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

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu



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Complementary and Alternative Medicine in the United States 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 INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Complementary and Alternative Medicine in the United States 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 Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by Contract No. 200N01-OD-4-2139 between the National Academy of Sciences and the Agency for Health Care Research and Quality, National Institutes of Health. Any opinions, findings, conclusions, or recommendations 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.

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Complementary and Alternative Medicine in the United States “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Adviser to the Nation to Improve Health

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Complementary and Alternative Medicine in the United States THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. 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

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Complementary and Alternative Medicine in the United States 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

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Complementary and Alternative Medicine in the United States 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

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Complementary and Alternative Medicine in the United States Preface Complementary and alternative medicine (CAM) therapies, by whatever 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 important 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 institutes, 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-

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Complementary and Alternative Medicine in the United States cant and increasing use of CAM therapies by the American public. Specifically, this study was asked to 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. Identify the major scientific, policy, and practice issues related to CAM research and to the translation of validated therapies into conventional medical practice. Develop conceptual models or frameworks to guide public- and private-sector decision making as research and practice communities confront the challenges of conducting research on CAM, translating research findings into practice, and addressing the distinct policy and practice barriers 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 participate 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 conventional 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 incorporation of CAM into health professions education. the impact of current regulations and legislation on CAM research and integration.

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Complementary and Alternative Medicine in the United States Committee membership was chosen to represent the most salient perspectives and competences, since there was no possibility that all or even most of the interest groups could be represented. Members included providers of CAM and conventional health care as well as analysts, observers, and managers of CAM and conventional health care systems. To ensure effective input from CAM providers, the committee established a working liaison group composed of 35 leaders of CAM and conventional medical disciplines and held a number of formal and informal interchanges with these groups. The committee proceeded to educate and inform itself through a systematic review of the extensive relevant literature, a series of expert presentations, discussions, and public comments in open meetings, and focused interchange and deliberation in committee meetings. The work of the committee 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 committee deliberated at length concerning whether and how to define CAM most usefully for the purpose of this report. All proposed definitions were imprecise, 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 determining that they are safe and effective. There are extremes of belief about effectiveness; for some individuals, no other evidence than hearsay or their

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Complementary and Alternative Medicine in the United States own experience or knowledge is necessary to determine that a CAM therapy is effective. For others, no evidence of any quality or quantity is sufficient to prove CAM effective. This report will please neither of those extremes. Recognizing that all scientific conclusions are tentative, the committee adopted proven and conventional standards of scientific evidence as the basis for judgments of the safety and effectiveness of both CAM and conventional medicine. The widespread use of CAM has focused attention on the need to find answers to the numerous questions surrounding such use, questions such as who is using CAM therapies and why, how does the public obtain information about CAM and how credible is that information, why aren’t users of CAM informing their physicians about such use, just what is CAM and are these therapies safe and effective? A significant portion of this report is devoted to an examination and analysis of evidence: what it is, how we obtain it, and how it is used by various stakeholders to make decisions. Methodological challenges are examined, and innovative study designs are discussed. Existing evidence about the effectiveness of some CAM therapies is reviewed and gaps in our knowledge are identified. Input from the liaison panel was particularly important as the committee explored the issue of evidence and how we know what we know. The report also addresses a number of issues related to the integration of CAM and conventional medicine, including how a therapy moves from a new idea to an accepted practice, a framework for advising patients about CAM, and approaches to integration. The committee concluded that the goal should be the provision of comprehensive medical care that is based on the best scientific evidence available regarding benefits and harm, that encourages patients to share in decision making about therapeutic options, and that promotes choices in care that can include CAM therapies, when appropriate. Our challenge was to eliminate parochial bias and to apply the best-available means of assessment of safety and effectiveness adapted to particular clinical circumstances of both CAM and conventional medicine. In this way we will be able to ensure that we are making informed, reasoned, and knowledge-based decisions about the safety, effectiveness, and use of CAM in health care. On behalf of every member of the committee, I want to express our unbounded respect and appreciation for the wisdom, industry, and judgment that Lyla Hernandez put into this study. At many critical junctures she kept the committee on track; and she was regularly a source of important ideas, data, and experts. The study would not have been completed without her gracious perseverance. We also want to thank Kysa Christie,

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Complementary and Alternative Medicine in the United States who provided thoughtful and invaluable research support. Ms. Christie identified, evaluated, and synthesized background information and issues throughout the committee’s deliberations. And we thank Makisha Wiley, who expertly managed our administrative, meeting, and travel needs. Stuart Bondurant, Committee Chair

