{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T12:04:34Z","timestamp":1790251474599,"version":"4.1.0"},"reference-count":44,"publisher":"BioExcel","license":[{"start":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T00:00:00Z","timestamp":1778630400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Pierre Fabre","id":[{"id":"https:\/\/ror.org\/04hdhz511","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["DIC"],"abstract":"<jats:p>This systematic review assessed the potential effectiveness and safety of Serenoa repens (saw palmetto) for benign prostatic disorders, mainly benign prostatic hyperplasia and associated lower urinary tract symptoms. Following PRISMA guidance (PROSPERO: CRD420251032255), we searched PubMed, Cochrane and ScienceDirect for human studies from January 2020 to May 2025. Sixteen studies (&gt;3000 participants) met criteria, including randomized trials, observational cohorts, a post hoc analysis, an open-label comparative study and a pharmacovigilance analysis. Overall, S. repens was associated with improvements in symptom severity (International Prostate Symptom Score) in several trials, with variable effects on urinary flow, postvoid residual volume, and patient-reported quality of life. Signals of benefit appeared more consistently with hexanic lipidosterolic extracts and \u03b2-sitosterol-enriched preparations, and some real-world and head-to-head comparisons suggested outcomes comparable to alpha-blockers with fewer adverse events. Combination therapy, especially with the addition of alpha-blockers, showed larger symptom reductions in select populations, particularly with more pronounced baseline symptoms or prostatic inflammation. However, heterogeneity in extract formulations, dosing, study design, and outcome reporting limited cross-study comparability. Safety findings were generally favourable, with mostly mild gastrointestinal events and fewer sexual adverse effects than reported for conventional pharmacotherapies. Taken together, recent evidence supports S. repens as a potentially useful, well-tolerated option for benign prostatic hyperplasia-related symptoms \u2013 especially in certain formulations and as part of combination strategies \u2013 whilst underscoring the need for standardized, adequately powered trials to clarify which patients benefit most, optimal dosing, and durability of effects.\n\nDownload the Plain Language Summary of this article: https:\/\/www.drugsincontext.com\/plain-language-summaries\/plain-language-summary-efficacy-and-safety-of-serenoa-repens-in-benign-prostatic-disorders-a-systematic-review-of-recent-clinical-evidence<\/jats:p>","DOI":"10.7573\/dic.2025-10-2","type":"journal-article","created":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T08:31:37Z","timestamp":1778661097000},"page":"1","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy and safety of Serenoa repens in benign prostatic disorders: a systematic review of recent clinical evidence"],"prefix":"10.7573","volume":"15","author":[{"given":"Iv\u00e1n","family":"Schwartzmann","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03qwx2883","id-type":"ROR","asserted-by":"publisher"}],"name":"Puigvert Foundation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Redondo","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03qwx2883","id-type":"ROR","asserted-by":"publisher"}],"name":"Puigvert Foundation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alba","family":"Farr\u00e9","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03qwx2883","id-type":"ROR","asserted-by":"publisher"}],"name":"Puigvert Foundation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paula","family":"Izquierdo","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03qwx2883","id-type":"ROR","asserted-by":"publisher"}],"name":"Puigvert Foundation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enver","family":"Moncada","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03qwx2883","id-type":"ROR","asserted-by":"publisher"}],"name":"Puigvert Foundation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda","family":"Montlle\u00f3","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03qwx2883","id-type":"ROR","asserted-by":"publisher"}],"name":"Puigvert Foundation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yesica","family":"Quiroz","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03qwx2883","id-type":"ROR","asserted-by":"publisher"}],"name":"Puigvert Foundation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto","family":"Breda","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03qwx2883","id-type":"ROR","asserted-by":"publisher"}],"name":"Puigvert Foundation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joan","family":"Palou","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03qwx2883","id-type":"ROR","asserted-by":"publisher"}],"name":"Puigvert Foundation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Ponce de Le\u00f3n","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03qwx2883","id-type":"ROR","asserted-by":"publisher"}],"name":"Puigvert Foundation"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10047","published-online":{"date-parts":[[2026,5,13]]},"reference":[{"key":"ref0","doi-asserted-by":"crossref","unstructured":"1.\tChen X, Yang S, He Z, et al. 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Clinical effect of phytosterol-enriched saw palmetto extract on urinary function in healthy middle-aged and older males: a double-blind, placebo-controlled randomized comparative study. Funct Foods Health Dis. 2024;14:114\u2013127. https:\/\/doi.org\/10.31989\/ffhd.v14i2.1312","DOI":"10.31989\/ffhd.v14i2.1312"},{"key":"ref22","doi-asserted-by":"crossref","unstructured":"23.\tIshii I, Wada T, Takara T. Effects of saw palmetto fruit extract intake on improving urination issues in Japanese men: a randomized, double-blind, parallel-group, placebo-controlled study. Food Sci Nutr. 2020;8(8):4017\u20134026. https:\/\/doi.org\/10.1002\/fsn3.1654","DOI":"10.1002\/fsn3.1654"},{"key":"ref23","doi-asserted-by":"crossref","unstructured":"24.\tKimura M, Ishii I, Baba A, Takara T. Beneficial effects of saw palmetto (Serenoa repens) fruit extract on the urinary symptoms of healthy Japanese adults with possible lower urinary tract symptoms: a randomized, double-blind, placebo-controlled study. 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Clin Pract. 2024;14(1):188\u2013197. https:\/\/doi.org\/10.3390\/clinpract14010016","DOI":"10.3390\/clinpract14010016"}],"container-title":["Drugs in Context"],"original-title":[],"link":[{"URL":"https:\/\/www.drugsincontext.com\/wp-content\/uploads\/2026\/05\/dic.2025-10-2.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T11:04:51Z","timestamp":1790247891000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.drugsincontext.com\/efficacy-and-safety-of-serenoa-repens-in-benign-prostatic-disorders-a-systematic-review-of-recent-clinical-evidence\/"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,13]]},"references-count":44,"URL":"https:\/\/doi.org\/10.7573\/dic.2025-10-2","relation":{},"ISSN":["1740-4398"],"issn-type":[{"value":"1740-4398","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,13]]},"article-number":"dic.2025-10-2"}}