COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) THERAPIES

In every generation, medical practices exist that are not accepted by the mainstream: they are viewed with suspicion and dismissed as implausible or irrational. For a time, approaches that evoked some appeal, but which had not been thoroughly tested, were deemed unconventional. Over the past decade or so, they have been called complementary or alternative medicine (CAM), to reflect their use as adjuncts to, or as substitutes for, more generally accepted practices, respectively. CAM does not encompass practices that have yet to be translated fully from the laboratory into the clinic, nor practices that were well studied and disproved, but which manage to persist in some fashion nonetheless. Rather, CAM entails approaches with surprising pervasiveness, many of which can claim at least some evidentiary support. Until recently, CAM could also be defined as practices that are not widely taught in medical schools or reimbursed. However, medical students increasingly seek and receive some instruction about CAM, while third-party payers have identified in CAM a marketing tool to attract new, well-heeled clients. In the past few years, another term has been coined—integrative medicine—to suggest encouragingly that some CAM approaches, and the practitioners who deliver them, will be shown worthy of being added to the health care repertoire. The myriad practices and products that encompass CAM can be organized into 5 somewhat overlapping domains.

All 3 of these CAM domains have well-accepted analogues in conventional medicine—low-fat, low-cholesterol diets; physical therapy; psychotherapy; to name but a few. Despite its enormous success, contemporary western biomedicine has features that can discourage patients: many diseases, especially chronic ones, are not cured or even adequately ameliorated; existing treatments can impose serious adverse reactions; and the care is fragmented and impersonal. CAM, despite its lack of proof, appeals to many because its practitioners are optimistic. They spend a lot of time talking with and touching their patients. CAM empowers patients to make their own health choices, its natural products are believed to be inherently healthier and safer than synthetic ones, and care is provided in a "holistic" fashion, meaning that the broader medical, social, and emotional contexts of illness are considered in designing the treatment plan. The very first large survey by Eisenberg in 1993 surprised the medical community by showing that >30% of Americans use CAM approaches. Countless studies since then have extended these conclusions by surveying specific demographic groups and patient populations. The Centers for Disease Control and Prevention (CDC) study of nearly 31,000 American adults revealed that in 1999 29% had used one or more modalities, with spiritual approaches, herbal medicine, chiropractic, and massage being the most prevalent. Over 1% underwent acupuncture treatment that year. Surveys among patients with cancer showed that 30 to 86% used CAM, with highest rates in those with more advanced disease and undergoing aggressive treatments. Similarly, among AIDS patients, 36 to 91% are reported to use CAM. In devastating chronic illnesses like these, CAM is called upon to provide hope of cures when conventional medicine cannot, to extend life, to ameliorate treatment side effects, and to provide emotional and physical comfort. While somewhat subject to vagaries of definition as to what counts as a CAM treatment, surveys have shown that Americans are willing to pay for these services out of pocket, with an estimated $7 billion each year on vitamins and mineral supplements, $4 billion on herbals and other natural products, and nearly $4 billion more on sports supplements. Total CAM expenditures in 1997 approached $30 billion, with more visits to practitioners for CAM services than to physicians in general. As indicated above, some CAM disciplines are carefully regulated. CAM products, however, are not strongly regulated. Herbal medicines, and dietary supplements more generally, occupy a unique regulatory status that affords the public remarkable freedom of choice but also many undesired challenges. Elements of virtually all traditional healing approaches, herbal medicines were presumed safe long before the implementation of stringent drug regulations by the U.S. Food and Drug Administration (FDA). In 1994, the United States Congress passed the Dietary Supplements Health and Education Act (DSHEA) that permits sale of dietary supplements "over-the-counter," as it were, but without the requirement imposed on manufacturers of prescription or classic over-the-counter drugs to prove their products to be safe and effective before marketing. Supplements can be removed by the FDA from the market only if they are proven to be hazardous. Dietary supplements, however, cannot legally claim to prevent or treat any disease. They can, however, claim to maintain "normal structure and function" of body systems. For example, a product cannot claim to treat arthritis, but it can claim to maintain "normal joint health." While the public may believe that "natural" equates with "safe," it is abundantly clear that natural products can be toxic. Misidentification of medicinal mushrooms has led to liver failure. Contamination of tryptophan supplements caused the eosinophilia-myalgia syndrome. Herbal products containing particular species of Aristolochia were associated with genitourinary malignancies. In 2001, extracts of kava, long used by Pacific Islanders for its mild anxiolytic and sedative properties, were associated with fulminant liver failure. A number of products, including the popular Ginkgo biloba, are known to prolong bleeding times and have been associated with postoperative hemorrhage. Among the most controversial is Ephedra sinica, or ma huang, a product used in traditional Chinese medicine for short-term treatment of asthma and bronchial congestion. The scientific basis for these indications was revealed when ephedra was shown to contain the ephedrine alkaloids, especially ephedrine and pseudoephedrine. With the promulgation of the DSHEA regulations, supplements containing ephedra and herbs rich in caffeine flooded the U.S. marketplace, claiming to promote weight loss and to enhance athletic performance. Reports of severe and fatal adverse events in young and, in some cases, well-known Americans led to calls for removal of ephedra-containing supplements. The constituents of natural products may not only be toxic but may also interfere with the metabolism of life-saving drugs. This effect was illustrated most profoundly with the demonstration in 2000 that consumption of St.