Babar 2017.

Study characteristics
Methods	Randomised, double‐blind, placebo controlled clinical trial
Participants	This trial assessed the effects of rifaximin versus placebo for secondary prevention of hepatic encephalopathy in 96 people with cirrhosis and a history of at least 2 episodes of overt hepatic encephalopathy in the preceding 6 months but who were in remission at baseline. As all participants were allowed to take lactulose throughout the trial, the comparison made was effectively rifaximin plus lactulose vs lactulose alone There were 45 participants in the rifaximin plus lactulose group and 43 in the placebo plus lactulose group Age (mean ± SD) years Rifaximin plus lactulose 46.7 ± 2.4 Placebo plus lactulose 44.3 ± 3.6 Proportion of men (%) Rifaximin plus lactulose 53.3 Placebo plus lactulose 51.2 Aetiology of cirrhosis (n: %) Rifaximin plus lactulose Hepatitis C 27 (60.0) Hepatitis B 13 (28.9) Alcohol 3 (6.7) Other 2 (4.4) Placebo plus lactulose Hepatitis C 30 (69.8) Hepatitis B 11 (25.6) Alcohol 1 (2.3) Other 1 (2.3)
Interventions	Intervention: rifaximin 550 mg twice daily plus lactulose of unknown dose Control intervention: placebo twice daily (no details provided) plus lactulose of unknown dose Co‐intervention: participants were allowed to take lactulose throughout the trial Duration of treatment: 6 months or until first breakthrough episode of hepatic encephalopathy
Outcomes	Neuropsychiatric assessment Mental status: West Haven criteria Breakthrough episode defined by a West Haven score of 2 or more
Inclusion period	January 2016 to June 2016
Outcomes included in meta‐analyses	Mortality, hepatic encephalopathy, adverse events
Country of origin	Single centre in Pakistan
Notes	Publication status: full paper Vested interests bias : none declared Additional information: authors contacted for further information on trial registration status, allocation concealment methods, blinding methods, and whether they collected data on our secondary outcomes. 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	Authors state that: 'participants [...] were randomized by simple lottery method 1:1', page 16.
Allocation concealment (selection bias)	Unclear risk	No mention of allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Double‐blind trial but no details are provided of the placebo preparation
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Double‐blind trial but no details are provided of the placebo preparation
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	All participants accounted for in report; unclear if the participants lost to follow‐up were included in the analyses
Selective reporting (reporting bias)	Low risk	All data published in full paper report
Other bias	Low risk	No other bias detected
Overall bias assessment (mortality)	Low risk	Low overall risk; deaths reported
Overall bias assessment (non‐mortality outcomes)	Unclear risk	Unclear risk of blinding and attrition bias