Report 12 of the Council on Scientific Affairs (A-97) Full Text
Alternative Medicine
http://www.ama-assn.org/ama/pub/article/2036-2523.html
FULL TEXT
NOTE: This report represents the medical/scientific literature on this subject as of June 1997.
The terms "alternative medicine," "complementary medicine," or "unconventional medicine" refer to diagnostic methods, treatments and therapies that appear not to conform to standard medical practice, or are not generally taught at accredited medical schools. The scope of alternative medicine is broad, with widespread use among the American public of a long list of treatments and practices, such as acupuncture, homeopathy, relaxation techniques, and herbal remedies. In an editorial about alternative practices in the New England Journal of Medicine, Murray and Rubel comment, "Many are well known, others are exotic and mysterious, and some are dangerous."1 This report will help to clarify and categorize the alternative medical systems most often used, create a context to assess their utility (or lack thereof), and discuss how physicians and the medical profession might deal with the issues surrounding these unconventional measures in health and healing. The Appendix lists various alternative systems and methods in common use.
At the turn of the last century, the effort led by the American Medical Association (AMA) to improve the quality of medical education and bring quality controls to curricula ultimately led to the landmark report by Flexner in 1910. Among other outcomes, the resulting changes in medical education led to the acceptance of the biological, disease-oriented models that dominate medicine in the United States today. State licensing boards, influenced by the AMA, limited the practice of medicine to graduates of accredited institutions, and research funding became the domain of the major teaching centers. All these factors put great pressure on smaller schools (and their graduates, many of whom were homeopaths) that could not meet the emerging requirements for medical education and practice. As a result, many schools that taught practices such as homeopathy were closed, homeopaths were shunned and stigmatized, and their therapies became the "alternatives" to the standards that evolved after acceptance of the Flexner reports. In contrast, Osteopathic schools like allopathic schools developed rigorous standards and practices.
I. Alternative Systems and Techniques
Most observers from outside the fields of alternative or unconventional medicine find no common or unifying theory or basis for its use; indeed, it may be that the variety of treatments in itself enhances their popularity. Many such therapies are characterized by a charismatic leader or proponent, and are driven by ideology; some spring from folk practices or quasi-religious groups, while others are recognized elements of religions such as those practiced by Native Americans.
Many alternative practitioners are unlicensed (except for chiropractic, and in some states, acupuncturists, naturopaths, and homeopathic therapists) and unregulated, particularly those dealing in alternative nutritional therapy.
The adherents of these fields, however, state that "most alternative systems of medicine hold some common beliefs."2 Many theories of alternative medicine attempt to pose a single explanation for most human illness; the therapy is thought to correct the source of the problem, not merely treat its symptoms. The recuperative power of the human body and the potential for certain stimuli to enhance this natural healing are central to many therapies. Other unifying threads include:2
Importance of spiritual values to health
Integration of individuals in the "stream of life"
Attribution of a causal, independent role to various "manifestations of consciousness"
Use of whole (unsynthesized) substances
Maintaining the injunction to "do no harm"
The philosophy that achieving and maintaining health is very different from fighting disease
A belief that personal experience and anecdote are as reliable as scientific study in determining whether something is effective.3,4
John Renner, MD, a board member of the National Council Against Health Fraud, has proposed a set of definitions3 that are useful in discussing of alternative therapies, treatments, and devices.
1. "Proven" products and services are those that have been scientifically tested, optimally through controlled clinical trials and double-blind studies, and found to be both safe and effective for the specific condition for which their use is proposed.
2. "Experimental" therapies or products are those undergoing controlled trials to determine their proper application, dose, frequency of use, general safety, and efficacy. Such trials should be conducted under the supervision of recognized entities such as the Food and Drug Administration (FDA), the National Institutes of Health (NIH), or in academic medical centers, with proper human subjects review and full informed consent among any persons involved.
3. "Untested" methods are those that have never been subjected to rigorous clinical testing or evaluation under standard protocols and controlled conditions. Many of the herbal, homeopathic, and dietary products described in the previous narrative would fall in this category.
4. "Folklore" remedies have usually been passed down through cultural tradition and oral history, including many home remedies such as chicken soup for colds and honey and lemon tea for sore throat. Most folk medicine is not done for personal enrichment and is noncommercial.
5. "Quackery" or health fraud involves commercial marketing or use of therapies, products, or procedures with no proven effectiveness that could also cause physical harm; indirectly harms patients by delaying appropriate therapy or diverting care to unproven methods; and often involves financial fraud as well. Promises of cure for cancer, human immuno-deficiency virus (HIV), and other conditions for which little hope is present attract desperate patients willing to try anything. Anecdotal testimonials are the main basis for the "success" of these modalities.
The failure (real or perceived) of many physicians and medical specialities to understand and practice preventive medicine and to communicate effectively with patients, and conventional medicine's dependence on costly diagnostic and procedural interaction that ignores the human side of medicine may have helped spur public interest in alternative and unconventional therapy.
continued
alternative medicine the medical/scientific literature
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alternative medicine the medical/scientific literature
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alternative medicine the medical/scientific literature
by malernee » Mon Oct 06, 2003 5:30 am
continued from previous post
AMA article
II. Theories of Alternative Medicine
Mind-body interventions
Much of alternative medicine deals with the relationship between the mind (as distinct from the brain and its biochemistry) and the body, with a chief goal of achieving a sense of psychological or spiritual well-being in persons and a feeling of wholeness even in the face of a disease process or condition. Patients with a wide range of conditions and disorders benefit from applications of techniques in this area; cancer, chronic pain and burns, chemical dependence, several neurological and psychiatric conditions, blood pressure and cholesterol reduction, home births, and other problems have been the subject of this set of treatments.
Some of the therapy sounds very familiar to orthodox clinicians--stress management through meditation, music and art therapy, hypnosis, focused relaxation, and psychotherapy are all known to physicians as useful treatments. Biofeedback has been used for years in helping with anxiety and stress-related disorders, and for adjunctive therapy in blood pressure management. Some of the clinical applications of these techniques are, however, decidedly unconventional. Guided imagery to produce spontaneous remission of cancer, for example, or hypnotherapy for immune disorders and hemophilia fall into this category. Meditation is touted for its ability to increase intelligence and longevity, and yoga for better diabetic control. Advocates call for research into the "nonlocal effects of consciousness" as well as for more traditional kinds of review such as the effects of personal belief, values, and meaning on health and illness.
Diet/nutrition
The knowledge that good nutrition and a balanced diet help maintain health is not new, or news. A cornerstone of belief in most alternative systems is the repudiation of the "modern, affluent diet" and its replacement with a diet rich in whole, "organic" products, often vegetarian in approach. Many healers maintain that certain diets promote anti-tumor immunity or cardiovascular health; other regimens advocate specific micronutrients or vitamins for particular conditions or overall longevity. There seems to be a continuum of beliefs ranging from promoting dietary supplements beyond the Recommended Dietary Allowances (RDAs), to elimination or addition of specific foods to "treat" specific conditions.
Much of the dietary intervention stressed by alternative healers is prudent and reasonable. The American diet is unarguably too rich in fat and empty calories. Dietitians and nutritionists are licensed in many states, and are an invaluable source of advice to physicians and patients alike regarding nutrition and dietary management of a host of conditions. But the approach taken by some alternative practitioners encourages what many consider the excessive use of health foods and dietary supplements, often of a proprietary nature and meant to enrich themselves while promoting several myths:4
it is difficult to get the nourishment one requires from ordinary foods
vitamin and mineral deficiencies are common
most diseases are caused by faulty diets and can be prevented by nutritional interventions
any use of food additives and pesticides is poisonous
Herbal remedies
Herbal medicine is a booming industry in the United States. The American market for herbal remedies has doubled since 1985, to $1.13 billion in 1993 (excluding homeopathic remedies and teas). Growth is expected to continue at 10% to 15% per year through 1997. Four-fifths of all people, worldwide, still rely to a great extent on traditional medicines based on plants and their components.5
The use of herbs in medicine is ancient in its origins, and several examples are well known to both physicians and the public: foxglove as the treatment for "dropsy" and later, the source for digitalis, and quinine's origins in Cinchona bark. New therapies such as taxol continue to show the usefulness of plants as a source of our pharmacopoeia. The director of collaborative services in the Department of Pharmacology at the University of Illinois at Chicago, a national botanical authority, states that only 90 plant species account for most of the plant-derived drugs in common use by physicians, about 120 drugs in all. Three-fourths of this list was discovered by following up on traditional folk medicine claims.5
Basic to the use of herbs in alternative medicine is the belief that whole plant material is superior to synthesized or isolated chemicals derived from plant sources. The material may be flowers, bark, roots, or leaves, used singly or in combination, often taken in the form of teas, or ground and taken as tablets, or used in salves. These compounds are thought to produce fewer unintended or dangerous effects, and a "balanced" action as opposed to single drugs. There is little evidence for this belief, however, and no standardization of the dose in herbal healing. The safety of many of the compounds is unknown, or the potential toxicity ignored.6,7
Folk healers, herbalists, naturopaths, traditional Chinese healers, homeopaths, and a host of others in alternative practices commonly use herbal remedies. As with other nutrition therapies, herbs are prescribed to prevent or treat specific conditions, and are consumed by many persons to maintain health. For example, a recent meta-analysis study on St. John's wort (Hypericium perforatum) suggests that this herb shows promise in treating mild to moderately severe depression.8 An accompanying editorial points out several limitations in these interesting data, including the need for trials longer than 8 weeks, better patient selection and categorization of diagnosis, and comparisons with therapeutic doses of standard antidepressants.9
The conclusion that St. John's wort needs more study is distinctly different, however, from the one expressed by the president of Bastyr University, a school of naturopathy in Seattle, Washington. In an article written in a popular consumer magazine,10 he describes common drugs he "personally would never take," offering "natural alternatives that help correct the underlying problem" that he describes as "safer, more effective, and less expensive" than such treatments as estrogens for menopausal symptoms, non-steroidal anti-inflammatory drugs, and conventional antidepressants. He advocates the use of St. John's wort or other herbs for mild to moderate depression. He does caution readers to consult with their doctor before beginning his suggested treatments, or making changes in current medication regimens.
Regulation of herbal and plant products in Germany has been assigned to a special commission within the Federal Health Agency that has produced a series of monographs on the safety of these products. More than 200 such products have been approved, some of which seem to have salutary effects. As opposed to the FDA requirements of evidence from randomized studies, the German commission demands a less stringent standard for efficacy, allowing material such as case reports, historical data, and other data in the scientific literature.11
The Dietary Supplement Health and Education Act of 1994 regulates the claims that can be made about the effects of herbal and nutritional products. The Act gives the FDA some controls over herbal supplements, vitamins, and amino acid preparations and similar products, classifying them as dietary supplements. Manufacturers cannot make claims as to the health or therapeutic benefits of their products on package labels and labeling without receiving FDA prior approval. However, general claims related to well-being and to the effect of a substance on the structure or function of the body can be made without any evaluation or approval by the FDA. The Act also shifts the burden of proof to the FDA to prove that a product in this category is unsafe prior to taking regulatory action, rather than requiring the manufacturer to obtain FDA approval by showing that the product is safe before offering the product to the public. New labeling requirements and an Office on Dietary Supplements in the NIH also are called for by the Act.
Because this category of products can be marketed without FDA review or approval, standards for dosage and other manufacturing safeguards, or evidence of safety, some health fraud experts worry that this new law will make it easier for nutrition to be misused by hucksters, and will hamper the FDA's ability to effectively monitor safety among the growing number of herbal and nutritional remedies being offered to the public. The burden now rests with the consumer to interpret claims made by the manufacturers of these products. For example, persons with acquired immunodeficiency syndrome (AIDS) might believe a claim made by an herbal product of "boosting T-cells" is true and leads to an improvement in the course of the disease from using the product.
An example of FDA intervention in this area involves ephedrine alkaloid containing dietary supplements that have been promoted as euphoric agents that are safe alternatives to illegal drugs, as well as for purposes such as weight loss, energy or body building. [NB: FDA has recorded very few adverse events with products marketed as euphorics.] Containing "natural" sources of ephedrine such as ma huang, ephedra, Ephedra sinica, or extracts of these substances, these compounds have been shown to have adverse effects such as headache, dizziness, palpitations, and possibly, clinically significant effects such as heart attack, stroke, seizures, and psychosis. The FDA considers marketing of these products, often aimed at adolescents looking for a "high," to be in violation of the Act, and is currently considering regulatory steps to ensure the safety of ephedrine-containing dietary supplements and what further action should be taken in this area.
Our ability to increase our understanding of the role of herbal remedies in medicine is hampered by deforestation, and the loss of knowledge held about plant therapies by indigenous people as the Amazon and other remote areas are developed. Activity in biodiversity is being supported by the NIH, the National Institute of Mental Health, the National Science Foundation, and the US Agency for International Development.2 Both the traditional medical community and the adherents of alternative therapy have called for increased research into this area.
Manual healing methods
The healer's touch has been considered a therapeutic instrument for the entire history of medicine, dating back to instructions by Hippocrates about therapeutic massage. Ancient Chinese medicine has strong roots in this system, and several areas of alternative medicine are associated with manual healing methods. The major fields of manual healing include (1) methods that use physical touch, manipulation, and pressure--chiropractic and osteopathic manipulation are primary examples; (2) therapies that use an "energy field" that can influence healing; and (3) mixed interventions that use both physical touch and energy field therapy.
Osteopathy
Osteopathic physicians derive their theories from the work of Andrew Taylor Still (1828-1917), a physician's son who was trained as an apprentice to his father. After the Civil War, he began an empirical study of healing by manipulating bones and soft tissues to allow the free circulation of blood and lymph, and to restore the nervous system to what he considered a more normal function. Known as the "lightning bone-setter," he disdained the common practices of physicians in the last century such as venesection, emesis, and sedation with narcotics, preferring to use manipulation to enhance the body's innate ability to heal itself. Instead of using drugs, he believed that the solution to illness lay in treating the underlying condition, allowing the body’s natural forces to return the patient to health. He proposed that much more than headache and back pain could be treated with manipulation, and set forth a regimen of therapy that included treatment for serious conditions such as pneumonia, dysentery, and typhoid fever.
The first school of osteopathy was opened in Missouri in 1892, teaching a variety of methods: manipulation of soft tissue, isometric and isotonic muscle techniques, manipulation with varying "velocity," the use of the percussion hammer to strike the body to alleviate "restrictions" in the joints and muscles that allowed internal processes to function normally, and other unorthodox therapies. Since that time, osteopathic education and its practitioners have become nearly indistinguishable from their allopathic cousins, with the exception of manipulation techniques that continue to be integral parts of osteopathic diagnostic and treatment modalities. Modern osteopathic physicians are considered to be in the mainstream of medical practice, with rigorous standards for education and specialty training. Osteopathic physicians commonly complete allopathic postgraduate specialty training, and are licensed to practice the full scope of medicine in all states, without restrictions. Some advocates of alternative medicine criticize modern osteopaths for abandoning the original scope and breadth of manipulation therapy.
Chiropractic
As with many systems in alternative medicine, chiropractic holds that the innate ability of the body to heal itself can be optimized by achieving a "balance"; that proper function of the nervous system is key to this homeostasis; that "subluxations" of the spine and misalignment of joints impinge on nerves, causing imbalance in internal systems; and that manual release of these structural and functional joint pathologies can heal a number of conditions, and prevent illness as well.12
The theories behind chiropractic have been widely criticized. A 1968 study by the US Department of Health, Education, and Welfare concluded that chiropractic schools did not prepare students to adequately diagnose and treat patients, and recommended that their services not be covered under Medicare.2,12 In 1972, Congress added Medicare benefits for "manual manipulation of the spine to correct a subluxation demonstrated to exist on x-ray." In 1974 the Council on Chiropractic Education was recognized to accredit schools of chiropractic, despite the absence of clear evidence of efficacy of chiropractic therapy.12 Over the years, bothpolitical pressure and consumer acceptance has won lincensure for chiropractic in all 50 states. Most of the nation's 45,000 chiropractors bill Medicare for services rendered, amounting to $181 million in 1990.12 Most third-party payors accept claims from chiropractors.
Manipulation has been shown to have a reasonably good degree of efficacy in ameliorating back pain, headache, and similar musculoskeletal complaints,13 and some chiropractors limit their practices to these conditions. While precise statistics are not available, a majority of chiropractors adhere to the method’s original theories, and continue to claim that chiropractic manipulation cures disease rather than simply relieving symptoms. (Personal communication, Denny Futch DC, Vice President, National Association of Chiropractic Medicine). They promote manipulation as useful in a host of conditions, ranging from infectious diseases to immune therapy, even claiming to prevent future conditions from occurring (even if years away) including menstrual irregularity, difficulty giving birth, and cancer.12 Chiropractors commonly provide advice in nutrition and other preventive practices, and maintain that a regular series of "adjustments" is needed by most persons to maintain optimal health.
Energy healing
Biofield, or energy healing, is described by its proponents as "one of the oldest forms of healing known to humankind."14 Theories related to this practice involve transfer of energy from healer to patient in unknown ways, either from a supernatural entity or by manipulating the body's own "energy fields." Over 25 terms are used in various cultures to describe this life force. Biofield practitioners incorporate a holistic focus into therapy, and promote their methods as useful for stress and general improvement of health; relief of pain, edema, and acceleration of wound and fracture healing; improvement in digestion, appetite, and various emotional states; and treatment of conditions such as eating disorders, irritable bowel syndrome, and pre-menstrual syndrome.
Some unique conditions are "diagnosed" by biofield practitioners, such as "accumulated tension" and "congested energy" that, when released, supposedly lead to improved health. A common form of this therapy is used by nurses, and is called "therapeutic touch." It involves moving the hands over (but not in direct contact with) the patient's body either to create a general state of well-being by enhancing "energy flow" in the subject, or to release "accumulated tension" and induce balance and harmony. At least one school of nursing has demanded that its faculty cease teaching these modalities as part of their curriculum (personal communication, John Renner, MD).
Therapies that combine manipulation and biofield therapy include "network chiropractic spinal analysis," which combines soft-tissue chiropractic and applications of the biofield, followed by conventional chiropractic treatment; "craniosacral therapy," an offshoot of osteopathic medicine involving manipulation of cranial and/or sacral bones to relieve "restrictions" in motion of these bones that are thought to help persons with seizures, immune disorders, learning disabilities, and assorted other conditions; and "polarity therapy," in which touch, energy field manipulation, and other modalities correct distortions in one's "energy anatomy."15
Pharmacologic methods
The area of pharmacologic treatment is rife with both opportunity and peril, since many of the modalities in unconventional medicine that use pharmacologic and biologic treatment may truly be deserving of clinical trials and well-funded investigation. At the same time, many therapies in this area represent true health fraud. Some areas under investigation include immunotherapies, including the use of antitumor antibodies; alternative strategies to treat menopausal conditions; the use of local anesthetic injection into autonomic ganglia and other sites, such as acupuncture points for chronic pain; and several cancer and HIV treatments.
Some methods proposed for study and further dissemination have been associated with proponents using questionable methods and possibly fraudulent research. Several of these are cancer therapies, including "antineoplastons," popularized by a physician named Burzynski who claims he can "normalize" tumor cells by shutting off their undifferentiated growth using peptides extracted from urine. A review of this method in JAMA15 concludes that no objective evidence exists to support the experimental claims.
Chelation with EDTA for heart disease and other cardiovascular conditions is another questionable practice in this category. Described by proponents as a nontoxic way to flush "toxins" and fatty deposits from the arterial system, it has also been touted for emphysema, kidney and endocrine disease, and arthritis. Ozone therapy has been advocated by alternative healers, as has intravenous hydrogen peroxide. Therapies involving bee pollen (and other products from bees) are in widespread use, with no scientific evidence for efficacy--but a Senator who attributed improvement in his health to bee pollen spurred the creation of the NIH Office of Alternative Medicine (OAM).
Investigators worry that the Internet has become a bazaar for alternative therapies, whose purveyors can use overseas addresses for distributing products that are not subject to any sort of scrutiny. There are now more than 100 commercial outlets for shark cartilage, a substance that is promoted for cancer treatment and prevention, arthritis, and a host of other ailments. Hormones such as DHEA (dihydroepiandosterone) get Internet claims for extending life, normalizing blood sugar and cholesterol, and sexual enhancement. Colloidal silver is said to be a "safe natural antibiotic" that "kills 650 disease causing organisms." Asparagus extract is said to "restrain and prevent metastasis of middle as well as late stage tumors," and the list goes on, with hundreds of alternative medicine home pages and links to mail order firms.17
Proponents of alternative pharmacotherapy argue that proper funding, well-organized trials, and modifications in FDA regulations for experimental therapy will help these therapies get a "fair hearing" by the traditional medical community. On the other hand, they have requested immunity from the FDA and other regulatory oversight, protecting investigators from fraud and licensing actions, raids, seizure of materials, import alerts, and other interventions for all clinical trials endorsed by the OAM.18
continued
AMA article
II. Theories of Alternative Medicine
Mind-body interventions
Much of alternative medicine deals with the relationship between the mind (as distinct from the brain and its biochemistry) and the body, with a chief goal of achieving a sense of psychological or spiritual well-being in persons and a feeling of wholeness even in the face of a disease process or condition. Patients with a wide range of conditions and disorders benefit from applications of techniques in this area; cancer, chronic pain and burns, chemical dependence, several neurological and psychiatric conditions, blood pressure and cholesterol reduction, home births, and other problems have been the subject of this set of treatments.
Some of the therapy sounds very familiar to orthodox clinicians--stress management through meditation, music and art therapy, hypnosis, focused relaxation, and psychotherapy are all known to physicians as useful treatments. Biofeedback has been used for years in helping with anxiety and stress-related disorders, and for adjunctive therapy in blood pressure management. Some of the clinical applications of these techniques are, however, decidedly unconventional. Guided imagery to produce spontaneous remission of cancer, for example, or hypnotherapy for immune disorders and hemophilia fall into this category. Meditation is touted for its ability to increase intelligence and longevity, and yoga for better diabetic control. Advocates call for research into the "nonlocal effects of consciousness" as well as for more traditional kinds of review such as the effects of personal belief, values, and meaning on health and illness.
Diet/nutrition
The knowledge that good nutrition and a balanced diet help maintain health is not new, or news. A cornerstone of belief in most alternative systems is the repudiation of the "modern, affluent diet" and its replacement with a diet rich in whole, "organic" products, often vegetarian in approach. Many healers maintain that certain diets promote anti-tumor immunity or cardiovascular health; other regimens advocate specific micronutrients or vitamins for particular conditions or overall longevity. There seems to be a continuum of beliefs ranging from promoting dietary supplements beyond the Recommended Dietary Allowances (RDAs), to elimination or addition of specific foods to "treat" specific conditions.
Much of the dietary intervention stressed by alternative healers is prudent and reasonable. The American diet is unarguably too rich in fat and empty calories. Dietitians and nutritionists are licensed in many states, and are an invaluable source of advice to physicians and patients alike regarding nutrition and dietary management of a host of conditions. But the approach taken by some alternative practitioners encourages what many consider the excessive use of health foods and dietary supplements, often of a proprietary nature and meant to enrich themselves while promoting several myths:4
it is difficult to get the nourishment one requires from ordinary foods
vitamin and mineral deficiencies are common
most diseases are caused by faulty diets and can be prevented by nutritional interventions
any use of food additives and pesticides is poisonous
Herbal remedies
Herbal medicine is a booming industry in the United States. The American market for herbal remedies has doubled since 1985, to $1.13 billion in 1993 (excluding homeopathic remedies and teas). Growth is expected to continue at 10% to 15% per year through 1997. Four-fifths of all people, worldwide, still rely to a great extent on traditional medicines based on plants and their components.5
The use of herbs in medicine is ancient in its origins, and several examples are well known to both physicians and the public: foxglove as the treatment for "dropsy" and later, the source for digitalis, and quinine's origins in Cinchona bark. New therapies such as taxol continue to show the usefulness of plants as a source of our pharmacopoeia. The director of collaborative services in the Department of Pharmacology at the University of Illinois at Chicago, a national botanical authority, states that only 90 plant species account for most of the plant-derived drugs in common use by physicians, about 120 drugs in all. Three-fourths of this list was discovered by following up on traditional folk medicine claims.5
Basic to the use of herbs in alternative medicine is the belief that whole plant material is superior to synthesized or isolated chemicals derived from plant sources. The material may be flowers, bark, roots, or leaves, used singly or in combination, often taken in the form of teas, or ground and taken as tablets, or used in salves. These compounds are thought to produce fewer unintended or dangerous effects, and a "balanced" action as opposed to single drugs. There is little evidence for this belief, however, and no standardization of the dose in herbal healing. The safety of many of the compounds is unknown, or the potential toxicity ignored.6,7
Folk healers, herbalists, naturopaths, traditional Chinese healers, homeopaths, and a host of others in alternative practices commonly use herbal remedies. As with other nutrition therapies, herbs are prescribed to prevent or treat specific conditions, and are consumed by many persons to maintain health. For example, a recent meta-analysis study on St. John's wort (Hypericium perforatum) suggests that this herb shows promise in treating mild to moderately severe depression.8 An accompanying editorial points out several limitations in these interesting data, including the need for trials longer than 8 weeks, better patient selection and categorization of diagnosis, and comparisons with therapeutic doses of standard antidepressants.9
The conclusion that St. John's wort needs more study is distinctly different, however, from the one expressed by the president of Bastyr University, a school of naturopathy in Seattle, Washington. In an article written in a popular consumer magazine,10 he describes common drugs he "personally would never take," offering "natural alternatives that help correct the underlying problem" that he describes as "safer, more effective, and less expensive" than such treatments as estrogens for menopausal symptoms, non-steroidal anti-inflammatory drugs, and conventional antidepressants. He advocates the use of St. John's wort or other herbs for mild to moderate depression. He does caution readers to consult with their doctor before beginning his suggested treatments, or making changes in current medication regimens.
