by Larry Dossey, M.D. and James P. Swyers, M.A.
The Constitution of this Republic should make special provision for Medical Freedom as well as Religious Freedom.... To restrict the art of healing to one class of men and deny equal privileges to others will constitute the Bastille of medical science. All such laws are un-American and despotic. They are fragments of monarchy and have no place in a Republic. — Benjamin Rush, Surgeon General of the Continental Army of the United States, Signer of the Declaration of Independence
Medicine in the United States has evolved from an eclectic mix of Native American, African/ Eastern, and European botanical traditions. In colonial and postcolonial America, there were dozens of competing medical philosophies, each claiming to have the "divine right" to practice medicine. By the early 1800s, medical practitioners included homeopaths, naturopaths, botanies, and Thomsonians. Competition was fierce, and the practice of medicine was essentially wide open (Hogan, 1979).
However, in the mid-1800s, the medical system we now refer to as biomedicine1 began to dominate the scene. Biomedicine was shaped by two important sets of observations made in the early 1800s: (1) specific organic entities—bacteria—were responsible for producing particular disease states and characteristic pathological damage; and (2) certain substances—antitoxins and vaccines—could improve an individual's ability to ward off the effects of these and other pathogens. Armed with this knowledge, investigators and clinicians began to conquer a myriad of devastating infectious diseases and to perfect surgical procedures. As their conquests mounted, biomedical scientists came to believe that once they found the offending pathogen, metabolic error, or chemical imbalance, all afflictions—including many mental illnesses—would eventually yield to the appropriate vaccine, antibiotic, or chemical compound (Gordon, 1980). This philosophy eventually led them to extend their purview beyond the bounds of physical and even mental disease to conditions that previously had been viewed in religious, moral, economic, or political terms. For example, births and deaths, which traditionally had taken place at home, were moved to the hospital.
During the late 1800s, the American Medical Association (AMA), which was first organized in 1847, sponsored and lobbied for enactment of State licensing laws. By 1900, every State had enacted such a law. The result was a quick decline in competition from other schools of medical practice (Starr, 1982). The ability of biomedicine to eliminate competition was further strengthened with the passage of the Pure Food and Drug Act of 1906 and the first court trial under this act in 1908 (McGinnis, 1991). In 1910, the fate of competing forms of medicine was sealed with the release of a report by Abraham Flexner, a U.S. educator and founder of the Institute for Advanced Study in Princeton, NJ. Flexner's report. Medical Education in the United States and Canada, was funded by the Carnegie Foundation and was instrumental in upgrading medical education. However, it also enabled medical schools with a greater orientation toward biomedicine research to receive preferential treatment from the large philanthropic foundations that were then awarding money for medical education. Indirectly, this development led to the demise of the more financially strapped alternative medical schools (King, 1984).
Although the Flexner Report is properly credited with closing many substandard medical teaching establishments, an unfortunate side effect was a complete stifling of all competing schools of thought regarding the origins of illness and the appropriateness of therapies (Coulter, 1973). This effect occurred even though Flexner had no firsthand knowledge of medicine or medical science, or of the scientific method and its potential inadequacies (King, 1984). Indeed, in the years after his report was published, Flexner became increasingly disenchanted with the rigidity of the educational standards that had become identified with his name (Starr, 1982).
With the loss of their medical schools, all but a few alternative medical systems and practices vanished into obscurity. In 1907 there were approximately 160 medical schools in the United States; by 1914, 4 years after the Flexner Report, that number had declined to around 100 (King, 1984). Thus, by the early part of this century, biomedicine had become the standard, or convention, for every facet of health and illness. As a result, for the next half century it overshadowed "less scientific" paradigms, and those who adopted and practiced it accumulated great power and prestige. Rival healing professions and perspectives gradually disappeared, were relegated to "fringe" status, or were swallowed up by the biomedical paradigm. Some alternative medicines degenerated into the stereotypical "snake oil" proprietary medicines, further eroding the credibility of legitimate alternative medicine practitioners.
