Effects of Serenoa Repens, Selenium and Lycopene (Profluss®) on chronic inflammation associated with Benign Prostatic Hyperplasia: results of ″FLOG″ (Flogosis and Profluss in Prostatic and Genital Disease), a multicentre Italian study
Morgia G, Cimino S, Favilla V, Russo GI, Squadrito F, Mucciardi G, Masieri L, Minutoli L, Grosso G, Castelli T. Int Braz J Urol. 2013 Mar-Apr;39(2):214-21. doi: 10.1590/S1677-5538.IBJU.2013.02.10.

Source

Department of Urology and Department of Hygiene and Public Health, University of Catania, Catania, Department of Urology and Department of Clinical and Experimental Medicine and Pharmacology - Section of Pharmacology, University of Messina Messina and Department of Urology, University of Florence, Florence, Italy.

Abstract

Objective: To evaluate the efficacy of Profluss® on prostatic chronic inflammation (PCI). Materials and Methods: We prospectively enrolled 168 subjects affected by LUTS due to bladder outlet obstruction submitted to 12 cores prostatic biopsy for suspected prostate cancer + 2 cores collected for PCI valuation. First group consisted of 108 subjects, with histological diagnosis of PCI associated with BPH and high grade PIN and/or ASAP, randomly assigned to 1:1 ratio to daily Profluss® (group I) for 6 months or to control group (group Ic). Second group consisted of 60 subjects, with histological diagnosis of BPH, randomly assigned to 1:1 ratio to daily Profluss® + a-blockers treatment (group II) for 3 months or to control group (group IIc). After 6 months first group underwent 24 cores prostatic re-biopsy + 2 cores for PCI while after 3 months second group underwent two-cores prostatic for PCI. Specimens were evaluated for changes in inflammation parameters and for density of T-cells (CD3, CD8), B-cells (CD20) and macrophages (CD68). Results: At follow-up there were statistical significant reductions of extension and grading of flogosis, mean values of CD20, CD3, CD68 and mean PSA value in group I compared to Ic, while extension and grading of flogosis in group II were inferior to IIc but not statistical significant. A statistically significant reduction in the density of CD20, CD3, CD68, CD8 was demonstrated in group II in respect to control IIc. Conclusions: Serenoa repens+Selenium+Lycopene may have an anti-inflammatory activity that could be of interest in the treatment of PCI in BPH and/or PIN/ASAP patients.