The Handbook of Clinically Tested Herbal Remedies, Volumes 1 & 2  book cover
1st Edition

The Handbook of Clinically Tested Herbal Remedies, Volumes 1 & 2

ISBN 9780415652469
Published May 29, 2015 by Routledge
1508 Pages

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Book Description

A single source for accurate scientific information on herbal remedies!

This comprehensive handbook (comprised of two volumes of 700+ pages each) provides a snapshot of 160 herbal products that have been tested in clinical trials. Details of the products and the clinical trials they underwent are here in an easy-to-read, at-a-glance format.

Each botanical profile in The Handbook of Clinically Tested Herbal Remedies contains a summary section (table, text and references), followed by product information and clinical trials for that particular product. An evaluation of the strength of the evidence from the trials, along with the context for therapeutics is included to give you a complete picture of each remedy and its usefulness or lack thereof. If there is more than one product based on a particular botanical then the trials are grouped according to the product.

This valuable book also makes purchasing easy with manufacturer contact information. With over 30 individual botanicals and 10 multi-ingredient formulas, 160 products and 360 clinical studies, The Handbook of Clinically Tested Herbal Remedies is the book you need to make an informed selection of herbal products. Not only does it list proprietary herbal products that have been tested in controlled clinical studies and provide a rating of the quality of those trials, but, it also describes the fundamentals of herbal medicine, including regulation, characterization, standardization, bioavailability, efficacy, safety, pharmacopoeial monographs as well as incentives, or lack of incentive, for US and European manufacturers to conduct clinical studies.

Contributors to the chapters describing the fundamentals of herbal medicine include:

* the late Dr. Varro Tyler, Distinguished Professor Emeritus at Purdue University and co-author of Tyler's Honest Herbal, Rational Phytotherapy, and Tyler's Herbs of Choice
* Loren Israelsen, JD, president of the LDI group
* Tieraona Low Dog, MD, Chair of the USP Dietary Supplement Information Committee
* Joerg Grünwald, PhD, co-author of the Physicians Desk Reference (PDR) for Herbal Medicines, and Stefan Spiess, RPh, President of Grünwalder GmbH
* Anton Biber, PhD, and Friedrich Lang, PhD, experts in the bioavailability of herbal medicine at Dr. Willmar Schwabe GmbH & Co., Germany
* Anthony Almada, MSc, founder and Chief Scientific Officer of IMAGINutrition, Inc.
* Joseph M. Betz, PhD, Director of the Dietary Supplements Methods and Reference Materials Program at the NIH Office of Dietary Supplements
* Ezra Bejar, PhD, president of Plant Bioassay
* Uwe Koetter, PhD, Director of New OTC and Dietary Supplement Product Development at GlaxoSmithKline
* Srini Srinivasan, PhD, Vice President of the Dietary Supplement Verification Program of the United States Pharmacopeia (USP)
* Roy Upton, Executive Director of the American Herbal Pharmacopoeia.

All of the clinical trials in The Handbook of Clinically Tested Herbal Remedies were rated as to their Level of Evidence according to a system designed by Tieraona Low Dog, MD, Chair of the United States Pharmacopoeia Dietary Supplements/Botanicals Expert Panel and a member of the White House Commission on Complementary and Alternative Medicine. The reviewers of the clinical trials included Karriem Ali, MD; Richard Aranda, MD; Elliot Fagelman, MD; Mary Hardy, MD; David Heber, MD, PhD, FACP, FACN; John Trimmer Hicks, MD, FACP, FACR; Hannah Kim, MD; Franklin C. Lowe, MD, MPH; Richard D. O'Connor, MD; Barry S. Oken, M.D; Lynn Shinto, ND; and Keith Wesnes, PhD.

Table of Contents


  • About the Editor
  • Contributors
  • Preface
  • Acknowledgments
  • Editor’s Note
  • Chapter 1. History and Regulation of Botanicals in the United States (Loren D. Israelsen and Marilyn Barrett)
  • Introduction
  • History
  • DSHEA Explained
  • Drugs: OTC and Rx
  • Prospectus
  • Chapter 2. Product Definition Deficiencies in Clinical Studies of Herbal Medicines (Varro E. Tyler)
  • Chapter 3. Identifying and Characterizing Botanical Products (Marilyn Barrett)
  • Identifying Plants by Name
  • Means of Assuring Plant Identity
  • Preparations and Formulations
  • Dose
  • Bioavailability
  • Guidelines
  • Appendix: Preparations and Formulations
  • Chapter 4. Standardization of Botanical Preparations: What It Does and Does Not Tell Us (Uwe Koetter and Marilyn Barrett)
  • Introduction
  • Standardization of Therapeutic Activity
  • Standardization to Meet a Chemical Norm
  • Standardization As a Reflection of Quality Assurance Programs
  • Guidance
  • Situation in the Marketplace
  • Perspective
  • Chapter 5. The Importance and Difficulty in Determining the Bioavailability of Herbal Preparations (Anton Biber and Friedrich Lang)
  • Chapter 6. “Borrowed Science” and “Phytoequivalence”: Can Two Herbal Products Be Judged Equivalent? (Marilyn Barrett)
  • Chemical or Pharmaceutical Equivalency
  • Bioequivalency or Therapeutic Equivalency
  • Application of the Concepts, Ginkgo As an Example
  • Meta-Analyses
  • Perspective
  • Chapter 7. Determining Efficacy of Herbal Preparations (Tieraona Low Dog)
  • Observational Medicine
  • “Evidence-Based” Medicine
  • Summary
  • Chapter 8. Evaluating Safety of Herbal Preparations (Ezra Béjar, Joseph M. Betz, and Marilyn Barrett)
  • Evaluation of Safety
  • Adverse Reactions
  • Adverse-Event Reporting Systems
  • Categorization According to the Degree of Safety
  • Product Quality As an Aspect of Safety
  • Contraindications
  • Drug-Herb Interactions
  • Improving Our Knowledge of Safety
  • Chapter 9. Conducting Clinical Trials on Herbal Dietary Supplements in North America: Commercialization, Confidence, and Conflicts (Anthony L. Almada)
  • The Spirit to Sponsor: Is There an Adequate Economic Incentive to Fund Research?
  • Extracting Value from Science
  • Competitor Kevlar: Preventing Piracy of Product-Specific Data
  • How Much Data Is Enough?
  • We Have Data—Now What?
  • Who Has Science and How Did They Acquire It?
  • Conclusion
  • Chapter 10. Motives for Conducting Clinical Trials on Botanicals in Europe: A Focus on Germany (Joerg Gruenwald and Stefan Spiess)
  • Chapter 11. Pharmacopoeias and Botanical Monographs (Marilyn Barrett, Roy Upton, and V. Srini Srinivasan)
  • United States Pharmacopeia and National Formulary (USP-NF)
  • American Herbal Pharmacopoeia (AHP) and Therapeutic Compendium
  • European Pharmacopoeia (EP)
  • British Herbal Pharmacopoeia (BHP) and British Herbal Compendium (BHC)
  • German Commission E
  • European Scientific Cooperative of Phytotherapy (ESCOP)
  • Chinese Pharmacopoeia
  • African Pharmacopoeia
  • The Pharmacopoeia of Japan
  • The Pharmacopoeias of India
  • World Health Organization (WHO)
  • Other Pharmacopoeias
  • Summary and Perspective
  • Sources of Pharmacopoeias
  • Chapter 12. Methods of Product and Trial Inclusion and Evaluation (Marilyn Barrett)
  • Gathering Information on Products and Trials
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