Several decades ago, however, consumer confidence in conventional medicine began to show some signs of waning. Reports emerged on the side effects and inadequacies of widely used drugs, and new strains of bacteria suddenly appeared that were resistant to the first "magic bullet" antibiotics. The use of new, more powerful antibiotics eventually resulted in microbes that could thwart them, too. Meanwhile, cures for arthritis, allergies, hypertension, cancer, depression, cardiovascular disease, digestive problems, and other chronic conditions—which had replaced infectious disease as the major killers and cripplers—eluded the best minds of biomedicine. Also, the civil rights, consumer's, and women's movements raised serious questions about the availability and equity of the allocation of health care resources under this system (Gordon, 1980).
As a result, many Americans began to look outside conventional medicine for relief. Indeed, according to a recent survey conducted by Dr. David Eisenberg of the Harvard School of Medicine and Ronald Kessler of the Survey Research Center, so-called alternative therapies appear to be as popular as ever (Eisenberg et al., 1993). This survey found that in 1990 an estimated 61 million Americans used an alternative therapy and 22 million saw a provider of alternative therapies for a principal medical condition.
More intriguing, Americans appear to have made more total visits to practitioners of alternative medicine than to conventional primary care physicians—425 million visits versus 388 million—even though most of these visits to alternative practitioners were paid out of pocket (i.e., were not covered by medical insurance). Americans spent an estimated $13.7 billion on alternative therapies in 1990, of which $10.3 billion was paid out of pocket. This is almost as much as the out-of-pocket expenditure for all hospital care in the United States that year ($12.8 billion), and it is nearly half the amount spent out of pocket for all physicians' services in the United States ($23.5 billion). Thus, alternative medicine appears to represent a significant portion of Americans' health care expenditures. Furthermore, as the Eisenberg and Kessler survey showed, the majority of people seeking alternative medical therapies are those with chronic illnesses who believe that conventional medicine has few, if any, effective treatments for their conditions.
In a narrow sense, alternative medical practices today are often defined as those that are not widely practiced in hospitals or taught in conventional U.S. medical school curriculums (Eisenberg et al., 1993). However, "alternative" medicine can refer to any one of a number of practices, techniques, and systems that may challenge the commonly assumed viewpoints or bureaucratic priorities of our dominant professionalized system of health care.
Besides wide differences in the philosophical underpinnings and the types of therapies offered by mainstream and alternative medicine, there are also major differences in how therapies are administered and how the practitioners and patients interact. For example, conventional medicine practitioners tend to give their patients standardized treatments (typically drugs or surgery or both) and medical advice on the basis of whether the patient fits into one of a number of broadly defined symptomatic categories. Furthermore, the educational theory most familiar to conventional physicians and the one they most frequently use when interacting with their patients is "physician centered." In this model, the physician is the authoritative expert and the patient is a receptive participant (Brunton, 1984). This type of communication has been found to be lacking in addressing patient needs; it encourages passivity in patients, which may undermine the patient's commitment and determination to carry out the recommended treatment regimen (McCann and Blossom, 1990).
In comparison, because alternative medical practitioners often see each patient as unique, they tend to individualize treatment to the extreme and to create elaborate procedures for identifying individual suitability and sensitivity to the interventions. They also frequently use multiple treatment modalities and judge effectiveness by using multiple or unusual outcomes, many of them subjective and patient derived (Jonas, 1993). Furthermore, many alternative systems of medicine are converging toward a client-centered relationship, where emphasis is placed on the patient's responsibility in the healing process. Patient- centered exchanges have been found to maximize the collaboration between the physician and patient, thus enhancing the benefits of a therapy. Indeed, Rosenberg (1971) showed that patients who feel they have some control over their treatment have better outcomes.
Because the term alternative medicine is used to describe such a wide variety of medical systems and therapies, they cannot easily be categorized. Despite this diversity, most alternative systems of medicine do hold some common beliefs. First, there is the overarching belief that humans have built-in recuperative powers, such as when a cut heals into a scar. Most alternative medicine adherents believe that this phenomenon, referred to as vis medicatrix naturae (the healing power of nature), can be speeded up, sometimes to an astonishing degree, by the proper stimuli (Inglis, 1965). Thus, alternative medical practitioners typically focus on therapies designed to stimulate the patient's constitution to fight on its own behalf, on the assumption that this emphasis on enhancing the natural healing process is the most appropriate foundation of any medical therapy.
