Charité́ - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, 10117 Berlin, Germany; Immanuel Hospital Berlin, Department for Complementary Medicine, Königstr. 63, 14109 Berlin, Germany.
Ministry of AYUSH, AYUSH Bhawan, B Block, GPO Complex, INA, New Delhi 110023, India; Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhavan, No.61-65, Institutional Area, Janakpuri, New Delhi 110058, India.
Osteoarthritis Cartilage. 2018 May;26(5):620-630. doi: 10.1016/j.joca.2018.01.022. Epub 2018 Feb 7.
Ayurveda is commonly used in South Asia to treat knee osteoarthritis (OA). We aimed to evaluate the effectiveness of Ayurvedic treatment compared to conventional conservative care in patients with knee OA.
According to American College of Rheumatology (ACR) criteria knee OA patients were included in a multicenter randomized, controlled, open-label trial and treated in 2 hospital clinics and 2 private outpatient clinics in Germany. Participants received either a multi-modal Ayurvedic treatment or multi-modal conventional care with 15 treatments over 12 weeks respectively. Primary outcome was the change on the Western Ontario and McMaster University Osteoarthritis (WOMAC) Index after 12 weeks. Secondary outcomes included WOMAC subscales; the pain disability index and a pain experience scale, numeric rating scales for pain and sleep quality, quality-of-life and mood, rescue medication use, and safety issues.
One hundred fifty-one participants (Ayurveda n = 77, conventional care n = 74) were included. Changes of the WOMAC Index from baseline to 12 weeks were more pronounced in the Ayurveda group (mean difference 61.0 [95%CI: 52.4;69.6]) than in the conventional group (32.0 [95%CI: 21.4;42.6]) resulting in a significant between-group difference (p < 0.001) and a clinically relevant effect size (Cohen's d 0.68 [95% CI:0.35;1.01]). Similar trends were observed for all secondary outcomes at week 12. Effects were sustained at follow-ups after 6 and 12 months.
Results suggest that Ayurvedic treatment is beneficial in reducing knee OA symptoms. Further studies should be conducted to confirm the magnitude of the effect and to clarify the role of different treatment components and non-specific effects. REGISTRATION: at clinicaltrials.gov (NCT01225133; initial release 10/06/2010).
阿育吠陀在南亚常用于治疗膝骨关节炎（OA）。我们旨在评估阿育吠陀治疗与膝关节 OA 患者常规保守治疗相比的效果。
根据美国风湿病学会（ACR）标准，将膝关节 OA 患者纳入一项多中心随机、对照、开放性试验，并在德国的 2 家医院诊所和 2 家私人门诊进行治疗。参与者分别接受多模式阿育吠陀治疗或多模式常规治疗，各治疗 15 次，共 12 周。主要结局是治疗 12 周后 Western Ontario and McMaster University Osteoarthritis（WOMAC）指数的变化。次要结局包括 WOMAC 子量表；疼痛残疾指数和疼痛体验量表、疼痛和睡眠质量的数字评分量表、生活质量和情绪、急救药物使用以及安全性问题。
共纳入 151 名参与者（阿育吠陀组 n=77，常规治疗组 n=74）。与常规治疗组相比（基线至 12 周 WOMAC 指数的变化为 32.0[95%CI：21.4；42.6]），阿育吠陀组的 WOMAC 指数变化更为明显（平均差异 61.0[95%CI：52.4；69.6]），两组间差异具有统计学意义（p<0.001），且具有临床相关的效应大小（Cohen's d 0.68[95%CI：0.35；1.01]）。所有次要结局在第 12 周时也呈现出类似的趋势。在 6 个月和 12 个月的随访中，效果持续存在。
结果表明，阿育吠陀治疗可有效减轻膝骨关节炎症状。应进一步开展研究以确认疗效的大小，并阐明不同治疗成分和非特异性作用的作用。
clinicaltrials.gov（NCT01225133；初始发布日期：2010 年 10 月 6 日）。