-John's-wort interferes with the bioavilability of many drugs. CAM evolved through an entirely different epistemologic framework than contemporary biomedicine. Empirical observations of individual patients constitute the primary evidentiary base on which CAM practices are guided and taught. Nonetheless, over the past few decades, thousands of studies have been performed of various CAM approaches, including hundreds of trials involving herbals, acupuncture, or homeopathy. To date, however, no single approach has been proven effective in a convincing way. (If they had, the practice would no longer be considered CAM!) Several factors contribute to this lack of convincing evidence. The vast majority of CAM studies have been seriously flawed by lack of appropriate controls, bias on the part of the investigators, small sample sizes, reliance on highly subjective and nonvalidated measures of benefit, and by inappropriate statistical tests. There are in addition, a series of methodologic issues that challenge even the better-designed CAM studies. No uniform practice guidelines exist, and the herbal products marketed in the United States are highly variable in quality and composition. Some CAM practices are not amenable to blinding. For example, both the patient and the practitioner would know if spinal manipulation had been performed. These problems are not unique to CAM, however, as they also complicate attempts to study conventional practices such as psychotherapy or surgery. Efforts are now being made to randomize patients to other equally demanding control interventions, and acupuncture at traditional needling points is being compared to needling at what are arguably irrelevant points. Even with ongoing improvements in study design and conduct, issues of belief stand in the way of comprehending and accepting the results of some CAM studies. Many physicians are reluctant to believe positive outcomes of exotic approaches that have not emerged through the classic experimental paradigm by which drugs and biological agents are now developed, namely, the orderly progression from preclinical testing through three phases of clinical trials. More importantly, it is difficult to accept results that are counterintuitive or whose mechanism cannot be rationally explained. Numerous CAM approaches lack coherent explanations and any credible body of data regarding their safety and effectiveness. And, while it is difficult to conclude decisively that an approach lacks any merit, it is quite feasible to discern that its effect size, or degree of benefit, is too small to be worth pursuing further. Over the past century, many approaches failed—one need only think back to the exotic electrical devices, procedures, and tonics that fell out of fashion. 2 questions are often asked: (1) Whether any of the more contemporary CAM modalities deserve to be rejected? (2) Whether data showing it to be ineffective would change anyone's mind about using it? The case of laetrile is instructive in this regard. This extract of apricot seeds was touted in the 1970s as a cure for solid tumors. Thousands crossed the Mexican border to be treated. The lack of any positive preclinical data discouraged oncologists from agreeing to study laetrile, until public pressure required that an answer be obtained. 2 studies in the 1980s showed no benefit of laetrile treatment. Today, some continue to seek the product, but the numbers are vastly smaller than before meaningful data were obtained. A similar fate befell a cocktail of drugs used for cancer patients through the 1970s and 1980s by Dr. Luigi DiBella in Italy, once large studies revealed it to have no detectable impact on the course of a variety of advanced cancers. In contrast, modalities that have been well tested and found ineffective are still in fairly common practice. For example, the renowned biochemist and peace activist Linus Pauling proclaimed vitamin C to be the answer to the common cold. Numerous, high-quality studies failed to demonstrate clinically important effects of vitamin C in preventing or treating viral colds. The early studies were criticized for using too little of the vitamin, yet doses that well exceeded its bioavailability also proved negative. Nonetheless, ingestion of extra vitamin C remains a common habit in individuals who perceive the onset of cold symptoms. For most people, this practice is wasteful but not harmful; however, people with iron overload (either hemochromatosis or chronic transfusion requirement) can be damaged by vitamin C, which generates free radicals in the setting of iron excess. Despite the failure of some CAM approaches, early studies have yielded positive or at least encouraging data for a number of them. Good sources of information include the Natural Medicines Comprehensive Database (http://www.NaturalDatabase.com) and National Institutes of Health (NIH) websites such as http://ods.od.nih.gov; http://nccam.nih.gov/health/ and http://www3.cancer.gov/occam/information.html. Web resources : Bibliography : Alternative Medicine and Rehabilitation: A Guide for Practitioners by Wainapel, Stanley F.; Fast, Avital; New York: Demos Medical Publishing, Inc.; c2003

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