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

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:
  • alcohol‐related cirrhosis: carvedilol 60%; propranolol 61.8%

  • hepatitis B‐related cirrhosis: carvedilol 29.1%; propranolol 27.3%

  • hepatitis C‐related cirrhosis: carvedilol 5.5%; propranolol 7.3%

  • large varices: carvedilol 100%; propranolol 100%

    • carvedilol: grade 2 81.8%; grade 3 18.2%

    • propranolol: grade 2 80%; grade 3 20%

  • ascites: carvedilol 60%; propranolol 60%

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
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