RT Journal Article
T1 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.
A1 Vela-Navarrete, Remigio
A1 Alcaraz, Antonio
A1 Rodríguez-Antolín, Alfredo
A1 Miñana López, Bernardino
A1 Fernández-Gómez, Jesús M
A1 Angulo, Javier C
A1 Castro Díaz, David
A1 Romero-Otero, Javier
A1 Brenes, Francisco J
A1 Carballido, Joaquín
A1 Molero García, José Mª
A1 Fernández-Pro Ledesma, Antonio
A1 Cózar Olmos, José Manuel
A1 Manasanch Dalmau, José
A1 Subirana Cachinero, Isaac
A1 Herdman, Michael
A1 Ficarra, Vincenzo
K1 Serenoa repens
K1 LUTS/BPH
K1 Permixon
K1 hexanic extract
K1 meta-analysis
K1 systematic review
AB To comprehensively evaluate the efficacy and safety of the hexanic extract of Serenoa repens (HESr, 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). We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) 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 (Qmax ), nocturia, quality of life, prostate volume, sexual function, and adverse drug reactions (ADRs). Data obtained from RCTs 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). Data from 27 studies (15 RCTs and 12 observational studies) were included for meta-analysis (total N = 5 800). Compared with placebo, the HESr was associated with 0.64 (95% confidence interval [CI] -0.98 to -0.31) fewer voids/night (P  The present meta-analysis, which includes all available RCTs and observational studies, shows that the HESr (Permixon) reduced nocturia and improved Qmax compared with placebo and had a similar efficacy to tamsulosin and short-term 5-ARI in relieving LUTS. HESr (Permixon) appears to be an efficacious and well-tolerated therapeutic option for the long-term medical treatment of LUTS/BPH.
YR 2018
FD 2018-06-06
LK http://hdl.handle.net/10668/12391
UL http://hdl.handle.net/10668/12391
LA en
DS RISalud
RD Apr 18, 2025