The Handbook of Clinically Tested Herbal Remedies

1 The Handbookof Clinically TestedHerbal RemediesVolume 1 Part I: Fundamentals of Herbal MedicinePart II: MethodsPart III: Botanical Profiles Product and Clinical Trial Information(Artichoke Ginseng)Marilyn Barrett, PhDEditorThe Haworth Herbal Press Pharmaceutical Products Press The Haworth Medical Press Imprints of The Haworth Press, York London OxfordPublished byThe Haworth Herbal Press , Pharmaceutical Products Press , and The Haworth Medical Press ,imprints of The Haworth Press, Inc., 10 Alice Street, Binghamton, NY 13904-1580. 2004 by The Haworth Press, Inc. All rights reserved. No part of this work may be reproduced orutilized in any form or by any means, electronic or mechanical, including photocopying, microfilm,and recording, or by any information storage and retrieval system, without permission in writingfrom the publisher.

2 Printed in the United States of : S NOTEThis book has been published solely for educational purposes and is not intended to substitutefor the medical advice of a treating is an ever-changing science. As newresearch and clinical experience broaden our knowledge, changes in treatment may be many potential treatment options are made herein, some or all of the options may not beapplicable to a particular individual. Therefore, the author, editor and publisher do not acceptresponsibility in the event of negative consequences incurred as a result of the informationpresented in this book.

3 We do not claim that this information is necessarily accurate by the rigidscientific and regulatory standards applied for medical Warranty, Expressed orImplied, is furnished with respect to the material contained in this book. The reader is urgedto consult with his/her personal physician with respect to the treatment of any design by Marylouise E. by Linda of Congress Cataloging-in-Publication DataThe Handbook of Clinically Tested Herbal Remedies , volumes 1 and 2 / Marilyn Barrett, ; bibliographical references and 0-7890-1068-2 Volumes 1 and 2 (hard : alk. paper)ISBN 0-7890-2723-2 Volume 1 (hard : alk.)

4 Paper)ISBN 0-7890-2724-0 Volume 2 (hard : alk. paper)1. Herbs Therapeutic use Handbooks, manuals, etc. [DNLM: 1. Plant Preparations Handbooks. QV 39 H2362 2004] I. Barrett, 2004615'.321 dc222003025270 CONTENTSVOLUME1 About the EditorxxiContributorsxxiiiPrefacexxxiAck nowledgmentsxxxvEditor s NotexxxviiPART I: FUNDAMENTALS OF Herbal MEDICINEC hapter 1. History and Regulation of Botanicalsin the United States3 Loren D. IsraelsenMarilyn BarrettIntroduction3 History3 DSHEA Explained5 Drugs: OTC and Rx10 Prospectus11 Chapter 2. Product Definition Deficiencies in ClinicalStudies of Herbal Medicines13 Varro E.

5 TylerChapter 3. Identifying and Characterizing BotanicalProducts23 Marilyn BarrettIdentifying Plants by Name24 Means of Assuring Plant Identity26 Preparations and Formulations30 Dose30 Bioavailability30 Guidelines31 Appendix: Preparations and Formulations32 Chapter 4. Standardization of Botanical Preparations:What It Does and Does Not Tell Us37 Uwe KoetterMarilyn BarrettIntroduction37 Standardization of Therapeutic Activity38 Standardization to Meet a Chemical Norm39 Standardization As a Reflection of QualityAssurance Programs41 Guidance43 Situation in the Marketplace44 Perspective45 Chapter 5. The Importance and Difficulty in Determiningthe Bioavailability of Herbal Preparations49 Anton BiberFriedrich LangChapter 6.

6 Borrowed Science and Phytoequivalence :Can Two Herbal Products Be Judged Equivalent?59 Marilyn BarrettChemical or Pharmaceutical Equivalency6162 Application of the Concepts, Ginkgo As an Example63 Meta-Analyses65 Perspective66 Chapter 7. Determining Efficacy of Herbal Preparations69 Tieraona Low DogObservational Medicine70 Evidence-Based Medicine71 Summary74 Chapter 8. Evaluating Safety of Herbal Preparations77 Ezra B jarJoseph M. BetzMarilyn BarrettEvaluation of Safety78 Adverse Reactions80 Adverse-Event Reporting Systems81 Categorization According to the Degree of Safety82 Product Quality As an Aspect of Safety84 Contraindications85 Drug-Herb Interactions85 Improving Our Knowledge of Safety87 Chapter 9.

