Methods | Double‐blind, parallel‐arm, single‐centre, placebo‐controlled RCT. | |
Participants | 12 participants with cirrhosis and an acute episode of hepatic encephalopathy defined as Grade IIIa with severely abnormal electroencephalography changes, but a Glasgow Coma Score of < 12 (Table 4). Proportion of men: not reported. Mean age ± SD: whole group 58.2 ± 5.4 years. Aetiology of liver disease: not reported. Proportion testing positive for benzodiazepines at baseline (Table 7): 0%. |
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Interventions |
Intervention comparison: intravenous infusion flumazenil 0.2 mg/kg over 10 minutes versus placebo (saline). Total dose of flumazenil: 0.2 mg/kg. Cointerventions: none described. |
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Outcomes | Outcomes included in meta‐analyses: mortality (Table 8) and serious adverse events (Table 8). | |
Neuropsychiatric assessment |
Baseline and post infusion: The timing of assessments post infusion was not described. |
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Inclusion period (date) | Not described. | |
Country | France. | |
Notes |
Included data: the trial report did not specifically state the number of participants with (or without) improvement in hepatic encephalopathy separately for the allocation groups. Therefore, we were unable to include the trial in the analysis of this outcome measure. Article published in French (full translation available). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. |
Allocation concealment (selection bias) | Low risk | Concealed drug containers. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of participants and personnel. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of outcome assessment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Trial report gave the impression that there were no missing outcome data although this was not specifically stated. |
Selective reporting (reporting bias) | Low risk | Trial described clinically relevant outcomes. We had no access to information about outcomes described in the original protocol or information in trial registries. |
For‐profit funding | Unclear risk | No information provided. |
Other bias | Low risk | No other biases. |
Overall assessment | High risk | High risk of bias. |