Alcaraz, AntonioGacci, MauroFicarra, VincenzoMedina-Polo, JoséSalonia, AndreaFernández-Gómez, Jesús MCiudin, AlexandruCastro-Díaz, DavidRodríguez-Antolín, AlfredoCarballido-Rodríguez, JoaquínCózar-Olmo, José MBúcar-Terrades, SantiagoPérez-León, NoemíBrenes-Bermúdez, Francisco JMolero-García, José MLedesma, Antonio Fernández-ProHerdman, MichaelManasanch, JoséAngulo, Javier CGroup, On Behalf Of The Qualiprost Study2023-05-032023-05-032022-02-122077-0383http://hdl.handle.net/10668/21238We 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 (penAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/BPHadverse effectshexanic extract of Serenoa repensmoderate-severe LUTSquality of lifesexual functiontolerabilitywatchful waitingEfficacy 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.research article35207238open access10.3390/jcm11040967PMC8878824https://www.mdpi.com/2077-0383/11/4/967/pdf?version=1645080435https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8878824/pdf