Background: Benign prostatic hyperplasia is the most common urologic disease among elderly men. The diagnosis of BPH is usually in response to the appearance of lower urinary tract obstructive, and post-micturition symptoms (LUTS) that can significantly affect the quality of life. In Aim of this study was to evaluate in a phase II prospective, randomized double-blinded, placebo-controlled study, the efficacy and safety of a novel whole tomato-based food supplement on LUTS of patients affected by benign prostatic hyperplasia. Methods: Thirty-four consecutive patients with histologically proved BPH were included in a phase II prospective, randomized double-blinded, placebo-controlled study. Patients were randomized to receive daily for two months a sachet (5 grams) of the tomato-based food supplement Lycoprozen® or an identical sachet containing placebo. Patients were asked to fill the “International Prostatic Symptom Score” questionnaire before and after treatment. Results: All patients successfully completed the scheduled regimen. No side effects were recorded. Lycoprozen® significantly reduced the LUTS severity. Particularly, the IPSS mean values before and after the treatment were 7.5+1.1 SE (range 16-2) and 5.1+1.0 SD (range 14-2), respectively (paired t-test, two-tailed p value <0.0002). A trend toward a reduction of total PSA levels was observed in Lycoprozen® treated patients (9.346 ng/ml+1.839 SE vs.7.906+0.928 SE, P = 0.096) (Fig 1, left). This trend was sustained by the significant reduction of PSA levels seen in 5 patients, (2 obese, 2 over-weight and 1 normal-weight) with basal levels >10 ng/ml (18.520ng/ml+2.747 SE vs. 10.323ng/ml+2.073 SE, P = 0.009)

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 two months a sachet (5 grams) 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 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 SE to 7.15+1.04 SD (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 SE vs 6.95+0.76 SE, P = 0.065), with changes being statistical significant only in the subgroup of patients with baseline levels above 10 ng/ml (18.5ng/ml+2.7vs. 10.3+2.1p= 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