Improvement of urinary tract symptoms and quality of life in benign prostate hyperplasia patients associated with consumption of a newly developed whole tomato-based food supplement: a phase II prospective, randomized double-blinded, placebo-controlled study

Abstract

Background Benign prostatic hyperplasia (BPH) is the most common urologic disease among elderly men. The diagnosis of BPH is usually driven by lower urinary tract symptoms (LUTS) that can significantly affect patients’ quality of life. This phase II prospective, randomized double-blinded, placebo-controlled study aimed to determine the efficacy and safety of a novel whole tomato-based food supplement on LUTS of patients diagnosed with BPH. Methods Forty consecutive patients with histologically proved BPH were randomized 1:1 to receive daily for 2 months a sachet (5 g) of a newly developed whole tomato food supplement (WTFS) (treatment = Group A) or placebo (Group B). Patients were asked to fill the International Prostatic Symptom Score (IPSS) questionnaire before and after treatment. Results All but 1 patient in Group B successfully completed the scheduled regimen. No side effects were recorded. Unlike placebo, treatment significantly reduced (P < 0.0002) LUTS since mean IPSS decreased from 9.05 ± 1.15 to 7.15 ± 1.04 (paired t-test, two-tailed P-value < 0.001), and improved life quality (P < 0.0001). A trend toward a reduction of total PSA levels was observed in WTFS treated patients (8.98 ng/mL ± 1.52 vs 6.95 ± 0.76, P = 0.065), with changes being statistically significant only in the subgroup of patients with baseline levels above 10 ng/mL (18.5 ng/mL ± 2.7 vs 10.3 ± 2.1, P = 0.009). Conclusions The new WTFS may represent a valid option for the treatment of symptomatic BPH patients. Unlike pharmacological treatments, the supplement is side effects free and highly accepted among patients.

FruHis significantly increases the anti-benign prostatic hyperplasia effect of lycopene: A double-blinded randomized controlled clinical trial

“…However, these positive effects were not statistically significant, and the size of changes is clinically notable. In agreement with our findings, Cormio et al reported that consumption of whole tomato food supplement (WTFS), which may contain both lycopene and FruHis, decreases the symptom score from 9.05 to 7.15 and improves QoL, about one score, in patients with BPH ( 43 ). In the mentioned study, these changes were not significant compared to the control group.…”

Prostate Artery Embolization Using N-Butyl Cyanoacrylate Glue for Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: A Valid Alternative to Microparticles?

“…The treatment of BPH-related LUTSs has changed markedly over the past 20-30 years, with a shift toward pharmacotherapy and management in primary care [1][2][3]. Until now, patients whose LUTSs become incapacitating have typically been offered TURP and, more recently, laser prostatectomy [2,8].…”

“…Benign prostatic hyperplasia (BPH) is associated with lower urinary tract symptoms (LUTSs) and quality-of-life (QoL) alterations in aging men [1]. Transurethral resection of the prostate (TURP) remains the standard of care for most patients with failure of, or intolerance to, first-line pharmacotherapy and/or specific food supplements [1][2][3]. However, TURP can be associated with complications such as bleeding, infection, and retrograde ejaculation [2].…”

Tomato and Olive Bioactive Compounds: A Natural Shield against the Cellular Effects Induced by β-Hexachlorocyclohexane-Activated Signaling Pathways

“…EP2851080A1) derived from the combination of spray-dried whole tomatoes and a small percentage olive mill wastewater (98:2 ratio). The supplement was shown to possess potent antioxidant and anti-inflammatory activity in animal model [ 36 ] and human disease [ 37 ]. On the basis of its varied nutraceutical composition, this supplement could be a valid functional food to be included in a green diet plan; in addition, the employment of tomato scraps and olive oil production wastes gives a nod to the environment, allowing the recovery of potential contamination sources.…”