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Toxicology and Clinical Pharmacology of Herbal Products
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Forensic Science and Medicine
Steven B. Karch, MD, S
ERIES
E
DITOR
T
OXICOLOGY
AND
C
LINICAL
P
HARMACOLOGY
OF
H
ERBAL
P
RODUCTS,
edited by Melanie Johns Cupp, 2000
CRIMINAL POISONING: INVESTIGATIONAL GUIDE FOR LAW ENFORCEMENT,
T
OXICOLOGISTS,
F
ORENSIC
S
CIENTISTS,
AND
A
TTORNEYS,
by John H. Trestrail, III, 2000
A PHYSICIAN'S GUIDE TO CLINICAL FORENSIC MEDICINE,
edited by Margaret M. Stark, 2000
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Toxicology and Clinical Pharmacology of Herbal Products
Edited by
Melanie Johns Cupp, PHARMD, BCPS
West Virginia University
Morgantown, WV
Humana Press Totowa, New Jersey
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© 2000 Humana Press Inc.
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Totowa, New Jersey 07512
All rights reserved. No part of this book may be reproduced, stored in a retrieval system, or transmitted
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otherwise without written permission from the Publisher.
The content and opinions expressed in this book are the sole work of the authors and editors, who have
warranted due diligence in the creation and issuance of their work. The publisher, editors, and authors
are not responsible for errors or omissions or for any consequences arising from the information or
opinions presented in this book and make no warranty, express or implied, with respect to its contents.
Due diligence has been taken by the publishers, editors, and authors of this book to assure the accuracy
of the information published and to describe generally accepted practices. The contributors herein have
carefully checked to ensure that the drug selections and dosages set forth in this text are accurate and in
accord with the standards accepted at the time of publication. Notwithstanding, as new research,
changes in government regulations, and knowledge from clinical experience relating to drug therapy
and drug reactions constantly occurs, the reader is advised to check the product information provided by
the manufacturer of each drug for any change in dosages or for additional warnings and
contraindications. This is of utmost importance when the recommended drug herein is a new or
infrequently used drug. It is the responsibility of the treating physician to determine dosages and
treatment strategies for individual patients. Further it is the responsibility of the health care provider to
ascertain the Food and Drug Administration status of each drug or device used in their clinical practice.
The publisher, editors, and authors are not responsible for errors or omissions or for any consequences
from the application of the information presented in this book and make no warranty, express or
implied, with respect to the contents in this publication.
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Printed in the United States of America. 10 9 8 7 6 5 4 3 2 1
Library of Congress Cataloging in Publication Data
Toxicology and clinical pharmacology of herbal products / edited by Melanie Johns Cupp.
p. ; cm.—(Forensic science and medicine)
Includes bibliographical references and index.
ISBN 0-89603-791-6 (alk. paper)
1. Herbs—Toxicology. 2. Materia medica, Vegetable—Toxicology. I. Title:Herbal
products. II. Cupp, Melanie Johns. III. Series.
[DNLM: 1. Herbs adverse effects. 2. Plants, Medicinal adverse effects. 3.
Pharmacology. QV 767 T755 2000]
RA 1250 .T68 2000
615.9'52—dc21
99-046505
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FOREWORD
The herbal medicine industry is growing at an astounding rate. Trade group estimates suggest that total
sales exceeded $4 billion dollars in 1999. Herbal remedies are for sale not just in health food stores, but
in supermarkets, drug stores, and even discount warehouses. Along with the proliferation in sales has
come a proliferation of information sources. Not all of the sources are equally reliable, or even
intelligible. Traditional herbalists classify thistle and mugwort as "cholagogues," substances used to
make the gallbladder contract and release bile. Medical school graduates are unlikely to have ever heard
the term, or even accept the notion that most right-sided abdominal pain is a result of diminished bile
flow.
Heroin and cocaine may not be the only drugs to come from plants, but a practicing physician or
toxicologist might be forgiven for thinking so. In 1998, 1264 papers were published about cocaine and
only 17 about kava kava, an abused herb that is not without toxic side effects. Unfortunately, the
majority of the papers about kava kava were published in journals not found in ordinary hospital
libraries. In recognition of this fact, and of the obvious need for a reliable reference work on herbal
toxicology, The Toxicology and Clinical Pharmacology of Herbal Products
was an early addition to our
new series in Forensic Science and Medicine. It is very badly needed.
The reason that herbalists and physicians use different terminology, and the reason that most herbal
medicine books are of little use to the physician confronted with a desperately ill patient, is that
herbalists and traditional physicians think about diseases (and the medicines used to treat them)
differently. Of course many of the drugs first used in modern medicine are extracted from plants. But
herbalists use whole plants and traditional physicians use purified ingredients derived from plants.
Traditional physicians and scientists generally believe that, if a plant has any medicinal value at all, it is
because it con-
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tains one "active" ingredient that must be isolated and purified. Herbalist believe results are better when
the whole herb is used, because different components of the plant act synergistically.
