Dihydrotestosterone (DHT) is implicated in the development of benign prostate hyperplasia (BPH). We investigated if Uromedic® pumpkin (variety of Cucurbita pepo L. convar. citrullinina GREB. var. styriaca GREB) seed soft extract (active ingredients of GRANUFINK® Prosta forte 500 mg), seed oil and isolated Δ7-sterols could inhibit the conversion of [1,2,6,7-3 H(N)]-testosterone to DHT by 5α-reductases. Also, we tested competition with [ 3 H]-DHT for binding to the androgen receptor (AR). Pumpkin seed oil and pumpkin seed soft extract were identified as moderately active inhibitors of 5α-R1 and 5α-R2, with almost similar inhibitory capacities (IC 50 < 5 mg/ml for 5α-R1 and about IC 50 = 6 mg/ml for 5α-R2). The isolated Δ7-sterols were more active inhibitors (IC 50 = 0.3 mg/ml for 5α-R1, IC 50 = 1.0 mg/ml for 5α-R2). All three test compounds bound to the AR dose-dependently, with strong binding by Δ7-sterols (IC 50 = 0.2 mg/ml) and weaker binding by pumpkin seed oil (IC 50 = 0.4 mg/ml) and pumpkin seed soft extract (IC 50 = 1.1 mg/ml). We propose that inhibition of 5α-reductases and competitive binding to the AR are mechanisms of action, by which the Uromedic® pumpkin seed derived test compounds, most specifically Δ7-sterols, counteract DHT and thereby exert clinically positive effects on the prostate, as well as bladder-strengthening effects.

Background In clinical practice, plant extracts are an option to treat mild-to-moderate lower urinary tract symptoms suggestive of benign prostate hyperplasia (LUTS/BPH). However, only a few herbal extracts have been investigated in long-term placebo-controlled studies. The safety and efficacy of a well-tolerated proprietary pumpkin seed soft extract (PSE) were investigated in two randomized placebo-controlled 12-month studies (Bach and GRANU study). Both trials studied LUTS/BPH patients with an International Prostate Symptom Score (IPSS) ≥13 points at baseline. The Bach study demonstrated positive effects of PSE compared to placebo, but no difference between treatments was observed in the GRANU study. We aimed to assess the efficacy of PSE in a meta-analysis using the patient-level data of these two studies. Methods Pooled analysis was performed in the intention-to-treat set using last-observation-carried-forward (ITT-LOCF). An IPSS improvement of ≥5 points after 12 months of therapy was the predefined response criterion. Logistic regression and ANCOVA models included the covariables treatment group, study, center size, and baseline IPSS. Each analysis was repeated for the per-protocol (PP) set. Results The ITT/PP analysis sets consisted of 687/485 and 702/488 patients in the PSE and placebo groups, respectively. At the 12-month follow-up, the response rates in the PSE group were 3% (ITT) and 5% (PP) higher than those in the placebo group. The odds ratio of response obtained by logistic regression analysis for comparing PSE versus placebo was 1.2 (95% CI 0.9, 1.5), favoring PSE (ITT- LOCF). For the IPSS change from baseline to 12 months, the ANCOVA estimated difference between the treatment groups was 0.7 points (95% CI 0.1, 1.2) in favor of PSE. The variables study, baseline IPSS, and center size had a relevant influence on treatment response. Conclusion Although the Bach and the GRANU study showed contradictory results, the analysis in a pooled form still pointed towards an advantage of PSE; namely, more patients in the PSE group showed an IPSS improvement of at least 5 points after 12 months. Therefore, the results of this meta-analysis suggest that patients with moderate LUTS/BPH may benefit from PSE treatment in terms of symptomatic relief.

This prospective, noninterventional, multicenter 12-wk study in women with overactive bladder investigated the effectiveness of Granu Fink femina, a herbal combination of seed oil from Uromedic pumpkin (cultivar of Cucurbita pepo), Rhus aromatica (fragrant sumach) bark extract, and Humulus lupulus (hop) cone extract in a clinical setting. Patients documented overactive bladder symptoms and quality of life using questionnaires as well as diaries recording day- and nighttime micturition frequencies, urine leakages during physical activity or at sneezing or coughing, and use of incontinence pads. The full analysis set included 117 women (age: 21 – 78 y). Urination frequency decreased significantly with improvement during daytime in 49, 71, and 77 (out of 99) patients and at night in 45, 63, and 70 (out of 100) patients after 1, 6, and 12 wk, respectively. The mean frequency of leakages and used pads decreased significantly from 0.9 leakages and 2.0 pads at baseline to 0.4 leakages and 1.4 pads after 12 wk. In all measured aspects of overactive bladder-related quality of life, (coping, concern, sleep, social), statistically significant improvement was reached after 1 wk, with further improvement at 6 and 12 wk. Ninety-nine percent of the physicians and 95.4% of the patients rated tolerability as “very good” or “good”. Treatment with Granu Fink femina progressively improved overactive bladder symptoms and related quality of life with significant improvements already after 1 wk. Based on these effects and the observed excellent tolerability profile, Granu Fink femina may be considered a valuable therapeutic option for overactive bladder.

Purpose To assess the symptoms, quality of life and sexual well-being in patients with lower urinary tract symptoms due to benign prostatic hyperplasia LUTS/BPH treated with pumpkin seed soft extract (PSE) in routine practice. Methods This noninterventional study included 130 men treated for up to 24 months. The International Prostate Symptom Score (IPSS) and related quality of life, Aging Males’ Symptoms Scale (AMS), and International Index of Erectile Function (IIEF-5) were recorded. Descriptive statistical methods were applied. The mean with 95% confidence interval (CI) was calculated for the primary end point (change in IPSS after 12-month treatment). Results Analysis at 12 months included 83 patients [mean (SD) age 65.2 (8.7) years and IPSS (15.6 (3.4), IPSS-QoL 3.4 (0.9)]. AMS and IIEF-5 indicated mild or mild to moderate disorder regarding sexual well-being and erectile dysfunction, respectively. After 12 months, the mean IPSS change from baseline was − 4.7 (95% CI − 5.4 to − 3.9), with 83% (95% CI 65.3 to 84.1) and 53% (95% CI 42.3 to 63.7) of the patients achieving reductions by at least 3 and 5 points, respectively. The proportion of patients with IPSS-QoL below 3 points (mostly satisfied) was 11% (9/83) at baseline and rose to 62% (51/83) and 73% (40/55) at 12 and 24 months, respectively. AMS and IIEF-5 scores did not indicate a negative impact on sexual function during treatment. Conclusion In men with a moderate LUTS suggestive of BPH, a low progression risk and an active sex life, treatment with pumpkin seed soft extract provided symptomatic relief, improved IPSS-QoL, and maintained sexual well-being. Trial registration DRKS00010729, June 22, 2016.