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Complementary and alternative medicine (CAM): epidemiology and implications for research
E.A. Mayer and C.B. Saper (Eds.)
Pmgress in Brain Research, Vol 122 0 2M)o Elsevier Science BV. All rights reserved.
CHAPTER 31
Complementary and alternative medicine (CAM): epidemiology and implications for research David L. Diehl’**and David Eisenberg2
’ UCLA School of Medicine, 16300 Sand Canyon Avenue, #loo, Irvine, CA 92618, USA ‘Center for Alternative Medicine Research, Beth IsraeVDeaconess Hospital, 330 Brookline Avenue, Boston, MA 02215, USA
Introduction Alternative medical therapies encompass a broad spectrum of practices and beliefs (Murray and Rubel, 1992). From a historical standpoint, they may be defined “. . .as practices that are not accepted as correct, proper, or appropriate or are not in conformity with the beliefs or standards of the dominant group of medical practitioners in a society” (Gevitz, 1988). From a functional standpoint, alternative therapies (also known as ‘complementary’, or ‘complementary and alternative medicine’ (‘CAM’), ‘holistic’, ‘integrative’) may be defined as interventions neither taught widely in medical schools nor generally available in hospitals (Eisenberg et al., 1993a). The tenninology currently in use to describe these practices remains controversial. Many commonly used labels (e.g. ‘alternative’, ‘unconventional’, ‘unproven’) are judgmental and may inhibit the collaborative inquiry and discourse necessary to distinguish useful from useless techniques (Eisenberg et al., 1993b). For the purposes of reference, the term CAM (Complementary and Alternative Medicine) will frequently be used in this review.
*Corresponding author. Tel.: 949-727-1232; e-mail: [email protected]
Prevalence, costs, and patterns of use of CAM therapies in the US and elsewhere Findings from a national survey of CAM prevalence, costs, and patterns of use (Eisenberg et al., 1993a) include the following: One in three respondents reported using at least one alternative therapy to treat a serious or bothersome medical problem during the past year. Seventy percent of alternative medicine consumers did not inform their medical doctors of their alternative therapy use. A majority of respondents used alternative therapies for chronic as opposed to life-threatening medical conditions. (Alternative therapies for cancer and HIV illnesses accounted for less than 3% of all alternative medicine use.) Extrapolating from survey data, Americans made an estimated 425 million visits to providers of alternative medical therapy in 1990, exceeding the 338 million visits made to all U.S. primary care physicians during the same period. Out-of-pocket expenditures associated with alternative therapy use in the US in 1990 was an estimated $10.3 billion, nearly equal to the $12.8 billion out-of-pocket expenses incurred that same year for all US health care. The authors concluded that the frequency of use of CAM in the US is far higher than previously
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reported and that medical doctors should ask about their patients’ use of these therapies whenever obtaining a medical history. A recent survey of family practice patients sought to obtain another estimate of usage of CAM (Elder et al., 1997). Questionnaires were completed by 113 patients in four family practices in Oregon. These authors found that about 50% of patients had used or were using some form of CAM. Similar to the previously mentioned study, almost half (47%) did not tell their family physician about this use. An international review of CAM patterns of use suggests that the US is one of many developed countries where these therapies are practiced by significant proportions of the population. Prevalence estimates range from 25-75% for the United Kingdom (Fulder and Munro, 1985; Thomas, et al., 1991), Australia (MacLennan, et al., 1996), France (Bouchayer, 1990), Germany (Himmel .et al., 1993), The Netherlands (Visser and Peters, 1990), Finland (Vaskilampi et al., 1993), and Israel (Schacter et al., 1993). Homeopathy in the United Kingdom is reimbursed by the National Health Service and by private insurers in Germany (if prescribed by a medical doctor). Japan spends an estimated $1.3 billion per year on herbal (kampo) medical remedies (Tsutani, 1993). An estimated 147 herbal remedies are covered by the Japanese National Health Service. When one considers the populations of India and China, the majority of whom receive traditional (i.e. Ayurvedic or Chinese) medical interventions, global estimates of alternative medicine use exceed two billion people.
What are the types of complementary and alternative medical (CAM) practice? In 1992, a report on alternative medical systems and practices in the US was made to the National Institutes of Health (Workshop on Alternative Medicine, 1994). For the purposes of this report, and to aid in the grant review process, seven general categories of CAM were defined, specifically: mind-body interventions, bioelectromagnetic applications, alternative systems of medical practice, manual healing methods, pharmacological and biological treatments, herbal medicine, and diet and
nutrition in prevention and treatment of chronic disease. A classification system that tries to highlight the differences between therapeutic approaches may be more useful for the purposes of understanding the various types of CAM therapies. In addition there are alternative systems of practice which may include a variety of methods from the basic seven categories. 1. Internallchemical: use of organic or chemical substances or dietary alterations to promote healing
This category is one of the broadest, and includes dietary therapy, herbal medicine, and dietary supplements (‘nutraceuticals’); other methods such as aromatherapy, and more controversial methods such as ozone therapy, cell therapy, and many others, including putative cancer therapies. The importance of proper diet and a normal amount of nutrients (vitamins, minerals, etc.) is acknowledged by mainstream medicine. In the field of CAM, various diets may be embraced (including macrobiotic diets, diet modification regimens, and even careful use of fasting), and the use of highdose nutrient therapy is often supported for the treatment of chronic disease. The mainstream medical community is often extremely cynical in this respect, with many, if not most practitioners not subscribing to the use of high-dose vitamin or supplement therapy. There is a great deal of interest in pursuing further research in this area by pharmacologists, clinicians, and manufacturers. Herbal medicine has a long history of use in almost every culture on earth. The World Health Organization (WHO) estimates that 80% of the world population use herbal medicine for some aspect of primary health care. Certainly, current biomedical pharmacology was initially based on herbal medicine. In other westernized countries, use of herbal medicine is much more widespread, and more well researched than in the US. It is likely that further clinical research will shed light on which herbal medications may be adapted for use in mainstream medicine. Many major pharmaceutical companies have ongoing research
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TABLE 1 Q p e s of CAM practice. The following list of therapies is not intended to be exhaustive. In addition, inclusion in this list does not imply endorsement 1. InternaYchemical: use of organic or chemical substances or dietary alterations to promote healing Widely used in a variety of systems Herbal medicine (phytotherapy) Western herbology Chinese herbal medicine Kampo (Japanese) Medicine Native herbal practices Dietary therapy Macrobiotic Elimination diets Juice therapy Fasting and modified fasting
Chinese and Ayurvedic diet modification Food combining Detoxifying diets
Supplements, nutraceuticals Vitamin and megavitamin therapy Trace minerals Enzyme therapy Less widely used, may be controversial Aromatherapy Biological Dentistry Cell therapy Heavy metal toxicity and detoxification Apitherapy (Bee therapy) Alternative cancer cures
Detoxification therapy Orthomolecular therapy Chelation therapy Oxygen and Ozone therapy Colonic therapy
2. Body-based therapies upon the patient’s body by a skilled practitioner
Manipulative therapy Osteopathic manipulative therapy Chiropractic Craniosacral therapy Body work Deep tissue massage Shiatsu Tuei Na Rolfing (and many others)
Manual lymph drainage Reflexology Trager therapy
Acupuncture Traditional Chinese Medicine (TCM) French Energetics Auricular acupuncture Japanese meridian therapy Neuroanatomic acupuncture Other Neural therapy Hydrotherapy
3. Electromagnetic: use of devices or forces having electromagnetic properties or energies Magnet therapy Electroacupuncture Electroacupuncture Light therapy EEG biofeedback Transcranial electrostimulation Subtle electromagnetic forces Sound therapy
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TABLE 1 Continued 4. Movement and Breath: the healing power of the body activated by breathing andor movement Yoga Tai Chi and other “Martial Arts” Meditative breathing Postural re-education: Alexander technique, Feldenkrais method
Qi Gong Dance therapy
5. Mind-Body and Psychological interventions: activation of emotional, psychological, and other mind-based mechanisms to promote healing
Hypnotherapy Transcendental Meditation (TM) hagery Dreamwork (and many others)
Biofeedback Dream analysis Meditation Neurolinguistic programming
6. Spiritual: beliefs in connection to spiritual realms to promote healing and cure Prayer Ceremony and Ritual Some native healing practices
Religious healing Shamanism Some aspects of dream analysis
7. Vibrational: undetermined mechanism of action to promote healing and effect cures Homeopathy Constitutional homeopathy Acute homeopathy Ultradiluted substances Biofield therapeutics Qi Gong Therapeutic touch Reiki therapy Others Bach flower therapy
programs to discover new pharmaceuticals from herbal sources.
