Objective. To evaluate the clinical therapeutic efficacy and safety of JieDuTongLuoShengJin granules + HCQ in patients with pSS.\nMethods. 40 patients with low-activity-level pSS and without visceral involvement participated in this study and were randomized\nto receive either JieDuTongLuoShengJin granules with HCQ or placebo with HCQ. Patients and investigators were blinded to\ntreatment allocation.The primary endpoint was week 12 ESSPRI score, while secondary endpoints included ESSDAI, salivary and\nlacrimal gland function, and some laboratory variables. Safety-related data were also assessed. Results. Comparing with the placebo\ngroup, the treatment group experienced statistically significant improvement in the mean change from baseline for the primary\nendpoint of ESSPRI score and also in PGA. Moreover, in comparison with baseline values, the treatment group had significantly\nimproved ESSDAI score, unstimulated saliva flow rate, and several laboratory variables. However, upon comparison of the two\ngroups, there were no significant differences for them.Theincidence of AEs was 10.0%, one in treatment group and three in placebo\ngroup. Conclusion. Treatment with a combination of JieDuTongLuoShengJin granules with HCQ is effective in improving patients�\nsubjective symptoms and some objective indicators of pSS. These results indicate that JieDuTongLuoShengJin is promising as a safe\nand effective treatment of pSS.
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