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The Handbook of Clinically Tested Herbal Remedies

Background of the Project

      The genesis of the idea for this book came from a conversation with my childhood physician, Larry Posner, MD, at a party in September 1998. He told me of his interest in botanicals due to the number of patients he had taking dietary supplements and of the limited knowledge he had of those products. He knew of my work with medicinal herbs and asked me to speak to him in his language regarding the evidence for these herbs. I inquired what language that might be and he replied, “double-blind, controlled, randomized clinical trials.” My response was that quite a few studies have been conducted on herbal remedies, probably more than he realized. Thus, the idea of this book was born.

Purpose and Scope of the Book

     This book provides consumers and health professionals with a means to distinguish those herbal products that have the backing of clinical evidence to substantiate claims of efficacy. It includes product descriptions provided largely from label information. In addition, this book describes in detail the trials associated with those products and provides an assessment of the quality of those trials.

     Only products that have undergone controlled clinical trials are included, as this research design is considered the most persuasive and is generally given the most weight by researchers and practitioners. Many herbal preparations commonly sold on the market are not included in this text, as they have not been subjected to controlled clinical trials.
     The book lists products, made with 32 herbs and ten formulas, that have been studied in a total of 369 clinical trials. Attempts were made to be systematic and inclusive in gathering products and trials; however, due to the magnitude of the effort and the amount of time required to complete the project, I acknowledge that it is essentially a snapshot—a sampling of the existing products and their clinical trials at the time when we were doing research for the book.
     It is my hope that this snapshot will assist in the evaluation of the clinical science behind botanical medicine and will help with the evaluation of the evidence for herbal product efficacy. I also hope that this book will help to bridge the gap between herbal medicine and standard Western therapies by using the language of the latter to describe the former. Ultimately it is my desire that this book will assist in establishing an appropriate place for botanical medicine alongside standard Western therapies in the medicine cabinet.
     The chapters in Part I: Fundamentals of Herbal Medicine provide background as well as context for the product and trial summaries that follow. These chapters provide information on the regulatory status of botanicals in the United States, the characterization and standardization of products, as well as the means to establish bioavailability, efficacy, and safety. Also included is a discussion on the “borrowing” of science from one product to support claims of efficacy for another. In addition, there is a discourse on the motives for conducting trials in the United States and in Europe, particularly in Germany. Finally, a chapter on pharmacopoeial monographs describes what they are and what information they provide.
     Part II: Methods describes the methods used to gather information on products and clinical studies. It includes the criteria for entry into the book and the means used to evaluate the efficacy of the individual trials.
     Part III: Botanical Profiles contains information on products and clinical trials. Products are grouped according to the principal botanical ingredient. If the products are multi-ingredient formulas, without a primary ingredient, then they are listed separately. Each botanical section is headed by a summary review of the products and trials.
This summary section contains an at-a-glance table listing the products included in that section, the indications addressed by the clinical studies, and the number and quality of those studies. The summary section also includes information from therapeutic monographs with use information for that herb. The summary section is followed by details on the products, which is in turn followed by a detailed account of the clinical trials for each product.
     Indexes allow for easy access to the product and trial information through the botanical common and scientific names, as well as by product and manufacturer names and therapeutic indication.

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