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. 2019 Jan 31;2019(1):CD012621. doi: 10.1002/14651858.CD012621.pub2

Jalalian 2015.

Methods Randomised placebo‐controlled trial
6 weeks duration
Participants Inclusion criteria:
  • Participants with beta‐thalassaemia intermedia

  • PH based on TTE


Exclusion criteria:
  • Participants with hepatic or renal insufficiency

  • Treated with organic nitrates or alpha‐blockers


(WHO Group 5)
n = 22
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
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