Regulation of herbal and plant products in Germany has been assigned to a special commission within the Federal Health Agency that has produced a series of monographs on the safety of these products. More than 200 such products have been approved, some of which seem to have salutary effects. As opposed to the FDA requirements of evidence from randomized studies, the German commission demands a less stringent standard for efficacy, allowing material such as case reports, historical data, and other data in the scientific literature.11
The Dietary Supplement Health and Education Act of 1994 regulates the claims that can be made about the effects of herbal and nutritional products. The Act gives the FDA some controls over herbal supplements, vitamins, and amino acid preparations and similar products, classifying them as dietary supplements. Manufacturers cannot make claims as to the health or therapeutic benefits of their products on package labels and labeling without receiving FDA prior approval. However, general claims related to well-being and to the effect of a substance on the structure or function of the body can be made without any evaluation or approval by the FDA. The Act also shifts the burden of proof to the FDA to prove that a product in this category is unsafe prior to taking regulatory action, rather than requiring the manufacturer to obtain FDA approval by showing that the product is safe before offering the product to the public. New labeling requirements and an Office on Dietary Supplements in the NIH also are called for by the Act.
Because this category of products can be marketed without FDA review or approval, standards for dosage and other manufacturing safeguards, or evidence of safety, some health fraud experts worry that this new law will make it easier for nutrition to be misused by hucksters, and will hamper the FDA's ability to effectively monitor safety among the growing number of herbal and nutritional remedies being offered to the public. The burden now rests with the consumer to interpret claims made by the manufacturers of these products. For example, persons with acquired immunodeficiency syndrome (AIDS) might believe a claim made by an herbal product of "boosting T-cells" is true and leads to an improvement in the course of the disease from using the product.
An example of FDA intervention in this area involves ephedrine alkaloid containing dietary supplements that have been promoted as euphoric agents that are safe alternatives to illegal drugs, as well as for purposes such as weight loss, energy or body building. [NB: FDA has recorded very few adverse events with products marketed as euphorics.] Containing "natural" sources of ephedrine such as ma huang, ephedra, Ephedra sinica, or extracts of these substances, these compounds have been shown to have adverse effects such as headache, dizziness, palpitations, and possibly, clinically significant effects such as heart attack, stroke, seizures, and psychosis. The FDA considers marketing of these products, often aimed at adolescents looking for a "high," to be in violation of the Act, and is currently considering regulatory steps to ensure the safety of ephedrine-containing dietary supplements and what further action should be taken in this area.
Our ability to increase our understanding of the role of herbal remedies in medicine is hampered by deforestation, and the loss of knowledge held about plant therapies by indigenous people as the Amazon and other remote areas are developed. Activity in biodiversity is being supported by the NIH, the National Institute of Mental Health, the National Science Foundation, and the US Agency for International Development.2 Both the traditional medical community and the adherents of alternative therapy have called for increased research into this area.
Manual healing methods
The healer's touch has been considered a therapeutic instrument for the entire history of medicine, dating back to instructions by Hippocrates about therapeutic massage. Ancient Chinese medicine has strong roots in this system, and several areas of alternative medicine are associated with manual healing methods. The major fields of manual healing include (1) methods that use physical touch, manipulation, and pressure--chiropractic and osteopathic manipulation are primary examples; (2) therapies that use an "energy field" that can influence healing; and (3) mixed interventions that use both physical touch and energy field therapy.
Osteopathy
Osteopathic physicians derive their theories from the work of Andrew Taylor Still (1828-1917), a physician's son who was trained as an apprentice to his father. After the Civil War, he began an empirical study of healing by manipulating bones and soft tissues to allow the free circulation of blood and lymph, and to restore the nervous system to what he considered a more normal function. Known as the "lightning bone-setter," he disdained the common practices of physicians in the last century such as venesection, emesis, and sedation with narcotics, preferring to use manipulation to enhance the body's innate ability to heal itself. Instead of using drugs, he believed that the solution to illness lay in treating the underlying condition, allowing the body’s natural forces to return the patient to health. He proposed that much more than headache and back pain could be treated with manipulation, and set forth a regimen of therapy that included treatment for serious conditions such as pneumonia, dysentery, and typhoid fever.
The first school of osteopathy was opened in Missouri in 1892, teaching a variety of methods: manipulation of soft tissue, isometric and isotonic muscle techniques, manipulation with varying "velocity," the use of the percussion hammer to strike the body to alleviate "restrictions" in the joints and muscles that allowed internal processes to function normally, and other unorthodox therapies. Since that time, osteopathic education and its practitioners have become nearly indistinguishable from their allopathic cousins, with the exception of manipulation techniques that continue to be integral parts of osteopathic diagnostic and treatment modalities. Modern osteopathic physicians are considered to be in the mainstream of medical practice, with rigorous standards for education and specialty training. Osteopathic physicians commonly complete allopathic postgraduate specialty training, and are licensed to practice the full scope of medicine in all states, without restrictions. Some advocates of alternative medicine criticize modern osteopaths for abandoning the original scope and breadth of manipulation therapy.
Chiropractic
As with many systems in alternative medicine, chiropractic holds that the innate ability of the body to heal itself can be optimized by achieving a "balance"; that proper function of the nervous system is key to this homeostasis; that "subluxations" of the spine and misalignment of joints impinge on nerves, causing imbalance in internal systems; and that manual release of these structural and functional joint pathologies can heal a number of conditions, and prevent illness as well.12
The theories behind chiropractic have been widely criticized. A 1968 study by the US Department of Health, Education, and Welfare concluded that chiropractic schools did not prepare students to adequately diagnose and treat patients, and recommended that their services not be covered under Medicare.2,12 In 1972, Congress added Medicare benefits for "manual manipulation of the spine to correct a subluxation demonstrated to exist on x-ray." In 1974 the Council on Chiropractic Education was recognized to accredit schools of chiropractic, despite the absence of clear evidence of efficacy of chiropractic therapy.12 Over the years, bothpolitical pressure and consumer acceptance has won lincensure for chiropractic in all 50 states. Most of the nation's 45,000 chiropractors bill Medicare for services rendered, amounting to $181 million in 1990.12 Most third-party payors accept claims from chiropractors.
Manipulation has been shown to have a reasonably good degree of efficacy in ameliorating back pain, headache, and similar musculoskeletal complaints,13 and some chiropractors limit their practices to these conditions. While precise statistics are not available, a majority of chiropractors adhere to the method’s original theories, and continue to claim that chiropractic manipulation cures disease rather than simply relieving symptoms. (Personal communication, Denny Futch DC, Vice President, National Association of Chiropractic Medicine). They promote manipulation as useful in a host of conditions, ranging from infectious diseases to immune therapy, even claiming to prevent future conditions from occurring (even if years away) including menstrual irregularity, difficulty giving birth, and cancer.12 Chiropractors commonly provide advice in nutrition and other preventive practices, and maintain that a regular series of "adjustments" is needed by most persons to maintain optimal health.
Energy healing
Biofield, or energy healing, is described by its proponents as "one of the oldest forms of healing known to humankind."14 Theories related to this practice involve transfer of energy from healer to patient in unknown ways, either from a supernatural entity or by manipulating the body's own "energy fields." Over 25 terms are used in various cultures to describe this life force. Biofield practitioners incorporate a holistic focus into therapy, and promote their methods as useful for stress and general improvement of health; relief of pain, edema, and acceleration of wound and fracture healing; improvement in digestion, appetite, and various emotional states; and treatment of conditions such as eating disorders, irritable bowel syndrome, and pre-menstrual syndrome.
Some unique conditions are "diagnosed" by biofield practitioners, such as "accumulated tension" and "congested energy" that, when released, supposedly lead to improved health. A common form of this therapy is used by nurses, and is called "therapeutic touch." It involves moving the hands over (but not in direct contact with) the patient's body either to create a general state of well-being by enhancing "energy flow" in the subject, or to release "accumulated tension" and induce balance and harmony. At least one school of nursing has demanded that its faculty cease teaching these modalities as part of their curriculum (personal communication, John Renner, MD).
Therapies that combine manipulation and biofield therapy include "network chiropractic spinal analysis," which combines soft-tissue chiropractic and applications of the biofield, followed by conventional chiropractic treatment; "craniosacral therapy," an offshoot of osteopathic medicine involving manipulation of cranial and/or sacral bones to relieve "restrictions" in motion of these bones that are thought to help persons with seizures, immune disorders, learning disabilities, and assorted other conditions; and "polarity therapy," in which touch, energy field manipulation, and other modalities correct distortions in one's "energy anatomy."15
Pharmacologic methods
The area of pharmacologic treatment is rife with both opportunity and peril, since many of the modalities in unconventional medicine that use pharmacologic and biologic treatment may truly be deserving of clinical trials and well-funded investigation. At the same time, many therapies in this area represent true health fraud. Some areas under investigation include immunotherapies, including the use of antitumor antibodies; alternative strategies to treat menopausal conditions; the use of local anesthetic injection into autonomic ganglia and other sites, such as acupuncture points for chronic pain; and several cancer and HIV treatments.
Some methods proposed for study and further dissemination have been associated with proponents using questionable methods and possibly fraudulent research. Several of these are cancer therapies, including "antineoplastons," popularized by a physician named Burzynski who claims he can "normalize" tumor cells by shutting off their undifferentiated growth using peptides extracted from urine. A review of this method in JAMA15 concludes that no objective evidence exists to support the experimental claims.
Chelation with EDTA for heart disease and other cardiovascular conditions is another questionable practice in this category. Described by proponents as a nontoxic way to flush "toxins" and fatty deposits from the arterial system, it has also been touted for emphysema, kidney and endocrine disease, and arthritis. Ozone therapy has been advocated by alternative healers, as has intravenous hydrogen peroxide. Therapies involving bee pollen (and other products from bees) are in widespread use, with no scientific evidence for efficacy--but a Senator who attributed improvement in his health to bee pollen spurred the creation of the NIH Office of Alternative Medicine (OAM).
Investigators worry that the Internet has become a bazaar for alternative therapies, whose purveyors can use overseas addresses for distributing products that are not subject to any sort of scrutiny. There are now more than 100 commercial outlets for shark cartilage, a substance that is promoted for cancer treatment and prevention, arthritis, and a host of other ailments. Hormones such as DHEA (dihydroepiandosterone) get Internet claims for extending life, normalizing blood sugar and cholesterol, and sexual enhancement. Colloidal silver is said to be a "safe natural antibiotic" that "kills 650 disease causing organisms." Asparagus extract is said to "restrain and prevent metastasis of middle as well as late stage tumors," and the list goes on, with hundreds of alternative medicine home pages and links to mail order firms.17
Proponents of alternative pharmacotherapy argue that proper funding, well-organized trials, and modifications in FDA regulations for experimental therapy will help these therapies get a "fair hearing" by the traditional medical community. On the other hand, they have requested immunity from the FDA and other regulatory oversight, protecting investigators from fraud and licensing actions, raids, seizure of materials, import alerts, and other interventions for all clinical trials endorsed by the OAM.18
continued
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alternative medicine the medical/scientific literature
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III. Alternative Systems of Practice
Several distinct systems of alternative practice encompass many of the theories and methods described above.
Acupuncture
Acupuncture is an ancient technique with its origins in traditional Chinese medicine. The internal study of the body was forbidden in China, so structural anatomy as defined by dissection was unknown. Twelve organs, or "spheres of function," were thought present, having minimal equivalency to anatomic definitions used in Western medicine. Body function was described in theories of energy flow, orch'i, from one organ to another. Each of these organs is described as having a superficial "meridian" with many numbered points, originally derived from Chinese astrologic calculations. By inserting needles into these points, acupuncturists believe energy flows can be manipulated or imbalance corrected, resulting in therapeutic effects on corresponding internal systems.
Western practitioners have increasingly begun to use acupuncture, but many may not be using techniques that correspond to traditional Chinese teaching. The American Academy of Medical Acupuncture is a group of more than 700 physicians who offer training and continuing medical education, and set "standards of practice" regarding use of these techniques in medical practice. Most often, acupuncture is used for acute or chronic pain relief, but some proponents also use it for smoking cessation and substance abuse treatment, asthma, arthritis, and other conditions. Endorphin release, stimulation of the peripheral nervous system, and pain mediation through the effects of other neuropeptides are currently thought to be the most likely conventional explanations for the effects of acupuncture.
Several variations on the general theme exist, including the use of heated needles, passing low-voltage current into the acupuncture point, and applying lasers to acupuncture points. Proponents from different traditions (i.e., Korean vs. Chinese) often disagree as to the "correct" location of acupuncture points for treating a given condition. Recently, the FDA reclassified acupuncture needles as devices that do not require clinical studies, thus easing requirements for marketing. Critics contend that acupuncturists, including many traditionally trained physicians, merely stick needles in patients as a way to offer another form of treatment for which they can be reimbursed, since many insurance companies will do so. Critical reviews of acupuncture summarized by Hafner4 and others19 conclude that no evidence exists that acupuncture affects the course of any disease.
Homeopathy
Homeopathy was begun in the early 1800s by Samuel Hahnemann (1755-1843), a traditionally trained German physician who renounced the practices of the day, such as bleeding and purging, taking an approach based in not inflicting harm. He studied the effect of drugs of the day on the body, and devised a new series of rules for their testing and later, their application. His primary theory is the "Law of Similars"--"like cures like." Coining the term homeopathy, he proposed that small amounts of a substance that could induce a set of symptoms in a patient could cure a disease with similar symptoms. This evolved into a highly structured, complex set of pharmacologic interventions or "provings" with formulation and administration of extremely dilute concentrations of substances and drugs, based in the "Law of Infinitesimals." Homeopaths believe that even extreme dilutions of a drug will have a salutary effect, and that the molecular structure of the diluent is somehow changed in the process of preparation, by vigorous shaking and striking the side of the flask containing the preparation. Then, the "memory" of the original drug is carried on even when, after multiple dilutions, none of the original substance could be theoretically present. Careful attention to the total history of the patient was emphasized, and the use of a single homeopathic remedy for a given condition or set of complaints was taught, based on detailed observations of the effects of these preparations.
Introduced into the United States in 1828, homeopathy spread and competed with traditional medicine, with results that were at least as favorable as bleeding and other customs of the day. By the turn of the century more than 14,000 homeopaths had been trained, and 22 schools taught the theory in the United States. As mentioned previously, advances in medical education, scientific theory, and pressure from organized medicine led to the decline of homeopathy. In 1938, a homeopath in the US Senate, Royal Copeland (D-NY), succeeded in giving homeopathic remedies legal status, adding the drugs found in the Homeopathic Pharmacopeia of the United States to the list of articles that the FDA recognizes as drugs. This automatically designated these drugs as "safe," although their efficacy was never proven.
Today, homeopathy is practiced mostly by persons licensed as physicians or holding another license allowing the prescription of drugs. Some lay healers use homeopathy, and homeopathic remedies abound in health food stores and many supermarkets that feature "organic" products. Some homeopathic healers continue the tradition of extensive patient interviews and the use of a single substance as instructed by Hahnemann's original treatises; others use several compounds simultaneously, and add other modalities to their range of treatments, such as massage and skeletal manipulation, acupuncture, and aromatherapy.
While most homeopathic remedies are not known to have harmed anyone (probably because of the extreme dilutions involved), the efficacy of most homeopathic remedies has not been proven. Some think it a placebo effect, augmented by the concern expressed by the healer; others propose new theories based on quantum mechanics and electromagnetic energy.
A randomized clinical trial of homeopathic remedies has been touted as showing the effectiveness of homeopathic treatments in childhood diarrhea.20 However, it has been criticized for inconsistent/incorrect data analysis; use of different diagnostic and treatment categories but combining them in the conclusions of efficacy; and lack of chemical analysis of different treatments. The clinical significance of the results, given the self-limiting condition being studied, has been called into question.21
Homeopathy's adherents propose new trials of these therapies, systematic review of standard pharmacologic agents subjected to homeopathic dilutions and therapeutic application, and investigation into clinical outcomes following homeopathic treatment.
Naturopathy
Naturopathy is a term coined by John Scheel in 1895 to describe his methods of healing. A poorly developed set of principles and theories, naturopathy may have its roots in the spas of Europe that flourished at the turn of the century. About 20 schools of naturopathy were present in the United States in the early 1900s. The Flexner report and other pressures led to its decline. It never had the political and professional stature of other alternative methods, and until recently, education in naturopathy was available only through schools of chiropractic.
Currently, three naturopathic colleges have been accredited by the profession, led by Bastyr University in Seattle. Naturopathy is a four-year course of study that involves two years of anatomy, physiology, and basic sciences, and two years of applied courses. Naturopaths practice various treatments such as manipulation and massage, and use herbs, acupuncture, and traditional Oriental medicine. Its practitioners treat underlying causes of illness by facilitating the body's response to disease through its "life force." Questionable therapy such as prescriptions of colonic irrigation, and chelation therapy to "remove toxins" presumed present in the body are commonly used by naturopaths. Some naturopaths use "diagnostic" techniques such as iridology hair shaft analysis. Naturopaths are licensed in 11 states, but most third-party payors, including Medicare, do not cover their services. Recently, the King County, WA, governing council voted to subsidize a naturopathic clinic operated by Bastyr.
Ayurveda
Ayurveda is a mind-body set of beliefs and principles that has its roots in ancient India, and has been practiced for over 5000 years. Disease is thought to arise from imbalance or stress in an individual’s conciousness, and is exacerbated by unhealthy lifestyles. Three doshas determine one’s unique "body type," and combined with diagnostic readings of the radial pulse, guides the healer to determinations of dysfunction and corresponding treatment.
Specific lifestyle and dietary interventions are prescribed, as well as measures to rid the body of certain toxins and metabolic byproducts that are thought to accumulate, to the detriment of the body. Meditation, exercise, herbal oil massage, and other therapy are promoted, much of which is proprietary and marketed commercially.
Folk therapies
Besides traditional Oriental medicine, other cultural systems within the United States use folk treatment and rely to at least some extent on self-care remedies. Some of the healers are shamanistic and blend religion with their efforts to heal, such as in Native American healing ceremonies or in Latin American and Caribbean culture. For physicians practicing in areas with significant ethnic populations, knowledge of these folk beliefs and cultural sensitivity in history-taking, physical examination, and instruction may enhance clinical interactions. Practitioners of traditional Chinese medicine use acupuncture, a host of herbal remedies, and sometimes include substances derived from sources such as the gallbladder of bears, tiger teeth and bones, and rhinoceros horn, increasing the hazards facing these endangered species.
The Office of Alternative Medicine (OAM)
Because of the high prevalence of use of alternative medicine in the United States, Congress passed legislation in 1991 that created the OAM at the NIH, with a directive to begin a program of research on alternative therapies. Its purpose is to "coordinate and support evaluations and investigations that assess the scientific validity, clinical usefulness, and theoretical implications of health care practices that prevent or alleviate suffering or promote healing."
An initial budget of $2 million has grown to $5.4 million for FY 1995 and $11.1 million for FY 1997. The OAM is funding a wide variety of investigator-initiated grant projects and creating a clearinghouse for information on alternative medical practices. Ten centers for research in complementary and alternative medicine have been funded with grants of about $1 million each, to study specific health conditions, including cancer and women's health issues. Each center will develop a program infrastructure, establish research priorities, conduct small "collaborative research projects" within the first year or two, propose larger research projects for future funding, and create systematic reviews of specified areas of alternative medicine using rigorous standards.
The OAM is also re-evaluating its database and its methods for research development, including controlled trials of alternative therapies. As its evaluation director Carole Hudgings, PhD, states in the OAM's October 1996 newsletter, "...it is important that the scientific rigor applied in conventional medicine also be applied to complementary and alternative practices."
Critics of the OAM wonder why the NIH is putting its imprimatur on some of the more questionable alternative techniques, pointing out that doing so allows practitioners of such therapy to cloak themselves in legitimacy by such an association, claiming (often correctly) that their methods are "under study" at OAM. Initially, no rules were set up to guard against conflicts of interest by panel members, or to prevent them from using their panel membership in self-promotion.22 As previously mentioned, proponents of alternative therapy make no secret of their desire to use OAM sanction to obtain freedom from regulatory oversight.
In an essay in the New York Times, two university scientists who discuss the OAM conclude, "Should there be an Office of Alternative Medicine to evaluate unconventional practices? Not one that elevates magical notions to matters of serious scientific debate. ...It is important to distinguish these experiences [such as kindness or sunsets] from claims that ignore natural law."23 Under its new director, it may be that the OAM will address these areas to the satisfaction of its critics.
The context of alternative medicine
In a national survey, at least one-third of persons claimed to have used at least one alternative therapy in the past year, and one-third of these persons saw a provider of alternative medical therapy. Among those using an unconventional healer, 83% also saw a medical doctor for the same condition, but nearly 75% of them did not report the use of alternative care to their traditional physician. The survey data estimated that in 1990 the out-of-pocket cost of unconventional therapy in the United States, including the cost of herbal medicines and health food/nutrition therapy, exceeded $10 billion. Another $3 billion of these costs were borne by third-party payors. The total estimated cost, $13.7 billion, exceeds the cost of hospital care in the United States in 1990 ($12.8 billion) and is about half of all the out-of-pocket expenses to physician services ($23.5 billion). The authors suggest that the total number of annual visits to alternative practitioners may exceed those to primary care physicians.25
The Oxford Health Plan, based in Norwalk, CT, is currently adding a network of about 1,000 holistic providers from which plan participants will be able to obtain chiropractic, acupuncture, and naturopathic treatment without prior approval of a "gatekeeper" at a cost of 2% to 3% added to the premium. Plan managers may believe that alternative therapies can decrease costs by decreasing utilization of conventional services. However, the Eisenberg study showed that the cost of alternative therapies averaged $27 per provider visit, and totaled over $500/year among those who used alternative methods, who usually sought simultaneous care from conventional physicians.25 The Oxford group has instituted several advisory committees to determine the "highest quality" of alternative practitioners, and plans to obtain feedback from patient encounters to monitor the type of treatments offered for different complaints. Quality-control committees will gauge appropriateness of care and whether the modality used lies within the scope of practice of the alternative therapist. They also hope to conduct outcomes research on this project. This new venture may have the effect of shifting the burden of seeking effective diagnosis and treatment to the consumer, since the plan has no clear idea whether most of the alternative treatments have any credibility besides that being claimed by proponents.
In an editorial, Campion24 cites several reasons for the public's "expensive romance with unconventional medicine." People have easy access to many options in medical care; disaffection with traditional care is widespread, fueled by media accounts of medical misadventures and uncaring managed care institutions; alternative practitioners often give people more time and attention than traditional providers; people want to feel in control of their bodies; and most of all, they want to feel well.
Americans seek alternative care for a wide variety of conditions. In one national study, the most common complaints presented to unconventional practitioners were back complaints (36%), anxiety (28%), headache (27%), chronic pain (26%), and cancer or tumors (24%). About one-third of patients in the same survey reported using alternative healers for health promotion and disease prevention advice, or for nonserious conditions not related to their chief complaint.25 A Canadian survey found that about 11% of children also attending a pediatric outpatient clinic in Quebec had been taken to chiropractic, homeopathic, naturopathic, and acupuncture practitioners, mostly for respiratory and ear-nose-throat problems. Parents assumed these treatments to be more "natural," and to have fewer side effects, but did not seek alternative therapy to receive more "personalized" care.26
Alternative therapy for cancer treatment has attracted much attention. Recent surveys show that from 3%25 to 9%27 of patients with cancer sought alternative methods of treatment for cancer. Older surveys with smaller data bases found higher usage rates, showing that 13%28 to about 50% of patients with cancer sought alternative treatments.29 That nearly half of all cancer patients have sought or seriously considered unconventional cancer therapy has been reported widely in the lay press as well, and adds to the perception that such practices are quite common and might be useful. Many cancer patients change diet, use multivitamin therapy, take shark cartilage, Chinese herbs, homeopathic pellets, and such therapies as mistletoe or mushroom extract with the expectation that their disease will be mitigated. The whole gamut of unconventional therapists is utilized by cancer patients, ranging from acupuncturists to Gestalt therapists.
Buckman30 points out that reports of success for many of the therapies being embraced by the public may be explained in several ways. The "cures" may have come from misdiagnosis, and when the anecdotes of healing are traced to the original sources, no data can be found. Patients may not have had the diagnosis for which they were "cured" or the data may have been falsified or misinterpreted by the healer. They may have experienced self-limiting or fluctuating illnesses, remission of which was wrongly attributed to the alternative treatment. After therapy, patients may not have been followed long enough to accurately assess cure or observe relapses. Concurrent conventional therapy is often being taken by patients who undergo alternative treatments, with inappropriate credit given to the unconventional method. Finally, misinterpretation of information by patients who believe themselves miraculously cured is often at the core of their success story. However, he points out that some of the clinical trials examining different areas of alternative therapy have raised enough questions to make further investigation of these methods desirable, in order to help answer the essential question in this debate: do these methods merely make one feel better, or do they really help one get better?