In addition, several other unifying threads are common to most alternative medical systems. These include emphasis on the
In addition, the following concepts often are used by alternative systems of medicine and their practitioners and are important in understanding the rationale for such treatments:
In some areas, the distinction between what is alternative and what is conventional is not always so clear-cut, because there is a constant progression of therapies from the "fringe" into the mainstream. For example, manipulative therapies such as chiropractic were considered fringe therapies 20 years ago but now are gaining increasing acceptance in mainstream medicine in the United States (Gherkin et al., 1989). In a recent survey of conventional physicians in Britain, 75 percent said that some alternative practices had become conventional between 1982 and 1987. Fifty-four percent said that musculoskeletal manipulation had become conventional, 47 percent reported the same for hypnosis, and 45 percent said that acupuncture had become conventional for certain problems (Reilly and Taylor, 1991).
This increasing acceptance of some forms of alternative medicine is demonstrated by the fact that in the past few decades, a small but growing number of M.D.S in America have organized and taken courses in manipulative medicine to better serve their patients (Gevitz, 1993). In addition, an estimated 3,000 conventionally trained physicians—M.D.s and D.O.s (doctors of osteopathy)—have been trained to incorporate acupuncture as a treatment modality in their medical practices through courses such as those affiliated with the University of California, Los Angeles, School of Medicine; the New York University School of Medicine and Dentistry; and St. Louis University Medical School (Lytle, 1993).
Furthermore, a number of tenets of naturopathy, especially those linking particular foods to the incidence of certain diseases such as cancer, are beginning to gain more credence in mainstream science. Many recent case control and cohort studies indicate associations between high intake of red meat and increased risk of some forms of cancer (Willett, 1990); other studies have focused on the anticancer protective effects of a vegetarian diet (Rao and Janezic, 1992). Such associations have led to increased interest among researchers worldwide in investigating the role that micronutrients and other substances in fruits and vegetables may play in preventing or inhibiting serious disease (Lee, 1993). (See the "Diet and Nutrition" chapter for more information on the latest research regarding these issues.)
Given that what is considered alternative today may be the accepted treatment for a particular condition in a decade or two, the following question arises: Could any of today's fringe therapies have a significant, immediate impact on the pressing and costly medical problems facing the Nation if they were more widely available?
Barriers to a fair, unbiased, scientific evaluation of alternative therapies can be categorized as structural barriers (problems caused by classification, definition, cultural, or language barriers), regulatory and economic barriers (the legal and cost implications of compliance or noncompliance with Federal and State regulations), and belief barriers (obstacles caused by ideology, misconceptions, myths, etc.).
As mentioned previously, a basic problem in investigating alternative therapies is that a clear definition of alternative medicine is almost impossible to devise. Alternative therapies are often referred to by a diverse group of sometimes derogatory pseudonyms, including "unconventional," "unorthodox," "integrated," "no mainstream," "traditional," "nontraditional," "natural," "unscientific," "holistic," "holistic," and many others, making classification difficult (Jonas, 1993). Other questions arise: Is the use of megavitamins, food supplements, or nutritional regimens to treat disease considered medicine, or is it a lifestyle change, or both? Can having one's aching back massaged be considered a medical therapy? How should spiritual healing and prayer—some of the oldest, most widely applied, and least studied unconventional approaches— be classified?
Because the line between conventional and alternative is imprecise and frequently changing, an approach to evaluation must be devised that is useful for comparing all types of therapy. The unfamiliar diagnostic outcome categories in many alternative approaches may require two sets of classification criteria (Wiegart et al., 1991). Traditional acupuncture, for example, classifies patients according to excesses or deficiencies in vital energy, or chi, in contrast to Western diagnostic classifications that are based on pathological or symptom complexes (coronary artery disease, depression, etc.). Scientists rarely understand and may oversimplify these alternative medicine concepts and thus may design methodologically correct research on the basis of incorrect classifications, resulting in unusable data (Bensoussan, 1991; Patel, 1991).
In addition, reprints of original research in alternative medicine are difficult to locate. Many alternative medicine research studies, especially those conducted in other countries, are not published in scientifically reviewed literature, and much of what does exist is not in English. For example, more than 600 research articles or abstracts have been published on the medical effects of qigong (a Chinese term for a form of energy), but few have been translated from Chinese (Sancier et al., 1993). The retrieval of information on alternative medicine from online databases is often inadequate, because these databases do not routinely collect articles from alternative medicine journals (Bareta et al., 1990; Dickerson, 1990; Easterbrook et al., 1991) or because the ones they do collect are not accessible by standard search languages (see the "Research Databases" chapter).