There are risks and benefits to both approaches. If an "active" ingredient is isolated, then it can be given
in a more concentrated form. This means that the effects, both therapeutic and toxic, will be
exaggerated. On the other hand, if the whole plant (or leaves, or roots, depending on the plant) is used,
the concentration of the active ingredient may or may not be sufficient to produce the desired
therapeutic result, but the chances for toxicity are decreased. The low concentration of active
ingredients may explain why, given the enormous numbers of people taking herbal products, relatively
few toxic reactions have been reported. Coca leaf is a good example. Indians who chew the leaves never
achieve blood cocaine concentrations high enough to produce serious toxicity. But the results of recent
studies suggest that coca leaf chewers do absorb other ingredients from the leaves that prevent high-
altitude sickness.
Herbalists also believe that combining herbs improves efficacy and reduces adverse effects. When
compounded by knowledgeable practitioners, some of the remedies do make sense. The combination of
Devil's claw, white willow, and tumeric, all agents with antiinflammatory effects, is rational, and quite
probably effective. But combining St. John's Wort, which contains a selective serotonin reuptake
inhibitor, with Ephedra, which causes increased catecholamine release, is both dangerous and ill
advised.
Whether a particular combination of herbs produces good or bad results depends on who is doing the
compounding. Under current US laws, anyone is free to market any combination of ingredients, no
matter how misguided the underlying science. Herbalists are not the only ones who combine agents. So
do patients. And they often forget to tell their physicians about it. Occassionally, this leads to dire
results. Terpenoids contained in Gingko biloba interact with platelet-activating factor. Fatal brain
hemorrhages have occurred in anticoagulated patients who self-medicated with gingko. Traditional
physicians generally avoid drugs in combination, because combinations often turn out to be
counterproductive or, as in the case of gingko, outright dangerous. For example, tetracycline and
penicillin would never be given at the same time, because the former slows bacterial growth, while the
later exerts its bactericidal effects only in growing bacteria.
Even without isolating the active principle, some herbal products are very toxic. Comfrey may be an
effective treatment for bruises and sprains, but it also contains pyrrazolidine alkaloids which can cause
severe liver damage. The alkaloid content is higher in comfrey's roots than in its leaves and higher
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in plants grown in Europe than in the United States. Yet neither the alkaloid content, the country of
origin, nor the portion of the plant used is likely to be indicated on the product label.
Dr. Cupp and her coauthors are to be congratulated for having done an excellent job in combing the
scientific literature for reliable, peer-reviewed, information about the most widely used herbal products.
They have also done a very good job in presenting that information in such a way that it is easily
accessible to practicing physicians and laboratory scientists, not to mention consumers who would be
well advised to read about any remedy, whether it is prescribed by their physician or their herbalist. The
28 subsections of this book deal with the herbs that are most often encountered. Hundreds of other
herbs exist, but reliable information about them is difficult to acquire. As more is learned, it will be
incorporated into future editions.
STEVEN B. KARCH, MD
BERKELEY, CA
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PREFACE
Sales of herbal products have increased dramatically over the past five years. Unfortunately, the
knowledge base devoted to the adverse effects of these products has not grown in proportion to their
increased usage. Data of questionable accuracy, often designed to sell products rather than to provide
objective information, can be found in the print and electronic media, most notably on the Internet.
Even in medical journals, misleading information about the beneficial and adverse effects of herbs can
be found.
Toxicology and Clinical Pharmacology of Herbal Products is designed to provide medical examiners,
toxicologists, and health care providers with an objective review of the available information on the
pharmacology and toxicology of commonly used herbs. Clinical and pathological findings from case
reports of herbal adverse effects are described in detail. Sections on the relevant pharmacokinetics,
chemical analysis, and analysis of biofluids are unique to this volume, and will be of use to pathologists
and forensic scientists, as well as to clinicians. Animal, human, and in vitro data are presented on the
known pharmacologic and toxicologic effects of each herb, arranged by organ, organ system, or
therapeutic/toxicologic effect. A good deal of pharmacology and therapeutics information is included in
this section, not only because toxicology is an extension of pharmacology, but also to make the book
useful for a wide variety of applications by professionals with various interests. Adverse effects noted
in clinical trials are noted in this section as well. At the end of the book, a summary table lists herbal
toxicities by affected organ, provides a list of herbs involved in drug interactions, and indicates the type
of data supporting the reported toxicities.
Each herbal monograph begins with a discussion of the herb's uses, products, and the dosage forms
available. This information, in conjuction with color photographs
1
of some of the most popular
products, can be of assistance in those situations where the identity of an herbal product is in question.