It is also interesting that in one survey of patients with cancer,27 patients claimed little opposition by their physicians in seeking such care, but their physicians reported these encounters differently. Patients reported that their physicians recommended or approved their use of unconventional therapy 50% of the time, and 31% cited the physician as the source of information about alternative methods. Forty percent of patients in this group reportedly abandoned traditional therapy after finding alternative care. In the same study, 52% of physicians who treated this group of patients reportedly objected to unorthodox treatments, and only 2% said they had recommended such treatment, although 37% said they "went along with" the patients. Patients did not tell physicians about their alternative cancer care 35% of the time.
Other surveys report that for all uses of alternative medicine, up to 70% of patients may not reveal their use of unconventional treatment to their physician.25 The former director of the OAM, Joseph Jacobs, MD, states that this lack of communication between doctor and patient about the use of alternative therapies "creates a very real challenge to the medical community, because not being able to understand what many [patients] are using outside of the medical mainstream presents a real barrier to good clinical care."31
On the other hand, many patients in the AIDS community, for example, have become quite vocal about the need for research in alternative medicine because they think many patients are being deceived by proponents of untested therapy, and have appealed to the OAM and others for definitive answers about unconventional AIDS treatments being offered.31
What do physicians think about alternative medicine? It is likely that most physicians are unaware of the scope, breadth, and extent of use of unconventional therapies in the United States.1 The level of interest among physicians in learning more about alternative therapy, however, seems to be high. A regional survey of family physicians in the Chesapeake Bay area showed that more than 70% were interested in training in such practices as herbal medicine, prayer therapy, acupressure, vegetarian and megavitamin diet therapy, acupuncture, and biofeedback.32 The results of this study, however, are curious in that 26% of respondents claim to have had training in chiropractic methods, 22% in acupuncture, and nearly 10% report training in traditional Oriental or Native American medicine. While informal training courses in these areas may be available, the scientific basis for such instruction is weak to nonexistent, and not usually accredited by specialty societies or traditional organized medical associations that govern continuing medical education. It would be most unusual if over 20% of family physicians in this area actually use chiropractic in their practice.
In a national survey of referral patterns by board-certified family physicians and internists, 94% indicated willingness to refer for at least one alternative therapy, 90% for at least two, 85% at least three, 77% at least four, and 66% at least five such modalities. The list of therapies for which these physicians expressed a willingness to refer patients included: relaxation techniques-86%, biofeedback-85%, therapeutic massage-66%, hypnosis-63%, acupuncture-56%, and meditation-54%. By contrast, 47% said they would refer for chiropractic, 24% for "spiritual" healing, 15% for homeopathy, 14% for energy healing, and 6% would refer for megavitamin or herbal therapy. In the same survey, 22% of respondents reported personally providing relaxation therapy, 17% "lifestyle diet (vegetarian, macrobiotic, etc.)," 5% hypnosis, 3% massage or chiropractic therapy, and 1% homeopathic or acupuncture therapies.33
The authors of the Chesapeake Bay study32 cite surveys of physicians in Great Britain, Israel, and New Zealand that show "similar interest" in studying alternative medicine. A more recent meta-analysis of European physicians and their attitudes about alternative medicine shows that on average, physicians view complementary medicine to have an "effectiveness rating" of 46+ 18 on a scale of 0-100. There was no trend among these data to suggest increasing endorsement of alternative medicine by conventional practitioners, but the authors conclude that European physicians give these therapies a "considerable degree of acceptance."34 They caution, however, that the perceived usefulness of such therapies by physicians or the public should not be equated with proven efficacy.
Many persons who are proponents of alternative medicine understand and acknowledge the role of traditional Western medicine for such problems as surgical intervention for appendicitis and fractures, or antibiotic therapy for specific infectious diseases. However, many in the alternative medical community spend a good deal of energy denigrating the role of allopathic intervention as dangerous, expensive, and impersonal. In the "deconstructionist" mode, they often change the vocabulary to make their methods seem rational and reasonable. In a critique of alternative medicine, Wallace Sampson, MD, points out that an editorial in Alternative Therapies poses:
"a non sequitur: present knowledge is adequate to dismiss the utility of most alternative methods; but [the editorial claims] there are ineffable qualities that [conventional] methods cannot detect and alternatives cannot define; therefore, alternative methods must be accepted, their practitioners licensed, and their services paid for by public funds and health insurance."35
In an unpublished survey of all 125 US medical schools, Sampson has found that just over 50 schools offer elective, for-credit courses on alternative therapy, and 18 other schools offer lecture series or seminars on the subject. His survey reveals that most are being given by "supporters or proponents of alternative methods," and that the "scientific view" is offered in only 7 courses.
In an editorial,36 Alpert argues that alternative medicine should not be "condemned out of hand," but suggests that traditional medicine approach alternative therapy based on five principles. Convinced that many unconventional treatments will eventually become mainstream, he proposes that physicians:
Maintain an open-minded attitude about all potentially new therapeutic interventions that include those commonly referred to as alternative.
Encourage carefully performed and appropriately controlled studies of these new therapies.
Do not ignore or ridicule the potential of the placebo effect to produce marked therapeutic benefit.
Do not accept all new therapies as efficacious on first acquaintance. Practitioners of quack medicine continue to abound as in all earlier times. Claims of therapeutic efficacy should be rationally examined and tested.
Avoid hubristic and arrogant attitudes toward alternative medical practices because one might be embarrassed by the subsequent demonstrations of their clinical efficacy.
Alpert says that these statements are guiding the University of Arizona as it sets up a program to "integrate and evaluate valuable alternative medical practices into routine allopathic care." Andrew Weil, MD, who has written several books on alternative medicine, is heading the new program.
It is clear that in the quest for wellness, the public is seeking new approaches to medical care. Some of the reasons may be understandable, such as the desire to find a healer with time to listen, to receive compassionate care, and to establish a partnership with a provider in seeking health.
In "Turning From Science and Reason," an address at the 1996 AMA National Leadership Conference, Jeremiah Barondess, MD, stated that many physicians may not deal effectively enough with illness, elements he identifies as those symptoms, anxieties, and concerns that make people feel sick, as opposed to our emphasis on disease, defined too often in biochemical and molecular terms that are far removed from the person being examined. Patients, he says, are increasingly taking more responsibility for their own health. Many are disaffected with medicine in general, as part of a trend of public suspicion of authoritarian, insular sections of society.
Some of the interest in alternative medicine may be due to an "outbreak of irrationalism" that includes New Age interest in "channeling" and astrology.37 Television talk shows and the proliferation of books and tapes on alternative therapies are gobbled up by an uncritical public that does not understand how to sort quack theories from what might be reasonable. Carl Sagan has recently lamented the phenomenon of our increasing scientific illiteracy and the rise of pseudoscience and superstition, noting that "baloney, bamboozles, careless thinking, and wishes disguised as fact...ripple through mainstream political, social, religious, and economic issues in every nation."40
Political decisions allow licensing of alternative practitioners without any scientific basis for accreditation of their schools or the methods used by their practitioners. Congress has recently dismantled its own scientific oversight section, the Office of Technology Assessment. Political pressure from the health food and vitamin supplement industry has hampered the FDA's ability to monitor their products, and legislative proposals have been advanced to allow such products to be covered by food stamps--in effect, paying for pills instead of food.38 There is, indeed, reason for concern.
Given the growing interest in alternative medicine by the public, accurate, even-handed education about alternative medicine is vital for both the public as well as for physicians, who should be familiar with unconventional therapies and be able to advise patients on their use. Sound, good quality research is needed to determine the potential benefits and avoid the risks inherent in unconventional therapy.
RECOMMENDATIONS
The following statements, recommended by the Council on Scientific Affairs, were adopted as AMA Policy at the 1997 AMA Annual Meeting.
There is little evidence to confirm the safety or efficacy of most alternative therapies. Much of the information currently known about these therapies makes it clear that many have not been shown to be efficacious. Well-designed, stringently controlled research should be done to evaluate the efficacy of alternative therapies.
Physicians should routinely inquire about the use of alternative or unconventional therapy by their patients, and educate themselves and their patients about the state of scientific knowledge with regard to alternative therapy that may be used or contemplated.
Patients who choose alternative therapies should be educated as to the hazards that might result from postponing or stopping conventional medical treatment.
Courses offered by medical schools on alternative medicine should present the scientific view of unconventional theories, treatments, and practice as well as the potential therapeutic utility, safety, and efficacy of these modalities.
References
Murray RH, Rubel AJ. Physicians and healers--unwitting partners in healthcare. N Engl J Med. 1992;326:61-645.
Dossey L, Swyers JP. Introduction to Alternative Medicine: Expanding Medical Horizons. Washington, DC: US Government Printing Office; 1994. NIH 94-066.
Renner JH. Health Smarts. Kansas City, Missouri:HealthFacts Publishing; 1990.
Hafner AW. Reader's Guide to Alternative Health Methods. Chicago:American Medical Association; 1992.
Coleman C. Herbal healing. Associated Press. Daily Herald, Chicago, Illinois. February 1, 1996: Section 4, p.1-2.
Tyler VE. The overselling of herbs. In: Barrett S, Jarvis WT, eds. The Health Robbers. Buffalo, NY:Prometheus Books, 1993.
Vautier G, Spiller RC. Safety of complementary medicines should be monitored. BMJ. 1995;311:633.
Linde K, Ramirez G, Mulrow CD, et al. St. John's wort for depression--an overview and meta-analysis of randomized controlled trials. BMJ. 1996;313:352-358.
DeSmet P, Nolen WA. St. John's wort as an antidepressant. BMJ. 1996;313:241-242.
Pizzorno JE. Ten drugs I would never take. Natural Health. September-October 1996; 84-85, 142-148.
Tyler V. Herbal remedies. J Pharm Technol. 1995;11:214-220.
Barrett S. The spine salesmen. In: Barrett S, Jarvis WT, eds. The Health Robbers. Buffalo, NY:Prometheus Books; 1993.
Bigos S, Bowyer O, Braen G, et al. Acute low back problems in adults. Clinical Practice Guideline. Quick Reference Guide Number 14. Rockville, MD: US Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research AHCPR Pub. No.95-0643. December 1994.
Brennan B, Rosner A, Demmerle A, et al. Manual healing methods. In: Alternative Medicine: Expanding Medical Horizons. Washington, DC: US Government Printing Office; 1994. NIH 94-066.
Brennan B, Rosner R, et al. Manual healing methods. In: Alternative Medicine: Expanding Medical Horizons. Washington, DC: US Government Printing Office; 1994. NIH 94-066.
Green S. "Antineoplastons": an unproven cancer therapy. JAMA. 1992;267:2924-2928.
Bower H. Internet sees growth of unverified health claims. BMJ. 1996;313:381.
Moss RW, Wiebel FD, et al. Pharmacologic and biological treatments. In: Alternative Medicine: Expanding Medical Horizons. Washington, DC: US Government Printing Office; 1994. NIH 94-066.
Taub A. Acupuncture: nonsense with needles. In:Barrett S, Jarvis WT, eds. The Health Robbers. Buffalo, NY:Prometheus Books; 1993.
Jacobs J, Jimenez LM, Gloyd SS, et al. Treatment of acute childhood diarrhea with homeopathic medicine: a randomized clinical trial in Nicaragua. Pediatrics. 1994;93:719-725.
Sampson W, London W. Analysis of homeopathic treatment of childhood diarrhea. Pediatrics. 1995;96:961-964.
Skolnick A. Science reporters hear wide range of data at 12th annual conference. JAMA. 1993;270:2416.
Park RL, Goodenough U. Buying snake oil with tax dollars. New York Times. January 3, 1996 A-15.
Campion EW. Why unconventional medicine? N Engl J Med. 1993;328:282-283.
Eisenberg DM, Kessler RC, Foster C, et al. Unconventional medicine in the United States. N Engl J Med. 1993;328:246-52.
Spigelblatt L, Laine-Ammara G, Pless IB, Guyver A. The use of alternative medicine by children. Pediatrics. 1994;94:811-814.
Lerner IJ, Kennedy BJ. The prevalence of questionable methods of cancer treatment in the United States. CA-Cancer J Clinicians. 1992;42:181-190.
Cassileth BR, Lusk EJ, Strouse TB, et al. Contemporary unorthodox treatment in cancer medicine: a study of patients, treatments, and practitioners. Ann Intern Med. 1984;101:105-112.
Cassileth BR. Unorthodox cancer medicine. Cancer Invest. 1986;4:591-598.
Buckman R, Sabbagh K. Magic or Medicine? An Investigation of Healing and Healers. New York, NY:Prometheus Books; 1995.
Jacobs J. Presentation to AMA Council on Scientific Affairs. September 8, 1996.
Berman BM, Singh BK, Lao L, et al. Physicians' attitudes toward complementary or alternative medicine: a regional survey. J Am Board Fam Pract. 1995; 8:361-366.
Blumberg DL, Grant WD, Hendricks SR, Kamps CA, Dewan MJ. The physician and unconventional medicine. Alternative Therapies. 1996;1:31-35.
Ernst E, Resch KL, White AR. Complementary medicine. what physicians think of it: a meta-analysis. Arch Intern Med. 1995;155:2405-2408.
Sampson W. Antiscience trends in the rise of the "alternative medicine" movement. Ann NY Acad Sci. 1996;775:188-197.
Alpert JS. The relativity of alternative medicine. Arch Intern Med. 1995;155:2385.
Krauthammer C. The return of the primitive. Time. January 20, 1996:82. Essay.
Skolnick A. Experts debate food stamp revision. JAMA. 1995;274:781-783.
Sagan C. The Demon-haunted World: Science as a Candle in the Dark. New York, NY:Random House; 1995
III. Alternative Systems of Practice
Several distinct systems of alternative practice encompass many of the theories and methods described above.
Acupuncture
Acupuncture is an ancient technique with its origins in traditional Chinese medicine. The internal study of the body was forbidden in China, so structural anatomy as defined by dissection was unknown. Twelve organs, or "spheres of function," were thought present, having minimal equivalency to anatomic definitions used in Western medicine. Body function was described in theories of energy flow, orch'i, from one organ to another. Each of these organs is described as having a superficial "meridian" with many numbered points, originally derived from Chinese astrologic calculations. By inserting needles into these points, acupuncturists believe energy flows can be manipulated or imbalance corrected, resulting in therapeutic effects on corresponding internal systems.
Western practitioners have increasingly begun to use acupuncture, but many may not be using techniques that correspond to traditional Chinese teaching. The American Academy of Medical Acupuncture is a group of more than 700 physicians who offer training and continuing medical education, and set "standards of practice" regarding use of these techniques in medical practice. Most often, acupuncture is used for acute or chronic pain relief, but some proponents also use it for smoking cessation and substance abuse treatment, asthma, arthritis, and other conditions. Endorphin release, stimulation of the peripheral nervous system, and pain mediation through the effects of other neuropeptides are currently thought to be the most likely conventional explanations for the effects of acupuncture.
Several variations on the general theme exist, including the use of heated needles, passing low-voltage current into the acupuncture point, and applying lasers to acupuncture points. Proponents from different traditions (i.e., Korean vs. Chinese) often disagree as to the "correct" location of acupuncture points for treating a given condition. Recently, the FDA reclassified acupuncture needles as devices that do not require clinical studies, thus easing requirements for marketing. Critics contend that acupuncturists, including many traditionally trained physicians, merely stick needles in patients as a way to offer another form of treatment for which they can be reimbursed, since many insurance companies will do so. Critical reviews of acupuncture summarized by Hafner4 and others19 conclude that no evidence exists that acupuncture affects the course of any disease.
Homeopathy
Homeopathy was begun in the early 1800s by Samuel Hahnemann (1755-1843), a traditionally trained German physician who renounced the practices of the day, such as bleeding and purging, taking an approach based in not inflicting harm. He studied the effect of drugs of the day on the body, and devised a new series of rules for their testing and later, their application. His primary theory is the "Law of Similars"--"like cures like." Coining the term homeopathy, he proposed that small amounts of a substance that could induce a set of symptoms in a patient could cure a disease with similar symptoms. This evolved into a highly structured, complex set of pharmacologic interventions or "provings" with formulation and administration of extremely dilute concentrations of substances and drugs, based in the "Law of Infinitesimals." Homeopaths believe that even extreme dilutions of a drug will have a salutary effect, and that the molecular structure of the diluent is somehow changed in the process of preparation, by vigorous shaking and striking the side of the flask containing the preparation. Then, the "memory" of the original drug is carried on even when, after multiple dilutions, none of the original substance could be theoretically present. Careful attention to the total history of the patient was emphasized, and the use of a single homeopathic remedy for a given condition or set of complaints was taught, based on detailed observations of the effects of these preparations.
Introduced into the United States in 1828, homeopathy spread and competed with traditional medicine, with results that were at least as favorable as bleeding and other customs of the day. By the turn of the century more than 14,000 homeopaths had been trained, and 22 schools taught the theory in the United States. As mentioned previously, advances in medical education, scientific theory, and pressure from organized medicine led to the decline of homeopathy. In 1938, a homeopath in the US Senate, Royal Copeland (D-NY), succeeded in giving homeopathic remedies legal status, adding the drugs found in the Homeopathic Pharmacopeia of the United States to the list of articles that the FDA recognizes as drugs. This automatically designated these drugs as "safe," although their efficacy was never proven.
Today, homeopathy is practiced mostly by persons licensed as physicians or holding another license allowing the prescription of drugs. Some lay healers use homeopathy, and homeopathic remedies abound in health food stores and many supermarkets that feature "organic" products. Some homeopathic healers continue the tradition of extensive patient interviews and the use of a single substance as instructed by Hahnemann's original treatises; others use several compounds simultaneously, and add other modalities to their range of treatments, such as massage and skeletal manipulation, acupuncture, and aromatherapy.
While most homeopathic remedies are not known to have harmed anyone (probably because of the extreme dilutions involved), the efficacy of most homeopathic remedies has not been proven. Some think it a placebo effect, augmented by the concern expressed by the healer; others propose new theories based on quantum mechanics and electromagnetic energy.
A randomized clinical trial of homeopathic remedies has been touted as showing the effectiveness of homeopathic treatments in childhood diarrhea.20 However, it has been criticized for inconsistent/incorrect data analysis; use of different diagnostic and treatment categories but combining them in the conclusions of efficacy; and lack of chemical analysis of different treatments. The clinical significance of the results, given the self-limiting condition being studied, has been called into question.21
Homeopathy's adherents propose new trials of these therapies, systematic review of standard pharmacologic agents subjected to homeopathic dilutions and therapeutic application, and investigation into clinical outcomes following homeopathic treatment.
Naturopathy
Naturopathy is a term coined by John Scheel in 1895 to describe his methods of healing. A poorly developed set of principles and theories, naturopathy may have its roots in the spas of Europe that flourished at the turn of the century. About 20 schools of naturopathy were present in the United States in the early 1900s. The Flexner report and other pressures led to its decline. It never had the political and professional stature of other alternative methods, and until recently, education in naturopathy was available only through schools of chiropractic.
Currently, three naturopathic colleges have been accredited by the profession, led by Bastyr University in Seattle. Naturopathy is a four-year course of study that involves two years of anatomy, physiology, and basic sciences, and two years of applied courses. Naturopaths practice various treatments such as manipulation and massage, and use herbs, acupuncture, and traditional Oriental medicine. Its practitioners treat underlying causes of illness by facilitating the body's response to disease through its "life force." Questionable therapy such as prescriptions of colonic irrigation, and chelation therapy to "remove toxins" presumed present in the body are commonly used by naturopaths. Some naturopaths use "diagnostic" techniques such as iridology hair shaft analysis. Naturopaths are licensed in 11 states, but most third-party payors, including Medicare, do not cover their services. Recently, the King County, WA, governing council voted to subsidize a naturopathic clinic operated by Bastyr.
Ayurveda
Ayurveda is a mind-body set of beliefs and principles that has its roots in ancient India, and has been practiced for over 5000 years. Disease is thought to arise from imbalance or stress in an individual’s conciousness, and is exacerbated by unhealthy lifestyles. Three doshas determine one’s unique "body type," and combined with diagnostic readings of the radial pulse, guides the healer to determinations of dysfunction and corresponding treatment.
Specific lifestyle and dietary interventions are prescribed, as well as measures to rid the body of certain toxins and metabolic byproducts that are thought to accumulate, to the detriment of the body. Meditation, exercise, herbal oil massage, and other therapy are promoted, much of which is proprietary and marketed commercially.
Folk therapies
Besides traditional Oriental medicine, other cultural systems within the United States use folk treatment and rely to at least some extent on self-care remedies. Some of the healers are shamanistic and blend religion with their efforts to heal, such as in Native American healing ceremonies or in Latin American and Caribbean culture. For physicians practicing in areas with significant ethnic populations, knowledge of these folk beliefs and cultural sensitivity in history-taking, physical examination, and instruction may enhance clinical interactions. Practitioners of traditional Chinese medicine use acupuncture, a host of herbal remedies, and sometimes include substances derived from sources such as the gallbladder of bears, tiger teeth and bones, and rhinoceros horn, increasing the hazards facing these endangered species.
The Office of Alternative Medicine (OAM)
Because of the high prevalence of use of alternative medicine in the United States, Congress passed legislation in 1991 that created the OAM at the NIH, with a directive to begin a program of research on alternative therapies. Its purpose is to "coordinate and support evaluations and investigations that assess the scientific validity, clinical usefulness, and theoretical implications of health care practices that prevent or alleviate suffering or promote healing."
An initial budget of $2 million has grown to $5.4 million for FY 1995 and $11.1 million for FY 1997. The OAM is funding a wide variety of investigator-initiated grant projects and creating a clearinghouse for information on alternative medical practices. Ten centers for research in complementary and alternative medicine have been funded with grants of about $1 million each, to study specific health conditions, including cancer and women's health issues. Each center will develop a program infrastructure, establish research priorities, conduct small "collaborative research projects" within the first year or two, propose larger research projects for future funding, and create systematic reviews of specified areas of alternative medicine using rigorous standards.
The OAM is also re-evaluating its database and its methods for research development, including controlled trials of alternative therapies. As its evaluation director Carole Hudgings, PhD, states in the OAM's October 1996 newsletter, "...it is important that the scientific rigor applied in conventional medicine also be applied to complementary and alternative practices."
Critics of the OAM wonder why the NIH is putting its imprimatur on some of the more questionable alternative techniques, pointing out that doing so allows practitioners of such therapy to cloak themselves in legitimacy by such an association, claiming (often correctly) that their methods are "under study" at OAM. Initially, no rules were set up to guard against conflicts of interest by panel members, or to prevent them from using their panel membership in self-promotion.22 As previously mentioned, proponents of alternative therapy make no secret of their desire to use OAM sanction to obtain freedom from regulatory oversight.
In an essay in the New York Times, two university scientists who discuss the OAM conclude, "Should there be an Office of Alternative Medicine to evaluate unconventional practices? Not one that elevates magical notions to matters of serious scientific debate. ...It is important to distinguish these experiences [such as kindness or sunsets] from claims that ignore natural law."23 Under its new director, it may be that the OAM will address these areas to the satisfaction of its critics.
The context of alternative medicine
In a national survey, at least one-third of persons claimed to have used at least one alternative therapy in the past year, and one-third of these persons saw a provider of alternative medical therapy. Among those using an unconventional healer, 83% also saw a medical doctor for the same condition, but nearly 75% of them did not report the use of alternative care to their traditional physician. The survey data estimated that in 1990 the out-of-pocket cost of unconventional therapy in the United States, including the cost of herbal medicines and health food/nutrition therapy, exceeded $10 billion. Another $3 billion of these costs were borne by third-party payors. The total estimated cost, $13.7 billion, exceeds the cost of hospital care in the United States in 1990 ($12.8 billion) and is about half of all the out-of-pocket expenses to physician services ($23.5 billion). The authors suggest that the total number of annual visits to alternative practitioners may exceed those to primary care physicians.25
The Oxford Health Plan, based in Norwalk, CT, is currently adding a network of about 1,000 holistic providers from which plan participants will be able to obtain chiropractic, acupuncture, and naturopathic treatment without prior approval of a "gatekeeper" at a cost of 2% to 3% added to the premium. Plan managers may believe that alternative therapies can decrease costs by decreasing utilization of conventional services. However, the Eisenberg study showed that the cost of alternative therapies averaged $27 per provider visit, and totaled over $500/year among those who used alternative methods, who usually sought simultaneous care from conventional physicians.25 The Oxford group has instituted several advisory committees to determine the "highest quality" of alternative practitioners, and plans to obtain feedback from patient encounters to monitor the type of treatments offered for different complaints. Quality-control committees will gauge appropriateness of care and whether the modality used lies within the scope of practice of the alternative therapist. They also hope to conduct outcomes research on this project. This new venture may have the effect of shifting the burden of seeking effective diagnosis and treatment to the consumer, since the plan has no clear idea whether most of the alternative treatments have any credibility besides that being claimed by proponents.
In an editorial, Campion24 cites several reasons for the public's "expensive romance with unconventional medicine." People have easy access to many options in medical care; disaffection with traditional care is widespread, fueled by media accounts of medical misadventures and uncaring managed care institutions; alternative practitioners often give people more time and attention than traditional providers; people want to feel in control of their bodies; and most of all, they want to feel well.
