[Systematic review and trial sequential analysis of randomized clinical trial of Hongjin Xiaojie Capsules for treatment of hyperplastic disease of breast].

To systemically evaluate the clinical efficacy and safety of Hongjin Xiaojie Capsules for hyperplastic disease of breast(HDBA), so as to provide the evidence for its clinical application. The inclusion criteria are the RCT of single administration of Hongjin Xiaojie Capsules for treatment of HDBA. We retrieved following databases(CNKI, WanFang, VIP, SinoMed, Cochrane Library and PubMed) from their inception to October 1, 2019. Two researchers independently screened out literatures and extracted data, and assessed the methodological quality of eligible RCT according to the criteria in Cochrane Handbook for Systematic Reviews of Interventions. RevMan 5.3 was used for data analysis, binary data was summarized by risk ratio(RR) with confidence intervals(CI) of 95%, and continuous data were summarized by mean difference(MD) with CI of 95%. To estimate the sample size of systematic review, trial sequential analysis(TSA) was performed base on software TSA v0.9 version. Totally 14 RCTs were included, involving 3 057 patients. The results of Meta-analysis showed a significantly higher cure rate(RR=1.13, 95%CI[1.03, 1.25], P=0.01) and higher total effective rate(RR=1.09, 95%CI[1.05, 1.13], P<0.000 1) in Hongjin Xiaojie Capsules group than those in the Juyuansuan Tamoxifen group. The incidence of adverse events was significantly higher in Juyuansuan Tamoxifen group than that in Hongjin Xiaojie Capsules group(RR=0.28 95%CI[0.16, 0.49], P<0.001), and the adverse events included nausea, vomiting, abdominal pain, diarrhea, irregular menstruation, amenorrhea, unclear vision, dizziness and headache. The TSA for the cure rate demonstrated that the current available data reached the expected value. However, due to the low effect intensity of evidence, the pooled results might be affected by high risk bias of trials. The quality of evidence of included trials was generally low or very low. Inverted funnel diagram showed possible publication bias. This review suggested that Hongjin Xiaojie Capsules were potentially effective and safe in treatment of HDBA, especially, the incidences of drug-related adverse events from Hongjin Xiaojie Capsules were significantly lower than those from tamoxifen. However, because of lack of high-quality evidence for drawing a conclusion, more rigorously designed and high-quality trials are needed to confirm the efficacy and safety of Hongjin Xiaojie Capsules.