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

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.

Phytotherapy Adds to the Therapeutic Armamentarium for the Treatment of Mild-To-Moderate Lower Urinary Tract Symptoms in Men

“…Not surprisingly, the inhibitory effects of Δ 7 -sterols are weak when compared to those of finasteride or antiandrogens. This fact coincides with the clinical experience that pumpkin seed extract does not influence PSA values, nor does it cause the typical side effects of finasteride [41,42]. Therefore, the postulated mechanisms could only be expected to show clinical effects on prostate size if patients used pumpkin seeds over a longer period than that of the currently available 12-month clinical studies.…”

“…At the end of the study, the response rate of crude pumpkin seeds exceeded that of placebo by 10%. The decrease in IPSS was accompanied by a continuous improvement in IPSS-related quality of life, which was more pronounced in the two pumpkin seed groups than in the placebo group [42].…”

“…The incidence of drug-related adverse events was very low and mainly consisted of transient gastrointestinal disorders. PSA levels, blood pressure, heart rate, and safety laboratory test results were not influenced [41,42].…”

“…The primary efficacy outcome was the response rate, whereby a reduction in IPSS by 5 points was the predefined threshold of response to treatment. In both studies, the LUTS improved progressively in all treatment arms from the start to the end of the study [41,42].…”

Beneficial Effect of a Multifunctional Polyphytocompound in Experimental Prostatic Hyperplasia in Rats

“…While there is a growing evidence in clinics of the rationale use of phytocompounds for prostate health [55][56][57], the present experimental work using a formula combining a number of the most effective phytochemicals, offers new hints for its larger use either This latter group did not show any significant difference as compared to untreated BPH model.…”