Toxicology and Clinical Pharmacology of Herbal Products

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© 2000 Springer Science+Business Media New York
Originally published by Humana Press Inc. in 2000
Softcover reprint of the hardcover 1st edition 2000

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10 9 8 7 6 5 4 3 2
Library of Congress Cataloging in Publication Data
Toxicology and clinical pharmacology ofherbal products I edited by Melanie Johns Cupp.
p. ; cm. -- (Forensic science and medicine)
Includes bibliographical references and index.
ISBN 978-1-61737-190-5 ISBN 978-1-59259-020-9 (eBook)
DOI 10.1007/978-1-59259-020-9
1. Herbs--Toxicology. 2. Materia medica, Vegetable--Toxicology. 1. 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]
RAI250 .T68 2000
615.9'52--dc21
99-046505
Foreword

The herbai medicine industry is growing at an astounding rate. Trade

group estimates suggest that total sales exceeded $4 billion dollars in 1999.
Herbai remedies are for sale not just in health food stores, but in supermar-
kets, drug stores, and even discount warehouses. Along with the proliferation
in sales has come a proliferation ofinformation sources. Not all ofthe sources
are equally reliable, or even intelligible. Traditional herbalists c1assify thistle
and mugwort as "cholagogues," substances used to make the gallbladder con-
tract 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 ordi-
nary hospitallibraries. In recognition ofthis fact, and ofthe obvious need for
a reliable reference work on herbai toxicology, The Toxicology and Clinical
Pharmacology 0/ Herbal Products was an early addition to our new series in
Forensie Science and Medicine. It is very badly needed.
The reason that herbalists and physicians use different terminology, and
the reason that most herbai medicine books are of little use to the physician
confronted with a desperately ill patient, is that herbalists and traditional phy-
sicians think about diseases (and the medicines used to treat them) differently.
Of course many ofthe 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 gener-
ally believe that, if a plant has any medicinal value at all, it is because it con-

v
vi Foreword
tains one "active" ingredient that must be isolated and purified. Herbalist
believe results are better when the whole herb is used, because different com-
ponents ofthe 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 ofthe active ingredient may or may not be sufficient to produce
the desired therapeutic result, but the chances for toxicity are decreased. The
low concentration ofactive ingredients may explain why, given the enormous
numbers of people taking herbai 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 re-
duces adverse effects. When compounded by knowledgeable practitioners,
some ofthe remedies do make sense. The combination ofDevil'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 ab out it.
Occassionally, this leads to dire results. Terpenoids contained in Gingka bi/aba
interact with platelet-activating factor. Fatal brain hemorrhages have occurred
in anticoagulated patients who self-medicated with gingko. Traditional physi-
cians 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 bac-
tericidal effects only in growing bacteria.
Even without isolating the active principle, some herbai 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
Foreword vii
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
exceIlent job in combing the scientific literature for reliable, peer-reviewed,
information about the most widely used herbaI 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 weIl 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 ex ist, but reliable information about them is difficult to acquire. As more
is leamed, it will be incorporated into future editions.
Steven B. Kareh, MD
Berkeley, CA
Preface

Sales of herbai produets have inereased dramatieally over the past five
years. Unfortunately, the knowledge base devoted to the adverse effeets of
these products has not grown in proportion to their increased usage. Data of
questionable aecuracy, 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 0/ Herbal Products is designed
to provide medieal examiners, toxieologists, and health eare providers with an
objeetive review of the available information on the pharmaeology and toxi-
eology of eommonly used herbs. Clinieal and pathological findings from case
reports of herbai adverse effects are deseribed in detail. Seetions on the rel-
evant pharmacokinetics, chemie al analysis, and analysis ofbiofluids are unique
to this volume, and will be of use to pathologists and forensie scientists, as
well as to clinieians. Animal, human, and in vitro data are presented on the
known pharmacologie and toxicologic effects of eaeh herb, arranged by
organ, organ system, or therapeutic/toxieologic effeet. A good deal of phar-
maeology and therapeutics information is included in this section, not only
beeause toxieology is an extension of pharmacology, but also to make the
book useful for a wide variety of applieations by professionals with various
interests. Adverse effects noted in clinieal trials are noted in this seetion as
weIl. At the end of the book, a summary table lists herbai toxieities by
affeeted organ, provides a list ofherbs involved in drug interactions, and indi-
eates the type of data supporting the reported toxieities.
Eaeh herbai monograph begins with a diseussion ofthe herb's uses, prod-
uets, 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 herbai product is in question.

