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

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.

Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study

“…Furthermore, a recent qualitative analysis showed that side effects affecting sexual function are of greater importance than non-sexual side effects for sexually active patients [32]. In that regard, HESr has been shown to improve symptoms and QoL in BPH patients, but with only limited side effects, which do not impact sexual function [1,7,10,11,33], and this could help to maintain adherence in patients worried about the effect of medical LUTS/BPH treatment on their sexual function. The HESr is recommended in the recent EAU Guidelines as a treatment "for men with LUTS who want to avoid any potential adverse events especially related to sexual function" [1].…”

Conditions Diagnosed on Bladder Biopsy in Adult Female Patients with Lower Urinary Tract Symptoms (LUTS) Refractory to Medical Treatment

“…For example, urinary incontinence, or involuntary leakage of urine, is one of the most commonly investigated sources of LUTS and reportedly affects between 13%-46% of Australian women 16 . However, urinary incontinence is an umbrella term which encompasses a range of leakage sub-types, such as stress urinary incontinence (SUI, leakage during physical activity), urge urinary incontinence (UUI, leakage associated with urgency) and mixed urinary incontinence [17][18][19] .…”

The Role of Combination Therapy with α-Blockers and Hexanic Extract of Serenoa repens in the Treatment of LUTS/BPH

“…Two meta-analyses focusing only on HESr found that HESr treatment reduced nocturia and improved maximum urinary flow rate (Qmax) compared to placebo and had a similar favourable effect on LUTS as the α-blocker tamsulosin and short-term 5-ARIs [ 29 , 30 ]. In addition, a recent paired matched clinical study demonstrated greater improvements of symptoms and QoL in patients treated with HESr versus watchful waiting [ 31 ]. The body of published clinical evidence therefore needs to be interpreted with caution.…”