Comparative efficacy of on-demand Sildenafil, Tadalafil and daily Tadalafil for treatment of erectile dysfunction: A 12-week randomized controlled study

Background: Comparison of available first line agents for treating Erectile Dysfunction (ED) with each other regarding efficacy in Indian context remains scant. Sexual and mental health disorders frequently overlap and it is prudent to explore the potential of these medications to improve common comorbid psychiatric symptoms. Aim: To compare the efficacy of on-demand Sildenafil, on-demand Tadalafil and daily Tadalafil for ED, as well as their impact on premature ejaculation (PME) and mental health. Methods: Seventy-five individuals diagnosed with ED (ICD-11) were randomly assigned to one of the three treatment groups with 25 participants in each group: Group A (Sildenafil 50–100 mg SOS), Group B (Tadalafil 10–20 mg SOS), and Group C (Tadalafil 5 mg daily). Severity of sexual functioning was evaluated using the International Index of Erectile Function (IIEF), Sexual Encounter Profile question 2 and 3 (SEP2/3), Premature Ejaculation Diagnostic Tool (PEDT). Depression, Anxiety, and Stress Scale (DASS-21) assessed mental health status. Assessments were repeated at 2 weeks intervals till 12 weeks. Blood investigations were carried out at baseline and at the end of study period. Results: Daily Tadalafil was superior to on-demand Sildenafil or Tadalafil in improving erectile function ( P < 0.05), particularly in penetration (SEP 2/3) and was equally effective as on-demand Tadalafil on IIEF, while outperforming Sildenafil. It also significantly reduced depression and anxiety symptoms at 12 weeks ( P < 0.05). On-demand Tadalafil was most effective for managing associated PME, which was comorbid with ED in 66.7% of cases. Conclusion: Daily Tadalafil was more effective than on-demand Tadalafil or Sildenafil for treating ED, especially in patients with mood symptoms. PME was found to be quite common with ED and responded best to on demand Tadalafil. Tadalafil was superior to Sildenafil in all domains.