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:
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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 |
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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 |