Objective To evaluate the clinical efficacy and safety of integrated traditional Chinese and Western medicine in treating active rheumatoid arthritis (aRA).Methods A prospective randomized controlled study was carried out. Totally 148 aRA patients were divided into the control group and the treatment group, 74 cases in each group. Control group was treated with MTX (methotrexate) and LEF (leflunomide), while the treatment group took traditional Chinese medicine based on syndrome differentiation, on the basis of treatment with MTX and LEF. The therapeutic course for all was 3 months. Efficacy indexes, like clinical symptoms and signs, ESR, TCM syndrome integrals, DAS 28 score, and safety indexes were observed.Results This study finally completed 136 cases, including 69 cases in the treatment group and 67 cases in the control group. In the two groups, significant improvement of clinical signs and symptoms, ESR, DAS28, and TCM syndrome integrals after treatment were shown, with statistical significance (P<0.01). Better effects were obtained in the treatment group in lessening tender joint numbers and swollen joint numbers, DAS28, and TCM syndrome integrals (P<0.01). The total effective rate of the TCM syndrome efficacy was 86.96% (60/69) in the treatment group, and 76.12% (51/67) in the control group, without statistical significance (P>0.05). The significant efficiency of the treatment group was 11.59% (8/69), and the control group was 5.97% (4/67), with statistical significance (P<0.05). Adverse reactions occurred fewer in the treatment group than in the control group (P<0.01).Conclusion Compared with single traditional Chinese medicine, integrated traditional Chinese and Western medicine for treating aRA can better improve DAS28 and TCM syndrome integrals, and reduce the incidence of adverse reactions.