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
Open accessAbstract
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; from 22.1 ± 2.2 to 27.8 ± 2 in group B, and from 22.2 ± 2.2 to 29.3 ± 0.9 in group C. We report a total of 11, 53, and 67 cases of adverse events in group A, B, and C respectively. Conclusions: Combination therapy was superior to monotherapies. Gallo L, Pecoraro S, Sarnacchiaro P, et al. 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. Sex Med 2020;8:178–185.
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Previous studies on the effectiveness of L-arginine in treating sexual disorders in men reported promising results.
“Previous studies on the effectiveness of L-arginine in treating sexual disorders in men were conducted, and promising results reported [31–33].”
From Effect of l-arginine compared to placebo on sexual function in women with major depressive disorder: a randomized controlled trial (2024) · cites this paper as [33]
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- Authors
- Gallo, L., Pecoraro, S., Sarnacchiaro, P., Silvani, M., & Antonini, G.
- Affiliations
- Gallo Uro-Andrology Centre , Naples , Italy
- Azienda Ospedaliera S.Giuseppe Moscati (IT)
- Unitelma Sapienza University (IT)
- Division of Urology , Vercelli , Italy
- Sapienza University of Rome (IT)
- Corresponding author
- Gallo, Luigi
- Venue
- Sexual Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2020-03-17
- Volume
- 8
- Issue
- 2
- Pages
- 178-185
- ISSN
- 2050-1161 (ISSN-L)
- PMC
- PMC7261690
- OpenAlex
- W3010867003
- Cited by
- 17
- References
- 29
- Citations by year
- 2026: 1 · 2024: 2 · 2023: 2 · 2022: 3 · 2021: 7 · 2020: 2
- FWCI
- 2.55
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Sexual Medicine (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
- Health Sciences › Medicine › Urology › Urological Disorders and Treatments
- Health Sciences › Medicine › Urology › Urinary Bladder and Prostate Research
- Keywords
- erectile dysfunction, L-arginine, tadalafil, combination therapy, monotherapy, IIEF-EF, Sexual Encounter Profile, treatment efficacy, tolerability, adverse events, phosphodiesterase-5 inhibitors, nitric oxide precursor, sexual arousal, sexual performance
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