ix
x Preface
A chapter on the legal aspects of herbai products provides an overview of
the regulation ofherbal products in the US and abroad. In addition, each herbai
mono graph reviews the herb's status internationally, inc1uding approved uses.
The incidence of adverse effects associated with the use of herbai prod-
ucts is unknown, and may be underreported. Without a foundation ofknowl-
edge upon which to inquire whether an herbai product might be the cause of a
given finding, further exploration of the possibility of an herb-induced toxic-
ity might not be undertaken. Even if an herbai 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 Clini-
cal Pharmacology of Herbai Products is designed to provide the necessary
knowledge base upon which such investigations may efficaciously proceed.
Melanie Johns Cupp

11 want to acknowledge Mark Branciaroli ofElkins, WV for producing the photo-

graphs of the herbai products.
Contents

Foreword by Steven B. Karch ............................................................... v

Preface ................................................................................................... ix
Contributors ....................................................................................... xxv
Product Identification Guide ......................................... following p.134

P ART I LEGAL/REGULATORY ASPECTS OF HERBAL PRODUCTS

Chapter 1: Legal/Regulatory Aspects of Herbal Products ................... 3
Melanie Johns Cupp
PART 11 MONOGRAPHS
Chapter 1: Ma Huang and the Ephedra Alkaloids ............................. 11
Steven B. Karch
1.1 Sources ................................................................................................ 11
1.2 History and Traditional Uses ............................................................. 11
1.3 Current Promoted Uses ...................................................................... 12
1.4 Available Products ............................................................................. 13
1.5 Pharmaeology ..................................................................................... 15
1.5.1 Introduetion .............................................................................. 15
1.5.2 Pharmacologic Effeets ............................................................. 16
1.5.3 Metabolism and Elimination .................................................... 16
1.5.4 Workplace and Sports Drug Testing ....................................... 17
1.6 Drug Interaetions ................................................................................ 17
1.7 Toxieology .......................................................................................... 18
1.7.1 Neurologie Disorders ............................................................... 18
1.7.2 Renal Disorders ........................................................................ 19
1.7.3 Cardiovaseular Diseases .......................................................... 21
1. 7.4 Other Medieal Problems and Effeets ....................................... 22

xi
xii Contents
1.8 Postmortem Toxieology ..................................................................... 23
1.9 Analytie Considerations ..................................................................... 24
1.10 Methamphetamine Manufaeture ........................................................ 24
1.11 Commission E Reeommendations ..................................................... 24
Chapter 2: Kava ................................................................................... 31
Shawn Reeder and Melanie Johns Cupp
2.1 History and Traditional Uses ............................................................. 31
2.2 Current Promoted Uses ...................................................................... 32
2.3 Produets Available ............................................................................. 32
2.4 Pharmaeologie/Toxieologie Effeets .................................................. 32
2.4.1 Neurologie Effeets .................................................................... 32
2.4.2 Dermatologieal Effeets ............................................................. 35
2.4.3 Museuloskeletal Effeets ........................................................... 36
2.4.4 Antimierobial Aetivity ............................................................. 36
2.4.5 Hepatotoxieity .......................................................................... 36
2.4.6 Antiplatelet Effeets ................................................................... 36
2.5 Case Reports of Toxieity Due to Commereially
Available Produets ........................................................................... 36
2.6 Toxieity Assoeiated with Traditional Use by Native Populations ..... 37
2.7 Drug Interaetions ................................................................................ 38
2.8 Pharmaeokineties/Toxieokineties ...................................................... 38
2.8.1 Absorption ................................................................................ 38
2.8.2 MetabolismiElimination ........................................................... 38
2.9 Analysis ofBiofluids ......................................................................... 38
2.10 Chemieal Analysis ............................................................................. 39
2.11 Regulatory Status ............................................................................... 39
Chapter 3: Ginkgo biloba .................................................................... 43
Forouzandeh Mahdavi and Melanie Johns Cupp
3.1 History and Traditional Use .............................................................. 43
3.2 Current Promoted Use ........................................................................ 43
3.3 Produets Available ............................................................................. 43
3.4 Pharmaeologie/Toxieologie Effeets .................................................. 44
3.4.1 Nervous System Effeets ........................................................... 44
3.4.2 Cardiovaseular Effeets ............................................................. 46
3.4.3 Careinogenieity/Mutagenieity/Teratogenieity .... :................... 46
3.4.4 Endoerine Effeets ..................................................................... 47
3.5 Case Reports ofToxieity Due to Commercially
Available Products ........................................................................... 47
3.6 Drug Interaetions ................................................................................ 48
3.7 Pharmaeokineties/Toxieokineties ...................................................... 48
Contents xiii

