To comprehensively evaluate the efficacy and safety of the hexanic extract of Serenoa repens (HESr, Permixon), at a dose of 320 mg daily, as monotherapy for the treatment of LUTS/BPH.
Systematic review and meta-analysis of randomized and observational studies in patients with LUTS/BPH identified through searches in Medline, Web of Knowledge [ISI], Scopus, the Cochrane Library, and bibliographic references up to March 2017. Articles studying S. repens extracts other than Permixon were excluded. Data was collected on IPSS score, peak urinary flow (Qmax), nocturia, quality of life, prostate volume, sexual function, and adverse drug reactions (ADR). Data obtained from randomized controlled trials (RCT) and observational studies (OS) were analysed jointly and separately using a random effects model. A sub-group analysis was performed of studies which included patients on longer-term treatment (≥one year).
Data from 27 studies (15 RCTs and 12 OS) were included for meta-analysis (total N=5,800). Compared with placebo, the HESr was associated with 0.64 (95% CI -0.98 to -0.31) fewer voids per night (p=0.0001) and an additional mean increase in Qmax of 2.75 mL/s (95% CI 0.57 to 4.93; p=0.01). When compared with alpha-blockers, the HESr showed similar improvements on IPSS (WMD 0.57; 95%CI, -0.27 to 1.42; p=0.18) and a comparable increase in Qmax to tamsulosin (WMD -0.02; 95%CI, -0.71 to 0.66; p=0.95). Efficacy assessed using the IPSS was similar after 6 months of treatment between the HESr and 5ARIs. Analysis of all available published data for the HESr showed a mean improvement in IPSS score from baseline of -5.73 points (95% CI -6.91 to -4.54; p<0.0001). HESr did not negatively affect sexual function and no clinically relevant effect was observed on PSA. Prostate volume decreased slightly. Similar efficacy results were observed in patients treated for ≥1 year (n=447). The HESr had a favourable safety profile, with gastrointestinal disorders being the most frequent ADR (mean incidence of 3.8%).
The present meta-analysis, which includes all available RCTs and OS, 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. This article is protected by copyright. All rights reserved.
BJU international. 2018 Apr 25 [Epub ahead of print]
Remigio Vela-Navarrete, Antonio Alcaraz, Alfredo Rodríguez-Antolín, Bernardino Miñana López, Jesús M Fernández-Gómez, Javier C Angulo, David Castro Díaz, Javier Romero-Otero, Francisco J Brenes, Joaquín Carballido, José M Molero García, Antonio Fernández-Pro Ledesma, José Manuel Cózar Olmos, José Manasanch Dalmau, Isaac Subirana Cachinero, Michael Herdman, Vincenzo Ficarra
Emeritus Professor of Urology, Universidad Autónoma de Madrid, Madrid, Spain., Urology Department, Hospital Clínic, IDIBAPS, Barcelona, Spain., Urology Department, Hospital Universitario 12 de Octubre. Instituto de Salud Integral del Varón. Fundación Investigación 12 de Octubre, Madrid, Spain., Urology Department, Hospital General Universitario Morales Meseguer, Universidad Católica San Antonio (UCAM), Murcia, Spain., Urology Department, Hospital Universitario Central de Asturias, Universidad de Oviedo, Oviedo, Spain., Urology Department, Hospital Universitario de Getafe, Departamento Clínico, Facultad de Ciencias Biomédicas, Universidad Europea de Madrid, Laureate Universities, Getafe, Madrid, Spain., Urology Department, Hospital Universitario de Canarias, Universidad de La Laguna, Tenerife, Spain., Llefià Primary Care Center, Badalona, Barcelona, Spain., Urology Department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain., San Andrés Primary Care Center, Madrid, Spain., Menasalbas Primary Care Center, Toledo, Spain., Urology Department, Complejo Hospitalario Universitario de Granada, Granada, Spain., Pierre Fabre Ibérica S.A, Spain., CIBER Epidemiología y Salud Pública. IMIM (Institut Hospital del Mar d'Investigacions Mèdiques. Grup d'Epidemiologia i Genètica Cardiovasculars (EGEC). REGICOR Study Group, Barcelona, Spain., Insight Consulting and Research, Mataró, Spain., Department of Urology, University of Messina, Italy.