2. Body-based: therapies upon the patient’s body by a skilled practitioner Skilled practitioners may utilize a variety of specific systems of therapy to treat their patients. These include manipulative therapy (includes osteopathic manipulation, chiropractic, craniosacral therapy), ‘body work’ (Shiatsu, reflexology, Trager, Rolfing, and others), and acupuncture (or acupressure). In the case of acupuncture, needles are inserted in different areas of the body (‘acupoints’) to act as a healing influence. ‘Biofield therapeutics’ which is sometimes referred to as ‘energy healing’ or ‘laying on of hands’ is covered
in a following section (‘Vibrational’). See also Chapter 33 by D.Johnson in this volume. 3. Electromagnetic: use of devices or forces having electromagnetic properties or energies
More research is being done on subtle effects of bioelectromagnetics on the body. At present, application of many of these concepts are not strictly ‘alternative’, since there is official approval for their use (e.g. the approval by the FDA for pulsed electromagnetic fields (PEMF) to promote healing of non-union bone fractures.) Electroacupunctureis another example of a more mainstream application. Other techniques are still being investigated and often are considered ‘alternative’ (e.g. transcranial electrostimulation, EEG biofeedback, magnet therapy, subtle electrical and magnetic influences on the body.)
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4. Movement and breath: the healing power of the body activated by breathing and movement
There are a large number of practices that incorporate movements and specific breathing patterns in their approach to healing. Yoga is one example in which there may be specific movement and breathing exercises to correct specific health problems. Many of the martial arts, for example Tai Chi, incorporate stylized movements along with focus on mental and physical grounding and can have healthful effects. Some recent studies have looked at the benefits of Tai Chi instruction in the elderly to improve balance (Wolf et al., 1996). Other examples include dance therapy, the Alexander technique, and Qi Gong. See also Chapter 34 by R. Sovik.
5. Mind-body and psychological interventions: activation of emotional, psychological, and other mind-based mechanisms to promote healing These acknowledge that distinctions between ‘mind’ and ‘body’ are artificial, since the mind and body are integrally related. There are many examples of physical activities being beneficial for the mind (an example would be yoga), and other examples in which imagery and meditation can benefit physical problems. Explaining a disease process as ‘psychological’ may not give enough credence to the very real physiologic processes that are being generated by the psychological state, and conversely, effects of the physiological state on the psychological state. More research is being carried out on discovering the mechanisms of how the mind and brain can control physiologic and healing activities. This volume provides an in-depth discussion of what is currently known about these mechanisms. Examples in this group include hypnotherapy, transcendental meditation (TM), biofeedback, Neurolinguistic Programming (NLP), Tibetan Meditation (see also Chapter 35 by Lopsang Rapgay) and others. 6. Spiritual: beliefs in connection to spiritual realms to promote healing and cure
Healing therapies that incorporate spiritual beliefs are probably the oldest in the history of mankind.
Prayer has been a powerful healing force for millennia, but only recently has there been carefully done trials of prayer effects on health. ‘Intercessory prayer’ has been studied in a randomized fashion (Byrd, 1988). Just how one defines ‘spiritual’ is a subject of great debate; one author has offered, “The spiritual dimension . . . is that aspect of the person concerned with meaning and the search for absolute reality that underlies the world of the senses and the mind and, as such, is distinct from adherence to a religious system”. (Hiatt, 1986) Other healing practices in this group include ceremony and ritual, shamanism, and others.
7. Vibrational: undetermined mechanism of action to promote healing and effect cures There are some complementary therapies that have an entirely unexplained mechanism of action, yet can still be shown to have real effects on improving health or effecting cure. A good example is homeopathy. In this discipline, ultradiluted substances are used to treat illness. In many cases, the dilutions are beyond Avogadro’s limit (6 x clearly then, the noted effects are not through the classic ligandreceptor interaction. However, a recent metanalysis of controlled studies concluded ‘The clinical effects of homeopathy are not due to placebo . . .” (Linde et al., 1997). Weil has written, very succinctly, “In attributing effects to dilutions of drugs higher than 24X (Avogadro’s limit) and refusing to concede that these remedies function as placebos, homeopaths are asking us to create new physical and chemical laws, to rewrite accepted scientific theory - nothing less. Scientific theory does not change easily or without good reason. Even with good reason, the process is slow and painful”. (Weil, 1983) ‘Biofield therapeutics’ which is sometimes referred to as ‘energy healing’ or ‘laying on of hands’ also functions through heretofore unknown mechanisms. In these methods, acknowledgment is made of the existence of a life energy that is not strictly electromagnetic (‘Qi’, for example), and specific techniques are used to address this level of dysfunction. Therapeutic touch and Reiki therapy are two well known examples of this practice that are widely used.
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Alternative systems of medical practice
The dominant biomedical model of medicine is but one system of medical practice. Alternative systems are often traditional to specific ethnic groups, incorporate a consistent theory and educational system. Examples of this are traditional oriental medicine, Ayurvedic medicine, or communitybased medicine such as Native American or Latin American traditional medicine, or Shamanic medicine. In other cases, the system may be more recently established, such as Naturopathic medicine or homeopathic practice. Alternative systems may utilize a variety of the types of CAM practices listed in the above seven categories. For example, Traditional Oriental Medicine utilizes herbal medicine and dietary changes, movement and breath, body work (Tuei Nu), acupuncture, and Qi Gong. Naturopathy may utilize dietary therapy, use of supplements and herbs, hydrotherapy, massage, and others.
Patient attitudes toward CAM Much work has been done on trying to find out why patients turn to complementary medicine. A recent study (Astin, 1998) sought to investigate predictors of CAM health care use, and tested three hypotheses: patients seek out alternatives because “( 1) they are dissatisfied in some way with conventional treatment; (2) they see alternative treatments as offering more personal autonomy and control over health care decisions; and (3) the alternatives are seen as more compatible with the patient’s values, worldview, or beliefs regarding the nature and meaning of health and illness”. The author found that dissatisfaction with conventional medicine did not predict use of alternative medicine; instead, the majority of alternative medicine users appeared to be doing so “largely because they find these health care alternatives to be more congruent with their own values, beliefs, and philosophical orientations toward health and life”. Another survey was carried out of 268 patients who sought consultation from three complementary medicine practices: acupuncture, osteopathy, and homeopathy (Vincent and Fumham, 1996). The reasons that were most strongly endorsed for why
they sought these treatments were “because I value the emphasis on treating the whole person”; “because I believe complementary therapy will be more effective for my problem than orthodox medicine”; “because I believe that complementary medicine will enable me to take a more active part in maintaining my health; and “because orthodox treatment was not effective for my particular problem”.
