]anthracene. Different assays have shown that not all botanical extracts that inhibit or stimulate AhR DNA binding in vitro are potent antagonists or activators, respectively, of DNA expression that requires passing through cellular membrane intact for bioactivity.1935,1936 Also, activity of a single component is not necessarily reflected in the complexity of an extract.1937 However, the in vitro induction by crucifer components of QR (isothiocyantes1195,21550), GST (sulforaphane860,2154,2415), and CYP 1A1 (indoles790,827,1179,1195) is somewhat reflected in findings from humans consuming cruciferous vegetables that induce UGT,100 GST,855,856,857 and CYP 1A2.97,99,620,801,1634,2462

CYP3A5 is expressed in 60% of African Americans but only 33% of Europeans and their American descendants. Since this isozyme represents at least 50% of the CYP3A content for those who have it, it may be the most important genetic contributor to differences in drug clearance and response between individuals and races. Genetic polymorphisms are not only evident in Phase I isozymes but are also found in humans for phase II enzymes such as glutathione S-transferases (GSTs) that exist in the primary classes alpha, pi, mu, theta, and zeta (A, P, M, T, and Z, respectively). UDP-glucuronosyltransferases (UGTs) have two main families, UGT1A and UGT2B, both of which asre highly polymorphic. The influence by inducers and inhibitors on the specific classes and families of these conjugating isozymes are noted when known.

Bold type face indicates human studies/reports, italics indicate animal studies; otherwise, studies are in vitro.

 [B.1.1.d & B.1.2.b,c  P-glycoprotein (Pgp) and similar efflux pumps designated multidrug resistance-associated proteins (MRP-1 to MRP-9) such as MRP-1 and 2 move metabolized conjugates from liver cells into the bile, while others remove glucuronidated drugs from kidney cells for excretion into the urine. MRP-1 and -3 also efflux drugs and their conjugates from other organs into the blood. This efflux activity is now being designated by scientists as “Phase III” drug detoxification. Both Pgp and MRP-2 efflux drugs from intestinal cells into the gut lumen. The enhancement or inhibition of these proteins before or following metabolism further impacts the bioavailability of drug substrates.]

 

B.7.1  Unspecified Influences of Herbal Agents on Substrate Pharmacokinetics     

 

B.7.1.a  Modulation by Phase I &/or Phase II Enzymes &/or Other Clearance Factors                                                                                                                                                                          p. 255

Substrates

benzoxyresorufin [2B1/2/6]  – Mg, mg,2266 rs2095                                             ;           my2067

coumarin [2A6] – rs,2095 sf2070

7-ethoxycoumarin [2E1]–  cm,1320 ep,1998 si1296

7-ethoxy-4-(Fl3Me)coumarin  [2B1/6] –          bi,2062 gb1615

7-ethoxyresorufin [1A1/2] –  Bm,1875 cc,1397 cc,1938,2035 Cn,2653 ea,1687 ep,1998 ga,1722,2093 gs,1082 Ku,2268 Kv,1733 na,849 pi,2073 pi2063 pu,2268 rs,1364,2095 sf2070

;           ds,1302 gi,859 my,2067 os,1302 tn2091

lauric acid [4A] – rs2095                                                                        ;           Te2098

7-pentoxyresorufin [2B1/2] – io,968 cc,2035 Ku,2268 pu2268                                 ;           ds,1302,2096 ds, Ga,2096,2097 os,1302 pi,2063 tn2091

Drugs:             aminopyrine [2C, 3A] – gp,6 Ku,2268 pu,2268 si1296                                             ;           gl,Li,1630 sc1292

            amitriptyline –                                                                                                             SJ1614

            antipyrine –                                                                                                     Sc1929

benzphetamine –                                                                                             sc1292

cyclosporine – bc,1572 Hc,2088 Pm1755                                                    ;           Cs,1572 Gp,1730 mo2116

ethylmorphine – cm,1320

etoposide –                                                                                                      Gf1329

hexobarbital – si1296

nevirapine –                                                                                                     SJ1972

nicotine – me2309

nimesulide – pp1821

paclitaxel – Fr, kb,2664 Gb, Go, Mt2145  

pentobarbital – bb1215                                                                           ;           SJ1338

            phenytoin – pp205

rhodamine 123 –                                                                                             Cs1572

rosiglitazone –                                                                                                             SJ2635

rosuvastatin –                                                                                                  SJ2631

saquinavir –                                                                                                     Ga1210

taxol – Eu, Gf, Kv, Po2568

warfarin –                                                                                                        Ag1600

zoxazolamine –           Pg2602                                                                                       sc1292

Steroids: estradiol –                                                                                         ;           gi,2462 is1326

            testosterone – Fa,1633 Fa1632                                                                  ;           gl, Li1630

Procarcinogens:         

benzo[a]pyrene – bc,1892 cc,1397 cs,1287 ct,1501 ea,1242 Nm,1155 rs,1364 si,1296 Tu,1301,1373 Tu1501     

;           +cs,1287 og,1155 +my,1284 +sc1292

dimethylbenz[a]anthracene (DMBA) – bi, pi,793 cc,1938 ga,1722,2093 rs,881 sp,1673 sr1723

methylnitrosamino-pyridyl-butanone (tobacco-specific NNK) – pi,2072 pi2063

Conversion/Clearance Inhibitors

(known inhibited Phase I CYP isozymes and inhibited phase II conjugating enzymes noted)

(ap) apigenin as in chamomile (Matricaria recutita) and Roman chamomile (Chamaemelum nobile) flowers, parsley (Petroselinum sativum) leaves, etc. – 1A2, 3A1848

(ba) I3,II8-biapigenin as in St. John’s wort (Hypericum perforatum), etc. – 1A2,1522 2C9, 2D6,1522 3A41522

(bb) berberine as in barberry (Berberis vulgaris), coptis (Coptis spp.), goldenseal (Hydrastis canadensis), and Oregon grape (Mahonia spp.) roots/barks

(bc) baicalin/baicalein and other Chinese skullcap flavones (Scutellaria baicalensis) – 1A2, 2C9, 3A41893 2B, 2E1, 3A,1892 2E11891 ; UGT1892

(bi) benzyl isothyocyanate in crucifers (Brassica spp.) – 2B1,2062 2E12061

(Bm) Bitter melon fruit (Momordica charantia) – 1A1, 2B1,2E11875 

(Bt) Black tea leaves (Camellia sinensis) – 2C9, 2C19. 1D6, 3A41577

(cc) curcumin in turmeric root (Curcuma longa, Curcuma aromatica) – 1A1,1938,2035 1A2,2035 1A1,1397 2B1, 2B22035 ; GST,2035 GST825 [not GST2057] [See Notes 2 & 8.]

(Cc) Cat’s claw bark (Uncaria tomentosa) – 3A41577

(Ch) Chamomile flowers (Matricaria recutita) – 2C9, 2C19, 2D6, 3A41577

(Cl) clove buds (Syzygium aromaticum) – 2C9, 2C19, 2D6, 3A41577

(cn) coumarin as in sweet clover (Melilotus officinalis), etc.

(Cn) Cannabis leaf tar (Cannabis sativa) – 1A12653

(cs) carnosol from rosemary leaves (Rosmarinum officinalis) – 1A11287

(ct) catechin as in catechu (Acacia catechu) bark, green tea (Camellia sinensis) leaves, etc.

(db) dihydroxybergamottin in grapefruit juice (Citrus paradisi) – 1A2, 2C9, 2C19, 2D6, 3A41458

(ds) diallyl sulfide in garlic oil (Allium sativum) – 2E11302,2096,2097 [Note 3.]

(ea) ellagic acid as in strawberry leaves, seeds (Fragaria spp.), raspberry leaves, seeds (Rubus spp.) and black walnut leaves, nuts (Juglans nigra), etc. – 2A2, 2B1/2B2, 2C6, 2C11, 3A1814 ; GST1687,2460

(El) Eleuthero roots (Eleutherococcus senticosus) 2C91577

(ep) epicatechins from green tea leaves (Camellia sinensis) – 1A1/1A21998

(Eu) Eucalyptus leaf oil (Eucalyptus globulus) – 2C8, 3A42568

(Fa) Fragrant angelica root (Angelica dahurica) – 2C9, 2D6, 3A41632

(Fr) Frankincense resin (Boswellia spp.) – 2C8, 2C9, 2C19, 3A42664 

(Fv) Feverfew leaves (Tanecetum parthenium) – 1A2,2568 2C9,1577,2568 2D6, 3A41577

(ga) galangin from China root (Alpinia officinarum) – 1A11722,2093

(Ga) Garlic cloves (Allium sativum) – 2E1,540,1629,2096,2097 2E1,540,1629 2E1,1328 3A41594 [Note 3]

(Gb) Ginkgo leaf extract (Ginkgo biloba) – 2C8,2C9, 3A42145

(gb) glabridin from licorice root (Glycyrrhiza glabra) – 2B6, 2C9, 3A41615

(Gf) Grapefruit juice (Citrus paradisi)

(Gk) Gotu kola herb (Centella asiatica) 3A41577

(Go) Goldenseal herb (Hydrastis canadensis) – 2C8,2145 2C9, 2C19,1577 2D6, 3A41577,2145

(gp) gossypol in cotton root bark (Gossypium herbaceum, Gossypium hirsutum) – GST6

(Gr) Ginger root/rhizome (Zingiber officinale) – 2C9, 2C19, 2D6, 3A41577

(Hc) Hierba del clavo herb (Geum chiloense)

(hp) hyperforin in St. John’s wort (Hypericum perforatum) – 1A2,1458 2C9, 2D6, 3A41522

(hp) hyperforin in St. John’s wort (Hypericum perforatum) – 2C9, 2D6, 3A41522

(kb) keto boswellic acids from frankincense resin (Boswellia spp.) – 2C8, 2C9, 2C19, 3A42664

(kl) kavalactones from kava root (Piper methysticum) – 1A2,1458 2C9, 2D6,1327 2C19, 3A41327,1458

(Ku) Kudzu roots (Pueraria lobata) – 2B1, 2E1, 3A2268

(Kv) Kava root (Piper methysticum) – 1A2, 2C19,1327,1733 2C8,2568 2C9,1327,1577,1733 2C19,2568 2D6,1327 3A4,1327,1475,1577,1733 4A9/111327

(me) menthol in peppermint leaves (Mentha piperita) – 2A62309 ; UGT2309

(Mg) Mango bark (Mangifera indica) – 1A2, 2B12266

(mg) mangiferin from mango bark (Mangifera indica) – 1A2, 2B1, 2C6,2E1, 3A12266

(mr) myricetin as in tea (black and green) leaves (Camellia sinensis), parsley (Petroselinum sativum) leaves, cranberry fruit/juice (Vaccinium macrocarpon), etc. – 1A2, 3A1848

(Mt) Milk thistle silymarin extract (Silybum marianum) – 2C8,2145 3A41293,1297,1398,2145 

(Nm) Nutmeg oil (Myristica fragrans)

(Or) Oregano leaves (Origanum vulgare) – 2C19, 2D6, 3A41577

(os) organosulfides in garlic cloves (Allium sativum) and onion bulbs (Allium cepa) – 2C9, 2C19,1458 2E1,864,1880 2E11302

(Pg) Pomegranate fruit/juice (Punica granatum) – 3A,1920,1923,2123,2213 3A1920 [no 3A2213]

(pi) phenethyl isothyocyanate from watercress herb (Nasturtium officinale), crucifers (Brassica spp.) – 1A,2063 1A2,2072,2073 2B1,2062 2E1,2073 2E1,2063,2073 3A2063 ; ST2063

(Pm) Peppermint leaves (Mentha piperita)

(Po) Peppermint oil (Mentha piperita) – 2C8, 2C9, 2C192568

(pp) piperine in black pepper (Piper nigrum) and long pepper fruit (Piper longum) – Pgp, 3A41820

(pu) puerarin in kudzu roots (Pueraria lobata) – 2B1, 2E1, 3A2268

(qu) quercetin as in onion bulbs (Allium cepa), tea leaves (Camellia sinensis), cranberry fruit/juice (Vaccinium macrocarpon), etc. – 1A2,1522,1848 2C8,2568 2C9,1458,1848 2C19,1458 3A1848

(rs) resveratrol as in dark-skin grapes (Vitis vinifera), mulberry fruit (Morus spp.), blueberry fruit (Vaccinium spp.) – 1A1,1364,1365,2095,2379 1A2,2095,23791B1, 2A6, 2B6, 4A,2095 2E1,2095,2379 3A41698,2095,2379 ; GST, QR2380 [See Note 8.]

(sf) safrole in sassafras bark oil (Sassafras albidum) – 1A2, 2A6, 2E12070

(Sg) Sage leaves (Salvia officinalis) – 1A2,2292 2C9, 2C19,1577 2D6, 3A41577,2292

(si) silymarin/silybin from milk thistle seeds (Silybum marianum) – 2C91297; GST,1285 UGT1293

(sp) soy protein isolate from soybeans (Glycine max) – 1B11673

(sr) sulforaphane from broccoli sprouts and tops (Brassica oleracea v. italica)

(Th) Thyme leaves (Thymus vulgaris) – 2C9, 2C19, 2D6, 3A41577

(Tu) Turmeric root (Curcuma longa, Curcuma aromatica) – 2C9, 2C19, 3A41577

Conversion/Clearance Inducers

(known induced Phase I CYP isozymes and induced phase II conjugating enzymes noted)

(Ag) American ginseng root (Panax quinquefolium)

(ar) artemisinin from sweet annie herb (Artemisia annua) – 2B6,1512,1930 2C19,1512,1931 2C19, 3A41930   [not 3A41931]

(bi) benzyl isothyocyanate in crucifers (Brassica spp.) – QR,1195,2155 QR2462

(cc) curcumin in turmeric root (Curcuma longa, Curcuma aromatica) – 1A1;1699,1938 GST,1396 QR,2154 ST,910 EH,1397 GST1395,1397 [not GST2057]  [See Notes 2 &  8.]

(cs) carnosol from rosemary leaves (Rosmarinum officinalis) – GST, QR1286,1287 [Note 2.]

(Cr) Crucifers edible parts (Brassica oleraceae) – 1A2,1987 1A22462 ; GST,2462  UGT-21987

(Cs) Chinese Skullcap roots (Scutellaria baicalensis)

(ct) catechin as in catechu (Acacia catechu) bark, green tea (Camellia sinensis) leaves, etc. – GST1501

(ds) diallyl sulfide in garlic cloves (Allium sativum) – 1A1,2096 1A2, 2B1,1302 2B2,1302,2096,2097 [CORRECTION] 2B1,967 3A1;2096 GST2096,2097 [Note 3.]

(Ga) Garlic cloves (Allium sativum) – 1A1, 3A1,1629,2096 1A1, 3A1,1629 2B12096,2097

(Gb) Ginkgo leaf extract (Ginkgo biloba) – 1A2,2292 1A1, 1A2, 2B, 2C9, 2E1, 3A4,1952 2C191617

(Gf) Grapefruit juice (Citrus paradisi)

(gi) glucobrassicin indole metabolites in specific crucifers (Brassica oleracea) – 1A1,1179,1195 1A2,798 2B1,1179 2B2/2B2,2462 3A12462 ; EH,2462 GST,1179 QR1179,1195 [Note 4.]

(gl) glycyrrhetinic acid/glycyrrhizin from licorice root (Glycyrrhiza glabra) – 1A2, 2B1, 3A1630

(Gp) Grape red wine (Vitis vinifera)

(hp) hyperforin from St. John’s wort tops (Hypericum perforatum) – PXR; 1A1, 1A2,1703 2C82107 3A4;1703,2107 GST, EH1703 

(is) isoflavones as in soy beans (Glycine max) [Note 4.]

(Li) Licorice root (Glycyrrhiza spp.) – 1A1/2, 2B1,1630,1650 2C9,1926 3A1630,1650 [Note 7.]

