title: 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.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  PRO 160/120 significantly improved nocturnal voiding frequency compared to placebo and similar to tamsulosin or finasteride.
authors.affiliation: Department of Urology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany, oelke.matthias@mh-hannover.de.
authors.forename: Matthias
authors.initials: M
authors.lastname: Oelke
authors.forename: Richard
authors.initials: R
authors.lastname: Berges
authors.forename: Sandra
authors.initials: S
authors.lastname: Schläfke
authors.forename: Martin
authors.initials: M
authors.lastname: Burkart
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D004338:Drug Combinations; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000150:complications; D008297:Male; D053158:Nocturia / Q000188:drug therapy* / Q000209:etiology; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage*; D011470:Prostatic Hyperplasia / Q000150:complications; D012074:Remission Induction
chemical_list: D004338:Drug Combinations; C476336:PRO 160-120; D010936:Plant Extracts