Effectiveness of Traditional Chinese Medicine Compound JieDuTongLuoShengJin Granules Treatment in Primary Sjögren’s Syndrome: A Randomized, Double‐Blind, Placebo‐Controlled Clinical Trial

Abstract

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

Integrated Network Pharmacology and Mice Model to Investigate Qing Zao Fang for Treating Sjögren’s Syndrome

“…In light of the principle of the traditional Chinese medicine (TCM), SS is classified into the “dryness arthralgia” category, and the symptoms has been demonstrated to be alleviated, guiding under the TCM pathogenesis of “deficiency, stasis, and toxicity” [ 13 ]. Some herbal formulae or single herb have been proved to play roles in reducing IFN- γ and IL-4 contents in the peripheral blood and increasing the secretion of saliva of SS patients [ 14 , 15 ]. Xuan-Shen (S crophularia ningpoensis ), Mai-Men-Dong ( Ophiopogon japonicus ), and Sheng-Di-Huang ( Rehmannia glutinosa ) were the widely introduced single herbs for treating SS [ 16 ].…”