(mo) morin as in mulberry leaf (Morus alba)

(my) myristicin from parsley leaf oil (Petroselinum sativum), nutmeg seed (Myristica fragrans), etc. – 1A1, 1A2, 2B1, 2B2, 2E1;2067 GST1284 [Note 2.]

(og) oil of ginger root (Zingiber officinale)

(os) organosulfides in garlic cloves (Allium sativum) and onion bulbs (Allium cepa) – 1A1, 1A2, 2B1/2B21302

(pi) phenethyl isothyocyanate from watercress herb (Nasturtium officinale), crucifers (Brassica spp.) – 2B1 ; GST2063

(rs) resveratrol as in dark-skin grapes (Vitis vinifera), mulberry fruit (Morus spp.), blueberry fruit (Vaccinium spp.)  – 1A11699 [See Note 8.]

(sc) schizandrins from schisandra berry (Schisandra chinensis) [Note 2.]

(Sc) Schisandra fruit (Schisandra chinensis) – 2C9, 2C9, 3A1926

(SJ) St. John’s wort tops (Hypericum perforatum) 2C19,1584 2E1,1328 3A41328,1478 [Note 5.]

(sr) sulforaphane from broccoli sprouts and tops (Brassica oleracea v. italica) – GST,2415 QR,1195,2154-2156.2161,2167,2325,2415 GST, QR,1688

(Te) Tea (green and black) leaves (Camellia sinensis) – 1A2, 2B, 4A12098 1A2;2058,2098 GST,858,867,1649 UGT1649

(tn) tangeritin as in citrus fruit/juice (Citrus spp.) – 1A1/2, 2B1/21941,2091

Notes:                                                                                                                                                                                                                                                                         

2. Induction of benzo[a]pyrene metabolism by curcumin,1699,1938 crucifers,98,102,807 carnosol,1287 myristicin, 1284 and schizandrins1292 actually resulted in a reduction of the more genotoxic metabolites and/or of induced tumors, rather than bioactivation into a carcinogen.

3. The reduced bioavailability of saquinavir, a CYP 3A4/P-glycoprotein substrate, suggests that garlic induces one or the other or both of these reducers of substrate bioavailability.1210 However, fresh and aged garlic extracts had a moderate effect on inhibiting P-glycoprotein in vitro. Also, freeze-dried, fresh, odorless, aged, and oil products inhibited CYP 3A4 in descending order, aged and odorless inhibited 2C9, but only odorless products inhibited 2C19, whereas 2D6 was relatively unaffected by all in vitro.1594 Though CYP 1A1 and 3A1 were induced by steam-distilled garlic oil in vitro,1629,2096 CYP isozymes 1A2, 2D6, and 3A4 were unaffected by the garlic oil orally in humans.1328  Garlic extract failed to inhibit CYP 2D6 or 3A4 when drug substrates were given following 2 weeks of using 3.6 gm extract daily orally in humans.1456 Single diallyl sulfide dose 500 mg/kg depresses CYP450, aniline hydroxylase and aminopyrine N-demythlase activity; but 50 mg/kg daily for 5 days increases CYP450, benzphetamine N-demethylase, and aminopyrine N-demythlase activity when injected in rats.1362

4. Conversion of estradiol by soy isoflavones,1326 crucifers, and their glucobrassicin metabolite indole-3-carbinol is directed preferentially to 2-hydroxyestrone.2462

5.In vitro St. John’s wort tea inhibits CYP 2C9, 2C19, and 3A4,1577 its tincture and component hypericin inhibit CYP 3A4,840 and extract capsules and tablets diluted in ethanol or DMSO inhibit 2C19, 2D6, and 3A4.1593

6. Though CYP 2D6, 2E1 and 3A4 were inhibited by silybin, silydianin, and silychristin at concentrations of 10 mcm or greater (in vitro), this was not considered therapeutically relevant because concentrations of these flavonolignans in the body do not exceed 0.5 mcm.1398

7. Though licorice extract was found to be a CYP 3A4 inhibitor (in vitro)840 and the extract and glycyrrhizin were 3A4 inducers in vivo (PO in mice),1630 a 1 gram dose of a freeze-dried water extract given twice daily to 10 subjects for 7 days did not affect the pharmacokinetics or pharmacodynamics of the 3A4 substrate midazolam (PO in human study).1631

8. Resveratrol,1364,1365,2095,2379 curcumin, 1397 galangin,1722 and green tea extract820,1937 have been found to inhibit CYP 1A1 in vitro. They also mildly induce its activation by AhR,1699,1938 and along with apigenin they all strongly antagonize AhR inductions of CYP 1A1 by the procarcinogenic dioxin TCDD.1699,1722,1937,1938

                                                                                                                                                                                                                                                                                                                                                               

 

B.7.1.b Influence on Pregnane X Receptor (PXR)                                                                                                            NEW

Receptor activators

(ar) artemisinin from sweet annie herb (Artemisia annua) – (liver, intestine)1930

(As) Astragalus root (Astragalus membranaceus) – (liver)1926 

(Dq) Dong quai root (Angelica sinensis) – (liver)1926

(fr) forskolin in Coleus roots (Coleum forskohlii) – (liver)2232

(gu) guggulipid/guggulsterones from guggul resin (Commiphora mukul) – (liver)1636

(hp) hyperforin in St. John’s wort herb (Hypericum perforatum) – (colon)2127

(Kv) Kava root (Piper methysticum) – (liver)1696

(CL) Chinese Licorice root (Glycyrrhiza uralensis) – (liver)1926

(Rh) Chinese Rhubarb root (Rheum palmatum v. tanguticum – (liver)1926

(Sc) Schisandra berry (Schisandra chinensis) – (liver)1926

(SJ) St. John’s wort (Hypericum perforatum) – (liver),1002,1703 (choriocarcinoma),1288 (colon)2127

(vE) vitamin E – (liver)2233 

(vK) Vitamin K2 – (bone)1934

Receptor non-activators

(Em) Epimedium leaf (Epimedium macranthum) – (liver)1926

(Ft) Fo-ti root (Polygonum multiflorum) – (liver)1926

(Gs) Ginseng (Asian) root (Panax ginseng) – (liver)1926

(Ly) Lycium fruit (Lycium spp.) – (liver)1926

(Rs) Reishi mushroom (Ganodernum lucidum) – (liver)1926

(Tu) Turmeric rhizome (Curcuma longa) – (liver)1926

 

B.7.1.c Influence on Aryl hydrocarbon Receptor (AhR)                                                                                                  NEW

Receptor inhibitors

(ap) apigenin as in chamomile (Matricaria recutita) and Roman chamomile (Chamaemelum nobile) flowers, parsley (Petroselinum sativum) leaves, etc. – liver1699,1939,1940 

(bc) baicalein in skullcap (Scutellaria lateriflora), Chinese skullcap (Scutellaria baicalensis) – liver1939,1940

(Br) Broccoli tops (Brassica oleracea v. italica) – liver1936

(cc) curcumin in turmeric root (Curcuma longa, Curcuma aromatica) – breast,1938 stomach1397 [See Note 1.]

(Cl) Clove buds (Syzygium aromaticum) – liver1936

(Ct) Citrus (Lemon, Lime, Orange) fruit (Citrus spp.) – liver1936

(cy) chrysin from passion flower plant (Passiflora incarnata, Passiflora coerulea) – liver1940

(ga) galangin from China root (Alpinia officinarum) – liver,1939,1940 breast2093 

(Gf) Grapefruit fruit (Citrus paradisi) – liver1936

(Gv) Guava leaf (Psidium spp.) – liver1936

(kf) kaempferol as in tea (black and green) leaves (Camellia sinensis), kale leaves (Brassica oleracea v. acephala), etc. – liver,1939,1940 breast2092 [See Note 1.]

(lt) luteolin as in thyme (Thymus spp.), asparagus (Asparagus officinalis), etc. – liver1939,1940 

(Lt) Lettuce leaves (Lactuca sativa) – liver1936

(Lv) Lavender (Lavandula spp.) – liver1936

(mo) morin in Mulberry twigs (Morus alba) – liver1939,1940

(mr) myricetin as in tea (black and green) leaves (Camellia sinensis), parsley (Petroselinum sativum) leaves, cranberry fruit/juice (Vaccinium macrocarpon), etc. – liver1940

(nr) naringenin as in grapefruit fruit/juice (Citrus paradisi) – liver1699,1939,1940 

(pl) polyphenols from green tea leaves (Camellia sinensis) – liver1936,1937

(Pm) Peppermint leaves (Mentha piperita) – liver1936

(qu) quercetin as in onion bulbs (Allium cepa), tea leaves (Camellia sinensis), kale leaves (Brassica oleracea v. acephala), etc. – liver1939,1940,2092 [See Note 2.]

(rs) resveratrol as in dark-skin grapes (Vitis vinifera), mulberry fruit (Morus spp.), blueberry fruit (Vaccinium spp.)  – liver1364,1365 [See Note 1.]

(Sg) Sage leaves (Salvia officinalis) – liver1936

(Sp) Spinach leaves (Spinacea oleracea) – liver1936

(tn) tangeritin as in citrus fruit/juice (Citrus spp.) – liver1939,1940

(Te) Tea (oolong>black>green) leaves (Camellia sinensis) – liver1936,1937 [See Note 1.]

Receptor activators

(Af) Alfalfa leaves (Medicago sativa) – liver1935

(Bc) Black cohosh root (Cimicifuga racemosa) – liver1935,2012

(Bt) Blessed thistle herb (Cnicus benedictus) – liver1935

(cc) curcumin in turmeric root (Curcuma longa, Curcuma aromatica) – breast1938 [See Note 1.]

(Dc) Devil’s claw rhizome (Harpagophytum procumbens) – liver1935

(dm) diosmin/diosmetin from citrus fruit (Citrus spp.) – breast2298

(Ft) Fo-ti root (Polygonum multiflorum) – liver1935

(ga) galangin from China root (Alpinia officinarum) – breast2093 

(Gb) Ginkgo leaves (Ginkgo biloba) – liver1935

(gi) glucobrassicin indole metabolites in certain crucifers (Brassica oleracea) – liver1942

(Gs) Ginseng (Asian) root (Panax ginseng) – liver1935

(Gt) Green tea leaves (Camellia sinensis) – liver1699,1937 [See Note 1.]

(Lc) Licorice root (Glycyrrhiza glabra) – liver1935

(qu) quercetin as in onion bulbs (Allium cepa), tea leaves (Camellia sinensis), kale leaves (Brassica oleracea v. acephala), etc. – breast2092 [See Note 2.]

(rs) resveratrol as in dark-skin grapes (Vitis vinifera), mulberry fruit (Morus spp.), blueberry fruit (Vaccinium spp.)  – liver1699,2012 [See Note 1.]

(tn) tangeritin as in citrus fruit/juice (Citrus spp.) – liver2091

(Wo) White oak bark (Quercus alba) – liver1935

No effect on receptor

(As) Asparagus stalk (Asparagus officinalis) – liver1936

(Av) Avocado fruit (Persea americana) – liver1936

(Bn) Banana fruit (Musa spp.) – liver1936

(Bs) Basil leaves (Ocimum basilicum) – liver1936

(Cn) Catnip herb (Nepeta cataria) – liver1935

(Ct) Carrot root (Daucus carota) – liver1936

(Cy) Cherry fruit (Prunus avium) – liver1936

(Cm) Cinnamon bark (Cinnamomum verum) – liver1936

(Dm) Damiana leaves (Turnera diffusa) – liver1935

(Dq) Dong quai root (Angelica sinensis) – liver1935

(Gr) Ginger root (Zingiber officinale) – liver1935

(Ht) Hawthorn berries (Crataegus spp.) – liver1935

(Kp) Kelp thallus (Laminaria spp.) – liver1935

(Lq) Loquat fruit (Eriobotrya japonica) – liver1936

(Mn) Mango fruit (Mangifera indica) – liver1936

(Nt) Nettles herb (Urtica spp.) – liver1935

(PA) Pau d’Arco inner bark (Tabebuia spp.) – liver1935

(Sp) Saw palmetto berries (Serenoa repens) – liver1935

(Uu) Uva ursi leaves (Arctostaphylos uva-ursi) – liver1935

(Va) Valerian root (Valeriana officinalis) – liver1935

(Ww) White willow bark (Salix alba) – liver1935

Notes

1) Resveratrol,1364,1365 curcumin,1397 kaempferol,1699,939,1940 galangin,1722 and green tea extract820,1699,1937 all inhibit CYP 1A1 expression in vitro. Though they also mildly induce its activation by AhR,1699,1938,2093 they strongly antagonize AhR inductions of CYP 1A1 by the procarcinogenic dioxin TCDD.1699,1722,1937,1938,2092,2093 

2) Quercetin has been shown in vitro to inhibit the activation of of AhR by tetrachlorodibenzo-dioxin at physiological micromolar levels1939,1940,2092 and also to activate AhR when given by itself in the same concentration range.2092

 

B.7.2  Influences of Herbal Agents in Phase I on Specific Cytochrome P450 Substrates   

 

B.7.2.a  Influence on CYP 1A2 Metabolic Conversion of Substrates                                                                                                                                     p. 259

Substrates:

3-cyano-7-ethoxy-coumarin – Ch,2013 Ep,2293 gg, hp, kl,1458 kf, mr, nr, qu,1766 xh2289

7-ethoxyresorufin – An,2230 cc,2035 cf,2059 is,2065 Kv,1733 pi,2073 rs2379     ;           my2067

7-methoxyresorufin – a,1766 og,2069 pi2072                                             ;           cf,2058 Gb,1952 gl,1630,1650 Ku,2268 Li,1630,1650 os,1302 pu,2268 Te,2058 tn2091

Drugs: acetanilide – hd,2145 Kv,1327 xh2290,2291

            caffeine – ap,1766 bc,1893 cy,1766 Ep,1588 kf, mr, qu1766 Um1634               ;           Cr,1634 SJ1838

clopidogrel –                                                                                        ;           Ts2306

phenacetin –  ap,1954 ba,1522 Dq,2671 gf, kf,1954 Mg, mg,2266 mr, qu,1522,1954 Sg,2292

Ch, Dl, Pm1608  ;           cf,1608 Gb2292

propranolol – pp206

tacrine – Fv,2568 Kv2568                                                                                             ;           Ts2211

theophylline – pp206                                                                             ;           Gb,2278 SJ2528

Steroids: estradiol –                                                                 [CORRECTION]          gi,798,2515 gi,803 Ts842

            [glucobrassicin indole metabolites (gi) should be in the inducer column along with Tobacco smoke, not the inhibitor column.]

Procarcinogens:         

            2-amino-3-methylimidazo[4,5f]quinoline – xh2290                               ;           Cr1987

Isozyme Inhibitors

(An) Andrographis leaves (Andrographis paniculata)

(ap) apigenin as in chamomile (Matricaria recutita) and Roman chamomile (Chamaemelum nobile) flowers, parsley (Petroselinum sativum) leaves, etc.

(ba) I3,II8-biapigenin as in St. John’s wort (Hypericum perforatum), etc.

(bc) baicalin/baicalein and other Chinese skullcap flavones (Scutellaria baicalensis)

(cc) curcumin in turmeric root (Curcuma longa, Curcuma aromatica)

(Ch) Chamomile flowers (Matricaria recutita)

(cy) chrysin from passion flower plant (Passiflora incarnata, Passiflora coerulea)

(Dl) Dandelion root (Taraxacum officinale)

(Dq) Dong quai root (Angelica sinensis)

(Ep) Echinacea purpurea roots and plant (Echinacea purpurea) [See Note 2.]

(Fv) Feverfew leaves (Tanecetum parthenium)

(ga) galangin from China root (Alpinia officinarum)

(gf) ginkgo flavonol aglycones in ginkgo leaves (Ginkgo biloba)

(gg) ginkgolic acids in ginkgo leaves (Ginkgo biloba)

(hd) hydrastine in Goldenseal root and herb (Hydrastis canadensis)

(hp) hyperforin in St. John’s wort (Hypericum perforatum)

(is) isoflavones as in soy beans (Glycine max), kudzu plant (Pueraria lobata), etc.

