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

ElRahim 2018.

Methods Single‐centre, open, randomised clinical trial evaluating primary prevention
Participants 330 participants with cirrhosis and endoscopically‐proven medium to large varices, without previous bleeding
Proportion of men: carvedilol 34%; propranolol 44%
Mean age: carvedilol 51.2 years; propranolol 51.8 years
Proportion for primary prevention: carvedilol 100%; propranolol 100%
Proportion with:
  • alcohol‐related cirrhosis: not reported

  • hepatitis B‐related cirrhosis: carvedilol: 16%; propranolol 14%

  • hepatitis C‐related cirrhosis: carvedilol 70%; propranolol 76%

  • large varices: carvedilol 32%; propranolol 36%

  • ascites: carvedilol 26%; propranolol 34%

Interventions Intervention comparison: band ligation vs propranolol vs carvedilol
Dose of carvedilol: initially 6.25 mg daily, titrated to reach 12.5 to 50 mg, to achieve a 25% reduction in heart rate while remaining > 55 beats per minute; mean 12.5 mg ± standard deviation 6.3 mg
Dose of propranolol: initially 40 mg daily, titrated to achieve a 25% reduction in heart rate while remaining > 55 beats per minute; mean 43.01 mg ± standard deviation 7.30 mg
Treatment duration: 12 months
Outcomes Outcomes included in meta‐analysis: variceal bleeding and adverse events after 1 year
Country of origin Egypt
Publication status Full‐paper
Inclusion period May 2015‐June 2016
Notes This trial did not include portal haemodynamic measures.
The trial report did not describe the allocation group of participants who died or participants with serious adverse events.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk 'Envelope technique'. The trial report does not describe if the envelopes were opaque, serially numbered or sealed.
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 analysis excluded participants who dropped out, bled or died.
Selective reporting (reporting bias) High risk The allocation group of participants who died is not described. We did not have access to the trial protocol.
For‐profit funding Unclear risk Not described
Other bias High risk Investigators reallocated participants initially randomised to carvedilol or propranolol to banding ligation if they had contraindications to medical interventions.
Overall bias assessment (mortality) High risk High risk of bias
Overall bias assessment (non‐mortality outcomes) High risk High risk of bias