C omplementary and A lternative M edicine IN THE UNITED STATES Committee on the Use of Complementary and Alternative Medicine by the American Public Board on Health Promotion and Disease Prevention THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Govern- ing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineer- ing, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropri- ate balance. This study was supported by Contract No. 200N01-OD-4-2139 between the Na- tional Academy of Sciences and the Agency for Health Care Research and Quality, National Institutes of Health. Any opinions, findings, conclusions, or recommenda- tions expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. Library of Congress Cataloging-in-Publication Data Institute of Medicine (U.S.). Committee on the Use of Complementary and Alternative Medicine by the American Public. Complementary and alternative medicine in the United States / Committee on the Use of Complementary and Alternative Medicine by the American Public, Board on Health Promotion and Disease Prevention. p. ; cm. Includes bibliographical references and index. ISBN 0-309-09270-1 (hardcover) 1. Alternative medicine—United States. [DNLM: 1. Complementary Therapies—United States. 2. Biomedical Research—United States. 3. Health Policy—United States. WB 890 I59 2004] I. Title. R733.I5633 2004 615.5′0973—dc22 2004029011 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http:// www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Cover design by Tim and Karin Martin. Copyright 2005 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. “Knowing is not enough; we must apply. 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The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org COMMITTEE ON THE USE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE BY THE AMERICAN PUBLIC Stuart Bondurant, MD (Chair), Interim Executive Vice President and Executive Dean, Georgetown University Medical Center Joyce K. Anastasi, PhD, RN, FAAN, LAc, Helen F. Pettit Endowed Chair, Professor of Clinical Nursing, Columbia University School of Nursing Brian Berman, MD, Professor of Family Medicine, Director, Center for Integrative Medicine, University of Maryland School of Medicine Margaret Buhrmaster, Director, Office of Regulatory Reform, New York State Department of Health Gerard N. Burrow, MD, David Paige Smith Professor Emeritus of Medicine, Dean Emeritus, Yale University School of Medicine Michele Chang, MPH, CMT, Private practice, Arlington, Virginia Larry R. Churchill, PhD, Anne Geddes Stahlman Professor of Medical Ethics, Vanderbilt University Florence Comite, MD, Associate Clinical Professor, Yale University School of Medicine, and Founder, Medical Director, DestinationsHealth Jeanne Drisko, MD, Associate Professor, Program in Integrative Medicine: Functional Medicine and Complementary and Alternative Therapies, University of Kansas Medical Center David M. Eisenberg, MD, Director, Osher Institute; Director, Division for Research and Education in Complementary and Integrative Medical Therapies; and The Bernard Osher Associate Professor of Medicine, Harvard Medical School Alfred P. Fishman, MD, William Maul Measey Professor Emeritus of Medicine, and Senior Associate Dean for Program Development, University of Pennsylvania Health System Susan Folkman, PhD, Director, Osher Center for Integrative Medicine, and Osher Foundation Distinguished Professor of Integrative Medicine, Professor of Medicine, University of California, San Francisco Albert Mulley, MD, Associate Professor of Medicine, Associate Professor of Health Policy, Harvard Medical School; Chief, General Medicine Division; and Director, Medical Practices Evaluation Center, Massachusetts General Hospital David Nerenz, PhD, Senior Staff Investigator, Center for Health Services Research, Henry Ford Health System v Mark Nichter, PhD, MPH, Professor of Anthropology, Professor of Family and Community Medicine, Professor of Public Health, University of Arizona Bernard Rosof, MD, FACP, Senior Vice President for Corporate Relations and Health Affairs, North Shore Long Island Jewish Health System Harold Sox, MD, FACP, Editor, Annals of Internal Medicine Liaison to Board on Health Promotion and Disease Prevention Ellen Gritz, PhD, Professor and Chair, Frank T. McGraw Memorial Chair in the Study of Cancer, and Department of Behavioral Science, The University of Texas M.D. Anderson Cancer Center Committee Consultant Michael H. Cohen, JD, MBA, MFA, Assistant Professor of Medicine, Harvard Medical School, and Attorney-at-Law Staff Lyla M. Hernandez, MPH, Study Director Kysa Christie, Senior Program Associate Makisha Wiley, Senior Program Assistant Rose Marie Martinez, ScD, Director, Board on Health Promotion and Disease Prevention vi Preface Complementary and alternative medicine (CAM) therapies, by what- ever name they are called, have existed from antiquity. Recognition of the widespread use of CAM by the people of the United States has given new emphasis to the need to better understand the effects of these treatments from the perspective of personal and public health. To provide a rational, effective, efficient, and personally satisfactory health care system, it is im- portant and useful to know who is using CAM therapies and why, how the public obtains information about CAM and how credible that information is, why many users of CAM do not inform their physicians about such use, just what CAM is, and whether these therapies are safe and effective. It is only relatively recently, however, that there has been a serious general interest in the United States in investigating and evaluating these therapies. In 1992 the U.S. Congress established the Office of Alternative Medicine (OAM) within the National Institutes of Health (NIH) to begin to develop a baseline of information on CAM use in the United States. In 1999 the Congress