Efficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical Study

Alcaraz Asensio, AntonioGacci, MauroFicarra, VincenzoMedina Polo, JoséSalonia, AndreaFernández Gómez, Jesús M.Ciudin, AlexandruCastro Diaz, DavidRodríguez Antolín, AlfredoCarballido Rodríguez, JoaquínCózar Olmo, José M.BúcarTerrades, SantiagoPérez León, NoemíBrenes Bermúdez, Francisco J.Molero García, José M.Fernández-Pro Ledesma, AntonioHerdman, MichaelManasanch, JoséAngulo, Javier C.QUALIPROST Study Group2023-09-212023-09-212022-02-122077-0383https://hdl.handle.net/2445/202098We investigated changes in symptoms and quality of life (QoL) in men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving the hexanic extract of Serenoa repens (HESr) and compared results with a matched group on watchful waiting (WW). Data was from a real-world, open-label, prospective, multicenter study. This sub-group analysis included patients with moderate-to-severe symptoms receiving either the HESr 320 mg/daily for six months (HESr) or who remained untreated for LUTS/BPH (WW). Changes in urinary symptoms and QoL were measured by IPSS and BII questionnaires. Two statistical approaches (iterative matching and propensity score pairing) were used to maximize between-group comparability at baseline. Tolerability was assessed in the HESr group. After iterative matching, data for analysis was available for 783 patients (102 WW, 681 HESr). IPSS scores improved by a mean (SD) of 3.8 (4.4) points in the HESr group and by 2.2 (4.5) points in the WW group (p = 0.002). Changes in BII score were 1.8 (2.4) points and 1.0 (2.2) points, respectively (p < 0.001). Three patients (0.9%) treated with the HESr reported mild adverse effects. Moderate-severe LUTS/BPH patients treated for six months with the HESr showed greater improvements in symptoms and QoL than matched patients on WW, with a very low rate of adverse effects.12 p.application/pdfengcc by (c) Alcaraz Asensio, Antonio et al., 2022http://creativecommons.org/licenses/by/4.0/Qualitat de vidaHomesMalalties de l'aparell urinariQuality of lifeMenDiseases of the urinary organsEfficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical Studyinfo:eu-repo/semantics/article2023-07-04info:eu-repo/semantics/openAccess929930635207238