Efficacy and Safety of Hexanic Lipidosterolic Extract of Serenoa repens (Permixon) in the Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: Systematic Review and Meta-analysis of Randomized Controlled Trials
Abstract
CONTEXT
A recent Cochrane Collaboration meta-analysis of randomized controlled trials (RCTs) evaluating the efficacy of different extracts of Serenoa repens in relieving lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) concluded that these extracts were no more effective than placebo. However, among all Serenoa repens extracts, Permixon (Pierre Fabre Medicament, Paris, France) has the highest activity and the most accurate standards of drug preparation and extraction.
OBJECTIVE
To evaluate the efficacy and safety of Permixon in the treatment of LUTS/BPH.
EVIDENCE ACQUISITION
A systematic review and meta-analysis of the literature was performed in January 2016 using the Medline, Scopus, and Web of Science databases, searching for the term Serenoa repens in all fields of the records. Only RCTs reporting on efficacy and safety of Permixon in the treatment of LUTS/BPH were selected.
EVIDENCE SYNTHESIS
The systematic search identified 12 RCTs: 7 compared Permixon with placebo; 2 compared Permixon with tamsulosin; 2 compared Permixon plus tamsulosin with, respectively, placebo plus tamsulosin and tamsulosin alone; and 1 compared Permixon with finasteride. Permixon was significantly more effective than placebo in reducing the number of nocturnal voids (weighted mean difference [WMD] -0.31; p=0.03) and increasing maximum flow rate (Qmax; WMD 3.37; p<0.0001). The rates of overall adverse events (odds ratio [OR] 1.12; p=0.92) and withdrawal (OR 1.52;…
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Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid.
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