Efficacy and safety of a hexanic extract of Serenoa repens (Permixon ® ) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia ( LUTS / BPH ): systematic review and meta‐analysis of randomised controlled trials and observational studies
Abstract
Objectives To comprehensively evaluate the efficacy and safety of the hexanic extract of Serenoa repens ( HES r, Permixon ® ; Pierre Fabre Médicament, Castres, France), at a dose of 320 mg daily, as monotherapy for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia ( LUTS / BPH ). Materials and methods We conducted a systematic review and meta‐analysis of randomised controlled trials ( RCT s) and prospective observational studies in patients with LUTS / BPH identified through searches in Medline, Web of Knowledge (Institute for Scientific Information), Scopus, the Cochrane Library, and bibliographic references up to March 2017. Articles studying S. repens extracts other than Permixon were excluded. Data were collected on International Prostate Symptom Score ( IPSS ), maximum urinary flow rate (Q max ), nocturia, quality of life, prostate volume, sexual function, and adverse drug reactions ( ADR s). Data obtained from RCT s and observational studies were analysed jointly and separately using a random effects model. A sub‐group analysis was performed of studies that included patients on longer‐term treatment (≥1 year). Results Data from 27 studies (15 RCT s and 12 observational studies) were included for meta‐analysis (total N = 5 800). Compared with placebo, the HES r was associated with 0.64 (95% confidence interval [ CI ] −0.98 to −0.31) fewer voids/night ( P < 0.001) and an additional mean increase in Q max of 2.75 mL/s (95% CI 0.57…
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Evidence Hub reads this as a systematic review, 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. Reported size: 447 participants or records.
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