Physician attitudes toward CAM In response to growing interest in CAM by patients, the medical profession has finally started paying attention to these therapies. The American Holistic Medical Association (AHMA) was one of the first organizations of physicians (and medical students) to endorse the integration of holistic techniques and ideas into conventional medical practice. A survey of the members of this organization was compared to a group of California family practice physicians (Goldstein, et al. 1987). The holistic physicians differed in their training, practice characteristics, attitudes, clinical behaviors, motivations, and feelings of marginality. The holistic practitioners were also more likely to report past religious or spiritual experiences as frequent, important, and influential in their lives. A survey of physicians that utilize acupuncture in their practice (Diehl, et al, 1997) demonstrated that these practitioners were more likely to use or endorse other CAM therapies, including herbal medicine, manipulative medicine, use of supplements, and homeopathy. The most common reasons given as to why these doctors used acupuncture included; efficacy of the technique (‘It works’), an alternative in cases of inadequacy of the standard medical approach, and that it provided a multidimensional approach to health care.
Educational programs in the US Approximately 64 US medical schools (out of 125) currently offer courses devoted to the topic of alternative medicine (Daly, 1997). The format and content of these curricula vary considerably. It has been proposed that a core content for curricula pertaining to theory, practice, safety, and efficacy
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should be defined. The Association of American Medical Colleges (AAMC) has established a Special Interest Group devoted to CAM. Development of opportunities for training in post-graduate residencies is also a suitable goal. For example, trainees should be aware of how to have appropriate and responsible discussion and referral with their patients (Eisenberg, 1997). Trainees may also be interested in doing clerkships in the offices of alternative medical practitioners; similarly, alternative medicine students in training (e.g. acupuncturists, chiropractors, naturopaths, etc.) may benefit from clerkships in allopathic hospitals and clinics. Fellowships in CAM have been established, notably at the University of Arizona under the direction of Andrew Weil, MD. Expansion of fellowship grants for primary care and subspecialty physicians may be useful. The notion here is to train ‘resident experts’ (e.g. general internists, rheumatologists, oncologists, pharmacists, etc.) who in addition to their conventional expertise and responsibilities, are knowledgeable about the state of the science pertaining to alternative medical treatments for specific patient populations. These individuals would be highly sought by peers and local patients, and may fill an important educational role for medical students and housestaff who will require mentoring in this complicated field. Continuing education courses for physicians, nurses, and allied health practitioners are becomingly increasingly popular, and topics range widely and include osteopathy, homeopathy, acupuncture, and herbal medicine as well as many others.
The National Center for Complementary and Alternative Medicine (NCCAM) In 1992, Congressional mandate established the Office of Alternative Medicine (now renamed the National Center for Complementary and Alternative Medicine, NCCAM), under the National Institutes of Health. The Congressional mandate establishing the NCCAM stated that the Center’s purpose is to “facilitate the evaluation of alternative medical treatment modalities” to determine their effectiveness. The mandate also provides for a
public information clearinghouse and a research training program. The NCCAM does not serve as a referral agency for various alternative medical treatments or individual practitioners, but instead facilitates and conducts research. This center serves a variety of functions, including: (a) sponsoring research, (b) development and oversight of 12 federally funded centers for alternative medicine research (c) organizing a comprehensive research database, (d) providing technical support in CAM through the Research Development and Investigation Program, (e) sponsoring and co-sponsoring conferences on CAM topics, (f) maintaining international and professional liaison, (g) maintaining liaison with NIH institutes and other governmental agencies (e.g. Health Care Financing Administration Agency (HCFA), Agency for Health Care Policy and Research (AHCPR), Food and Drug Administration (FDA), and Centers for Disease Control and Prevention (CDC) and (h) maintaining a clearinghouse of information on CAM topics.
Research issues in CAM Despite findings which confirm extensive use of CAM in the US and internationally, relatively little is known about the safety, efficacy, cost-effectiveness, and mechanism of action of individual therapies. Historically, practitioners of CAM therapies have not been highly trained in research methodology; also, experts in research methodology have little training in or experience with CAM medical practices. In addition, research grants have been scarce and there is often less financial incentive to fund research. As a result, sound research methodologies have not been applied to produce authoritative findings in the majority of instances. Of particular interest is the extent to which non-specific (i.e. placebo) interactions affect the design, implementation, and analysis of research in this area (Joyce, 1994, Kleijnen et al, 1994). Expectation, belief, and conditioning on the part of both the patient and provider may influence the effectiveness of a given therapy (conventional or alternative) and therefore must be critically evaluated. It is hoped that the methodological challenges inherent in CAM
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research will attract qualified clinical epidemiologists, statisticians, and economists to this line of inquiry. At the same time, the design of prospective trials must take into account the theory, diagnostic strategies, and common proactive patterns of providers of CAM therapy. In short, there must be full collaboration between conventional medical researchers and practitioners of alternative therapy to ensure a fair evaluation of CAM therapies. The NIH has supported the creation of 11 centers of excellence to explore the safety, efficacy, cost effectiveness, and mechanism of action of CAM therapies. It is anticipated that this line of inquiry as well as increased funding from both the federal and private sectors will attract clinician researchers and improve the quality of surveys, outcomes research, randomized clinical trials, and laboratory investigations pertaining to CAM therapies. In addition to federally funded projects, managed care organizations and national insurance carriers are increasingly interested in collaborative research pertaining to the safety, efficacy, and costeffectiveness of alternative medical care. Some managed care organizations are making a formal commitment to perform collaborative research in this area.
An atmosphere of mistrust, misperception and extremism is common to both the medical and the alternative medical communities. These problems demand tools so that modern medicine can begin to fairly evaluate these therapies and improve the status quo. Some of these necessary tools include: Development of a full text database of peerreviewed studies, systematic reviews, meta-analyses, and selected texts involving CAM therapies. Development of a comprehensive toxicology index pertaining to herbs, vitamins and supplements commonly used by the public, accessible to practitioners and pharmacists. The equivalent of a MedWatch initiative to provide surveillance of adverse effects pertaining to alternative medical therapies and/or their interaction with conventional treatments (e.g. prescription medications). Progress toward a more uniform credentialing process for alternative practitioners. Clearly defined scope of practice guidelines pertaining to each of the alternative medical licensed professionals.
The current status quo and considerations for the future
Unaddressed policy issues
In spite of the creation of a federally based National Center for Complementary and Alternative Medicine, and a growing body of literature, the current status quo may be described as follows:
There are several areas of public health policy that require further discussion and planning. These include:
There is an enormous popular demand. There is a paucity of satisfactory research. CAM treatments lack standardization and include both relatively safe and toxic interventions. The training, licensing, and credentialing of CAM providers, with the possible exception of chiropractors, is highly inconsistent. Malpractice liability issues remain unclear. Toxicity and efficacy issues pertaining to herbs, vitamins, and supplements remain poorly studied and are not readily available. Professional guidelines whereby medical doctors refer to providers of CAM therapy are absent.
Liability and malpractice guidelines concerning referrals to CAM providers. Specific referral guidelines unique to each of the CAM professions. A review of educational requirement of licensed CAM medical providers. Suggested educational requirements for allopathic physicians with regards to CAM practices. Heterogeneous reimbursement patterns which now include paid benefits andor a range of reduced fee-for-service products and CAM medicine ‘carve-outs’.
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The need for coordination with the Federation of State Medical Boards and other licensing organizations.
Conclusion Historically, communication between the conventional and alternative medical communities has been poor, and there has been little professional collaboration. There is every reason to believe that collaborative projects can be undertaken without relinquishing professional responsibilities or abandoning scientific principles. A quote from David Grimes, MD offers an appropriate philosophy: “Doing everything for everyone is neither tenable nor desirable. what is done should, ideally, be inspired by compassion and guided by science, not merely reflect what the market will bear” (Grimes, 1993). As we plan for medical training in the future, the field of complementary and alternative medicine will likely be recognized as an identifiable component of organized health care. There must be cooperation between academic medicine, the federal government, the private sector, and the leadership of the alternative medical community to jointly distinguish useful from useless therapies. Those therapies that may have a real role in modern medicine should be evaluated with fairness and objectiveness. In many cases development of new research methodologies to adequately test them will be necessary. However, as an ancient Chinese proverb says: “Real gold does not fear the heat of even the hottest fire”.
