Salem 2013.
Methods | Randomised, placebo‐controlled trial 6 weeks duration |
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Participants | Inclusion criteria:
Exclusion criteria:
n = 40 |
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Interventions | Oral sildenafil (N=20) or matched placebo (N=20) was given in a titrated dose, starting with 25 mg 3 times daily for 1 week, then the dose was doubled to 50 mg 3 times daily according to side effects and tolerability until 6‐week period | |
Outcomes | Improvement in NYHA functional class PASP LVEF |
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Notes | Funding source not stated Location of trial and dates of recruitment not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised using simple randomisation (1:1) to either sildenafil therapy in a titrating dose or placebo |
Allocation concealment (selection bias) | Low risk | Placebo‐controlled |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo‐controlled |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It was unclear if the outcome assessors were blinded to the intervention |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | It was not explicitly stated if all randomised participants completed the trial; no withdrawals were reported |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes were reported |
Other bias | Low risk | Other risk of bias is unlikely |