Ovchinnov 2015.
Methods | Randomised parallel‐group placebo‐controlled trial 12 weeks duration |
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Participants | Inclusion criteria:
n = 50 |
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Interventions | Sildenafil (25 mg 3 times a day for 12 weeks followed by 50 mg 3e times a day for 12 weeks; n = 30) or to control group (no sildenafil, n = 20) | |
Outcomes | 6MWD Cycle ergometer exercise duration Systolic pulmonary artery pressure RV function assessed by tricuspid annular systolic excursion Left‐sided diastolic function (E/é ratio) |
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Notes | Quantitative outcomes were only reported for the sildenafil group; the trial reported "no improvement in control group was observed" so this trial was unable to be included in the meta‐analysis We tried to contact all authors, but at the time of this review publication there has been no reply, or contact details were unavailable Funding source not stated Location and dates not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Paper states participants were randomly assigned, but no methods were given |
Allocation concealment (selection bias) | High risk | Compared sildenafil to "no sildenafil" ‐ unclear if placebo was used |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unclear if placebo was used or if participants were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear if outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Number of completers were not reported. Mortality or loss to follow‐up were not reported. Methods using intention‐to‐treat or per‐protocol analysis was not specified |
Selective reporting (reporting bias) | High risk | Quantitative outcome data were only reported for the sildenafil group, not placebo group, and no P values between groups were reported |
Other bias | Unclear risk | Not clear if other bias is possible ‐ abstract from conference proceedings with limited data presented |