Americans seek alternative care for a wide variety of conditions. In one national study, the most common complaints presented to unconventional practitioners were back complaints (36%), anxiety (28%), headache (27%), chronic pain (26%), and cancer or tumors (24%). About one-third of patients in the same survey reported using alternative healers for health promotion and disease prevention advice, or for nonserious conditions not related to their chief complaint.25 A Canadian survey found that about 11% of children also attending a pediatric outpatient clinic in Quebec had been taken to chiropractic, homeopathic, naturopathic, and acupuncture practitioners, mostly for respiratory and ear-nose-throat problems. Parents assumed these treatments to be more "natural," and to have fewer side effects, but did not seek alternative therapy to receive more "personalized" care.26
Alternative therapy for cancer treatment has attracted much attention. Recent surveys show that from 3%25 to 9%27 of patients with cancer sought alternative methods of treatment for cancer. Older surveys with smaller data bases found higher usage rates, showing that 13%28 to about 50% of patients with cancer sought alternative treatments.29 That nearly half of all cancer patients have sought or seriously considered unconventional cancer therapy has been reported widely in the lay press as well, and adds to the perception that such practices are quite common and might be useful. Many cancer patients change diet, use multivitamin therapy, take shark cartilage, Chinese herbs, homeopathic pellets, and such therapies as mistletoe or mushroom extract with the expectation that their disease will be mitigated. The whole gamut of unconventional therapists is utilized by cancer patients, ranging from acupuncturists to Gestalt therapists.
Buckman30 points out that reports of success for many of the therapies being embraced by the public may be explained in several ways. The "cures" may have come from misdiagnosis, and when the anecdotes of healing are traced to the original sources, no data can be found. Patients may not have had the diagnosis for which they were "cured" or the data may have been falsified or misinterpreted by the healer. They may have experienced self-limiting or fluctuating illnesses, remission of which was wrongly attributed to the alternative treatment. After therapy, patients may not have been followed long enough to accurately assess cure or observe relapses. Concurrent conventional therapy is often being taken by patients who undergo alternative treatments, with inappropriate credit given to the unconventional method. Finally, misinterpretation of information by patients who believe themselves miraculously cured is often at the core of their success story. However, he points out that some of the clinical trials examining different areas of alternative therapy have raised enough questions to make further investigation of these methods desirable, in order to help answer the essential question in this debate: do these methods merely make one feel better, or do they really help one get better?
It is also interesting that in one survey of patients with cancer,27 patients claimed little opposition by their physicians in seeking such care, but their physicians reported these encounters differently. Patients reported that their physicians recommended or approved their use of unconventional therapy 50% of the time, and 31% cited the physician as the source of information about alternative methods. Forty percent of patients in this group reportedly abandoned traditional therapy after finding alternative care. In the same study, 52% of physicians who treated this group of patients reportedly objected to unorthodox treatments, and only 2% said they had recommended such treatment, although 37% said they "went along with" the patients. Patients did not tell physicians about their alternative cancer care 35% of the time.
Other surveys report that for all uses of alternative medicine, up to 70% of patients may not reveal their use of unconventional treatment to their physician.25 The former director of the OAM, Joseph Jacobs, MD, states that this lack of communication between doctor and patient about the use of alternative therapies "creates a very real challenge to the medical community, because not being able to understand what many [patients] are using outside of the medical mainstream presents a real barrier to good clinical care."31
On the other hand, many patients in the AIDS community, for example, have become quite vocal about the need for research in alternative medicine because they think many patients are being deceived by proponents of untested therapy, and have appealed to the OAM and others for definitive answers about unconventional AIDS treatments being offered.31
What do physicians think about alternative medicine? It is likely that most physicians are unaware of the scope, breadth, and extent of use of unconventional therapies in the United States.1 The level of interest among physicians in learning more about alternative therapy, however, seems to be high. A regional survey of family physicians in the Chesapeake Bay area showed that more than 70% were interested in training in such practices as herbal medicine, prayer therapy, acupressure, vegetarian and megavitamin diet therapy, acupuncture, and biofeedback.32 The results of this study, however, are curious in that 26% of respondents claim to have had training in chiropractic methods, 22% in acupuncture, and nearly 10% report training in traditional Oriental or Native American medicine. While informal training courses in these areas may be available, the scientific basis for such instruction is weak to nonexistent, and not usually accredited by specialty societies or traditional organized medical associations that govern continuing medical education. It would be most unusual if over 20% of family physicians in this area actually use chiropractic in their practice.
In a national survey of referral patterns by board-certified family physicians and internists, 94% indicated willingness to refer for at least one alternative therapy, 90% for at least two, 85% at least three, 77% at least four, and 66% at least five such modalities. The list of therapies for which these physicians expressed a willingness to refer patients included: relaxation techniques-86%, biofeedback-85%, therapeutic massage-66%, hypnosis-63%, acupuncture-56%, and meditation-54%. By contrast, 47% said they would refer for chiropractic, 24% for "spiritual" healing, 15% for homeopathy, 14% for energy healing, and 6% would refer for megavitamin or herbal therapy. In the same survey, 22% of respondents reported personally providing relaxation therapy, 17% "lifestyle diet (vegetarian, macrobiotic, etc.)," 5% hypnosis, 3% massage or chiropractic therapy, and 1% homeopathic or acupuncture therapies.33
The authors of the Chesapeake Bay study32 cite surveys of physicians in Great Britain, Israel, and New Zealand that show "similar interest" in studying alternative medicine. A more recent meta-analysis of European physicians and their attitudes about alternative medicine shows that on average, physicians view complementary medicine to have an "effectiveness rating" of 46+ 18 on a scale of 0-100. There was no trend among these data to suggest increasing endorsement of alternative medicine by conventional practitioners, but the authors conclude that European physicians give these therapies a "considerable degree of acceptance."34 They caution, however, that the perceived usefulness of such therapies by physicians or the public should not be equated with proven efficacy.
Many persons who are proponents of alternative medicine understand and acknowledge the role of traditional Western medicine for such problems as surgical intervention for appendicitis and fractures, or antibiotic therapy for specific infectious diseases. However, many in the alternative medical community spend a good deal of energy denigrating the role of allopathic intervention as dangerous, expensive, and impersonal. In the "deconstructionist" mode, they often change the vocabulary to make their methods seem rational and reasonable. In a critique of alternative medicine, Wallace Sampson, MD, points out that an editorial in Alternative Therapies poses:
"a non sequitur: present knowledge is adequate to dismiss the utility of most alternative methods; but [the editorial claims] there are ineffable qualities that [conventional] methods cannot detect and alternatives cannot define; therefore, alternative methods must be accepted, their practitioners licensed, and their services paid for by public funds and health insurance."35
In an unpublished survey of all 125 US medical schools, Sampson has found that just over 50 schools offer elective, for-credit courses on alternative therapy, and 18 other schools offer lecture series or seminars on the subject. His survey reveals that most are being given by "supporters or proponents of alternative methods," and that the "scientific view" is offered in only 7 courses.
In an editorial,36 Alpert argues that alternative medicine should not be "condemned out of hand," but suggests that traditional medicine approach alternative therapy based on five principles. Convinced that many unconventional treatments will eventually become mainstream, he proposes that physicians:
Maintain an open-minded attitude about all potentially new therapeutic interventions that include those commonly referred to as alternative.
Encourage carefully performed and appropriately controlled studies of these new therapies.
Do not ignore or ridicule the potential of the placebo effect to produce marked therapeutic benefit.
Do not accept all new therapies as efficacious on first acquaintance. Practitioners of quack medicine continue to abound as in all earlier times. Claims of therapeutic efficacy should be rationally examined and tested.
Avoid hubristic and arrogant attitudes toward alternative medical practices because one might be embarrassed by the subsequent demonstrations of their clinical efficacy.
Alpert says that these statements are guiding the University of Arizona as it sets up a program to "integrate and evaluate valuable alternative medical practices into routine allopathic care." Andrew Weil, MD, who has written several books on alternative medicine, is heading the new program.
It is clear that in the quest for wellness, the public is seeking new approaches to medical care. Some of the reasons may be understandable, such as the desire to find a healer with time to listen, to receive compassionate care, and to establish a partnership with a provider in seeking health.
In "Turning From Science and Reason," an address at the 1996 AMA National Leadership Conference, Jeremiah Barondess, MD, stated that many physicians may not deal effectively enough with illness, elements he identifies as those symptoms, anxieties, and concerns that make people feel sick, as opposed to our emphasis on disease, defined too often in biochemical and molecular terms that are far removed from the person being examined. Patients, he says, are increasingly taking more responsibility for their own health. Many are disaffected with medicine in general, as part of a trend of public suspicion of authoritarian, insular sections of society.
Some of the interest in alternative medicine may be due to an "outbreak of irrationalism" that includes New Age interest in "channeling" and astrology.37 Television talk shows and the proliferation of books and tapes on alternative therapies are gobbled up by an uncritical public that does not understand how to sort quack theories from what might be reasonable. Carl Sagan has recently lamented the phenomenon of our increasing scientific illiteracy and the rise of pseudoscience and superstition, noting that "baloney, bamboozles, careless thinking, and wishes disguised as fact...ripple through mainstream political, social, religious, and economic issues in every nation."40
Political decisions allow licensing of alternative practitioners without any scientific basis for accreditation of their schools or the methods used by their practitioners. Congress has recently dismantled its own scientific oversight section, the Office of Technology Assessment. Political pressure from the health food and vitamin supplement industry has hampered the FDA's ability to monitor their products, and legislative proposals have been advanced to allow such products to be covered by food stamps--in effect, paying for pills instead of food.38 There is, indeed, reason for concern.
Given the growing interest in alternative medicine by the public, accurate, even-handed education about alternative medicine is vital for both the public as well as for physicians, who should be familiar with unconventional therapies and be able to advise patients on their use. Sound, good quality research is needed to determine the potential benefits and avoid the risks inherent in unconventional therapy.
RECOMMENDATIONS
The following statements, recommended by the Council on Scientific Affairs, were adopted as AMA Policy at the 1997 AMA Annual Meeting.
There is little evidence to confirm the safety or efficacy of most alternative therapies. Much of the information currently known about these therapies makes it clear that many have not been shown to be efficacious. Well-designed, stringently controlled research should be done to evaluate the efficacy of alternative therapies.
Physicians should routinely inquire about the use of alternative or unconventional therapy by their patients, and educate themselves and their patients about the state of scientific knowledge with regard to alternative therapy that may be used or contemplated.
Patients who choose alternative therapies should be educated as to the hazards that might result from postponing or stopping conventional medical treatment.
Courses offered by medical schools on alternative medicine should present the scientific view of unconventional theories, treatments, and practice as well as the potential therapeutic utility, safety, and efficacy of these modalities.
References
Murray RH, Rubel AJ. Physicians and healers--unwitting partners in healthcare. N Engl J Med. 1992;326:61-645.
Dossey L, Swyers JP. Introduction to Alternative Medicine: Expanding Medical Horizons. Washington, DC: US Government Printing Office; 1994. NIH 94-066.
Renner JH. Health Smarts. Kansas City, Missouri:HealthFacts Publishing; 1990.
Hafner AW. Reader's Guide to Alternative Health Methods. Chicago:American Medical Association; 1992.
Coleman C. Herbal healing. Associated Press. Daily Herald, Chicago, Illinois. February 1, 1996: Section 4, p.1-2.
Tyler VE. The overselling of herbs. In: Barrett S, Jarvis WT, eds. The Health Robbers. Buffalo, NY:Prometheus Books, 1993.
Vautier G, Spiller RC. Safety of complementary medicines should be monitored. BMJ. 1995;311:633.
Linde K, Ramirez G, Mulrow CD, et al. St. John's wort for depression--an overview and meta-analysis of randomized controlled trials. BMJ. 1996;313:352-358.
DeSmet P, Nolen WA. St. John's wort as an antidepressant. BMJ. 1996;313:241-242.
Pizzorno JE. Ten drugs I would never take. Natural Health. September-October 1996; 84-85, 142-148.
Tyler V. Herbal remedies. J Pharm Technol. 1995;11:214-220.
Barrett S. The spine salesmen. In: Barrett S, Jarvis WT, eds. The Health Robbers. Buffalo, NY:Prometheus Books; 1993.
Bigos S, Bowyer O, Braen G, et al. Acute low back problems in adults. Clinical Practice Guideline. Quick Reference Guide Number 14. Rockville, MD: US Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research AHCPR Pub. No.95-0643. December 1994.
Brennan B, Rosner A, Demmerle A, et al. Manual healing methods. In: Alternative Medicine: Expanding Medical Horizons. Washington, DC: US Government Printing Office; 1994. NIH 94-066.
Brennan B, Rosner R, et al. Manual healing methods. In: Alternative Medicine: Expanding Medical Horizons. Washington, DC: US Government Printing Office; 1994. NIH 94-066.
Green S. "Antineoplastons": an unproven cancer therapy. JAMA. 1992;267:2924-2928.
Bower H. Internet sees growth of unverified health claims. BMJ. 1996;313:381.
Moss RW, Wiebel FD, et al. Pharmacologic and biological treatments. In: Alternative Medicine: Expanding Medical Horizons. Washington, DC: US Government Printing Office; 1994. NIH 94-066.
Taub A. Acupuncture: nonsense with needles. In:Barrett S, Jarvis WT, eds. The Health Robbers. Buffalo, NY:Prometheus Books; 1993.
Jacobs J, Jimenez LM, Gloyd SS, et al. Treatment of acute childhood diarrhea with homeopathic medicine: a randomized clinical trial in Nicaragua. Pediatrics. 1994;93:719-725.
Sampson W, London W. Analysis of homeopathic treatment of childhood diarrhea. Pediatrics. 1995;96:961-964.
Skolnick A. Science reporters hear wide range of data at 12th annual conference. JAMA. 1993;270:2416.
Park RL, Goodenough U. Buying snake oil with tax dollars. New York Times. January 3, 1996 A-15.
Campion EW. Why unconventional medicine? N Engl J Med. 1993;328:282-283.
Eisenberg DM, Kessler RC, Foster C, et al. Unconventional medicine in the United States. N Engl J Med. 1993;328:246-52.
Spigelblatt L, Laine-Ammara G, Pless IB, Guyver A. The use of alternative medicine by children. Pediatrics. 1994;94:811-814.
Lerner IJ, Kennedy BJ. The prevalence of questionable methods of cancer treatment in the United States. CA-Cancer J Clinicians. 1992;42:181-190.
Cassileth BR, Lusk EJ, Strouse TB, et al. Contemporary unorthodox treatment in cancer medicine: a study of patients, treatments, and practitioners. Ann Intern Med. 1984;101:105-112.
Cassileth BR. Unorthodox cancer medicine. Cancer Invest. 1986;4:591-598.
Buckman R, Sabbagh K. Magic or Medicine? An Investigation of Healing and Healers. New York, NY:Prometheus Books; 1995.
Jacobs J. Presentation to AMA Council on Scientific Affairs. September 8, 1996.
Berman BM, Singh BK, Lao L, et al. Physicians' attitudes toward complementary or alternative medicine: a regional survey. J Am Board Fam Pract. 1995; 8:361-366.
Blumberg DL, Grant WD, Hendricks SR, Kamps CA, Dewan MJ. The physician and unconventional medicine. Alternative Therapies. 1996;1:31-35.
Ernst E, Resch KL, White AR. Complementary medicine. what physicians think of it: a meta-analysis. Arch Intern Med. 1995;155:2405-2408.
Sampson W. Antiscience trends in the rise of the "alternative medicine" movement. Ann NY Acad Sci. 1996;775:188-197.
Alpert JS. The relativity of alternative medicine. Arch Intern Med. 1995;155:2385.
Krauthammer C. The return of the primitive. Time. January 20, 1996:82. Essay.
Skolnick A. Experts debate food stamp revision. JAMA. 1995;274:781-783.
Sagan C. The Demon-haunted World: Science as a Candle in the Dark. New York, NY:Random House; 1995
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The evidence for evidence-based medicine
by guest » Thu Mar 04, 2004 6:31 am
The evidence for evidence-based medicine
R. Imrie
448 NE Ravenna Blvd., #106, Seattle, WA
98115, USA
D.W. Ramey
PO Box 5231, Glendale, CA 91221, USA
Reprinted with permission from Complementary Therapies in Medicine (2000), 8, 123–126 © 2000 Harcourt Publishers Ltd. (This article has also been accepted for publication in the Winter 2000-2001 edition of the Scientific Review of Alternative Medicine.)
INTRODUCTION
In recent years the claim that only 20% or less of standard Western medicine is evidence-based has been repeated widely by health professionals and others.[1] This assertion is perhaps most often made by proponents of unproven (‘alternative’ and ‘complementary’) therapies with the implication that, if true, it might somehow justify the integration of any number of unconventional modalities with a similar dearth of supporting scientific evidence into main-stream medical practice. It should be immediately noted that this line of reasoning is an example of the logical fallacy tu quoque (‘you did it too’): one party cannot criticize another because both parties are guilty of the same ‘sin.’ While this argument may be without merit, it is often made and widely held to be valid. Therefore, the authors of this paper have attempted to identify the sources of, and examine the evidence for, the ‘20% or less’ claim.
ORIGIN OF THE CLAIMS
Laments about the state of conventional medicine are nothing new. In 1861, Oliver Wendell Holmes wrote: ‘I firmly believe that if the whole materia medica as used now, could be sunk to the bottom of the sea, it would be all the better for mankind – and all the worse for the fishes.’[2]
The original claim that ‘It has been estimated that only 10 to 20% of all procedures currently used in medical practice have been shown to be efficacious by controlled trial’ first appeared in print in a document published by the U.S. Congressional Office of Technology Assessment (OTA) in 1979[3] and was repeated in 1983.[4] The claim stems from the comments of OTA advisory panel member and noted epidemiologist, Kerr White. Dr White based his informal ‘10–20%’ estimate on a 1963 paper that reported on two surveys of the prescribing practices of 19 family doctors in a northern British town for 2 weeks (one conducted in December 1960, and another in March 1961).[5] Interestingly, the paper was never intended to evaluate the science of medical practice, rather its purpose was to look toward controlling prescribing costs in terms of standard (i.e., ‘generic’) versus ‘proprietary’ drugs. The ‘intent’ of each prescription was analyzed according to how specific it was for the condition. Intent was ‘specific’ for the condition for which it was pre-scribed only about 10% of the time; ‘probable’ in about 22%; ‘possible’ in 26%; ‘hopeful’ in 28%; ‘placebo’ in 10%; and, ‘not stated’ in 3.6%. From these data White estimated that ‘specific measures’ accounted for 10–20% of the benefits of patient care, that the combined placebo and other non-specific effects accounted for another 20–40%; and the rest (which he referred to as a ‘mystery’) accounts for 40–70%.[6]
In 1995, Dr White stated:
Some 20 years ago, as a member of the original Health Advisory Panel to the US Congressional Office of Technology Assessment I ventured the 10–20% figure again and invited anyone to provide more timely data. No one could. The figure was immortalized in OTA circles and publications for almost a decade. In countless addresses and conferences I often challenged others to provide better evidence but none was forthcoming. So the northern industrial town ‘arm-chair’ assessment persisted.3
Little about these surveys was relevant to medical practice across-the-board when they were first published nearly four decades ago, and they are almost certainly even less relevant today. Dr White himself has noted that his assessments were never intended to be applied generally.[7]
Nevertheless, even more gloomy pronouncements as to the evidential basis for medical practice have subsequently turned up in the medical literature.[8],[9] In 1991, Dr David Eddy, at a conference in Manchester, UK, claimed that only 15% of medical practice was based on any evidence at all. He apparently based this sweeping conclusion entirely on his studies of treatments for just two specific conditions: arterial blockage in the legs and glaucoma.[10] Subsequently, Dr Eddy’s claim, rather than the much more conservative OTA ‘armchair estimate,’ has been widely cited as a criticism of mainstream medicine.
IS MEDICAL PRACTICE EVIDENCE-BASED?
Regardless of the origin or intent of the original assessments, critics of the ‘10 to 20%’ claims were originally unable to refute them because no solid evidence existed either in favor of or against them. That situation has changed in recent years. A growing body of evidence now exists regarding the extent to which medical practice is evidence-based.
Still, in order to fully respond to either claim, one must ask, ‘What constitutes acceptable scientific evidence of efficacy, and how might one establish the relative “weight” to be ascribed to different types of evidence?’ Various rating systems have been devised, some describing levels of evidence ranging from I to V, with evidence from randomized controlled trials (RCTs) being generally given a rating of level I, and the lowest grade being generally assigned to interventions performed without substantial evidence. Interventions other than level I that are nonetheless considered compelling evidence include evidence from prospective and/or comparative studies, and evidence from follow-up studies and/or retrospective case series.[11]
One category of evidence that appears to be unique to science-based medicine, and the occasional subject of criticism from those who wish to criticize the concept of evidence-based practice,[12] are so-called self-evident interventions. These are incidences of treatments without compelling evidence obtained from RCTs and are considered as evidence in discussions of the extent of evidence-based practice. Examples of such interventions include blood transfusions, starting the stopped hearts of victims with heart attacks, antibiotics for meningitis, or a tourniquet for a gushing wound. Such interventions would not require RCTs to demonstrate proof of efficacy; indeed, such trials would most likely be considered unethical. There appear to be no comparable situations of the obvious necessity for and benefit from the interventions of ‘alternative’ medicine. Consequently, it would appear that ‘compelling evidence’ may occasionally be obtained from uncontrolled case series in science-based medicine but probably not in ‘alternative’ medicine.
Evaluations of published studies suggest that Dr. White’s and the OTA’s figures substantially underestimate the extent to which clinical decisions are or could be made on the basis of evidence from randomized trials only. Evaluations of those same studies suggest that Dr Eddy’s pronouncements wildly underestimate the extent to which standard medical practice is based on any evidence. Contrary to the claims, evidence-based practice appears to be prevalent, and it appears to be widely distributed geographically. Evidence for evidence-based practice includes those listed in the box (q.v.).
• 96.7% of anesthetic interventions (32% by RCT, UK)[13]
• approximately 77% of dermatologic out-patient therapy (38% by RCT, Denmark)[14]
• 64.8% of ‘major therapeutic interventions’ in an internal medicine clinic (57% by RCT, Canada)[15]
• 95% of surgical interventions in one practice (24% by RCT, UK)[16]
• 77% of pediatric surgical interventions (11% by RCT, UK)[17]
• 65% of psychiatric interventions (65% by RCT, UK)[18]
• 81% of interventions in general practice (25.5% by RCT, UK)[19]
• 82% of general medical interventions (53% by RCT, UK)[20]
• 55% of general practice interventions (38% by RCT, Spain)[21]
• 78% of laparoscopic procedures (50% by RCT, France)[22]
• 45% of primary hematology–oncology interventions (24% by RCT, USA)[23]
• 84% of internal medicine interventions (50% by RCT, Sweden)[24]
• 97% of pediatric surgical interventions (26% by RCT, UK)11
• 70% of primary therapeutic decisions in a clinical hematology practice (22% by RCT, UK)[25]
• 72.5% of interventions in a community pediatric practice (39.9% by RCT, UK)[26]
Box 1
Thus, published results show an average of 37.02% of interventions are supported by RCT (median = 38%). They show an average of 76% of interventions are supported by some form of compelling evidence (median = 78%).
There appear to be some areas of medical practice where interventions are less frequently based on level I evidence than others. Published surveys of ENT surgery,[27] burn therapy,[28] retinal breaks and lattice degeneration[29] and pediatric surgery[30] have concluded that there is not a strong foundation of evidence obtained from RCTs on which to base practice in these areas. However, in the studies of burn therapy and pediatric surgery, it was noted that the number of RCTs has grown dramatically in the past decade. This suggests that those practising in these fields are aware of the need to generate unbiased data in support of clinical practice and that they support the effort to develop effective practice guidelines.
Calls for the evidence-based practice of ‘complementary’ medicine have also been issued,[31] and established scientific methodologies have been deemed ‘quite satisfactory’ for addressing the majority of study questions related to ‘alternative’ medicine by the United States Office of Alternative Medicine.[32]
DOES EVIDENCE-BASED PRACTICE BENEFIT PATIENTS?
Basing medical practice on the best available scientific evidence does have its critics. Some, for instance, assert that this philosophy of practice has major limitations when considering the care of individual patients. Others have argued that ‘science’ and ‘objectivity’ are themselves merely arbitrary ‘social constructs,’ and therefore anecdote, testimony, and clinical (personal) experience should be afforded equal weight to ostensibly more objective scientific lines of evidence. Still other critics of EBM note that the data available under its framework may not apply to many treatments offered to patients in clinical practice or to subgroups of various diseases, nor may it be applicable to various types of prophylactic interventions, diagnostic decisions, or psychosocial factors.[33]
Notwithstanding such criticisms or claims regarding the prevalence of evidence-based medical practice, health professionals must address the essential question: ‘Does providing evidence-based care improve outcomes for patients?’ Unfortunately, no pertinent data is currently available from randomized controlled trials, most likely because no investigative team or research granting agency has yet overcome the problems of sample size, contamination, blinding and long-term follow-up that such trials would entail. Moreover, such trials pose serious ethical questions and concerns: for instance, would it be ethical to withhold evidence-based treatment from the control arm?