(kf) kaempferol as in tea (black and green) leaves (Camellia sinensis), kale leaves (Brassica oleracea v. acephala), etc.

(kl) kavalactones from kava root (Piper methysticum)

(Kv) Kava root (Piper methysticum)

(Mg) Mango bark (Mangifera indica)

(mg) mangiferin from mango bark (Mangifera indica)

(mr) myricetin as in tea (black and green) leaves (Camellia sinensis), parsley (Petroselinum sativum) leaves, cranberry fruit/juice (Vaccinium macrocarpon), etc.

(nr) naringenin as in grapefruit juice (Citrus paradisi)

(og) oleuropein glycoside from olive fruit oil (Olea europaea)

(pi) phenethyl isothyocyanate from watercress herb (Nasturtium officinalecrucifers (Brassica spp.)

(Pm) Peppermint leaves (Mentha piperita)

(pp) piperine in black pepper (Piper nigrum) and long pepper fruit (Piper longum)

(qu) quercetin as in onion bulbs (Allium cepa), tea leaves (Camellia sinensis), cranberry fruit/juice (Vaccinium macrocarpon), etc.

(Sg) Sage leaves (Salvia officinalis)

(Um) Umbellifers: carrots (Daucus carota), celery (Apium graveolens), dill (Anethum graveolens), parsley (Petroselinum sativum) & parsnips (Pastinaca sativa)

(xh) xanthohumol and/or isoxanthohumol in hops strobiles (Humulus lupulus)

Isozyme Inducers

(cf) caffeine as in coffee (Coffea arabica), cola (Cola nitida), tea (Camellia sinensis), etc. [See Note 5.]

(Cr) Crucifers: broccoli, cauliflower, cabbage (Brassica oleracea)

(Gb) Ginkgo leaf extract (Ginkgo biloba)  [See Note 4.]

(gi) glucobrassicin indole metabolites in specific crucifers (Brassica oleracea)

(gl) glycyrrhetinic acid/glycyrrhizin from licorice root (Glycyrrhiza glabra)

(kf) kaempferol as in tea (black and green) leaves (Camellia sinensis), kale leaves (Brassica oleracea v. acephala), etc.

(Ku) Kudzu roots (Pueraria lobata)

(Li) Licorice root (Glycyrrhiza glabra)

(my) myristicin from parsley leaf oil (Petroselinum sativum), nutmeg seed (Myristica fragrans), etc. 

(pu) puerarin in kudzu roots (Pueraria lobata)

(SJ) St. John’s wort (Hypericum perforatum) [Women only.1838 See Note 3.]

(Te) Tea (green and black) leaves (Camellia sinensis)

(Ts) Tobacco smoke from leaf *(Nicotiana tabacum)  [See Note 6.]

No Effect in Human Studies with Isozyme CYP 1A2 Substrates  ^                                     NEW

(Al) Alliums: fresh leeks, onion, chives & garlic (Allium spp.) – caffeine1634

(Bc) Black cohosh roots/rhizome (Cimicifuga racemosa) – caffeine1807

(Bo) Bitter orange (Citrus aurantium) – caffeine1589

(Cb) Cranberry fruit/juice (Vaccinium macrocarpon) – R-warfarin, tizanidine2316

(Ep) Echinacea purpurea (Echinacea purpurea) – caffeine1589  [See Note 2.]

(Ga) Garlic oil (Allium sativum) – caffeine1328,1808

(Gb) Ginkgo leaf extract (Ginkgo biloba) – caffeine1328,1808,2302  [See Note 4.]

(Go) Goldenseal herb (Hydrastis canadensis) – caffeine1807

(Gs) Ginseng (Asian) root (Panax ginseng) – caffeine1328,1808 

(Kv) Kava root (Piper methysticum) – caffeine1807

(me) menthol in peppermint leaves (Mentha piperita) – caffeine2308

(Mt) Milk thistle silymarin extract (Silybum marianum) – caffeine1589

(Sp) Saw palmetto liposterolic extract (Serenoa repens) – caffeine1589

(SJ) St. John’s wort (Hypericum perforatum) – caffeine,1217,1328,1584,1775,1808 theophylline1585 [See Note 3.]

(Va) Valerian root (Valeriana officinalis) – caffeine1807

Notes:                                                                                                                                                                                                                                                                         

1. In vivo induction of estradiol is directed preferentially to 2-hydroxyestrone in humans, thereby increasing its ratio to 16alpha-hydroxyestrone and estriol and reducing breast cancer risk.798,2515,2516,2517

2. One study using 1.6 gm/day Echinacea purpurea root extract for 8 days inhibited intestinal CYP1A2, increasing caffeine bioavailability.1588 However, another study using a whole plant E. purpurea extract and dose for 28 days failed to affect the metabolism of caffeine.1589 This likely reflects the phytochemical differences in the root extract versus the the whole plant extract. This likely reflects the phytochemical differences in the root extract versus the the whole plant extract. While the whole plant extract inhibits CYP 1A2 in vitro, the alkamides components did not.2610

3. A human study of theophylline metabolism in 12 men found no effect with 900 mg St. John’s wort extract,1585 though a woman needed to increase her dosage when using this drug with 300 mg St. John’s wort.435 Studies on caffeine metabolism with 900 mg/day St. John’s wort extract found no significant changes with 12 men1584 or when combining data from men and women with 5 females and 7 males1217 or 6 females and 6 males.1328,1808 However, another study using caffeine found no effect in 8 men but significantly increased metabolic ratios in 8 women.1838 This may help explain the single likely case of interaction between St. John’s wort and theophylline in the female.

4. Ginkgo extract is a CYP1A2 inducer at low concentrations (2.2 mcg/ml) but an inhibitor at high concentrations (22 and 220 mcg/ml) in vitro.2292 At 100 mg/kg orally and as 0.5% of the diet in rats was shown to induce this isozyme,1952,2278 but normal therapeutic doses do not produce this effect in humans.1328,1808,2302 Recovery from CYP1A2 induction occurs within 2 weeks.1952 

5. Caffeine is not only a substrate of CYP1A2, but also an inducer in vitro1608 and in rats.2058,2059 However, when caffeine use is suddenly withdrawn in humans, this can also lead to a reduction of other CYP1A2 substrates like clozapine,458 probably because it no longer acts as a competitor for binding to the isozyme that it has induced.

6. For the antiplatelet prodrug clopidogrel the active therapeutic agent is its metabolite. Therefore, its induced metabolism in tobacco smokers increases rather than decreases its activity.2306

                                                                                                                                                                                                                                                                                   

 

B.7.2.b  Influence on CYP 2E1 Metabolic Conversion of Substrates                                          p. 260

Substrates:

            acetone – ds1154

            aniline –                                                                                                           ;           my2067

            carbon tetrachloride – ds812

            7-ethoxy-4-(triFMe)coumarin –           bi2061

            p-nitrophenol – al,2609 bb,2145,2609 Dl,1608 eg, eg,1687 Ep, Go, hd,2609 is,2065 Ku,2268 Pm,1608 pu2268                       ;            Gb1952

Drugs:acetaminophen – bc,1891 ds,1153 pi,2073 Wc2009

            chlorzoxazone – Dq,2671 ds,1717 Ga,1328,1808 Kv,1807 mg,2266 rh,2492 rs,2095,2379 sf,2070 Wc1642 ;     Gb,2302 SJ1328,1808

theophylline –                                                                                                              SJ435

[CORRECTION: enhanced theophylline metabolism by St. John’s wort (SJ435) is likely due to CYP 2E1 induction, rather than CYP 1A2.1328]

Procarcinogens:

NDMA (N-nitrosodimethylamine) – bc,1892 ds,1181,2096 Ga,2096 pi,2073 pi2063

            DEN (diethylnitrosamine) – ds, ds,809 Ga1716

Isozyme Inhibitors

(al) alkymides from Echinacea purpurea fresh root (Echinacea purpurea) [See Note 5.]

(bb) berberine as in barberry (Berberis vulgaris), coptis (Coptis spp.), goldenseal (Hydrastis canadensis), and Oregon grape (Mahonia spp.) roots/barks [See Note 4.]

(bc) baicalin/baicalein and other Chinese skullcap flavones (Scutellaria baicalensis)

(bi) benzyl isothyocyanate in crucifers (Brassica spp.)

(Dl) Dandelion root (Taraxacum officinale) 

(Dq) Dong quai root (Angelica sinensis)

(ds) diallyl sulfide from garlic cloves (Allium sativum) [See Note 3.]

(ea) ellagic acid as in strawberry leaves, seeds (Fragaria spp.), raspberry leaves, seeds (Rubus spp.) and black walnut leaves, nuts (Juglans nigra), etc.

(Ep) Echinacea purpurea fresh root (Echinacea purpurea) [See Note 5.]

(Ga) Garlic cloves (Allium sativum) [See Note 3.]

(Go) Goldenseal root (Hydrastis canadensis) [See Note 4.]

(hd) hydrastine in goldenseal root (Hydrastis canadensis) [See Note 4.]

(is) isoflavones as in soy beans (Glycine max), kudzu plant (Pueraria lobata), etc.

(Ku) Kudzu roots (Pueraria lobata)

(Kv) Kava root (Piper methysticum)

(mg) mangiferin from mango bark (Mangifera indica)

(pi) phenethyl isothyocyanate from watercress herb (Nasturtium officinalecrucifers (Brassica spp.)

(Pm) Peppermint leaves (Mentha piperita)

(pu) puerarin in kudzu roots (Pueraria lobata)

(rh) rhein as in Chinese rhubarb root (Rheum palmatum), aloes (Aloe spp.), etc.

(rs) resveratrol as in dark-skin grapes (Vitis vinifera), mulberry fruit (Morus spp.), blueberry fruit (Vaccinium spp.)   

(sf) safrole in sassafras bark oil (Sassafras albidum) – 1A2, 2A6, 2E12070

(Wc) Watercress plant (Nasturtium officinale)

Isozyme Inducers

(Gb) Ginkgo leaf extract (Ginkgo biloba) [See Note 2.]

(my) myristicin from parsley leaf oil (Petroselinum sativum), nutmeg seed (Myristica fragrans), etc.

(SJ) St. John’s wort tops (Hypericum perforatum) [See Note 1.]

[CORRECTION: Contrary to an earlier report,1082 no evidence was found of a relevant interaction of (si) silymarin/silybin from milk thistle seeds (Silybum marianum) inducing CYP 2E1 in other studies.1123,1297,1398 In fact, when hepatotoxicity of 2E1 substrate methotrexate is increased 2 to 3 times by inducers acetaminophen and ethanol, respectively, silymarin abolishes this enhanced toxicity.1124 An uncharacterized milk thistle product failed to alter bioavailability of 2E1 substrate chlorzoxazone in 12 humans after 4 weeks.1589 See B.7.1.a for in vitro evidence that silymarin/silybin inhibits other phase I isozymes and phase II enzymes.]

No Effect in Human Studies with Isozyme CYP 2E1 Substrates          ^                                              NEW

(Bc) Black cohosh roots/rhizome (Cimicifuga racemosa) – chlorzoxazone1807

(Bo) Bitter orange (Citrus aurantium) – chlorzoxazone1589

(Ep) Echinacea purpurea whole plant (Echinacea purpurea) – chlorzoxazone1589 [See Note 5.]

(Ga) Garlic aged clove extract (Allium sativum) [See Note 3.]

(Go) Goldenseal root (Hydrastis canadensis) – chlorzoxazone1807 [See Note 4.]

(Gs) Ginseng (Asian) root (Panax ginseng) – chlorzoxazone1328,1808 

(Mt) Milk thistle silymarin extract (Silybum marianum) – chlorzoxazone1589 

(Sp) Saw palmetto liposterolic extract (Serenoa repens) – chlorzoxazone1589 

(Va) Valerian root (Valeriana officinalis) – chlorzoxazone1807

Notes:                                                                                                                                                                                                                                                                         

1. In spite of one case report suggesting induced theophylline metabolism,435 after 2 weeks St. John’s wort extract 900 mg/day did not reduce theophylline plasma levels.1585

2. EGb761 at 280 mg twice daily for 12 days in 12 human subjects significantly modulated metabolism of a single dose of the CYP 2E1 substrate chlorzoxazone, showing a mean change of 15.0%,2302 though in other studies normal therapeutic doses do not produce this effect in humans.1328,1808 Ginkgo extract as 0.5% of the diet in rats was shown to induce this isozyme. Recovery from CYP2E1 induction occurs within 2 weeks.1952 

3. CYP 2E1 was inhibited with oral consumption of 500 mg of garlic oil 3 times daily in humans1328,1808 and by fresh garlic orally at 0.5 gm/mg in mice.540 Its component diallyl sulfide is also inhibitory of this isozyme in animals812,1181,1153,1154 and in humans.1717 Diallyl sulfone, a metabolite of diallyl sulfide, given in oral doses as low as 25 mg/kg prevented acetaminophen hepatotoxicity in mice.1816 However, 10 ml of aged garlic extract daily for 12 weeks in humans caused no effect on CYP 2E1 metabolism of acetaminophen. This extract had as its major constituent S-allyl-L-cyseine, but very little diallyl sulfide.1815

4. Berberine modestly or weakly inhibited CYP2E1 in vitro,2145, 2609 and goldenseal aqueous and alcoholic rhizome extracts and hydrastine had no effect in one study2145 but a 50% ethanolic root extract had relatively potent effects in another study in vitro.2609 However, in humans a goldenseal root extract had no effect on CYP 2E1.1807

5. Though the 95% ethanolic Echinacea purpurea fresh root extract, its alkamide fraction, and individual isobutylamides inhibit CYP 2E1 in vitro, the caffeic acid derivatives and a 33% ethanolic extract low in alkamides showed no inhibition.2609

                                                                                                                                                                                                                                                                                   

 

B.7.2.c  Influence on CYP 3A Metabolic Conversion of Substrates                                p. 260

Substrates:

            aminopyrine –             Ku, pu, pu2268                                                               ;           gl, Li1630,1650

            7-benzyloxyresorufin –           Cs,1894 gs,1812 Bt, Cc, Ch, Cl, Fv, Go, Gr, Kv,1577 Mt,840 Or, Sg, SJ,1577 Sk,1894 Sp,2151 Th, Tu,1577 Va840

7-benzyloxy-4-(Fl3Me)coumarin – db,1458 Ep,2610,2612 gs,1812 Gb,2151 gb, Li,1615 si,2210 SJ,1593 Sp,2151 Va1593

dibenzylfluorescein – So,2208 Va1748

Drugs: alprazolam–                                                                                                     SJ1478  

amiodarone – Gf1161,1333

            atorvastatin – Gf1161,1333,2047,2048

            buspirone – Gf1161,1333,2052

            carbamazepine – Gf,1161,1333 Pg, Pg1920

            cerivastatin – Gf1161,1333

            cisapride – Gf1161,1731,2053

            clomipramine –            Gf2589 

cyclosporine – bb,2281 Bo, Po,2028  Po2021

denitronifedipine – si1297

dextromethorphan – Bo, Gf,2666 kl,1327 Kv,1327  rh,2492 si1297

diazepam – Fa,1632 Gf1161,1333                                                               ;           SJ1338

diltiazem – Gb, Gb,1823 Gf2100

docetaxel –                                                                                                      hp2107 

erythromycin –            An, Az,2123 bc,1892 Bp, Cl, Cu, Li, Pg, Rh, Sw2123         ;           SJ1350

felodipine – Bo, Gf,1729 Pm1756

halofantrine – Gf1918

imatinib –                                                                                                        SJ1668,1692

irinotecan –                                                                                                      SJ1342

itraconazole – *Gf2503

ivabradine –                                                                                                     SJ2630

lidocaine –                                                                                           ;           CL2573

lovastatin – Gf2049

methadone – Gf2591

methylprednisolone – Gf1161

midazolam – Cb,2699 db,476,1454 Ep,1588 Eu,2568 Fr,2664 Gb, Gd, Go, gs,2145 Gb,2015 Gf,1923,2568 Gf,1885,2213 Go,1807,2501 kb,2664 Mb,1885 mg,2266 Mt,2145 Pg, Pp, Sf,1923 Wg1885    

