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. 2022 Feb 12;11(4):967.
doi: 10.3390/jcm11040967.

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

Antonio Alcaraz  1 , Mauro Gacci  2   3 , Vincenzo Ficarra  4 , José Medina-Polo  5   6   7 , Andrea Salonia  8   9 , Jesús M Fernández-Gómez  10 , Alexandru Ciudin  11 , David Castro-Díaz  12 , Alfredo Rodríguez-Antolín  5 , Joaquín Carballido-Rodríguez  13 , José M Cózar-Olmo  14 , Santiago Búcar-Terrades  15 , Noemí Pérez-León  16 , Francisco J Brenes-Bermúdez  17 , José M Molero-García  18 , Antonio Fernández-Pro Ledesma  19 , Michael Herdman  20   21 , José Manasanch  22 , Javier C Angulo  23   24 , On Behalf Of The Qualiprost Study Group
Affiliations

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

Antonio Alcaraz et al. J Clin Med. .

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&nbsp;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.

Keywords: BPH; adverse effects; hexanic extract of Serenoa repens; moderate-severe LUTS; quality of life; sexual function; tolerability; watchful waiting.

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Conflict of interest statement

D.C.-D.: speaker for Astellas, Medtronic, Nobel, Recordati, Boston Scientific and consultant for Bayer; M.G.: trial participation and speaker honorarium for Pierre Fabre; J.M.-P.: speaker for Astellas Pharma, Boston Scientific, Coloplast, Gebro Pharma, GSK, Lacer, Pierre Fabre and Wellspect; F.J.B.-B.: speaker and consultant for GSK, Almirall, Pierre Fabre Ibérica, Astellas, Lacer, Recordati, Lilly, Pfizer, Ferrer and Zambon; M.H.: honoraria or consulting fees from Pierre Fabre, Novartis, and Merck; J.M. is a medical advisor with Pierre Fabre Ibérica S.A., a company that commercializes an extract of Serenoa repens. The other authors do not declare any conflict of interest.

Figures

Figure 1
Figure 1
Study flow-chart (iterative matching sample). HESr: hexanic extract of Serenoa repens; WW: watchful waiting.
Figure 2
Figure 2
Mean (95% CI) improvement in IPSS total score from baseline to 6 months for the HESr and WW groups. Dotted line indicates the level at which a clinically relevant difference is observed. HESr: hexanic extract of Serenoa repens; WW: watchful waiting; IPSS: International Prostate Symptom Score.
Figure 3
Figure 3
Mean (95% CI) improvement in BII total score from baseline to 6 months for the HESr and WW groups. HESr: hexanic extract of Serenoa repens; WW: watchful waiting; BII: Benign Prostatic Hyperplasia Impact Index.
See this image and copyright information in PMC

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