On the other hand, ‘outcomes research’ has documented that patients who receive evidence-based therapies often have better outcomes than those who don’t. For example, myocardial infarction survivors prescribed aspirin[34] or beta-blockers[35] have lower mortality rates than those who aren’t prescribed those drugs. Where clinicians use more warfarin and stroke unit referrals, stroke mortality declines by > 20%.[36] For a negative example, patients undergoing carotid surgery, despite failing to meet evidence-based operative criteria, when compared with operated patients who meet those criteria are more than three times as likely to suffer major stroke or death in the next month.[37]
CONCLUSION
Dr White has stated that the ‘10–20%’ figure was used heuristically to stimulate the search for more accurate information. To some extent, he has succeeded in attaining that goal. However, Dr White also notes that he had no control over the fact that the OTA used his ‘armchair estimate’ in its final report, and that neither he nor the OTA can be blamed for the abuse of the statement. Clearly the intent of the OTA report was to strengthen the scientific basis for medical care, not to promote an ‘open door policy’ for unproven alternative and complementary therapies.[38] In 1995, Dr White stated that he suspected the proportion of interventions based on evidence was higher than 20%.3 Even if Dr. Eddy’s estimates were accurate with regard to the two conditions he studied a decade ago, they appear to be clearly inapplicable to many conditions and therapeutic interventions which have been evaluated more recently.
Whatever the merits or faults of evidence-based medicine, a growing body of evidence demonstrates that the practice is widespread and becoming more so. More importantly, there is emerging evidence that, when EBM is practised, patients benefit. Clearly, demanding rigorous evidence in evaluating the effectiveness of medical interventions is a good thing. One may quibble with bits of evidence provided in individual studies: for example, the figures cited above are lower when only the results of RCTs are considered as ‘evidence,’ although they are still higher than the ‘10–20%’ figure. In any case, while the evidence for evidence-based medicine may be held, for good reason, to exclude anecdote and subjective personal experience, it is not restricted to randomized trials and meta-analyses. Rather, it involves tracking down the best objective evidence in order to answer clinically relevant questions.[39]
Claims that conventional medicine is not widely based on evidence should be rejected, as should logically fallacious arguments based on such claims. The evidence fails to support them.
126 Complementary Therapies in Medicine
--------------------------------------------------------------------------------
REFERENCES
[1] Heptonstall J. Traditional Chinese Medical Science. eBMJ, 11 Nov 1999
[2] Holmes OW. In: Strasuu MB, ed. Familiar quotations. Boston: Little Brown, 1968: 124.
[3] Congress of the United States, Office of Technology Assessment: Assessing the efficacy and safety of medical technologies. Washington, DC: US Government Printing Office, 1978.
[4] Congress of the United States, Office of Technology Assessment. The impact of randomized clinical trials on health care policy and medical practice. Washington, DC: US Government Printing Office, 1983.
[5] Forsyth G. An inquiry into the drug bill, Medical Care 1963;1:10–16.
[6] White K. Lancet 1995; 346; 837–838
[7] Ontario College of Physicians and Surgeons, Report of the Ad Hoc Committee on ‘Alternative’ Medicine, September, 1997.
[8] Smith R. Where is the wisdom … the poverty of medical evidence. BMJ 1991; 303: 798–799.
[9] Smith R. The ethics of ignorance. J Med Ethics 1992; 18: 117–118.
[10] Dubinsky M, Ferguson JH. Analysis of the National Institutes of Health Medicare Coverage Assessment. Int J Technol Assess Health Care 1990; 6: 480–488.
[11] Baraldini V, Spitz V, Pierro A. Evidence-based operations in paediatric surgery. Pediatr Surg Int 1998; 13(5–6): 331–335.
[12] Churchill W. Clarifications. eBMJ, 20 Nov 1999,
[13] Myles PS, Bain DL, Johnson F, et al. Is anaesthesia evidence-based? A survey of anaesthetic practice. Br J Anaesth 1999 Apr,82(4): 591–595.
[14] Jemec GB, Thorsteinsdottir, H, Wulf, HC. Evidence-based dermatologic out-patient treatment. Int J Dermatol 1998 Nov; 37(11): 850–854.
[15] Michaud G, McGowan JL, van der Jagt R, Wells G, Tugwell P. Are therapeutic decisions supported by evidence from health care research? Arch Intern Med 1998; 158(15): 1665–1668
[16] Howes N, Chagla L, Thorpe M, et al. Surgical practice is evidence based. Br J Surg 1997; 84(9): 1220–1223.
[17] Kenney SE, Shankar KR, Rintala KR, et al. Evidence-based surgery: interventions in a regional paediatric surgical unit. Arch Dis Child 1997; 76(1): 50–53.
[18] Geddes JR, Game D, Jenkins NE, et al. What proportion of primary psychiatric interventions are based on evidence from randomised controlled trials? Qual Health Care 1996; 5(4): 215–217
[19] Gill P, Dowell AC, Neal RD, et al. Evidence based general practice: a retrospective study of interventions in one training practice. BMJ 1996; 312(7034): 819–821.
[20] Ellis J, Mulligan I, Rowe J, et al. Inpatient general medicine is evidence based. A-Team, Nuffield Department of Clinical Medicine. Lancet 1995; 346(8972): 407–410.
[21] Suarez-Varela MM, Llopis-Gonzalez A, Bell J, Tallon-Guerola M, et al. Evidence based general practice. Eur J Epidemiol 1999; 15(9): 815–819.
[22] Slim K, Lescure G, Voitellier M, et al. [Is laparoscopic surgical practice ‘factual’ (evidence based)? Results of a prospective regional survey]. Presse Med 1998; 27(36): 1829–1833.
[23] Djulbegovic B, Loughran TP Jr, Hornung CA, et al. The quality of medical evidence in hematology-oncology. Am J Med 1999; 106(2): 198–205.
[24] Nordin-Johansson A, Asplund K J Randomized controlled trials and consensus as a basis for interventions in internal medicine. Intern Med 2000; 247(1): 94–104.
[25] Galloway M, Baird G, Lennard A. Haematologists in district general hospitals practise evidence based medicine. Clin Lab Haematol 1997; 19(4): 243–248.
[26] Rudolf MC, Lyth N, Bundle A, et al. A search for the evidence supporting community paediatric practice. Arch Dis Child 1999; 80(3): 257–261.
[27] Maran HG, Malony NC, Armstrong MW, et al. Is there an evidence base for practice in ENT surgery? Clin Otolyngol 1997;22(2):152-157
[28] Childs C. Is there an evidence-based practice for burns? Burns 1998; 24(1): 29–33
[29] Wilkinson CP. Evidence-based analysis of prophylactic treatment of asymptomatic retinal breaks and lattice degeneration. Opthalmology 2000 107(1): 12–15
[30] Hardin WD Jr, Stylianos S, Lally KP J. Evidence-based practice in pediatric surgery. Pediatr Surg 1999; 34(5):908–912.
[31] Lewith GT, Ernst E, Mills S, et al. Complementary medicine must be research led and evidence based. BMJ. 2000; 320(7228): 188.
[32] Levin JS, Glass TA, Kushi LH, et al. Quantitative methods in research on complementary and alternative medicine. A methodological manifesto. NIH Office of Alternative Medicine. Med Care 1997 Nov; 35(11):1079–1094
[33] Feinstein AR, Horwitz RI. Problems in the ‘evidence’ of ‘evidence-based medicine’. Am J Med 1997; 103(6):529–535.
[34] Krumholz HM, Radford MJ, Ellerbeek FF, et al. Aspirin for secondary prevention after acute myocardial infarction in the elderly; prescribed use and outcomes. Ann Intern Med 1996; 124; 292–298.
[35] Krumholz HM, Radford MJ, Wang Y, et al. National use and effectiveness of beta-blockers for the treatment of elderly patients after acute myocardial infarction. National Cooperative Cardiovascular Project. JAMA 1998; 280: 623–629.
[36] Mitchell JG, Ballard DJ, Whisnant JP, et al. What role do neurologists play in determining the costs and outcomes of stroke patients? Stroke 1996; 27:1937–1943.
[37] Wong JH, Findlay JM, Suarez-Almazor ME. Regional performance of carotid endarterectomy appropriateness, outcomes and risk factors for complications. Stroke 1997; 28: 891–898.
[38] Blame for Abuse of OTA Reports of Dubious Estimate: ‘Only 10–20% of Medical Procedures are Proved.’ NCAHF Newsletter, 1996: 19(5).
[39] Sackett DL, Rosenberg WMC, Muir Gray JA, et al. Evidence based medicine: what it is and what it isn’t. BMJ 1996; 312: 71–72.
R. Imrie
448 NE Ravenna Blvd., #106, Seattle, WA
98115, USA
D.W. Ramey
PO Box 5231, Glendale, CA 91221, USA
Reprinted with permission from Complementary Therapies in Medicine (2000), 8, 123–126 © 2000 Harcourt Publishers Ltd. (This article has also been accepted for publication in the Winter 2000-2001 edition of the Scientific Review of Alternative Medicine.)
INTRODUCTION
In recent years the claim that only 20% or less of standard Western medicine is evidence-based has been repeated widely by health professionals and others.[1] This assertion is perhaps most often made by proponents of unproven (‘alternative’ and ‘complementary’) therapies with the implication that, if true, it might somehow justify the integration of any number of unconventional modalities with a similar dearth of supporting scientific evidence into main-stream medical practice. It should be immediately noted that this line of reasoning is an example of the logical fallacy tu quoque (‘you did it too’): one party cannot criticize another because both parties are guilty of the same ‘sin.’ While this argument may be without merit, it is often made and widely held to be valid. Therefore, the authors of this paper have attempted to identify the sources of, and examine the evidence for, the ‘20% or less’ claim.
ORIGIN OF THE CLAIMS
Laments about the state of conventional medicine are nothing new. In 1861, Oliver Wendell Holmes wrote: ‘I firmly believe that if the whole materia medica as used now, could be sunk to the bottom of the sea, it would be all the better for mankind – and all the worse for the fishes.’[2]
The original claim that ‘It has been estimated that only 10 to 20% of all procedures currently used in medical practice have been shown to be efficacious by controlled trial’ first appeared in print in a document published by the U.S. Congressional Office of Technology Assessment (OTA) in 1979[3] and was repeated in 1983.[4] The claim stems from the comments of OTA advisory panel member and noted epidemiologist, Kerr White. Dr White based his informal ‘10–20%’ estimate on a 1963 paper that reported on two surveys of the prescribing practices of 19 family doctors in a northern British town for 2 weeks (one conducted in December 1960, and another in March 1961).[5] Interestingly, the paper was never intended to evaluate the science of medical practice, rather its purpose was to look toward controlling prescribing costs in terms of standard (i.e., ‘generic’) versus ‘proprietary’ drugs. The ‘intent’ of each prescription was analyzed according to how specific it was for the condition. Intent was ‘specific’ for the condition for which it was pre-scribed only about 10% of the time; ‘probable’ in about 22%; ‘possible’ in 26%; ‘hopeful’ in 28%; ‘placebo’ in 10%; and, ‘not stated’ in 3.6%. From these data White estimated that ‘specific measures’ accounted for 10–20% of the benefits of patient care, that the combined placebo and other non-specific effects accounted for another 20–40%; and the rest (which he referred to as a ‘mystery’) accounts for 40–70%.[6]
In 1995, Dr White stated:
Some 20 years ago, as a member of the original Health Advisory Panel to the US Congressional Office of Technology Assessment I ventured the 10–20% figure again and invited anyone to provide more timely data. No one could. The figure was immortalized in OTA circles and publications for almost a decade. In countless addresses and conferences I often challenged others to provide better evidence but none was forthcoming. So the northern industrial town ‘arm-chair’ assessment persisted.3
Little about these surveys was relevant to medical practice across-the-board when they were first published nearly four decades ago, and they are almost certainly even less relevant today. Dr White himself has noted that his assessments were never intended to be applied generally.[7]
Nevertheless, even more gloomy pronouncements as to the evidential basis for medical practice have subsequently turned up in the medical literature.[8],[9] In 1991, Dr David Eddy, at a conference in Manchester, UK, claimed that only 15% of medical practice was based on any evidence at all. He apparently based this sweeping conclusion entirely on his studies of treatments for just two specific conditions: arterial blockage in the legs and glaucoma.[10] Subsequently, Dr Eddy’s claim, rather than the much more conservative OTA ‘armchair estimate,’ has been widely cited as a criticism of mainstream medicine.
IS MEDICAL PRACTICE EVIDENCE-BASED?
Regardless of the origin or intent of the original assessments, critics of the ‘10 to 20%’ claims were originally unable to refute them because no solid evidence existed either in favor of or against them. That situation has changed in recent years. A growing body of evidence now exists regarding the extent to which medical practice is evidence-based.
Still, in order to fully respond to either claim, one must ask, ‘What constitutes acceptable scientific evidence of efficacy, and how might one establish the relative “weight” to be ascribed to different types of evidence?’ Various rating systems have been devised, some describing levels of evidence ranging from I to V, with evidence from randomized controlled trials (RCTs) being generally given a rating of level I, and the lowest grade being generally assigned to interventions performed without substantial evidence. Interventions other than level I that are nonetheless considered compelling evidence include evidence from prospective and/or comparative studies, and evidence from follow-up studies and/or retrospective case series.[11]
One category of evidence that appears to be unique to science-based medicine, and the occasional subject of criticism from those who wish to criticize the concept of evidence-based practice,[12] are so-called self-evident interventions. These are incidences of treatments without compelling evidence obtained from RCTs and are considered as evidence in discussions of the extent of evidence-based practice. Examples of such interventions include blood transfusions, starting the stopped hearts of victims with heart attacks, antibiotics for meningitis, or a tourniquet for a gushing wound. Such interventions would not require RCTs to demonstrate proof of efficacy; indeed, such trials would most likely be considered unethical. There appear to be no comparable situations of the obvious necessity for and benefit from the interventions of ‘alternative’ medicine. Consequently, it would appear that ‘compelling evidence’ may occasionally be obtained from uncontrolled case series in science-based medicine but probably not in ‘alternative’ medicine.
Evaluations of published studies suggest that Dr. White’s and the OTA’s figures substantially underestimate the extent to which clinical decisions are or could be made on the basis of evidence from randomized trials only. Evaluations of those same studies suggest that Dr Eddy’s pronouncements wildly underestimate the extent to which standard medical practice is based on any evidence. Contrary to the claims, evidence-based practice appears to be prevalent, and it appears to be widely distributed geographically. Evidence for evidence-based practice includes those listed in the box (q.v.).
• 96.7% of anesthetic interventions (32% by RCT, UK)[13]
• approximately 77% of dermatologic out-patient therapy (38% by RCT, Denmark)[14]
• 64.8% of ‘major therapeutic interventions’ in an internal medicine clinic (57% by RCT, Canada)[15]
• 95% of surgical interventions in one practice (24% by RCT, UK)[16]
• 77% of pediatric surgical interventions (11% by RCT, UK)[17]
• 65% of psychiatric interventions (65% by RCT, UK)[18]
• 81% of interventions in general practice (25.5% by RCT, UK)[19]
• 82% of general medical interventions (53% by RCT, UK)[20]
• 55% of general practice interventions (38% by RCT, Spain)[21]
• 78% of laparoscopic procedures (50% by RCT, France)[22]
• 45% of primary hematology–oncology interventions (24% by RCT, USA)[23]
• 84% of internal medicine interventions (50% by RCT, Sweden)[24]
• 97% of pediatric surgical interventions (26% by RCT, UK)11
• 70% of primary therapeutic decisions in a clinical hematology practice (22% by RCT, UK)[25]
• 72.5% of interventions in a community pediatric practice (39.9% by RCT, UK)[26]
Box 1
Thus, published results show an average of 37.02% of interventions are supported by RCT (median = 38%). They show an average of 76% of interventions are supported by some form of compelling evidence (median = 78%).
There appear to be some areas of medical practice where interventions are less frequently based on level I evidence than others. Published surveys of ENT surgery,[27] burn therapy,[28] retinal breaks and lattice degeneration[29] and pediatric surgery[30] have concluded that there is not a strong foundation of evidence obtained from RCTs on which to base practice in these areas. However, in the studies of burn therapy and pediatric surgery, it was noted that the number of RCTs has grown dramatically in the past decade. This suggests that those practising in these fields are aware of the need to generate unbiased data in support of clinical practice and that they support the effort to develop effective practice guidelines.
Calls for the evidence-based practice of ‘complementary’ medicine have also been issued,[31] and established scientific methodologies have been deemed ‘quite satisfactory’ for addressing the majority of study questions related to ‘alternative’ medicine by the United States Office of Alternative Medicine.[32]
DOES EVIDENCE-BASED PRACTICE BENEFIT PATIENTS?
Basing medical practice on the best available scientific evidence does have its critics. Some, for instance, assert that this philosophy of practice has major limitations when considering the care of individual patients. Others have argued that ‘science’ and ‘objectivity’ are themselves merely arbitrary ‘social constructs,’ and therefore anecdote, testimony, and clinical (personal) experience should be afforded equal weight to ostensibly more objective scientific lines of evidence. Still other critics of EBM note that the data available under its framework may not apply to many treatments offered to patients in clinical practice or to subgroups of various diseases, nor may it be applicable to various types of prophylactic interventions, diagnostic decisions, or psychosocial factors.[33]
Notwithstanding such criticisms or claims regarding the prevalence of evidence-based medical practice, health professionals must address the essential question: ‘Does providing evidence-based care improve outcomes for patients?’ Unfortunately, no pertinent data is currently available from randomized controlled trials, most likely because no investigative team or research granting agency has yet overcome the problems of sample size, contamination, blinding and long-term follow-up that such trials would entail. Moreover, such trials pose serious ethical questions and concerns: for instance, would it be ethical to withhold evidence-based treatment from the control arm?
On the other hand, ‘outcomes research’ has documented that patients who receive evidence-based therapies often have better outcomes than those who don’t. For example, myocardial infarction survivors prescribed aspirin[34] or beta-blockers[35] have lower mortality rates than those who aren’t prescribed those drugs. Where clinicians use more warfarin and stroke unit referrals, stroke mortality declines by > 20%.[36] For a negative example, patients undergoing carotid surgery, despite failing to meet evidence-based operative criteria, when compared with operated patients who meet those criteria are more than three times as likely to suffer major stroke or death in the next month.[37]
CONCLUSION
Dr White has stated that the ‘10–20%’ figure was used heuristically to stimulate the search for more accurate information. To some extent, he has succeeded in attaining that goal. However, Dr White also notes that he had no control over the fact that the OTA used his ‘armchair estimate’ in its final report, and that neither he nor the OTA can be blamed for the abuse of the statement. Clearly the intent of the OTA report was to strengthen the scientific basis for medical care, not to promote an ‘open door policy’ for unproven alternative and complementary therapies.[38] In 1995, Dr White stated that he suspected the proportion of interventions based on evidence was higher than 20%.3 Even if Dr. Eddy’s estimates were accurate with regard to the two conditions he studied a decade ago, they appear to be clearly inapplicable to many conditions and therapeutic interventions which have been evaluated more recently.
Whatever the merits or faults of evidence-based medicine, a growing body of evidence demonstrates that the practice is widespread and becoming more so. More importantly, there is emerging evidence that, when EBM is practised, patients benefit. Clearly, demanding rigorous evidence in evaluating the effectiveness of medical interventions is a good thing. One may quibble with bits of evidence provided in individual studies: for example, the figures cited above are lower when only the results of RCTs are considered as ‘evidence,’ although they are still higher than the ‘10–20%’ figure. In any case, while the evidence for evidence-based medicine may be held, for good reason, to exclude anecdote and subjective personal experience, it is not restricted to randomized trials and meta-analyses. Rather, it involves tracking down the best objective evidence in order to answer clinically relevant questions.[39]
Claims that conventional medicine is not widely based on evidence should be rejected, as should logically fallacious arguments based on such claims. The evidence fails to support them.
126 Complementary Therapies in Medicine
--------------------------------------------------------------------------------
REFERENCES
[1] Heptonstall J. Traditional Chinese Medical Science. eBMJ, 11 Nov 1999
[2] Holmes OW. In: Strasuu MB, ed. Familiar quotations. Boston: Little Brown, 1968: 124.
[3] Congress of the United States, Office of Technology Assessment: Assessing the efficacy and safety of medical technologies. Washington, DC: US Government Printing Office, 1978.
[4] Congress of the United States, Office of Technology Assessment. The impact of randomized clinical trials on health care policy and medical practice. Washington, DC: US Government Printing Office, 1983.
[5] Forsyth G. An inquiry into the drug bill, Medical Care 1963;1:10–16.
[6] White K. Lancet 1995; 346; 837–838
[7] Ontario College of Physicians and Surgeons, Report of the Ad Hoc Committee on ‘Alternative’ Medicine, September, 1997.
[8] Smith R. Where is the wisdom … the poverty of medical evidence. BMJ 1991; 303: 798–799.
[9] Smith R. The ethics of ignorance. J Med Ethics 1992; 18: 117–118.
[10] Dubinsky M, Ferguson JH. Analysis of the National Institutes of Health Medicare Coverage Assessment. Int J Technol Assess Health Care 1990; 6: 480–488.
[11] Baraldini V, Spitz V, Pierro A. Evidence-based operations in paediatric surgery. Pediatr Surg Int 1998; 13(5–6): 331–335.
[12] Churchill W. Clarifications. eBMJ, 20 Nov 1999,
[13] Myles PS, Bain DL, Johnson F, et al. Is anaesthesia evidence-based? A survey of anaesthetic practice. Br J Anaesth 1999 Apr,82(4): 591–595.
[14] Jemec GB, Thorsteinsdottir, H, Wulf, HC. Evidence-based dermatologic out-patient treatment. Int J Dermatol 1998 Nov; 37(11): 850–854.
[15] Michaud G, McGowan JL, van der Jagt R, Wells G, Tugwell P. Are therapeutic decisions supported by evidence from health care research? Arch Intern Med 1998; 158(15): 1665–1668
[16] Howes N, Chagla L, Thorpe M, et al. Surgical practice is evidence based. Br J Surg 1997; 84(9): 1220–1223.
[17] Kenney SE, Shankar KR, Rintala KR, et al. Evidence-based surgery: interventions in a regional paediatric surgical unit. Arch Dis Child 1997; 76(1): 50–53.
[18] Geddes JR, Game D, Jenkins NE, et al. What proportion of primary psychiatric interventions are based on evidence from randomised controlled trials? Qual Health Care 1996; 5(4): 215–217
[19] Gill P, Dowell AC, Neal RD, et al. Evidence based general practice: a retrospective study of interventions in one training practice. BMJ 1996; 312(7034): 819–821.
[20] Ellis J, Mulligan I, Rowe J, et al. Inpatient general medicine is evidence based. A-Team, Nuffield Department of Clinical Medicine. Lancet 1995; 346(8972): 407–410.
[21] Suarez-Varela MM, Llopis-Gonzalez A, Bell J, Tallon-Guerola M, et al. Evidence based general practice. Eur J Epidemiol 1999; 15(9): 815–819.
[22] Slim K, Lescure G, Voitellier M, et al. [Is laparoscopic surgical practice ‘factual’ (evidence based)? Results of a prospective regional survey]. Presse Med 1998; 27(36): 1829–1833.
[23] Djulbegovic B, Loughran TP Jr, Hornung CA, et al. The quality of medical evidence in hematology-oncology. Am J Med 1999; 106(2): 198–205.
[24] Nordin-Johansson A, Asplund K J Randomized controlled trials and consensus as a basis for interventions in internal medicine. Intern Med 2000; 247(1): 94–104.
[25] Galloway M, Baird G, Lennard A. Haematologists in district general hospitals practise evidence based medicine. Clin Lab Haematol 1997; 19(4): 243–248.
[26] Rudolf MC, Lyth N, Bundle A, et al. A search for the evidence supporting community paediatric practice. Arch Dis Child 1999; 80(3): 257–261.
[27] Maran HG, Malony NC, Armstrong MW, et al. Is there an evidence base for practice in ENT surgery? Clin Otolyngol 1997;22(2):152-157
[28] Childs C. Is there an evidence-based practice for burns? Burns 1998; 24(1): 29–33
[29] Wilkinson CP. Evidence-based analysis of prophylactic treatment of asymptomatic retinal breaks and lattice degeneration. Opthalmology 2000 107(1): 12–15
[30] Hardin WD Jr, Stylianos S, Lally KP J. Evidence-based practice in pediatric surgery. Pediatr Surg 1999; 34(5):908–912.
[31] Lewith GT, Ernst E, Mills S, et al. Complementary medicine must be research led and evidence based. BMJ. 2000; 320(7228): 188.
[32] Levin JS, Glass TA, Kushi LH, et al. Quantitative methods in research on complementary and alternative medicine. A methodological manifesto. NIH Office of Alternative Medicine. Med Care 1997 Nov; 35(11):1079–1094
[33] Feinstein AR, Horwitz RI. Problems in the ‘evidence’ of ‘evidence-based medicine’. Am J Med 1997; 103(6):529–535.
[34] Krumholz HM, Radford MJ, Ellerbeek FF, et al. Aspirin for secondary prevention after acute myocardial infarction in the elderly; prescribed use and outcomes. Ann Intern Med 1996; 124; 292–298.
[35] Krumholz HM, Radford MJ, Wang Y, et al. National use and effectiveness of beta-blockers for the treatment of elderly patients after acute myocardial infarction. National Cooperative Cardiovascular Project. JAMA 1998; 280: 623–629.
[36] Mitchell JG, Ballard DJ, Whisnant JP, et al. What role do neurologists play in determining the costs and outcomes of stroke patients? Stroke 1996; 27:1937–1943.