References Astin, J.A. (1998) Why patients use alteFative medicine: results of a national study. JAMA, 279: 1548-1553. Bouchayer, F. (1990) Alternative medicines: a general approach to the French situation. Comp. Med. Res., 4: 4-8. Byrd, RC. (1988) Positive therapeutic effects of intercessory prayer in a coronary care unit population. South. Med. J., 8 l(7): 826-829. Daly, D. (1997) Alternative medicine courses taught at US medical schools: an ongoing list. J. Alt. Comp. Med., 3: 4 0 5 4 10. Diehl, D.L., Kaplan, G., Coulter, I., Glik, D. and Hurwitz, E.L. (1997) Use of acupuncture by American physicians. J. Alt. Cornpl. Med., 3: 119-126.
Eisenberg, D., Kessler, R.C., Foster, C., Norlock, F.E., Calkins, D.R. and Delbanco, T.L. (1 993) ‘Unconventional’ medicine in the US prevalence, costs and patterns of use. N. Engl. J. Med., 328: 246-252. Eisenberg, D., Delbanco, T.L. and Kessler, R.C. (1993) Letter to the editor. N. Engl. J. Med., 329: 1203. Eisenberg, D. (1997) Advising patients who seek alternative medical therapies. Ann. Intern. Med., 127: 6 1-69. Elder, N.C., Gillcrist, A. and Minz, R. (1997) Use of alternative health care by family practice patients. Arch. Fam. Med., 6(2): 181-184. Fulder, S.J. and Munro, R.E.(1985) Complementary medicine in the United Kingdom: patients, practitioners, and consultants. Lancet, 7: 542-545. Gevitz, N. (1988) Three perspectives on unorthodox medicine. In: N. Gevitz (Ed.), Other Healers: Unorthodox Medicine in America, Johns Hopkins University Press, Baltimore, pp. 1-28. Goldstein, M.S., Jaffe, D.T., Sutherland, C. and Wilson, J. (1987) Holistic physicians: implications for the study of the medical profession. J. Health SOC.Behav., 28: 103-119. Grimes, D.A.. (1993) Technology follies: the uncritical acceptance of medical innovation. JAMA, 269: 3030. Hiatt, J. (1986) Spirituality, medicine, and healing. South. Med. J., 79: 736-743. Himmel, W., Schulte, M. and Kochen, M.M. (1993) Complementary medicine: are patient’s expectations being met by their general practitioners? BE J. Gen. Pract., 43: 232-235. Joyce, C.R. (1994) Placebo and complementary medicine. Lancet, 344: 1279-1281. Kleijnen, J., de Craen, A.J. and van Everdingen, J. (1994) Placebo effect in double-blind clinical trial: a review of interactions with medications. Lancet, 344: 1347-1349. Linde, K., Clausius, N., Ramirez, G., Melchart, D., Eitel, F,, Hedges, L.V. and Jonas, W.B. (1997) Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebocontrolled\rials. Lancet, 350: 834-843. MacLennan, A.H., Wilson, D.H. and Taylor, A.W. (1996) Prevalence and cost of alternative medicine in Australia. Lancet, 347: 569-573. Murray, R.H. and Rubel, A.J. (1992) Physicians and healers unwitting partners in health care. N. Engl. J. Med., 326: 61-64. Schachter, L., Weingarten, M.A. and Kahan, E.E. (1993) Attitudes of family physicians to nonconventional therapies. A challenge to science as the basis of therapeutics. Arch. Fam. Med., 2: 1268-1270. Thomas, K.J., Carr, J., Westlake, L. and Williams, B.T. (1991) Use of non-orthodox and conventional health care in Great Britain. BMJ, 302: 207-210. Tsutani, K. (1993) The evaluation of herbal medicines: an East Asian perspective. In: G.T. Lewith and D. Aldridge (Eds), Clinical Research Methodology for Complementary Therapies, Hodder & Stoughton, London. Vaskilampi, T. et al. (1993) The use of alternative treatments in the Finnish population. In: G.T. Lewith and D. Aldridge
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Wolf, S.L., Barnhart, H.X., Kutner, N.G., McNeely, E., Coogler, C. and Xu, T.(1996) Reducing frailty and falls in older persons: an investigation of Tai Chi and computerized balance training. Atlanta FICSIT Group. Frailty and Injuries: Cooperative Studies of Intervention Techniques. J. Am. Geriatx SOC., 44:489-497. Workshop on Alternative Medicine, Chantilly, Virginia, Sept 14-1 6, 1992. Alternative Medicine: Expanding Medical Horizons. 1994, NIH Publication No. 94-066; US. Govt. Printing Office, Washington, D.C.
Appendix Specialty research centers previously or currently funded by the National Center for Complementary and Alternative Medicine (NCCAM)" Research Center
Specialty
Center for Addiction and Alternative Medicine Research (CAAMR) Minneapolis Medical Research Foundation, Hennepin County Medical Center, Minneapolis, MN
Addictions
Complementary and Alternative Medicine Program at Stanford (CAMPS), Stanford University School of Medicine, Pa10 Alto, CA
Aging
Center for CAM Research in Aging, Columbia University, College of Physicians and Surgeons, New York, NY
Aging and Women's Health
Center for Alternative Medicine Research on Arthritis, University of Maryland School of Medicine, Division of Complementary Medicine, Baltimore, MD
Arthritis
Center for Alternative Medicine Research in Asthma and Allergy, University of California, Davis, Davis, CA
Asthma, Allergy and Immunology
University of Texas Center for Alternative Medicine (UT-CAM), University of Texas Health Science Center, Houston, TX
Cancer
Center for Complementary and Alternative Medicine Research in Cardiovascular Diseases, The University of Michigan Taubman Health Care Center, Ann Arbor, MI
Cardiovascular Diseases
Cardiovascular Disease and Aging in African Americans, Center for Natural Medicine and Prevention, Maharishi University of Management, Fairfield, IA
Cardiovascular Disease and Aging in African Americans
Consortia1Center for Chiropractic Research, Palmer Center for Chiropractic Research, Davenport, IA
Chiropractic
Oregon Center for Complementary and Alternative Research in Craniofacial Disorders, Center for Health Research, Kaiser Foundation Hospitals, Portland, OR
Craniofacial Disorders
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Center for Alternative Medicine Research, Beth Israel Hospital Deaconess Medical Center, Harvard Medical School, Boston, MA
General Medical Conditions
Bastyr University AIDS Research Center, Bastyr University of Naturopathic Medicine, Bothell, WA
HIV/AIDS
Oregon Center for Complementary and Alternative Medicine in Neurological Disorders, Oregon Health Sciences University, Portland, OR
Neurological Disorders
University of Virginia Center for the Study of Complementary and Alternative Therapies (CSCAT), University of Virginia School of Nursing, Charlottesville, VA
Pain
Pediatric Center for Complementary and Alternative Medicine, University of Arizona Health Sciences Center, Department of Pediatrics, Tucson, AZ
Pediatrics
Center for Research in Complementary and Alternative Medicine for Stroke and Neurological Disorders, Kessler Institute for Rehabilitation, West Orange, NJ
Stroke and Neurological Conditions
,
* See also the NCCAM website: http://nccam.nih.gov/
Overview of the specialty centers The National Center for Complementary and Alternative Medicine (NCCAM) provides funding to ten research centers which evaluate alternative treatments for many chronic health conditions including: HIV/AIDS, Cancer, Addictions, Asthma, Allergy and Immunologic Disorders, Women’s Health, General Medical Conditions, Geriatrics, Stroke and Neurological Conditions, and several areas of Pain. The Centers are designed to efficiently evaluate promising alternative medical practices by establishing mechanisms for investigators to have their research ideas reviewed,
developed and executed in a scientifically rigorous manner. The first year goals for each Center included the development of an organizational structure and operating plan. The second and third years will focus on the execution and evaluation of programmatic objectives. Each Center will assess and evaluate research opportunities in their specialty area, and develop a prioritized research agenda. These Centers will allow alternative medicine practitioners and research scientists to conduct specific joint research projects. Results of this research will be published in the scientific literature and disseminated to the public.
