Complementary and Alternative Medicine in the United States (Free Executive Summary) COMPLEMENTARY AND ALTERNATIVE MEDICINE …

Complementary and Alternative Medicine in the United States Free Executive Summary http://wwwnapedu/catalog/11182html

Free Executive Summary
Complementary and Alternative Medicine in the United States Committee on the Use of Complementary and Alternative Medicine by the American Public ISBN: 0-309-09270-1, 300 pages, 6 x 9, hardback 2005

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Integration of complementary and alternative medicine therapies CAM with
conventional medicine is occurring in hospitals and physicians offices,health maintenance organizations HMOs are covering CAM therapies,insurance coverage for CAM is increasing, and integrative medicine centersand clinics are being established, many with close ties to medical schoolsand teaching hospitals In determining what care to provide, the goalshould be comprehensive care thatand CAM best scientific evidence It outlines areas of research in convention uses the therapies, ways ofintegrating these availableregarding benefitscurriculum that provides a focus on healing, recognizesthe therapies, development of and harm, encourages furthereducation to health importance of compassion and caring, emphasizes the centralityof relationship-based to professionals, and an amendment of the DietarySupplement Health and Education Act care, encourages patientslabeling,research into use of supplements, incentives for improve quality, accurate to share in decision makingabout therapeutic options,
and promotesfunded researchinto their includecomplementary therapies where appropriate privately choices in care that can efficacy, and consumer protection against all potential hazards approaches to delivering integrative medicine have evolvedComplementary Numerous and Alternative Medicine in the United States identifies anurgent need for health systems research that focuses on identifying the elementsof these models, the outcomes of care delivered in these models,and whether these models are cost-effective when compared to conventionalpractice settings

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Executive Summary

Americans use of complementary and alternative medicine CAM– approaches such as chiropractic or acupuncture–is widespread More than a third of American adults report using some form of CAM, with total visits to CAM providers each year now exceeding those to primary-care physicians An estimated 15 million adults take herbal remedies or high-dose vitamins along with prescription drugs It all adds up to annual out-of pocket costs for CAM that are estimated to exceed 27 billion Friends confer with friends about CAM remedies for specific problems, CAM-related stories appear frequently in the print and broadcast media, and the Internet is replete with CAM information Many hospitals, managed care plans, and conventional practitioners are incorporating CAM therapies into their practices, and schools of medicine, nursing, and pharmacy are
beginning to teach about CAM CAMs influence is substantial yet much remains unknown about these therapies, particularly with regard to scientific studies that might convincingly demonstrate the value of individual therapies Against this background the National Center for Complementary and Alternative Medicine NCCAM, 15 other centers and institutes of the National Institutes of Health NIH, and the Agency for Healthcare Research and Quality commissioned the Institute of Medicine IOM to convene a committee that would: Describe the use of CAM therapies by the American public and provide a comprehensive overview, to the extent data are available, of the

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COMPLEMENTARY AND ALTERNATIVE MEDICINE

therapies in widespread use, the populations that use
them, and what is known about how they are provided Identify major scientific, policy, and practice issues related to CAM research, and to the translation of validated therapies into conventional practice Develop conceptual models or frameworks to guide public- and private-sector decisionmaking as research and practice communities increasingly conduct research on CAM, translate the research findings into practice, and address the barriers that may impede such translation TOWARD COMMON RESEARCH GROUND Decisions about the use of specific CAM therapies should primarily depend on whether they have been shown to be safe and effective But this is easier said than done, as there are extremes of belief about what counts as evidence For some individuals, evidence limited to their own experience or knowledge is all that is necessary as proof that a CAM therapy is successful; for others, no amount of evidence is sufficient This report will please neither of those extremes There are unproven
ideas of all kinds, stemming from CAM and conventional medicine alike, and the committee believes that the same principles and standards of evidence should apply regardless of a treatments origin Study results may then move useful therapies from unproven ideas into evidence-based practice The goal should be the provision of comprehensive care that respects contributions from all sources Such care requires decisions based on the results of scientific inquiry, which in turn can lead to new information that results in improvements in patient care This reports core message is therefore as follows: The committee recommends that the same principles and standards of evidence of treatment effectiveness apply to all treatments, whether currently labeled as conventional medicine or CAM Implementing this recommendation requires that investigators use and develop as necessary, common methods, measures, and standards for the generation and interpretation of evidence necessary for making decisions
about the use of CAM and conventional therapies The committee acknowledges that the characteristics of some CAM therapies–such as variable practitioner approaches, customized treatments, bundles combinations of treatments, and hard-to-measure outcomes– are difficult to incorporate into treatment-effectiveness studies These characteristics are not unique to CAM, but they are more frequently found in CAM than in conventional therapies The effects of mass-produced, essentially identical prescription drugs, for example, are somewhat easier to

