Safety and efficacy of sildenafil citrate in treating erectile dysfunction in patients with combat-related post-traumatic stress disorder: A double-blind, randomized and placebo-controlled study

Abstract

To evaluate the safety and efficacy of sildenafil citrate for treating erectile dysfunction (ED) in patients with combat related post-traumatic stress disorder (PTSD).

Patients and methods

In all, 266 combat-exposed war veterans with ED (aged 37–59 years) were recruited. They met the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for PTSD according to the Structured Clinical Interview for Patients, Investigator Version. The patients were also evaluated with the Clinician-Administered PTSD Scale, both to establish the diagnosis of PTSD and to measure symptom severity. Only patients with psychogenic ED were included in the study. The patients were randomly divided into a group of 133 who received 100 mg of on-demand sildenafil 0.75–2 h before sexual stimulation, and 133 who received placebo. Patients were asked to use ≥ 16 doses or attempts at home.

Results

Sildenafil did not produce significantly and substantially greater improvement than placebo in each of the primary and secondary outcome measures (P = 0.08). A normal EF domain score (≥ 26) at endpoint was reported by 13 (9.8%), and 11 (8.3%) of patients on the sildenafil and placebo regimens, respectively (P = 0.09). Patients treated with sildenafil had no statistically significantly greater improvement in the five sexual function domains of the IIEF questionnaire than those treated with placebo (P = 0.08). The incidences of treatment-emergent adverse events were significantly greater in the sildenafil arm than in the placebo group (P = 0.01).

Conclusions

Sildenafil is no better than placebo in treating PTSD-emergent ED.

Disclosure of interest

The author has not supplied his declaration of competing interest.