Jalalian 2015.
Methods | Randomised placebo‐controlled trial 6 weeks duration |
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Participants | Inclusion criteria:
Exclusion criteria:
(WHO Group 5) n = 22 |
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Interventions | Tadalafil (40 mg daily) (N=22) or placebo (N=22) | |
Outcomes | PASP TRV and parameters related to systolic function of the right ventricle including changes in TAPSE, pulsed Doppler peak velocity at the tricuspid annulus (S') were measured by TTE | |
Notes | Publicly funded Trial conducted at Babol, Northern Iran between December 2013 and April 2014 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "the participants were randomly divided" but methods are 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 | Blinding of outcome assessment was not clear |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals were accounted for, and were even across both groups. Quote: "Three participants in the tadalafil group and one participant in the placebo group withdrew due to side effects" |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes were reported |
Other bias | Low risk | Other bias is unlikely |