Effectiveness of an Ayurveda treatment approach in knee osteoarthritis - a randomized controlled trial.

OBJECTIVE: 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. METHOD: 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. RESULTS: 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. CONCLUSION: 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).

Qigong versus exercise therapy for chronic low back pain in adults--a randomized controlled non-inferiority trial.

BACKGROUND: The value of qigong in the treatment of chronic low back pain is unclear. In a randomized controlled trial, we evaluated whether qigong is non-inferior to exercise therapy in patients with chronic low back pain. METHODS: German outpatients (aged 46.7 ± 10.4) with chronic low back pain [mean visual analogue scale (VAS), 53.9 ± 12.5 mm] were enrolled and randomly allocated in a 1:1 ratio to receive either qigong (64 patients, 12 sessions with 1 × 90 min/week over 3 months) or exercise therapy (63 patients, 12 sessions 1 × 60 min/week). The primary outcome measure was the average pain intensity over the last 7 days on a VAS (0-100 mm, 0 = no pain, 100 = worst imaginable pain, non-inferiority margin = 5 mm) after 3 months. Follow-up was measured after 6 and 12 months. RESULTS: The mean adjusted low back pain intensity after 3 months was 34.8 mm [95% confidence interval (CI) 29.5; 40.2] in the qigong group and 33.1 mm (95% CI 27.7; 38.4) in the exercise group. Non-inferiority of the qigong group compared with the exercise group failed to show statistical significance (p = 0.204). In both groups, 10 patients reported suspected adverse reactions (e.g., muscle soreness, dizziness, pain) the total number was comparable in both groups (qigong n = 40, exercise n = 44). CONCLUSIONS: Qigong was not proven to be non-inferior to exercise therapy in the treatment of chronic low back pain. Its role in the prevention of chronic low back pain might be addressed in further studies.