Kim 2016.
Methods | Parallel‐arm, open‐label, multi‐centre, randomised clinical trial evaluating primary prevention | |
Participants | 110 participants with cirrhosis, endoscopically verified grade 2 or 3 varices, and no previous bleeding Proportion of men: carvedilol 74.5%; propranolol 76.4% Mean age: carvedilol 51.7 years; propranolol 70.6 years Proportion for primary prevention: carvedilol 100%; propranolol 100% Proportion with:
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Interventions |
Intervention comparison: carvedilol vs propranolol Dose of carvedilol: initially 6.25 mg once daily, increased to 12.5 mg; mean 11.6 mg/dL (range 6.25‐12.5 mg/dL) Dose of propranolol: initially 20 mg twice daily, titrated until heart rate decreased by 25%, or to 55 beats per minute; mean 152.6 mg/dL (range 40‐320 mg/dL) Treatment duration: 6 weeks |
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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 6 weeks | |
Country of origin | Korea | |
Publication status | Full‐paper | |
Inclusion period | August 2012‐December 2014 | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated, random number table, block size of 2 and stratified block randomisation |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open trial without blinding or participants or personnel |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open trial without blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data. All participants are accounted for and included in the analyses. |
Selective reporting (reporting bias) | Low risk | Clinically relevant outcomes are reported. We did not have access to the trial protocol. |
For‐profit funding | High risk | Received funding from ChongKunDang Pharmaceutical |
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 |