Singh 2006.
Methods | Randomised, double‐blind, placebo‐controlled cross‐over trial 6 weeks duration with a wash‐out of 2 weeks |
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Participants | Inclusion criteria:
Exclusion criteria:
WHO FC II/III n = 20 |
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Interventions | Oral sildenafil versus placebo Adult participants were given 25 mg sildenafil on the first day and repeated after 6 hours under observation. If there was no hypotension, they were given 100 mg 3 times a day. In children weighing < 30 kg, an initial dose of 3.125 mg of sildenafil was given and maintained at 25 mg 3 times daily. In older children weighing > 30 kg, initial dose of 6.25 mg was given and maintained at 50 mg 3 times a day. Participants were given second dose only if there was no significant fall in BP. Treatment was given for 6 weeks, which was followed by a 2‐week washout before crossing over Routine medication, as prescribed by the treating physician, including digitalis, diuretics, and oral anticoagulants, was continued throughout the study Compliance was assessed by the pill‐count method |
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Outcomes | The primary endpoint of efficacy was the improvement in distance covered in 6MWD. Secondary endpoints were reduction in PAP as measured by Doppler echocardiography after 6 weeks of treatment, improvement in clinical condition, NYHA class, and exercise duration and metabolic equivalents (Mets) achieved on modified Bruce exercise protocol | |
Notes | Funding source not stated Location and dates of enrolment not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation, blinding, and drug/placebo administration were done by the Department of Pharmacology |
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 | Low risk | Unclear if outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | It is not explicitly stated if there were any withdrawals |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes were reported |
Other bias | Low risk | Other risk of bias is unlikely |