title: Effects of pumpkin seed in men with lower urinary tract symptoms due to benign prostatic hyperplasia in the one-year, randomized, placebo-controlled GRANU study.
abstract: BACKGROUND
  The German Research Activities on Natural Urologicals (GRANU) study was a randomized, partially blinded, placebo-controlled, parallel-group trial that investigated the efficacy of pumpkin seed in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH/LUTS).
  
  
  METHODS
  A total of 1,431 men (50-80 years) with BPH/LUTS were randomly assigned to either pumpkin seed (5 g b.i.d.), capsules with pumpkin seed extract (500 mg b.i.d.) or matching placebo. The primary response criterion was a decrease in International Prostate Symptom Score (IPSS) of ≥5 points from baseline after 12 months. Secondary outcome measures included IPSS-related quality of life, IPSS single items and diary-recorded nocturia.
  
  
  RESULTS
  After 12 months, the response rate (intention-to-treat/last-observation-carried-forward approach) did not differ between pumpkin seed extract and placebo. In the case of pumpkin seed (responders: 58.5%), the difference compared with placebo (responders: 47.3%) was descriptively significant. The study products were well tolerated. Overall, in men with BPH, 12 months of treatment with pumpkin seed led to a clinically relevant reduction in IPSS compared with placebo.
  
  
  CONCLUSIONS
  In order to fully justify a recommendation for the use of pumpkin seed to treat moderate LUTS, these findings need to be substantiated in a confirmatory study or systematic review.
authors.affiliation: Department of Urology, Kurpark Hospital, Bad Nauheim, Germany.
authors.forename: Winfried
authors.initials: W
authors.lastname: Vahlensieck
authors.forename: Christoph
authors.initials: C
authors.lastname: Theurer
authors.forename: Edith
authors.initials: E
authors.lastname: Pfitzer
authors.forename: Brigitte
authors.initials: B
authors.lastname: Patz
authors.forename: Norbert
authors.initials: N
authors.lastname: Banik
authors.forename: Udo
authors.initials: U
authors.lastname: Engelmann
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D028464:Cucurbita / Q000737:chemistry; D004311:Double-Blind Method; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D010936:Plant Extracts / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy*; D011788:Quality of Life; D012639:Seeds / Q000737:chemistry*
chemical_list: D010936:Plant Extracts