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CONTENTS About the Editor Contributors Introduction History DSHEA Explained Drugs: OTC and Rx Prospectus PART I: FUNDAMENTALS OF HERBAL MEDICINE Chapter 1. History and Regulation of Botanicals in the United States Loren D. Israelsen Marilyn Barrett 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 Chapter 4. Standardization of Botanical Preparations: What It Does and Does Not Tell Us Uwe Koetter 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 Friedrich Lang Chapter 6. "Borrowed Science" and "Phytoequivalence": Can Two Herbal Products Be Judged Equivalent? Marilyn Barrett Chemical or Pharmaceutical 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 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 Grünwald Stefan Spiess Chapter 11. Pharmacopoeias and Botanical Monographs Marilyn Barrett Roy Upton 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 Pharmacopoeia 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 Preparations Used in Reviewed Clinical Studies Summary of Reviewed Clinical Studies Artichoke Summary Table Post-Marketing 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 Summary of Reviewed Clinical Studies Elderberry Summary Table 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 Echinacea 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 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 Preparation 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 of 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 Summary Table Summary of Reviewed Clinical Studies Adverse Reactions or Side Effects Details on Red Yeast 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 2nd WindTM Preparations Used in Reviewed Clinical Studies Summary of Reviewed Clinical Studies 2nd WindTM Summary Table Adverse Reactions or Side Effects Details on 2nd WIND Products 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 Clinical Studies Summary of Reviewed Clinical Studies Geriforte Summary Table Adverse Reactions or Side Effects Details on Geriforte Product and Clinical Studies IberogastTM 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 28 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 PhytodolorTM Preparations Used in Reviewed Clinical Studies PhytodolorTM 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® Preparation 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
Library of Congress Subject Headings for this publication: Herbs Therapeutic use Handbooks, manuals, etc, Plant Preparations Handbooks, Plants, Medicinal Handbooks, Clinical Trials Handbooks