Prospective Multicenter Open-Label One-Arm Trial Investigating a Pumpkin Seed, Isoflavonoids, and Cranberry Mix in Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia: A Pilot Study

Abstract

Phytotherapy for lower urinary tract symptoms (LUTSs) due to benign prostate hyperplasia (BPH) is progressively demanded by patients and trusted by physicians. The aim was to assess the efficacy of a mix of pumpkin seed extract, soy germ isoflavonoids, and cranberry (Novex®) in the management of mild to moderate LUTS in BPH patients. Male patients aged ≥40 years, who had had mild to moderate LUTS for >6 months at screening, with no previous therapy or who are still symptomatic despite current use of alpha-blockers, were recruited. Exclusion criteria were an IPSS >19 and an age >80 years. The mixed compound was administered orally, daily, for 3 months. Patients were evaluated by means of IPSS, urological quality of life (uQoL) index, and International Index of Erectile Function (IIEF-5) at 3 visits: baseline (visit 1), 30 days (visit 2), and 90 days after treatment (visit 3). Among 163 screened patients, 128 patients (61.8 ± 9.9 years) were recruited. IPSS improved from 15 (Q1 : 12–Q3 : 17) in visit 1, to 11 (Q1 : 8–Q3 : 14) in visit 2, and to 9 (Q1 : 6–Q3 : 12) in visit 3 (p<0.001). uQoL improved from 4 (3–4) in visit 1, to 3 (2–3) in visit 2, and to 2 (1–2) in visit 3 (p<0.001). The patients had an IIEF-5 score of 15 (12–18.7) in visit 1, 15 (12–18) in visit 2, and 17 (13–19) in visit 3 (p=0.99 visits 1 vs. 2, p=0.004 visits 2 vs. 3, and p=0.001 visits 1 vs. 3). Treating mild to moderate LUTS/BPH patients with Novex® might therefore relieve symptoms, improve the quality of life, and have a mild beneficial effect on erectile function.

Evaluation of Diclofenac (DCF) Potassium as a Possible Predisposer of Benign Prostatic Hyperplasia in Wistar Albino Rats

“…Benign Prostate Hyperplasia (BPH) is a progressive pathologic condition associated with elderly men and characterized by proliferation of prostatic tissues, prostate enlargement and consequent lower urinary tract symptoms [1]. These include urinary reluctance, frequent urination, weak stream, and nocturia [2]. Although nearly 70% of men, experience prostate enlargement, after the age of 50, the pathogenesis of BPH is yet to be fully understood [2].…”

“…These include urinary reluctance, frequent urination, weak stream, and nocturia [2]. Although nearly 70% of men, experience prostate enlargement, after the age of 50, the pathogenesis of BPH is yet to be fully understood [2]. Within the transitional zone of the prostate, proliferation of both epithelial and stromal cells occurs.…”

“…This accumulation of cells could lead to prostatitis and fibrosis, collectively causing lower urinary tract symptoms [3]. BPH development is associated with increased levels of dihydrotestosterone (DHT), produced from testosterone by the 5α-reductase enzyme within the prostate glands [2,3].There is an increased accumulation of DHT in the prostate with aging which results in increased cell growth and hyperplasia [3].…”

Overview of BPH: Symptom Relief with Dietary Polyphenols, Vitamins and Phytochemicals by Nutraceutical Supplements with Implications to the Prostate Microbiome

“…Finally, in 2020, Nemer et al examined a combination treatment of pumpkin seed, isoflavonoids, and cranberry mix in LUTS/BPH subjects in a multicenter open-label one-arm pilot study [ 147 ]. Male patients were recruited, who still had LUTS/BPH symptoms despite current use of alpha-1 blockers, which included 128 men (61.8 + 9.9 years of age).…”

“…IPSS values significantly decreased from baseline from a value of fifteen compared to 30 days of a score of eleven to 90 days where the IPSS score was nine. QOL values significantly increased from baseline, while HEF-5 levels also improved [ 147 ]. The results suggested that the combination treatment of pumpkin seed extract, soy isoflavones and cranberry relieved LUTS/BPH symptoms in men and had a mild beneficial effect on erectile function.…”