Ahmed 2018.

Study characteristics
Methods	Randomised, open‐label clinical trial
Participants	The trial assessed the effects of rifaximin plus lactulose versus lactulose alone in 120 people with decompensated cirrhosis who presented with an acute episode of hepatic encephalopathy, grades I‐IV There were 60 participants in each of the groups. Age (mean ± SD) years Rifaximin plus lactulose 54.1 ± 9.8 Lactulose only 53.2 ± 10.6 Proportion of men (%) Rifaximin plus lactulose 56.7 Lactulose only 53.3 Aetiology of cirrhosis (n: %) Hepatitis C 45 (75.0) Hepatitis B 16 (13.3) Other 14 (11.7)
Interventions	Intervention: rifaximin 550 mg twice daily plus lactulose 30 mL thrice daily Control intervention: lactulose 30 mL thrice daily Co‐interventions: none Duration of treatment: 3 days
Outcomes	Neuropsychiatric assessment Mental status: West Haven criteria
Inclusion period	January 2017 to August 2017
Outcomes included in meta‐analyses	Mortality, hepatic encephalopathy
Country of origin	Single centre in Pakistan
Notes	Publication status: full paper Vested interests bias: none reported. Additional information: overall 76.7% of the participants had grade III/IV hepatic encephalopathy at inclusion. Efficacy was determined by the reversal of grade III/IV hepatic encephalopathy to grade 0/1. However, 23.2% of the participants had grade I/II hepatic encephalopathy at inclusion and no mention is made about how treatment efficacy was measured in these. Mortality deduced as all participant outcomes were accounted for. Authors contacted for further data on the aetiology of cirrhosis of participants, trial registry status, conflicts of interest, mortality outcomes, and adverse events. Request sent on 3 April 2021; still awaiting response.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation via lottery method
Allocation concealment (selection bias)	Unclear risk	No mention of allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open trial with no blinding
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open trial with no blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants are accounted for and included in the results
Selective reporting (reporting bias)	Low risk	All outcomes were reported on
Other bias	Low risk	No other bias identified
Overall bias assessment (mortality)	Low risk	Mortality deduced as all participant outcomes were accounted for
Overall bias assessment (non‐mortality outcomes)	High risk	Open trial with no blinding