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EXECUTIVE SUMMARY

study than those of Chinese herbal medicines tailored to the needs of individual patients But while randomized controlled trials RCTs remain the gold standard of evidence for treatment
efficacy, other study designs can be used to provide information about effectiveness when RCTs cannot be done or when their results may not be generalizable to the real world of CAM practice These innovative designs include: Preference RCTs: trials that include randomized and non-randomized arms, which then permit comparisons between patients who chose a particular treatment and those who were randomly assigned to it Observational and cohort studies, which involve the identification of patients who are eligible for study and who may receive a specified treatment, but are not randomly assigned to the specified treatment as part of the study Case-control studies, which involve identifying patients who have good or bad outcomes, then working back to find aspects of treatment associated with those different outcomes Studies of bundles of therapies: analyses of the effectiveness, as a whole, of particular packages of treatments Studies that specifically incorporate, measure, or account
for placebo or expectation effects: patients hopes, emotional states, energies, and other self-healing processes are not considered extraneous but are included as part of the therapys main mechanisms of action Attribute-treatment interaction analyses: a way of accounting for differences in effectiveness outcomes among patients within a study and among different studies of varying design Given limited available funding, prioritization is necessary regarding which CAM therapies to evaluate The following criteria could be used to help make this determination A biologically plausible mechanism exists for the intervention, but the science base on which plausibility is judged is a work in progress Research could plausibly lead to the discovery of biological mechanisms of disease or treatment effect The condition is highly prevalent eg, diabetes mellitus The condition causes a heavy burden of suffering The potential benefit is great Some evidence that the intervention is effective
already exists Some evidence exists that there are safety concerns

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The research design is feasible, and research will likely yield an unambiguous result The target condition or the intervention is important enough to have been detected by existing population-surveillance mechanisms A therapy should not be excluded from consideration because it does not meet any one particular criterion–say, biological plausibility However, the absence of such a mechanism will inevitably raise the level of skepticism about the potential effectiveness of the treatment whether conventional or CAM Moreover, the amount of basic research needed to justify funding for clinical studies of the treatment, and the level of evidence
from those studies that is needed to consider the treatment as established, will both increase under such circumstances A NEW POSITION ON DIETARY SUPPLEMENTS The committee has taken a similarly pragmatic approach to dietary supplements, which have become a prominent part of American popular health culture but continue to present unique regulatory, safety, and efficacy challenges Under the Dietary Supplement Health and Education Act of 1994–the capstone, thus far, of herbal-medicine regulation–the Food and Drug Administration FDA was authorized to establish good-manufacturing-practice regulations specific to dietary supplements But the Act did not subject supplements to the same safety precautions that apply to prescription and over-the-counter medications Instead, it designated that supplements be regulated like foods, a crucial distinction that exempted manufacturers from conducting premarket safety and efficacy testing Similarly, FDAs regulatory-approval process–which would be
standard operating procedure if supplements had been classified as drugs–was eliminated, thereby limiting the agency to a reactive, postmarketing role The committee is therefore concerned about the quality of dietary supplements in the United States Product reliability is low, and because patent protection is not available for natural substances there is little incentive for manufacturers to invest resources in improving product standardization Yet reliable and standardized supplements are needed not only for consumer protection but also for research on safety and efficacy Without consistent products, research is extremely difficult to conduct or generalize And without high-quality research, medical practitioners cannot make evidence-based recommendations to help guide patients Therefore the committee recommends that the US Congress and federal agencies, in consultation with industry, research scientists, consum-

