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Patients in the placebo arms of randomized controlled trials (RCT) often experience positive changes from baseline. While multiple theories concerning such "placebo effects" exist, peculiarly, none has been informed by actual interviews of patients undergoing placebo treatment. Here, we report on a qualitative study (n = 27) embedded within a RCT (n = 262) in patients with irritable bowel syndrome. Besides identical placebo acupuncture treatment in the RCT, the qualitative study patients also received an additional set of interviews at the beginning, midpoint, and end of the trial. Interviews of the 12 qualitative subjects who underwent and completed placebo treatment were transcribed. We found that patients (1) were persistently concerned with whether they were receiving placebo or genuine treatment; (2) almost never endorsed "expectation" of improvement but spoke of "hope" instead and frequently reported despair; (3) almost all reported improvement ranging from dramatic psychosocial changes to unambiguous, progressive symptom improvement to tentative impressions of benefit; and (4) often worried whether their improvement was due to normal fluctuations or placebo effects. The placebo treatment was a problematic perturbation that provided an opportunity to reconstruct the experiences of the fluctuations of their illness and how it disrupted their everyday life. Immersion in this RCT was a co-mingling of enactment, embodiment and interpretation involving ritual performance and evocative symbols, shifts in bodily sensations, symptoms, mood, daily life behaviors, and social interactions, all accompanied by self-scrutiny and re-appraisal. The placebo effect involved a spectrum of factors and any single theory of placebo--e.g. expectancy, hope, conditioning, anxiety reduction, report bias, symbolic work, narrative and embodiment--provides an inadequate model to explain its salubrious benefits. [ABSTRACT FROM AUTHOR]

Governments, international agencies and corporations are increasingly investing in traditional herbal medicine research. Yet little literature addresses ethical challenges in this research. In this paper, we apply concepts in a comprehensive ethical framework for clinical research to international traditional herbal medicine research. We examine in detail three key, underappreciated dimensions of the ethical framework in which particularly difficult questions arise for international herbal medicine research: social value, scientific validity and favourable risk-benefit ratio. Significant challenges exist in determining shared concepts of social value, scientific validity and favourable risk-benefit ratio across international research collaborations. However, we argue that collaborative partnership, including democratic deliberation, offers the context and process by which many of the ethical challenges in international herbal medicine research can, and should be, resolved. By 'cross-training' investigators, and investing in safety-monitoring infrastructure, the issues identified by this comprehensive framework can promote ethically sound international herbal medicine research that contributes to global health. [ABSTRACT FROM AUTHOR]

In this, the first of 2 companion papers, we present a framework for viewing t'ai chi as a complex, multicomponent intervention that integrates numerous physical, cognitive, and ritualistic components. We discuss how the richness and complexity of t'ai chi poses challenges related to the traditional distinction between specific versus nonspecific effects, the development and interpretation of valid sham controls, and more generally, to the reductionist causal approach of attributing observed outcomes to single, independent component factors. We also discuss parallels between t'ai chi research and the emerging field of whole systems research, and how t'ai chi research may benefit from the use of an ecologic framework. In a second, companion paper, we discuss additional challenges inherent in defining the t'ai chi intervention itself, and more comprehensively outline the benefits and limitations of commonly used clinical research designs to evaluate the efficacy and safety of t'ai chi. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

OBJECTIVES: This study quantifies and compares patient characteristics in outpatient acupuncture. SETTING/DESIGN: Prospective primary source evidence was gathered at two prominent outpatient acupuncture clinics in Beijing, China (n = 563, n = 233). RESULTS: The most common condition was Bell's palsy, which represented 20.6% and 25.3% of total cases at the two clinics, respectively. The second most common condition was cerebrovascular accident (CVA) rehabilitation. These treatments represented 11.9% and 12.0% of treatments at the two clinics, respectively. Other trends at the clinics included the following: (1) neurologic complaints predominated; (2) doctors see a large number of patients per day; (3) the majority of patients overall were female; while (4) the majority of patients treated for CVAs rehabilitation were male. As cultural and socioeconomic differences in perceptions of acupuncture exist between peoples of different countries, this study also compared patient main complaints in China to available data on acupuncture patients seen in other parts of China, Germany, the United Kingdom, Australia, and the United States. Except for the German clinic data, Western clinic acupuncturists saw more musculoskeletal complaints compared to China, where neurologic complaints predominated. Another significant difference between Asian and Western clinics was the number of patients seen per hour. While acupuncturists were reported to see 1.2 patients per hour in U. S. clinics, acupuncturists at the two Beijing, China, clinics saw 7.0 and 10.4 patients per hour, respectively. CONCLUSION: The main complaints seen in acupuncture outpatient clinics throughout the world likely result from a combination of inherent disease prevalence as well as patients' attitudes toward what acupuncture can treat successfully. Copyright Mary Ann Liebert, Inc. [ABSTRACT FROM AUTHOR]