;           SJ,1217,1328,1590,1613,1808,1809,2599 tn1766

            nicardipine – Gf2099

nifedipine – bc,1892 Fa,1632 Gb, Gs,1728 mt, Pm1756                                ;           SJ1728,2623

 

quazepam –                                                                                                     SJ1819

            quinidine – Kv1733       

R-warfarin –                                                                                                                                         SJ1578 

saquinavir –                                                                                                     Ga1210

sertraline – Gf2592

sildenafil – Gf2590

simvastatin – Gf2046

            tacrolimus – Gf,2030 Gf,1161,1333 Po,2030 Po2027                                       ;           SJ1349,1376,1552

            triazolam – am, ap, gf, kf, mr, qu,1954 Gf, Pg,2213 Gf2051

            verapamil – pp,1820 Gf320,1304,2584                                                          ;           SJ1675

            voriconazole –                                                                                                             SJ1839

[Interactions small and not clinically significant for the following: ]

alprazolam – Va1676

amlodipine – Gf1161

                        omeprazole –                                                                                       SJ1674

quinidine – Gf1161,1333

                        verapamil – Gf1161,1333,2586                                                        ;           SJ1675

Steroids: androstenedione – og2068,2069                                                                         ;           gl, Li1630,1650

            cortisol –                                                                                                          SJ1595,1819,1838

desogestrel [3-keto metabolite] –                                                                     SJ1505

ethinylestradiol –                                                                                             SJ1802 

norethindrone –                                                                                               SJ1524,1802,1809  

testosterone –   An,2230 ba,1522 bc,1893 Bo,1633 db,1637 Dq,1633 Ea,2581 Ep,2292,2581,2608 Fa,1633 Fa,1632 fc,1637 Gb,2292,2608 Gd,2145 Gf,1450,1732,2030 Go,1813,2145

Gp,1698,1732 gs,2145 Hc,2608 hd,1813 hp, hy1522 Kv, kl,1475,2146 Mt,2145 Po,2030 Qi,1633 rs,1698,2095,2379 Sg,2292,2608 si,1293,2210 SJ,2608 Va2608

;           Gb,1952 gl, Li,1630,1650 SJ,2292 Va2292

Isozyme Inhibitors

(am) amentoflavone in ginkgo leaves (Ginkgo biloba), St. John’s wort flowers (Hypericum perforatum)

(An) Andrographis leaves (Andrographis paniculata)

(ap) apigenin as in chamomile (Matricaria recutita) and Roman chamomile (Chamaemelum nobile) flowers, parsley (Petroselinum sativum) leaves, etc.

(Az) Aromatic zingiber rhizome (Zingiber aromaticum)

(ba) I3,II8-biapigenin as in St. John’s wort (Hypericum perforatum), etc.

(bb) berberine as in barberry (Berberis vulgaris), coptis (Coptis spp.), goldenseal (Hydrastis canadensis), and Oregon grape (Mahonia spp.) roots/barks [See Note 10.]

(bc) baicalin/baicalein and other Chinese skullcap flavones (Scutellaria baicalensis)

(Bo) Bitter orange fruit (Citrus aurantium) [See Note 8.]

(Bp) Black pepper fruit (Piper nigrum)

(Bt) Black tea leaves (Camellia sinensis)

(Cb) Cranberry fruit/juice (Vaccinium macrocarpon) [See Note 18.]

(Cc) Cat’s claw bark (Uncaria tomentosa)

(Ch) [CORRECTION] CHAMOMILE herb (Matricaria recutita)

(Cl) Clove buds (Syzygium aromaticum)

(Cs) Chinese skullcap flavones (Scutellaria baicalensis)

(Cu) Cubeb fruit (Piper cubeba)

(db) dihydroxybergamottin in grapefruit fruit/juice (Citrus paradisi) and bitter orange fruit juice (Citrus aurantium) [See Note 8.]

(Dq) Dong quai root (Angelica sinensis) [See Note 17.]

(Ea) Echinacea angustifolia root (Echinacea angustifolia)

(Ec) Echinacea (Echinacea spp.) [See Note 3.]

(Ep) Echinacea purpurea roots, plant (Echinacea purpurea) [See Note 3.]

(Eu) Eucalyptus leaf oil (Eucalyptus globulus)

(Fa) Fragrant angelica root (Angelica dahurica) [See Note 6.]

(fc) furanocoumarins from fragrant angelica root (Angelica dahurica)

(Fr) Frankincense resin (Boswellia spp.)

(Fv) Feverfew leaves (Tanecetum parthenium)

(gb) glabridin from licorice root (Glycyrrhiza glabra)

(Gb) Ginkgo leaf extract (Ginkgo biloba) [See Note 15.]

(Gd) Grape seed (Vitis vinifera)

(gf) ginkgo flavonol aglycones in ginkgo leaves (Ginkgo biloba)

(Gf) Grapefruit fruit/juice (Citrus paradisi) [intestinal CYP3A4 only] [See Note 14.]

(Gk) Gotu kola herb (Centella asiatica)

(Go) Goldenseal root or herb (Hydrastis canadensis)

(Gp) Grape red wine (Vitis vinifera) [See Note 5.]

(Gr) Ginger root/rhizome (Zingiber officinale)

(gs) ginsenosides (F1, Rd, Rh1) from Asian ginseng (Panax ginseng) roots

(Gs) Ginseng (Asian) root (Panax ginseng) [See Note 11.]

(Hc) Horse chestnut seeds (Aesculus hippocastanum)

(hd) hydrastine in goldenseal root (Hydrastis canadensis)  [See Note 10.]

(hp) hyperforin in St. John’s wort (Hypericum perforatum)

(kb) keto boswellic acids from frankincense resin (Boswellia spp.)

(kf) kaempferol as in tea (black and green) leaves (Camellia sinensis), kale leaves (Brassica oleracea v. acephala), etc.

(kl) kavalactones from kava root (Piper methysticum)

(Ku) Kudzu roots (Pueraria lobata)

(Kv) Kava root (Piper methysticum) [See Note 9.]

(Li) Licorice root (Glycyrrhiza glabra) [See Note 4.]

(Mb) Mulberry fruit (Morus nigra)

(mg) mangiferin from mango bark (Mangifera indica)

(mn) menthol in peppermint leaves (Mentha piperita)

(mr) myricetin as in tea (black and green) leaves (Camellia sinensis), parsley (Petroselinum sativum) leaves, cranberry fruit/juice (Vaccinium macrocarpon), etc.

(Mt) Milk thistle seeds (Silybum marianum) [See Note 1.]

(og) oleuropein glycoside from olive fruit oil (Olea europaea)

(Or) Oregano leaves (Origanum vulgare)

(Pg) Pomegranate fruit (Punica granatum) [See Note 16.]

(Pm) Peppermint leaves (Mentha piperita)

(Po) Pomelo fruit juice (Citrus grandis)

(pp) piperine in black pepper (Piper nigrum) and long pepper fruit (Piper longum)

(Pp) Papaya fruit juice (Carica papaya)

(pu) puerarin in kudzu roots (Pueraria lobata)

(Qi) Qianghuo root (Notopterygium incisum, Notopterygium forbesii)

(qu) quercetin as in onion bulbs (Allium cepa), tea leaves (Camellia sinensis), cranberry fruit/juice (Vaccinium macrocarpon), etc. [See Note 9.]

(rh) rhein as in Chinese rhubarb root (Rheum palmatum), aloes (Aloe spp.), etc.

(Rh) Chinese rhubarb root (Rheum palmatum) [See Note 17.]

(rs) resveratrol as in dark-skin grapes (Vitis vinifera), mulberry fruit (Morus spp.), blueberry fruit (Vaccinium spp.)  

(Sf) Star fruit fruit juice (Averrhoa carambola)

(Sg) Sage leaves (Salvia officinalis)

(si) silymarin/silybin from milk thistle seeds (Silybum marianum) [See Note 1.]

(SJ) St. John’s wort tops (Hypericum perforatum) [See Note 2.]

(Sk) Skullcap herb (Scutellaria lateriflora)

(So) Shrubby sophora (Sophora flavescens) 

(Sp) Saw palmetto liposterolic extract (Serenoa repens)

(Sw) Sandalwood wood (Santalum album)

(Th) Thyme leaves (Thymus vulgaris)

(Tu) Turmeric root (Curcuma longa, Curcuma aromatica)

(Va) Valerian root (Valeriana officinalis) [See Note 13.]

(Wg) Wild grape fruit (Vitis coignetiae)

Isozyme Inducers

(CL) Chinese Licorice root (Glycyrrhiza uralensis) [See Note 4.]

(Dq) Dong quai root (Angelica sinensis) [See Note 17.]

(Ga) Garlic cloves (Allium sativum) [See Note 7.]

(Gb) Ginkgo leaf extract (Ginkgo biloba) [See Note 15.]

(gl) glycyrrhetinic acid/glycyrrhizin from licorice root (Glycyrrhiza glabra) [See Note 4.]

(hp) hyperforin in St. John’s wort (Hypericum perforatum)

(Kv) Kava root (Piper methysticum) [pregnane X receptor activator1696,1702] [See Note 9.]

(Li) Licorice root (Glycyrrhiza glabra) [See Note 4.]

(Rh) Chinese rhubarb root (Rheum palmatum) [See Note 17.]

(SJ) St. John’s wort tops (Hypericum perforatum) [pregnane X receptor activator1002,1288,1703] [See Note 2.]

(tn) tangeritin as in citrus fruit/juice (Citrus spp.)

No Effect in Human Studies with Isozyme CYP 3A4 Substrates  ^                         NEW

(Ag) American ginseng root (Panax quinquefolium) – indinavir2530 

(ar) artemisinin from sweet annie herb (Artemisia annua) – cortisol1931 

(Bc) Black cohosh roots/rhizome (Cimicifuga racemosa) – midazolam1807,2500

(Bo) Bitter orange (Citrus aurantium) – indinavir,2588 midazolam1589 [See Note 8.]

(Ct) Carrot root juice (Daucus carota) – midazolam1885

(El) Eleuthero extract (Eleutherococcus senticosus) – alprazolam2086 

(Ep) Echinacea purpurea root or whole plant (Echinacea purpurea) – midazolam1588,1589  [See Note 3.]

(Ga) Garlic cloves (Allium sativum) – alprazolam,1456 docetaxel,2514 midazolam,1328,1808 ritonavir1734 [See Note 7.]

(Gb) Ginkgo leaf extract (Ginkgo biloba) – alprazolam,1840 cortisol, omeprazole,2301 donepizil,1824 midazolam1328 [See Note 15.]

(Gf) Grapefruit furanocoumarin-free juice (Citrus paradisi) – indinavir,2587,2588 felodipine,1862 [See Note 14.]

(Gs) Ginseng (Asian) root (Panax ginseng) – cortisol,1811 midazolam1328 [See Note 11.]

(Kv) Kava root (Piper methysticum) – midazolam1807,2501

(Li) Licorice root (Glycyrrhiza glabra) – midazolam1631  [See Note 4.]

(me) menthol in peppermint leaves (Mentha piperita) – felodipine2307 

(Mt) Milk thistle silymarin extract (Silybum marianum) – indinavir,1374,1431,1718  irinotecan,2106 midazolam,1589,2500 nifedipine2265 [See Note 1.]

(Or) Orange fruit juice (Citrus sinensis)1885

(Pg) Pomegranate fruit (Punica granatum) [See Note 16.]

(Pl) Plum fruit (Prunus mume) – midazolam1885

(Sp) Saw palmetto liposterolic extract (Serenoa repens) – alprazolam,1810 midazolam1589

(SJ) St. John’s wort herb (Hypericum perforatum) carbamazepine,1083 prednisone2216 [See Note 2.]

(Sy) Soy bean extract (Glycine max) – cortisol1811 [See Note 12.]

(Te) Tea (green) leaf decaffeinated extract (Camellia sinensis) – alprazolam1710

(Tm) Tomato fruit juice (Lycopersicon esculentum) – midazolam1885

Notes:                                                                                                                                                                                                                                                                         

1. In two separate studies, milk thistle extract was given to 10 human subjects (153 mg or 173 mg silymarin 3 times daily for 2 or 3 weeks, respectively) and did not inhibit 3A4 metabolism of substrate indinavir.1374,1431 In a controlled human study, 1350 mg daily of an uncharacterized milk thistle extract likewise produced no significant change in indinavir levels.1718 Milk thistle extract (80% silymarin) 350 mg daily failed to alter bioavailability of CYP 3A4 substrate midazolam in 12 humans after 4 weeks,1589 the same nonresponse as with 300 mg/day in 19 subjects after 2 weeks.2500 Silymarin given is doses of 160 mg three times daily for 2 weeks slightly decreased bioavailability of irinotecan given to 6 cancer patients.2106 When 280 mg of silymarin was given 10 hours and 1.5 hours prior to a single dose of nifedipine to 16 healthy men, the nifedipine bioavailability was increased by 1.3 and the maximum concentration was decreased by 0.7 with great individual variability, indicating a probable decrease in rate of absorption.2265 While metabolism of erythromycin by CYP 3A4 was not siginificantly inhibited by silybin, 3A4 oxidation of denitronifedipine was clearly inhibited in a mostly non-competitive fashion in vitro.1297 The inhibition of CYP 3A4 by silymarin and its components silybin, silydianin, and silycristin was shown in vitro to be dose dependent but not therapeutically relevant due to the concentrations required.1293,1398,2145

2. Extracts have been shown to induce CYP 3A4 in at least 14 human studies (see above), primarily through hyperforin activation of pregnane X receptor. 1002,1288,1703 Even though St. John’s wort tea,1577 3 commercial solid extracts,1593,2608 its tincture, and its components quercetin,1854 I3,II8-biapigenin, hyperforin,1522 and hypericin840,1522,1854 all inhibited CYP 3A4 in vitro, in another in vitro study 10 extracts and 6 commercial extracts showed PXR-mediated induction of CYP 3A4 based on hyperforin content.2127 St. John’s wort extract inhibits CYP 3A4 at 800 mcg/ml but induced it at 8 and 80 mcg/ml in vitro.2292 Hyperforin also induced docetaxel metabolism in vitro2107 and prolonged exposure to quercetin and hyperforin caused upregulation of CYP 3A4 gene expression in vitro.1854 A human study with CYP 3A4 and 2C19 substrate voriconazole showed that inhibition can occur during the first day but induction occurs after 15 days.1839 Two human studies showed no change in the metabolism of CYP 3A4 substrates carbamazepine and prednisone after using 300 mg tablets standardized to 0.3% hypericin three times daily for 14 and 28 days, respectively.1083,2216 An extract providing a daily dose of only 3.5 mg hyperforin failed to induce metabolism of the substrate alprazolam in humans.1775 Similarly, 500 mg/day of a solid ethanolic extract with < 0.2% hyperforin providing < 1 mg daily for 14 days did not significantly alter the pharmacokinetics of ethinylestradiol or desogestrel/3-ketodesogestrel in low-dose contraceptive pills used by 16 healthy females.2569 In 14-day studies using midazolam as a probe drug, St. John’s wort products reduced its bioavailability compared to baseline, and the degree of reduction showed a strong correlation to the relative hyperforin doses, 2598,2599 though the doses of total flavonoids, but not hypericins, also significantly correlated with the reductions.2599

3. Echinacea purpurea root extract 1.6 gm/day for 8 days inhibits intestinal 3A4 but induces liver 3A4. The net result was no increased clearance when E. purpurea extract was taken with midazolam orally.1588 Another study using 1.6 gm/day E. purpurea whole plant extract for 28 days also failed to affect the serum clearance after one hour of oral midazolam.1589 The in vitro results indicate that the herb juice, fresh plant tincture, and 9 commercial extracts inhibit 3A4 to different degrees, varying by a factor of 150.2292,2293,2610,2612 The inhibitory potency is associated with the total alkamide content.2610,2612 The tincture of E. purpurea root is a stronger CYP3A4 inhibitor than the tops, but the root tincture of E. angustifolia is the strongest in vitro inhibitor.840 

