Zhu 1998.
Methods | Double‐blind, single‐centre, parallel‐arm, placebo‐controlled RCT. | |
Participants | 25 participants with cirrhosis and overt hepatic encephalopathy (Grade II to IV). Precipitating factors are described (Table 5). Mean age ± SD: flumazenil: 62.2 ± 2.7 years; placebo: 52.2 ± 3.3 years. Proportion of men: 69%. Aetiology of cirrhosis: alcohol 80%; hepatitis B/C 12%. Proportion testing positive for benzodiazepines at baseline (Table 6): not conducted (not specifically stated). |
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Interventions |
Intervention comparison: intravenous infusion flumazenil 1 mg over 5 minutes versus placebo (saline). Total dose of flumazenil: 1 mg. Cointerventions: intravenous branched‐chain amino acids. |
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Outcomes | Outcomes included in meta‐analyses: mortality, hepatic encephalopathy (Table 2), and serious adverse events (Table 7) assessed for a maximum of 2 weeks (until death or discharge). | |
Neuropsychiatric assessment |
Baseline and post infusion:
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Inclusion period (date) | April 1995 to March 1996. | |
Country | China. | |
Notes | Included data: all participants were included in the analyses. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers with stratified block randomisation. |
Allocation concealment (selection bias) | Low risk | Administration of concealed drug containers with sealed, opaque, serially numbered envelopes. |
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 | Missing outcome data not described. |
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 | High risk | Roche supplied the flumazenil. |
Other bias | Low risk | No other biases. |
Overall assessment | High risk | High risk of bias. |
RCT: randomised clinical trial; SD: standard deviation.