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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 +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) |
