Suntharalingham 2008.
Methods | Randomised, double‐blind, placebo‐controlled trial 12 weeks duration |
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Participants | Inclusion criteria:
Exclusion criteria:
n = 19 |
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Interventions | Sildenafil at 40 mg 3 times a day (N=9) or placebo (N=10) at 2 tablets 3 times per day in a 1:1 ratio At the end of the study, all participants were transferred to open‐label sildenafil at 40 mg 3 times a day and offered repeat assessment at 12 months |
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Outcomes | Primary endpoint was change in 6MWD Secondary endpoints included changes in WHO class, cardiopulmonary haemodynamics, QOL scores, and NT‐proBNP | |
Notes | Funding source not stated Trial conducted at the Pulmonary Vascular Diseases Unit, Papworth Hospital, Cambridgeshire, UK, enrolled between August 2004 and August 2007 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
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 | Not clearly stated if outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Withdrawals were accounted for: Quote: "An extensive urticarial rash developed in one subject in the sildenafil arm, who was thus withdrawn from the study" |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes were reported |
Other bias | Low risk | Other risk of bias is unlikely |