The Handbook of Clinically Tested Herbal Remedies Book

VOLUME 1

About the Editor
Contributors
Preface
Acknowledgments
Editor s Note

PART I: FUNDAMENTALS OF HERBAL MEDICINE

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

PART II: METHODS

Chapter 12. Methods of Product and Trial Inclusion and Evaluation (Marilyn
Barrett)
Gathering Information on Products and Trials
Data on Products and Trials
Evaluation of Clinical Trial Quality

Chapter 13. Clinical Trial Reviewer s Guidance and Checklist (Tieraona Low
Dog)
Levels of Evidence
Guidelines for Reviewer Checklist: Part I
Guidelines for Reviewer Checklist: Part II
Scoring

PART III: BOTANICAL PROFILES PRODUCT AND CLINICAL TRIAL INFORMATION
(Artichoke Ginseng)

Single Herbs

Artichoke
Preparations Used in Reviewed Clinical Studies
Artichoke Summary Table
Summary of Reviewed Clinical Studies
Postmarketing Surveillance Studies
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Artichoke Products and Clinical Studies

Bilberry
Preparations Used in Reviewed Clinical Studies
Bilberry Summary Table
Summary of Reviewed Clinical Studies

Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Bilberry Products and Clinical Studies

Black Cohosh
Preparations Used in Reviewed Clinical Studies
Black Cohosh Summary Table
Summary of Reviewed Clinical Studies
Postmarketing Surveillance Studies
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Black Cohosh Products and Clinical Studies

Boxwood
Preparations Used in Reviewed Clinical Studies
Summary of Reviewed Clinical Studies
Boxwood Summary Table
Adverse Reactions or Side Effects
Details on Boxwood Products and Clinical Studies

Butterbur, Purple
Preparations Used in Reviewed Clinical Studies
Butterbur Summary Table
Summary of Reviewed Clinical Studies
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Butterbur Products and Clinical Studies

Cat s Claw
Preparations Used in Reviewed Clinical Studies
Cat s Claw Summary Table
Summary of Reviewed Clinical Studies
Adverse Reactions or Side Effects
Details on Cat s Claw Products and Clinical Studies

Chaste Tree
Preparations Used in Reviewed Clinical Studies
Chaste Tree Summary Table
Summary of Reviewed Clinical Studies
Postmarketing Surveillance Studies
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Chaste Tree Products and Clinical Studies

Cordyceps
Preparations Used in Reviewed Clinical Studies
Summary of Reviewed Clinical Studies
Cordyceps Summary Table
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Cordyceps Products and Clinical Studies

Cranberry
Preparations Used in Reviewed Clinical Studies
Summary of Reviewed Clinical Studies
Cranberry Summary Table
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Cranberry Products and Clinical Studies

Devil s Claw
Preparations Used in Reviewed Clinical Studies
Summary of Reviewed Clinical Studies
Devil s Claw Summary Table
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Devil s Claw Products and Clinical Studies

Dragon s Blood Croton
Preparations Used in Reviewed Clinical Studies
Dragon s Blood Croton Summary Table
Summary of Reviewed Clinical Studies
Adverse Reactions or Side Effects
Details on Dragon s Blood Products and Clinical Studies

Echinacea
Preparations Used in Reviewed Clinical Studies
Echinacea Summary Table
Summary of Reviewed Clinical Studies
Reviews and Meta-Analyses of Clinical Studies
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Echinacea Products and Clinical Studies

Elderberry
Preparations Used in Reviewed Clinical Studies
Elderberry Summary Table
Summary of Reviewed Clinical Studies
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Elderberry Products and Clinical Studies

Evening Primrose
Preparations Used in Reviewed Clinical Studies
Evening Primrose Summary Table
Summary of Reviewed Clinical Studies
Systematic Reviews and Meta-Analyses
Adverse Reactions or Side Effects
Details on Evening Primrose Products and Clinical Studies

Garlic
Preparations Used in Reviewed Clinical Studies
Garlic Summary Table
Summary of Reviewed Clinical Studies
Meta-Analyses and Systematic Clinical Reviews
Epidemiological Studies
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Garlic Products and Clinical Studies

Ginger
Preparations Used in Reviewed Clinical Studies
Ginger Summary Table
Summary of Reviewed Clinical Studies
Systematic Reviews and Meta-Analyses
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Ginger Products and Clinical Studies

Ginkgo
Preparations Used in Reviewed Clinical Studies
Ginkgo Summary Table
Summary of Reviewed Clinical Studies
Meta-Analyses and Systematic Reviews
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Ginkgo Products and Clinical Studies

Ginseng
Preparations Used in Reviewed Clinical Studies
Ginseng Summary Table
Summary of Reviewed Clinical Studies
Systematic Reviews
Epidemiological Studies
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Ginseng Products and Clinical Studies

VOLUME 2

PART III: BOTANICAL PROFILES PRODUCT AND CLINICAL TRIAL INFORMATION (Grape
Seed Valerian and Herbal Formulas)

Grape Seed
Preparations Used in Reviewed Clinical Studies
Grape Seed Summary Table
Summary of Reviewed Clinical Studies
Adverse Reactions or Side Effects
Details on Grape Seed Products and Clinical Studies

Grass Pollen
Preparations Used in Reviewed Clinical Studies
Summary of Reviewed Clinical Studies
Grass Pollen Summary Table
Systematic Reviews
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Grass Pollen Products and Clinical Studies