7 Conducting Clinical Trials on Herbal DietarySupplements in North America: Commercialization,Confidence, and Conflicts91 Anthony L. AlmadaThe Spirit to Sponsor: Is There an Adequate EconomicIncentive to Fund Research?92 Extracting Value from Science95 Competitor Kevlar: Preventing Piracy of Product-SpecificData96 How Much Data Is Enough?100We Have Data Now What?103 Who Has Science and How Did They Acquire It?105 Conclusion105 Chapter 10. Motives for Conducting Clinical Trialson Botanicals in Europe: A Focus on Germany107 Joerg GruenwaldStefan SpiessChapter 11. Pharmacopoeias and Botanical Monographs115 Marilyn BarrettRoy UptonV.

8 Srini SrinivasanUnited States Pharmacopeia and National Formulary(USP-NF)116 American Herbal Pharmacopoeia (AHP) and TherapeuticCompendium118 European Pharmacopoeia (EP)119 British Herbal Pharmacopoeia (BHP)andBritish HerbalCompendium (BHC)119 German Commission E120 European Scientific Cooperative on Phytotherapy (ESCOP) 121 Chinese Pharmacopoeia121 African Pharmacopoeia122 The Pharmacopoeia of Japan122 The Pharmacopoeias of India123 World Health Organization (WHO)123 Other Pharmacopoeias124 Summary and Perspective124 Sources of Pharmacopoeias125 PART II: METHODSC hapter 12. Methods of Product and Trial Inclusionand Evaluation129 Marilyn BarrettGathering Information on Products and Trials129 Data on Products and Trials134 Evaluation of Clinical Trial Quality137 Chapter 13.

9 Clinical Trial Reviewer s Guidanceand Checklist141 Tieraona Low DogLevels of Evidence141 Guidelines for Reviewer Checklist: Part I142 Guidelines for Reviewer Checklist: Part II144 Scoring146 PART III: BOTANICAL PROFILES PRODUCT AND CLINICAL TRIAL INFORMATION(Artichoke Ginseng)Single Herbs151 Artichoke151 Preparations Used in Reviewed Clinical Studies151 Artichoke Summary Table152 Summary of Reviewed Clinical Studies153 Postmarketing Surveillance Studies154 Adverse Reactions or Side Effects154 Information from Pharmacopoeial Monographs155 Details on Artichoke Products and Clinical Studies157 Bilberry163 Preparations Used in Reviewed Clinical Studies163 Bilberry Summary Table164 Summary of Reviewed Clinical Studies165 Adverse Reactions or Side Effects167 Information from Pharmacopoeial Monographs168 Details on Bilberry Products and Clinical Studies171 Black Cohosh185

10 Preparations Used in Reviewed Clinical Studies185 Black Cohosh Summary Table186 Summary of Reviewed Clinical Studies187 Postmarketing Surveillance Studies189 Adverse Reactions or Side Effects189 Information from Pharmacopoeial Monographs190 Details on Black Cohosh Products and Clinical Studies194 Boxwood207 Preparations Used in Reviewed Clinical Studies207 Summary of Reviewed Clinical Studies207 Boxwood Summary Table208 Adverse Reactions or Side Effects209 Details on Boxwood Products and Clinical Studies210 Butterbur, Purple213 Preparations Used in Reviewed Clinical Studies213 Butterbur Summary Table214 Summary of Reviewed Clinical Studies215 Adverse Reactions or Side Effects216 Information from Pharmacopoeial Monographs216 Details on Butterbur Products and Clinical Studies218 Cat s Claw225 Preparations Used in Reviewed Clinical Studies225 Cat s Claw Summary Table226 Summary of Reviewed Clinical Studies227 Adverse Reactions or Side Effects227 Details on Cat s Claw Products and Clinical Studies228 Chaste Tree231 Preparations Used in Reviewed Clinical Studies231 Chaste Tree Summary Table232 Summary of Reviewed