Abstract: OBJCTIVE: To compare the clinical efficacy of Traditional Chinese Medicine(TCM) to Western Medicine in the treatment of primary Sj?gren's syndrome(p SS).METHODS: We collected randomized controlled trials of TCM vs Western Medicine for the treatment of p SS in Chinese and foreign databases. The study quality was evaluated as suggested in the Cochrane Handbook. The Meta-analysis was performed using Review Manager 5.0 statistical software.RESULTS: A total of 31 randomized controlled trials with 2137 cases were retrieved. The efficiencies of TCM and control treatments were 87.18% and65.63%, respectively. The results of heterogeneity tests showed that the data were homogeneous(P = 0.83), thus a fixed effects model was used for analysis. The results revealed an odds ratio of 3.74 with a 95% confidence interval of 2.99-4.69. The overall effectiveness value was 11.48(P < 0.000 01).These results suggest the efficacy of TCM therapy for p SS better than Western Medicine.CONCLUSION: Although our findings reveal that the TCM treatment of p SS had significant advantages over its counterpart, there were some flaws in the studies included. The findings warrant further investigation.

Key words: Primary Sj?gren's syndrome, Clinical research, Meta-analysis, Medicine, Chinese Traditional