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EXECUTIVE SUMMARY

ers, and other stakeholders, amend the Dietary Supplement Health and Education Act of 1994 and the current regulatory scheme for dietary supplements, with emphasis on strengthening: Seed-to-shelf quality-control [based on standards for each step of the manufacturing process--from planting to growth, harvest, extraction, and screening for impurities] Accuracy and comprehensiveness in labeling and other disclosures Enforcement efforts against inaccurate and misleading claims Research into how consumers use supplements Incentives for privately funded research into the efficacies of products and brands, and Consumer protection against all potential hazards FILLING THE GAPS Evidence of the safety and efficacy of individual CAM treatments is essential, but it represents just one facet of the
research that is needed For example, there is a paucity of clinical research that compares CAM therapies with each other or with conventional interventions Very little research has been done on the cost-effectiveness of CAM And although there is great opportunity for scientific discovery in the study of CAM treatments, it is an opportunity largely missed Such investigations are hindered by shortages of established scientists engaged in CAM research, which tends to involve subject matter beyond the conventional scientists knowledge base CAM also needs a cadre of new junior researchers While major US health-sciences campuses have long offered training in basic and clinical research for conventional medicine, the challenge is to induce these schools to embrace CAM research as well One approach might be to add specific CAM content to conventionalmedicine postdoctoral training programs Furthermore, CAM research will benefit from the contributions of more than one discipline In addition to
providers who have specialized knowledge of CAM treatments and methodologists who can address the challenges inherent in CAM study design, investigators with backgrounds in fields such as psychology, sociology, anthropology, economics, genetics, pharmacology, neuroscience, health services, and health policy can make important contributions Interdisciplinary teams, grouped into critical masses at various locations, will be favorably positioned to probe the many factors that influence individuals to use CAM treatments and that determine the outcomes of those treatments Research on CAM is inexticably linked to practice CAM therapies are already in widespread use today, it is reasonable to attempt to evaluate the

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COMPLEMENTARY AND ALTERNATIVE
MEDICINE

outcomes of that use, and in the practice setting one can focus on research that answers questions about how therapies function in the real world where patients vary, often have a number of health problems, and are using multiple therapies Practice-based research addresses real world practice issues and facilitates adoption of practice changes that are based on research results To address these gaps, the committee recommends that the NIH and other public agencies provide the support necessary to: Develop and implement a sentinel surveillance system [composed of selected sites able to collect and report data on patterns of use of CAM and conventional medicine]; practice-based research networks [defined by the Agency for Healthcare Research and Quality as a group of ambulatory practices devoted principally to the primary care of patients, affiliated with each other and often with an academic or professional organization in order to investigate questions related to
community-based practice]; and CAM research centers to facilitate the work of the networks [by collecting and analyzing information from national surveys, identifying important questions, designing studies, coordinating data collection and analysis, and providing training in research and other areas] Include CAM-relevant questions in federally funded health care surveys eg, the National Health Interview Survey and in ongoing studies of specific groups of individuals over time eg, the Nurses Health Study and Framingham Heart Study Implement periodic comprehensive, representative national surveys to assess the changes in prevalence, patterns, perceptions, and costs of therapy use both CAM and conventional, with oversampling of ethnic minorities INTEGRATING CAM AND CONVENTIONAL MEDICINE Even as CAM and conventional medicine each maintain their identities, traditions, and practitioners, integration of CAM and conventional medicine is occuring in many settings Hospitals are offering CAM
therapies, a growing number of physicians are using them in their private practices, integrative-medicine centers many with close ties to medical schools and teaching hospitals are being established, and health maintenance organizations and insurance companies are covering CAM Cancer treatment centers in particular often use CAM therapies in combination with conventional approaches For example, the Memorial Sloan-Kettering Cancer Center has developed an Integrative Medicine Service that offers music therapy, massage, reflexology, and mind-body thera-

