Luigi Cormio1,2, Beppe Calò1,2, Ugo Falagario1, Manuela Iezzi3, Alessia Lamolinara3, Paola Vitaglione4, Giovanni Silecchia1,2, Giuseppe Carrieri1, Vincenzo Fogliano5, Stefano Iacobelli6, Pier Giorgio Natali7, Mauro Piantelli3. 1. Urology and Renal Transplantation Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy. 2. Bonomo Teaching Hospital, Andria (BAT), Italy. 3. Department of Medicine and Aging Sciences, Center for Advanced Studies and Technology (CAST), G.d'Annunzio University, Chieti, Italy. 4. Department of Agricultural Sciences, University of Naples, Portici, Italy. 5. Department of Agrotechnology and Food Science, Wageningen University, Wageningen, The Netherlands. 6. Janus Pharma S.r.l., Via Giacomo Peroni 386, 00131, Roma, Italy. 7. Department of Medicine and Aging Sciences, Center for Advanced Studies and Technology (CAST), G.d'Annunzio University, Chieti, Italy. natalipg2002@yahoo.it.
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.
RCT Entities:
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.
Authors: Aminah Jatoi; Patrick Burch; David Hillman; Joanne M Vanyo; Shaker Dakhil; Daniel Nikcevich; Kendrith Rowland; Roscoe Morton; Patrick J Flynn; Charles Young; Winston Tan Journal: Urology Date: 2007-02 Impact factor: 2.649