[...]... legal aspects of herbal products provides an overview of the regulation of herbal products in the US and abroad In addition, each herbal monograph reviews the herb's status internationally, including approved uses The incidence of adverse effects associated with the use of herbal products is unknown, and may be underreported Without a foundation of knowledge upon which to inquire whether an herbal product... cause of a given finding, further exploration of the possibility of an herb-induced toxicity might not be undertaken Even if an herbal product is suspected of causing an adverse outcome, without information about similar cases, toxicological analysis of biofluids, or the pharmacologic or toxicologic effects of the herb, further investigation might prove difficult or impossible Toxicology and Clinical Pharmacology. .. Legal/Regulatory Aspects of Herbal Products Chapter 1: Legal/Regulatory Aspects of Herbal Products Melanie Johns Cupp 3 Part II Monographs Chapter 1: Ma Huang and the Ephedra Alkaloids Steven B Karch 11 1.1 Sources 11 1.2 History and Traditional Uses 11 1.3 Current Promoted Uses 12 1.4 Available Products 13 1.5 Pharmacology 15 1.5.1 Introduction 15 1.5.2 Pharmacologic Effects 16 1.5.3 Metabolism and Elimination... Antihyperglycemic Effects 182 16.5 Case Reports of Toxicity Due to Commercially Available Products 182 16.6 Drug Interactions 187 16.7 Pharmacokinetics 187 16.8 Chemical Analysis/Analysis of Biofluids 188 16.9 Regulatory Status 188 Chapter 17: Coltsfoot Amanda Dailey and Melanie Johns Cupp 191 17.1 History and Traditional Uses 191 17.2 Current Promoted Uses 191 17.3 Products Available 192 17.4 Pharmacologic/Toxicologic... Mutagenicity/Carcinogenicity 90 7.4.7 Reproduction 90 7.5 Case Reports of Toxicity Due to Commercially Available Products 90 7.6 Chemical Analysis 91 7.7 Regulatory Status 91 Chapter 8: Feverfew Brian Schuller and Melanie Johns Cupp 95 8.1 History and Traditional Uses 95 8.2 Current Promoted Uses 95 8.3 Products Available 96 8.4 Pharmacology /Toxicology 97 8.4.1 Neurologic Effects 97 8.4.2 Anti-Inflammatory... of Toxicity Due to Commercially Available Products 136 11.6 Pharmacokinetics/Toxicokinetics 137 11.6.1 Absorption 137 11.6.2 Distribution 137 11.6.3 Metabolism/Excretion 137 11.7 Analysis of Biofluids 137 11.8 Chemical Analysis 138 11.9 Regulatory Status Chapter 12: Panax Ginseng Angela Morgan and Melanie Johns Cupp 138 141 12.1 History and Traditional Uses 141 12.2 Current Promoted Uses 142 12.3 Products. .. investigation might prove difficult or impossible Toxicology and Clinical Pharmacology of Herbal Products is designed to provide the necessary knowledge base upon which such investigations may efficaciously proceed MELANIE JOHNS CUPP 1I want to acknowledge Mark Branciaroli of Elkins, WV for producing the photographs of the herbal products Page xi CONTENTS Foreword by Steven B Karch Preface Contributors Product... Pharmacokinetics/Toxicokinetics 38 2.8.1 Absorption 38 2.8.2 Metabolism/Elimination 38 2.9 Analysis of Biofluids 38 2.10 Chemical Analysis 39 2.11 Regulatory Status 39 Chapter 3: Ginkgo biloba Forouzandeh Mahdavi and Melanie Johns Cupp 43 3.1 History and Traditional Use 43 3.2 Current Promoted Use 43 3.3 Products Available 43 3.4 Pharmacologic/Toxicologic Effects 44 3.4.1 Nervous System Effects 44 3.4.2... Effects 114 9.5 Case Reports of Toxicity 115 9.6 Drug Interactions 118 9.7 Pharmacokinetics/Toxicokinetics 118 9.7.1 Absorption 118 9.7.2 Distribution 118 9.7.3 Metabolism/Elimination 118 9.8 Analysis of Biofluids 120 9.9 Regulatory Status 120 Chapter 10: Ginger Charity Metz and Melanie Johns Cupp 123 10.1 History and Traditional Uses 123 10.2 Current Promoted Uses 124 10.3 Products Available 124 10.4... Effects 47 3.5 Case Reports of Toxicity Due to Commercially Available Products 47 3.6 Drug Interactions 48 3.7 Pharmacokinetics/Toxicokinetics 48 Page xiii 3.7.1 Absorption 48 3.7.2 Distribution 49 3.7.3 Metabolism/Elimination 49 3.8 Chemical Analysis 49 3.9 Analysis of Biofluids 50 3.10 Regulatory Status 50 Chapter 4: Valerian Marlea Givens and Melanie Johns Cupp 53 4.1 History and/ Traditional Uses 53 . recognition of this fact, and of the obvious need for a reliable reference work on herbal
toxicology, The Toxicology and Clinical Pharmacology of Herbal Products
. States of America. 10 9 8 7 6 5 4 3 2 1
Library of Congress Cataloging in Publication Data
Toxicology and clinical pharmacology of herbal products
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