Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients

Antonio Alcaraz,Vincenzo Ficarra,José M Molero-García,Joan Palou,José Medina-Polo,Joaquín Carballido-Rodríguez,Javier Ponce De León Roca,Antonio Fernández-Pro Ledesma,Alfredo Rodríguez-Antolín,José Manasanch,Jesús M Fernández-Gómez,Noemí Pérez-León,Javier C Angulo,José M Cózar-Olmo,Manuel Esteban-Fuertes,Francisco J Brenes-Bermúdez,David Castro-Díaz

doi:10.1038/s41598-021-98586-5

Abstract

In a subset analysis of data from a 6-month, multicenter, non-interventional study, we compared change in symptoms and quality of life (QoL), and treatment tolerability, in men with moderate to severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving tamsulosin (TAM, 0.4 mg/day) or the hexanic extract of Serenoa repens (HESr, 320 mg/day) as monotherapy. Symptoms and QoL were assessed using the IPSS and BII questionnaires, respectively. Patients in the treatment groups were matched using two statistical approaches (iterative and propensity score matching). Within the iterative matching approach, data was available from a total of 737 patients (353 TAM, 384 HESr). After 6 months, IPSS scores improved by a mean (SD) of 5.0 (4.3) points in the TAM group and 4.5 (4.7) points in the HESr group (p = 0.117, not significant). Improvements in QoL were equivalent in the two groups. TAM patients reported significantly more adverse effects than HESr patients (14.7% vs 2.1%; p < 0.001), particularly ejaculation dysfunction and orthostatic hypotension. These results show that HESr is a valid treatment option for men with moderate/severe LUTS/BPH; improvements in urinary symptoms and QoL were similar to those observed for tamsulosin, but with considerably fewer adverse effects.

Highlights

Benign prostatic hyperplasia (BPH) is a non-malignant growth of the prostate tissue and is a frequent cause of lower urinary tract symptoms (LUTS) in men[1,2]
QUALIPROST provided further evidence that hexanic extract of S. repens (HESr) appears to be as effective as adrenergic receptors blockers (AB) and 5-alpha-reductase inhibitors (5ARI) for the treatment of moderate to severe LUTS/BPH when used as monotherapy or in combination with one of the other treatments over a six-month treatment period[18] and confirmed the low level of adverse effects associated with HESr treatment, especially in comparison to AB and 5ARI
randomized controlled trials (RCTs) reported by Debruyne et al[27], which showed similar efficacy for the HESr (PERMIXON) and tamsulosin in providing relief from symptoms, or that reported by Latil et al[28], which showed that HESr reduced inflammatory activity in the prostate to a greater extent than tamsulosin, are clearly important but the results may not always translate to clinical practice

Summary

Introduction

Benign prostatic hyperplasia (BPH) is a non-malignant growth of the prostate tissue and is a frequent cause of lower urinary tract symptoms (LUTS) in men[1,2]. Medical treatments most frequently used for LUTS/BPH include alpha-1-adrenergic receptors blockers (AB) and 5-alpha-reductase inhibitors (5ARI), or a combination of both in some patients Such treatments have demonstrated their effectiveness in reducing symptoms, they can negatively affect sexual function, especially ejaculatory function[9]. In the original QUALIPROST publication[18], it was not possible to analyze in-depth the outcomes in patients treated with tamsulosin (TAM) and compare them with patients receiving the HESr after applying matching techniques In this subset analysis of data from the QUALIPROST study, we compared changes in urinary symptoms (overall, voiding and storage) and QoL in men with moderate to severe LUTS/BPH receiving TAM or HESr as monotherapy using two different matching approaches to optimize comparability of the treatment groups.

Methods

Results

Conclusion