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 st

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.

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.

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).

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.

Journal of translational medicine. 2021 Jan 06*** epublish ***

Luigi Cormio, Beppe Calò, Ugo Falagario, Manuela Iezzi, Alessia Lamolinara, Paola Vitaglione, Giovanni Silecchia, Giuseppe Carrieri, Vincenzo Fogliano, Stefano Iacobelli, Pier Giorgio Natali, Mauro Piantelli

Urology and Renal Transplantation Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy., Department of Medicine and Aging Sciences, Center for Advanced Studies and Technology (CAST), G.d'Annunzio University, Chieti, Italy., Department of Agricultural Sciences, University of Naples, Portici, Italy., Department of Agrotechnology and Food Science, Wageningen University, Wageningen, The Netherlands., Janus Pharma S.r.l., Via Giacomo Peroni 386, 00131, Roma, Italy., Department of Medicine and Aging Sciences, Center for Advanced Studies and Technology (CAST), G.d'Annunzio University, Chieti, Italy. .

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