{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:45:48Z","timestamp":1787013948249,"version":"build-2736575974"},"reference-count":67,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2018,6,6]],"date-time":"2018-06-06T00:00:00Z","timestamp":1528243200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Pierre Fabre Ib\u00e9rica, S.A, Barcelona, Spain"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2018,12]]},"abstract":"\n Objectives<\/jats:title>\n \n To comprehensively evaluate the efficacy and safety of the hexanic extract of\n Serenoa repens<\/jats:italic>\n (\n HES<\/jats:styled-content>\n r, Permixon\n \u00ae<\/jats:sup>\n ; Pierre Fabre M\u00e9dicament, Castres, France), at a dose of 320\u00a0mg daily, as monotherapy for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (\n LUTS<\/jats:styled-content>\n \/\n BPH<\/jats:styled-content>\n ).\n <\/jats:p>\n <\/jats:sec>\n \n Materials and methods<\/jats:title>\n \n We conducted a systematic review and meta\u2010analysis of randomised controlled trials (\n RCT<\/jats:styled-content>\n s) and prospective observational studies in patients with\n LUTS<\/jats:styled-content>\n \/\n BPH<\/jats:styled-content>\n 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\n S.\u00a0repens<\/jats:italic>\n extracts other than Permixon were excluded. Data were collected on International Prostate Symptom Score (\n IPSS<\/jats:styled-content>\n ), maximum urinary flow rate (Q\n max<\/jats:sub>\n ), nocturia, quality of life, prostate volume, sexual function, and adverse drug reactions (\n ADR<\/jats:styled-content>\n s). Data obtained from\n RCT<\/jats:styled-content>\n s and observational studies were analysed jointly and separately using a random effects model. A sub\u2010group analysis was performed of studies that included patients on longer\u2010term treatment (\u22651\u00a0year).\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Data from 27 studies (15\n RCT<\/jats:styled-content>\n s and 12 observational studies) were included for meta\u2010analysis (total\n N<\/jats:italic>\n = 5\u00a0800). Compared with placebo, the\n HES<\/jats:styled-content>\n r was associated with 0.64 (95% confidence interval [\n CI<\/jats:styled-content>\n ] \u22120.98 to \u22120.31) fewer voids\/night (\n P<\/jats:italic>\n < 0.001) and an additional mean increase in Q\n max<\/jats:sub>\n of 2.75\u00a0mL\/s (95%\n CI<\/jats:styled-content>\n 0.57 to 4.93;\n P<\/jats:italic>\n = 0.01). When compared with \u03b1\u2010blockers, the\n HES<\/jats:styled-content>\n r showed similar improvements on\n IPSS<\/jats:styled-content>\n (weighted mean difference [\n WMD<\/jats:styled-content>\n ] 0.57, 95%\n CI<\/jats:styled-content>\n \u22120.27 to 1.42;\n P<\/jats:italic>\n = 0.18) and a comparable increase in Q\n max<\/jats:sub>\n to tamsulosin (\n WMD<\/jats:styled-content>\n \u22120.02, 95%\n CI<\/jats:styled-content>\n \u22120.71 to 0.66;\n P<\/jats:italic>\n = 0.95). Efficacy assessed using the\n IPSS<\/jats:styled-content>\n was similar after 6\u00a0months of treatment between the\n HES<\/jats:styled-content>\n r and 5\u03b1\u2010reductase inhibitors (5\n ARI<\/jats:styled-content>\n s). Analysis of all available published data for the\n HES<\/jats:styled-content>\n r showed a mean improvement in\n IPSS<\/jats:styled-content>\n from baseline of \u22125.73 points (95%\n CI<\/jats:styled-content>\n \u22126.91 to \u22124.54;\n P<\/jats:italic>\n < 0.001).\n HES<\/jats:styled-content>\n r did not negatively affect sexual function and no clinically relevant effect was observed on prostate\u2010specific antigen. Prostate volume decreased slightly. Similar efficacy results were seen in patients treated for \u22651\u00a0year (\n n<\/jats:italic>\n = 447). The\n HES<\/jats:styled-content>\n r had a favourable safety profile, with gastrointestinal disorders being the most frequent\n ADR<\/jats:styled-content>\n (mean incidence of 3.8%).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n The present meta\u2010analysis, which includes all available\n RCT<\/jats:styled-content>\n s and observational studies, shows that the\n HES<\/jats:styled-content>\n r (Permixon) reduced nocturia and improved Q\n max<\/jats:sub>\n compared with placebo and had a similar efficacy to tamsulosin and short\u2010term 5\u2010\n ARI<\/jats:styled-content>\n in relieving\n LUTS<\/jats:styled-content>\n .\n HES<\/jats:styled-content>\n r (Permixon) appears to be an efficacious and well\u2010tolerated therapeutic option for the long\u2010term medical treatment of\n LUTS<\/jats:styled-content>\n \/\n BPH<\/jats:styled-content>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/bju.14362","type":"journal-article","created":{"date-parts":[[2018,4,25]],"date-time":"2018-04-25T13:17:11Z","timestamp":1524662231000},"page":"1049-1065","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":86,"title":["Efficacy and safety of a hexanic extract of\n Serenoa repens<\/i>\n (Permixon\n \u00ae<\/sup>\n ) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (\n LUTS<\/scp>\n \/\n BPH<\/scp>\n ): systematic review and meta\u2010analysis of randomised controlled trials and observational studies"],"prefix":"10.1111","volume":"122","author":[{"given":"Remigio","family":"Vela\u2010Navarrete","sequence":"first","affiliation":[{"name":"Emeritus Professor of Urology Universidad Aut\u00f3noma de Madrid Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Alcaraz","sequence":"additional","affiliation":[{"name":"Urology Department IDIBAPS Hospital Cl\u00ednic Universitat de Barcelona Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfredo","family":"Rodr\u00edguez\u2010Antol\u00edn","sequence":"additional","affiliation":[{"name":"Urology Department Instituto de Salud Integral del Var\u00f3n Fundaci\u00f3n Investigaci\u00f3n 12 de Octubre Hospital Universitario 12 de Octubre Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernardino","family":"Mi\u00f1ana L\u00f3pez","sequence":"additional","affiliation":[{"name":"Urology Department Cl\u00ednica Universidad de Navarra Universidad de Navarra Pamplona, Navarra Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jes\u00fas M.","family":"Fern\u00e1ndez\u2010G\u00f3mez","sequence":"additional","affiliation":[{"name":"Urology 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