Compared with other specialties, the field of physical and rehabilitation medicine has not received the deserved recognition from clinicians and researchers in the scientific community. One of the reasons is the lack of sound evidence to support the traditional physical and rehabilitation medicine treatments. The best way to change this disadvantage is through a well conducted clinical research, such as standard placebo- or sham-controlled randomized clinical trials. Therefore, having placebo groups in clinical trials is essential to improve the level of evidence-based practice in physical and rehabilitation medicine that ultimately translates to better clinical care. To address the challenges for the use of placebo in physical and rehabilitation medicine and randomized clinical trials and to create useful recommendations, we convened a working group during the inaugural International Symposium in Placebo (February 2009, in Sao Paulo, Brazil) in which the following topics were discussed: (1) current status of randomized clinical trials in physical and rehabilitation medicine, (2) challenges for the use of placebo in physical and rehabilitation medicine, (3) bioethics, (4) use of placebo in acupuncture trials and for the treatment of low-back pain, (5) mechanisms of placebo, and (6) insights from other specialties. The current article represents the consensus report from the working group. [ABSTRACT FROM AUTHOR]

Aim: We aim to determine the safety and effectiveness of a standard therapeutic package of Korean medicine for the treatment of unexplained infertility in a cross-section of women who sought treatment at an integrative hospital in Seoul, Korea. Background: Infertility affects more than 1.2 million women in the United States alone. Treatment options for infertility vary, yet the barriers of invasiveness, cost, and access inhibit treatment use for many women. Alternative medical approaches exist for this indication, and sustain certain popularity. Therefore, we systematically studied a standard therapeutic package of Korean medicine to treat unexplained infertility in women. Methods: Female participants included in this observational study met inclusion criteria before receiving a set of treatments including herbal medicine, acupuncture, and moxibustion. A study physician screened each patient in accordance with inclusion criteria, provided study information, and after the patients consented, performed the baseline assessment. Assessments included age, the history of assisted reproductive technology, and duration of infertility. The key outcome measure included the number who achieved pregnancy and any neo-natal morbidity and mortality at follow-up stage for those who got pregnant. Any other adverse events including aggravation of existing symptoms, and the number of dropouts, were recorded. Treatments were supposed to be completed after 6 menstrual cycles between February 2005 and April 2006. Results: One hundred and four (104) women with unexplained infertility were included in this observational study. Participant mean age was 32 years (SD: 2.7), with a range between 26 and 41 years. The median duration of infertility after diagnosis was 33.5 weeks (interquartile range: 20.8-50.3). In total, 41 participants (39.4%) had undergone a mean number of 1.4 (SD: 2.2) assisted reproductive technology treatments prior to joining the study. The number of patients remaining in or achieving pregnancy throughout the 6-month study period was 23 (14 pregnancies), 22.1%. Six (6) participants (4.8%) reported minor adverse events including rash in the face ( n = 1), diarrhea ( n = 2), dizziness ( n = 1), and heartburn ( n = 2). Of the 14 pregnancies, there were 10 normal births, and 4 miscarriages; otherwise, no neonatal morbidity/mortality occurred. According to per protocol analysis, 14 pregnancies out of 23 total were achieved by those who remained for the entire six menstruation cycle treatments, yielding a pregnancy rate of 60.9%. Conclusions: The standard therapeutic package for unexplained infertility in women studied here is safe for infants and the treated women, when administered by licensed professionals. While it remains challenging to have the target population complete a 6-month treatment course, during which most patients have to pay out of pocket, the extent of successfully achieved pregnancy in those who received full treatment provides meaningful outcomes, warranting further attention. A future study that includes subsidized treatment costs, encouraging the appropriate compliance rate, is warranted. [ABSTRACT FROM AUTHOR]

Few complementary and alternative medicine (CAM) institutions require their students to undergo substantive training in research literacy and conduct, and well-developed programs to train CAM institution faculty in research are virtually non-existent. As part of a National Center for Complementary and Alternative Medicine (NCCAM) initiative to increase research capacity at CAM institutions, the New England School of Acupuncture (NESA), in collaboration with the Harvard Medical School (HMS) Osher Institute, was awarded a Developmental Center for Research on Complementary and Alternative Medicine (DCRC) grant. This article discusses a number of initiatives that we designed and implemented to train NESA students, faculty members, and alumni in the foundations of clinical research and to stimulate interest in both participating in research and receiving additional research training. Specific initiatives included a 30-hour faculty 'Foundations of Research' course; a year-long course entitled, 'How to Write a Publishable Case Report'; institution of a monthly research seminar series; revision of an already required student research course; and the addition of 2 new student-mentored independent research electives. We discuss successes and challenges encountered in developing and administering these initiatives and the overall impact they have had on research culture and productivity at NESA. [ABSTRACT FROM AUTHOR]

A significant practical, yet perhaps under-appreciated, barrier to a more active role of complementary and alternative medicine (CAM) institutions in research is the organizational infrastructure required for submitting and managing research grants. In this article, we discuss how the New England School of Acupuncture, in collaboration with the Harvard Medical School Osher Institute and with the support of a Developmental Center for Research on Complementary and Alternative Medicine grant awarded by the National Center for Complementary and Alternative Medicine of the National Institutes of Health, developed its grants management infrastructure and increased its research capacity. We highlight initiatives that have been successful, challenges we have encountered, and lessons we learned that may be relevant to other CAM institutions that may wish to develop a research program. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]