3.7.1 Absorption ................................................................................ 48

3.7.2 Distribution ............................................................................... 49
3.7.3 MetabolisrnlElimination ........................................................... 49
3.8 Chemie al Analysis ............................................................................. 49
3.9 Analysis of Biofluids ......................................................................... 50
3.10 Regulatory Status ............................................................................... 50
Chapter 4: Valerian .............................................................................. 53
Marlea Givens and Melanie Johns Cupp
4.1 History andiTraditional Uses ............................................................. 53
4.2 Current Promoted Uses ...................................................................... 53
4.3 Produets Available ............................................................................. 54
4.4 Pharmaeologie/Toxieologie Effeets .................................................. 54
4.4.1 Central Nervous System Effeets .............................................. 54
4.4.2 Museuloskeletal Effeets ........................................................... 59
4.4.3 Reproduetion ............................................................................ 59
4.4.4 Cardiovaseular Effeets ............................................................. 60
4.4.5 Cytotoxieity .............................................................................. 60
4.5 Case Reports of Toxieity Due to Commereially
Available Produets ........................................................................... 61
4.6 Drug Interactions ................................................................................ 63
4.7 Chemical Analysis ............................................................................. 64
4.8 Regulatory Status ............................................................................... 64
Chapter 5: St. lohn's Wort ................................................................... 67
John T. Schwarz and Melanie Johns Cupp
5.1 History and Traditional Uses ............................................................. 67
5.2 Current Promoted Uses ...................................................................... 67
5.3 Produets Available ............................................................................. 68
5.4 Pharmaeologic/Toxicologie Effeets .................................................. 68
5.4.1 Neurological Effects ................................................................. 68
5.4.2 Antimicrobial Effeets ............................................................... 70
5.4.3 Mutagenicity ............................................................................. 70
5.4.4 Reproduetion ............................................................................ 70
5.5 Adverse Effeets and Toxieity ............................................................ 70
5.6 Drug Interactions ................................................................................ 72
5.7 Pharmaeokineties/Toxieokineties ...................................................... 74
5.7.1 Absorption ................................................................................ 74
5.7.2 Distribution ............................................................................... 75
5.7.3 Metabolism/Elimination ........................................................... 75
5.8 Chemieal Analysis ............................................................................. 76
5.9 Analysis ofBiofluids ......................................................................... 76
5.10 Regulatory Status ............................................................................... 76
xiv Contents

Chapter 6: Chamomile ......................................................................... 79

