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

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:
  • alcohol‐related cirrhosis: carvedilol 47%; propranolol 48%

  • viral hepatitis‐related cirrhosis: carvedilol 33%; propranolol 24%

  • large varices: carvedilol 100%; propranolol 100%

    • carvedilol: grade 2: 0%; grade 3: 50%; grade 4: 50%.

    • propranolol: grade 2: 3.5%; grade 3: 48%; grade 4: 48%

  • previous bleeding: carvedilol 100%; propranolol 100%

  • ascites: carvedilol 53%; propranolol 72%

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
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