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The Daily Therapy With L-Arginine 2,500 mg and Tadalafil 5 mg in Combination and in Monotherapy for the Treatment of Erectile Dysfunction: A Prospective, Randomized Multicentre Study

L. Gallo, S. Pecoraro, P. Sarnacchiaro, M. Silvani, G. Antonini

Sexual Medicine, 2020

300 participants · 18 citations

Abstract

Introduction A synergistic effect of the combination therapy tadalafil plus L-Arginine is conceivable in patients affected by erectile dysfunction (ED). Aim To evaluate the effectiveness and tolerability of tadalafil 5 mg and L-Arginine 2.5 grams in monotherapy and combination therapy. Methods Recruited patients completed the International Index of Erectile Function – Erectile Function domain (IIEF-EF) and Sexual Encounter Profile diaries completed at baseline and after treatment. The survey was randomized into 3 groups with an equal allocation ratio. Group A received daily L-Arginine 2,500 mg, group B received daily tadalafil 5 mg, and group C received both daily L-Arginine 2,500 mg plus daily tadalafil 5 mg. The duration of therapy in all 3 groups was 12 weeks. Safety was assessed by evaluating all reported treatment-emergent adverse events. Main Outcome Measure The main outcome measure was the change in IIEF-EF score and in per-patient percentage of “yes” responses to Sexual Encounter Profile Question 3 from baseline to after treatment. Results 300 eligible patients were enrolled, and 100 subjects for each group were allocated. Based on the IIEF-EF score, the participants were divided into 3 categories: severe, moderate, and mild ED. IIEF-EF score increased in group A from 15 ± 7 to 18.1 ± 9.2, in group B from 14.8 ± 6.9 to 20.8 ± 7.3, and in group C from 14.9 ± 7.1 to 22 ± 7.5. In mild ED group, the mean IIEF-EF score increased from 22.1 ± 2.2 to 27.5 ± 2.3 in group A;…

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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 300 participants or records.

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