elevated OAM to the National Center for Complementary and Alternative Medicine and appropriated $48.9 million to carry out work directly related to CAM. Other institutes of NIH and other federal agencies also engaged in the effort and by 2003, 19 institutes and centers within NIH were collectively spending $315.5 million on CAM-related research and other activities. This report was commissioned in September 2002, when 16 NIH insti- tutes, centers, and offices plus the Agency for Healthcare Research and Quality asked the Institute of Medicine to convene a study committee to explore scientific, policy, and practice questions that arise from the signifi- vii viii PREFACE cant and increasing use of CAM therapies by the American public. Specifi- cally, this study was asked to 1. Describe the use of CAM therapies by the American public and provide a comprehensive overview, to the extent that data are available, of the therapies in widespread use, the populations that use them, and what is known about how they are provided. 2. Identify the major scientific, policy, and practice issues related to CAM research and to the translation of validated therapies into conven- tional medical practice. 3. Develop conceptual models or frameworks to guide public- and private-sector decision making as research and practice communities con- front the challenges of conducting research on CAM, translating research findings into practice, and addressing the distinct policy and practice bar- riers inherent in that translation. Furthermore, the committee was asked to explore several issues, including • the methodological difficulties in the conduct of rigorous research on CAM therapies and how these relate to issues in regulation and practice, with exploration of the options that can be used to address the difficulties identified. • the shortage of highly skilled practitioners who are able to partici- pate in scientific inquiry that meets NIH guidelines and who have access to the institutions where such research is conducted. • the shortage of receptive, integrated research environments and the barriers to developing multidisciplinary teams that include CAM and con- ventional medical practitioners. • the availability of standardized and well-characterized materials and practices to be studied and incorporated, when appropriate, into practice. • the existing decision-making models used to determine whether or not to incorporate new therapies and practices into conventional medicine, including evidence thresholds. • the applicability of these decision-making models to CAM therapies and practices; that is, do they form good precedents for decisions relating to regulation, accreditation, or integration of CAM therapies? • identification and analysis of successful approaches to the incorpo- ration of CAM into health professions education. • the impact of current regulations and legislation on CAM research and integration. PREFACE ix Committee membership was chosen to represent the most salient per- spectives and competences, since there was no possibility that all or even most of the interest groups could be represented. Members included provid- ers of CAM and conventional health care as well as analysts, observers, and managers of CAM and conventional health care systems. To ensure effec- tive input from CAM providers, the committee established a working liai- son group composed of 35 leaders of CAM and conventional medical disci- plines and held a number of formal and informal interchanges with these groups. The committee proceeded to educate and inform itself through a sys- tematic review of the extensive relevant literature, a series of expert presen- tations, discussions, and public comments in open meetings, and focused interchange and deliberation in committee meetings. The work of the com- mittee was especially informed by discussions and a paper on experimental design written for the committee by Naihua Duan, Joel Braslow, Alison Hamilton Brown, Ted J. Kaptchuk, and Louise E. Tallen. The agendas and participants in the public meetings are listed in Appendix G. As described more extensively in Chapter 1 of the report, the commit- tee deliberated at length concerning whether and how to define CAM most usefully for the purpose of this report. All proposed definitions were impre- cise, ambiguous, or otherwise subject to misinterpretation. Judging that a definition was necessary, for the purposes of this report the committee adopted the definition stated on page 19. Several important caveats need to be understood to interpret correctly the committee’s meaning of statements concerning CAM in this report. The definition is necessarily imprecise and nonlimiting since it is based in part on the implied intended purpose of the practitioner and the user (i.e., improvement of health outcomes) and in part on exclusion from a category (the dominant health care system) that itself is not precisely defined and that changes substantially over time. The term CAM, as used in this report, encompasses a large, diverse, and changing set of “systems, modalities, and practices and their theories and beliefs.” The diversity of practice within CAM is so great that there are few, if any, generalizations that apply equally to all systems, modalities, and practices defined as CAM. When the term CAM is used in this report, it is not intended to include all CAM practices equally but, rather, to refer to a substantial group of CAM practices. The work of the committee began with the question, what do patients and health professionals need to know to make good decisions about the use of health care interventions, including CAM? Of primary importance in making decisions about whether to use specific CAM therapies is determin- ing that they are safe and effective. There are extremes of belief about effectiveness; for some individuals, no other evidence than hearsay or their