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)

Prostate. 2014 Nov;74(15):1471-80. doi: 10.1002/pros.22866. Epub 2014 Aug 23.


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.

Conclusion: SeR-Se-Ly + tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS.

Keywords: BPH; LUTS; lycopene; phytotherapy; selenium; serenoa repens; tamsulosin.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antioxidants / therapeutic use*
  • Carotenoids / therapeutic use
  • Double-Blind Method
  • Drug Therapy, Combination
  • Humans
  • Italy
  • Lower Urinary Tract Symptoms / drug therapy*
  • Lycopene
  • Male
  • Middle Aged
  • Phytotherapy / methods*
  • Prostatic Hyperplasia / drug therapy*
  • Quality of Life
  • Selenium / therapeutic use
  • Serenoa / chemistry
  • Sulfonamides / therapeutic use
  • Tamsulosin
  • Treatment Outcome
  • Urodynamics / drug effects
  • Urological Agents / therapeutic use*


  • Antioxidants
  • Sulfonamides
  • Urological Agents
  • Carotenoids
  • Tamsulosin
  • Selenium
  • Lycopene