There was a statistically significant difference among the three groups in changes from baseline to week 12 in physical symptom score (p=0.024). The treatment effect for the lower and higher doses of sildenafil compared with placebo were 8.4 (95% CI 20.2 to 17.0) and 14.0 (95% CI 4.0 to 24.1; p=0.009), respectively. For the combined sildenafil treatments the statistically significant treatment effect size (p=0.012) was 10.4 compared with placebo (95% CI 2.5 to 18.3). There was no significant treatment effect on systemic blood pressure. Sildenafil was well tolerated. All subjects reported some improvement in wellbeing and no adverse effects were reported.
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