Pmgress in Brain Research, Vol 122 0 2M)o Elsevier Science BV. All rights reserved.
CHAPTER 31
Complementary and alternative medicine (CAM): epidemiology and implications for research David L. Diehl’**and David Eisenberg2
’ UCLA School of Medicine, 16300 Sand Canyon Avenue, #loo, Irvine, CA 92618, USA ‘Center for Alternative Medicine Research, Beth IsraeVDeaconess Hospital, 330 Brookline Avenue, Boston, MA 02215, USA
Introduction Alternative medical therapies encompass a broad spectrum of practices and beliefs (Murray and Rubel, 1992). From a historical standpoint, they may be defined “. . .as practices that are not accepted as correct, proper, or appropriate or are not in conformity with the beliefs or standards of the dominant group of medical practitioners in a society” (Gevitz, 1988). From a functional standpoint, alternative therapies (also known as ‘complementary’, or ‘complementary and alternative medicine’ (‘CAM’), ‘holistic’, ‘integrative’) may be defined as interventions neither taught widely in medical schools nor generally available in hospitals (Eisenberg et al., 1993a). The tenninology currently in use to describe these practices remains controversial. Many commonly used labels (e.g. ‘alternative’, ‘unconventional’, ‘unproven’) are judgmental and may inhibit the collaborative inquiry and discourse necessary to distinguish useful from useless techniques (Eisenberg et al., 1993b). For the purposes of reference, the term CAM (Complementary and Alternative Medicine) will frequently be used in this review.
*Corresponding author. Tel.: 949-727-1232; e-mail: [email protected]
Prevalence, costs, and patterns of use of CAM therapies in the US and elsewhere Findings from a national survey of CAM prevalence, costs, and patterns of use (Eisenberg et al., 1993a) include the following: One in three respondents reported using at least one alternative therapy to treat a serious or bothersome medical problem during the past year. Seventy percent of alternative medicine consumers did not inform their medical doctors of their alternative therapy use. A majority of respondents used alternative therapies for chronic as opposed to life-threatening medical conditions. (Alternative therapies for cancer and HIV illnesses accounted for less than 3% of all alternative medicine use.) Extrapolating from survey data, Americans made an estimated 425 million visits to providers of alternative medical therapy in 1990, exceeding the 338 million visits made to all U.S. primary care physicians during the same period. Out-of-pocket expenditures associated with alternative therapy use in the US in 1990 was an estimated $10.3 billion, nearly equal to the $12.8 billion out-of-pocket expenses incurred that same year for all US health care. The authors concluded that the frequency of use of CAM in the US is far higher than previously
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reported and that medical doctors should ask about their patients’ use of these therapies whenever obtaining a medical history. A recent survey of family practice patients sought to obtain another estimate of usage of CAM (Elder et al., 1997). Questionnaires were completed by 113 patients in four family practices in Oregon. These authors found that about 50% of patients had used or were using some form of CAM. Similar to the previously mentioned study, almost half (47%) did not tell their family physician about this use. An international review of CAM patterns of use suggests that the US is one of many developed countries where these therapies are practiced by significant proportions of the population. Prevalence estimates range from 25-75% for the United Kingdom (Fulder and Munro, 1985; Thomas, et al., 1991), Australia (MacLennan, et al., 1996), France (Bouchayer, 1990), Germany (Himmel .et al., 1993), The Netherlands (Visser and Peters, 1990), Finland (Vaskilampi et al., 1993), and Israel (Schacter et al., 1993). Homeopathy in the United Kingdom is reimbursed by the National Health Service and by private insurers in Germany (if prescribed by a medical doctor). Japan spends an estimated $1.3 billion per year on herbal (kampo) medical remedies (Tsutani, 1993). An estimated 147 herbal remedies are covered by the Japanese National Health Service. When one considers the populations of India and China, the majority of whom receive traditional (i.e. Ayurvedic or Chinese) medical interventions, global estimates of alternative medicine use exceed two billion people.
What are the types of complementary and alternative medical (CAM) practice? In 1992, a report on alternative medical systems and practices in the US was made to the National Institutes of Health (Workshop on Alternative Medicine, 1994). For the purposes of this report, and to aid in the grant review process, seven general categories of CAM were defined, specifically: mind-body interventions, bioelectromagnetic applications, alternative systems of medical practice, manual healing methods, pharmacological and biological treatments, herbal medicine, and diet and
nutrition in prevention and treatment of chronic disease. A classification system that tries to highlight the differences between therapeutic approaches may be more useful for the purposes of understanding the various types of CAM therapies. In addition there are alternative systems of practice which may include a variety of methods from the basic seven categories. 1. Internallchemical: use of organic or chemical substances or dietary alterations to promote healing
This category is one of the broadest, and includes dietary therapy, herbal medicine, and dietary supplements (‘nutraceuticals’); other methods such as aromatherapy, and more controversial methods such as ozone therapy, cell therapy, and many others, including putative cancer therapies. The importance of proper diet and a normal amount of nutrients (vitamins, minerals, etc.) is acknowledged by mainstream medicine. In the field of CAM, various diets may be embraced (including macrobiotic diets, diet modification regimens, and even careful use of fasting), and the use of highdose nutrient therapy is often supported for the treatment of chronic disease. The mainstream medical community is often extremely cynical in this respect, with many, if not most practitioners not subscribing to the use of high-dose vitamin or supplement therapy. There is a great deal of interest in pursuing further research in this area by pharmacologists, clinicians, and manufacturers. Herbal medicine has a long history of use in almost every culture on earth. The World Health Organization (WHO) estimates that 80% of the world population use herbal medicine for some aspect of primary health care. Certainly, current biomedical pharmacology was initially based on herbal medicine. In other westernized countries, use of herbal medicine is much more widespread, and more well researched than in the US. It is likely that further clinical research will shed light on which herbal medications may be adapted for use in mainstream medicine. Many major pharmaceutical companies have ongoing research
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TABLE 1 Q p e s of CAM practice. The following list of therapies is not intended to be exhaustive. In addition, inclusion in this list does not imply endorsement 1. InternaYchemical: use of organic or chemical substances or dietary alterations to promote healing Widely used in a variety of systems Herbal medicine (phytotherapy) Western herbology Chinese herbal medicine Kampo (Japanese) Medicine Native herbal practices Dietary therapy Macrobiotic Elimination diets Juice therapy Fasting and modified fasting
Chinese and Ayurvedic diet modification Food combining Detoxifying diets
Supplements, nutraceuticals Vitamin and megavitamin therapy Trace minerals Enzyme therapy Less widely used, may be controversial Aromatherapy Biological Dentistry Cell therapy Heavy metal toxicity and detoxification Apitherapy (Bee therapy) Alternative cancer cures
Detoxification therapy Orthomolecular therapy Chelation therapy Oxygen and Ozone therapy Colonic therapy
2. Body-based therapies upon the patient’s body by a skilled practitioner
Manipulative therapy Osteopathic manipulative therapy Chiropractic Craniosacral therapy Body work Deep tissue massage Shiatsu Tuei Na Rolfing (and many others)
Manual lymph drainage Reflexology Trager therapy
Acupuncture Traditional Chinese Medicine (TCM) French Energetics Auricular acupuncture Japanese meridian therapy Neuroanatomic acupuncture Other Neural therapy Hydrotherapy
3. Electromagnetic: use of devices or forces having electromagnetic properties or energies Magnet therapy Electroacupuncture Electroacupuncture Light therapy EEG biofeedback Transcranial electrostimulation Subtle electromagnetic forces Sound therapy
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TABLE 1 Continued 4. Movement and Breath: the healing power of the body activated by breathing andor movement Yoga Tai Chi and other “Martial Arts” Meditative breathing Postural re-education: Alexander technique, Feldenkrais method
Qi Gong Dance therapy
5. Mind-Body and Psychological interventions: activation of emotional, psychological, and other mind-based mechanisms to promote healing
Hypnotherapy Transcendental Meditation (TM) hagery Dreamwork (and many others)
Biofeedback Dream analysis Meditation Neurolinguistic programming
6. Spiritual: beliefs in connection to spiritual realms to promote healing and cure Prayer Ceremony and Ritual Some native healing practices
Religious healing Shamanism Some aspects of dream analysis
7. Vibrational: undetermined mechanism of action to promote healing and effect cures Homeopathy Constitutional homeopathy Acute homeopathy Ultradiluted substances Biofield therapeutics Qi Gong Therapeutic touch Reiki therapy Others Bach flower therapy
programs to discover new pharmaceuticals from herbal sources.