4. Though licorice extract was found to be a CYP 3A4 inhibitor in vitro,840,1615 along with its isoflavan component glabridin,1615 the extract and glycyrrhizin were 3A4 inducers in vivo in mice,1630,1650 as was 3 g/kg of a decoction of G. uralensis given orally to rats.2573 However, a 1 gram dose of a freeze-dried water extract given orally twice daily to 10 subjects for 7 days did not affect the pharmacokinetics or pharmacodynamics of the 3A4 substrate midazolam in human study.1631

5. Grape red wine, its component resveratrol, and fractions not containing resveratrol are shown to inhibit CYP 3A4 in vitro.1698,1732 Red wine inhibition of CYP 3A4 in humans slightly increased cisapride bioavailability after a single 250 ml dose, though not significantly.1731 Red wine reduced the Pgp and CYP 3A4 substrate cyclosporine in humans after only one dose, suggesting not induction but possibly activation or stimulation of Pgp or, unlikely, CYP 3A4.1730

6. Though oral fragrant angelica extract had little effect on diazepam administered IV to rats, it increase 4 times the diazepam maximum concentration when both were given orally.1632

7. Though 2 garlic caplets for 3 weeks in 10 healthy subjects reduced plasma content of saquinavir by 50%,1210 2 soft caps equivalent to 1 gram of fresh garlic daily for 4 days did not affect the metabolism of a single dose of ritonavir in 10 healthy humans.1734 In 10 human subjects 1.2 grams/day of garlic with 7.2 mg allicin did not alter the pharmacokinetics of docetaxel.2514 In 14 healthy human volunteers 1.8 grams orally of a standardized garlic extract daily for 14 days did not impact the metabolism of alprazolam,1456 nor did garlic oil for 28 days affect midazolam in 12 healthy subjects.1328 Odorless garlic, garlic oil, aged garlic, and especially freeze-dried garlic inhibited CYP 3A4 in vitro.1594

8. Bitter orange juice in a single 240 ml dose increased felodipine bioavailability due to 6',7'-dihydroxybergamottin, bergamottin, and begapten inhibiting intestinal CYP 3A4.1729 The bioavailability of indinavir was not impacted by consumption with bitter orange juice in healthy human subjects, though there was a delay in indinavir absorption.2588 The juice also reduced enterocyte CYP3A4 concentrations in humans but did not influence cyclosporine metabolism in humans, probably because of a lack of effect on Pgp by 6',7'-dihydroxybergamottin as shown in vitro.1031 The juice did increase dextromethorphan bioavailability by inhibiting intestinal CYP 3A and affecting a transport protein.2666 A product standardized to 4% synephrine and given to 12 subjects at a dose of 700 mg daily was devoid of the CYP 3A4 inhibitor 6',7'-dihydrooxybergamottin.1589 The decoction of the fruit and unripe fruit were slightly inhibitory for CYP3A4 testosterone metabolism in vitro.1633 

9. Although kava root1327,1475,1577,1733 and quercetin475,915 have been shown to be in vitro inhibitors of CYP 3A4 substrate metabolism, along with grapeseed extract they induced production of CYP 3A4 mRNA in vitro; kava induction was mediated by pregnane X receptor (PXR).1696 The strong CYP3A activators dihydromethysticin and desmethoxyyangonin only slightly activated PXR in vitro, suggesting an indirect or independent mechanism.1702 A human study using 1 gram root extract twice daily for 28 days found no effect on metabolism of the CYP3A4 substrate midazolam in 12 men and women.1807

10. Goldenseal extracts and/or the alkaloid hydrastine were strong CYP 3A4 inhibitors tested in vitro;1813,2145 its root tincture the strongest among 21 herb extracts840 and its herb tea the strongest among 20 herb and black teas.1577 Likewise, 2.7 gram daily for 28 days of goldenseal extract inhibited midazolam metabolism by 40% in 12 men and women,1807 while 3.97 gram/day of the extract for 14 days also significantly reduced midazolam bioavailability in 16 men and women.2501 Berberine at 0.6 grams daily for 3 months increased previously stabilized cyclosporin trough blood concentrations by 90% in 52 renal transplant patients, and when given for 12 days to 6 transplant patients increased the cyclosporine bioavailability by 35%.2281 However, 2.28 grams of the root given daily to 10 healthy volunteers for 14 days failed to affect the pharmacokinetics of CYP 3A4 substrate indinavir.1700 

11. Daily doses for 28 days of 1.5 gm Asian ginseng standardized to 5% ginsenosides failed to alter the metabolism of CYP 3A4 substrate midazolam in humans.1328,1808 Likewise, 200 mg/day for 14 days of ginseng extract standardized to 4% ginsenosides failed to alter cortisol metabolism in 20 humans.1811 200 mg/day of uncharacterized "ginseng" or 120 mg/day of uncharacterized ginkgo for 18 days each inhibited metabolism of CYP 3A4 substrate nifedipine, as indicated by increased peak plasma concentrations of 29% and 53%, respectively.1728 Ginsenosides inhibit CYP3A4 in vitro.1812

12. Though soy extract with 100 mg isoflavones daily for 14 days produced no effect in humans, unhydrolyzed soy extracted tended to induce CYP3A4 in vitro, while hydrolyzed soy extract strongly inhibited CYP3A4 in vitro.1811

13. Though valerian preparations have been shown to induce2292 and inhibit CYP3A4 in vitro,840, 1593,1748,2608 a 1 gram extract dose for 14 days in 12 healthy subjects increased the maximum concentration of a single dose of the CYP3A4 substrate alprazolam. However, the time to reach the maximum and the bioavailability were unaffected, and the small though significant change is unlikely to alter clinical responses.1676 Also, 375 mg daily for 28 days of valerian root extract had no effect on midazolam in another study with 12 men and women.1807

14. Furanocoumarin-free grapefruit juice did not alter felodipine pharmacokinetics compared with grapefruit juice that did not have the furanocoumarins removed in a human study with 18 subjects. Other CYP 3A4 substrates will theoretically also not have their metabolism altered by grapefruit juice, if the furanocoumarins are removed from the juice.1862

            Itraconazole oral clearance was reduced and bioavailability was increased in 10 women taking 240 ml juice compared to water, whereas the juice produced no differences in 10 men. The juice-induced clearance differences between the women and the men were not significant, although after water women has significantly greater clearance of itraconazole than men.2503

            The bioavailability of the HIV drug indinavir was not impacted by consumption with grapefruit juice in either healthy subjects or HIV-positive subjects in human studies. There was a delay in indinavir absorption in those with HIV with grapefruit juice.2587,2588

15. Concerning ginkgo, 360 mg/day EGb 671 increased midazolam and decreased its oral clearance,2015 but 240 mg standardized ginkgo failed to alter the metabolism of CYP 3A4 substrate midazolam in humans,1328,1808 nor did 280 mg standard extract for 12 days impact cortisol metabolism in 18 healthy men or increase omeprazole metabolism to omeprazole sulfone.2301 Also, 90 mg/day of its extract for 30 days did not affect metabolism of CYP3A4 substrate donepezil in 14 patients during long-term use.1824 However, 120 mg/day of uncharacterized ginkgo for 18 days inhibited metabolism of CYP 3A4 substrate nifedipine, as indicated by increased peak plasma concentration 53%.1728 On the other hand, 240 mg daily for 14 days of ginkgo extract slightly decreased alprazolam availability, suggesting CYP 3A4 induction.1840 Recovery from CYP 3A4 induction occurs within 1 week in rats given the extract as 0.5% of their diet.1952 Ginkgo leaf extract is a CYP3A4 inhibitor in vitro.1823,2145,2151,2292,2608 Ginkgo flavonol aglycones quercetin, kaempferol, apigenin, myricetin, and tamarixetin all inhibited CYP 3A4 in micromolar concentrations in vitro, but its flavonol glycosides and terpene lactones did not.1848

16. Though pomegranate juice inhibited CYP 3A in rats1920 and in vitro,1920,1923,2123,2213 2 doses of 8 oz each given about 12 hrs and 1 hr prior to midazolam had no effect on IV or oral midazolam clearance in healthy human volunteers.2213

17. The aqueous extract of dong quai root increased strongly the N-demethylation of dextromethorphan in rats, but dong quai ethanolic extract inhibited this metabolism.2671 Similarly, in vitro a 40% ethanol extract inhibited testosterone metabolism, but it was unaffected by an aqueous decoction.1633 In contrast the Chinese rhubarb root aqueous extract inhibited dextromethorphan N-demethylation but its ethanolic extract increased its metabolism in rats.2671

18. Only 1 of 5 commercial cranberry juice samples tested in vitro at 0.05% showed inhibitory effects on metabolism of midazolam by CYP3A, and this inhibition was confirmed for intestinal but not hepatic CYP3A by this brand in 16 human subjects after orally consuming 3 glasses with 240 ml of double-strength cranberry juice prior to a single dose of midazolam.2699 In prior human studies no inhibition was shown by cranberry juice with midazolam2316 or CYP3A substrate cyclosporine. 2021

                                                                                                                                                                                                                                                                                   

 

B.7.2.d  Influence on CYP 2C9 Metabolic Conversion of Substrates                            ^                        NEW

Substrates:

7-ethoxy-3-cyanocoumarin – Cl, Gr, Sg, Th, Tu1577

7-ethoxy-4-(Fl3Me)coumarin – gl,1615 si2210

7-methoxy-4-(Fl3Me)coumarin – db, gg, hp,os, qu,1458 Ch,1577 Ea,2581 Ep,2151,2581 Fv,1577 Gb,2151 Go,1577 Ga,1594 Kv,1733 Sp2151

Drugs:  diclofenac – ba,1522 bc,1893 br,2288 Go,1813 hp, hy,1522 mg,2266 Pi2288

            flurbiprofen – am, qu1954

            gliclazide –                                                                                          SJ2624

            tolbutamide – An,2230 Dq,2671 Fa1632 Fr,2664 Fv,2568 Gb, Gd,2145 kb,2664 kl, Kv,1327,1733,2146 Pi,2288 Po,2568 rh2492    ;  Gb,2015 Go2145

            S-warfarin – Gb,2011 si1297                                                        ;           Ag,1600 Gb,1952 Li, Sc,1926 SJ1578

 

Isozyme Inhibitors

(am) amentoflavone in ginkgo leaves (Ginkgo biloba), St. John’s wort flowers (Hypericum perforatum)

(An) Andrographis leaves (Andrographis paniculata)

(ba) I3,II8-biapigenin as in St. John’s wort (Hypericum perforatum), etc. [See Note 1.]

(bc) baicalin/baicalein and other Chinese skullcap flavones (Scutellaria baicalensis)

(br) bromelain in pineapple (Ananas comosus)

(Ch) Chamomile (Matricaria recutita)

(Cl) Clove buds (Syzygium aromaticum)

(db) dihydroxybergamottin in grapefruit juice (Citrus paradisi)

(Dq) Dong quai root (Angelica sinensis)

(Ea) Echinacea angustifolia root (Echinacea angustifolia) [See Note 5.]

(Ep) Echinacea purpurea herb, root (Echinacea purpurea) [See Note 5.]

(Fa) Fragrant angelica root (Angelica dahurica)

(Fr) Frankincense resin (Boswellia spp.)

(Fv) Feverfew leaves (Tanecetum parthenium)

(Ga) Garlic cloves (Allium sativum) [See Note 6.]

(Gb) Ginkgo leaf extract (Ginkgo biloba) [See Note 3.]

(Gd) Grape seed (Vitis vinifera)

(gg) ginkgolic acids in ginkgo leaves (Ginkgo biloba)

(gl) glabridin from licorice root (Glycyrrhiza glabra)

(Go) Goldenseal root or herb (Hydrastis canadensis)

(Gr) Ginger root/rhizome (Zingiber officinale) [See Note 4.]

(hp) hyperforin in St. John’s wort (Hypericum perforatum) [See Note 1.]

(hy) hypericin as in St. John’s wort (Hypericum perforatum) [See Note 1.]

(kb) keto boswellic acids from frankincense resin (Boswellia spp.)

(kl) kavalactones from kava root (Piper methysticum)

(Kv) Kava root (Piper methysticum)

(mg) mangiferin from mango bark (Mangifera indica)

(os) organosulfides in garlic cloves (Allium sativum) and onion bulbs (Allium cepa)

(Pi) Pineapple fruit (Ananas comosus)

(Po) Peppermint oil (Mentha piperita)

(qu) quercetin as in onion bulbs (Allium cepa), tea leaves (Camellia sinensis), cranberry fruit/juice (Vaccinium macrocarpon), etc.

(rh) rhein as in Chinese rhubarb root (Rheum palmatum), aloes (Aloe spp.), etc.

(Sg) Sage leaves (Salvia officinalis)

(si) silymarin/silybin from milk thistle seeds (Silybum marianum)

(Sp) Saw palmetto liposterolic extract (Serenoa repens)

(Th) Thyme leaves (Thymus vulgaris)

(Tu) Turmeric root (Curcuma longa, Curcuma aromatica)

Isozyme Inducers

(Ag) American ginseng root (Panax quinquefolium)

(Ea) Echinacea angustifolia root (Echinacea angustifolia) [See Note 5.]

(Ep) Echinacea purpurea herb, root (Echinacea purpurea) [See Note 5.]

(Gb) Ginkgo leaf extract (Ginkgo biloba) [See Note 3.]

(CL) Chinese Licorice root (Glycyrrhiza uralensis)

(Sc) Schisandra berry (Schisandra chinensis)

(SJ) St. John’s wort tops (Hypericum perforatum) [See Note 1.]

No Effect in Human Studies with Isozyme CYP 2C9 substrates                                  NEW

(ar) artemisinin from sweet annie herb (Artemisia annua) – tolbutamide1512

(Bt) Black tea leaves (Camellia sinensis) – flurbiprofen1947 [See Note 2.]

(Cb) Cranberry fruit/juice (Vaccinium macrocarpon) – flurbiprofen,1947 S-warfarin2316,2509

(Ep) Echinacea purpurea root (Echinacea purpurea) – tolbutamide1588

(Ga) Garlic cloves (Allium sativum) – warfarin2509 [See Note 6.]

(Gb) Ginkgo leaf extract (Ginkgo biloba) – diclofenac,2011 flurbiprofen,1842 tolbutamide,2011 S-warfarin1433,1774 [See Note 3.]

(Gp) Grape fruit/juice (Vitis vinifera) – flurbiprofen1947 [See Note 2.]

(Gr) Ginger root (Zingiber officinale) – S-warfarin1774  [See Note 4.]

(Gs) Ginseng (Asian) root (Panax ginseng) – S-warfarin1578,2326

(SJ) St. John’s wort herb (Hypericum perforatum) –  ibuprofen,2079 tolbutamide1217,1775 [See Note 1.]

