RT Journal Article T1 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. A1 Alcaraz, Antonio A1 Gacci, Mauro A1 Ficarra, Vincenzo A1 Medina-Polo, José A1 Salonia, Andrea A1 Fernández-Gómez, Jesús M A1 Ciudin, Alexandru A1 Castro-Díaz, David A1 Rodríguez-Antolín, Alfredo A1 Carballido-Rodríguez, Joaquín A1 Cózar-Olmo, José M A1 Búcar-Terrades, Santiago A1 Pérez-León, Noemí A1 Brenes-Bermúdez, Francisco J A1 Molero-García, José M A1 Ledesma, Antonio Fernández-Pro A1 Herdman, Michael A1 Manasanch, José A1 Angulo, Javier C A1 Group, On Behalf Of The Qualiprost Study K1 BPH K1 adverse effects K1 hexanic extract of Serenoa repens K1 moderate-severe LUTS K1 quality of life K1 sexual function K1 tolerability K1 watchful waiting AB We 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 SN 2077-0383 YR 2022 FD 2022-02-12 LK http://hdl.handle.net/10668/21238 UL http://hdl.handle.net/10668/21238 LA en DS RISalud RD Apr 17, 2025