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:
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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 |
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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. |
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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 |