Systematic review and meta-analysis of randomized controlled trials evaluating silodosin in the treatment of non-neurogenic male lower urinary tract symptoms suggestive of benign prostatic enlargement

Abstract

Purpose: To perform a systematic review and meta-analysis of randomized clinical trials (RCTs) reporting the efficacy and safety of silodosin in the treatment of non-neurogenic male LUTS suggestive of benign prostatic enlargement.

Patients and methods: A systematic review searching multiple dataset for the term "silodosin". A meta-analysis was conducted using Review Manager software (Cochrane Collaboration, Oxford, UK).

Results: Our systematic search retrieved four studies summarizing the data of five RCTs. Silodosin was more effective than placebo with regard to mean change in all the parameters related to the IPSS and Qmax (all p values <0.0003). Adverse events (AE), abnormal ejaculation (AEj), and withdrawal due to AE were all more common with silodosin (all p values <0.001). The prevalence of dizziness and adverse events other than AEj was similar with silodosin and placebo. Silodosin was more effective than tamsulosin 0.2 mg with regard to some IPSS-related parameters. [corrected] Silodosin and tamsulosin 0.4 mg were similarly effective in all the efficacy analyses. AEj was less common with tamsulosin 0.2 and 0.4 mg (p values <0.00001); adverse events other than AEj were more common with tamsulosin 0.2 and 0.4 mg (p values ≤ 0.05).

Conclusions: Silodosin was significantly more effective than placebo and tamsulosin 0.2 mg in improving symptoms and as effective as tamsulosin 0.4 mg. With regard to adverse events, AEj was more common with silodosin. All the adverse events other than AEj were significantly more common with tamsulosin 0.2 and 0.4 mg and as frequent with silodosin and placebo.