Melanie Johns Cupp
6.1 History and Traditional Uses ............................................................. 79
6.2 Current Promoted Uses ...................................................................... 79
6.3 Produets Available ............................................................................. 79
6.4 Pharmaeologie/Toxieologie Effeets .................................................. 79
6.4.1 Neurologie Effeets .................................................................... 79
6.4.2 Antineoplastie Effeets .............................................................. 80
6.4.3 Anti-Inflammatory Aetivity ..................................................... 80
6.5 Case Reports of Toxieity Due to Commereially
Available Produets .......................................................................... 80
6.6 Pharmaeokinetics/Toxieokineties ...................................................... 82
6.7 Analysis of Biofluids ......................................................................... 82
6.8 Regulatory Status ............................................................................... 82
Chapter 7: Echinacea ........................................................................... 85
Julie Davis and Melanie Johns Cupp
7.1 History and Traditional Uses ............................................................. 85
7.2 Current Promoted Uses ...................................................................... 86
7.3 Produets A vailable ............................................................................. 86
7.4 Pharmaeologie/Toxieologie Effeets .................................................. 86
7.4.1 Immunologie Effeets ................................................................ 86
7.4.2 AntimierobiallAntiviral Effeets ............................................... 87
7.4.3 Antineoplastie Aetivity ............................................................ 89
7.4.4 Wound-Healing ........................................................................ 89
7.4.5 Anti-Inflammatory Effeets ....................................................... 90
7.4.6 Mutagenieity/Careinogenieity ................................................. 90
7.4.7 Reproduetion ............................................................................ 90
7.5 Case Reports ofToxieity Due to Commereially
A vailable Produets ........................................................................... 90
7.6 Chemie al Analysis ............................................................................. 91
7.7 Regulatory Status ............................................................................... 91
Chapter 8: Feverfew ............................................................................. 95
Brian Schuller and Melanie Johns Cupp
8.1 History and Traditional Uses ............................................................. 95
8.2 Current Promoted Uses ...................................................................... 95
8.3 Produets Available ............................................................................. 96
8.4 Pharmaeology/Toxieology ................................................................. 97
8.4.1 Neurologie Effeets .................................................................... 97
8.4.2 Anti-Inflammatory Effeets ..................................................... 100
8.4.3 Mutagenieity/Careinogenieity/Teratogenieity ...................... 101
Contents xv
8.5 Case Reports of Toxicity Due to Commercially
Available Products ......................................................................... 102
8.6 Drug Interactions .............................................................................. 102
8.7 Chemical Analysis ........................................................................... 103
8.8 Regulation ........................................................................................ 103
Chapter 9: Garlic ................................................................................ 107
lames Allman and Melanie lohns Cupp
9.1 History and Traditional U ses ........................................................... 107
9.2 Current Promoted U ses .................................................................... 107
9.3 Products Available ........................................................................... 107
9.4 PharmacologiclToxicologic Effects ................................................ 109
9.4.1 Cardiovascular Effects ........................................................... 109
9.4.2 Gastrointestinal Effects .......................................................... 112
9.4.3 Antimicrobial Activity ........................................................... 112
9.4.4 Antineoplastic Effects ............................................................ 113
9.4.5 Immunostimulant Effects ....................................................... 114
9.5 Case Reports of Toxicity ................................................................. 115
9.6 Drug Interactions .............................................................................. 118
9.7 PharmacokineticslToxicokinetics .................................................... 118
9.7.1 Absorption .............................................................................. 118
9.7.2 Distribution ............................................................................. 118
9.7.3 MetabolismlElimination ......................................................... 118
9.8 Analysis of Biofluids ....................................................................... 120
9.9 Regulatory Status ............................................................................. 120
Chapter 10: Ginger ............................................................................ 123
Charity Metz and Melanie lohns Cupp
10.1 History and Traditional U ses .......................................................... 123
10.2 Current Promoted Uses ................................................................... 124
10.3 Products Available .......................................................................... 124
10.4 Pharmacologic/Toxicologic Effects ............................................... 125
10.4.1 Gastrointestinal Effects ........................................................ 125
10.4.2 Anti-Inflammatory Activity ................................................. 126
104.3 Use in Migraine .................................................................... 127
10.4.4 Cardiovascular Effects ......................................................... 127
10.4.5 Mutagenicity ......................................................................... 128
10.4.6 Reproduction ........................................................................ 128
10.5 Case Reports of Toxicity Due to Commercially
Available Products ........................................................................ 128
10.6 Drug Interactions ............................................................................. 129
10.7 Chemical Analysis .......................................................................... 129
10.8 Regulatory Status ............................................................................ 129
xvi Contents

Chapter 11: Saw Palmetto ................................................................. 133

