Serenoa repens + selenium + lycopene vs tadalafil 5 mg for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction: a Phase IV, non-inferiority, open-label, clinical study (SPRITE study)

BJU Int. 2018 Aug;122(2):317-325. doi: 10.1111/bju.14209. Epub 2018 Apr 16.

Abstract

Objective: To compare in a randomised, open-label, non-inferiority clinical study, the efficacy and tolerability of Serenoa repens (SeR) + selenium (Se) + lycopene (Ly) (SeR-Se-Ly) therapy vs tadalafil 5 mg in men with lower urinary tract symptoms (LUTS).

Patients and methods: From May 2015 to January 2017, 427 patients were enrolled in 21 different centres (International Standard Randomised Controlled Trial Number Register [ISRCTN] 73316039). Inclusion criteria included: age between 50 and 80 years, International Prostate Symptom Score (IPSS) ≥12, maximum urinary flow rate (Qmax ) ≤ 15 mL/s, and post-void residual (PVR) <100 mL. Patients were randomised into two groups in a 2:1 ratio: Group A (SeR-Se-Ly, 1 tablet daily for 6 months) and Group B (tadalafil 5 mg, 1 tablet daily for 6 months). The primary endpoint of the study was the non-inferior variation in the IPSS and Qmax in Group A vs Group B after 6 months of treatment.

Results: In all, 404 patients completed the full protocol. When comparing both therapies, Group A was statistically not inferior to Group B considering the median change in IPSS (-3.0 vs -3.0; P < 0.01), IPSS quality of life (-2.0 vs -2.0; P < 0.05), and Qmax (2.0 vs 2.0 mL/s; P < 0.01). We found statistically significant differences in the increase of at least 3 points in Qmax (38.2% vs 28.1%; P = 0.04) and of at least 30% of Qmax (39.2% vs 27.3%; P < 0.01) in Group A compared to Group B. The percentage of patients with an increase of at least 3 points in the IPSS and a decrease of at least 25% of the IPSS was not statistically different between the two groups. For adverse events, four patients in Group A (1.44%) and 10 in Group B (7.81%) (P < 0.05) reported side-effects.

Conclusion: We have shown that treatment with SeR-Se-Ly was not inferior to tadalafil 5 mg for improving IPSS and Qmax in men with LUTS.

Keywords: LUTS; Serenoa repens; benign prostatic enlargement; prostate; tadalafil.

Publication types

  • Clinical Trial, Phase IV
  • Comparative Study
  • Equivalence Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Drug Combinations
  • Humans
  • Lower Urinary Tract Symptoms / drug therapy*
  • Lower Urinary Tract Symptoms / etiology
  • Lycopene / administration & dosage*
  • Male
  • Middle Aged
  • Phosphodiesterase 5 Inhibitors / administration & dosage
  • Plant Extracts / administration & dosage*
  • Prostatic Hyperplasia / complications
  • Selenium / administration & dosage*
  • Serenoa
  • Tablets
  • Tadalafil / administration & dosage*
  • Treatment Outcome
  • Urological Agents / administration & dosage*

Substances

  • Drug Combinations
  • Phosphodiesterase 5 Inhibitors
  • Plant Extracts
  • Tablets
  • Urological Agents
  • Tadalafil
  • Selenium
  • saw palmetto extract
  • Lycopene

Associated data

  • ISRCTN/ISRCTN73316039