Commentary: unbiased divination, unbiased evidence, and the patulin clinical trial.
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Biomedical subjects
Publications and source records attributed to Ted J Kaptchuk.
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Homeopathy is a 200-year-old therapeutic system that uses small doses of various substances to stimulate autoregulatory and self-healing processes. Homeopathy selects substances by matching a patient's symptoms with symptoms produced by these substances in healthy individuals. Medicines are prepared by serial dilution and shaking, which proponents claim imprints information into water. Although many conventional physicians find such notions implausible, homeopathy had a prominent place in 19th-century health care and has recently undergone a worldwide revival. In the United States, patients who seek homeopathic care are more affluent and younger and more often seek treatment for subjective symptoms than those who seek conventional care. Homeopathic remedies were allowed by the 1939 Pure Food and Drug Act and are available over the counter. Some data--both from randomized, controlled trials and laboratory research--show effects from homeopathic remedies that contradict the contemporary rational basis of medicine. Three independent systematic reviews of placebo-controlled trials on homeopathy reported that its effects seem to be more than placebo, and one review found its effects consistent with placebo. There is also evidence from randomized, controlled trials that homeopathy may be effective for the treatment of influenza, allergies, postoperative ileus, and childhood diarrhea. Evidence suggests that homeopathy is ineffective for migraine, delayed-onset muscle soreness, and influenza prevention. There is a lack of conclusive evidence on the effectiveness of homeopathy for most conditions. Homeopathy deserves an open-minded opportunity to demonstrate its value by using evidence-based principles, but it should not be substituted for proven therapies.
Increased use of complementary and alternative medicine (CAM) has made it imperative that these topics be included in medical education from the preclinical years through residency and beyond. There has been progress in this direction in recent years, with a steady increase in the number of medical schools that include CAM therapies in their curricula. There remains, however, a lack of clear goals and concrete suggestions for implementing these changes. This article examines the questions that arise when medical educators consider how to incorporate CAM therapies as an integral part of the medical curriculum. It offers practical suggestions for finding time in an already packed curriculum, getting started, including faculty and students in the process, and sustaining the initiative with the necessary administrative and institutional support.
OBJECTIVE: To conduct a systematic review of the published literature on the efficacy and safety of herbal therapies and vitamin/mineral supplements for glucose control in patients with diabetes. RESEARCH DESIGN AND METHODS: We conducted an electronic literature search of MEDLINE, OLDMEDLINE, Cochrane Library Database, and HealthSTAR, from database inception to May 2002, in addition to performing hand searches and consulting with experts in the field. Available clinical studies published in the English language that used human participants and examined glycemic control were included. Data were extracted in a standardized manner, and two independent investigators assessed methodological quality of randomized controlled trials using the Jadad scale. RESULTS: A total of 108 trials examining 36 herbs (single or in combination) and 9 vitamin/mineral supplements, involving 4,565 patients with diabetes or impaired glucose tolerance, met the inclusion criteria and were analyzed. There were 58 controlled clinical trials involving individuals with diabetes or impaired glucose tolerance (42 randomized and 16 nonrandomized trials). Most studies involved patients with type 2 diabetes. Heterogeneity and the small number of studies per supplement precluded formal meta-analyses. Of these 58 trials, the direction of the evidence for improved glucose control was positive in 76% (44 of 58). Very few adverse effects were reported. CONCLUSIONS: There is still insufficient evidence to draw definitive conclusions about the efficacy of individual herbs and supplements for diabetes; however, they appear to be generally safe. The available data suggest that several supplements may warrant further study. The best evidence for efficacy from adequately designed randomized controlled trials (RCTs) is available for Coccinia indica and American ginseng. Chromium has been the most widely studied supplement. Other supplements with positive preliminary results include Gymnema sylvestre, Aloe vera, vanadium, Momordica charantia, and nopal.