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EXECUTIVE SUMMARY

pies As the Website of the Dana Farber Cancer Institutes own Zakim Center for Integrated Therapies explains, When patients integrate these therapies into their medical and surgical
care, they are creating a more comprehensive treatment plan and helping their own bodies to regain health and vitality In response to the growing recognition of CAM therapies by conventional-medicine practitioners for their patients care, the Federation of State Medical Boards of the United States has developed Model Guidelines for the Use of Complementary and Alternative Therapies in Medical Practice Other tools are also needed to aid conventional practitioners decisionmaking about offering or recommending CAM, where patients might be referred, and what organizational structures are most appropriate for the delivery of integrated care The committee believes that the overarching rubric for guiding the development of these tools should be the goal of providing comprehensive care that is safe, effective, interdisciplinary, and collaborative; is based on the best scientific evidence available; recognizes the importance of compassion and caring; and encourages patients to share in the
choices of therapeutic options Studies show that patients frequently do not limit themselves to a single modality of care–they do not see CAM and conventional medicine as being mutually exclusive–and this pattern will probably continue and may even expand as evidence of therapies effectiveness accumulates Therefore it is important to understand how CAM and conventional medical treatments and providers interact with each other and to study models of how the two kinds of treatments can be provided in coordinated ways In that spirit, there is an urgent need for health systems research that focuses on identifying the elements of these integrative-medicine models, their outcomes, and whether they are cost-effective when compared to conventional practice The committee recommends that NIH and other public and private agencies sponsor research to compare: Outcomes and costs of combinations of CAM and conventional medical treatments and models that deliver such care Models of care delivery
involving CAM practitioners alone, both CAM and conventional medical practitioners, and conventional practitioners alone Outcome measures should include reproducibility, safety, costeffectiveness, and research capacity Additionally, the committee recommends that the Secretary of the US Department of Health and Human Services and the Secretary of the US Department of Veterans Affairs support research on integrated care delivery, as well as the development of a research infrastructure within such

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organizations and clinical training programs to expand the number of providers able to work in integrated care The pursuit of such goals requires examination of the ethics of medicine, both in the provision of personal
health services and the professions advocacy for public health Medicine is continuously shaped by larger social, cultural, and political forces, and the integration of CAM therapies is another juncture in this evolutionary process The ethical principles that guide conventional biomedical research should also be applied to CAM research Legal and ethical issues often arise and sometimes conflict with use of CAM therapies because the decision facing a conventional practitioner or institution may engender a conflict between medical paternalism the desire to protect patients from foolish or ill-informed, though voluntary decisions, and patient autonomy The Model Guidelines noted above seek to establish greater balance between physician and patient preferences In addition, a number of legal rules– including state licensure laws, precedents regarding malpractice liability and professional discipline, state and federal food and drug laws, and statutes on health care fraud–protect patients by
enhancing quality assurance, offering enhanced access to therapies, and honoring medical pluralism in creating models of integrative care Without rejecting what has been of great value and service in the past, it is important that these ethical and legal norms be brought under critical scrutiny and evolve along with medicines expanding knowledge base and the larger aims and meanings of medical practice The integration of CAM therapies with conventional medicine requires that practitioners and researchers be open to diverse interpretations of health and healing, to finding innovative ways of obtaining evidence, and to expanding the medical knowledge base EDUCATING FOR IMPROVED CARE Essential to conventional and CAM practitioners alike is education about the others field Conventional professionals in particular need enough CAM-related training, the committee believes, so that they can counsel patients in a manner consistent with high-quality comprehensive care Therefore the committee
recommends that health profession schools eg, schools of medicine, nursing, pharmacy, and allied health incorporate sufficient information about CAM into the standard curriculum at the undergraduate, graduate, and postgraduate levels to enable licensed professionals to competently advise their patients about CAM Because the content and organization of an education initiative on CAM will vary from institution to institution, depending on the objectives

