Gill 2014.

Study characteristics
Methods	Randomised, double‐blind clinical trial
Participants	This trial assessed the effects of rifaximin versus placebo in 200 people with cirrhosis and an acute episode of hepatic encephalopathy. As all the participants received lactulose this was essentially a comparison of rifaximin plus lactulose versus lactulose alone. There were 100 participants in each group. Age (mean) years 40, no reporting of subgroups Proportion of men (n: %) 140 (70), no reporting of subgroups Aetiology of cirrhosis Not reported
Interventions	Intervention: rifaximin 550 mg twice daily Control group: placebo tablets twice daily Co‐intervention: all participants received lactulose 30 to 60 ml 2 to 3 times daily Duration of treatment: 10 days
Outcomes	Neuropsychiatric status Mental status: modified version of West Haven criteria No information provided on the definition of encephalopathy reversal.
Inclusion period	Not reported
Outcomes included in meta‐analyses	Mortality, hepatic encephalopathy, length of hospital stay
Country of origin	Single centre in Pakistan
Notes	Publication status: abstract only Vested interests bias: no information provided Additional information: randomisation methods and blinding were retrieved from the corresponding author in May 2014 and March 2016 Authors contacted again on 5 April 2021 for additional information on study characteristics, conflicts of interest, method of randomisation, allocation concealments, blinding of outcome data and dealing with incomplete outcome data, and data on both primary and secondary outcomes after further planned analysis; response still awaited.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were allocated to 1 of 2 groups: group A was given rifixamin and lactulose and group B was given lactulose plus placebo pills. Corresponding author states that trial was randomised but the method was not specified.
Allocation concealment (selection bias)	Unclear risk	No information provided on allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Information from authors: "Patients and research medical authors were blinded to the study (it was double‐blinded)." Judgement: Probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Information from authors: "Patients and research medical authors were blinded to the study (it was double‐blinded)." Judgement: Probably done
Incomplete outcome data (attrition bias) All outcomes	High risk	No data on attrition or withdrawal from trial are reported. Corresponding author states that follow‐up and participants are still under review.
Selective reporting (reporting bias)	High risk	Data on mortality and hospital stay not reported in abstract. Corresponding author states that follow‐up and participants are still under review.
Other bias	Low risk	None identified
Overall bias assessment (mortality)	High risk	High risk of detection, attrition and reporting bias
Overall bias assessment (non‐mortality outcomes)	High risk	High risk of detection, attrition and reporting bias