Institute for Social Medicine Epidemiology and Health Economics, Charité -Universitätsmedizin Berlin, Berlin, Germany.
Trials. 2013 May 23;14:149. doi: 10.1186/1745-6215-14-149.
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.
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.
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.
NCT01225133.
传统的印度阿育吠陀医学采用复杂的治疗方法，包括手法治疗、生活方式和营养建议、饮食补充剂、药物、瑜伽和净化技术。阿育吠陀策略常用于治疗膝骨关节炎（OA）；然而，与标准护理相比，目前尚无关于其有效性的系统数据。本研究旨在评估与常规治疗 OA 症状的方法相比，复杂的阿育吠陀治疗在膝骨关节炎患者中的疗效。
在一项前瞻性、多中心、随机对照试验中，将 150 名年龄在 40 至 70 岁之间、符合美国风湿病学会标准且基线时受影响膝关节的平均疼痛强度≥40mm 的膝骨关节炎患者随机分为两组。在阿育吠陀组中，治疗将包括量身定制的手法治疗、按摩、饮食和生活方式建议、考虑选择的食物、营养补充剂、瑜伽姿势建议和膝关节按摩的组合。常规组患者将根据当前国际指南接受自我护理建议、疼痛药物、减肥建议（如果超重）和物理治疗。两组患者均将在 12 周内接受 15 次治疗。将在 6 周和 12 周以及 6 个月和 12 个月后评估结果。主要终点是在 12 周后 Western Ontario and McMaster University Osteoarthritis Index (WOMAC) 评分的变化。次要终点测量将使用 WOMAC 子量表、疼痛残疾指数、疼痛和睡眠质量的视觉模拟量表、疼痛体验量表、生活质量指数、心境状态剖面图和患者满意度、患者日记和安全性的 Likert 量表。使用改编后的 PRECIS 量表，该试验被确定主要位于疗效-有效性连续体的中间。
这是首次在西方医疗环境中比较复杂的阿育吠陀干预与复杂的常规干预在膝骨关节炎患者中的疗效的试验。在试验设计过程中，讨论了疗效和有效性的各个方面。由此产生的设计是在严谨性和实用性之间的妥协。
NCT01225133。