OBJECTIVES: To assess whether and how investigators of placebo controlled randomised trials inform participants of their treatment allocation at trial closure and to assess barriers to feedback. DESIGN: Postal survey with a semistructured questionnaire. PARTICIPANTS: All investigators who published a placebo controlled randomised trial in 2000 in five leading medical journals, and a random sample of 120 trials listed in the national research register database. MAIN OUTCOME MEASURES: Number of investigators who informed participants of their treatment allocation at trial closure, methods for delivering the information, and barriers to unmasking treatment. RESULTS: 45% of investigators informed either all or most participants of their treatment allocation, and 55% did not inform any participant or only informed those who asked. The main reasons for not informing participants were that the investigators never considered this option (40%) or to avoid biasing results at study follow up (24%). CONCLUSION: Further research is required to examine sensitive ways to communicate treatment information to trial participants.
Many patients with cancer use complementary and alternative medical (CAM) therapies. Physicians need authoritative information on CAM therapies to responsibly advise patients who seek these interventions. This article summarizes current evidence on the efficacy and safety of selected CAM therapies that are commonly used by patients with cancer. The following major categories of interventions are covered: dietary modification and supplementation, herbal products and other biological agents, acupuncture, massage, exercise, and psychological and mind-body therapies. Two categories of evidence on efficacy are considered: possible effects on disease progression and survival and possible palliative effects. In evaluating evidence on safety, two types of risk are considered: the risk for direct adverse effects and the risk for interactions with conventional treatments. For each therapy, the current balance of evidence on efficacy and safety points to whether the therapy may be reasonably recommended, accepted (for example, dietary fat reduction in well-nourished patients with breast or prostate cancer), or discouraged (for example, high-dose vitamin A supplementation). This strategy allows the development of an approach for providing responsible, evidence-based, patient-centered advice to persons with cancer who seek CAM therapies.
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In alternative medicine, the main question regarding placebo has been whether a given therapy has more than a placebo effect. Just as mainstream medicine ignores the clinical significance of its own placebo effect, the placebo effect of unconventional medicine is disregarded except for polemics. This essay looks at the placebo effect of alternative medicine as a distinct entity. This is done by reviewing current knowledge about the placebo effect and how it may pertain to alternative medicine. The term placebo effect is taken to mean not only the narrow effect of a dummy intervention but also the broad array of nonspecific effects in the patient-physician relationship, including attention; compassionate care; and the modulation of expectations, anxiety, and self-awareness. Five components of the placebo effect--patient, practitioner, patient-practitioner interaction, nature of the illness, and treatment and setting--are examined. Therapeutic patterns that heighten placebo effects are especially prominent in unconventional healing, and it seems possible that the unique drama of this realm may have "enhanced" placebo effects in particular conditions. Ultimately, only prospective trials directly comparing the placebo effects of unconventional and mainstream medicine can provide reliable evidence to support such claims. Nonetheless, the possibility of enhanced placebo effects raises complex conundrums. Can an alternative ritual with only nonspecific psychosocial effects have more positive health outcomes than a proven, specific conventional treatment? What makes therapy legitimate, positive clinical outcomes or culturally acceptable methods of attainment? Who decides?
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Traditionally, acupuncture is embedded in naturalistic theories that are compatible with Confucianism and Taoism. Such ideas as yin-yang, qi, dampness, and wind represent East Asian conceptual frameworks that emphasize the reliability of ordinary, human sensory awareness. Many physicians who practice acupuncture reject such prescientific notions. Numerous randomized, controlled trials and more than 25 systematic reviews and meta-analyses have evaluated the clinical efficacy of acupuncture. Evidence from these trials indicates that acupuncture is effective for emesis developing after surgery or chemotherapy in adults and for nausea associated with pregnancy. Good evidence exists that acupuncture is also effective for relieving dental pain. For such conditions as chronic pain, back pain, and headache, the data are equivocal or contradictory. Clinical research on acupuncture poses unique methodologic challenges. Properly performed acupuncture seems to be a safe procedure. Basic-science research provides evidence that begins to offer plausible mechanisms for the presumed physiologic effects of acupuncture. Multiple research approaches have shown that acupuncture activates endogenous opioid mechanisms. Recent data, obtained by using functional magnetic resonance imaging, suggest that acupuncture has regionally specific, quantifiable effects on relevant brain structures. Acupuncture may stimulate gene expression of neuropeptides. The training and provision of acupuncture care in the United States are rapidly expanding.
