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Int Urol Nephrol. 2012 Dec;44(6):1601-9. doi: 10.1007/s11255-012-0261-6. Epub 2012 Aug 24.

The efficacy and safety of silodosin in treating BPH: a systematic review and meta-analysis.

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Department of Urology, Beijing Tian-Tan Hospital, Capital Medical University, No. 6 Tiantan Xi Li, Dongcheng District, Beijing, 100050, China.



Pharmacological therapy is typically the first-line treatment for patients with benign prostatic hyperplasia (BPH). We carried out a systematic review and meta-analysis to assess the efficacy and safety of silodosin for treating BPH.


A literature review was performed to identify all published randomized placebo-controlled trials (RCT) of silodosin for the treatment of BPH. The search included the following databases: PUBMED, EMBASE, and the Cochrane Controlled Trail Register of Controlled Trials. The reference lists of retrieved studies were also investigated. A systematic review and meta-analysis were conducted.


Four publications involving a total of 2,543 patients were used in the analysis, including 3 RCTs that compared silodosin with placebo and 3 RCTs that compared silodosin with tamsulosin. We found that silodosin was effective in treating BPH in our meta-analysis. Total international prostate symptom score (IPSS) (P=0.92 SWD=2.92 95% CI=2.19-3.65 the mean decrease of total IPSS was from 6.4 to 10.6), voiding symptom score, storage symptom score, and quality-of-life score indicated that silodosin was more effective than the placebo. Silodosin's efficacy is similar to that of tamsulosin (P=0.37 SWD=1.14 95% CI=0.18-2.11) in our meta-analysis. However, the incidence of abnormal ejaculation was higher in patients treated with tamsulosin therapy compared with the placebo (234/1128=20.74% 12/680=1.76% 6/736=0.82%).


This meta-analysis proves silodosin to be an effective and safe treatment for the relief of lower urinary tract symptom associated with BPH. Silodosin and tamsulosin were similar in terms of efficacy. The major adverse event associated with silodosin treatment was abnormal ejaculation.

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