Double blind placebo controlled crossover clinical trial of sildenafil citrate in patients with diabetes mellitus and erectile dysfunction

Abstract

Objective: To assess the efficacy, side-effects and client acceptability of oral sildenafil citrate in patients with diabetes mellitus having erectile dysfunction.

 Method: 103 diabetes patients with erectile dysfunction attending the Endocrine Clinic at National Hospital of Sri Lanka were selected for the study. Sildenafil citrate 50mg or placebo was given to alternate patients, and after a wash-out period of 2 weeks, those who received the drug were given the placebo and vice versa. The 5- item version of International Index of Erectile Function (IIEF-5) was used to assess the degree of erectile dysfunction. IIEF-5 was assessed before and after the placebo and the drug.

Results: 95 (92.3%) patients completed the study. There was a significant improvement (P<0.001) in IIEF-5 score after sildenafil citrate (IIEF-5 mean 17.1) when compared to placebo (IIEF-5 mean 10.7). 48 (50.5%) patients had at least one side-effect attributable to the drug. These were transient and mild in nature, and included transient nasal congestion, gastrointestinal disturbances, disturbance of colour vision, headache, dizziness and faintness. 92 (96.8%) patients said that the use of sildenafil citrate was acceptable to them and their partners.

Conclusion: Sildenafil citrate is an effective drug in the management of erectile dysfunction in patients having diabetes mellitus, with only transient and mild side-effects. Acceptability of the drug by patients and their partners was very high. Males with diabetes expect their physicians to initiate a dialogue on their sexual functioning.

DOI: http://dx.doi.org/10.4038/jccp.v41i2.3769  

Journal of the Ceylon College of Physicians, 2010, 41, 72-75