Amy Meadows and Melanie Johns Cupp
11.1 History and Traditional Uses .......................................................... 133
11.2 Current Promoted Uses ................................................................... 133
11.3 Produets Available .......................................................................... 134
11.4 Pharmaeologie/Toxieologie Effeets ............................................... 134
11.4.1 Immunologie Effeets ............................................................ 134
11.4.2 Genitourinary/Endoerine Effeets ......................................... 134
11.4.3 Anti-Inflammatory Effeets ................................................... 136
11.5 Case Reports of Toxieity Due to Commereially
Available Produets ........................................................................ 136
11.6 Pharmaeokineties/Toxieokineties ................................................... 13 7
11.6.1 Absorption ............................................................................ 137
11.6.2 Distribution ........................................................................... 137
11.6.3 MetabolisrnlExeretion .......................................................... 137
11.7 Analysis ofBiofluids ...................................................................... 137
11.8 Chemieal Analysis .......................................................................... 138
11.9 Regulatory Status ............................................................................ 138
Chapter 12: Panax Ginseng ............................................................... 141
Angela Morgan and Melanie Johns Cupp
12.1 History and Traditional Uses .......................................................... 141
12.2 Current Promoted Uses ................................................................... 142
12.3 Produets Available .......................................................................... 142
12.4 Pharmaeologie/Toxieologie Effeets ............................................... 143
12.4.1 Endoerine Effeets ................................................................. 143
12.4.2 Neurologie Effeets ................................................................ 144
12.4.3 Cardiovaseular Effeets ......................................................... 144
12.4.4 Hematologie Effeets ............................................................. 144
12.4.5 Immunologie Effeets ............................................................ 145
12.4.6 Antineoplastie Effeets .......................................................... 145
12.5 CaseReports ofToxieity Due to Commereially
A vailable Produets ........................................................................ 145
12.6 Drug Interaetions ............................................................................. 147
12.7 Pharmaeokineties/Toxieokineties ................................................... 148
12.7.1 Absorption ............................................................................ 148
12.7.2 Distribution ........................................................................... 148
12.7.3 MetabolisrnlElimination ....................................................... 149
12.8 Analysis ofBiofluids ...................................................................... 149
12.9 Chemie al Analysis .......................................................................... 150
12.10 Regulatory Status ........................................................................... 150
Contents xvii
Chapter 13: Cranberry ....................................................................... 155
Angela l. Lawson and Melanie lohns Cupp
13.1 History and Traditional Uses .......................................................... 155
13.2 Current Promoted Uses ................................................................... 155
13.3 Produets Available .......................................................................... 155
13.4 Pharmaeologie/Toxieologie Effeets ............................................... 157
13.4.1 Antimierobial Aetivity ......................................................... 157
13.4.2 Gastrointestinal Effeets ........................................................ 158
13.4.3 Renal Effeets ........................................................................ 158
13.5 Chemie al Analysis .......................................................................... 159
13.6 Regulatory Status ............................................................................ 159
Chapter 14: Borage ............................................................................ 161
Melanie lohns Cupp
14.1 History and Traditional Uses .......................................................... 161
14.2 Current Promoted Uses ................................................................... 162
14.3 Produets Available .......................................................................... 162
14.4 Pharmaeologie/Toxieologie Effeets ............................................... 162
14.4.1 Anti-Inflammatory Effeets ................................................... 162
14.4.2 Dermatologie Effeets ........................................................... 165
14.4.3 Respiratory Effeets ............................................................... 166
14.4.4 Careinogenieity .................................................................... 166
14.4.5 Hematologie Effeets ............................................................. 166
14.4.6 Effeets in Diabetie Neuropathy ........................................... 166
14.4.7 Cardiovaseular Effeets ......................................................... 166
14.5 Case Reports ofToxicity ................................................................ 167
14.6 Pharmacokinetics/T oxicokineties ................................................... 167
14.7 Chemical Analysis .......................................................................... 167
14.8 Regulatory Status ............................................................................ 167
Chapter 15: Calamus ......................................................................... 171
Melanie Johns Cupp
15.1 History and Traditional U ses .......................................................... 171
15.2 Current Promoted U ses ................................................................... 172
15.3 Produets Available .......................................................................... 172
15.4 Pharmaeologie/Toxieologie Effeets ............................................... 172
15.4.1 Careinogenieity .................................................................... 172
15.4.2 Mutagenieity/Genotoxieity .................................................. 172
15.4.3 Antimierobial Aetivity ......................................................... 172
15.4.4 Central Nervous System Effects .......................................... 172
15.4.5 Museuloskeletal Effeets ....................................................... 173