title: 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.
abstract: OBJECTIVE
  To evaluate the efficacy of Profluss® on prostatic chronic inflammation (PCI).
  
  
  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.
authors.affiliation: Department of Urology and Department of Hygiene and Public Health, University of Catania, Catania, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Morgia
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Cimino
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Favilla
authors.forename: Giorgio Ivan
authors.initials: GI
authors.lastname: Russo
authors.forename: Francesco
authors.initials: F
authors.lastname: Squadrito
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Mucciardi
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Masieri
authors.forename: Letteria
authors.initials: L
authors.lastname: Minutoli
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Grosso
authors.forename: Tommaso
authors.initials: T
authors.lastname: Castelli
mesh_terms: D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D001402:B-Lymphocytes; D001706:Biopsy; D002338:Carotenoids / Q000627:therapeutic use*; D006801:Humans; D007558:Italy; D000077276:Lycopene; D008264:Macrophages; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D010936:Plant Extracts / Q000627:therapeutic use*; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000473:pathology; D011472:Prostatitis / Q000188:drug therapy* / Q000473:pathology; D012643:Selenium / Q000627:therapeutic use*; D028024:Serenoa; D013601:T-Lymphocytes; D016896:Treatment Outcome; D001748:Urinary Bladder Neck Obstruction / Q000188:drug therapy / Q000209:etiology
chemical_list: D000893:Anti-Inflammatory Agents; D010936:Plant Extracts; D002338:Carotenoids; D017430:Prostate-Specific Antigen; D012643:Selenium; D000077276:Lycopene