{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T01:57:16Z","timestamp":1789610236308,"version":"build-2803163510"},"reference-count":21,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,10,16]],"date-time":"2025-10-16T00:00:00Z","timestamp":1760572800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Prostate"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Chronic inflammation is commonly observed in benign prostatic hyperplasia (BPH) tissue and may contribute to lower urinary tract symptoms (LUTS) as well as disease progression. This study evaluated the efficacy of combining a standardized extract of\n                      <jats:italic>Serenoa repens<\/jats:italic>\n                      (Sr) with alfuzosin versus alfuzosin monotherapy in men with LUTS due to BPH.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In this prospective Phase III, randomized, multicenter, real\u2010world study, 300 treatment\u2010na\u00efve men with moderate\u2010to\u2010severe LUTS (IPSS\u2009&gt;\u20097) and prostate volume\u2009&gt;\u200930 cc were enrolled. Patients received either alfuzosin 10\u2009mg\/day or alfuzosin 10\u2009mg plus HESr 320\u2009mg\/day for 12 months. Primary endpoints included changes in IPSS and uroflowmetry (Q\n                      <jats:sub>max<\/jats:sub>\n                      ). Secondary endpoints included quality of life (IPSS\u2010Q8), storage symptoms (IPSS\u2010Q2 and Q4), nocturia (IPSS\u2010Q7), erectile function (IIEF\u20105), and ejaculatory function (MSHQ\u2010Ej). Outcomes were analyzed using mixed\u2010model ANOVA with post hoc Tukey's tests. Statistical analysis was performed using JMP Pro 14 (SAS Institute Inc.). The protocol was approved by our Ethical Committee Lazio Area 1, Protocol 0949\/2023, Rif 7385 on December 12, 2023.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Both treatments significantly improved total IPSS over time (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.0001). Across all time points, combination therapy was associated with consistently lower IPSS scores, demonstrating a significant time\u2010by\u2010treatment interaction (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.007). Nocturia improved significantly over time (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.0001); the combination group showed greater benefit from Month 3 onward (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.006), though the main treatment effect was not statistically significant (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.076). Q\n                      <jats:sub>max<\/jats:sub>\n                      improved in both groups (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.0001), with a significant time\u2013treatment interaction (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.006), but no significant main effect of treatment type (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.113). A mild but significant decline in IIEF\u20105 was observed in both groups over time. Treatment adherence exceeded 86% in both arms.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      The combination of HESr and alfuzosin was significantly more effective than alfuzosin monotherapy in relieving LUTS, with greater benefits from Month 3 onward. Q\n                      <jats:sub>max<\/jats:sub>\n                      and nocturia also showed greater, although mild, improvements with combination therapy. Sexual function outcomes were comparable between groups. High adherence and real\u2010world applicability support the clinical value of this combination in managing BPH\u2010related LUTS.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pros.70071","type":"journal-article","created":{"date-parts":[[2025,10,16]],"date-time":"2025-10-16T07:46:36Z","timestamp":1760600796000},"page":"204-218","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Efficacy of\n                    <i>Serenoa repens<\/i>\n                    Extract Combined With Alfuzosin Versus Alfuzosin Alone in Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: A Multicenter Randomized Study"],"prefix":"10.1002","volume":"86","author":[{"given":"Giulio","family":"Bevilacqua","sequence":"first","affiliation":[{"name":"Department Materno Infantile e Scienze Urologiche University Sapienza Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dalila","family":"Carino","sequence":"additional","affiliation":[{"name":"Department Materno Infantile e Scienze Urologiche University Sapienza Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7899-8056","authenticated-orcid":false,"given":"Stefano","family":"Salciccia","sequence":"additional","affiliation":[{"name":"Department Materno Infantile e Scienze Urologiche University Sapienza Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Gentilucci","sequence":"additional","affiliation":[{"name":"Department Materno Infantile e Scienze Urologiche University Sapienza Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Flavio","family":"Forte","sequence":"additional","affiliation":[{"name":"Vannini\u2010Figlie San Camillo Hospital Rome 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Prostate"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pros.70071","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T13:32:51Z","timestamp":1765805571000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pros.70071"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,16]]},"references-count":21,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,2]]}},"alternative-id":["10.1002\/pros.70071"],"URL":"https:\/\/doi.org\/10.1002\/pros.70071","archive":["Portico"],"relation":{},"ISSN":["0270-4137","1097-0045"],"issn-type":[{"value":"0270-4137","type":"print"},{"value":"1097-0045","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,16]]},"assertion":[{"value":"2025-04-21","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication 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