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 6). 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 7): not conducted (not specifically stated).
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.
Outcomes	Outcomes included in meta‐analyses: mortality, hepatic encephalopathy (Table 3), and serious adverse events (Table 8) assessed for a maximum of 2 weeks (until death or discharge).
Neuropsychiatric assessment	Baseline and post infusion: Clinical assessment of hepatic encephalopathy (Table 4).
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.