To systematically evaluate the clinical efficacy and safety of modified Chaihu Shugan powder compared with conventional western medicine in the treatment of chronic cholecystitis,so as to provide an evidence-based basis for the clinical application of Chaihu Shugan powder.Methods:We searched PubMed,Embase,the Cochrane Library,China National Knowledge Infrastructure(CNKI),China Science Periodical Database(CSPD),Chinese Citation Database(CCD),and China Biology Medicine disc(CBMdisc) for randomized controlled trials involving the treatment of chronic cholecystitis with modified Chaihu Shugan powder from inception to August 2020.Two researchers independently selected the papers according to the screening criteria,extracted data,and evaluated the risk of bias.We employed Revman5.3 to carry out meta-analysis,Stata15.0 to evaluate publication bias,TSA0.9 to perform trial sequential analysis(TSA),and GRADE3.6 to evaluate the quality of evidence.Results:Eleven clinical studies involving 1 772 cases(1 034 cases in the observation group and 738 cases in the control group) were included in this study.1) Meta-analysis:Compared with conventional western medicine,Chaihu Shugan powder can improve the clinical cure rate of chronic cholecystitis(RR=1.35,95%CI 1.21 to 1.50,P<0.000 01) and the clinical total effective rate(RR=1.17,95%CI 1.13 to 1.22,P<0.000 01),and it can reduce the recurrence rate(RR=0.07,95%CI 0.01 to 0.34,P=0.001) and the incidence of adverse reactions(RR=0.06,95%CI 0.01 to 0.33,P=0.000 9).2) TSA:The cumulative Z value of TSA reported clinical total effective rate reached the traditional and TSA cut-off values in the third study,indicating that the results were conclusive.3) Publication bias:The Harbord test showed no existence of publication bias(P=0.23).4) Evaluation of evidence quality:The grading of recommendations,assessment,development,and evaluation(GRADE) showed low quality of the evidence for clinical cure rate and clinical total effective rate,extremely low quality of the evidence for recurrence rate and incidence of adverse reactions,and weak recommendation.Conclusion:Chaihu Shugan powder demonstrates the clinical efficacy and safety superior to conventional western medicine in the treatment of chronic cholecystitis and has the potential to be applied in the treatment after syndrome differentiation.