%0 Journal Article
%A Alcaraz, Antonio
%A Gacci, Mauro
%A Ficarra, Vincenzo
%A Medina-Polo, José
%A Salonia, Andrea
%A Fernández-Gómez, Jesús M
%A Ciudin, Alexandru
%A Castro-Díaz, David
%A Rodríguez-Antolín, Alfredo
%A Carballido-Rodríguez, Joaquín
%A Cózar-Olmo, José M
%A Búcar-Terrades, Santiago
%A Pérez-León, Noemí
%A Brenes-Bermúdez, Francisco J
%A Molero-García, José M
%A Ledesma, Antonio Fernández-Pro
%A Herdman, Michael
%A Manasanch, José
%A Angulo, Javier C
%A Group, On Behalf Of The Qualiprost Study
%T 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.
%D 2022
%@ 2077-0383
%U http://hdl.handle.net/10668/21238
%X 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
%K BPH
%K adverse effects
%K hexanic extract of Serenoa repens
%K moderate-severe LUTS
%K quality of life
%K sexual function
%K tolerability
%K watchful waiting
%~