Aim: Although previous studies assessed the effects of Serenoa repens, quercetin and β-sitosterol on inflammatory parameters, no randomized studies have tested the combination of these agents neither on BPH symptoms nor on the inflammatory pattern. The aim of this trial was to evaluate the effects of Difaprost® on voiding dysfunction, histological inflammatory alterations and apoptotic molecular mechanisms in BPH patients.
Methods: We included 36 patients affected by BPH with obstructive symptoms eligible for surgery. Patients were randomly assigned to two groups: 18 patients received Difaprost® for three months before surgery, and 18 patients did not receive any additional therapy and were scheduled for surgery. All patients receiving Difaprost® were evaluated with uroflowmetry with post-void residual volume (PVR) evaluation, serum PSA, and IPSS questionnaire before and after treatment. Moreover, we evaluated inflammatory patterns in prostatic specimens at final pathology.
Results: Even without statistically significant differences on inflammatory pattern between patients receiving Difaprost® and controls, patients receiving Difaprost® had lower presence of edema and angiectasia at histological evaluation of prostate specimens. Moreover, patients included in the treatment group had a clinically significant reduction of PVR (46.1 vs. 25.2 mL; P=0.1) and a slight increase in Qmed (5.6 vs. 6.5 mL/s; P=0.9) after three months of chronic treatment with Difaprost®. No statistically significant differences were recorded in other clinical parameters between patients receiving Difaprost® and controls.
Conclusion: Although not statistically significant, patients treated with Difaprost® showed an improvement in voiding function compared to controls (namely, an increase in Qmed and a reduction of PVR). Future trials with a larger number of patients and a longer treatment period could be necessary to evaluate the clinical efficacy of Difaprost®.