Objective: To evaluate the efficacy and safety of combination therapy of Zhengqing Fengtongning (ZQFTN) and chemical drugs on rheumatoid arthritis (RA). Method: Literature databases of CNKI

VIP

WanFang

SinoMed

and PubMed were included in the study. The quality assessment of literatures was done by the Cochrane Evaluation Handbook 5.1.0

and qualified literatures were reviewed and analyzed by using the Review Manger 5.3.5 Statistical Software. Result: Eight randomized controlled trials with total of 708 cases met the inclusion criteria

and were enrolled in the meta-analysis. Results showed that the efficacy of combination therapy of ZQFTN and chemical drugs for 12 weeks was significantly superior to that of chemical drugs alone (P =0.0003). Morning stiffness[MD=-13.29

95%CI (-24.66

-1.92)

P=0.02]and joint tenderness index[MD=-0.94

95%CI (-1.82

-0.07)

P=0.03]of patients treated with combination of ZQFTN and chemical drugs were more significantly improved than those treated with chemical drugs alone. Combination therapy of ZQFTN and chemical drugs also reduced the frequency of adverse events (P<0.000 01). Conclusion: Current clinical studies demonstrate the efficacy and safety of combination therapy of ZQFTN and chemical drugs in RA is superior to that of chemical drugs alone. However

multicenter

large-scale

double-blinded

double-simulated and high-quality randomized controlled trials are necessary to support the widespread use of combination therapy of ZQFTN and chemical drugs in RA.