This phase II prospective, randomized double-blinded, placebo-controlled study was conducted to determine the efficacy and safety of a novel whole tomato-based food supplement (WTFS) on lower urinary tract symptoms (LUTS) of patients diagnosed with benign prostatic hyperplasia (BPH).
To do so, 40 patients with BPH were randomized to receive either 5 g/d of WTFS or placebo for 2 months. Patients were asked to fill the International Prostatic Symptom Score (IPSS) questionnaire before and after treatment.
Results showed that unlike placebo, treatment significantly reduced (p < 0.0002) LUTS since mean IPSS decreased significantly (p < 0.001), and improved life quality (p < 0.0001). A trend toward a reduction of total PSA levels was observed in WTFS treated patients (p = 0.065), with changes being statistically significant only in the subgroup of patients with baseline levels above 10 ng/mL (p = 0.009).
In conclusion, this new whole tomato-based food supplement may represent a valid and safe option for the treatment of symptomatic BPH patients.
Cormio L, Calò B, Falagario U, Iezzi M, Lamolinara A, Vitaglione P, Silecchia G, Carrieri G, Fogliano V, Iacobelli S, Natali PG, Piantelli M. 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. J Transl Med. 2021 Jan 6;19(1):24.