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QUESTION: In men with erectile dysfunction (ED) and mild-to-moderate depression, does depression affect ED treatment response to sildenafil and does improvement in ED affect depression?
Design
Randomised {allocation concealed*}†, blinded {patients, clinicians, data collectors, and outcome assessors}†,* placebo controlled trial with 12 weeks of follow up.
Setting
20 urology clinics in the USA.
Patients
152 men (mean age 56 y) who had ED for ≥ 6 months (mean duration 6 y); a stable relationship with a female partner for ≥ 6 months; a Diagnostic and Statistical Manual of Mental Disorders, 4th ed, diagnosis of depressive disorder not otherwise specified; and a Hamilton Depression Rating Scale score of ≥ 12. Exclusion criteria included presence of another axis I psychiatric disorder, current use of nitrates or any antidepressant medication, and abnormal serum hormone concentrations. 89% of patients were included in the analysis.
Intervention
74 men were …