BACKGROUND: Chronic low back pain patients have a high rate of psychopathology, comprised mainly of depression, anxiety, and high levels of neuroticism. We previously found that psychopathology is associated with increased placebo analgesia in this patient group. OBJECTIVE: To better understand this finding in the context of other known predictors of placebo response (such as expectations for relief), we performed a detailed analysis of expectations and other possible covariates. DESIGN: We conducted a double-blind, placebo-controlled, randomized, crossover-designed trial of intravenous morphine vs. placebo in 60 subjects with chronic low back pain and discogenic abnormalities. Patients were stratified into three groups of psychiatric symptom severity (Low, Moderate, and High), based on composite scores on depression, anxiety for pain, and neuroticism scales. Subjects were given intravenous morphine and placebo in random order on separate visits, and completed serial pain ratings over 3 h at each session. RESULTS: With 20 subjects per group, there were small, but significant differences between groups in baseline pain ratings. No differences were found between groups in age, gender, and radicular pain. Patients with low psychological symptomatology reported 7.7% total pain relief with placebo compared with 23.4% in the Moderate group and 23.5% in the High group (P < 0.05). Expectations were not significantly different between groups, but in the High group expectation levels predicted placebo analgesia (P < 0.001). Neuropathic pain quality was also a predictor (P < 0.05). CONCLUSIONS: This study indicates that high and moderate levels of psychopathology are associated with heightened placebo analgesia in chronic low back pain patients. Expectations were only an influence in the high psychopathology group, and neuropathic pain affects placebo responses. These findings have implications for future research characterizing placebo responders.
BACKGROUND: Despite the growing popularity of complementary and alternative medical (CAM) therapies, little is known about the professionals who provide them. Our objective was to describe the characteristics of the four largest groups of licensed CAM providers in the United States and to compare them with the characteristics of conventional physicians. METHODS: Random statewide samples of licensed acupuncturists, chiropractors, massage therapists, and naturopathic physicians living in Arizona, Connecticut, Massachusetts and Washington were interviewed by telephone. Sociodemographic, training, and practice characteristics of CAM providers were elicited and compared with data on conventional physicians published by the American Medical Association. RESULTS: More than 160 providers in each profession were interviewed. Participation rates ranged between 78% and 94% except for Arizona chiropractors (61%). The proportion of female respondents was highest for massage therapy (85%) and acupuncture and naturopathy (almost 60%) and was lowest for chiropractic (about 25%) and conventional medicine (23%). Except for acupuncturists, only 5% of CAM providers were nonwhite. CAM providers were more likely than conventional physicians to practice solo (51%-74% vs 26%, respectively), and less than 10% practiced with medical physicians. Massage therapists saw the fewest patients per week (about 14), and chiropractors and conventional physicians the most (about 100). Chiropractors and conventional physicians saw about 3 patients per hour compared with roughly 1 patient per hour for the other CAM professions. Interstate differences were small. CONCLUSIONS: This characterization of CAM providers will help inform decisions about the future role of CAM providers in the health care system.