Many alternative medicine practitioners are primarily clinicians rather than researchers, and medical practice is their primary priority. Therefore, case series and anecdotal reports are often their only evidence that a practice is effective. Even so, the quality of the research presented by alternative medical practitioners is not always poor, and the fact that an article is published in an alternative medical journal does not mean the study is inferior. For example, a meta-analysis of 107 published controlled trials of homeopathic treatments to assess their methodological quality found that while many of the trials were of "low" methodological quality, there appeared to be an overall positive effect from the homeopathic treatment regardless of the quality of the trial. The authors of the study noted that while no definitive conclusions about the effectiveness of homeopathic treatments could be drawn, the meta-analysis supported a legitimate case for the further evaluation of homeopathy (Kleijnen et al., 1991).
Therefore, one cannot assume that practices unfamiliar to conventional physicians and researchers are necessarily backed by poor-quality research. Surprisingly, adequate methods for judging the quality of research in individual alternative medicine studies, both published and unpublished, still remain an underdeveloped research area. Scientists who conduct reviews of the literature on alternative medicine must be comprehensive, systematic, and explicit (Fuchs and Garber, 1990; Larson et al. 1986; Sachett et al., 1991).
Finally, many conventional physicians remain virtually unaware that alternative approaches exist, even though their patients are seeing them and alternative medical practitioners simultaneously for the same condition. The Eisenberg-Kessler survey (Eisenberg et al., 1993) found that 70 percent of patients seeking alternative practices did not reveal to their conventional physicians that they had done so. Patients' un-willingness to reveal this information to their conventional physicians may be largely due to the physician-centered model discussed above. Recently, an increasing number of members of the conventional medical community have called for physicians to move toward a patient-centered model for educating and interacting with patients. The impetus for this is a realization that the majority of patients want to participate in their clinical decision making and are more likely to adhere to a prescribed therapy using this approach (Brody and Larson, 1992; Brunton, 1984;Titus et al., 1980).
Today there are literally hundreds of treatments that are considered alternative, or outside the range of conventional medical treatment modalities. These treatments include various forms of behavioral, psychological, and spiritual interventions, as well as a host of herbal, pharmacological, nutritional, and mechanical therapies. Promoters of these therapies include trained physicians and other allied health care practitioners as well as laypersons.
The U.S. Food and Drug Administration (PDA) is the Federal agency most responsible for protecting consumers against unsafe and ineffective medicines and health products in the marketplace. Armed with broad regulatory powers delegated to the agency by the Food, Drug, and Cosmetic Act (FDCA), FDA oversees distribution of the Nation's food supply, oversees development and marketing of new drugs and medical devices, and generally supervises the promotion of these items to ensure that consumers are not harmed or defrauded.
Under the FDCA, new drugs require extensive laboratory and animal testing before their sponsors can petition FDA for an investigational new drug (IND) application for limited testing in humans. IND applications must state in detail how the clinical trials will be conducted (e.g., how subjects will be selected and how many will be involved with the studies), where the studies will be done and by whom, and how the product's safety and effectiveness will be evaluated.
Clinical trials are generally done in three phases. Phase I studies are designed to determine the safety of the product using small numbers of healthy subjects. Phase II studies are concerned more with the effectiveness of the product, usually employ up to several hundred volunteers diagnosed with the particular disease or condition under investigation, and may take 2 years or more to complete. Phase III studies, which may require several hundred to several thousand subjects and take 4 years or more to complete, are then designed to elaborate the correct dosage and frequency of administration of the product (Evers, 1988).
The entire drug approval process is time-consuming and extremely expensive, forcing treatment sponsors to spend millions of dollars each year to comply with FDA's safety and efficacy regulations. For example, a manufacturer must submit more than 100,000 pages of supporting documentation in connection with a single new drug application (Hect, 1983). It can take up to 10 years and cost hundreds of millions of dollars to obtain FDA approval of a new drug (Evers, 1988; also see the "Herbal Medicine" chapter). These astronomical costs are beyond the reach of all but a few corporations and can be recouped only by exercising the legal 17-year monopolies conferred by the U.S. patent laws. With a patent, drug companies can and do charge whatever the market will bear.