[37] Wong JH, Findlay JM, Suarez-Almazor ME. Regional performance of carotid endarterectomy appropriateness, outcomes and risk factors for complications. Stroke 1997; 28: 891–898.
[38] Blame for Abuse of OTA Reports of Dubious Estimate: ‘Only 10–20% of Medical Procedures are Proved.’ NCAHF Newsletter, 1996: 19(5).
[39] Sackett DL, Rosenberg WMC, Muir Gray JA, et al. Evidence based medicine: what it is and what it isn’t. BMJ 1996; 312: 71–72.
- guest
quackery internet definition and unproven medical care
by guest » Thu Mar 11, 2004 6:55 am
http://www.quackwatch.org/01QuackeryRel ... ckdef.html
Quackery: How Should It Be Defined?
Stephen Barrett, M.D."Quackery" derives from the word quacksalver (someone who boasts about his salves). Dictionaries define quack as "a pretender to medical skill; a charlatan" and "one who talks pretentiously without sound knowledge of the subject discussed." These definitions suggest that the promotion of quackery involves deliberate deception, but many promoters sincerely believe in what they are doing. The FDA defines health fraud as "the promotion, for profit, of a medical remedy known to be false or unproven." This also can cause confusion because in ordinary usage -- and in the courts -- the word "fraud" connotes deliberate deception. Quackery's paramount characteristic is promotion ("Quacks quack!") rather than fraud, greed, or misinformation.
Most people think of quackery as promoted by charlatans who deliberately exploit their victims. Actually, most promoters are unwitting victims who share misinformation and personal experiences with others. Customers of multilevel companies that sell health-related products typically have been persuaded by friends, relatives, and neighbors who use the products because they believe them effective. Pharmacists also profit from the sale of nutrition supplements that few customers need. In most cases pharmacists do not champion the products but simply profit from the misleading promotions of others. Much quackery is involved in telling people something is bad for them (such as food additives) and selling a substitute (such as "organic" or "natural" food). Quackery is also involved in misleading advertising of dietary supplements, homeopathic products, and some nonprescription drugs. In many such instances no individual "quack" is involved -- just deception by manufacturers and their advertising agencies.
Quackery is not an all-or-nothing phenomenon. A practitioner may be scientific in many respects and only minimally involved in unscientific practices. Also, products can be useful for some purposes but worthless for others. For example, vitamin B12 shots are lifesaving in cases of pernicious anemia, but giving them frequently to "pep you up" is a form of medical fraud.
Quackery and poor medical care overlap but are not identical. Quackery entails the use of methods that are not scientifically accepted. Malpractice involves failure by a health professional to meet accepted standards of diagnosis and treatment. It includes situations in which the practitioner was negligent while using standard methods of care. Leaving a surgical instrument in a patient's abdomen or operating on the wrong part of the body are examples of malpractice unrelated to quackery.
To avoid semantic problems, quackery could be broadly defined as "anything involving overpromotion in the field of health." This definition would include questionable ideas as well as questionable products and services, regardless of the sincerity of their promoters. In line with this definition, the word "fraud" would be reserved only for situations in which deliberate deception is involved.
Unproven methods are not necessarily quackery. Those consistent with established scientific concepts may be considered experimental. Legitimate researchers and practitioners do not promote unproven procedures in the marketplace but engage in responsible, properly-designed studies. Methods not compatible with established scientific concepts should be classified as nonsensical or disproven rather than experimental.
Quackery: How Should It Be Defined?
Stephen Barrett, M.D."Quackery" derives from the word quacksalver (someone who boasts about his salves). Dictionaries define quack as "a pretender to medical skill; a charlatan" and "one who talks pretentiously without sound knowledge of the subject discussed." These definitions suggest that the promotion of quackery involves deliberate deception, but many promoters sincerely believe in what they are doing. The FDA defines health fraud as "the promotion, for profit, of a medical remedy known to be false or unproven." This also can cause confusion because in ordinary usage -- and in the courts -- the word "fraud" connotes deliberate deception. Quackery's paramount characteristic is promotion ("Quacks quack!") rather than fraud, greed, or misinformation.
Most people think of quackery as promoted by charlatans who deliberately exploit their victims. Actually, most promoters are unwitting victims who share misinformation and personal experiences with others. Customers of multilevel companies that sell health-related products typically have been persuaded by friends, relatives, and neighbors who use the products because they believe them effective. Pharmacists also profit from the sale of nutrition supplements that few customers need. In most cases pharmacists do not champion the products but simply profit from the misleading promotions of others. Much quackery is involved in telling people something is bad for them (such as food additives) and selling a substitute (such as "organic" or "natural" food). Quackery is also involved in misleading advertising of dietary supplements, homeopathic products, and some nonprescription drugs. In many such instances no individual "quack" is involved -- just deception by manufacturers and their advertising agencies.
Quackery is not an all-or-nothing phenomenon. A practitioner may be scientific in many respects and only minimally involved in unscientific practices. Also, products can be useful for some purposes but worthless for others. For example, vitamin B12 shots are lifesaving in cases of pernicious anemia, but giving them frequently to "pep you up" is a form of medical fraud.
Quackery and poor medical care overlap but are not identical. Quackery entails the use of methods that are not scientifically accepted. Malpractice involves failure by a health professional to meet accepted standards of diagnosis and treatment. It includes situations in which the practitioner was negligent while using standard methods of care. Leaving a surgical instrument in a patient's abdomen or operating on the wrong part of the body are examples of malpractice unrelated to quackery.
To avoid semantic problems, quackery could be broadly defined as "anything involving overpromotion in the field of health." This definition would include questionable ideas as well as questionable products and services, regardless of the sincerity of their promoters. In line with this definition, the word "fraud" would be reserved only for situations in which deliberate deception is involved.
Unproven methods are not necessarily quackery. Those consistent with established scientific concepts may be considered experimental. Legitimate researchers and practitioners do not promote unproven procedures in the marketplace but engage in responsible, properly-designed studies. Methods not compatible with established scientific concepts should be classified as nonsensical or disproven rather than experimental.
- guest
what science means in relation to the world of spirituality
by malernee » Sat Dec 18, 2004 6:56 am
what science means in relation to the world of spirituality
BMJ 2004;329:1444-1446 (18 December), doi:10.1136/bmj.329.7480.1444
Many claims are made for the power of prayer, but the idea that it could work retrospectively has caused considerable controversy. It is also beyond current scientific knowledge
Leibocivi first raised the possibility of retroactive prayer in 2001. He reported a study that showed prayer done for patients well after they had left the hospital, had reduced the length of stay in hospital and duration of fever from blood stream infections.1 In short, prayer somehow seemed to act backward in time to shorten patients' stay in the hospital. The study was intended lightheartedly to illustrate the importance of asking research questions that fit with the scientific model of the world.2 Olshansky and Dossey subsequently argued that a logical explanation might be found for Leibovici's results.3 They point to numerous other randomised controlled trails to support their thesis that prayer could work at a distance of space and that it might be plausible that prayer could act retroactively in time. We argue that their claim is built on a confusion and lacks a deep physical model. There is considerable fogginess about what science means in relation to the world of spirituality, and we wish to throw some light on the subject.
Examining the clinical science
The latest reported clinical trial of intercessory prayer is a three year study of 750 patients in nine hospitals and 12 prayer groups from around the world, including lay and monastic Christians, Sufi Muslims, and Buddhist monks.4 Prayers were even emailed to Jerusalem and placed in the Wailing Wall. Patients awaiting angioplasty for coronary artery obstruction were selected at random by computer and sent to the 12 prayer groups. The prayer groups prayed for complete recovery of patients. The clinical trial was double blind; neither the hospital staff nor the patients knew who was being prayed for. The findings were reported at the American College of Cardiology's second annual conference on the integration of complementary medicine into cardiology and showed no significant differences in the recovery and health between the two groups. Olshansky and Dossey cite an earlier study by this same group as supporting their thesis. However, this also found no significant differences between the two groups on any of the 18 outcomes.5 These results seem to conflict with the hypothesis, not support it.
Next, consider the study by Harris et al that examined the effects of intercessory prayer on clinical outcomes of 466 people who were prayed for and 524 who had usual care.6 This study found a difference in only 1 of 35 individual comparisons (P = 0.03 for that measure) and a significant difference (weighted score 6.4 v 7.1, P = 0.04) for the primary outcome of overall complications. No differences were found on a global measure (Byrd score) or on length of hospital stay. The significance for the difference on the primary outcome was reduced (6.2 v 7.0, P = 0.05) when corrections were made in response to letters to the editor.7
Finally, the first study that Olshansky and Dossey reference examined the effects of distant healing, including prayer and psychic healing, on health outcomes over six months in patients with AIDS.8 Outcomes, as reported in the article, were new AIDS defining illnesses, illness severity, doctor visits, hospital admissions, days in hospital, and mood scores. All outcomes were marginally (but significantly) better in the 20 participants randomised to distant healing than in the 20 control participants.
After one of the lead authors (Targ) died, however, a reporter discovered some disturbing information about how the study was done.9 The study was designed to measure mortality, not AIDS related illnesses or other cited outcomes. When the authors broke the blinding and found no difference in mortality (because of a low number of deaths), they scoured the data for differences on secondary measures such as HIV physical symptoms and quality of life. When these analyses showed no differences between groups, they analysed other outcomes (P values were not corrected for these multiple comparisons). They then decided to reblind the study and collect more data on outcomes by conducting a chart review (targeting AIDS related illnesses, doctors' visits, and hospital admissions). The chart review raises concern about bias since the two lead authors did the chart reviews themselves and thus failed to meet blindness criteria. The reported results are therefore probably an artefact of sifting and resifting of the data, unblinding and reblinding, and collecting new data in a questionable manner after the primary analysis until a result is found that supports the investigators original expectations. Such a study can hardly be set forth as exemplary.
The evidence reviewed by Olshansky and Dossey seems weak for an even ordinary scientific claim, let alone one that might support the extraordinary claim that prayer works retroactively or distantly. Now we will show that quantum physics provides no basis to expect such a phenomenon.
Physical mechanisms
The notion that human consciousness can supervene the material principles of physics is often found in the literature on parapsychology and complementary medicine. Olshansky and Dossey refer to experiments by Schmidt in which humans attempt to mentally affect radioactive decays, which are inherently quantum events.10 Although Schmidt claims positive results, they are not significant and have not been replicated in the 35 years since his first experiments were reported.11 12
The claim that quantum mechanics implies that human consciousness can control physical reality can be traced to a misinterpretation of wave-particle duality.12 Popular, non-technical literature often reports that quantum mechanics shows that an object is either a wave or a particle, depending on what you measure. If you measure its wavelength, then it is a wave. If you measure its position, then it is a particle. Since measurement is an act of human consciousness, then the implication is that thought processes in fact determine reality. Human consciousness is also often invoked as the mechanism for the so called collapse of the wave function when a measurement is made. Again we can find no basis for this in quantum theory, where some formulations do not contain wave function collapse or even wave functions.
The popular picture of particles as somehow also being waves is an oversimplification used pedagogically to explain interference and diffraction effects in familiar terms. All experiments detect particles, and our theories describe these particles as the "quanta" of quantum fields and not as waves. This theoretical description does not imply a dual reality in which one form of reality is changed to another by the act of measurement or human thought. Olshansky and Dossey also suggest that modern quantum physics provides a plausible mechanism for the backward causality implied by retroactive prayer. Although the results of some quantum experiments may be interpreted as evidence for events in the future affecting events in the past at the quantum level, no theoretical basis exists for applying this notion on the macroscopic scale of human experience.13 14
The human body and its parts, such as cells that are normally considered microscopic, are too large and contain too many particles to exhibit quantum effects in their collective behaviour. For example, the motion of the neurotransmitters that carry signals across synapses and constitute part of the mechanism for our thinking processes can be described without recourse to quantum mechanics. Of course, the atoms in biological systems are quantum in nature, as are the atoms in rocks, but their collective behaviour does not exhibit any quantum effects. Although multiple body quantum systems, such as lasers and superconductors, exist, proposals that the brain is somehow a quantum device are not supported by any convincing evidence. What is more, even if the brain were a quantum system, that would not imply that it can break the laws of physics any more than electrons or photons, which are inarguably quanta.
Summary points
Claims have been made that prayer can act distant in space and time, including retroactively
Very few studies have been done on retroactive prayer
Studies on the effects of distant prayer are poorly designed and have weak results
Current scientific theory does not support effectual benefit of prayer distant in space or time
Olshansky and Dossey use the term "non-local."1 15 Non-locality refers to the apparent faster than light correlations exhibited between separated parts of some quantum systems. It is interesting that the problem of non-locality disappears when we allow backward causality, exactly the phenomenon that Olshansky and Dossey are attempting to exploit.12 16 They can't have both. In any case, while non-locality and backward causality remain controversial topics in discussions on the philosophical foundations of quantum mechanics, they have little to do with religion, medicine, or parapsychology.
Conclusions
Health research using spirituality occurs in two types. One type of research examines the effects that religious or spiritual beliefs and practices have on mental and physical health through psychological, social, and physiological mechanisms that are well established in the traditional social, behavioural, and medical sciences.17-19 In this research, no appeal to extraordinary mechanisms is made. We need apply only ordinary psychological, social, or physiological phenomena. Health benefits might reasonably result from the comforting belief that a spiritual world exists, even if it does not. Psychological and behavioural factors have well established health effects, so it is not a far step to accept that spiritual belief, or perhaps non-belief, also has health consequences.
Until recently, the scientific community has been sceptical that religious and spiritual factors can be quantified. Lately, however, methods have been developed to assess religiosity and spiritual beliefs. Some doubt remains on whether the methods are adequate or whether what science means by religious or spiritual beliefs is the same as what religious or spiritual traditions mean by these beliefs.20 Yet, religiosity and spirituality can be reasonably related to health outcomes similar to other psychosocial factors. Within a scientific framework, the benefits of prayer might also be attributed to these factors.
The claims put forward by Olshansky and Dossey are quite different from health outcomes research, which might reasonably be related to religion or spirituality. They argue that prayer might be used instrumentally to bring about desired effects in the world at a distance of space and time. The studies they cite have very little or nothing to do with established psychological, social, or behavioural pathways. Firstly, the findings from human studies which Olshansky and Dossey cite are hardly robust; in places, they are clinically insignificant in terms of effect size and not uncommonly steeped in controversy. Secondly, they call on theoretical mechanisms that have, at best, a questionable connection to medicine. Without plausible mechanism, abundant data with strong significance is necessary. That evidence does not exist.
--------------------------------------------------------------------------------
Contributors and sources: JPB is an internist, philosopher, and Episcopal priest. He wrote the introduction, clinical science section, and conclusion. VJS is professor emeritus of physics at the University of Hawaii and has published extensively on science and religion. He wrote the physical mechanisms section and the conclusion.
Competing interests: None declared.
References
Leibovici L. Effects of remote, retroactive intercessory prayer on outcomes in patients with bloodstream infections: a controlled trial. BMJ 2001;323: 1450-1.[Abstract/Free Full Text]
Leibovici L. Author's comments [Electronic response to: Effects of remote, retroactive intercessory prayer on outcomes in patients with bloodstream infections BMJ 2001]. http://bmj.com/cgi/content/full/324/7344/1037#art
Olshansky B, Dossey L. Retroactive prayer: a preposterous hypothesis? BMJ 2003;327: 1465-8.[Free Full Text]
Petre J. Power of prayer found wanting in hospital trial. Daily Telegraph 2003; Oct 15.
Krucoff MW, Crater SW, Green CL, Maas AC, Seskevich JE, Lane JD, et al. Integrative noetic therapies as adjuncts to percutaneous intervention during unstable coronary syndromes: monitoring and actualization of noetic training (MANTRA) feasibility pilot. Am Heart J 2001;142: 760-9.[CrossRef][ISI][Medline]
Harris WS, Gowda M, Kolb JW, Strychacz CP, Vacek JL, Jones PG, et al. The randomized, controlled trial of the effects of remote, intercessory prayer on outcomes in patients admitted to the coronary care unit. Arch Intern Med 1999;159: 2273-8.[Abstract/Free Full Text]
Harris WS, Gowda M, Kolb JW, Strychacz CP, Vacek JL, Jones PG, et al. A randomized, controlled trial of the effects of remote, intercessory prayer on outcomes in patients admitted to the coronary care unit: correction. Arch Intern Med 2000;160: 1878.[Free Full Text]
Sicher F, Targ E, Moore D 2nd, Smith HS. A randomized double-blind study of the effect of distant healing in a population with advanced AIDS: report of a small-scale study. West J Med 1998;169: 356-63.[ISI][Medline]
Bronson P. A prayer before dying. Wired 2002;10. www.wired.com/wired/archive/10.12/prayer_pr.html (accessed 14 Oct 2004).
Schmidt H. Collapse of the state vector and psychokinetic effect. FoundPhysics 1982;12: 565-81.
Druckman D, Swets JA, eds. Enhancing human performance: issues, theories, and techniques. Washington, DC: National Academy Press, 1987.
Stenger VJ. Physics and psychics: the search for a world beyond the senses. Amherst, NY: Prometheus Books, 1990.
Price H. Time's arrow and archimedes point: new directions for the physics of time. Oxford: Oxford University Press, 1996.
Stenger VJ. Timeless reality: symmetry, simplicity, and multiple universes. Amherst, NY: Prometheus Books, 2000.
Dossey L. Reinventing medicine: beyond mind-body to a new era of healing. San Francisco: Harper, 1999.
Costa de Beauregard O. Une response á l'argument dirige par Einstein. Podolsky et Rosen contre l'interpretaton bohrienne de phenomenes quantiques. Comptes Rendus 1953;236: 1632-4.[ISI]
Koenig HG, McCullough M, Larson D. Handbook of religion and health. New York: Oxford University Press, 2003.
Mueller PS, Plevak DJ, Rummans TA. Religious involvement, spirituality, and medicine: implications for clinical practice. Mayo Clin Proc 2001;76: 1225-35.[ISI][Medline]
George LK, Ellison CG, Larson DB. Explaining the relationships between religious involvement and health. Psychol Inq 2002;13: 190-200.[CrossRef][ISI]
Bishop JP. Prayer, science and the moral life of medicine. Arch Intern Med 2003;163: 1405-8.[Free Full Text]
BMJ 2004;329:1444-1446 (18 December), doi:10.1136/bmj.329.7480.1444
Many claims are made for the power of prayer, but the idea that it could work retrospectively has caused considerable controversy. It is also beyond current scientific knowledge
Leibocivi first raised the possibility of retroactive prayer in 2001. He reported a study that showed prayer done for patients well after they had left the hospital, had reduced the length of stay in hospital and duration of fever from blood stream infections.1 In short, prayer somehow seemed to act backward in time to shorten patients' stay in the hospital. The study was intended lightheartedly to illustrate the importance of asking research questions that fit with the scientific model of the world.2 Olshansky and Dossey subsequently argued that a logical explanation might be found for Leibovici's results.3 They point to numerous other randomised controlled trails to support their thesis that prayer could work at a distance of space and that it might be plausible that prayer could act retroactively in time. We argue that their claim is built on a confusion and lacks a deep physical model. There is considerable fogginess about what science means in relation to the world of spirituality, and we wish to throw some light on the subject.
Examining the clinical science
The latest reported clinical trial of intercessory prayer is a three year study of 750 patients in nine hospitals and 12 prayer groups from around the world, including lay and monastic Christians, Sufi Muslims, and Buddhist monks.4 Prayers were even emailed to Jerusalem and placed in the Wailing Wall. Patients awaiting angioplasty for coronary artery obstruction were selected at random by computer and sent to the 12 prayer groups. The prayer groups prayed for complete recovery of patients. The clinical trial was double blind; neither the hospital staff nor the patients knew who was being prayed for. The findings were reported at the American College of Cardiology's second annual conference on the integration of complementary medicine into cardiology and showed no significant differences in the recovery and health between the two groups. Olshansky and Dossey cite an earlier study by this same group as supporting their thesis. However, this also found no significant differences between the two groups on any of the 18 outcomes.5 These results seem to conflict with the hypothesis, not support it.
Next, consider the study by Harris et al that examined the effects of intercessory prayer on clinical outcomes of 466 people who were prayed for and 524 who had usual care.6 This study found a difference in only 1 of 35 individual comparisons (P = 0.03 for that measure) and a significant difference (weighted score 6.4 v 7.1, P = 0.04) for the primary outcome of overall complications. No differences were found on a global measure (Byrd score) or on length of hospital stay. The significance for the difference on the primary outcome was reduced (6.2 v 7.0, P = 0.05) when corrections were made in response to letters to the editor.7
Finally, the first study that Olshansky and Dossey reference examined the effects of distant healing, including prayer and psychic healing, on health outcomes over six months in patients with AIDS.8 Outcomes, as reported in the article, were new AIDS defining illnesses, illness severity, doctor visits, hospital admissions, days in hospital, and mood scores. All outcomes were marginally (but significantly) better in the 20 participants randomised to distant healing than in the 20 control participants.
After one of the lead authors (Targ) died, however, a reporter discovered some disturbing information about how the study was done.9 The study was designed to measure mortality, not AIDS related illnesses or other cited outcomes. When the authors broke the blinding and found no difference in mortality (because of a low number of deaths), they scoured the data for differences on secondary measures such as HIV physical symptoms and quality of life. When these analyses showed no differences between groups, they analysed other outcomes (P values were not corrected for these multiple comparisons). They then decided to reblind the study and collect more data on outcomes by conducting a chart review (targeting AIDS related illnesses, doctors' visits, and hospital admissions). The chart review raises concern about bias since the two lead authors did the chart reviews themselves and thus failed to meet blindness criteria. The reported results are therefore probably an artefact of sifting and resifting of the data, unblinding and reblinding, and collecting new data in a questionable manner after the primary analysis until a result is found that supports the investigators original expectations. Such a study can hardly be set forth as exemplary.
The evidence reviewed by Olshansky and Dossey seems weak for an even ordinary scientific claim, let alone one that might support the extraordinary claim that prayer works retroactively or distantly. Now we will show that quantum physics provides no basis to expect such a phenomenon.
Physical mechanisms
The notion that human consciousness can supervene the material principles of physics is often found in the literature on parapsychology and complementary medicine. Olshansky and Dossey refer to experiments by Schmidt in which humans attempt to mentally affect radioactive decays, which are inherently quantum events.10 Although Schmidt claims positive results, they are not significant and have not been replicated in the 35 years since his first experiments were reported.11 12
The claim that quantum mechanics implies that human consciousness can control physical reality can be traced to a misinterpretation of wave-particle duality.12 Popular, non-technical literature often reports that quantum mechanics shows that an object is either a wave or a particle, depending on what you measure. If you measure its wavelength, then it is a wave. If you measure its position, then it is a particle. Since measurement is an act of human consciousness, then the implication is that thought processes in fact determine reality. Human consciousness is also often invoked as the mechanism for the so called collapse of the wave function when a measurement is made. Again we can find no basis for this in quantum theory, where some formulations do not contain wave function collapse or even wave functions.
The popular picture of particles as somehow also being waves is an oversimplification used pedagogically to explain interference and diffraction effects in familiar terms. All experiments detect particles, and our theories describe these particles as the "quanta" of quantum fields and not as waves. This theoretical description does not imply a dual reality in which one form of reality is changed to another by the act of measurement or human thought. Olshansky and Dossey also suggest that modern quantum physics provides a plausible mechanism for the backward causality implied by retroactive prayer. Although the results of some quantum experiments may be interpreted as evidence for events in the future affecting events in the past at the quantum level, no theoretical basis exists for applying this notion on the macroscopic scale of human experience.13 14
The human body and its parts, such as cells that are normally considered microscopic, are too large and contain too many particles to exhibit quantum effects in their collective behaviour. For example, the motion of the neurotransmitters that carry signals across synapses and constitute part of the mechanism for our thinking processes can be described without recourse to quantum mechanics. Of course, the atoms in biological systems are quantum in nature, as are the atoms in rocks, but their collective behaviour does not exhibit any quantum effects. Although multiple body quantum systems, such as lasers and superconductors, exist, proposals that the brain is somehow a quantum device are not supported by any convincing evidence. What is more, even if the brain were a quantum system, that would not imply that it can break the laws of physics any more than electrons or photons, which are inarguably quanta.
Summary points
Claims have been made that prayer can act distant in space and time, including retroactively
Very few studies have been done on retroactive prayer
Studies on the effects of distant prayer are poorly designed and have weak results
Current scientific theory does not support effectual benefit of prayer distant in space or time
Olshansky and Dossey use the term "non-local."1 15 Non-locality refers to the apparent faster than light correlations exhibited between separated parts of some quantum systems. It is interesting that the problem of non-locality disappears when we allow backward causality, exactly the phenomenon that Olshansky and Dossey are attempting to exploit.12 16 They can't have both. In any case, while non-locality and backward causality remain controversial topics in discussions on the philosophical foundations of quantum mechanics, they have little to do with religion, medicine, or parapsychology.
Conclusions
Health research using spirituality occurs in two types. One type of research examines the effects that religious or spiritual beliefs and practices have on mental and physical health through psychological, social, and physiological mechanisms that are well established in the traditional social, behavioural, and medical sciences.17-19 In this research, no appeal to extraordinary mechanisms is made. We need apply only ordinary psychological, social, or physiological phenomena. Health benefits might reasonably result from the comforting belief that a spiritual world exists, even if it does not. Psychological and behavioural factors have well established health effects, so it is not a far step to accept that spiritual belief, or perhaps non-belief, also has health consequences.
