Gupta 2016.
Methods | Open‐label, parallel‐arm, single‐centre randomised clinical trial evaluating secondary prevention | |
Participants | 59 participants with cirrhosis and portal hypertension (hepatic venous pressure gradient > 12 mmHg) with a previous bleeding episode Proportion of men: carvedilol 96.7%; propranolol 89.7% Mean age: carvedilol 41.7 years; propranolol 45.0 years Proportion for primary prevention: carvedilol 0%; propranolol 0% Proportion with:
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Interventions |
Intervention comparison: carvedilol vs propranolol Dose of carvedilol: initially 3.125 mg twice daily; increased in 3.125 mg increments until heart rate was between 55 to 60 beats per minute, or to a total daily dose of 25 mg, or to intolerance; median 6.25 mg Dose of propranolol: initially 40 mg once daily, increased in 20 to 40 mg increments until the heart rate was between 55 to 60 beats per minute, to a total daily dose of 320 mg, or to intolerance; median 40 mg Co‐intervention: all participants underwent endoscopic banding ligation Treatment duration: 1 month |
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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), after 1 month | |
Country of origin | India | |
Publication status | Full‐paper | |
Inclusion period | 1 June 2013‐31 December 2013 | |
Notes | ||
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 | High risk | Open trial without blinding of outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | High risk | The analyses exclude participants who dropped out |
Selective reporting (reporting bias) | Low risk | Clinically relevant outcomes are reported. 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 identified |
Overall bias assessment (mortality) | High risk | High risk of bias |
Overall bias assessment (non‐mortality outcomes) | High risk | High risk of bias |