Thus, the current Federal mechanisms of regulating medical research do not favor the evaluation of many forms of alternative treatment. Because the costs of developing, evaluating, and marketing new drugs are so prohibitive, pharmaceutical companies are not likely to invest time and effort in therapies, such as nutritional or behavioral approaches, that cannot be patented and are therefore unlikely to offer the opportunity to recover their investment and provide a return to stockholders. This means that many alternative therapies are likely to be casualties of the formal research process.
Although foods are exempt from such extensive remarketing clearance, the FDA often regulates foods as if they were drugs whenever any health claims are associated with a product, even though the same product may also qualify as a food or as a cosmetic. A recent controversy surrounding the advertising campaign of a popular breakfast cereal demonstrates how overzealous FDA can be at times. FDA disapproved of the manufacturer's claims that its cereal would help prevent colon cancer, even though the company had prepared the advertisement in cooperation with the National Cancer Institute. FDA launched a probe into the matter, which it later had to abandon (Evers, 1988).
FDA has long attempted to regulate vitamins and minerals as drugs. The AMA supports this view and has urged Congress to grant FDA such authority (U.S. Congress, 1984). To date. Congress has not chosen to extend FDA's drug jurisdiction to encompass vitamins and minerals, except in cases where therapeutic claims are made for products.
Although the FDCA is the most comprehensive law designed to prevent interstate marketing of unapproved drugs, several other Federal statutes also are applicable to promotion or sale. The Federal Trade Commission (FTC) often uses the term false advertisement under the Federal Trade Commission Act to prevent the manufacturers of alternative therapies from promoting their products or services. Courts have generally held that the FTC does not have to show that an advertiser lacked good faith or intended to deceive, nor must it show that actual deception occurred. Rather, it has to show only that the potential to deceive might be there.
The FTC frequently seeks to hinder what it considers false advertising dealing with disease prevention or cure. For example, in 1983 the FTC sought to prohibit the manufacturer of a dietary supplement—which contained vitamins A, C, and E; selenium; beta-carotene; and dehydrated vegetables—from advertising its product as reducing the risk of certain cancers. The manufacturer's claims were based on the findings of a report entitled Diet, Nutrition, and Cancer, published by the National Research Council (1982). The FTC successfully argued that the manufacturer's representations went well beyond the re-port's conclusions and thus were false, misleading, and deceptive because they conveyed the impression that simply consuming daily portions of the product would prevent cancer. Accordingly, an injunction was issued prohibiting such advertisements (Evers, 1988).
In addition to FDA and FTC restrictions and regulations, the Federal Government routinely uses numerous other statutes to curtail the promotion of alternative treatments and practices. Statutes such as the mail fraud and wire fraud statutes and the "smuggling statute" are among the many laws that provide criminal penalties for those who promote unapproved products through the mail or on the radio or attempt to import them from overseas. Penalties can be fines of up to $10,000 or 5 years' imprisonment or both.
Another major barrier to the investigation and acceptance of alternative medicine is the existence in all States of medical practice acts that limit the practice of healing arts to holders of medical licenses. The history of medical licensure illustrates not only the enormous power bestowed on professional groups by regulation, but also the ways licensing has been used to eliminate or curtail the activities of alternative medical practitioners, regardless of whether their methods have been proved harmful. For example, throughout this century the medical professional organizations have used a variety of weapons to harass osteopathic and chiropractic physicians. Indeed, conventional medical organizations have historically prohibited their members from even consulting with "sectarian" practitioners such as homeopaths and chiropractors (see below). Medical organizations establish such prohibitions for reasons that have to do as much with ideology as with economics. The ideological reasons are discussed below.
Conventional physicians in general adhere to a number of beliefs and misconceptions about themselves and the type of medicine they practice that prevent them from viewing anything labeled "alternative" in a positive light or taking it seriously. The following are some of the ideological grounds for conventional physicians' skepticism of alternative systems of medicine and their therapies.