Until recently, the scientific community has been sceptical that religious and spiritual factors can be quantified. Lately, however, methods have been developed to assess religiosity and spiritual beliefs. Some doubt remains on whether the methods are adequate or whether what science means by religious or spiritual beliefs is the same as what religious or spiritual traditions mean by these beliefs.20 Yet, religiosity and spirituality can be reasonably related to health outcomes similar to other psychosocial factors. Within a scientific framework, the benefits of prayer might also be attributed to these factors.
The claims put forward by Olshansky and Dossey are quite different from health outcomes research, which might reasonably be related to religion or spirituality. They argue that prayer might be used instrumentally to bring about desired effects in the world at a distance of space and time. The studies they cite have very little or nothing to do with established psychological, social, or behavioural pathways. Firstly, the findings from human studies which Olshansky and Dossey cite are hardly robust; in places, they are clinically insignificant in terms of effect size and not uncommonly steeped in controversy. Secondly, they call on theoretical mechanisms that have, at best, a questionable connection to medicine. Without plausible mechanism, abundant data with strong significance is necessary. That evidence does not exist.
--------------------------------------------------------------------------------
Contributors and sources: JPB is an internist, philosopher, and Episcopal priest. He wrote the introduction, clinical science section, and conclusion. VJS is professor emeritus of physics at the University of Hawaii and has published extensively on science and religion. He wrote the physical mechanisms section and the conclusion.
Competing interests: None declared.
References
Leibovici L. Effects of remote, retroactive intercessory prayer on outcomes in patients with bloodstream infections: a controlled trial. BMJ 2001;323: 1450-1.[Abstract/Free Full Text]
Leibovici L. Author's comments [Electronic response to: Effects of remote, retroactive intercessory prayer on outcomes in patients with bloodstream infections BMJ 2001]. http://bmj.com/cgi/content/full/324/7344/1037#art
Olshansky B, Dossey L. Retroactive prayer: a preposterous hypothesis? BMJ 2003;327: 1465-8.[Free Full Text]
Petre J. Power of prayer found wanting in hospital trial. Daily Telegraph 2003; Oct 15.
Krucoff MW, Crater SW, Green CL, Maas AC, Seskevich JE, Lane JD, et al. Integrative noetic therapies as adjuncts to percutaneous intervention during unstable coronary syndromes: monitoring and actualization of noetic training (MANTRA) feasibility pilot. Am Heart J 2001;142: 760-9.[CrossRef][ISI][Medline]
Harris WS, Gowda M, Kolb JW, Strychacz CP, Vacek JL, Jones PG, et al. The randomized, controlled trial of the effects of remote, intercessory prayer on outcomes in patients admitted to the coronary care unit. Arch Intern Med 1999;159: 2273-8.[Abstract/Free Full Text]
Harris WS, Gowda M, Kolb JW, Strychacz CP, Vacek JL, Jones PG, et al. A randomized, controlled trial of the effects of remote, intercessory prayer on outcomes in patients admitted to the coronary care unit: correction. Arch Intern Med 2000;160: 1878.[Free Full Text]
Sicher F, Targ E, Moore D 2nd, Smith HS. A randomized double-blind study of the effect of distant healing in a population with advanced AIDS: report of a small-scale study. West J Med 1998;169: 356-63.[ISI][Medline]
Bronson P. A prayer before dying. Wired 2002;10. www.wired.com/wired/archive/10.12/prayer_pr.html (accessed 14 Oct 2004).
Schmidt H. Collapse of the state vector and psychokinetic effect. FoundPhysics 1982;12: 565-81.
Druckman D, Swets JA, eds. Enhancing human performance: issues, theories, and techniques. Washington, DC: National Academy Press, 1987.
Stenger VJ. Physics and psychics: the search for a world beyond the senses. Amherst, NY: Prometheus Books, 1990.
Price H. Time's arrow and archimedes point: new directions for the physics of time. Oxford: Oxford University Press, 1996.
Stenger VJ. Timeless reality: symmetry, simplicity, and multiple universes. Amherst, NY: Prometheus Books, 2000.
Dossey L. Reinventing medicine: beyond mind-body to a new era of healing. San Francisco: Harper, 1999.
Costa de Beauregard O. Une response á l'argument dirige par Einstein. Podolsky et Rosen contre l'interpretaton bohrienne de phenomenes quantiques. Comptes Rendus 1953;236: 1632-4.[ISI]
Koenig HG, McCullough M, Larson D. Handbook of religion and health. New York: Oxford University Press, 2003.
Mueller PS, Plevak DJ, Rummans TA. Religious involvement, spirituality, and medicine: implications for clinical practice. Mayo Clin Proc 2001;76: 1225-35.[ISI][Medline]
George LK, Ellison CG, Larson DB. Explaining the relationships between religious involvement and health. Psychol Inq 2002;13: 190-200.[CrossRef][ISI]
Bishop JP. Prayer, science and the moral life of medicine. Arch Intern Med 2003;163: 1405-8.[Free Full Text]
- malernee
- Site Admin
- Posts: 462
- Joined: Wed Aug 13, 2003 5:56 pm
recently adopted "AVMA Guidelines for Alternative medic
by guest » Wed Mar 30, 2005 9:03 pm
Letter to the AVMA
-------------------------------------------------------------------------
John I. Freeman, DVM
President, American Veterinary Medical Association
Pocomoke Rd.
Franklinton, NC 27525
Dr. Freeman,
A growing number of veterinarians have registered concern over the recently adopted "AVMA Guidelines for Alternative and Complementary Veterinary Medicine." In October of 1997 the National Council Against Health Fraud established a special task force to deal with the issues of pseudoscience, critical thinking, and health fraud in veterinary medicine. The mission of the NCAHF Task Force on Veterinary Pseudoscience is to promote animal health and welfare, to protect consumers from fraudulent, unsafe, and unproven veterinary practices, to promote science-based medicine and the critical examination of medical claims and to provide sound information and leadership to veterinary practitioners and their clients.
We believe the honest and rigorous scientific examination of new and unconventional ideas, claims and therapies is absolutely essential to the sound future of medical practice. Therefore, we support such rigorous investigation. Furthermore, when the preponderance of evidence from properly designed and implemented studies supports the efficacy and safety of a particular "alternative" therapy, said therapy should be embraced by the veterinary profession. Likewise, if it fails to meet this standard, it should be repudiated by the profession.
In keeping with these principles, we hereby request that we be allowed to take an active part in any future consideration by the AVMA of their 1996 "Guidelines for Alternative and Complementary Veterinary Medicine."
We object to the current "Guidelines" on several grounds including the following:
1. They contain inaccurate and misleading statements (several of which are cited below.)
2. The "Guidelines," in fact, condone and promote the general employment of unproven and scientifically untenable therapies without prior, rigorous scientific validation. Therefore, they are not in the best interest of either the consuming public or the veterinary profession. As consumer advocates, we believe they constitute a "breach of contract" by the AVMA with the public interest.
3. While the "Guidelines" emphasize our responsibility as practitioners to employ "alternative" therapies only on the basis of "a valid veterinarian/client/patient relationship," only after obtaining "education in their proper use," no mention whatever is made of our responsibility to base any therapy we employ on the best available science. In fact, the word "science" appears exactly nowhere in the "Guidelines." We believe this is a telling omission.
4. The "Guidelines" state: "Veterinary acupuncture and acutherapy are now considered an integral part of veterinary medicine." They are? "Considered integral" by whom?… by advocates of acupuncture therapy?… by veterinary acupuncturists? How did the "Guidelines" committee or the Board determine that acupuncture is "considered an integral part of veterinary medicine"? We don't believe "rank and file" veterinarians have ever taken a vote on this issue. If the committee means that acupuncture is "considered integral" in the same sense that, in a pre-scientific age, "bleeding," purgatives, and mercurial "therapy" were "considered integral parts" of human medicine merely because they were widely employed, we would have to agree. On the other hand, if they mean that science-based veterinary medicine has embraced acupuncture on the basis of scientific support for its efficacy, we strongly disagree. We object to the notion that, merely because unproven and scientifically untenable therapies have become "popular" among some practitioners, they have "become an integral part of veterinary medicine." The most rigorous scientific data available, based on properly designed and controlled studies, suggest that alleged acupuncture efficacy is due almost entirely to a very potent placebo effect.*
5. The "Guidelines" state: "… sufficient research exists documenting efficacy of chiropractic in humans…" This statement is simply wrong. The best available science strongly indicates that chiropractic "subluxations" are imaginary and that the alleged benefits from chiropractic manipulation are due to the placebo effect.*
6. In several places, the "Guidelines" recommend that "further research be conducted… to evaluate efficacy." We feel it's inappropriate, irresponsible, and against the public interest for the AVMA to condone the general employment of any therapy until and unless its efficacy has been clearly and unequivocally established by means of rigorous, objective science. Most of the modalities cited in the "Guidelines" have, to date, clearly failed to met this criterion.
7. The "Guidelines" state that, in homeopathy, patients are treated "by the administration of substances that are capable of producing clinical signs in healthy animals… These substances are used therapeutically in minute doses." This is not entirely true. According to homeopaths, by virtue of the alleged "Law of Infinitesimals," "medications" which contain not a single molecule of "solute" (i.e. the "substance on the label") constitute the most potent (or highly "potentized") homeopathic "medications." Therefore, the patient is literally being treated by the absence of the ingredient on the label. Homeopathy is clearly a pseudoscientific medical cult based on the "revelations" of 18th Century physician and eccentric Samuel Hahnemann. Its tenets are steeped in mysticism and have no basis in bona fide science. The most rigorous scientific trials have failed to demonstrate any "homeopathic effect" beyond placebo.*
8. In view of these and other points, contrary to condoning unproven and scientifically questionable therapies and practices, we feel the AVMA has a moral and ethical responsibility to take a pro-active stand against their employment outside of formal scientific research programs.
9. We suspect that, in part, the guidelines were adopted to provide some legal protection to practitioners who employ "alternative" and otherwise unproven therapies. We believe this effort is ill-advised, counter-productive, and will ultimately fail. Including unproven and unscientific therapies under the "standard of practice" umbrella, merely serves to lower that standard and make the AVMA, itself, vulnerable to liability. Furthermore, it seems unlikely to provide much protection to practitioners guilty of employing unproven and unscientific therapies, and could be construed as making the AVMA a party to such behavior. The public has a right to expect and to demand that veterinary practice be based on the highest quality science available, and the veterinary profession has a moral and ethical obligation to provide such science-based medicine. We feel the AVMA can best serve and protect both the public, and the veterinary profession by issuing the simple, firm caveat "avoid unproven and unscientific therapies."
10. We believe that rigorous science, rather than popularity, metaphysical appeal, or social/fiscal considerations should be the final arbiter of what is and is not deemed acceptable therapy and/or practice by the AVMA.
11. By "exempting" veterinary practitioners from any requirement for scientific rigor, the AVMA has in effect "exempted" itself from serious consideration by the scientific community. They have, thereby, diminished the scientific standing of the entire profession. Science and the scientific community have little regard for "what is popular" or "what is metaphysically pleasing." A professional organization cannot acquiesce to bad science, pseudoscience, or anti-science, and expect not to be "tarred by the same brush" when the scientific community repudiates the nonsense - as it must inevitably do. We feel the "Guidelines" constitute an effort by the Association to "promote 'inclusiveness' among all practitioners - science-based and otherwise" while at the same time maintaining "scientific respectability." The reality is, you can't have it both ways. We are convinced the AVMA has promoted this "inclusiveness" at the expense of "scientific respectability." As advocates of rigorous Veterinary Science, we find this situation unacceptable.
12. We suspect the Committee on Alternative and Complementary Therapies was unduly swayed by questionable and unreliable information provided by "advocates" of said therapies rather than by objective, scientific investigators of "alternative" therapeutic claims. This is not difficult to understand since the great bulk of existent "alt med" literature has been produced by practitioners and advocates of such therapies. (It seems unlikely that, under any circumstances, a practitioner already employing -- and therefore committed to -- such practices without "prior scientific proof of efficacy" would be inclined to advise the committee that they are a "bad idea.")
A small but growing body of rigorous, critical, and genuinely scientific literature is available on the subject of "alternative" and "complementary" medicine. We hope, in the future, we can help any committee charged with reviewing "alternative" and/or "complementary" therapies by availing them of not only critical literature and the best scientific evidence available, but also expert opinion from "non-advocate" scientists and veterinarians.
The original Committee on Alternative and Complementary Therapies recommended that the Guidelines be reviewed within three years (before mid-June of 1999). We agree whole-heartedly, and look forward to taking part in the review process. We hope that one or more Task Force members might be named to sit on any committee designated to that end. If such a review process has not yet been initiated, we urge you and the Executive Board to address the situation in the near future.
We look forward to your response.
Sincerely,
Robert Imrie, DVM
coordinator
NCAHF Task Force on Veterinary Pseudoscience
David W. Ramey, DVM
equine advisor
NCAHF Task Force on Veterinary Pseudoscience
*references available on request
cc: Harmon A Rogers (Dist. XI Delegate)
Stanley Held (Chairman, Committee on Alt. and Comp. Vet. Med)
J Clyde Johnson (Chairman, Judicial Council)
Robert W Fulton (Chairman, Council on Research)
Janver Krehbiel (Chairman, Committee on Veterinary Informatics)
Samuel E Strahm (Chairman, AVM Foundation Directors)
J Karl Wise (Director of Information Management)
Lyle P Vogel (Director, Scientific Activities Division)
Janis A Audin (Editor-In-Chief, JAVMA)
Craig A Smith (Assistant Editor, Publications Division, JAVMA)
William Jarvis, (Executive Director, National Council Against Health Fraud)
Stephen Barrett, (Co-Chair., Paranormal Health Claims Sub-Committee, CSICOP)
James Randi (Chairman, James Randi Educational Foundation)
Wallace Sampson (Editor, Scientific Review of Alternative Medicine)
Alan Moghissi (Chairman, American Council for Science and Health)
Michael Shermer, (Director, Skeptics Society)
-------------------------------------------------------------------------
John I. Freeman, DVM
President, American Veterinary Medical Association
Pocomoke Rd.
Franklinton, NC 27525
Dr. Freeman,
A growing number of veterinarians have registered concern over the recently adopted "AVMA Guidelines for Alternative and Complementary Veterinary Medicine." In October of 1997 the National Council Against Health Fraud established a special task force to deal with the issues of pseudoscience, critical thinking, and health fraud in veterinary medicine. The mission of the NCAHF Task Force on Veterinary Pseudoscience is to promote animal health and welfare, to protect consumers from fraudulent, unsafe, and unproven veterinary practices, to promote science-based medicine and the critical examination of medical claims and to provide sound information and leadership to veterinary practitioners and their clients.
We believe the honest and rigorous scientific examination of new and unconventional ideas, claims and therapies is absolutely essential to the sound future of medical practice. Therefore, we support such rigorous investigation. Furthermore, when the preponderance of evidence from properly designed and implemented studies supports the efficacy and safety of a particular "alternative" therapy, said therapy should be embraced by the veterinary profession. Likewise, if it fails to meet this standard, it should be repudiated by the profession.
In keeping with these principles, we hereby request that we be allowed to take an active part in any future consideration by the AVMA of their 1996 "Guidelines for Alternative and Complementary Veterinary Medicine."
We object to the current "Guidelines" on several grounds including the following:
1. They contain inaccurate and misleading statements (several of which are cited below.)
2. The "Guidelines," in fact, condone and promote the general employment of unproven and scientifically untenable therapies without prior, rigorous scientific validation. Therefore, they are not in the best interest of either the consuming public or the veterinary profession. As consumer advocates, we believe they constitute a "breach of contract" by the AVMA with the public interest.
3. While the "Guidelines" emphasize our responsibility as practitioners to employ "alternative" therapies only on the basis of "a valid veterinarian/client/patient relationship," only after obtaining "education in their proper use," no mention whatever is made of our responsibility to base any therapy we employ on the best available science. In fact, the word "science" appears exactly nowhere in the "Guidelines." We believe this is a telling omission.
4. The "Guidelines" state: "Veterinary acupuncture and acutherapy are now considered an integral part of veterinary medicine." They are? "Considered integral" by whom?… by advocates of acupuncture therapy?… by veterinary acupuncturists? How did the "Guidelines" committee or the Board determine that acupuncture is "considered an integral part of veterinary medicine"? We don't believe "rank and file" veterinarians have ever taken a vote on this issue. If the committee means that acupuncture is "considered integral" in the same sense that, in a pre-scientific age, "bleeding," purgatives, and mercurial "therapy" were "considered integral parts" of human medicine merely because they were widely employed, we would have to agree. On the other hand, if they mean that science-based veterinary medicine has embraced acupuncture on the basis of scientific support for its efficacy, we strongly disagree. We object to the notion that, merely because unproven and scientifically untenable therapies have become "popular" among some practitioners, they have "become an integral part of veterinary medicine." The most rigorous scientific data available, based on properly designed and controlled studies, suggest that alleged acupuncture efficacy is due almost entirely to a very potent placebo effect.*
5. The "Guidelines" state: "… sufficient research exists documenting efficacy of chiropractic in humans…" This statement is simply wrong. The best available science strongly indicates that chiropractic "subluxations" are imaginary and that the alleged benefits from chiropractic manipulation are due to the placebo effect.*
6. In several places, the "Guidelines" recommend that "further research be conducted… to evaluate efficacy." We feel it's inappropriate, irresponsible, and against the public interest for the AVMA to condone the general employment of any therapy until and unless its efficacy has been clearly and unequivocally established by means of rigorous, objective science. Most of the modalities cited in the "Guidelines" have, to date, clearly failed to met this criterion.
7. The "Guidelines" state that, in homeopathy, patients are treated "by the administration of substances that are capable of producing clinical signs in healthy animals… These substances are used therapeutically in minute doses." This is not entirely true. According to homeopaths, by virtue of the alleged "Law of Infinitesimals," "medications" which contain not a single molecule of "solute" (i.e. the "substance on the label") constitute the most potent (or highly "potentized") homeopathic "medications." Therefore, the patient is literally being treated by the absence of the ingredient on the label. Homeopathy is clearly a pseudoscientific medical cult based on the "revelations" of 18th Century physician and eccentric Samuel Hahnemann. Its tenets are steeped in mysticism and have no basis in bona fide science. The most rigorous scientific trials have failed to demonstrate any "homeopathic effect" beyond placebo.*
8. In view of these and other points, contrary to condoning unproven and scientifically questionable therapies and practices, we feel the AVMA has a moral and ethical responsibility to take a pro-active stand against their employment outside of formal scientific research programs.
9. We suspect that, in part, the guidelines were adopted to provide some legal protection to practitioners who employ "alternative" and otherwise unproven therapies. We believe this effort is ill-advised, counter-productive, and will ultimately fail. Including unproven and unscientific therapies under the "standard of practice" umbrella, merely serves to lower that standard and make the AVMA, itself, vulnerable to liability. Furthermore, it seems unlikely to provide much protection to practitioners guilty of employing unproven and unscientific therapies, and could be construed as making the AVMA a party to such behavior. The public has a right to expect and to demand that veterinary practice be based on the highest quality science available, and the veterinary profession has a moral and ethical obligation to provide such science-based medicine. We feel the AVMA can best serve and protect both the public, and the veterinary profession by issuing the simple, firm caveat "avoid unproven and unscientific therapies."
10. We believe that rigorous science, rather than popularity, metaphysical appeal, or social/fiscal considerations should be the final arbiter of what is and is not deemed acceptable therapy and/or practice by the AVMA.
11. By "exempting" veterinary practitioners from any requirement for scientific rigor, the AVMA has in effect "exempted" itself from serious consideration by the scientific community. They have, thereby, diminished the scientific standing of the entire profession. Science and the scientific community have little regard for "what is popular" or "what is metaphysically pleasing." A professional organization cannot acquiesce to bad science, pseudoscience, or anti-science, and expect not to be "tarred by the same brush" when the scientific community repudiates the nonsense - as it must inevitably do. We feel the "Guidelines" constitute an effort by the Association to "promote 'inclusiveness' among all practitioners - science-based and otherwise" while at the same time maintaining "scientific respectability." The reality is, you can't have it both ways. We are convinced the AVMA has promoted this "inclusiveness" at the expense of "scientific respectability." As advocates of rigorous Veterinary Science, we find this situation unacceptable.
12. We suspect the Committee on Alternative and Complementary Therapies was unduly swayed by questionable and unreliable information provided by "advocates" of said therapies rather than by objective, scientific investigators of "alternative" therapeutic claims. This is not difficult to understand since the great bulk of existent "alt med" literature has been produced by practitioners and advocates of such therapies. (It seems unlikely that, under any circumstances, a practitioner already employing -- and therefore committed to -- such practices without "prior scientific proof of efficacy" would be inclined to advise the committee that they are a "bad idea.")
A small but growing body of rigorous, critical, and genuinely scientific literature is available on the subject of "alternative" and "complementary" medicine. We hope, in the future, we can help any committee charged with reviewing "alternative" and/or "complementary" therapies by availing them of not only critical literature and the best scientific evidence available, but also expert opinion from "non-advocate" scientists and veterinarians.
The original Committee on Alternative and Complementary Therapies recommended that the Guidelines be reviewed within three years (before mid-June of 1999). We agree whole-heartedly, and look forward to taking part in the review process. We hope that one or more Task Force members might be named to sit on any committee designated to that end. If such a review process has not yet been initiated, we urge you and the Executive Board to address the situation in the near future.
We look forward to your response.
Sincerely,
Robert Imrie, DVM
coordinator
NCAHF Task Force on Veterinary Pseudoscience
David W. Ramey, DVM
equine advisor
NCAHF Task Force on Veterinary Pseudoscience
*references available on request
cc: Harmon A Rogers (Dist. XI Delegate)
Stanley Held (Chairman, Committee on Alt. and Comp. Vet. Med)
J Clyde Johnson (Chairman, Judicial Council)
Robert W Fulton (Chairman, Council on Research)
Janver Krehbiel (Chairman, Committee on Veterinary Informatics)
Samuel E Strahm (Chairman, AVM Foundation Directors)
J Karl Wise (Director of Information Management)
Lyle P Vogel (Director, Scientific Activities Division)
Janis A Audin (Editor-In-Chief, JAVMA)
Craig A Smith (Assistant Editor, Publications Division, JAVMA)
William Jarvis, (Executive Director, National Council Against Health Fraud)
Stephen Barrett, (Co-Chair., Paranormal Health Claims Sub-Committee, CSICOP)
James Randi (Chairman, James Randi Educational Foundation)
Wallace Sampson (Editor, Scientific Review of Alternative Medicine)
Alan Moghissi (Chairman, American Council for Science and Health)
Michael Shermer, (Director, Skeptics Society)
- guest
Double-blind evaluation of acupuncture in dogs
by malernee » Sat Aug 13, 2005 11:08 am
Double-blind evaluation of implants of gold wire at acupuncture points in the dog as a treatment for osteoarthritis induced by hip dysplasia.
Vet Rec 149[15]:452-6 2001 Oct 13
Hielm-Bjorkman A, Raekallio M, Kuusela E, Saarto E, Markkola A, Tulamo RM
Thirty-eight dogs with hip dysplasia were studied to evaluate the use of gold wire implants at acupuncture points around the hip joints. They were assigned at random into two groups of 19. In the treated group, gold wire was inserted through hypodermic needles at electrically found acupuncture points around both hips. In the control group, the areas were prepared in the same way but had only the skin pierced at sites which were not acupuncture points, with a needle of the same size as that used in the treated group. Over a period of six months the dogs were studied repeatedly by two veterinarians and by the dogs' owners who were unaware of the treatments the dogs had received; they assessed the dogs' locomotion, hip function and signs of pain. Radiographs were taken at the beginning and end of the study. Although the data collected from both groups by the veterinarians and the owners showed a significant improvement of locomotion and reduction in signs of pain (P=0.036 for the veterinary evaluation and locomotion and P=0.0001 and P=0.0034 for the owners' evaluation of locomotion and pain, respectively), there were no statistically significant differences between the treated and control groups (P=0.19 and P=0.41, P=0.24, respectively).
Vet Rec 149[15]:452-6 2001 Oct 13
Hielm-Bjorkman A, Raekallio M, Kuusela E, Saarto E, Markkola A, Tulamo RM
Thirty-eight dogs with hip dysplasia were studied to evaluate the use of gold wire implants at acupuncture points around the hip joints. They were assigned at random into two groups of 19. In the treated group, gold wire was inserted through hypodermic needles at electrically found acupuncture points around both hips. In the control group, the areas were prepared in the same way but had only the skin pierced at sites which were not acupuncture points, with a needle of the same size as that used in the treated group. Over a period of six months the dogs were studied repeatedly by two veterinarians and by the dogs' owners who were unaware of the treatments the dogs had received; they assessed the dogs' locomotion, hip function and signs of pain. Radiographs were taken at the beginning and end of the study. Although the data collected from both groups by the veterinarians and the owners showed a significant improvement of locomotion and reduction in signs of pain (P=0.036 for the veterinary evaluation and locomotion and P=0.0001 and P=0.0034 for the owners' evaluation of locomotion and pain, respectively), there were no statistically significant differences between the treated and control groups (P=0.19 and P=0.41, P=0.24, respectively).
