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:
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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 |
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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 |