Green Tea
Preparations Used in Reviewed Clinical Studies
Green Tea Summary Table
Summary of Reviewed Clinical Studies
Epidemiological Studies
Adverse Reactions or Side Effects
Details on Green Tea Products and Clinical Studies

Hawthorn
Preparations Used in Reviewed Clinical Studies
Hawthorn Summary Table
Summary of Reviewed Clinical Studies
Postmarketing Surveillance Studies
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Hawthorn Products and Clinical Studies

Horse Chestnut
Preparations Used in Reviewed Clinical Studies
Horse Chestnut Summary Table
Summary of Reviewed Clinical Studies
Systematic Reviews
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Horse Chestnut Products and Clinical Studies

Kava
Preparations Used in Reviewed Clinical Studies
Summary of Reviewed Clinical Studies
Kava Summary Table
Systematic Reviews
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Kava Products and Clinical Studies

Lemon Balm
Preparations Used in Reviewed Clinical Studies
Summary of Reviewed Clinical Studies
Lemon Balm Summary Table
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Lemon Balm Products and Clinical Studies

Milk Thistle
Preparations Used in Reviewed Clinical Studies
Milk Thistle Summary Table
Summary of Reviewed Clinical Studies
Meta-Analyses and Systematic Reviews
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Milk Thistle Products and Clinical Studies

Pygeum
Preparations Used in Reviewed Clinical Studies
Pygeum Summary Table
Summary of Reviewed Clinical Studies
Systematic Reviews
Adverse Reactions or Side Effects
Details on Pygeum Products and Clinical Studies

Red Clover
Preparations Used in Reviewed Clinical Studies
Summary of Reviewed Clinical Studies
Red Clover Summary Table
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Red Clover Products and Clinical Studies

Red Yeast Rice
Preparations Used in Reviewed Clinical Studies
Red Yeast Rice Summary Table
Summary of Reviewed Clinical Studies
Adverse Reactions or Side Effects
Details on Red Yeast Rice Products and Clinical Studies

Saw Palmetto
Preparations Used in Reviewed Clinical Studies
Saw Palmetto Summary Table
Summary of Reviewed Clinical Studies
Meta-Analyses and Systematic Reviews
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Saw Palmetto Products and Clinical Studies

St. John s Wort
Preparations Used in Reviewed Clinical Studies
St. John s Wort Summary Table
Summary of Reviewed Clinical Studies
Systematic Reviews and Meta-Analyses
Postmarketing Surveillance Studies
Adverse Reactions or Side Effects
Drug Interactions
Information from Pharmacopoeial Monographs
Details on St. John s Wort Products and Clinical Studies

Valerian
Preparations Used in Reviewed Clinical Studies
Valerian Summary Table
Summary of Reviewed Clinical Studies
Adverse Reactions or Side Effects
Information from Pharmacopoeial Monographs
Details on Valerian Products and Clinical Studies
Herbal Formulas

2nd Wind
Preparations Used in Reviewed Clinical Studies
Summary of Reviewed Clinical Studies
2nd Wind Summary Table
Adverse Reactions or Side Effects
Details on 2nd Wind Product and Clinical Studies

Cystone
Preparations Used in Reviewed Clinical Studies
Cystone Summary Table
Summary of Reviewed Clinical Studies
Adverse Reactions or Side Effects
Details on Cystone Product and Clinical Studies

Gastrim
Preparations Used in Reviewed Clinical Studies
Gastrim Summary Table
Summary of Reviewed Clinical Studies
Adverse Reactions or Side Effects
Details on Gastrim Product and Clinical Studies

Geriforte
Preparations Used in Reviewed Clinical Studies
Geriforte Summary Table
Summary of Reviewed Clinical Studies
Adverse Reactions or Side Effects
Details on Geriforte Product and Clinical Studies

Iberogast
Preparations Used in Reviewed Clinical Studies
Summary of Reviewed Clinical Studies
Iberogast Summary Table
Adverse Reactions or Side Effects
Details on Iberogast Product and Clinical Studies

Padma
Padma Summary Table
Preparations Used in Reviewed Clinical Studies
Summary of Reviewed Clinical Studies
Adverse Reactions or Side Effects
Details on Padma Product and Clinical Studies

Phytodolor
Preparations Used in Reviewed Clinical Studies
Phytodolor Summary Table
Summary of Reviewed Clinical Studies
Systematic Reviews
Adverse Reactions or Side Effects in Clinical Studies
Details on Phytodolor Product and Clinical Studies

Prostane
Preparations Used in Reviewed Clinical Studies
Summary of Reviewed Clinical Studies
Prostane Summary Table
Adverse Reactions or Side Effects
Details on Prostane Product and Clinical Studies

Resistex
Preparations Used in Reviewed Clinical Studies
Summary of Reviewed Clinical Studies
Resistex Summary Table
Adverse Reactions or Side Effects
Details on Resistex Product and Clinical Studies

Sinupret
Preparations Used in Reviewed Clinical Studies
Summary of Reviewed Clinical Studies
Sinupret Summary Table
Postmarketing Surveillance Study
Adverse Reactions or Side Effects
Details on Sinupret Product and Clinical Studies

Appendix A. Products Listed by Manufacturer/Distributor
Appendix B. Manufacturer/Distributor Contact Information
Index
Reference Notes Included