2. Body-based: therapies upon the patient’s body by a skilled practitioner Skilled practitioners may utilize a variety of specific systems of therapy to treat their patients. These include manipulative therapy (includes osteopathic manipulation, chiropractic, craniosacral therapy), ‘body work’ (Shiatsu, reflexology, Trager, Rolfing, and others), and acupuncture (or acupressure). In the case of acupuncture, needles are inserted in different areas of the body (‘acupoints’) to act as a healing influence. ‘Biofield therapeutics’ which is sometimes referred to as ‘energy healing’ or ‘laying on of hands’ is covered
in a following section (‘Vibrational’). See also Chapter 33 by D.Johnson in this volume. 3. Electromagnetic: use of devices or forces having electromagnetic properties or energies
More research is being done on subtle effects of bioelectromagnetics on the body. At present, application of many of these concepts are not strictly ‘alternative’, since there is official approval for their use (e.g. the approval by the FDA for pulsed electromagnetic fields (PEMF) to promote healing of non-union bone fractures.) Electroacupunctureis another example of a more mainstream application. Other techniques are still being investigated and often are considered ‘alternative’ (e.g. transcranial electrostimulation, EEG biofeedback, magnet therapy, subtle electrical and magnetic influences on the body.)
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4. Movement and breath: the healing power of the body activated by breathing and movement
There are a large number of practices that incorporate movements and specific breathing patterns in their approach to healing. Yoga is one example in which there may be specific movement and breathing exercises to correct specific health problems. Many of the martial arts, for example Tai Chi, incorporate stylized movements along with focus on mental and physical grounding and can have healthful effects. Some recent studies have looked at the benefits of Tai Chi instruction in the elderly to improve balance (Wolf et al., 1996). Other examples include dance therapy, the Alexander technique, and Qi Gong. See also Chapter 34 by R. Sovik.
5. Mind-body and psychological interventions: activation of emotional, psychological, and other mind-based mechanisms to promote healing These acknowledge that distinctions between ‘mind’ and ‘body’ are artificial, since the mind and body are integrally related. There are many examples of physical activities being beneficial for the mind (an example would be yoga), and other examples in which imagery and meditation can benefit physical problems. Explaining a disease process as ‘psychological’ may not give enough credence to the very real physiologic processes that are being generated by the psychological state, and conversely, effects of the physiological state on the psychological state. More research is being carried out on discovering the mechanisms of how the mind and brain can control physiologic and healing activities. This volume provides an in-depth discussion of what is currently known about these mechanisms. Examples in this group include hypnotherapy, transcendental meditation (TM), biofeedback, Neurolinguistic Programming (NLP), Tibetan Meditation (see also Chapter 35 by Lopsang Rapgay) and others. 6. Spiritual: beliefs in connection to spiritual realms to promote healing and cure
Healing therapies that incorporate spiritual beliefs are probably the oldest in the history of mankind.
Prayer has been a powerful healing force for millennia, but only recently has there been carefully done trials of prayer effects on health. ‘Intercessory prayer’ has been studied in a randomized fashion (Byrd, 1988). Just how one defines ‘spiritual’ is a subject of great debate; one author has offered, “The spiritual dimension . . . is that aspect of the person concerned with meaning and the search for absolute reality that underlies the world of the senses and the mind and, as such, is distinct from adherence to a religious system”. (Hiatt, 1986) Other healing practices in this group include ceremony and ritual, shamanism, and others.
7. Vibrational: undetermined mechanism of action to promote healing and effect cures There are some complementary therapies that have an entirely unexplained mechanism of action, yet can still be shown to have real effects on improving health or effecting cure. A good example is homeopathy. In this discipline, ultradiluted substances are used to treat illness. In many cases, the dilutions are beyond Avogadro’s limit (6 x clearly then, the noted effects are not through the classic ligandreceptor interaction. However, a recent metanalysis of controlled studies concluded ‘The clinical effects of homeopathy are not due to placebo . . .” (Linde et al., 1997). Weil has written, very succinctly, “In attributing effects to dilutions of drugs higher than 24X (Avogadro’s limit) and refusing to concede that these remedies function as placebos, homeopaths are asking us to create new physical and chemical laws, to rewrite accepted scientific theory - nothing less. Scientific theory does not change easily or without good reason. Even with good reason, the process is slow and painful”. (Weil, 1983) ‘Biofield therapeutics’ which is sometimes referred to as ‘energy healing’ or ‘laying on of hands’ also functions through heretofore unknown mechanisms. In these methods, acknowledgment is made of the existence of a life energy that is not strictly electromagnetic (‘Qi’, for example), and specific techniques are used to address this level of dysfunction. Therapeutic touch and Reiki therapy are two well known examples of this practice that are widely used.
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Alternative systems of medical practice
The dominant biomedical model of medicine is but one system of medical practice. Alternative systems are often traditional to specific ethnic groups, incorporate a consistent theory and educational system. Examples of this are traditional oriental medicine, Ayurvedic medicine, or communitybased medicine such as Native American or Latin American traditional medicine, or Shamanic medicine. In other cases, the system may be more recently established, such as Naturopathic medicine or homeopathic practice. Alternative systems may utilize a variety of the types of CAM practices listed in the above seven categories. For example, Traditional Oriental Medicine utilizes herbal medicine and dietary changes, movement and breath, body work (Tuei Nu), acupuncture, and Qi Gong. Naturopathy may utilize dietary therapy, use of supplements and herbs, hydrotherapy, massage, and others.
Patient attitudes toward CAM Much work has been done on trying to find out why patients turn to complementary medicine. A recent study (Astin, 1998) sought to investigate predictors of CAM health care use, and tested three hypotheses: patients seek out alternatives because “( 1) they are dissatisfied in some way with conventional treatment; (2) they see alternative treatments as offering more personal autonomy and control over health care decisions; and (3) the alternatives are seen as more compatible with the patient’s values, worldview, or beliefs regarding the nature and meaning of health and illness”. The author found that dissatisfaction with conventional medicine did not predict use of alternative medicine; instead, the majority of alternative medicine users appeared to be doing so “largely because they find these health care alternatives to be more congruent with their own values, beliefs, and philosophical orientations toward health and life”. Another survey was carried out of 268 patients who sought consultation from three complementary medicine practices: acupuncture, osteopathy, and homeopathy (Vincent and Fumham, 1996). The reasons that were most strongly endorsed for why
they sought these treatments were “because I value the emphasis on treating the whole person”; “because I believe complementary therapy will be more effective for my problem than orthodox medicine”; “because I believe that complementary medicine will enable me to take a more active part in maintaining my health; and “because orthodox treatment was not effective for my particular problem”.