Although the AMA gradually relaxed some of its taboos regarding chiropractors, these relaxed positions were generally not communicated to AMA members (Gevitz, 1989). However, in the August 1987 Wilk et al. v. the American Medical Association decision, a Federal judge found that the AMA, the American College of Radiology, and the American College of Surgeons had conspired to intentionally harm the chiropractic profession and were thus guilty of violating the Sherman Antitrust Act (Special Communication, 1988). Under the court's ruling, the AMA was ordered to cease and desist its hampering of chiropractors and to send a copy of the injunction to each of its members.
The barriers facing many aspects of alternative medicine today are typical of the barriers that have faced novel scientific ideas throughout the centuries. At the root of this conflict is the fact that alternative and mainstream medical scientists often have two diametrically opposed views, not just on which drugs and vaccines are appropriate or most effective for a particular condition, but on the nature of life itself.
The 20th-century scientific philosopher Thomas Kuhn put this age-old conflict into perspective by stating that scientific doctrines rest not just on facts, but more fundamentally on paradigms (i.e., broad views of how those facts should be organized).3 Differences in views among groups of people are a reflection of the different scientific paradigms they adhere to. According to Kuhn, because unusual scientific discoveries often require more than incremental adjustments to the dominant scientific paradigm, the hapless innovator who stumbles upon some new set of facts that run counter to the dominant paradigm often finds it necessary to elaborate a whole new paradigm to accommodate them. When this happens, the innovator often becomes a scientific outcast, for, as Kuhn wrote, "to desert the paradigm is to cease practicing the science it defines" (Kuhn, 1970). For example, Louis Pasteur, the father of microbiology, was thrown out of the Academy of Medicine for suggesting that microbes that could not be seen by the naked eye were responsible for causing food to spoil and that spontaneous generation (life arising from nonliving matter) was an impossibility (Kostychev, 1978).
Thus, bridging the gap between the different paradigms of the conventional medical and alternative medical communities is and always has been a formidable challenge. However, as the public turns increasingly to alternative medical practitioners for treatment, pressure is mounting on the mainstream scientific and medical communities as well as on Federal and State scientific and regulatory bodies to speed up the investigation and evaluation of "novel" approaches. The public is demanding a streamlined evaluation process not only to provide it with more health care options, but also to provide definitive answers about the safety and efficacy of alternative therapies that are being offered.
In response to this increasing public pressure, in 1992 Congress established the Office of Alternative Medicine (OAM) in the Office of the Director of the National Institutes of Health (NIH). OAM's mandate is to facilitate the evaluation of alternative medical treatments that might offer promise for addressing a number of serious health problems that afflict the Nation. OAM also was mandated to establish an information clearinghouse to exchange information with the public about alternative medicine. In addition, OAM was charged with supporting research training in topics related to alternative medicine that are not typically included in the training curriculums of mainstream physicians and other health professionals.
OAM has been guided through its early stages by an ad hoc advisory panel of alternative medical practitioners and mainstream medical researchers who have an interest in alternative medicine. With its recent formal charter as an NIH advisory council status, this panel will play an increasing role in helping OAM to fulfill its mandate.
OAM's mandate is not to be an advocate of any particular alternative medicine treatment, but rather to advocate the fair scientific evaluation of alternative therapies that are found to have potential for improving the health and well-being of a significant number of people. In doing so, OAM has positioned itself as an intermediary between the alternative medical community and the Federal research and regulatory communities, in order to help reduce the barriers that may keep promising alternative therapies from coming to light.
Traditionally, alternative medical disciplines often have been divided into four categories on the basis of the type of treatment or treatments offered by their practitioners. The psychological and spiritual category (often referred to as mind-body) includes practitioners who use psychological techniques such as mental imaging, hypnosis, and art therapy. The diet and nutrition category includes those who recommend dietary supplementation with vitamins or minerals and prescribe specific diets, such as a vegetarian or macrobiotic diet, for specific conditions. The drug and biological category comprises specialists in the use of assorted chemicals, drugs, serums, and vaccines (e.g., treatments to enhance the immune system) and the injection of live cells from fetuses and animals. The fourth category, involving treatment with physical forces and devices, includes chiropractors, massage and touch therapists, acupuncturists, and practitioners of various electrotherapies.
