Abstract:Objective: To observe the efficacy and safety of rheumatoid arthritis treated with Busheng Quhan Zhiwan decoction and external bathing. Method: One hundred patients were divided into treatment group (Busheng Quhan Zhiwan decoction and external bathing) and control group (Celebrex 0.2 g, qd ig, methotrexate 10 mg qw ig, leflunomide 20 mg qd ig, total glucosides of paeonia 0.6 g, bid ig and symptomatic Chinese medicinal decoctions). After 24 weeks treatment, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Rheumatoid factor (RF) and clinical scales was measured and safety was evaluated. Result: There was no significant difference in the effective rate of ACR 20 between two groups. The traditional Chinese medicine syndrome scores, joint pressure pain index number, joint swell index number,early morning stiffness, sufferers' break pain, 20-metre walking times, equally hold dint, Health Assessment Questionnaire(HAQ), ESR, RF and CRP of both groups was significantly improved after the treatments, but there were no significant difference between two groups. The common side effect of two groups was digestive system reaction while blood system impairment was found in the control group. Conclusion: Rheumatoid arthritis treated with Busheng Quhan Zhiwan decoction and external bathing had the same efficacy in clinical improvement and inflammation reduction with few adverse reactions, compared with the integrative therapy with both Chinese and western medicine. Busheng Quhan Zhiwan decoction and external bathing was suggested for clinical aplication.