Physician attitudes toward CAM In response to growing interest in CAM by patients, the medical profession has finally started paying attention to these therapies. The American Holistic Medical Association (AHMA) was one of the first organizations of physicians (and medical students) to endorse the integration of holistic techniques and ideas into conventional medical practice. A survey of the members of this organization was compared to a group of California family practice physicians (Goldstein, et al. 1987). The holistic physicians differed in their training, practice characteristics, attitudes, clinical behaviors, motivations, and feelings of marginality. The holistic practitioners were also more likely to report past religious or spiritual experiences as frequent, important, and influential in their lives. A survey of physicians that utilize acupuncture in their practice (Diehl, et al, 1997) demonstrated that these practitioners were more likely to use or endorse other CAM therapies, including herbal medicine, manipulative medicine, use of supplements, and homeopathy. The most common reasons given as to why these doctors used acupuncture included; efficacy of the technique (‘It works’), an alternative in cases of inadequacy of the standard medical approach, and that it provided a multidimensional approach to health care.
Educational programs in the US Approximately 64 US medical schools (out of 125) currently offer courses devoted to the topic of alternative medicine (Daly, 1997). The format and content of these curricula vary considerably. It has been proposed that a core content for curricula pertaining to theory, practice, safety, and efficacy
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should be defined. The Association of American Medical Colleges (AAMC) has established a Special Interest Group devoted to CAM. Development of opportunities for training in post-graduate residencies is also a suitable goal. For example, trainees should be aware of how to have appropriate and responsible discussion and referral with their patients (Eisenberg, 1997). Trainees may also be interested in doing clerkships in the offices of alternative medical practitioners; similarly, alternative medicine students in training (e.g. acupuncturists, chiropractors, naturopaths, etc.) may benefit from clerkships in allopathic hospitals and clinics. Fellowships in CAM have been established, notably at the University of Arizona under the direction of Andrew Weil, MD. Expansion of fellowship grants for primary care and subspecialty physicians may be useful. The notion here is to train ‘resident experts’ (e.g. general internists, rheumatologists, oncologists, pharmacists, etc.) who in addition to their conventional expertise and responsibilities, are knowledgeable about the state of the science pertaining to alternative medical treatments for specific patient populations. These individuals would be highly sought by peers and local patients, and may fill an important educational role for medical students and housestaff who will require mentoring in this complicated field. Continuing education courses for physicians, nurses, and allied health practitioners are becomingly increasingly popular, and topics range widely and include osteopathy, homeopathy, acupuncture, and herbal medicine as well as many others.
The National Center for Complementary and Alternative Medicine (NCCAM) In 1992, Congressional mandate established the Office of Alternative Medicine (now renamed the National Center for Complementary and Alternative Medicine, NCCAM), under the National Institutes of Health. The Congressional mandate establishing the NCCAM stated that the Center’s purpose is to “facilitate the evaluation of alternative medical treatment modalities” to determine their effectiveness. The mandate also provides for a
public information clearinghouse and a research training program. The NCCAM does not serve as a referral agency for various alternative medical treatments or individual practitioners, but instead facilitates and conducts research. This center serves a variety of functions, including: (a) sponsoring research, (b) development and oversight of 12 federally funded centers for alternative medicine research (c) organizing a comprehensive research database, (d) providing technical support in CAM through the Research Development and Investigation Program, (e) sponsoring and co-sponsoring conferences on CAM topics, (f) maintaining international and professional liaison, (g) maintaining liaison with NIH institutes and other governmental agencies (e.g. Health Care Financing Administration Agency (HCFA), Agency for Health Care Policy and Research (AHCPR), Food and Drug Administration (FDA), and Centers for Disease Control and Prevention (CDC) and (h) maintaining a clearinghouse of information on CAM topics.
Research issues in CAM Despite findings which confirm extensive use of CAM in the US and internationally, relatively little is known about the safety, efficacy, cost-effectiveness, and mechanism of action of individual therapies. Historically, practitioners of CAM therapies have not been highly trained in research methodology; also, experts in research methodology have little training in or experience with CAM medical practices. In addition, research grants have been scarce and there is often less financial incentive to fund research. As a result, sound research methodologies have not been applied to produce authoritative findings in the majority of instances. Of particular interest is the extent to which non-specific (i.e. placebo) interactions affect the design, implementation, and analysis of research in this area (Joyce, 1994, Kleijnen et al, 1994). Expectation, belief, and conditioning on the part of both the patient and provider may influence the effectiveness of a given therapy (conventional or alternative) and therefore must be critically evaluated. It is hoped that the methodological challenges inherent in CAM
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research will attract qualified clinical epidemiologists, statisticians, and economists to this line of inquiry. At the same time, the design of prospective trials must take into account the theory, diagnostic strategies, and common proactive patterns of providers of CAM therapy. In short, there must be full collaboration between conventional medical researchers and practitioners of alternative therapy to ensure a fair evaluation of CAM therapies. The NIH has supported the creation of 11 centers of excellence to explore the safety, efficacy, cost effectiveness, and mechanism of action of CAM therapies. It is anticipated that this line of inquiry as well as increased funding from both the federal and private sectors will attract clinician researchers and improve the quality of surveys, outcomes research, randomized clinical trials, and laboratory investigations pertaining to CAM therapies. In addition to federally funded projects, managed care organizations and national insurance carriers are increasingly interested in collaborative research pertaining to the safety, efficacy, and costeffectiveness of alternative medical care. Some managed care organizations are making a formal commitment to perform collaborative research in this area.
An atmosphere of mistrust, misperception and extremism is common to both the medical and the alternative medical communities. These problems demand tools so that modern medicine can begin to fairly evaluate these therapies and improve the status quo. Some of these necessary tools include: Development of a full text database of peerreviewed studies, systematic reviews, meta-analyses, and selected texts involving CAM therapies. Development of a comprehensive toxicology index pertaining to herbs, vitamins and supplements commonly used by the public, accessible to practitioners and pharmacists. The equivalent of a MedWatch initiative to provide surveillance of adverse effects pertaining to alternative medical therapies and/or their interaction with conventional treatments (e.g. prescription medications). Progress toward a more uniform credentialing process for alternative practitioners. Clearly defined scope of practice guidelines pertaining to each of the alternative medical licensed professionals.
The current status quo and considerations for the future
Unaddressed policy issues
In spite of the creation of a federally based National Center for Complementary and Alternative Medicine, and a growing body of literature, the current status quo may be described as follows:
There are several areas of public health policy that require further discussion and planning. These include:
There is an enormous popular demand. There is a paucity of satisfactory research. CAM treatments lack standardization and include both relatively safe and toxic interventions. The training, licensing, and credentialing of CAM providers, with the possible exception of chiropractors, is highly inconsistent. Malpractice liability issues remain unclear. Toxicity and efficacy issues pertaining to herbs, vitamins, and supplements remain poorly studied and are not readily available. Professional guidelines whereby medical doctors refer to providers of CAM therapy are absent.
Liability and malpractice guidelines concerning referrals to CAM providers. Specific referral guidelines unique to each of the CAM professions. A review of educational requirement of licensed CAM medical providers. Suggested educational requirements for allopathic physicians with regards to CAM practices. Heterogeneous reimbursement patterns which now include paid benefits andor a range of reduced fee-for-service products and CAM medicine ‘carve-outs’.
