Rao 2011.
Methods | Randomised, double‐blind placebo‐controlled trial 12 weeks duration |
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Participants | Inclusion criteria:
Exclusion criteria:
n = 37 |
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Interventions | Oral sildenafil 20 mg 3 times a day (N=17) compared to identical placebo (N=20) | |
Outcomes | Primary outcome: change in 6MWD. Improvement in PAP was taken as secondary outcome of the study | |
Notes | Industry provided the drugs. No other funding source stated Trial conducted at SMS Medical College and Hospital, Jaipur (Rajasthan), India (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 | Sildenafil and placebo were dispensed according to random allocation of computer‐generated code |
Allocation concealment (selection bias) | Low risk | Drug was dispensed by an unblinded co‐ordinator, who dispensed the drug to blinded co‐ordinator, who gave it to the participants |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Drug was dispensed by an unblinded co‐ordinator, who dispensed the drug to blinded co‐ordinator, who gave it to the participants |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not explicitly stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals were accounted for and similar across the 2 groups ‐ where in each group 1 was lost to follow‐up, 1e in the sildenafil group had an acute exacerbation, and 1 in the placebo group withdrew consent |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes were reported |
Other bias | Low risk | Other risk of bias is unlikely |