Notes:                                                                                                                                                                                                                                                                         

1.  In vitro St. Johns wort extracts were inhibitory to CYP 2C9,1522 though human studies found extracts to have either no effect on CYP 2C9 substrate tolbutamide1217,1775 or ibuprofen2079 and induction of metabolism of the CYP 2C9 substrate S-warfarin.1578 In one tolbutamide human pharmacokinetic study, the extract that failed to induce metabolism provided a daily dose of only 3.5 mg hyperforin.1775  The activation of pregnane X receptor in human liver cells in vitro by St. John’s wort extract1002 and its major active component hyperforin1703 indicates the probable mechanism of St. John’s wort acting as an inducer of CYP 3A4, CYP 2C9, and P-glycoprotein1926 which is born out in human studies.1350,1578,1590,1613 The product that failed to alter ibuprofen metabolism in humans after 22 days of taking 900 mg daily was standardized to 0.3% hypericin, so its hyperforin content, if any, is unknown.2079

2. Though brewed black tea and grape juice both failed to alter the metabolism of CYP 2C9 substrate flurbipofen in humans, they both inhibited its hydroxylation in human liver microsomes in vitro1947 as black tea had previously inhibited a marker substrate in vitro.1577

3. Though ginkgo leaf extract acts as an inhibitor in vitro,2011,2145,2151 at 360 mg/day EGb 761 in humans2015 and as 0.5% of the diet in rats it was shown to induce this isozyme.1952 Normal therapeutic doses do not produce either effect in humans.1433,1774,1842,2011 Rat recovery from CYP 2C9 induction occurs within 1 week.1952  

4. The in vitro inhibition evidence for ginger1577 is superceded by its lack of effect in the metabolism of warfarin in humans.1774

5. While both Echinacea angustifolia and E. purpurea root preparations were shown in vitro to inhibit metabolism of CYP2C9 substrates,2581 a combination extract from these two roots given 4 times daily for 14 days to 12 men followed by racemic warfarin resulted in increased S-warfarin clearance but no effect on R-warfarin clearance or on the anticoagulant response.2582

6. Though garlic inhibited the metabolism of a probe substrate in vitro,1594 an enteric-coated garlic tablet from 2 gm of fresh garlic with 3.7 mg allicin per tablet given twice daily for 3 weeks to 12 healthy subjects, no change in bioavailability of warfarin isomers as reflected by the plasma concentration-time profiles nor in INR was detected over the next week, indicating a lack of effect on CYP 2C9.2509

                                                                                                                                                                                                                                                                                                                                                                               

 

B.7.2.e  Influence on CYP 2C19 Metabolic Conversion of Substrates                          ^                        NEW

Substrates:

7-ethoxy-3-cyanocoumarin – db, gg, hp, kl, os, qu,1458 Bt, Ch, Cl,1577 Ea, Ep,2581 Go, Gr, Or, Sg, Th, Tu,1577 Ga1594

Drugs: 

            amitriptyline –                                                                         SJ1614

            imiprimine – Fr, kb,2664 Gf, Kv, Po2568 

            mephenytoin –             kl, Kv,1327,2146 mg2266                ;           ar,1512 Gb,2302 SJ1584

            omeprazole –                                                               ar,1931 Gb,1617,2301 SJ1674

            voriconazole –                                                                         SJ1839

 

Isozyme Inhibitors

(Bt) Black tea leaves (Camellia sinensis)

(Ch) Chamomile (Matricaria recutita)

(Cl) Clove buds (Syzygium aromaticum)

(db) dihydroxybergamottin in grapefruit juice (Citrus paradisi)

(Ea) Echinacea angustifolia root (Echinacea angustifolia)

(Ep) Echinacea purpurea herb, root (Echinacea purpurea)

(Fr) Frankincense resin (Boswellia spp.)

(Ga) Garlic cloves (Allium sativum)

(gg) ginkgolic acids in ginkgo leaves (Ginkgo biloba)

(Go) Goldenseal herb (Hydrastis canadensis)

(Gf) Grapefruit fruit/juice (Citrus paradisi)

(Gr) Ginger root/rhizome (Zingiber officinale)

(hp) hyperforin in St. John’s wort (Hypericum perforatum)

(kb) keto boswellic acids from frankincense resin (Boswellia spp.)

(kl) kavalactones from kava root (Piper methysticum)

(Kv) Kava root (Piper methysticum)

(mg) mangiferin from mango bark (Mangifera indica)

(Or) Oregano leaves (Origanum vulgare)

(os) organosulfides in garlic cloves (Allium sativum) and onion bulbs (Allium cepa)

(Po) Peppermint oil (Mentha piperita)

(qu) quercetin as in onion bulbs (Allium cepa), tea leaves (Camellia sinensis), cranberry fruit/juice (Vaccinium macrocarpon), etc.

(Sg) Sage leaves (Salvia officinalis)

(Th) Thyme leaves (Thymus vulgaris)

(Tu) Turmeric root (Curcuma longa, Curcuma aromatica)

Isozyme Inducers

(ar) artemisinin from sweet annie herb (Artemisia annua)

(Gb) Ginkgo leaf extract (Ginkgo biloba) [See Note 1.]

(SJ) St. John’s wort tops (Hypericum perforatum)

Notes:                                                                                                                                                                                                                                                                         

1. In a 12-day study with 18 healthy Chinese men, an ethnic group known for 15-20% CYP2C19 genetic polymorphism, 6 were homozygous and 5 were heterozygous excellent metabolizers while 7 were poor metabolizers. Though ginkgo standardized extract at 280 mg daily increased metabolism of omeprazole in all three groups, the increase for the poor metabolizers was significantly greater than for both groups of excellent metabolizers.2301 However, a reportedly standardized ginkgo extract at 120 mg daily for 12 days in 7 poor and 7 extensive CYP2C19 metabolizers did not change the metabolism of the substrate voriconazole in either group of healthy humans. This may be due to an inhibitory effect on CYP3A4 metabolism of voriconazole.2679

 

B.7.2.f  Influence on CYP 2D6 Metabolic Conversion of Substrates                            ^                        NEW

Substrates:

2-(N,N-diethylamino)ethyl-7OH-4MeCoumarin – Ea, Ep2581

7-ethoxy-3-cyanocoumarin – Cl, Gr, Or, Sg, Th1577

3-[A]-7-methoxy-4-methylcoumarin – db, gg,1458 gs,1812 Bt, Ch, Fv, Go,1577 Sp2151

Drugs:  bufuralol – ba,1522 br, Go,1813 hp, hy,1522 Fa1632

            debrisoquin – Bc,1807 Gs,1808 Go1807,2502

            dextromethorphan – Ag, Az, Bp, Cl,2123 Ep,2292 Gb,2292 Gd, Go,2145 kl, Kv,1327 Li, Mp, Pg, Rh, 2123 Sg,2292 Sw2123 

            propranolol – pp206

            sparteine – pp204

 

Isozyme Inhibitors

(An) Andrographis herb (Andrographis paniculata)

(Az) Aromatic zingiber rhizome (Zingiber aromaticum)

(ba) I3,II8-biapigenin as in St. John’s wort (Hypericum perforatum), etc. [See Note 2.]

(Bc) Black cohosh roots/rhizome (Cimicifuga racemosa) [See Note 3.]

(Bp) Black pepper fruit (Piper nigrum)

(bn) berberine in goldenseal root (Hydrastis canadensis)

(Bt) Black tea leaves (Camellia sinensis)

(Ch) Chamomile (Matricaria recutita)

(Cl) Clove buds (Syzygium aromaticum)

(db) dihydroxybergamottin in grapefruit juice (Citrus paradisi) and bitter orange fruit juice (Citrus aurantium) [Note 1]

(Ea) Echinacea angustifolia root (Echinacea angustifolia)

(Ep) Echinacea purpurea herb, root (Echinacea purpurea)

(Fa) Fragrant angelica root (Angelica dahurica)

(Fv) Feverfew leaves (Tanecetum parthenium)

(Gb) Ginkgo leaf extract (Ginkgo biloba)

(Gd) Grape seed (Vitis vinifera)

(gg) ginkgolic acids in ginkgo leaves (Ginkgo biloba)

(Go) Goldenseal root or herb (Hydrastis canadensis)

(Gr) Ginger root/rhizome (Zingiber officinale)

(Gs) Ginseng (Asian) root (Panax ginseng) [See Note 4.]  

(gs) ginsenoside (Rd) from Asian ginseng (Panax ginseng) roots

(hp) hyperforin in St. John’s wort (Hypericum perforatum) [See Note 2.]

(hy) hypericin as in St. John’s wort (Hypericum perforatum) [See Note 2.]

(kl) kavalactones from kava root (Piper methysticum)

(Kv) Kava root (Piper methysticum)

(Li) Licorice root (Glycyrrhiza glabra)

(Mp) Madagascar periwinkle herb (Catharanthus roseus)

(Or) Oregano leaves (Origanum vulgare)

(Pg) Pomegranate fruit (Punica granatum)

(pp) piperine in black pepper (Piper nigrum) and long pepper fruit (Piper longum)

(Rh) Chinese Rhubarb root (Rheum palmatum)

(Sg) Sage leaves (Salvia officinalis)

(Sp) Saw palmetto liposterolic extract (Serenoa repens)

(Sw) Sandalwood wood (Santalum album)

(Th) Thyme leaves (Thymus vulgaris)

Isozyme Inducers

[The constitutive isozyme CYP 2D6 is not considered inducible. However, it has been activated at high concentrations in vitro by ginkgo extract and valerian extract2292 and in vivo by aqueous and ethanolic extracts of dong quai and aqueous extract of rhubarb root in rats.2671]

No Effect in Human Studies with Isozyme CYP 2D6 substrates                                  NEW

(Bc) Black cohosh roots/rhizome (Cimicifuga racemosa) – debrisoquin2502 [See Note 3.]

(Bo) Bitter orange (Citrus aurantium) – debrisoquin1589 [See Note 1.]

(El) Eleuthero extract (Eleutherococcus senticosus) – dextromethorphan2086  

(Ep) Echinacea purpurea root or whole plant (Echinacea purpurea) – debrisoquin,1589,2502 dextromethorphan1588

(Ga) Garlic oil (Allium sativum) – debrisoquin1328,1808 

(Gb) Ginkgo leaf extract (Ginkgo biloba) – debrisoquin,1328,1808,2302 dextromethorphan1840 

(Kv) Kava root (Piper methysticum) – debrisoquin1807,2502

(Mt) Milk thistle silymarin extract (Silybum marianum) – debrisoquin1589,2502 

(Sp) Saw palmetto liposterolic extract (Serenoa repens) – debrisoquin,1589 dextromethorphan1810 

(SJ) St. John’s wort (Hypericum perforatum) – debrisoquin,1328,1808,2502 dextromethorphan1217,1478,1838 [See Note 2.]

(Te) Tea (green) leaf decaffeinated extract (Camellia sinensis) – dextromethorphan1710

(Va) Valerian root (Valeriana officinalis) – debrisoquin,1807 dextromethorphan1676 

Notes:                                                                                                                                                                                                                                                                         

1.  A study with 12 humans given a bitter orange (Citrus aurantium) product that did not inhibit metabolism of the CYP 2D6 substrate debrisoquine was lacking 6,7-dihydroxybergamottin.1589

2. In vitro St. Johns wort extracts were inhibitory to CYP 2D61522 but were found to have no effect on CYP 2D6 substates debrisoquin and dextromethorphan in humans.1217,1328,1478,1808

3. The inhibition of debrisoquin metabolism by black cohosh extract (2.18 grams daily) for 28 days in 12 volunteers was statistically significant at 7%, but this is not likely significant clinically.1807 Another human study using 40 mg of extract twice daily for 2 weeks in 18 healthy volunteers found no effect on CYP 2D6.2502 

4. Though inhibition of debrisoquin metabolism by Asian ginseng root extract (1.5 gram daily) was statistically significant at 7%, this effect is probably not clinically significant.1808 While this inhibitory effect by ginseng extract was found in those between ages of 60 and 76 years,1808 another study of the Asian ginseng extract and dose did not alter the metabolism of debrisoquin in those between the ages of 21 and 29 years.1328

                                                                                                                                                                                                                                                                                   

 

B.7.3  Specific Enzyme Influences of Herbal Agents on Phase II Conjugation

 

B.7.3.a  Influence on Glutathione S-Transferase [GST] Activity or Levels                                                                    p. 262

Conjugation Inhibitors

(ao) anthocyanins from blueberry fruit (Vaccinium spp.) – colon2419 

(ar) artemisinin from Chinese wormwood plant (Artemisia annua) – (A1-1)1547

(cc) curcumin in turmeric root (Curcuma longa, Curcuma aromatica) – liver,2035 liver825,2593 [See Note 1.]

(Cl) Chaparral leaves (Larrea tridentata) – liver1322

(dp) diospyrin from Indian persimmon stem bark (Diospyros montana) – (A1-1, M1-1, P1-1)1670   

(ge) geshoidin from African dogwood leaves and bark (Rhamnus prinoides) – (M1-1)1670

(gp) gossypol in cotton root bark (Gossypium herbaceum, Gossypium hirsutum) – liver6

(qn) quinine/quinidine from cinchona bark (Cinchona spp.) – (M1-1)1547  

(si) silymarin/silybin in milk thistleseeds (Silybum marianum) – liver (1-1, 2-2, 3-3, 4-4)1285

(Sn) Stinging nettle leaves/herb (Urtica dioica) – brain, liver, kidney2303

(Tb) Tobacco leaves *(Nicotiana tabacum) – liver1182

(Tu) Turmeric root (Curcuma longa) – lymphocyte (M1, P1, T1)2488

Conjugation Inducers

(ac) S-allylcysteine in garlic cloves (Allium sativum) – liver,865,1180 intestine,1180 colon865

(Bm) Black mustard seeds (Brassica nigra) – liver1182

(cc) curcumin in turmeric root (Curcuma longa, Curcuma aromatica) – liver (A4-4),1396 liver (A8-8),1395 (P1-1)1397 [See Note 1.]

(cs) carnosol from rosemary leaves (Rosmarinum officinalis) – liver (P),1287 liver1286

(ct) catechin as in catechu (Acacia catechu) bark, green tea (Camellia sinensis) leaves, etc. – stomach, liver1501

(Cy) Celery seed oil (Apium graveolens) – liver1155

(Cn) Coriander oil (Coriandrum sativum) – liver1155

(ds) diallyl sulfide in garlic cloves (Allium sativum) – liver,1302, 2083,2097 placenta2096,2097

(ea) ellagic acid as in strawberry leaves, seeds (Fragaria spp.), raspberry leaves, seeds (Rubus spp.) and black walnut leaves, nuts (Juglans nigra), etc. – liver1687,2460

(Ga) Garlic cloves (Allium sativum) – liver,861,1179,1182,2097 (Ya, Yb1, Yc)1629 breast,861 placenta2096,2097

(Gb) Ginkgo leaf extract (Ginkgo biloba) – liver1952

(gi) glucobrassicin indole metabolites in specific crucifers (Brassica oleracea) – liver (Yc2),1179 liver 858,859,1179 

(Gr) Ginger oil (Zingiber officinale) – liver1155

(Hn) Henna leaves (Lawsonia inermis) – liver1960

(mi) 6-methylsulfinylhexyl isothocyanate in wasabi roots (Wasabia japonica) – liver (A1, P1),1688,1689 (Ya),1689,1877 liver1688,1689

(my) myristicin from parsley leaf oil (Petroselinum sativum), nutmeg seed (Myristica fragrans), etc. – liver, intestine1284,1295

(Nm) Nutmeg oil *(Myristica fragrans) – liver1155

(os) organosulfides in garlic cloves (Allium sativum) and onion bulbs (Allium cepa) – intestine, liver1302

(pi) phenethyl isothyocyanate from watercress (Nasturtium officinale), crucifers (Brassica spp.) – liver,1179,2063,2460 (Yc2)1179

(qu) quercetin as in onion bulbs (Allium cepa), tea leaves (Camellia sinensis), kale leaves (Brassica oleracea v. acephala), etc. – liver1179

(Rm) Rosemary leaves (Rosmarinum officinalis) – liver1286

(rs) resveratrol as in dark-skin grapes (Vitis vinifera), mulberry fruit (Morus spp.), blueberry fruit (Vaccinium spp.)   – heart2380

(Sc) Schisandra berry (Schisandra chinensis) – liver1294 

(si) silymarin/silybin in milk thistle seeds (Silybum marianum) – liver, lung, skin, stomach, intestine1622

(sn) sinigrin in Chinese mustard (Brassica juncea) and black mustard seeds (Brassica nigra) – liver1179

(sr) sulforaphane from broccoli sprouts and tops (Brassica oleracea v. italica) – liver (A1, P1),1688 liver,1688 bladder2415

