OBJECTIVE: To evaluate the effect and safety of Qianlieshutong Capsules (QC) in the treatment of BPH. METHODS: We searched 10 Chinese and English databases up to July 2019 for randomized controlled trials (RCT) on treatment of BPH with QC followed by a meta-analysis on the included articles using Cochrane Handbook 5.1.0 and Revman5.3 software. RESULTS: A total of 18 RCTs involving 1 802 cases of BPH were included out of the 175 articles identified. The baseline data from the RCTs were all comparable. Compared with the controls, the patients treated with QC showed a significantly higher rate of clinical effectiveness and better improvement in IPSS as well as in the maximum urinary flow rate (Qmax), postvoid residual urine (PVR) and prostate volume after 3 months of medication. No serious adverse drug events or reactions were reported. CONCLUSIONS: The existing data and methodology indicate the efficacy and safety of Qianlieshutong Capsules in the treatment of BPH, which, however, has to be further verified by more well-designed large-sample multi-center high-quality randomized controlled trials.