Daily Oral l-Arginine Plus Tadalafil in Diabetic Patients with Erectile Dysfunction: A Double-Blinded, Randomized, Controlled Clinical Trial

Abstract

Introduction Erectile dysfunction is a common condition among diabetic men. Many treatments are now available with variable responses. Aim This study aimed to evaluate the effect of daily oral l-arginine plus tadalafil in diabetic patients with mild to moderate erectile dysfunction. Methods A double-blinded, randomized, controlled clinical trial was conducted with 108 diabetic male patients. Each patient was assessed by medical and sexual histories, International Index of Erectile Function 5-item questionnaires, pharmaco-penile duplex ultrasonography, and serum testosterone level. Main Outcome Measure Improvement in International Index of Erectile Function 5-item, serum testosterone level and pharmaco-penile duplex ultrasonography. Results Erectile functions were significantly improved in all patients after treatment as compared with baseline and placebo (P < .001). Patients who received both drugs showed significant improvement compared to those treated with single drugs, as assessed by International Index of Erectile Function scores and total testosterone (P < .001). Pharmaco-penile ultrasound duplex results showed non-significant differences among patients treated with both drugs and those with each drug alone. Conclusion Daily use of l-arginine with tadalafil significantly increased the International Index of Erectile Function scores and total testosterone levels as compared to each drug alone in diabetic patients with erectile dysfunction. No differences were found based on pharmaco-penile duplex findings.

Comparison of efficacy and safety of daily oral L‐arginine and PDE5Is alone or combination in treating erectile dysfunction: A systematic review and meta‐analysis of randomised controlled trials

“…Due to the lack of useful data, 61 studies were excluded. Four RCTs (Abu El‐Hamd & Hegazy, 2020; El Taieb et al., 2019; El‐Wakeel et al., 2020; Gallo et al., 2020) including 373 patients were used to access the effect and safety of daily oral L‐arginine and PDE5Is alone or combination in treating patients with ED. A selection process is shown in Figure 1.…”

“…The above results are consistent with the results of previous research. One RCT found that compared with L‐arginine or tadalafil alone, daily oral L‐arginine and tadalafil significantly improved the IIEF score and total testosterone levels in patients with diabetic ED (El Taieb et al., 2019). Another RCT reported that compared with sildenafil alone, IIEF scores of the combination of L‐arginine and sildenafil daily group were significantly increased in patients with ED (Gallo et al., 2020).…”

Long-term high-dose l-arginine supplementation in patients with vasculogenic erectile dysfunction: a multicentre, double-blind, randomized, placebo-controlled clinical trial

“…In l-ARG group, at T1, IIEF-6 score was significantly increased compared to T0 [24 (19-25.3) vs 20 (16)(17)(18)(19)(20)(21)(22); p < 0.0001] (Fig. 2).…”

Is vitamin D and L-arginine deficiency associated with male erectile dysfunction?

“…Moreover, the combination of L-arginine with a phosphodiesterase type 5 inhibitor (e.g., tadalafil) is more effective in improving erectile function in men [14,15]. Daily intake of L-arginine with tadalafil significantly increased the IIEF 5-item questionnaire scores, and total testosterone levels compared to single dose of each medication in diabetic patients with ED [16]. The normal range of L-arginine plasma levels has been specified as 81.6 ± 7.3 mmol/L in young men and 113.7 ± 19.8 μmol/L in elderly men [17].…”