This report deviates from this scheme in several ways. For example, although it includes the above-mentioned categories—mind-body, diet and nutrition, biologist and pharmacologist (i.e., drugs), and manual healing (i.e., massage, chiropractic, etc.)—it also includes a separate section on bioelectromagnetics therapies instead of grouping them with massage and chiropractic. In addition, there is a chapter on alternative systems of medicine (i.e., homeopathy, traditional Asian medicine, etc.) as well as a chapter on herbal medicine. Part II deals with issues that are germane to all areas of alternative medicine, including research methodology issues, peer review, research training, database establishment, and so on.
Each chapter presents an overview of the discipline (i.e., historical background as well as how the system or therapy is used today), the research base, future research opportunities, barriers to research, and key issues. Many sections also contain specific recommendations relating to priorities for research and evaluation activities as well as specific illnesses or groups of patients that may benefit from such therapies.
This report is by no means all-inclusive; a number of alternative medical systems and therapies are not discussed here. For instance/ midwifery is not discussed, even though in many States midwifery is considered outside the mainstream of medicine and midwives are legally prevented from practicing. Midwifery and a number of other important alternative medicine disciplines were left out because of limited time and resources rather than because of a conscious decision to overlook them. The present plan is for this report to be updated so that later editions will be more accurate and more comprehensive.
Neither is this a consensus document. Contributors to this report do not necessarily agree with all of its content and recommendations. It covers such an array of topics and required input from such a diverse group of experts and disciplines that reaching consensus even within a particular area of expertise, such as diet and nutrition, would have been virtually impossible without a prohibitively lengthy and costly peer review process. Because much of the research on alternative medicine, by definition, has been conducted outside the mainstream of medicine, it is not possible to verify all of the individual claims of efficacy made in this report. Rather, the report is a good-faith effort to point out research directions to OAM and other Federal agencies where there is at least some evidence to suggest that further inquiry is warranted.
Claire Cassidy, Ph.D., James S. Gordon, M.D., Ralph W. Moss, Ph.D., and Richard Pavek contributed to this section.
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1 This is the more accurate technical term for the style of medical practice in which practitioners hold either an M.D. (medical doctor) or D.O. (doctor of osteopathy) degree. Other terms for this system include allopathy. Western medicine, regular medicine, conventional medicine, mainstream medicine, and cosmopolitan medicine. All of these terms have some applicability, but none is as accurate as biomedicine. Allopathy, the most specific of these terms, denotes a tendency to choose therapies that oppose symptoms (allo = opposite) and enables parallels with terms such as osteopathy, homeopathy, and naturopathy. The other terms (mainstream, conventional, etc.) are less accurate but are better known and thus will be used throughout this text interchangeably with biomedicine.
2 Disease is a technical concept, especially developed in biomedicine, that refers to a limited, well-defined condition such as a specific infection (measles) or deficiency (beri-beri). It has expanded to take in many less well-defined conditions for which the "cause" is complex, such as duodenal ulcer, stroke, or breast cancer. Some conditions, especially psychosocial conditions such as alcoholism and depression, which straddle the line between moral failing and disease, are becoming "medicalized," or pushed away from the moral failing category and into the disease category. In contrast, illness and sickness are social terms that emphasize sensations of unwellness and discomfort and imply a change in relationship toward family and work. Sociologically speaking, people fake on the "sick role" at the time when they claim sickness and those around them accept the claim. People can have a disease and not know it, in which case they are not ill or sick because they have not recognized their condition of frailty and have not sought the sick role. Or a person can feel ill or sick and seek the sick role but be denied it, at least by medical specialists, if they "can find no wrong." When both sickness and disease overlap, everyone involved in the communication agrees that "something is wrong with this person."
3 A paradigm is an overarching cosmological conceptual scheme; an explanatory model explains a limited set of events or observations from within a paradigm and using the guidance of a paradigm. Alternative words for paradigm include worldview, framework, and weltanschauung, all of which suggest the largeness of the concept. A paradigm tells whole societies in whole historical periods how to think about such "big issues" as goodness, success, holiness, love, and evS. Much of a paradigm is out of awareness—that is, people act on it without realizing that they have other choices. In contrast, an explanatory model is the way one discipline, denomination, or health care system explains itself—the details of its assumptions, logic, and rationale—and much of this is within the awareness of its practitioners, and is therefore open to argument, criticism, and change.