Ali 2014.

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 126 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 versus lactulose alone. There were 63 participants in the both the rifaximin and placebo groups. Age (mean ± SD) years Rifaximin plus lactulose 42.9 ± 4.5 Placebo plus lactulose 40.2 ± 2.3 Proportion of men (%) Rifaximin plus lactulose 49.2 Placebo plus lactulose 46.0 Aetiology of cirrhosis (n: %) Rifaximin plus lactulose Hepatitis C 54 (85.7) Hepatitis B 6 (9.5) Alcohol 2 (3.2) Placebo plus lactulose Hepatitis C 50 (79.4) Hepatitis B 10 (15.9) Alcohol 2 (3.2)
Interventions	Intervention: rifaximin 550 mg twice daily plus lactulose of unknown dose Control intervention: identically presented and packaged placebo twice daily plus lactulose of unknown dose Co‐intervention: all participants received lactulose before randomisation and continued on lactulose throughout the trial. Duration of treatment: 6 months or until first breakthrough episode of hepatic encephalopathy, adverse event or death
Outcomes	Neuropsychiatric assessment Mental status: West Haven criteria Breakthrough episode of hepatic encephalopathy defined as West Haven score of 2 or more.
Inclusion period	October 2012 to April 2013
Outcomes included in meta‐analyses	Mortality, adverse events, blood ammonia
Country of origin	Single centre in India
Notes	Publication status: full paper Vested interests bias: rifaximin and placebo preparation supplied by Brooke's Pharmaceuticals who also paid an honorarium to the Principal Investigator.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated random numbers
Allocation concealment (selection bias)	Low risk	Central randomisation
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinding of participants and personnel using placebo of the same size, shape and colour with similar packing (page 270, first column).
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinding of outcome assessment using placebo
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants are accounted for and included in the description of the results with carry forward of the last observed response (126 participants are randomised and the same number of participants are included in the analysis).
Selective reporting (reporting bias)	Unclear risk	Clinically relevant outcomes are reported. Tables 3 and 4 are referred to, but missing in the published report and the data were not otherwise retrievable from the trialists or publisher.
Other bias	Low risk	No other biases identified
Overall bias assessment (mortality)	Unclear risk	Data on deaths pre‐trial and during the trial are reported in the text despite the missing Tables
Overall bias assessment (non‐mortality outcomes)	High risk	High risk of reporting bias