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Complementary and Alternative Medicine in the United States Acknowledgments Throughout the past two years, the IOM Committee on the Use of Complementary and Alternative Medicine (CAM) by the American Public was fortunate to interact with many individuals interested in the role of CAM in the United States and willing to share their expertise, time and thoughts with the committee. The study sponsors at the NIH Institutes and Centers and the Agency for Healthcare Research and Quality willingly responded to questions and provided information on historical and ongoing projects related to complementary and alternative medicine. In particular, the committee wishes to thank Stephen E. Straus, Linda W. Engel, and Wendy Smith. Speakers at the five public meetings provided a broad overview of the field of CAM and its interaction with conventional medicine, as well as providing specific information about CAM. We would like to thank those speakers: Joseph Betz, Timothy Birdsall, Opher Caspi, Garrett Cuneo, Steven Dentali, George DeVries, Claude Gagnon, Harley Goldberg, James Gordon, Milton Hammerly, Aviad Haramati, William R. Hazzard, Dilip Jeste, Wayne Jonas, Mary Jo Kreitzer, Lee Lipsenthal, John Melnychuk, Will Morris, David Morrison, Donald Novey, Willo Pequegnat, Rowena Richter, Lawrence Smith, and Stephen E. Straus. In addition to the invited presentations, the committee wishes to acknowledge the contributions of those individuals who provided their insights during public comment sessions: Susan Bonfield Herschkowitz, Ardith Dentzer, Victoria Goldsten, William Lauretti, John Longhurst, Antonio C. Martinez II, Randall Neustaedter, Anthony Rosner, Harry Swope, Marissa Valeri, Kelly Welch, and James Winterstein.

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Complementary and Alternative Medicine in the United States Understanding and exploring research methods were crucial to the committee’s deliberations and the committee is indebted to Naihua Duan and his collaborators, Joel Braslow, Alison Hamilton Brown, Ted J. Kaptchuk, and Louise E. Tallen who were commissioned to write a paper on the strengths and limitations of clinical research. Thanks also go to the reviewers of that paper Elizabeth Barrett-Connor, Wayne Jonas, Roger Lewis, and Lee Sechrest. The committee would also like to thank Eric Manheimer for his contributions about emerging evidence in Chapter 5. Finally, a unique and informative component of the committee’s information gathering processes was the liaison panel with representatives from professional organizations in both conventional, and complementary and alternative medicine. Members of the liaison panel who met with, and provided input to the committee included: John Balletto, Timothy Birdsall, John P. Borneman, Gene C. Bruno, Clair Callan, Edward H. Chapman, Council on Homeopathic Education, Bryn Clark, Robert M. Duggan, Charlotte Eliopoulis, Joyce Frye, Milt Hammerly, Mark Houston, Herb Jacobs, Reiner Kremer, William Lauretti, John Lunstroth, Robert S. McCaleb, Alice McCormick, Matthew McCoy, Walter J. McDonald, William McCarthy, Ana C. Micka, David Molony, Will Morris, Wayne Mylin, Hiroshi Nakazawa, Randall Neustaedter, Martha S. O’Connor, Carole Ostendorf, Lawrence B. Palevsky, John Pan, Reed Phillips, Marcia Prenguber, Iris Ratowsky, Cynthia K. Reeser, David Rosengard, Cynthia Reeser, Rustum Roy, William D. Rutenberg, David M. Sale, Arnold Sandlow, Edward Shalts, Thomas Shepherd, Harry Swope, John Tooker, Richard Walls, Don Warren, Kathryn A. Weiner, Julian Whitaker, James F. Winterstein, Jackie Wootton.

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Complementary and Alternative Medicine in the United States Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Donald Berry, The University of Texas M.D. Anderson Cancer Center Timothy C. Birdsall, Cancer Treatment Centers of America Robert Boruch, Graduate School of Education, University of Pennsylvania Howard Brody, Center for Ethics and Humanities in the Life Sciences, Michigan State University Phil B. Fontanarosa, The Journal of the American Medical Association Janet Kahn, Department of Psychiatry, University of Vermont Mary Anne Koda-Kimble, School of Pharmacy, University of California, San Francisco Christine Laine, Annals of Internal Medicine, and American College of Physicians Roger J. Lewis, Department of Emergency Medicine, Harbor-University of California at Los Angeles Medical Center

