title: Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double-blinded randomized study between single or combination therapy (PROCOMB trial).
abstract: BACKGROUND
  Phytotherapy has been used to treat patients with lower urinary tract symptoms (LUTS). We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens (SeR), Lycopene (Ly), and Selenium (Se) + tamsulosin versus single therapies.
  
  
  METHODS
  PROCOMB trial (ISRCTN78639965) was a randomized double-blinded, double-dummy multicenter study of 225 patients between 55 and 80 years old, PSA ≤ 4 ng/ml, IPSS ≥12, prostate volume ≤60 cc, Qmax ≤15 ml/sec, postvoid residual urine (PVR) <150 ml. Participants were randomized group A (SeR-Se-Ly), group B (tamsulosin 0.4 mg), group C (SeR-Se-Ly + tamsulosin 0.4 mg). The primary endpoints of the study were the reduction of IPSS, PVR, and increase of Qmax in group C versus monotherapy groups.
  
  
  RESULTS
  The decrease for combination therapy was significantly greater versus group A (P < 0.05) and group B (P < 0.01) for IPSS and versus group A (P < 0.01) for PVR from baseline to 6 months. A greater decrease in IPSS was observed for Group C versus group A (P < 0.01) and increase in Qmax versus group B (P < 0.01), from 6 months to 12 months. At one year, the changes of IPSS and Qmax were greater for Group C versus monotherapies (each comparison <0.05). The proportions of men with a decrease of at least three points (each comparison P < 0.05) and decrease of 25% for IPSS (each comparison P < 0.01) were greater for Group C.
  
  
  CONCLUSIONS
  SeR-Se-Ly + tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS.
authors.affiliation: Department of Urology, University of Catania, Catania, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Morgia
authors.forename: Giorgio I
authors.initials: GI
authors.lastname: Russo
authors.forename: Salvatore
authors.initials: S
authors.lastname: Voce
authors.forename: Fabiano
authors.initials: F
authors.lastname: Palmieri
authors.forename: Marcello
authors.initials: M
authors.lastname: Gentile
authors.forename: Antonella
authors.initials: A
authors.lastname: Giannantoni
authors.forename: Franco
authors.initials: F
authors.lastname: Blefari
authors.forename: Marco
authors.initials: M
authors.lastname: Carini
authors.forename: Andrea
authors.initials: A
authors.lastname: Minervini
authors.forename: Andrea
authors.initials: A
authors.lastname: Ginepri
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Salvia
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Vespasiani
authors.forename: Giorgio
authors.initials: G
authors.lastname: Santelli
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Cimino
authors.forename: Rosalinda
authors.initials: R
authors.lastname: Allegro
authors.forename: Zaira
authors.initials: Z
authors.lastname: Collura
authors.forename: Eugenia
authors.initials: E
authors.lastname: Fragalà
authors.forename: Salvatore
authors.initials: S
authors.lastname: Arnone
authors.forename: Rosaria M
authors.initials: RM
authors.lastname: Pareo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000975:Antioxidants / Q000627:therapeutic use*; D002338:Carotenoids / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D006801:Humans; D007558:Italy; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy*; D000077276:Lycopene; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy / Q000379:methods*; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D011788:Quality of Life; D012643:Selenium / Q000627:therapeutic use; D028024:Serenoa / Q000737:chemistry; D013449:Sulfonamides / Q000627:therapeutic use; D000077409:Tamsulosin; D016896:Treatment Outcome; D014563:Urodynamics / Q000187:drug effects; D064804:Urological Agents / Q000627:therapeutic use*
chemical_list: D000975:Antioxidants; D013449:Sulfonamides; D064804:Urological Agents; D002338:Carotenoids; D000077409:Tamsulosin; D012643:Selenium; D000077276:Lycopene
keywords: BPH; LUTS; lycopene; phytotherapy; selenium; serenoa repens; tamsulosin