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. 2018 Oct 29;2018(10):CD011510. doi: 10.1002/14651858.CD011510.pub2

De 2002.

Methods Double‐blind, parallel‐arm, single‐centre, randomised clinical trial evaluating primary and secondary prevention
Participants 36 participants with cirrhosis and endoscopically verified varices with 1 previous bleeding episode in the 7 to 10 days before inclusion, or without previous bleeding
Proportion of men: carvedilol 83%; propranolol 94%
Mean age: carvedilol 42.3 years; propranolol 47.3 years
Proportion for primary prevention: carvedilol 61.1%; propranolol 61.1%
Proportion with:
  • alcohol‐related cirrhosis: carvedilol 28%; propranolol 56%

  • hepatitis B‐related cirrhosis: carvedilol 39%; propranolol 22%

  • hepatitis C‐related cirrhosis: carvedilol 11%; propranolol 6%

  • large varices: carvedilol 100%; propranolol 100%

    • carvedilol: grade 3 89%; grade 4 11%

    • propranolol: grade 3 83%; grade 4 17%

  • previous bleeding: carvedilol 39%; propranolol 39%

  • ascites: carvedilol 67%; propranolol 89%

Interventions Intervention comparison: carvedilol vs propranolol
Dose of carvedilol: 12.5 mg once daily
Dose of propranolol: 80 mg once daily
Treatment duration: 7 days
Outcomes Outcomes included in meta‐analysis: mortality, variceal bleeding, adverse events, reduction in hepatic venous pressure gradient, treatment response (gradient reduction by ≥ 20% from baseline or to ≤ 12 mmHg) assessed, after 7 days
Country of origin India
Publication status Full‐paper
Inclusion period Not reported
Notes Outcome data were not available by type of prevention
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Drawing of lots (independent researcher not otherwise involved in the trial)
Allocation concealment (selection bias) Low risk Serially numbered, opaque, sealed envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Blinding of participants and personnel
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Blinded outcome assessment
Incomplete outcome data (attrition bias) 
 All outcomes High risk The investigators only report per protocol analyses of haemodynamic changes.
Selective reporting (reporting bias) Low risk Clinically relevant outcomes are described. We did not have access to the trial protocol.
For‐profit funding High risk Support from ICI Pharmaceuticals India Ltd, India (supplied propranolol) and Sun Pharmaceutical Industries Ltd, India (supplied carvedilol).
Other bias Low risk No other biases
Overall bias assessment (mortality) High risk High risk of bias
Overall bias assessment (non‐mortality outcomes) High risk High risk of bias