Meridian-sinew release therapy for the treatment of refractory rheumatoid arthritis.

OBJECTIVE To evaluate the efficacy and safety of Meridian-sinew Release therapy in Chinese patients with refractory active Rheumatoid Arthritis (RA). SUMMARY OF BACKGROUND DATA Few studies focused on the effect of combination of Meridian-sinew Release therapy and Methotrexate (MTX) on refractory active RA of Chinese patients. METHODS Eighty refractory active rheumatoid arthritis patients were randomized to receive Meridian-sinew Release+MTX 10 mg (n=40), MTX 10 mg (n=40) every week for 12 weeks. The primary end point was the proportion of patients achieving ≥20% improvement in the American College of Rheumatology criteria (ACR20) at week 12. Secondary efficacy endpoints included 28-joint disease activity score with ESR (DAS28-ESR), simplified disease activity index (SDAI), clinical disease activity index (CDAI) and Health Assessment Questionnaire-Disability Index (HAQ-DI). RESULTS Week 12 ACR20 response rates were significantly greater in Meridian-sinew Release+MTX group (30/38 (78.9%)) than in MTX group (19/37 (51.3%)), (P<0.001), as were ACR50 and ACR70 response rates. Patients treated with Meridian-sinew Release+MTX were significantly more likely to achieve clinical remission, using various definitions, at 12 weeks versus MTX alone. A larger percentage of Meridian-sinew+MTX patients than MTX alone patients were in states of low disease activity or remission for DAS28-ESR, SDAI and CDAI after 12 weeks of treatment. CONCLUSION Our study suggests that Meridian-sinew Release therapy was well tolerated and efficacious in improving clinical outcomes in Chinese patients with refractory active RA.