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

Int Braz J Urol. Mar-Apr 2013;39(2):214-21. doi: 10.1590/S1677-5538.IBJU.2013.02.10.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Anti-Inflammatory Agents / therapeutic use
  • B-Lymphocytes
  • Biopsy
  • Carotenoids / therapeutic use*
  • Humans
  • Italy
  • Lycopene
  • Macrophages
  • Male
  • Middle Aged
  • Neoplasm Grading
  • Plant Extracts / therapeutic use*
  • Prospective Studies
  • Prostate-Specific Antigen / blood
  • Prostatic Hyperplasia / drug therapy*
  • Prostatic Hyperplasia / pathology
  • Prostatitis / drug therapy*
  • Prostatitis / pathology
  • Selenium / therapeutic use*
  • Serenoa*
  • T-Lymphocytes
  • Treatment Outcome
  • Urinary Bladder Neck Obstruction / drug therapy
  • Urinary Bladder Neck Obstruction / etiology

Substances

  • Anti-Inflammatory Agents
  • Plant Extracts
  • Carotenoids
  • Prostate-Specific Antigen
  • Selenium
  • Lycopene