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

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.

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

“…The improvement of 1.8 points on the BII in the HESr group is similar to that observed for other drugs used to treat LUTS/BPH, such as dutasteride and tamsulosin, which showed improvements of 1.7 points and 1.5 points, respectively, after 2 years of treatment in the COMBAT trial [27]. Improvements on the BII were reported in other publications evaluating the efficacy of the HESr; Alcaraz et al [11] reported a mean reduction of 2.2 points for patients receiving the HESr in a comparison with tamsulosin and a mean improvement of 2.7 points in an analysis comparing the HESr with tamsulosin and with a combination of both drugs [10].…”

“…As has been shown in several previous studies [7,10,11,16], the improvements in symptoms and QoL associated with the HESr do not come at the expense of any relevant incidence of adverse effects. In the present sub-analysis, only 1% of patients receiving HESr reported an AE, and they were all classified as mild.…”

“…The reduction in IPSS score is in line with that seen in previous articles evaluating the efficacy of the HESr. In a study comparing the HESr with tamsulosin to treat LUTS/BPH, the IPSS score improved by 4.5 points in the HESr group [11]. In another publication comparing the HESr and tamsulosin versus a combination of the two, the IPSS score decreased by 5.4 points in the HESr group [10].…”

“…Phytotherapy compounds, which form a heterogeneous group that includes extracts from plants such as Serenoa repens, Pygeum africanum, Urtica dioica, Cucurbita pepo and others, are also commonly used to treat LUTS/BPH [1]. The hexanic extract of S. repens (HESr) in particular has been shown to be as effective as AB [7][8][9][10][11] and 6-month treatment with 5ARI [8,9] in improving symptoms and QOL in men with LUTS/BPH, but without their negative side effects, as recently recognized in the EAU Guidelines. It is frequently administered to patients with mild or moderate LUTS/BPH who wish to avoid adverse events which may be associated with other medical treatments, especially those related to sexual function [1].…”

Hexanic Extract of Serenoa repens (Permixon®): A Review in Symptomatic Benign Prostatic Hyperplasia

“…In terms of compliance, most (≈ 90%) patients in each medical treatment group took the medication with no difficulty [ 21 ]. In a subset analysis, the efficacy of HE S. repens was similar to that of tamsulosin in men with moderate to severe LUTS associated with BPH [ 23 ]. In patients who received monotherapy with HE S. repens 320 mg/day ( n = 384) or tamsulosin 0.4 mg/day ( n = 353), changes from baseline to 6 months in I-PSS total score, Q max , prostate volume and PSA were not significantly different between treatment groups.…”