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.

2014-09-05
Urologia internationalis 94(3)
- Winfried Vahlensieck
- Christoph Theurer
- Edith Pfitzer
- Brigitte Patz
- Norbert Banik
- Udo Engelmann

PubMed: 25196580
DOI: 10.1159/000362903

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 431
Population: 1,431 men (50-80 years) with BPH/LUTS
Methods: randomized, partially blinded, placebo-controlled, parallel-group trial; assigned to pumpkin seed (5 g b.i.d.), capsules with pumpkin seed extract (500 mg b.i.d.) or matching placebo
Blinding: Single-blind
Duration: 12 months
Funding: Unclear

Large Human Trial

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.

Research Insights

Pumpkin→Improved Quality of Life
Secondary outcome measures included IPSS-related quality of life, IPSS single items and diary-recorded nocturia.
Effect
Neutral
Effect size
Small
Dose
500 mg b.i.d.
Pumpkin→Reduced International Prostate Symptom Score
the response rate (intention-to-treat/last-observation-carried-forward approach) did not differ between pumpkin seed extract and placebo.
Effect
Neutral
Effect size
Small
Dose
500 mg b.i.d.
Pumpkin→Reduced Nocturia
Secondary outcome measures included IPSS-related quality of life, IPSS single items and diary-recorded nocturia.
Effect
Neutral
Effect size
Small
Dose
500 mg b.i.d.
pumpkin seed→Reduced International Prostate Symptom Score
the response rate (intention-to-treat/last-observation-carried-forward approach) did not differ between pumpkin seed extract and placebo.
Effect
Neutral
Effect size
Small
Dose
500 mg b.i.d.

Adverse Events Reported

Pumpkin→Overall tolerability
The study products were well tolerated.
Finding
Reported
pumpkin seed→Overall tolerability
The study products were well tolerated.
Finding
Reported