Clinical Efficacy and Safety of Total Glucosides of Paeony for Primary Sjögren's Syndrome: A Systematic Review.

OBJECTIVE: To evaluate the clinical efficacy and safety of total glucosides of paeony (TGP) for primary Sjögren's syndrome (pSS).

METHODS: Eight electronic databases were searched from their inception to July 2016. Clinical randomized controlled trials (RCTs) were included. The study quality was evaluated according to the standard suggested in the Cochrane Handbook. RevMan 5.1 was used for statistical analysis.

RESULTS: Seven RCTs involving 443 patients were included. The results showed that TGP combined with an immunosuppressant (IS) showed greater efficacy for improving the saliva flow test of pSS compared to immunosuppressant alone (WMD -6.88, 95% CI -9.02 to -4.74, and P < 0.00001). And the same trend favouring TGP-IS dual combination was found in Schirmer test (WMD 1.63, 95% CI 0.26 to 3.01, and P = 0.02), ESR (WMD 7.33, 95% CI -10.08 to -4.59, and P < 0.00001), CRP (WMD -6.00, 95% CI -7.17 to -4.83, and P < 0.00001), IgM (WMD = -0.42, 95% CI -0.70 to 0.13, and P = 0.004), and IgG (WMD -3.22, 95% CI -4.32 to -2.12, and P < 0.00001) analysis. However, TGP did not affect IgA (WMD 0.53, 95% CI -1.34 to -0.29, and P = 0.20). The adverse events manifested no significant differences between the two groups.

CONCLUSIONS: The TGP-IS combination is superior to IS alone in the treatment of pSS. However, due to the low quality of included studies, high-quality RCTs are needed to confirm the beneficial effects of TGP.