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EXECUTIVE SUMMARY

of each program, there is no consensus on what should be taught and how to fit it into an already crowded set of courses At Brown University School of Medicine, for example, the program includes didactic sessions in acupuncture, chiropractic, and massage therapy and an elective
clinical experience; and variations exist at many of the other leading schools Some of these initiatives have been aided by NCCAMs education projects, which aim to develop new ways of incorporating CAM into health-professional curricula and training programs CAM practitioners, for their part, need training that will enable them to participate as full partners and leaders in research so that studies may accurately reflect how CAM therapies are practiced But many CAM institutions do not have an infrastructure for research or the financial resources to develop them Training in research has not traditionally been part of CAM curricula, nor for the most part have practitioners careers been dependent on publishing research findings CAM institutions focus primarily on training for practice Strategic partnerships between CAM institutions, NIH, and healthsciences universities would help foster development of the necessary infrastructure; and NCCAM has already begun funding such partnerships In
addition, lessons can be learned from other fields, such as geriatrics and HIV/AIDS research, which have gone through processes relevant to CAMs current need to develop qualified researchers In geriatrics, for instance, the establishment of centers of excellence at major academic health centers, foundation support for the development of curricula and partnerships, and continuing-education mechanisms such as summer institutes illustrate the importance of using multiple strategies to create an environment in which new science has been able to flourish The committee recommends that federal and state agencies, and private and corporate foundations, alone and in partnership, create models in research training for CAM practitioners Furthermore, both CAM research and the quality of CAM treatment would be fostered by the development of practice guidelines–what a 1992 IOM report defined as systematically developed statements to assist practitioner and patient decisions about appropriate health
care for specific clinical circumstances Key to guideline development is the participation of those who will be most directly affected This means that CAM practitioners, possibly through their own professional organizations, should formulate guidelines for their own therapies The committee recommends that national professional organizations for all CAM disciplines ensure the presence of training standards and develop practice guidelines Health care professional licensing boards and accrediting and certifying agencies for both CAM and conventional medicine should set competency standards in the appropriate use of both con-

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COMPLEMENTARY AND ALTERNATIVE MEDICINE

ventional medicine and CAM therapies, consistent with practitioners scope of practice
and standards of referral across health professions KNOWNS AND UNKOWNS ABOUT CAM USE Prevalence estimates for CAM use range from 30 percent to 62 percent of US adults, depending on the definition of CAM Women are more likely than men to seek CAM therapies, use appears to increase as education level increases, and there are varying patterns of use by race Adults who undergo CAM therapies usually draw on more than one type, and they tend to do so in combination with conventional medical care–though a majority do not disclose the CAM use to their physicians, thereby incurring the risk, for example, of potential interactions between subscription drugs and CAMrelated herbs Studies of specific illnesses have documented the popularity of CAM for health problems that lack definitive cures, have unpredictable courses and prognoses, and are associated with substantial pain, discomfort, or medicinal side effects Existing surveys tell us little, however, about how CAM treatment is initiated Does
the patient unilaterally decide to use a therapy? Does a CAM or a conventional provider recommend the therapy?, and we have scant data about how the American public makes decisions about accessing CAM options While there is an extensive literature on adherence to conventional treatment, there are virtually no data available on adherence to CAM treatment This is an important issue given that any therapy, even if efficacious, may place users at risk of harm, or cause them to experience little or no effect, when used in the wrong way Similarly, we have virtually no information about the extent to which the use of a CAM therapy may interfere with compliance in the use of conventional therapies, how peoples self-administration of CAM therapies changes over time, and the factors that influence such change Moreover, there is little research on the publics perceptions of information as alternatively credible, marginal, or spurious; how people understand such information in terms of risks and
benefits; and what they expect their providers to tell them Because the few small studies that have occurred suggest that considerable misinformation is dispensed by vendors and on the Web, a closer monitoring of Websites, enhanced enforcement of the Dietary Supplement Health and Education Act as well as of Federal Trade Commission regulations, and the creation of a user-friendly authoritative Website on CAM modalities are needed As a means of remedying the dearth of information noted above, the committee recommends the following: The National Institutes of Health and other public or private agencies should sponsor quantitative and qualitative research to examine:

