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Background: Traditional Indian Ayurvedic medicine uses complex treatment approaches, including manual therapies, lifestyle and nutritional advice, dietary supplements, medication, yoga, and purification techniques. Ayurvedic strategies are often used to treat osteoarthritis (OA) of the knee; however, no systematic data are available on their effectiveness in comparison with standard care. The aim of this study is to evaluate the effectiveness of complex Ayurvedic treatment in comparison with conventional methods of treating OA symptoms in patients with knee osteoarthritis. Methods and design: In a prospective, multicenter, randomized controlled trial, 150 patients between 40 and 70 years, diagnosed with osteoarthritis of the knee, following American College of Rheumatology criteria and an average pain intensity of >= 40 mm on a 100 mm visual analog scale in the affected knee at baseline will be randomized into two groups. In the Ayurveda group, treatment will include tailored combinations of manual treatments, massages, dietary and lifestyle advice, consideration of selected foods, nutritional supplements, yoga posture advice, and knee massage. Patients in the conventional group will receive self-care advice, pain medication, weight-loss advice (if overweight), and physiotherapy following current international guidelines. Both groups will receive 15 treatment sessions over 12 weeks. Outcomes will be evaluated after 6 and 12 weeks and 6 and 12 months. The primary endpoint is a change in the score on the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after 12 weeks. Secondary outcome measurements will use WOMAC subscales, a pain disability index, a visual analog scale for pain and sleep quality, a pain experience scale, a quality-of-life index, a profile of mood states, and Likert scales for patient satisfaction, patient diaries, and safety. Using an adapted PRECIS scale, the trial was identified as lying mainly in the middle of the efficacy-effectiveness continuum. Discussion: This trial is the first to compare the effectiveness of a complex Ayurvedic intervention with a complex conventional intervention in a Western medical setting in patients with knee osteoarthritis. During the trial design, aspects of efficacy and effectiveness were discussed. The resulting design is a compromise between rigor and pragmatism.

OBJECTIVE: Medicinal plants are the primary ingredients of Tibetan medicinal formulae. The aim of the present study was to evaluate the spectrum of medical complaints treated by a Tibetan doctor in Sikkim and Nepal, and to determine which plants the doctor used most frequently to treat these complaints.DESIGN: Two prospective observational studies were carried out at two locations (Sikkim and Nepal). Patients who visited the participating Tibetan doctor were included consecutively. Medical symptoms, Tibetan syndrome diagnoses, and treatments were documented. The most frequently used plants were identified retrospectively. RESULTS: A total of 238 patients were included (Sikkim: n = 135, 62.2% women, mean age 33.9 3.4 years; Nepal: n = 103, 54.4% men, mean age 42.9 2.4 years). The most frequent medical complaint was pain (Sikkim: 46% of patients; Nepal: 51% of patients). The most frequent Tibetan syndrome diagnosis was Bad-kan in Sikkim (20.7% of patients; a cold disorder affecting the lower body) and a combination of Bad-kan and mKhris-pa in Nepal (28.2%; a mixed cold/hot disorder affecting the lower and middle body). A total of 71 different Tibetan medicines were prescribed, including 138 different plants. Of these 138 plants, 81 typically grow at high and medium altitudes, and 57 grow in tropical and subtropical areas. Nevertheless, most (93%) of the prescribed formulae contained high-altitude plants. CONCLUSIONS: For the first time, information on medical complaints and treatments has been evaluated systematically for patients receiving treatment from a Tibetan doctor. These data provide a good foundation for further research on Tibetan medicine. Further studies should go a step farther and include follow-up data and information about the effectiveness and safety of Tibetan medicines.

Objectives: Chronic low-back pain (CLBP) is burdensome and costly, and a common condition for which adults use integrative therapies. The effectiveness of multidisciplinary integrative approaches has not been well studied. The purpose of this observational study was to compare characteristics and outcomes of CLBP patients treated at the Osher Clinical Center (OCC) versus other clinics at Brigham and Women's Hospital. Design: Observational comparative effectiveness study. Setting: Tertiary care hospital. Subjects: Patients >= 21 years with 3+ months of CLBP or 6+ months of intermittent low-back pain. Intervention: All patients were observed for 12 months. OCC patients received care at the integrative clinic (7.3 visits on average over 13 weeks); non-OCC patients received usual care at other clinics of the same hospital. Outcome measures: Primary outcomes: change from baseline to 6 months in functional status (Roland Disability Questionnaire [RDQ]) and bothersomeness of pain (BOP). Secondary outcomes: change in RDQ and BOP at 3 and 12 months, percentages of patients with clinically meaningful (>= 30%) improvements. Results: One hundred fifty-six OCC and 153 non-OCC participants were enrolled; follow-up was 90.4 and 98.0%, respectively, at 12 months. There were substantial differences in baseline characteristics between groups. For RDQ, the adjusted mean group difference was nonsignificant at 6 months; for BOP, the differences were significant, but clinically small. At 12 months, the observed benefit on RDQ was significant and clinically meaningful; for BOP, there were significant, but clinically small differences. Percentages of patients with >= 30% improvements in RDQ were significantly greater in the OCC group only at 12 months, and both 6 and 12 months for BOP. Conclusions: Baseline characteristics can differ between those who select different sources of healthcare for CLBP. While benefits seen in the OCC versus non-OCC clinics were not large, further evaluation through randomized trials might be warranted to provide a more definitive evaluation.

Background. Little is known about Tibetan medicine (TM), in Western industrialized countries. Objectives. To provide a systematic review of the clinical studies on TM available in the West. Data Sources. Seven literature databases, published literature lists, citation tracking, and contacts to experts and institutions. Study Eligibility Criteria. Studies in English, German, French, or Spanish presenting clinical trial results. Participants. All patients of the included studies. Interventions. Tibetan medicine treatment. Study Appraisal and Synthesis Methods. Included studies were described quantitatively; their quality was assessed with the DIMDI HTA checklist; for RCTs the Jadad score was used. Results. 40 studies from 39 publications were included. They were very heterogeneous regarding study type and size, treated conditions, treatments, measured outcomes, and quality. Limitations. No Russian, Tibetan, or Chinese publications were included. Possible publication bias. Conclusions. The number of clinical trials on TM available in the West is small; methods and results are heterogeneous. Implications of Key Findings. Higher quality larger trials are needed, as is a general overview of traditional usage to inform future clinical trials. Systematic Review Registration Number. None.