BACKGROUND: Despite growing popularity of complementary and alternative medical (CAM) therapies, little is known about the patients seen by CAM practitioners. Our objective was to describe the patients and problems seen by CAM practitioners. METHODS: We collected data on 20 consecutive visits to randomly sampled licensed acupuncturists, chiropractors, massage therapists, and naturopathic physicians practicing in Arizona, Connecticut, Massachusetts, and Washington. Data were collected on patient demographics, smoking status, referral source, reasons for visit, concurrent medical care, payment source, and visit duration. Comparative data for conventional physicians were drawn from the National Ambulatory Medical Care Survey. RESULTS: In each profession, at least 99 practitioners collected data on more than 1,800 visits. More than 80% of visits to CAM providers were by young and middle-aged adults, and roughly two thirds were by women. Children comprised 10% of visits to naturopathic physicians but only 1% to 4% of all visits to other CAM providers. At least two thirds of visits resulted from self-referrals, and only 4% to 12% of visits were from conventional physician referrals. Chiropractors and massage therapists primarily saw musculoskeletal problems, while acupuncturists and naturopathic physicians saw a broader range of conditions. Visits to acupuncturists and massage therapists lasted about 60 minutes compared with 40 minutes for naturopathic physicians and less than 20 minutes for chiropractors. Most visits to chiropractors and naturopathic physicians, but less than one third of visits to acupuncturists and massage therapists, were covered by insurance. CONCLUSIONS: This information will help inform discussions of the roles CAM practitioners will play in the health care system of the future.
CONTEXT: Outpatient clinical studies of magnet therapy, a complementary therapy commonly used to treat osteoarthritis (OA), have been limited by the absence of a credible placebo control. OBJECTIVE: Our objective was to assess the feasibility and promise of studying static magnetic therapy for knee OA and determine the ability of a new placebo-magnet device to provide concealment of group assignment. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING: Academic teaching hospital in Boston. PARTICIPANTS: We enrolled 29 subjects with idiopathic or post-traumatic OA of the knee. INTERVENTIONS: Subjects received either high-strength magnetic (active) or placebo-magnetic (placebo) knee sleeve treatment for 4 hours in a monitored setting and self-treatment 6 hours daily for 6 weeks. MAIN OUTCOME MEASURES: Primary outcomes were change in knee pain as measured by the WOMAC Osteoarthritis Index Pain Subscale at 6 weeks and extent of group concealment at study end. RESULTS: At 4 hours, VAS pain scores (+/- SE) on a 5-item scale (0-500, 500 worst) decreased 79 +/- 18 mm in the active group and 10 +/- 21 mm in the placebo group (P < 0.05). There were no significant differences in any primary or secondary measure of efficacy between the treatment groups at 6 weeks. Despite widespread testing for magnetic properties, at study end, 69% of the active group and 77% of the placebo group (P > 0.2) believed that they had been assigned to the active treatment group. CONCLUSION: Despite our small sample size, magnets showed statistically significant efficacy compared to placebo after 4 hours under rigorously controlled conditions. The sustained efficacy of magnetic therapy for knee osteoarthritis could be assessed in an adequately powered trial utilizing an appropriate control such our new placebo-magnet device.
Since the early 1970s, acupuncture has been the subject of multiple animal experiments and randomized clinical trials. Our understanding of acupuncture from both the clinical and mechanistic perspectives has, as a result, grown tremendously. Yet the final word on acupuncture as a therapy remains mixed, largely due to the contradictory nature of the evidence. With some exception, what clinical conditions would benefit and how acupuncture physiologically operates remains unclear. The impediment to progress is found in three disjunctions in acupuncture research: (1) the biomedical need to standardize treatments creates uncertainty about whether we are studying acupuncture appropriately; (2) the variability in acupuncture styles creates ambiguity about whether we are studying the right style; and (3) the discrepancy between animal and human studies creates questions about whether we truly understand the underlying mechanism responsible for acupuncture's therapeutic effect. We propose that these disjunctions are best addressed with the use of "manualized" protocols in clinical trials that are linked with mechanistic studies. Through this approach, we can create a healthy dialogue between the medical and acupuncture communities and recognize the unique physiologic properties that may be found in each acupuncture style. To illustrate how this proposal may fundamentally change acupuncture research, we present diabetic neuropathy as a particularly interesting model because of its complex heterogeneous pathophysiology.