Muhammad 2016.

Study characteristics
Methods	Randomised, cross‐sectional, open‐label clinical trial
Participants	This trial assessed the effects of rifaximin plus lactulose versus lactulose for the prevention of hepatic encephalopathy, over a 3‐month period, in 98 people with cirrhosis previously admitted with an episode of overt hepatic encephalopathy who had little or no evidence of encephalopathy on discharge from hospital. Although one group is referred to as the 'placebo' group they did not receive a placebo preparation but conventional treatment, i.e. lactulose 30 to 60 ml in 2 to 3 divided doses per day. There were 49 participants in each group. Age (mean ± SD) years Rifaximin plus lactulose 43.8 ± 10.5 Lactulose alone 43.7 ± 11.1 Proportion of men (n: %) Rifaximin plus lactulose 36 (73) Lactulose alone 33(67) Aetiology of cirrhosis Not reported
Interventions	Intervention: rifaximin 550 mg twice daily plus lactulose 30 to 60 ml daily in 2 to 3 divided doses Control intervention: lactulose 30‐60 ml daily in 2 to 3 divided doses Co‐intervention: none Duration of treatment: 3 months
Outcomes	Neuropsychiatric assessment Mental status: West Haven criteria Recurrence defined as the development of grade II change or more
Inclusion period	June 2015 to May 2016
Outcomes included in meta‐analyses	Hepatic encephalopathy
Country of origin	Single centre in Pakistan
Notes	Publication status: full paper Vested interests bias: no information provided Additional information: trial not registered in clinicaltrials.gov
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Report states that:"Patients randomly divided into two groups i.e. treatment and placebo groups using random numbers generated from random table". Although one group is referred to as the 'placebo' group, they did not receive a placebo preparation but conventional treatment i.e. lactulose.
Allocation concealment (selection bias)	Unclear risk	No mention of allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label trial
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding of evaluators is mentioned in the paper.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	All participants appear to be accounted for but no details are provided on time to the end point, which was the recurrence of hepatic encephalopathy.
Selective reporting (reporting bias)	High risk	The only reported outcome was 'recurrence of hepatic encephalopathy'; no information provided on mortality or serious adverse events.
Other bias	High risk	The full paper report does not mention how participants were selected; no data are provided on the numbers of people eligible for inclusion or the numbers excluded and the reasons why. Thus, selection bias, prior to inclusion, cannot be excluded.
Overall bias assessment (mortality)	High risk	No information provided on mortality in this 3‐month follow‐up study.
Overall bias assessment (non‐mortality outcomes)	High risk	High risk of selection and performance bias; unclear risk of reporting bias