1. 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.
- Author
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Vahlensieck W, Theurer C, Pfitzer E, Patz B, Banik N, and Engelmann U
- Subjects
- Aged, Aged, 80 and over, Cucurbita chemistry, Double-Blind Method, Humans, Lower Urinary Tract Symptoms etiology, Male, Middle Aged, Patient Safety, Prostatic Hyperplasia complications, Quality of Life, Lower Urinary Tract Symptoms drug therapy, Plant Extracts therapeutic use, Prostatic Hyperplasia drug therapy, Seeds chemistry
- Abstract
Introduction: 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)., Subjects and 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., Conclusion: 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., (2014 S. Karger AG, Basel)
- Published
- 2015
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