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EXECUTIVE SUMMARY

The social and cultural dimensions of illness experiences,
health care-seeking processes and preferences, and practitioner-patient interactions How often users of CAM, including patients and providers, adhere to treatment instructions and guidelines The effects of CAM on wellness and disease-prevention How the American public accesses and evaluates information about CAM modalities Adverse events associated with CAM therapies and interactions between CAM and conventional treatments Further, the committee recommends that the National Library of Medicine and other federal agencies develop criteria to assess the quality and reliability of information about CAM

We are in the midst of an exciting time of discovery, when evidencebased approaches to health bring opportunities for incorporating the best from all sources of care, be they conventional medicine or CAM Our challenge is to keep an open mind and to regard each treatment possibility with an appropriate degree of skepticism Only then will we be able to ensure that we are making informed
and reasoned decisions

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Complementary and Alternative Medicine CAM in the United States

Committee on the Use of Complementary and Alternative Medicine by the American Public Board on Health Promotion and Disease Prevention

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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 authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Lockbox 285, Washington, DC 20055; 800 624-6242 or 202
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Knowing is not enough; we must apply Willing is not enough; we must do
–Goethe

Adviser to the Nation to Improve Health

Copyright 2004 National Academy of Sciences All rights reserved
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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

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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 Academys
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

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COMMITTEE ON THE USE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE BY THE AMERICAN PUBLIC Stuart Bondurant, MD Chair, Professor of Medicine and Dean Emeritus, School
of Medicine, University of North Carolina at Chapel Hill 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 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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Mark Nichter, PhD, MPH, Professor of Anthropology, Professor of Family and Community Medicine, Professor of Public Health, University of Arizona Bernard Rosof, MD, MACP, Senior Vice President for Corporate Relations and Health Affairs, North Shore Long Island Jewish Health System Harold Sox, MD, MACP, 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 MD Anderson Cancer Center Committee Consultant Michael H Cohen, JD, MBA, Assistant Professor of Medicine, Harvard Medical School, and Attorney-at-Law Staff Lyla M Hernandez, 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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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 US 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 489 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 3155 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 signifivii
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viii

PREFACE

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 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 new therapies and practices should be incorporated 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; and the impact of present regulations and legislation on CAM research and integration

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PREFACE

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 32 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 D 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 committees 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 ie, 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

Complementary and Alternative Medicine in the United States
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PREFACE

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 arent 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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PREFACE

who provided thoughtful and invaluable research support Ms Christie identified, evaluated, and synthesized background information and issues throughout the committees deliberations And we thank Makisha Wiley, who expertly managed our administrative, meeting, and travel needs

Stuart Bondurant, Committee Chair

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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 xiii
Copyright 2004 National Academy of Sciences All rights reserved This executive summary plus thousands more available at http://wwwnapedu

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xiv

ACKNOWLEDGMENTS

Understanding and exploring research methods were crucial to the committees 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 Finally, a unique and informative component of the committees 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 OConnor, 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

Complementary and Alternative Medicine in the United States http://booksnapedu/catalog/11182html

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 NRCs 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 MD 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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xvi

