To observe the clinical efficacy of Mayi Tongbi capsule on thetreatment of rheumatoid arthritis. Methods:The patients with rheumatoid arthritis meeting the diagnostic criteria were randomly divided into the treatment group (340 cases), receiving Methotrexate combined with Diclofenac Sodium Enteric Capsules, and thecontrol group(300 cases), treated with Mayi Tongbi capsule combined with Diclofenac Sodium Enteric Capsules. Observation was made on the efficacy of the disease, the TCM syndrome, improvement of clinical symptoms, and the changes in DAS28 over 12 weeks of follow-up. Results:There was obvious improvement on the disease after treatment in the two groups, the difference being statistically significant (P<0.05); after treatment, the treatment shows better effect compared with in terms of decreasing ESR, CRP, RF and improving morning stiffness time, number of swollen joints, grip strength and TCM syndrome integral treatment group.There was statistic significance in the difference (P<0.05), and, the disease condition was relatively stable over 12-week follow up, with Diclofenac Sodium Enteric Capsules taken in the treatment group being gradually reeduced. Conclusion:The combination of Mayi Tongbi capsule and Diclofenac Sodium Enteric Capsules can effectively improve and cure the symptoms of rheumatoid arthritis patients.