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Efficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men_ClincalMedicine.pdf (776.23 KB)

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Published version

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2022-02-12

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cc by (c) Alcaraz Asensio, Antonio et al., 2022
Please use this identifier to cite or link to this item: https://hdl.handle.net/2445/202098

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

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https://doi.org/10.3390/jcm11040967

Abstract

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 < 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.

Subject

Qualitat de vida, Homes, Malalties de l'aparell urinari

Subject (English)

Quality of life, Men, Diseases of the urinary organs

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Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)

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ALCARAZ ASENSIO, Antonio, et al. 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. Journal of Clinical Medicine. 2022. Vol. 11, num. 4, pags. 967. ISSN 2077-0383. [consulted: 18 of August of 2026]. Available at: https://hdl.handle.net/2445/202098

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