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Fixed-dose combination PRO 160/120 of sabal and urtica extracts improves nocturia in men with LUTS suggestive of BPH: re-evaluation of four controlled clinical studies.

AbstractPURPOSE:
To determine the effects of the herbal fixed-dose combination PRO 160/120 (extracts from saw palmetto fruits and stinging nettle roots) on nocturnal voiding frequency, as measured by question 7 of the IPSS questionnaire, in patients with moderate-to-severe LUTS/BPH after 24 weeks of treatment compared to placebo, to the α-blocker tamsulosin, or to the 5α-reductase inhibitor finasteride.
METHODS:
The study is about post hoc evaluation of four published randomized, double-blind clinical trials on PRO 160/120, two compared with placebo, one with finasteride and one with tamsulosin. In addition, a pooled data analysis of the two placebo-controlled trials was conducted.
RESULTS:
We analyzed data from a total of 922 patients with a mean age of 66 years and a mean baseline nocturnal voiding frequency of 2.1. In the pooled analysis of placebo-controlled trials, nocturnal voids improved by 0.8 (29 %) with PRO 160/120 compared to 0.6 (18 %) with placebo (p = 0.015, Wilcoxon test, one-tailed). The 69 % responder rate to PRO 160/120 was significantly superior to the placebo response (52 %; p = 0.003, χ (2)-test, two-tailed). The majority of responders improved by 1 void/night. Absolute improvements and response rates were consistently higher with PRO 160/120 than with placebo over a range of baseline nocturnal voiding frequencies. There were no differences between PRO 160/120 and finasteride or tamsulosin regarding absolute improvement of nocturnal voids or responds rates.
CONCLUSION:
PRO 160/120 significantly improved nocturnal voiding frequency compared to placebo and similar to tamsulosin or finasteride.
AuthorsMatthias Oelke, Richard Berges, Sandra Schläfke, Martin Burkart
JournalWorld journal of urology (World J Urol) Vol. 32 Issue 5 Pg. 1149-54 (Oct 2014) ISSN: 1433-8726 [Electronic] Germany
PMID24938176 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Drug Combinations
  • PRO 160-120
  • Plant Extracts
Topics
  • Aged
  • Double-Blind Method
  • Drug Combinations
  • Humans
  • Lower Urinary Tract Symptoms (complications)
  • Male
  • Nocturia (drug therapy, etiology)
  • Phytotherapy
  • Plant Extracts (administration & dosage)
  • Prostatic Hyperplasia (complications)
  • Remission Induction

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