Sharma 2013.

Study characteristics
Methods	Randomised, double‐blind, placebo‐controlled clinical trial
Participants	This trial assessed the effects of rifaximin plus lactulose versus placebo plus lactulose in 120 people with cirrhosis and an acute episode of hepatic encephalopathy, grade II‐IV. There were 63 participants in the rifaximin plus lactulose group and 57 in the placebo plus lactulose group. Age (mean ± SD) years Rifaximin plus lactulose 40.4 ± 8.5 Placebo plus lactulose 37.5 ± 10.5 Proportion of men (n: %) Rifaximin plus lactulose 47 (75) Placebo plus lactulose 42 (74) Aetiology of cirrhosis (n: %) Rifaximin plus lactulose Alcohol 40 (63.4) Hepatitis B virus 10 (15.9) Hepatitis C virus 3 (4.8) Other 10 (15.9) Placebo plus lactulose Alcohol 32 (56.1) Hepatitis B virus 12 (21.1) Hepatitis C virus 4 (7) Other 9 (15.8)
Interventions	Intervention: rifaximin 400 mg thrice daily plus lactulose 30 to 60 ml thrice daily titrated to allow passage of 2 to 3 semi‐soft stools daily Control intervention: placebo capsule (sugar) thrice daily plus lactulose 30 to 60 ml thrice daily titrated to allow passage of 2 to 3 semi‐soft stools daily Co‐intervention: people also received standard treatment which in 70 (58%) including antibiotics. In case of treatment failure, participants in group B were given rifaximin and those in group A were given L‐ornithine L‐aspartate ‐ however, no participants had refractory encephalopathy. Duration of treatment: until recovery, or for a maximum of 10 days
Outcomes	Neuropsychiatric assessment Mental status: West Haven criteria End point was 'complete reversal of hepatic encephalopathy' but no criteria for reversal provided, and no allowance made for improvement in mental status short of complete reversal or for deterioration.
Inclusion period	October 2010 to September 2012
Outcomes included in meta‐analyses	Mortality, hepatic encephalopathy, adverse events, length of hospital stay
Country of origin	Single centre in India
Notes	Publication status: full paper Vested interests bias: none reported Additional information: authors contacted on 11 April 2021 for data on adverse events, quality of life outcomes, and blood ammonia levels. We also enquired regarding a discrepancy in participants recovering from hepatic encephalopathy between 2 publications; still awaiting response.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation using computer‐generated random numbers
Allocation concealment (selection bias)	Low risk	Treatment envelopes with the randomisation code were distributed to the treating nurse by the statistician who was aware of the allocation.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants, investigators, and study staff (nurse) were blinded to treatment assignments.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The statistician was unblinded to allocation ‐ the authors report this was to prevent mixing of rifaximin and placebo.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All enrolled participants have outcome data.
Selective reporting (reporting bias)	Low risk	All end points reported.
Other bias	Unclear risk	There is a discrepancy between the full‐text paper published in the American Journal of Gastroenterology in 2013 and the 2012 abstract in the Journal of Gastroenterology and Hepatology in the number of people recovering from hepatic encephalopathy (25 vs 29 in the lactulose group, respectively), but it is not unusual to find minor discrepancies between abstracts and published papers.
Overall bias assessment (mortality)	Low risk	All but one categories are judged to be low risk.
Overall bias assessment (non‐mortality outcomes)	Low risk	All but one categories are judged to be low risk.