Objective: To compare in a randomised, open-label, non-inferiority clinical study, the efficacy and tolerability of Serenoa repens (SeR) + selenium (Se) + lycopene (Ly) (SeR-Se-Ly) therapy vs tadalafil 5 mg in men with lower urinary tract symptoms (LUTS). Patients and methods: From May 2015 to January 2017, 427 patients were enrolled in 21 different centres (International Standard Randomised Controlled Trial Number Register [ISRCTN] 73316039). Inclusion criteria included: age between 50 and 80 years, International Prostate Symptom Score (IPSS) ≥12, maximum urinary flow rate (Q max ) ≤ 15 mL/s, and post-void residual (PVR) <100 mL. Patients were randomised into two groups in a 2:1 ratio: Group A (SeR-Se-Ly, 1 tablet daily for 6 months) and Group B (tadalafil 5 mg, 1 tablet daily for 6 months). The primary endpoint of the study was the non-inferior variation in the IPSS and Q max in Group A vs Group B after 6 months of treatment. Results: In all, 404 patients completed the full protocol. When comparing both therapies, Group A was statistically not inferior to Group B considering the median change in IPSS (−3.0 vs −3.0; P < 0.01), IPSS quality of life (−2.0 vs −2.0; P < 0.05), and Q max (2.0 vs 2.0 mL/s; P < 0.01). We found statistically significant differences in the increase of at least 3 points in Q max (38.2% vs 28.1%; P = 0.04) and of at least 30% of Q max (39.2% vs 27.3%; P < 0.01) in Group A compared to Group B. The percentage of patients with an increase of at least 3 points in the IPSS and a decrease of at least 25% of the IPSS was not statistically different between the two groups. For adverse events, four patients in Group A (1.44%) and 10 in Group B (7.81%) (P < 0.05) reported side-effects. Conclusion: We have shown that treatment with SeR-Se-Ly was not inferior to tadalafil 5 mg for improving IPSS and Q max in men with LUTS.
Serenoa repens + selenium + lycopene vs tadalafil 5 mg for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction: a Phase IV, non-inferiority, open-label, clinical study (SPRITE study) / Morgia G., Vespasiani G., Pareo R.M., Voce S., Madonia M., Carini M., Ingrassia A., Terrone C., Gentile M., Carrino M., Giannantoni A., Blefari F., Arnone S., Santelli G., Russo G.I., Reale G., Di Mauro M., Fedelini P., Pucci L., Veneziano P., et al.. - In: BJU INTERNATIONAL. - ISSN 1464-4096. - ELETTRONICO. - 122:(2018), pp. 317-325. [10.1111/bju.14209]
Serenoa repens + selenium + lycopene vs tadalafil 5 mg for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction: a Phase IV, non-inferiority, open-label, clinical study (SPRITE study)
Morgia G.;Giannantoni A.;Blefari F.;Santaniello F.;Cocci A.;Lanciotti M.;
2018
Abstract
Objective: To compare in a randomised, open-label, non-inferiority clinical study, the efficacy and tolerability of Serenoa repens (SeR) + selenium (Se) + lycopene (Ly) (SeR-Se-Ly) therapy vs tadalafil 5 mg in men with lower urinary tract symptoms (LUTS). Patients and methods: From May 2015 to January 2017, 427 patients were enrolled in 21 different centres (International Standard Randomised Controlled Trial Number Register [ISRCTN] 73316039). Inclusion criteria included: age between 50 and 80 years, International Prostate Symptom Score (IPSS) ≥12, maximum urinary flow rate (Q max ) ≤ 15 mL/s, and post-void residual (PVR) <100 mL. Patients were randomised into two groups in a 2:1 ratio: Group A (SeR-Se-Ly, 1 tablet daily for 6 months) and Group B (tadalafil 5 mg, 1 tablet daily for 6 months). The primary endpoint of the study was the non-inferior variation in the IPSS and Q max in Group A vs Group B after 6 months of treatment. Results: In all, 404 patients completed the full protocol. When comparing both therapies, Group A was statistically not inferior to Group B considering the median change in IPSS (−3.0 vs −3.0; P < 0.01), IPSS quality of life (−2.0 vs −2.0; P < 0.05), and Q max (2.0 vs 2.0 mL/s; P < 0.01). We found statistically significant differences in the increase of at least 3 points in Q max (38.2% vs 28.1%; P = 0.04) and of at least 30% of Q max (39.2% vs 27.3%; P < 0.01) in Group A compared to Group B. The percentage of patients with an increase of at least 3 points in the IPSS and a decrease of at least 25% of the IPSS was not statistically different between the two groups. For adverse events, four patients in Group A (1.44%) and 10 in Group B (7.81%) (P < 0.05) reported side-effects. Conclusion: We have shown that treatment with SeR-Se-Ly was not inferior to tadalafil 5 mg for improving IPSS and Q max in men with LUTS.
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