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

Bañares 2002.

Methods Single‐blind, parallel‐arm, single‐centre randomised clinical trial evaluating primary prevention
Participants 51 participants with cirrhosis and endoscopically proven oesophageal varices without previous bleeding
Proportion of men: carvedilol 73%; propranolol 60%
Mean age: carvedilol 57.9 years; propranolol 58.4 years
Proportion for primary prevention: carvedilol 100%; propranolol 100%
Proportion with:
  • alcohol‐related cirrhosis: carvedilol 23%; propranolol 36%

  • hepatitis B‐related cirrhosis: carvedilol: 15%; propranolol 8%

  • hepatitis C‐related cirrhosis: carvedilol 54%; propranolol 56%

  • large varices: carvedilol 38%; propranolol 56%

  • ascites: carvedilol 39%; propranolol 24%

Interventions Intervention comparison: carvedilol vs propranolol
Dose of carvedilol: 6.25 mg once daily titrated to a mean of 31 mg to achieve a 25% reduction in heart rate
Dose of propranolol: 20 mg once daily titrated to a mean of 73 mg to achieve a 25% reduction in heart rate
Treatment duration: approximately 3 months
Outcomes Outcomes included in meta‐analysis: mortality, upper gastrointestinal bleeding, serious adverse events, non‐serious adverse events; reduction in hepatic venous pressure gradient and haemodynamic response (gradient reduction by ≥ 20% from baseline or to ≤ 12 mmHg) after a mean period of 11 weeks.
Country of origin Spain
Publication status Full‐paper
Inclusion period Not reported
Notes The publication does not describe the type of serious adverse events. The discussion section gives the impression that serious adverse events were associated with systemic hypotension, although this is not stated specifically.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers
Allocation concealment (selection bias) Low risk Serially numbered, opaque, sealed envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open trial without blinding of participants or personnel
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Blinding of outcome assessment
Incomplete outcome data (attrition bias) 
 All outcomes High risk The trial only describes per protocol analyses in the haemodynamic assessments.
Selective reporting (reporting bias) High risk The trial report does not describe the types of serious adverse events. We did not have access to the trial protocol.
For‐profit funding Low risk No for‐profit funding
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