Methods | Double‐blind, single‐centre, placebo‐controlled RCT. Cross‐over design: investigators crossed over all participants to the alternative intervention. |
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Participants | 10 participants with cirrhosis and no clinical evidence of overt hepatic encephalopathy; 5 participants had minimal hepatic encephalopathy based on the finding of either abnormal visual evoked potentials or Number Connection Test results. Age (range): 40 to 60 years. Proportion of men: 80%. Aetiology of cirrhosis: alcohol 30%; hepatitis B/C 70%. Proportion testing positive for benzodiazepines at baseline (Table 7): 0%. |
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Interventions |
Intervention comparison: intravenous infusion flumazenil 1 mg over 2 minutes versus placebo. Total dose of flumazenil: 1 mg. Washout period: 4 hours. Cointerventions: none reported. |
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Outcomes | Outcomes included in meta‐analyses: none. | |
Neuropsychiatric assessment |
At baseline and post infusion:
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Inclusion period (date) | Not described. | |
Country | The Netherlands. | |
Notes | Included data: trial did not include separate information about the first allocation period. Therefore, we were unable to include the trial in our meta‐analyses. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
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 | Low risk | No missing outcome data. |
Selective reporting (reporting bias) | Low risk | The trial describes 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. |