Uthman 2020.

Study characteristics
Methods	Randomised, single‐centre, placebo‐controlled clinical trial
Participants	This trial assessed the effects of rifaximin plus lactulose, compared to placebo plus lactulose, for the treatment of overt hepatic encephalopathy in 84 people with cirrhosis. There were 42 participants in the rifaximin + lactulose group and 42 in the placebo plus lactulose group. Age (reported as % participants < 60 years) Rifaximin plus lactulose 81% Placebo plus lactulose 19% Proportion of men (n: %) Rifaximin plus lactulose 30 (71) Placebo plus lactulose 32 (76) Aetiology of cirrhosis not stated
Interventions	Intervention: rifaximin 550 mg twice daily Control: placebo, frequency unknown Co‐intervention: none Duration of treatment: 15 days or until discharge
Outcomes	Neuropsychiatric assessment Mental status ( West Haven criteria); portosystemic encephalopathy index
Inclusion period	July 2019 to December 2019
Outcomes included in meta‐analyses	Mortality
Country of origin	India
Notes	Publication status: full paper Vested interests bias: none Additional Information: although data on the number of participants in whom hepatic encephalopathy completely resolved is provided (rifaximin plus lactulose 34/42 (80.9%); placebo + lactulose alone 20/42 (47.6%); chi2 P = 0.003, no information is provided on the number of participants in whom there was no change or worsening of hepatic encephalopathy.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Study is classified as randomised but no details are provided on randomisation method ‐ participants were divided into 2 groups.
Allocation concealment (selection bias)	Unclear risk	No information on allocation concealment methods provided.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Participants were randomised to rifaximin plus lactulose or placebo plus lactulose, but no information is provided on the placebo preparation or blinding,
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Participants were randomised to rifaximin plus lactulose or placebo plus lactulose, but no information is provided on the placebo preparation or blinding,
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants accounted for in final analyses.
Selective reporting (reporting bias)	High risk	Mortality can be deduced from the data although were not specifically reported; the number of people in whom hepatic encephalopathy resolved completely is reported but the numbers in whom hepatic encephalopathy remained unchanged or worsened is not provided. Trial not available in registries.
Other bias	Low risk	No other bias identified
Overall bias assessment (mortality)	High risk	High risk of bias in more than one domain
Overall bias assessment (non‐mortality outcomes)	High risk	High risk of bias in more than one domain