Efficacy and Safety of Traditional Chinese Patent Medicine Qizhi Weitong Granules(气滞胃痛颗粒) in Irritable Bowel Syndrome with Predominant Constipation:A Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Trials

Objective: To systematically review the efficacy and clinical safety of Qizhi Weitong Granules(气滞胃痛颗粒)(QZWT) in the treatment of irritable bowel syndrome with predominant constipation(IBS-C). Methods: Randomized controlled trials(RCTs) of QZWT in patients with IBS-C were retrieved from Pub Med, EMBASE, Cochrane Library, China National Knowledge Infrastructure(CNKI), Wanfang, Chinese Scientific Journals Database(VIP), and Chinese Biological Medical Database(CBM) from inception to December 3, 2022. Conventional meta-analysis with random-effects model or fixed-effects model and trial sequential analysis(TSA) were performed by Review Manager 5.4, Stata and TSA software. Results: A total of 4 RCTs and 368 patients with IBS-C were included in this study. The findings of the meta-analysis indicated that the cure and efficacy rate of the experimental group was significantly higher than that of the control group [RR=2.19;(95% CI, 1.35–3.55), P<0.01; RR=1.14;(95% CI, 1.03–1.27), P<0.05], while the result of Bristol Score was negative. The funnel plot was probably symmetry, and the P value was >0.05 in the Egger test, which confirmed the nonexistence of significant publication bias in this outcome. TSA showed the cumulative z-value crossed the traditional threshold and TSA threshold, while it didn't get to the required information size. Finally, 2 studies reported adverse events after QZWT treatment, including 3 cases of diarrhea. No serious adverse events were reported. Conclusion: QZWT was an effective and safe complementary therapy in the treatment of IBS-C with no obvious adverse reactions. TSA analysis confirmed our meta-analysis results. Therefore, QZWT may be a potential candidate for the treatment of IBS-C. However, due to the limited quality of current studies, more long-term, randomized, double-blinded clinical trials are needed in future studies.