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The need for coordination with the Federation of State Medical Boards and other licensing organizations.
Conclusion Historically, communication between the conventional and alternative medical communities has been poor, and there has been little professional collaboration. There is every reason to believe that collaborative projects can be undertaken without relinquishing professional responsibilities or abandoning scientific principles. A quote from David Grimes, MD offers an appropriate philosophy: “Doing everything for everyone is neither tenable nor desirable. what is done should, ideally, be inspired by compassion and guided by science, not merely reflect what the market will bear” (Grimes, 1993). As we plan for medical training in the future, the field of complementary and alternative medicine will likely be recognized as an identifiable component of organized health care. There must be cooperation between academic medicine, the federal government, the private sector, and the leadership of the alternative medical community to jointly distinguish useful from useless therapies. Those therapies that may have a real role in modern medicine should be evaluated with fairness and objectiveness. In many cases development of new research methodologies to adequately test them will be necessary. However, as an ancient Chinese proverb says: “Real gold does not fear the heat of even the hottest fire”.
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Eisenberg, D., Kessler, R.C., Foster, C., Norlock, F.E., Calkins, D.R. and Delbanco, T.L. (1 993) ‘Unconventional’ medicine in the US prevalence, costs and patterns of use. N. Engl. J. Med., 328: 246-252. Eisenberg, D., Delbanco, T.L. and Kessler, R.C. (1993) Letter to the editor. N. Engl. J. Med., 329: 1203. Eisenberg, D. (1997) Advising patients who seek alternative medical therapies. Ann. Intern. Med., 127: 6 1-69. Elder, N.C., Gillcrist, A. and Minz, R. (1997) Use of alternative health care by family practice patients. Arch. Fam. Med., 6(2): 181-184. Fulder, S.J. and Munro, R.E.(1985) Complementary medicine in the United Kingdom: patients, practitioners, and consultants. Lancet, 7: 542-545. Gevitz, N. (1988) Three perspectives on unorthodox medicine. In: N. Gevitz (Ed.), Other Healers: Unorthodox Medicine in America, Johns Hopkins University Press, Baltimore, pp. 1-28. Goldstein, M.S., Jaffe, D.T., Sutherland, C. and Wilson, J. (1987) Holistic physicians: implications for the study of the medical profession. J. Health SOC.Behav., 28: 103-119. Grimes, D.A.. (1993) Technology follies: the uncritical acceptance of medical innovation. JAMA, 269: 3030. Hiatt, J. (1986) Spirituality, medicine, and healing. South. Med. J., 79: 736-743. Himmel, W., Schulte, M. and Kochen, M.M. (1993) Complementary medicine: are patient’s expectations being met by their general practitioners? BE J. Gen. Pract., 43: 232-235. Joyce, C.R. (1994) Placebo and complementary medicine. Lancet, 344: 1279-1281. Kleijnen, J., de Craen, A.J. and van Everdingen, J. (1994) Placebo effect in double-blind clinical trial: a review of interactions with medications. Lancet, 344: 1347-1349. Linde, K., Clausius, N., Ramirez, G., Melchart, D., Eitel, F,, Hedges, L.V. and Jonas, W.B. (1997) Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebocontrolled\rials. Lancet, 350: 834-843. MacLennan, A.H., Wilson, D.H. and Taylor, A.W. (1996) Prevalence and cost of alternative medicine in Australia. Lancet, 347: 569-573. Murray, R.H. and Rubel, A.J. (1992) Physicians and healers unwitting partners in health care. N. Engl. J. Med., 326: 61-64. Schachter, L., Weingarten, M.A. and Kahan, E.E. (1993) Attitudes of family physicians to nonconventional therapies. A challenge to science as the basis of therapeutics. Arch. Fam. Med., 2: 1268-1270. Thomas, K.J., Carr, J., Westlake, L. and Williams, B.T. (1991) Use of non-orthodox and conventional health care in Great Britain. BMJ, 302: 207-210. Tsutani, K. (1993) The evaluation of herbal medicines: an East Asian perspective. In: G.T. Lewith and D. Aldridge (Eds), Clinical Research Methodology for Complementary Therapies, Hodder & Stoughton, London. Vaskilampi, T. et al. (1993) The use of alternative treatments in the Finnish population. In: G.T. Lewith and D. Aldridge
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Appendix Specialty research centers previously or currently funded by the National Center for Complementary and Alternative Medicine (NCCAM)" Research Center
Specialty
Center for Addiction and Alternative Medicine Research (CAAMR) Minneapolis Medical Research Foundation, Hennepin County Medical Center, Minneapolis, MN
Addictions
Complementary and Alternative Medicine Program at Stanford (CAMPS), Stanford University School of Medicine, Pa10 Alto, CA
Aging
Center for CAM Research in Aging, Columbia University, College of Physicians and Surgeons, New York, NY
Aging and Women's Health
Center for Alternative Medicine Research on Arthritis, University of Maryland School of Medicine, Division of Complementary Medicine, Baltimore, MD
Arthritis
Center for Alternative Medicine Research in Asthma and Allergy, University of California, Davis, Davis, CA
Asthma, Allergy and Immunology
University of Texas Center for Alternative Medicine (UT-CAM), University of Texas Health Science Center, Houston, TX
Cancer
Center for Complementary and Alternative Medicine Research in Cardiovascular Diseases, The University of Michigan Taubman Health Care Center, Ann Arbor, MI
Cardiovascular Diseases
Cardiovascular Disease and Aging in African Americans, Center for Natural Medicine and Prevention, Maharishi University of Management, Fairfield, IA
Cardiovascular Disease and Aging in African Americans
Consortia1Center for Chiropractic Research, Palmer Center for Chiropractic Research, Davenport, IA
Chiropractic
Oregon Center for Complementary and Alternative Research in Craniofacial Disorders, Center for Health Research, Kaiser Foundation Hospitals, Portland, OR
Craniofacial Disorders
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Center for Alternative Medicine Research, Beth Israel Hospital Deaconess Medical Center, Harvard Medical School, Boston, MA
General Medical Conditions
Bastyr University AIDS Research Center, Bastyr University of Naturopathic Medicine, Bothell, WA
HIV/AIDS
Oregon Center for Complementary and Alternative Medicine in Neurological Disorders, Oregon Health Sciences University, Portland, OR
Neurological Disorders
University of Virginia Center for the Study of Complementary and Alternative Therapies (CSCAT), University of Virginia School of Nursing, Charlottesville, VA
Pain
Pediatric Center for Complementary and Alternative Medicine, University of Arizona Health Sciences Center, Department of Pediatrics, Tucson, AZ
Pediatrics
Center for Research in Complementary and Alternative Medicine for Stroke and Neurological Disorders, Kessler Institute for Rehabilitation, West Orange, NJ
Stroke and Neurological Conditions
,
* See also the NCCAM website: http://nccam.nih.gov/
Overview of the specialty centers The National Center for Complementary and Alternative Medicine (NCCAM) provides funding to ten research centers which evaluate alternative treatments for many chronic health conditions including: HIV/AIDS, Cancer, Addictions, Asthma, Allergy and Immunologic Disorders, Women’s Health, General Medical Conditions, Geriatrics, Stroke and Neurological Conditions, and several areas of Pain. The Centers are designed to efficiently evaluate promising alternative medical practices by establishing mechanisms for investigators to have their research ideas reviewed,
developed and executed in a scientifically rigorous manner. The first year goals for each Center included the development of an organizational structure and operating plan. The second and third years will focus on the execution and evaluation of programmatic objectives. Each Center will assess and evaluate research opportunities in their specialty area, and develop a prioritized research agenda. These Centers will allow alternative medicine practitioners and research scientists to conduct specific joint research projects. Results of this research will be published in the scientific literature and disseminated to the public.