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Complementary and Alternative Medicine in the United States William Meeker, Palmer Center for Chiropractic Research, Palmer Chiropractic University Foundation Anne Nedrow, Women’s Primary Care and Integrative Medicine, Oregon Health & Science University Susan Scrimshaw, School of Public Health, University of Illinois at Chicago Michael Trujillo, Department of Family and Community Medicine, University of New Mexico Health Sciences Center Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Dan G. Blazer, J.P. Gibbons Professor of Psychiatry, Duke University Medical Center, and Henry W. Riecken, Professor of Behavioral Sciences, Emeritus, University of Pennsylvania. Appointed by the National Research Council and the Institute of Medicine, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Complementary and Alternative Medicine in the United States Contents     EXECUTIVE SUMMARY   1      Toward Common Research Ground,   2      A New Position on Dietary Supplements,   4      Filling the Gaps,   5      Integrating CAM and Conventional Medicine,   6      Educating for Improved Care,   8      Knowns and Unknowns About CAM Use,   10 1   INTRODUCTION   13      Context,   14      Definition of CAM,   16      Recent Milestones in the History of CAM,   20      CAM Activities at NIH and AHRQ,   23      Report Contents,   31 2   PREVALENCE, COST, AND PATTERNS OF CAM USE   34      Overall Use,   34      Use by Population Subgroups,   41      Types of Illness,   45      Frequency of Use,   46      Long-Term Trends in CAM Use,   47      Cost-Effectiveness,   49      What Motivates People to Use CAM,   50      Accessing Information About CAM,   58      How the American Public Uses CAM Modalities,   60

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Complementary and Alternative Medicine in the United States      Characteristics of CAM Therapies Provided by Licensed Acupuncturists, Chiropractors, Massage Therapists, and Naturopaths,   63      Conclusions and Recommendations,   64 3   CONTEMPORARY APPROACHES TO EVIDENCE OF TREATMENT EFFECTIVENESS: A CONTEXT FOR CAM RESEARCH   74      A Brief Account of the Development of Treatment Effectiveness Research,   74      Basic Features of Contemporary Clinical Effectiveness Research,   79      Contemporary Issues in Study Design and Analysis,   85      Levels of Evidence,   94      Applying Contemporary Research Methods to CAM,   99 4   NEED FOR INNOVATIVE DESIGNS IN RESEARCH ON CAM AND CONVENTIONAL MEDICINE   108      Characteristics of CAM Treatments and Modalities,   108      Innovative Study Designs to Assess Treatment Effectiveness of CAM,   111      Use of Both Traditional and Innovative Study Designs to Create a Rich Body of Knowledge,   119      Relationship Between Basic Research and Clinical Research,   120      Conceptual Models to Guide Research,   122      Conclusions and Recommendations,   123 5   STATE OF EMERGING EVIDENCE ON CAM   129      Sources of Information on High-Quality Evidence,   130      Gaps in Evidence,   146      A Research Framework,   151      Conclusions and Recommendations,   161 6   AN ETHICAL FRAMEWORK FOR CAM RESEARCH, PRACTICE, AND POLICY   168      Value Commitments That Inform This Chapter,   168      Value Judgments in Defining CAM,   174      Ethical Issues in CAM Research,   174      Ethical Issues in the Integration of CAM Therapies into Conventional Medical Practice,   179      Related Legal and Regulatory Issues,   183

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Complementary and Alternative Medicine in the United States 7   INTEGRATION OF CAM AND CONVENTIONAL MEDICINE   196      From Idea to Practice,   196      Growing Integration of CAM,   201      Why Is Integration Occurring?,   208      Integrative Medicine,   209      Advising Patients,   213      Health Care Institutions,   215      Approaches to Integration,   217      Conclusions and Recommendations,   220 8   EDUCATIONAL PROGRAMS IN CAM   226      CAM in Health Professions Education,   226      Educating CAM Practitioners,   237      Lessons from Other Fields,   242      Practice Guidelines,   246      Conclusions and Recommendations,   248 9   DIETARY SUPPLEMENTS   253      Dietary Supplement Use in the United States,   253      Regulation of Dietary Supplements,   257      Product Quality and Safety,   265      Safety,   270      Research on Dietary Supplements,   272      Conclusions and Recommendations,   274 10   CONCLUSION   278     APPENDIXES     A   CAM Therapies, Practices, and Systems   283 B   Consortium of Academic Health Centers for Integrative Medicine   293 C   Table 1-1 List of Abbreviations   295 D   Liaison Panel Organizations   296 E   Model Guidelines for the Use of Complementary and Alternative Therapies in Medical Practice   298

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Complementary and Alternative Medicine in the United States F   National Center for Complementary and Alternative Medicine Research Centers   307 G   Public Meetings   310 H   Committee Biosketches   319     INDEX   327

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Complementary and Alternative Medicine in the United States Complementary and Alternative Medicine IN THE UNITED STATES

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