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

Giuseppe Morgia,Francesco Squadrito,Vincenzo Favilla,Giuseppe Mucciardi,Tommaso Castelli,Giorgio Ivan Russo,Giuseppe Grosso,Sebastiano Cimino,Lorenzo Masieri,Letteria Minutoli

doi:10.1590/s1677-5538.ibju.2013.02.10

Giuseppe Morgia, Francesco Squadrito + Show 8 more

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https://doi.org/10.1590/s1677-5538.ibju.2013.02.10

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Abstract

To evaluate the efficacy of Profluss® on prostatic chronic inflammation (PCI). 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). 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. 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.

Highlights

Benign prostatic hyperplasia (BPH) is a common cause of bothersome lower urinary tract symptoms in man, representing a growing entity in terms of healthcare costs and morbidity.Approximately 50% of men aged between 50 and 60 years, 60% of men aged between 60 ibju | Effects of Serenoa Repens, Selenium and Lycopene on chronic inflammation associated with Benign Prostatic Hyperplasia and 70 years, and up to 90% of men aged > 80 years have some degree of benign prostatic enlargement (BPE) [1].Medical therapies can provide adequate alleviation of BPE symptoms (LUTS): The two primary classes of oral medications that are prescribed for the treatment of symptoms are alpha-blockers and 5-alpha-reductase inhibitors (5ARIs)
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 prostatic chronic inflammation (PCI) valuation
The aim of this study is to evaluate the efficacy of Profluss® ( Serenoa Repens (SeR)-Se-LY) in reducing chronic inflammation in patient with benign prostatic hyperplasia and/or PIN/ASAP

Summary

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® + α-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. 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

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MATERIALS AND METHODS

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