REVIEWERS

William Meeker, Palmer Center for Chiropractic Research Palmer Chiropractic University Foundation Anne Nedrow, Womens 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 Dan G Blazer, JP 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 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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Contents

EXECUTIVE SUMMARY Toward Common Research Ground A New Position on Dietary Supplements Filling the Gaps Integrating CAM and Conventional Medicine Educating for Improved Care Known and Unknowns About CAM Use 1 INTRODUCTION Context Definition of CAM Recent Milestones in the
History of CAM CAM Activities at NIH and AHRQ Report Contents 2 PREVALENCE, COST, AND PATTERNS OF USE Overall Use Use by Population Subgroups Use by Types of Illness Frequency of Use Long Term Trends in Use of CAM Cost-Effectiveness What Motivates People to Use CAM Accessing Information About CAM How the American Public Uses CAM xvii
Copyright 2004 National Academy of Sciences All rights reserved This executive summary plus thousands more available at http://wwwnapedu

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xviii

CONTENTS

Characteristics of CAM Therapies Provided by Licensed Acupuncturists, Chiropractors, Massage Therapists, and Naturopaths Conclusions and Recommendations 3 CONTEMPORARY APPROACHES TO EVIDENCE OF TREATMENT EFFECTIVENESS: A CONTEXT FOR CAM RESEARCH A Brief Account of the Development of Treatment Effectiveness Research Basic Features of Contemporary Clinical Effectiveness Research Contemporary Issues in Study
Design and Analysis Levels of Evidence Applying Contemporary Research Methods to CAM 4 NEED FOR INNOVATIVE DESIGNS IN CAM AND CONVENTIONAL MEDICINE Characteristics of CAM Treatments and Modalities Innovative Study Designs to Assess Treatment Effectiveness of CAM Use of Both Traditional and Innovative Study Designs to Create a Rich Body of Knowledge Relationship Between Basic Research and Clinical Research Conceptual Models to Guide Research Conclusions and Recommendations 5 STATE OF THE EMERGING EVIDENCE ON CAM Sources of Information on High Quality Evidence Gaps in Evidence A Research Framework Conclusions and Recommendations 6 AN ETHICAL FRAMEWORK FOR CAM RESEARCH, PRACTICE, AND POLICY Value Commitments That Inform This Chapter Value Judgments in Defining CAM Ethical Issues in CAM Research Ethical Issues in the Integration of CAM Therapies into Conventional Practice Related Legal and Regulatory Issues

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CONTENTS

xix

7 INTEGRATION OF CAM AND CONVENTIONAL MEDICINE From Idea to Practice Growing Integration of CAM Why Is Integration Occurring Integrative Medicine Advising Patients Health Care Institutions Approaches to Integration Conclusions and Recommendations 8 EDUCATIONAL PROGRAMS IN CAM CAM in Health Professions Education Educating CAM Practitioners Programs in CAM Research Lessons from Other Fields Practice Guidelines Conclusions and Recommendations 9 DIETARY SUPPLEMENTS Dietary Supplement Use in the United States Regulation of Dietary Supplements Product Quality and Safety Safety Research on Dietary Supplements Conclusions and Recommendations 10 CONCLUSION

APPENDIXES A CAM THERAPIES, PRACTICES AND SYSTEMS B CONSORTIUM OF ACADEMIC HEALTH CENTERS FOR INTEGRATIVE MEDICINE C TABLE C-1 LIST OF ABBREVIATIONS D LIAISON PANEL
ORGANIZATIONS E MODEL GUIDELINES FOR THE USE OF COMPLEMENTARY AND ALTERNATIVE THERAPIES IN MEDICAL PRACTICE FEDERATION OF STATE MEDICAL BOARDS

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xx F NATIONAL CENTER FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE RESEARCH CENTERS G PUBLIC MEETINGS H COMMITTEE BIOSKETCHES INDEX

CONTENTS

Source:amsa.org

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