- malernee
- Site Admin
- Posts: 462
- Joined: Wed Aug 13, 2003 5:56 pm
Comp-Alternative Medicine in the USA barrett MD book review
by guest » Tue Oct 18, 2005 11:42 am
NOTE: To view the article with Web enhancements, go to:
http://www.medscape.com/viewarticle/513139
--------------------------------------------------------------------------------
Book Review
Complementary and Alternative Medicine in the United States
Stephen Barrett, MD
Medscape General Medicine. 2005;7(4):16. ©2005 Medscape
Posted 10/18/2005
By the Institute of Medicine Committee on the Use of Complementary and Alternative Medicine by the American Public
National Academies Press
Copyright 2005
357 pages
ISBN: 0-309-09270-1$47.95 hardcover
Until recently, the prevailing scientific view has been that (1) health-related methods that are plausible should be tested with well-designed clinical trials; (2) the rest should be discarded; and (3) no method should be marketed, promulgated, or taught without proof that it is safe and effective.
Two events during the 1990s changed the above situation. One was the creation of a National Institutes of Health (NIH) entity whose actual purpose was to promote pseudoscientific methods. Since that time, hundreds of millions of dollars have been wasted on useless research, and scores of medical schools have established courses that promote quack methods.[1] The other event was the passage of the Dietary Supplement and Health Education Act (DSHEA), which greatly reduced the US Food and Drug Administration's (FDA's) ability to stop the marketing of herbs, dietary supplements, and other nondrug products that are unsafe or promoted with misleading claims.[2]
The combined effect of these 2 events and the development of the Internet have led to the greatest explosion of quackery that the world has ever seen. However, the "q" word has nearly vanished from the American scene and has been replaced by euphemistic slogans, such as "complementary and alternative medicine" (CAM).
In 2002, the NIH National Center for Complementary and Alternative Medicine (NCCAM) commissioned the Institute of Medicine (IOM) to investigate the use of "CAM therapies" by the American public, identify the major issues related to CAM research, and develop frameworks to guide future CAM research. The NCCAM also asked the IOM to explore things, such as "the shortage of highly skilled practitioners who are able to participate in scientific inquiry that meets NIH guidelines" and the incorporation of "successful approaches" into health professions education.
The project was deliberately crafted to avoid critiquing the methods themselves, listing those for which research would be a waste of money, or examining the quality of CAM teaching in medical schools.
The report's preface states that its authors "began with the question what do patients and health professionals need to know to make good decisions about the use of health care interventions, including CAM?" To me, the answer is very simple: accurate information. Methods that are plausible should be tested with well-designed clinical trials. The rest should be discarded. Despite all the alleged experts involved in its preparation, the IOM report does not contain a single word of criticism against methods that are sufficiently irrational to be discarded now. Instead, it makes broad, sweeping generalizations and attempts to set an agenda for the widespread adoption of "CAM" research and teaching.
This does not surprise me because the 17-person committee that was appointed to write it included at least 9 members with a financial conflict of interest, 5 of whom have received multiple grants from the NCCAM. At least 6 of the members either espouse, directly promote, or engage in pseudoscientific practices and had previously overstated CAM's value or promise.[3] Even worse, knowledgeable critics were excluded from membership on the committee, and the report's administrators did not permit testimony or invite review by anyone who might embarrass them by demanding that the report include appropriate criticism.
Most medical school teaching about CAM promotes its unscientific theories and practices. A survey of CAM curricula in 1995-1997 showed that only 4 of 56 course offerings were oriented toward criticism.[4] But instead of noting this problem, the committee merely recommended that more be taught.
CAM cannot be meaningfully defined because it is a marketing term that quackery proponents use as they please to make themselves sound respectable. But instead of recognizing this, the IOM committee adopted one of the many meaningless definitions and included a glossary of brief descriptions of about 120 methods derived from proponent claims. Enough is already known about 70% of these items to conclude that they should be discarded. (Palmistry, crystal therapy, trepanation, iridology, and various methods alleged to the manipulation of nonmaterial forces are stellar examples that deserve extinction.) However, the report does not criticize them or advise that they deserve no NIH research support.
In short, this is not a scientific report. It fulfilled self-serving questions asked by the sponsoring agency (NCCAM). It avoided the scientific questions that one expects the National Academies to address. It was prepared by a combination of individuals with economic conflicts of interest, ideologic devotion to the methods at issue, and a small number of academics who lack experience in detecting pseudoscience and misrepresentation. The report's only redeeming feature is its acknowledgment that the dietary supplement market is a mess. However, instead of concluding that the FDA cannot protect consumers unless DSHEA is repealed and the FDA is given powerful new tools, the committee made vague suggestions for "strengthening" it.
References
Sampson WI. Why the National Center for Complementary and Alternative Medicine (NCCAM) should be defunded. Quackwatch. December 10, 2002. Available at: http://www.quackwatch.org/01QuackeryRel ... nccam.html. Accessed September 30, 2005.
Barrett S. How the Dietary Supplement Health and Education Act of 1994 weakened the FDA. Quackwatch. June 8, 2000. Available at: http://www.quackwatch.org/02ConsumerPro ... dshea.html. Accessed September 30, 2005.
Barrett S. Some notes on the Institute of Medicine's panel on "complementary and alternative medicine." Quackwatch. January 15, 2005. Available at: http://www.quackwatch.org/iom. Accessed September 30, 2005.
Sampson WI. The need for educational reform in teaching about alternative therapies. Acad Med. 2001;76:248-250. Available at: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?
cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11242574&query_hl=1. Accessed September 30, 2005.
Stephen Barrett, MD, Board Chairman, Quackwatch, Inc., Allentown, Pennsylvania
Disclosure: Stephen Barrett, MD, has disclosed no relevant financial relationships.
http://www.medscape.com/viewarticle/513139
--------------------------------------------------------------------------------
Book Review
Complementary and Alternative Medicine in the United States
Stephen Barrett, MD
Medscape General Medicine. 2005;7(4):16. ©2005 Medscape
Posted 10/18/2005
By the Institute of Medicine Committee on the Use of Complementary and Alternative Medicine by the American Public
National Academies Press
Copyright 2005
357 pages
ISBN: 0-309-09270-1$47.95 hardcover
Until recently, the prevailing scientific view has been that (1) health-related methods that are plausible should be tested with well-designed clinical trials; (2) the rest should be discarded; and (3) no method should be marketed, promulgated, or taught without proof that it is safe and effective.
Two events during the 1990s changed the above situation. One was the creation of a National Institutes of Health (NIH) entity whose actual purpose was to promote pseudoscientific methods. Since that time, hundreds of millions of dollars have been wasted on useless research, and scores of medical schools have established courses that promote quack methods.[1] The other event was the passage of the Dietary Supplement and Health Education Act (DSHEA), which greatly reduced the US Food and Drug Administration's (FDA's) ability to stop the marketing of herbs, dietary supplements, and other nondrug products that are unsafe or promoted with misleading claims.[2]
The combined effect of these 2 events and the development of the Internet have led to the greatest explosion of quackery that the world has ever seen. However, the "q" word has nearly vanished from the American scene and has been replaced by euphemistic slogans, such as "complementary and alternative medicine" (CAM).
In 2002, the NIH National Center for Complementary and Alternative Medicine (NCCAM) commissioned the Institute of Medicine (IOM) to investigate the use of "CAM therapies" by the American public, identify the major issues related to CAM research, and develop frameworks to guide future CAM research. The NCCAM also asked the IOM to explore things, such as "the shortage of highly skilled practitioners who are able to participate in scientific inquiry that meets NIH guidelines" and the incorporation of "successful approaches" into health professions education.
The project was deliberately crafted to avoid critiquing the methods themselves, listing those for which research would be a waste of money, or examining the quality of CAM teaching in medical schools.
The report's preface states that its authors "began with the question what do patients and health professionals need to know to make good decisions about the use of health care interventions, including CAM?" To me, the answer is very simple: accurate information. Methods that are plausible should be tested with well-designed clinical trials. The rest should be discarded. Despite all the alleged experts involved in its preparation, the IOM report does not contain a single word of criticism against methods that are sufficiently irrational to be discarded now. Instead, it makes broad, sweeping generalizations and attempts to set an agenda for the widespread adoption of "CAM" research and teaching.
This does not surprise me because the 17-person committee that was appointed to write it included at least 9 members with a financial conflict of interest, 5 of whom have received multiple grants from the NCCAM. At least 6 of the members either espouse, directly promote, or engage in pseudoscientific practices and had previously overstated CAM's value or promise.[3] Even worse, knowledgeable critics were excluded from membership on the committee, and the report's administrators did not permit testimony or invite review by anyone who might embarrass them by demanding that the report include appropriate criticism.
Most medical school teaching about CAM promotes its unscientific theories and practices. A survey of CAM curricula in 1995-1997 showed that only 4 of 56 course offerings were oriented toward criticism.[4] But instead of noting this problem, the committee merely recommended that more be taught.
CAM cannot be meaningfully defined because it is a marketing term that quackery proponents use as they please to make themselves sound respectable. But instead of recognizing this, the IOM committee adopted one of the many meaningless definitions and included a glossary of brief descriptions of about 120 methods derived from proponent claims. Enough is already known about 70% of these items to conclude that they should be discarded. (Palmistry, crystal therapy, trepanation, iridology, and various methods alleged to the manipulation of nonmaterial forces are stellar examples that deserve extinction.) However, the report does not criticize them or advise that they deserve no NIH research support.
In short, this is not a scientific report. It fulfilled self-serving questions asked by the sponsoring agency (NCCAM). It avoided the scientific questions that one expects the National Academies to address. It was prepared by a combination of individuals with economic conflicts of interest, ideologic devotion to the methods at issue, and a small number of academics who lack experience in detecting pseudoscience and misrepresentation. The report's only redeeming feature is its acknowledgment that the dietary supplement market is a mess. However, instead of concluding that the FDA cannot protect consumers unless DSHEA is repealed and the FDA is given powerful new tools, the committee made vague suggestions for "strengthening" it.
References
Sampson WI. Why the National Center for Complementary and Alternative Medicine (NCCAM) should be defunded. Quackwatch. December 10, 2002. Available at: http://www.quackwatch.org/01QuackeryRel ... nccam.html. Accessed September 30, 2005.
Barrett S. How the Dietary Supplement Health and Education Act of 1994 weakened the FDA. Quackwatch. June 8, 2000. Available at: http://www.quackwatch.org/02ConsumerPro ... dshea.html. Accessed September 30, 2005.
Barrett S. Some notes on the Institute of Medicine's panel on "complementary and alternative medicine." Quackwatch. January 15, 2005. Available at: http://www.quackwatch.org/iom. Accessed September 30, 2005.
Sampson WI. The need for educational reform in teaching about alternative therapies. Acad Med. 2001;76:248-250. Available at: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?
cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11242574&query_hl=1. Accessed September 30, 2005.
Stephen Barrett, MD, Board Chairman, Quackwatch, Inc., Allentown, Pennsylvania
Disclosure: Stephen Barrett, MD, has disclosed no relevant financial relationships.
- guest
European veterinary specialist denounce alternative medicine
by guest » Mon Jan 23, 2006 1:27 pm
http://www.vetscite.org/publish/article ... index.html
17 January 2006
European veterinary specialists denounce alternative medicine
Marian C. Horzinek and Anjop Venker-van Haagen
In a review article in Veterinary Sciences Tomorrow (30 November 2004), F.J. van Sluijs, Head of the Department of Clinical Sciences of Companion Animals, Utrecht University, discussed the question whether homeopathy can withstand scientific testing. He concluded that the gold standard for the therapeutic effectiveness of a medication is the outcome of a randomized double-blind clinical trial, and that after 7 years of investigation there is still no evidence whatever that extremely diluted solutions of homeopathic substances have any effect.
What is the attitude of European associations of veterinary practitioners concerning the use of homeopathy in veterinary practice? The New Scientist (10 December 2005, http://press.newscientist.com/data/pdf/ ... 252908.pdf) reported some of their statements. On November 19, the Federation of Veterinarians in Europe (FVE) issued a policy statement urging its 200,000 members "to work only on the basis of scientifically proven and evidence-based methods and to stay away from non-evidence-based methods." The Swedish Veterinary Association banned its members from homeopathic practice decades ago, and its president stated that it is "absolutely unacceptable for vets to work without a scientific basis." UK's Royal College of Veterinary Surgeons (RCVS) rejects any suggestion that it supports homeopathy, but states that it takes a neutral stance. In early September the British Veterinary Association issued a statement attacking plans by the UK Medicines and Healthcare Product Regulatory Agency to license homeopathic medicines without demanding clinical trials. It looks like there is a move, at least by some associations, toward advice to eliminate homeopathy from veterinary practice.
Remarkably more robust is the announcement by the European veterinary specialists. The European Board of Veterinary Specialisation (EBVS), an organization which oversees veterinary specialization, is now officially moving against supplementary, alternative and complimentary medicine. In its meeting on April 16 and 17, 2005, this Board unanimously agreed on incorporation of the following statement into its Policies and Procedures: "The EBVS only recognizes scientific, evidence-based veterinary medicine which complies with animal welfare legislation. Specialists or Colleges who practice or support implausible treatment modalities with no proof of effectiveness run the risk of withdrawal of their specialist status. No credit points can be granted for education or training in these so-called supplementary, complementary and alternative treatment modalities. Failure of a college to comply with any of the Policies and Procedures of the EVBS may lead to the withdrawal of provisional or full recognition." In a comment to the New Scientist (10 December 2005) J.T. Lumeij, EBVS President, said: "The basics of homeopathy are not in agreement with science."
The tough standpoint of the EBVS banning the use of supplementary, complementary and alternative medicine in specialist practices in Europe is a courageous and necessary step and deserves the support of every veterinary scientist. On the other hand: are there not treatments and medications in veterinary medicine whose effectiveness still needs to be proven by evidence-based methods? The finger must be pointed in both directions...
17 January 2006
European veterinary specialists denounce alternative medicine
Marian C. Horzinek and Anjop Venker-van Haagen
In a review article in Veterinary Sciences Tomorrow (30 November 2004), F.J. van Sluijs, Head of the Department of Clinical Sciences of Companion Animals, Utrecht University, discussed the question whether homeopathy can withstand scientific testing. He concluded that the gold standard for the therapeutic effectiveness of a medication is the outcome of a randomized double-blind clinical trial, and that after 7 years of investigation there is still no evidence whatever that extremely diluted solutions of homeopathic substances have any effect.
What is the attitude of European associations of veterinary practitioners concerning the use of homeopathy in veterinary practice? The New Scientist (10 December 2005, http://press.newscientist.com/data/pdf/ ... 252908.pdf) reported some of their statements. On November 19, the Federation of Veterinarians in Europe (FVE) issued a policy statement urging its 200,000 members "to work only on the basis of scientifically proven and evidence-based methods and to stay away from non-evidence-based methods." The Swedish Veterinary Association banned its members from homeopathic practice decades ago, and its president stated that it is "absolutely unacceptable for vets to work without a scientific basis." UK's Royal College of Veterinary Surgeons (RCVS) rejects any suggestion that it supports homeopathy, but states that it takes a neutral stance. In early September the British Veterinary Association issued a statement attacking plans by the UK Medicines and Healthcare Product Regulatory Agency to license homeopathic medicines without demanding clinical trials. It looks like there is a move, at least by some associations, toward advice to eliminate homeopathy from veterinary practice.
Remarkably more robust is the announcement by the European veterinary specialists. The European Board of Veterinary Specialisation (EBVS), an organization which oversees veterinary specialization, is now officially moving against supplementary, alternative and complimentary medicine. In its meeting on April 16 and 17, 2005, this Board unanimously agreed on incorporation of the following statement into its Policies and Procedures: "The EBVS only recognizes scientific, evidence-based veterinary medicine which complies with animal welfare legislation. Specialists or Colleges who practice or support implausible treatment modalities with no proof of effectiveness run the risk of withdrawal of their specialist status. No credit points can be granted for education or training in these so-called supplementary, complementary and alternative treatment modalities. Failure of a college to comply with any of the Policies and Procedures of the EVBS may lead to the withdrawal of provisional or full recognition." In a comment to the New Scientist (10 December 2005) J.T. Lumeij, EBVS President, said: "The basics of homeopathy are not in agreement with science."
The tough standpoint of the EBVS banning the use of supplementary, complementary and alternative medicine in specialist practices in Europe is a courageous and necessary step and deserves the support of every veterinary scientist. On the other hand: are there not treatments and medications in veterinary medicine whose effectiveness still needs to be proven by evidence-based methods? The finger must be pointed in both directions...
- guest
acupuncture RCT studies
by malernee » Mon Apr 10, 2006 11:04 am
It is not a matter of time nor of the number of studies; it is a matter
of the quality of the evidence, as well as the plausibility of the effect.
When a new treatment is first reported in the medical literature, the
first study usually shows positive results. If the treatment really works,
this will be confirmed by other studies, the majority of studies will be
clearly positive, and the positive studies will increasingly outweigh the
negative and eventually add up to a convincing body of evidence. Over all,
the great majority of new treatments do not pan out, and subsequent studies show that either they don't work or they have unacceptable side effects. In
the case of acupuncture, the very fact that some studies
have shown effectiveness and some have not should be a wake-up call.
Obviously some of the studies are wrong - which ones? This is typical of so
many treatments in alternative medicine. The studies that support the
treatment tend to be done by advocates, they tend to be less rigorous, and
the better the study, the smaller the effect. If advocates do a study that
turns out negative, they tend not to publish it (this is called the "file
drawer" effect). Scientists are human beings, and there are many factors
that can lead to faulty research results: unconscious bias, outright fraud,
poor record-keeping, poor selection of subjects, a nonrepresentative control group, inadequate blinding, faulty assumptions, faulty statistical analysis,
etc. If you really want to understand why many studies show effectiveness
for ineffective treatments, you can get a complete education by reading a
superb book entitled "Critical Thinking About Research" by Julian Meltzoff,
published by the American Psychological Association and available at a
discount from Amazon.com - see
http://www.amazon.com/gp/product/155798 ... &;n=283155
Here is a study (below)that shows when you do a good job randomizing the placebo in acupuncture study's you start to loose any real nausea effect. Good study's show sham acupuncture using good acupuncturist actors works just as well by putting the needles willy -nilly rather than a specific points promoted in alternative medicine acupuncture charts. If you get the same effect no matter where you put the needles why even certify people to stick needles in people and animals? A fake needle has been developed so people do not know when the needle entered the skin and when it did not. This has helped randomize acupunture studys but you still need a good actor that can make people think the correct area of the body is being needled.
Effect of Acupuncture Compared with Placebo-Acupuncture at P6 as Additional Antiemetic Prophylaxis in High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation: A Randomized Controlled Single-Blind Trial.
Streitberger K, Friedrich-Rust M, Bardenheuer H, Unnebrink K, Windeler J, Goldschmidt H, Egerer G.
Departments of Anaesthesiology [K. S., M. F.-R.] and Medicine V [H. G., G. E.], and Coordination Centre for Clinical Trials [K. U.], University of Heidelberg, and Medizinischer Dienst der Spitzenverbande der Krankenkassen - Department of Evidence Based Medicine, Essen [J. W.].
PURPOSE: The purpose is to investigate an additional antiemetic effect to ondansetron with needle acupuncture at P6 compared with nonskin-penetrating placebo acupuncture in patients undergoing high-dose chemotherapy and autologous peripheral blood stem cell transplantation. Experimental Design: Eighty patients who were admitted to hospital for high-dose chemotherapy and autologous peripheral blood stem cell transplantation were included into a randomized placebo-controlled single-blind trial. The patients were randomized to receive acupuncture (n = 41) or noninvasive placebo acupuncture (n = 39) at the acupuncture point P6 30 min before first application of high-dose chemotherapy and the day after. All patients received 8 mg ondansetron/day i.v. as basic antiemetic prophylaxis. The main outcome measure was the rate of patients who either had at least one episode of vomiting or required any additional antiemetic drugs on the first 2 days of chemotherapy. RESULTS: The main outcome measure showed no significant difference (P = 0.82): 61% failure in the acupuncture group and 64% in the placebo acupuncture group (95% confidence interval of 3% difference: -18.1 and 24.3%). Comparing nausea, episodes of vomiting or retching and number of additionally required antiemetic drugs did not provide any discrepancy with the main result. CONCLUSIONS: This study suggests that in combination with ondansetron i.v., invasive needle acupuncture at P6 compared with nonskin-penetrating placebo acupuncture has no additional effect for the prevention of acute nausea and vomiting in high-dose chemotherapy.
PMID: 12855628 [PubMed - as supplied by publisher]
art malernee dvm
of the quality of the evidence, as well as the plausibility of the effect.
When a new treatment is first reported in the medical literature, the
first study usually shows positive results. If the treatment really works,
this will be confirmed by other studies, the majority of studies will be
clearly positive, and the positive studies will increasingly outweigh the
negative and eventually add up to a convincing body of evidence. Over all,
the great majority of new treatments do not pan out, and subsequent studies show that either they don't work or they have unacceptable side effects. In
the case of acupuncture, the very fact that some studies
have shown effectiveness and some have not should be a wake-up call.
Obviously some of the studies are wrong - which ones? This is typical of so
many treatments in alternative medicine. The studies that support the
treatment tend to be done by advocates, they tend to be less rigorous, and
the better the study, the smaller the effect. If advocates do a study that
turns out negative, they tend not to publish it (this is called the "file
drawer" effect). Scientists are human beings, and there are many factors
that can lead to faulty research results: unconscious bias, outright fraud,
poor record-keeping, poor selection of subjects, a nonrepresentative control group, inadequate blinding, faulty assumptions, faulty statistical analysis,
etc. If you really want to understand why many studies show effectiveness
for ineffective treatments, you can get a complete education by reading a
superb book entitled "Critical Thinking About Research" by Julian Meltzoff,
published by the American Psychological Association and available at a
discount from Amazon.com - see
http://www.amazon.com/gp/product/155798 ... &;n=283155
Here is a study (below)that shows when you do a good job randomizing the placebo in acupuncture study's you start to loose any real nausea effect. Good study's show sham acupuncture using good acupuncturist actors works just as well by putting the needles willy -nilly rather than a specific points promoted in alternative medicine acupuncture charts. If you get the same effect no matter where you put the needles why even certify people to stick needles in people and animals? A fake needle has been developed so people do not know when the needle entered the skin and when it did not. This has helped randomize acupunture studys but you still need a good actor that can make people think the correct area of the body is being needled.
Effect of Acupuncture Compared with Placebo-Acupuncture at P6 as Additional Antiemetic Prophylaxis in High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation: A Randomized Controlled Single-Blind Trial.
Streitberger K, Friedrich-Rust M, Bardenheuer H, Unnebrink K, Windeler J, Goldschmidt H, Egerer G.
Departments of Anaesthesiology [K. S., M. F.-R.] and Medicine V [H. G., G. E.], and Coordination Centre for Clinical Trials [K. U.], University of Heidelberg, and Medizinischer Dienst der Spitzenverbande der Krankenkassen - Department of Evidence Based Medicine, Essen [J. W.].
PURPOSE: The purpose is to investigate an additional antiemetic effect to ondansetron with needle acupuncture at P6 compared with nonskin-penetrating placebo acupuncture in patients undergoing high-dose chemotherapy and autologous peripheral blood stem cell transplantation. Experimental Design: Eighty patients who were admitted to hospital for high-dose chemotherapy and autologous peripheral blood stem cell transplantation were included into a randomized placebo-controlled single-blind trial. The patients were randomized to receive acupuncture (n = 41) or noninvasive placebo acupuncture (n = 39) at the acupuncture point P6 30 min before first application of high-dose chemotherapy and the day after. All patients received 8 mg ondansetron/day i.v. as basic antiemetic prophylaxis. The main outcome measure was the rate of patients who either had at least one episode of vomiting or required any additional antiemetic drugs on the first 2 days of chemotherapy. RESULTS: The main outcome measure showed no significant difference (P = 0.82): 61% failure in the acupuncture group and 64% in the placebo acupuncture group (95% confidence interval of 3% difference: -18.1 and 24.3%). Comparing nausea, episodes of vomiting or retching and number of additionally required antiemetic drugs did not provide any discrepancy with the main result. CONCLUSIONS: This study suggests that in combination with ondansetron i.v., invasive needle acupuncture at P6 compared with nonskin-penetrating placebo acupuncture has no additional effect for the prevention of acute nausea and vomiting in high-dose chemotherapy.
PMID: 12855628 [PubMed - as supplied by publisher]
art malernee dvm
- malernee
- Site Admin
- Posts: 462
- Joined: Wed Aug 13, 2003 5:56 pm
bmj sham acupuncture study
by malernee » Thu Jan 29, 2009 9:11 am
http://www.bmj.com/cgi/content/full/338/jan27_2/a3115
I'll summarize:<G>
- "Real" acupuncture is fractionally better than sham acupuncture --
but the difference is tiny, and not clinically relevant.
- The tiny difference is most likely because sham acupuncture can
only enable a single (rather than double) blind research design.
Bottom line: Acupuncture is nothing more than a distraction stimulus
with a hefty pricetag, and tons of woo-woo baggage!
art malernee dvm
I'll summarize:<G>
- "Real" acupuncture is fractionally better than sham acupuncture --
but the difference is tiny, and not clinically relevant.
- The tiny difference is most likely because sham acupuncture can
only enable a single (rather than double) blind research design.
Bottom line: Acupuncture is nothing more than a distraction stimulus
with a hefty pricetag, and tons of woo-woo baggage!
art malernee dvm
- malernee
- Site Admin
- Posts: 462
- Joined: Wed Aug 13, 2003 5:56 pm
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