(Te) Tea (green and black) leaves (Camellia sinensis) – liver1649

Notes                                                                                                                                                                                                              

1. No effect on GST isozymes were observed in 15 cancer patients receiving oral curcumin doses between 0,45-3.6 grams/day for up to 4 months.2057

 

B.7.3.b  Influence on Activity and/or Content of UDP-Glucuronosyltransferases [UGT]                                                        p. 263

Conjugation Inhibitors

(bc) baicalin/baicalein and other Chinese skullcap flavones (Scutellaria baicalensis) – liver, kidney1892

(Cl) Chaparral leaves (Larrea tridentata) – liver1322

(is) isoflavones as in soy beans (Glycine max), kudzu plant (Pueraria lobata), etc. – liver2064

(si) silymarin/silybin from milk thistle seeds (Silybum marianum) – purified (potent 1A1),2210 liver & purified (mild 1A6/9)1293,2210  [not in 6 cancer patients 2106]

(Sy) Soy bean extract (Glycine max) – liver (2B15; dihydrotestosterone)1811

Conjugation Inducers

(Cr) Crucifers, especially broccoli, cauliflower, cabbage (Brassica oleracea) – colon, liver (2),1987

(cu) coumarins of Eriostemon (Philotheca spp.) and Phebalium (Phebalum spp.) – liver (1A1)2144

(cy) chrysin from passion flower plant (Passiflora incarnata, Passiflora coerulea) – liver (1A1)2144

(ds) diallyl sulfide in garlic cloves (Allium sativum) – liver (1)1302

(ea) ellagic acid as in strawberry leaves, seeds (Fragaria spp.), raspberry leaves, seeds (Rubus spp.) and black walnut leaves, nuts (Juglans nigra), etc. – liver1687

(Gt) Green tea leaves (Camellia sinensis) – liver1999

(os) organosulfides in garlic cloves (Allium sativum) and onion bulbs (Allium cepa) – intestine, liver1302

(Te) Tea (green and black) leaves (Camellia sinensis) – liver1649

 

B.7.3.c  Influence on NADPH-Quinone Reductase [QR]

(NAD(P)H:Quinone Oxidoreductase 1 or DT-Diaphorase) Activity and/or Content                                         p. 263

Conjugation Inhibiters

(ao) anthocyanins from blueberry fruit (Vaccinium spp.) – colon2419 

(fg) flavone glucuronides of Chinese skullcap root (Scutellaria baicalensis) – liver1237

Conjugation Inducers

(Ag) American ginseng root (Panax quinquefolium) – liver2325 

(As) Asparagus stalk (Asparagus officinalis) – liver1363

(At) Ashitaba (Angelica keiskei) – liver2171 

(Bb) Bilberry fruit extract (Vaccinium myrtillus) – liver1259,1354

(bi) benzyl isothyocyanate in crucifers (Brassica spp.) – colon,1195 liver2155

(Br) Broccoli florets (Brassica oleracea v. italica) – liver1363,2162,2171

(Cb) Cranberry fruit extract (Vaccinium macrocarpus) – liver1259,1354

(cc) curcumin in turmeric root (Curcuma longa, Curcuma aromatica) – liver,2154,2561 kidney2154

(Cr) Crucifers, especially Brussels sprouts, cabbage, cauliflower, kale, and kohlrabi (Brassica oleracea) – liver1363

(cs) carnosol from rosemary leaves (Rosmarinum officinalis) – liver,1287 liver1286

(Cy) Celery seed oil (Apium graveolens) – liver1363,2171

(Dl) Dandelion root (Taraxacum officinale) – liver1608

(ds) diallyl sulfide in garlic cloves (Allium sativum) – lungs,1178 heart, bladder, GI, colon, brain2154

(ea) ellagic acid as in strawberry leaves, seeds (Fragaria spp.), raspberry leaves, seeds (Rubus spp.) and black walnut leaves, nuts (Juglans nigra), etc. – liver1687

(Gi) Ginger rhizome (Zingiber officinale) – liver1363

(Gb) Green bean pods (Phaseolus vulgaris) – liver1363

(gm) glucosinolates and/or indole metabolites in crucifers (Brassica oleracea) – colon,1195 liver2159,2160

(Hn) Henna leaves (Lawsonia inermis) – liver1960

(Lk) Leek stems (Allium porrum) – liver1363

(Lt) Lettuce leaves (Lactuca sativa) – liver1363

(mi) methylsulfinyl isothocyanates in wasabi roots (Wasabia japonica), watercress herb (Nasturtium officinale), Broccoli florets [See (sr).] (Brassica oleracea v. italica) – liver,2157-8,2162 liver1688

(Ms) Mitsuba (Cryptotaenia japonica) liver2171 

(On) Onion green tops (Allium cepa) – liver1363

(os) organosulfides in garlic cloves (Allium sativum) and onion bulbs (Allium cepa) – forestomach,1178 lung, heart, bladder, GI, colon, brain2154

(pf) prenylflavonoids from hops strobiles (Humulus lupulus) – liver1591

(Pc) Pak choi leaves (Brassica campestris v. chinesensis) – liver1363

(pi) phenethyl isothiocyanate from watercress herb (Nasturtium officinale), crucifers (Brassica spp.) – colon,1195 liver1179

(Ps) Parsley leaf (Petroselinum sativum) – liver2171  

(qu) quercetin as in onion bulbs (Allium cepa), tea leaves (Camellia sinensis), cranberry fruit/juice (Vaccinium macrocarpon), etc. – liver,2169,2170 breast2154

(Rd) Radish root (Raphanus sativus) – liver1363

(Rm) Rosemary leaves (Rosmarinum officinalis) – liver1286

(rs) resveratrol as in dark-skin grapes (Vitis vinifera), mulberry fruit (Morus spp.), blueberry fruit (Vaccinium spp.)  – liver,881 heart2380

(si) silymarin/silybin in milk thistle seeds (Silybum marianum) – liver, lung, skin, stomach, intestine1622

(Sp) Spinach leaves (Spinacea oleracea) – liver1363

(sr) sulforaphane from broccoli sprouts and tops (Brassica oleracea v. italica) – bladder,2415 breast,2154 colon,1195 liver,1688,2155-6,2161,2167,2325

(Tg) Thai ginger rhizome (Boesenbergia pandurata) – liver2169

(Tp) Tephrosia flowers and fruit (Tephrosia purpurea) – liver2178

(Tt) Tomatillo fruit (Physalis philadelphica) – liver2167,2168

(xh) xanthohumol and/or isoxanthohumol in hops strobiles (Humulus lupulus) – liver2289

 

B.7.3.d  Influence on Epoxide Hydrolase (Epoxide Hydratase)[EH] Activity                                                     p. 264

Conjugation Inducers

(cc) curcumin in turmeric root (Curcuma longa, Curcuma aromatica) –liver1397

(ds) diallyl sulfide in garlic cloves (Allium sativum) – intestine, liver1302

(os) organosulfides in garlic cloves (Allium sativum) and onion bulbs (Allium cepa) – intestine, liver1302

 

B.7.3.e Influence on Activity of Phenol Sulfotransferases [PSTs or SULT1A1]

(pi) phenethyl isothyocyanate from watercress herb (Nasturtium officinale), crucifers (Brassica spp.) – liver2063

(xn) xanthones from guanadi heartwood (Calophyllum brasiliense) – liver2571

 

B.7.4  Specific Enzyme Influences of Herbal Agents on Steroid Metabolism

(Bold abbreviations indicate human studies with subject criteria noted; organ enzyme sources identified for in vitro tissue studies [non-italicized] and animal studies [italicized])

 

B.7.4.a  Aromatase (CYP19) Conversion of Androstenedione to Estrone and Testosterone to 17beta-Estradiol            p. 265

Conversion Inhibitors

(ap) apigenin as in chamomile (Matricaria recutita) and Roman chamomile (Chamaemelum nobile) flowers, parsley (Petroselinum sativum) leaves, etc. – placenta1766,1780

(bA) biochanin A from red clover leaves, flowers (Trifolium pratense), etc. – fat1435

(Cu) Cubeb seeds (Piper cubeba) – (androstenedione)2264 

(cy) chrysin from passion flower plant (Passiflora incarnata, Passiflora coerulea) – fat,1435 placenta1766,1780,2040

(er) eriodictyol as in lemon fruit/juice (Citrus limon), peppermint (Mentha piperita), etc.. – placenta1779

(et) ellagitannins from pomegranate (Punica granatum) – breast2645

(Gp) Grape red wine (Vitis vinifera) – placenta2040

(hs) hesperetin as in orange fruit/juice (Citrus sinensis), lemon fruit/juice (Citrus limon), etc. – placenta1779

(kf) kaempferol as in tea (black and green) leaves (Camellia sinensis), kale leaves (Brassica oleracea v. acephala), etc. – fat, 914 placenta2040 

(ln) lignan metabolites from flax seed (Linum usitatissimum) – placenta,913 fat914

(lt) luteolin as in thyme (Thymus spp.), asparagus (Asparagus officinalis), etc. – placenta1779 

(mr) myricetin as in tea (black and green) leaves (Camellia sinensis), parsley (Petroselinum sativum) leaves, cranberry fruit/juice (Vaccinium macrocarpon), etc. – placenta1766,2040

(nr) naringenin as in grapefruit fruit/juice (Citrus paradisi) – placenta1766,1779,2040

(pl) polyphenols from green tea leaves (Camellia sinensis) – placenta1599

(Qc) Quinine conk mushroom (Fomitopsis officinalis) – prostate1861

(qu) quercetin as in onion bulbs (Allium cepa), tea leaves (Camellia sinensis), cranberry fruit/juice (Vaccinium macrocarpon), etc. – placenta2040 

(rs) resveratrol as in dark-skin grapes (Vitis vinifera), mulberry fruit (Morus nigra), blueberry fruit (Vaccinium spp.)  – placenta2040 

(Rs) Reishi mushrooms (Ganoderma lucidum) – prostate1861

(Te) Tea (green and black) leaves (Camellia sinensis) – placenta2040 

(Wb) White button mushroom (Agaricus bisporus) – prostate, prostate1861 

Conversion Inducers

(Cs) Cordyceps mycelium (Cordyceps sinensis) – granulose-lutein cells1932 

 

B.7.4.b  5alpha-Reductase Conversion of Testosterone to Dihydrotestosterone                                                             p. 265

Conversion Inhibitors

(Bc) Black cohosh roots/rhizome (Cimicifuga racemosa) – prostate2056

(Cu) Cubeb seeds (Piper cubeba) – prostate2254 

(is) isoflavones as in soy beans (Glycine max), kudzu plant (Pueraria lobata), red clover flowers (Trifolium pratense), etc. – prostate, foreskin1652

(ln) lignan metabolites from flax seed (Linum usitatissimum) – prostate, foreskin1652

(Py) Pygeum bark (Pygeum africanum) –  [neg. prostate2249]

(Qc) Quinine conk mushroom (Fomitopsis officinalis) – prostate1861

(Rs) Reishi mushrooms (Ganoderma lucidum) – prostate1861

(SJ) St. John’s wort tops (Hypericum perforatum) – men and women2122

(Sn) Stinging nettle root (Urtica dioica) – [neg. prostate2249]

(Sw) Saw palmetto fruit extracts (Serenoa repens) – skin,1677 prostate,1678 in balding men1679

(Tj) Thuja seeds (Thuja occidentalis) – kidney, skin2136

(Wb) White button mushroom (Agaricus bisporus) – prostate, prostate1861 

 

B.7.4.d  11beta-Hydroxysteroid Dehydrogenase type 2 Conversion of Cortisol to Cortisone                           p. 266

Conversion Inhibitors

(gl) glycyrrhetinic acid/glycyrrhizin from licorice (Glycyrrhiza glabra, Glycyrrhiza uralensis) – in healthy young adults1667

 

B.7.4.e  17beta-Hydroxysteroid Dehydrogenase type 5 Conversion of Androstanediol to Androsterone

and Androstenedione to Testosterone                                                                                                                     p. 266

Conversion Inhibitors

(bA) biochanin A from red clover leaves, flowers (Trifolium pratense), etc. – microsomes1778

(cm) coumestrol as in alfalfa herb (Medicago sativa) – microsomes1778

(gl) glycyrrhetinic acid/glycyrrhizin from licorice (Glycyrrhiza glabra, Glycyrrhiza uralensis) – microsomes1778

(Li) Licorice root (Glycyrrhiza glabra, Glycyrrhiza uralensis) – in healthy young women1767

(og) oleuropein glycoside from olive fruit oil (Olea europaea) – liver microsomes2068

(qu) quercetin as in onion bulbs (Allium cepa), tea leaves (Camellia sinensis), cranberry fruit/juice (Vaccinium macrocarpon), etc. – microsomes1778

 

B.7.4.f  17beta-Hydroxysteroid Dehydrogenase type 2 Conversion

of Testosterone to Androstenedione or Estradiol to Estrone                                                                               NEW

Conversion Inhibitors

(ga) galangin from China root (Alpinia officinarum) – prostate1858

(kf) kaempferol as in tea (black and green) leaves (Camellia sinensis), kale leaves (Brassica oleracea v. acephala), etc. – prostate1858 

(is) isoflavones as in soy beans (Glycine max), kudzu plant (Pueraria lobata), red clover flowers (Trifolium pratense), etc. – foreskin,1652 microsomes1950

(ln) lignan metabolites from flax seed (Linum usitatissimum) – foreskin1652

 

B.7.4.g  17beta-Hydroxysteroid Dehydrogenase type 1 Conversion of Estrone to Estradiol                             NEW

Conversion Inhibitors

(ap) apigenin as in chamomile (Matricaria recutita) and Roman chamomile (Chamaemelum nobile) flowers, parsley (Petroselinum sativum) leaves, etc. – placenta1777,1779,1780,1858

(cm) coumestrol as in alfalfa herb (Medicago sativa) – placenta1777,1780

(is) isoflavones daidzein and/or genistein as in soy beans (Glycine max), kudzu plant (Pueraria lobata), etc. – placenta1777,1780

(lt) luteolin as in thyme (Thymus spp.), asparagus (Asparagus officinalis), etc. – placenta1779 

 

B.7.4.h  3beta-Hydroxysteroid Dehydrogenase type 1 or 2 Conversion

of DHEA to Androstenedione and/or Pregnenolone to Progesterone                                                                  NEW

Conversion Inhibitors

(is) isoflavones as in soy beans (Glycine max), kudzu plant (Pueraria lobata), red clover flowers (Trifolium pratense), etc. – microsomes1950

 

B.7.5  Herbs containing Monoamine Oxidase –A &/or –B Inhibitors                                 p. 266

Sources of MAO-Inhibitors

(Bp) Black pepper fruit (Piper nigrum) – pos A & B (brain)2002

(Ft) Fo-ti root (Polygonum multiflorum) – pos B (brain)2002

(Kv) Kava root *(Piper methysticum) – pos B (platelet)514

(Lp) Long pepper fruit (Piper longum) – pos A & B (brain)2002

(Tp) Tree peony bark (Paeonia suffruticosa) – pos A & B (brain)2002

                                                                                                                                                                                                                                                                                   

 

Appendix C

HERBALS CONTRAINDICATED FOR MOTHERS AND CHILDREN

 

C.1  During Pregnancy                                                                                                       p. 269

            Use of herbs during pregnancy does not appear to be as extensive as the 22% incidence reported among presurgical patients. A 2002 survey of 1203 pregnant women seen at a Boston hospital at 20 weeks gestation resulted in responses from 734 indicating that only 7.1% used herbal remedies while 75.6% used over the counter medications, mostly cold remedies, pain relievers, and heartburn medication. Echinacea (2.6%), ephedra (1.8%) [before in became unavailable], and St. John's wort (1.4%) were the most commonly used botanicals. Of all those who had used herbal remedies, 46% did so at the recommendation of their health care provider, and 8.9% ceased use, mostly of ephedra, once pregnancy was confirmed. Those most likely to use botanicals were in the age range of 41-50 years (17.1% of this group).1671

Pregnancy is a special time, when ordinary influences can have extraordinary consequences. Uterine contractions or changes in uterine tone can have disruptive effects, since carrying a baby to term necessitates normal development for the uterus as well as the child. Alterations in uterine circulation may disturb developmental processes. Rapid system and organ growth is especially vulnerable to substances that interfere with cellular division. Abnormal hormonal influences may result in permanent developmental alterations. The occassional consumption of a cup of a weak herbal beverage tea is unlikely to have any more untoward effects that eating plate of garden vegetables. As with higher risk medicinal interventions, herbal disruptive effects during pregnancy are most likely to occur with large doses, regular consumption, and/or prolonged use.

