Objective: This study is designed to compare the therapeutic effects and safety of traditional Chinese medicine (CM) therapy and western combined therapy (WM) in the treatment of rheumatoid arthritis (RA). Methods: After 24 weeks' treatment, the efficacy, safety and the improvement on symptoms of traditional Chinese medicine in 199 patients and western medicine therapy in 197 patients of RA were analyzed. CM therapy included Glucosidorum Tripterygll Totorum tablet and Yishen Juanbi Tablet. The WM therapy included voltaren extended action tablet, methotrexate and sulfasalazine. The American College of Rheumatology (ACR) 20, 50 and 70 responses were employed as primary end-point analysis and the 18 symptoms as secondary end-point analysis. All data were analyzed on SPSS11.5 statistical package. Results: The ACR20 and ACR50 responses in WM were higher than in CIA group, but more improvement on the symptoms and less adverse events were observed in CM therapy. The 18 CM symptoms in RA could be grouped into four symptom combinations with factor analysis method. The factor loading value difference (which reflects the degree of improvement) in responded cases was lower than in non-responded cases in the symptom combination 1. The loading value difference in both responded and non-responded cases in CIA treated patients were higher than those in WM treated group in the symptom combination 2 and 3. Conclusions: WM combined therapy was more effective in the treatment of RA in ACR20 evaluation, but more improvement on CIA symptoms were seen in the CIA therapy. (C) 2007 Etsevier Ltd. All rights reserved.