Abstract: OBJECTIVE: To systematically evaluate the curative clinical efficacy and safety of sinomenine(SIN) in treatment of rheumatoid arthritis(RA) in comparison to methotrexate(MTX).METHODS: We searched the China National Knowledge Infrastructure Database, Chinese Biomedical Literature Database, China Science and Technology Journal Database, Wanfang Database, Pubmed and Cochrane Library electronically up to August 31,2015, without language limitation. Only randomized controlled trials(RCTs) were included. Software Review Manager 5.3 was used for Meta-analysis.RESULTS: A total of 16 eligible studies within 1500RA patients were included. The meta-analysis indicated that on basis of MTX, SIN was more effective in total effective rate(P < 0.000 01). Besides, SIN alone versus MTX also showed advantages in RA therapy(P = 0.04) Taken together, adverse events occurred less frequently in combination of SIN and MTX than MTX alone(P < 0.0001), especially in digestive system(P < 0.000 01),while occurred more in dermato mucosal system with SIN treatment versus MTX(P = 0.02), and were similar for both remedies in nervous system(P = 0.12) and hematological system(P = 0.25).CONCLUTION: Compared to MTX, SIN had better clinical efficacy and relatively fewer adverse events in treatment of RA, especially when it was used together with MTX. Due to the poor methodological quality, well-designed, multiple-center RCTs are still required to further confirm the findings.

Key words: Sinomenine, Randomized controlled trials, Arthritis, rheumatoid, Methotrexate, Meta-analysis