Non-nutritive substances affecting vital functions in the human body should be avoided during pregnancy, unless there is a recognized need for such agents. Such needs would include enhancing nutrition, such as by palliating nausea and vomiting or improving appetite and digestion. Otherwise, the focus should be on optimizing dietary intake, while possibly supplementing essential vitamins, minerals, and essential oils in proper amounts. Indiscriminate or excessive consumption of synthetic or herbal medicines is especially irresponsible when it endangers the life, health, and future of a vulnerable developing embryo or fetus. Trained doctors, pharmacists, or other practitioners knowledgeable in the art and science of utilizing medicinal agents should be consulted for information, advice, or instructions on their proper use or avoidance during pregnancy.

While deltrimental effects by potentially fetotoxic and genotoxic botanical agents on fetal development should be, and have been, studied in cell systems in vitro and in animals to identify agents to be avoided by humans, these are not the only influences that can interfere with pregnancy. Plant substances that stimulate the uterus during labor as oxytocics may also produce this effect in early pregnancy when it is most undesirable; some women can be more sensitive to this influence than others. Small doses of certain tonic herbs a few weeks prior to labor may be valuable if there is a history of inadequate contractions in prior labors.

A number of herbal advocates believe that it is an inappropriate and unnecessary to emphasize avoidance in pregnancy of plants that simply have a reputation for being used traditionally, or in isolated cultures, for stimulating the onset of menses or strengthening labor contractions. It has occasionally been suggested that such warnings amount to scare tactics, since these effects have not been confirmed by modern in vivo research. Human studies on botanicals for their potential as uterine stimulants can not ethically be performed on pregnant women, so it is reasonable to examine the historical and cultural records to identify those agents that have been used empirically and found potentially active in this regard. This is especially necessary to warn about those agents that have been used as abortifacients, even though scientific confirmation is lacking. To inadvertently disrupt normal healthy human functions and growth development through negligence is tragically bad medicine, but to risk destroying a developing human life by willfully disregarding empirical herbal knowledge is an inexcusable version of Russian roulette. Intentionally employing plants as abortifacients carries high risks, not only for the fetus but for the mother as well.

            A number of native American plants have been identified as emmenogogues (E) or abortifacients (A) according to their internal uses by indigenous tribes.  Some of these plants may not currently be popular herbal medicines. However, with a renewed regional interest in herbs and exploration of ethnopharmacological applications, personal experimentation or the re-introduction of such plants into use as alternative remedies is not unlikely. For these reasons it is important to list potential risks that have been identified concerning traditional remedies based on their empirical use. Unfortunately, in a few cases the plant part is not identified.1125 A number of these plants or their components have been previously identified as either abortifacients, emmenogogues, or uterine stimulants74 or designated as contraindicated in pregnancy without a specified rationale.150

            In the cases of gender-specific reproductive organs, plants shown in humans or animals to cause hormonal (H) changes may alter normal expression. Mutagens (M) and genotoxins (G) can likewise disturb normal growth as shown by in vitro studies. Teratogens (T) have been shown to interfere with normal development of particular structures, and plants with fetotoxins (F) endanger the very life of the developing child. In cases where these effects occur, birth defects are a possible unfortunate result.

In many cases specific parts of the plant or certain extracts are known to have the above-mentioned effects, but in other instances only isolated components ( c )  of the plant have been shown to demonstrate a particular activity. If only the isolated constituent has shown activity, the use of the plant part itself or its native extract may be safe if used in small quantities. Also, the particular part of the plant utilized and the components found therein have everything to do with the relative risk. For example, critics who have inferred that this book warned against the use of chamomile flowers during pregnancy were not perceptive enough to recognize that it actually identifies the plant itself as being traditionally used as an emmenogogue.

  (Based on references 75, 1125, 1308, 1441, 1573, 1636, 1825, 1890, 1944,1945, 2221.)

 

C.1.1  Herbals That May Impact the Uterus or Fetal Development       

Aloe leaf extract (Aloe vera) US, A; T

Altamisa leaves (Artemisia franserioides) E

American beech bark (Fagus grandifolia) A

American bittersweet root, leaves, stem (Celastrus scandens) E

American hellebore juice *(Veratrum viride) A

American mistletoe roots *(Phoradendron leucacarpum) A

American skunkcabbage raw root (Lysichiton americanus) A

American strawberry-bush plant (Euonymus americana) E

American sycamore (Platanus occidentalis) E

Anise-scented goldenrod (Solidago odora) E

Asian ginseng root (Panax ginseng) H

Balsam fir pitch (Abies balsamea) E

Beelieswari balli plant (Aristolochia indica) A

Bittersweet stem (Solanum dulcumara) F

Black cohosh root (Cimicifuga racemosa) E

Blazing star root *(Aletris farinose) E

Bloodroot rhizome *(Sanguinaria canadensis) E, A

Boldo leaves (Peumus boldus) F

Boneset root (Eupatorium perfoliatum) E

Bur oak inner bark (Quercus macrocarpa) E

Calamus root *(Acorus calamus) A

California croton *(Croton californicus) A

Canada yew branches (Taxus canadensis) E

Canadian blacksnake root (Sanicula canadensis) E

Canadian lily plant (Lillium canadense) E

Canadian lousewort leaves (Pedicularis canadensis) A

Cedron (Aloysia spp.) A

Chamiso hediondo leaves (Artemisia tridentata) E

Chaparral leaves (Larrea tridentate) A

Cola de quirquincho plant (Lycopodium saururus) A

Common sowthistle plant (Sonchus oleraceus) E

Common twinpod plant (Physaria didymocarpa) A

Common vetch plant (Vicia sativa ssp. nigra) E

Crataeva bark (Crataeva nurvala, Crataeva religiosa) F

Cup plant root (Silphium perfoliatum) E

Douglas’s sagewort plant (Artemisia douglasiana) E

Dwarf red blackberry plant (Rubus pubescens v. pubescens) E

Eastern red cedar *(Juniperus virginiana) E

Espina colorada (Solanum sisymbriifolium) A

Estafiate leaves (Artemisia ludoviciana v. mexicana) E, A

Feverwort root (Triosteum perfoliatum) E

Field sagewort leaves (Artemisia campestris) A

Floripon (Brugmansia arborea) A

Francisco alvarez (Luhea divaricata) A

Fringed sagewort plant (Artemisia frigida) E

Guggul gum-resin (Commiphora mukul) H, F

Hackberry bark (Celtis occidentalis) E

Hairy skullcap root (Scutellaria elliptica) E

Hoary skullcap root (Scutellaria incana) E

Horseradish root (Armoracia rusticana) E

Indian frankincense gum resin (Boswellia serrata) E 

Indian hemp root *(Apocynum cannabinum) E

Jamaica dogwood root (Piscidia erythrina)  F

Lajalo leaves (Mimosa pudica) A

Maidenhair spleenwort (Asplenium trichomanes) E

Maryland sanicle root (Sanicula marilandica) E

Meadowsweet herb (Filipendula ulmaria) F

Mexican dock root (Rumex salicifolius v. mexicanus) E

Mountain alder (Alnus incana) E

Northern bedstraw plant (Galium boreale) E

Northern spicebush (Lindera benzoin) E

Northwestern Indian paintbrush plant (Castilleja angustifolia) E

Orangegrass (Hypericum gentianoides) E

Pacific anemone plant *(Anemone multifida) A

Pacific mistletoe leaves, plant *(Phoradendron villosum) E, A

Pacific red elder leaves (Sambucus racemosa ssp. pubens v. arborescens) A

Partridge berry plant (Mitchella repens) E

Pau d’arco bark (Tabebuia spp.) A; Fc

Ponderosa pine green buds (Pinus ponderosa) A

Poverty weed plant (Iva axillaris) A

Prickly ash bark (Zanthoxylum americanum) A

Puncture vine seeds (Tribulus terrestris) A, USc

Purplestem angelica root (Angelica atropurpurea) E

Purplestem aster roots (Aster puniceus) E

Red bay leaves (Persea borbonia) A

Red currant stalk (Ribes triste) E

Red root dried root (Ceanothus americanus) A

Rehmannia uncured root (Rehmannia glutinosa)

Robin’s plantain (Erigeron pulchellus) E

Romerillo leaves (Artemisia cana, Artemisia filifolia) E, A

Round-lobed hepatica roots (Hepatica nobilis v. obtusa) E

Sampson’s snakeroot (Orbexilum pedunculatum v. psoralioides) E

Sand hickory (Carya pallica) E

Scouring rush plant (Equisetum hymenale) E

Skullcap root (Scutellaria lateriflora ) E

Sedge leaves (Carex spp.) A

Senega root *(Polygala senega) E

Sidebeak pencilflower (Stylosanthes biflora) E

Slender poreleaf root, plant (Porophyllum gracile) E

Small spikenard root (Aralia nudicaulis) E

Smooth horsetail plant (Equisetum laevigatum) E

Snow trillium root (Trillium grandiflorum) E

Snowberry branches (Symphoricarpos albus) E

Spikenard root, plant (Aralia racemosa) E

St. Andrew’s cross (Hypericum hypericoides) E

St. John’s wort plant (Hypericum perforatum) H, T

Sweet crabapple root (Malus coronaria v. coronaria) E

Sweet viburnum roots (Viburnum lentago) E

Toyon leaves (Heteromeles arbutifolia) E

Tylophora leaves *(Tylophora indica)  F

Uva ursi leaves (Arctostaphylos uva-ursi) E

Velvetleaf huckleberry leaves, stems (Vaccinium myrtilloides) E

Virginia mountain-mint root (Pycnanthemum virginianum) E

Virginia snakeroot *(Aristolochia serpentaria) E

Virginia strawberry plant (Fragaria virginiana) E

Virginia tephrosia plant (Tephrosia virginiana) E

Wand blackroot plant (Pterocaulon virgatum) E

Water birch leaves, flowers (Betula occidentalis) E

Wavyleaf silktassel leaves (Garrya elliptica) E

Western red cedar bark (Thuja plicata) E

Western yarrow leaves/stem (Achillea millefolium v. occidentalis) A

White ash bark (Fraxinus americana) E

White crownbeard plant (Verbesina virginica) E

Wild cucumber (Echinocystis lobata) E

Yankee blackberry root (Rubus frondosus) E

Yellowstone whitlowgrass plant (Draba incerta) A

Yerba de la perdiz (Margiricarpus pinnatus) A

 

C.2  While Breast Feeding                                                                                        p. 279

Some contain compounds that are potentially toxic (T) to small children. Normal development may also be impaired with exposure to substances having a hormonal (H) influence. Certain plants should be avoided while nursing due to their antiprolactin (AP) effects. Some galactogogues used to stimulated milk production have shown toxicity in infants when used in excess (E) of 2 liters daily. The risk due to some potentially disruptive herbal components is unknown (U), so due to this uncertainty their use while nursing is not recommended.

(Based on references 1141, 1319, 1890, 1944, 1945.)

 

C.2.1  Herbals to be Avoided in Medicinal Amounts by Nursing Mothers     

Anise seed/fruit (Pimpinella anisum) E

Arnica flowers *(Arnica montana) T

Blue cohosh root *(Caulophyllum thalictroides) T

Boldo leaves (Peumus boldus) T

Buchu leaves (Agathosma betulina) U

Celandine root and leaves (Chelidonium majus) T

Chaparral leaves (Larrea tridentata, Larrea divaricata) AP

European pennyroyal herb (Mentha pulegium) T

Fennel fruit (Foeniculum vulgare) E

Guggul resin (Commiphora mukul) U

Jamaica dogwood root bark (Piscidia erythrina) T

St. John’s wort plant (Hypericum perforatum) H, T

Tansy herb (Tanacetum vulgare) T

Thuja leaves *(Thuja occidentalis) T

Tylophora leaves *(Tylophora indica)  T

Willow bark (Salix spp.) U

Wormwood herb (Artemisia absinthium) T

 

C.3  In Children                                                                                                          p. 281

            Great care should be taken to insure proper dosage in utilizing a plant with any record of adverse effects, but this applies most especially when medicating the young who are often more reactive to large doses (LD). The age limits for restricted use can vary, such as infants under one (<1), young children under six (<6), or teens under eighteen (<18) years of age, depending on the agent and the effect.  The possibility of creating an imbalance exists even when employing plants that are relatively safe in adults.  Children tend to be more sensitive to certain local irritants (I) and effects produced on the nervous system (NS). The following representative herb restrictions are designated by age limits, dosage, herb form, type of application, and/or effect to be avoided.

The use of concentrated essential oils (EO) containing volatile aromatic components should not be given internally (orally) to anyone, especially children, except by practitioners specially trained in this approach. Some oils that are safe for adults should not be used in toddlers or younger children in this form. Teas containing small amounts of these components are safe and effective in most cases. Tinctures have higher concentrations of essential oil components than the teas but are generally safe for children if the herbs are nontoxic. (The alcohol used as an extracting solvent and preservative in tinctures is not toxic in normal doses given to children.) Certain aromatic components have been shown to exert an adverse influence on the nervous system even when used as an inhalant or near the nose of infants (N) or toddlers under two (<2) years of age.

            (Based on reference 400, 1370.)

 

C.3.1  Herbals Whose Medicinal Use Should be Restricted in Children                             

Horse chestnut seed/escin (Aesculus hippocastanum) <18, I

Oregano leaf (Origanum vulgare) <2, EO

Valerian root (Valeriana officinalis) < 3, C, NS

                                                                                                                                                                                                                                                                                                           

 

Appendix D

VITAMIN/MINERAL/DRUG INTERACTIONS

 

D.1  Drug and Mineral Interactions with Vitamin Supplements                         p. 286

                Interference between vitamins and drugs or prescription mineral supplements can work both ways.  In some cases drugs will lower vitamin (LV) oral absorption and/or serum levels or increase excretion or metabolism, while in other cases medications can raise vitamin (RV) bioavailability or increase their effects.  Vitamins may also raise drug (RD) or mineral (RM) serum levels or increase their effects, or they may lower drug (LD) or mineral (LM) levels or reduce their effects.  Vitamin/drug or vitamin/mineral interactions listed below which have caused either toxicity (t) or insufficient (i) effects for one or the other clinically in humans are emphasized in bold. The other interactions listed have produced observable changes without clinically-demonstrated effects.

Other types of interactions are now receiving attention.  In these cases a vitamin is shown to prevent drug toxicity (PDt) or reduce adverse drug effects or to enhance drug effects (EDe) by making it more efficacious.    

Plants included in the lists as having high content of certain vitamins are mostly herbs. Some common vegetable leaves, roots, flower buds, and berries are mentioned elsewhere in the text have been included. However, fleshy fruit and vegetables, nuts and seeds are generally excluded since these have less crossover uses for medicinal applications.

(Based on primary references 1164-1166, 1199, 1280, 1324, 1325, 1340, 1361, 1474, 1654,1745,1934, 1985, 2078, 2317, 2646, 2647)

 

D.1.1.a  Provitamin A (Beta-Carotene)-Rich Herb and Vegetable Sources                                                        p. 288

Beet leaves (Beta vulgaris)

Calendula flowers (Calendula officinalis)

Mustard leaves (Brassica juncea)

Stinging nettle leaf (Urtica dioica)

 

D.1.4  Vitamin B3 (Niacin, Niacinamide) Drug Interaction                                                                                               p. 289

Atorvastatin – RDt, EDt (very-low-dose niacin)

Busulfan