The Clinical Impact of Hexanic Extract of Serenoa repens in Men with Prostatic Inflammation: A Post Hoc Analysis of a Randomized Biopsy Study

Abstract

A randomized biopsy study showed that hexanic Serenoa repens (HESr) treatment resulted in prostatic inflammation reduction. This post-hoc analysis evaluated the clinical impact of HESr and investigated correlations between baseline parameters and treatment response. Patients were randomized to receive HESr 320mg/day for six months or no therapy. Assessment included International Prostate Symptoms Score (IPSS), prostate volume (PV), and maximum flow rate (Qmax). Baseline characteristics were recorded, including body mass index (BMI) and metabolic syndrome (MetS) components. In patients under α1-adrenoceptor antagonists (α1-blockers), the addition of HESr resulted in statistically significant IPSS improvement after 6 months (p = 0.006). IPSS remained stable in patients under a1-blockers only (p = 0.346). Patients treated only with HESr reported a significant IPSS amelioration (p = 0.001). In the control group of naïve patients, no significant IPSS change was detected (p = 0.298). Baseline PV showed fair correlation (r = −0.20) with inflammation reduction in the HESr patients. BMI (r = 0.40), diabetes mellitus (r = 0.40), and PV (r = 0.23) showed fair correlation with Qmax increase but without reaching statistical significance. MetS (p = 0.06) was an influent biomarker for Qmax improvement. Treatment with HESr (as monotherapy or add-on therapy to a-blockers) may improve urinary symptoms in terms of IPSS in patients with prostatic inflammation.

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

“…After six months of follow-up, patients receiving the HESr reported better outcomes in terms of symptoms and QoL than patients managed with watchful waiting. The focus on QoL in the present study and the inclusion of patients with moderate-severe symptoms adds to evidence from earlier studies which studied the effects of the HESr in patients with mild symptoms [20], or reported the effect on clinical symptoms, rather than QoL [21,22], or which focused on the HESr's anti-inflammatory action [23].…”

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

“…The key drivers of HESr combination therapy choice were reported as clinical symptom alleviation, strong association with the lack of sexual dysfunction risk and reduction of inflammation [ 50 ]. In addition, patients with PIS and a specific clinical profile tend to show a better treatment response and should be targeted for combination treatment [ 37 ]. The general clinical condition and comorbidities of the patient should be carefully evaluated in order to personalise the treatment and choose the right therapy for the right patient.…”

“…HESr has been shown to have anti-inflammatory, anti-androgenic and anti-proliferative activity [ 33 , 34 , 35 ]. Recent studies have demonstrated that HESr relieves LUTS by reducing underlying prostatic inflammation [ 12 , 36 , 37 ]. In a randomised clinical trial including 97 patients with histologically confirmed prostatic inflammation on prostate biopsy, 6 months of treatment with HESr (320 mg/day) significantly improved Irani’s inflammation grading, aggressiveness and total score in a second prostate biopsy done after the treatment ( Figure 2 ) [ 36 ].…”

“…A post hoc analysis of a randomised biopsy study [ 36 ] evaluated the clinical impact of 6 months of treatment with HESr (320 mg/day) on patients with LUTS/BPH and confirmed prostatic inflammation and investigated potential baseline parameters that may be associated with a better response to treatment [ 37 ]. The study population included 110 patients without any previous treatment for LUTS/BPH or under treatment with α-blockers at baseline.…”

“… Improvement in mean IPSS after 6 months of HESr therapy (320 mg/day) in men without previous treatment ( a ) and men under treatment with α-blockers ( b ) [ 37 ]. …”