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
Mohammad Reza Safarinejad, Ali Asgar Kolahi* and Gholamhossein Ghaedi † Urology and Nephrology Research Centre, *Department of Health and Community Medicine, Shahid Beheshti University Research Centre (MC) and † Department of Psychiatry, Faculty of Medicine, Shahed University, Tehran, Iran Accepted for publication 21 November 2008
OBJECTIVE 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 37–۵۹ 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. Patients with comorbid conditions (diabetes mellitus, hypercholesterolaemia,hypertension, Peyronie’s disease) and smokers of more than ﬁve cigarettes daily were excluded. The patients were randomly divided into a group of 133 who received 100 mg of on-demand sildenaﬁl 0.75–۲ h before sexual stimulation, and 133 who received placebo. Patients were asked to use ≥ ۱۶ doses or attempts at home. The efﬁcacy of the treatments was assessed every four attempts during treatment, and at the end of the study, using responses to the 15- question International Index of Erectile Function (IIEF), Sexual Encounter Proﬁle diary questions 2 and 3, Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire, patients’ event logs of sexual activity, and a Global Assessment Question about erections.
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 ( ≥ ۲۶) 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. Further randomized clinical trials are warranted in combat veterans and other populations with PTSD to better elucidate the role of phosphodiesterase type 5 inhibitors in treating PTSD-emergent ED.
KEYWORDS erectile dysfunction, post-traumatic stress disorder, sildenaﬁl, treatment.