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Executive Summary
Pages 1-12

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From page 1...
... 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. CAM's 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.
From page 2...
... 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 report's 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.
From page 3...
... 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 therapy's 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.
From page 4...
... 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)
From page 5...
... 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.
From page 6...
... 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.
From page 7...
... The committee recommends that NIH and other public and private agencies sponsor research to compare: · the 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 U.S.
From page 8...
... 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.
From page 9...
... 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.
From page 10...
... 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 prescription drugs and CAMrelated herbs.
From page 11...
... 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.


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