Maharshi 2015.

Study characteristics
Methods	Randomised, open‐label clinical trial
Participants	This trial assessed the effects of rifaximin versus lactulose for prevention of hepatic encephalopathy in 120 people with cirrhosis and an acute variceal bleed who were free of hepatic encephalopathy at the time of presentation. There were 60 participants in each group. Age (mean ± SD) years Rifaximin 39.2 ± 10.3 Lactulose 41.8 ± 9.5 Proportion of men (n: %) Rifaximin 51 (85) Lactulose 50 (83) Aetiology of cirrhosis Not reported
Interventions	Intervention: rifaximin 400 mg thrice daily Control intervention: lactulose 30 ml 4 times daily Co‐intervention: both trial arms received concomitant standard treatment for acute variceal bleeding as per Baveno V guidelines, including antibiotics. Duration of treatment: 5 days
Outcomes	Development of overt hepatic encephalopathy defined using West Haven criteria
Inclusion period	Not reported
Outcomes included in meta‐analyses	Mortality, serious adverse events, hepatic encephalopathy, length of hospital stay
Country of origin	Single centre in India
Notes	Publication status: letter to journal Vested interests bias: no conflicts of interest declared Additional information: authors confirmed that the 53 participants reported in their published abstract, Maharshi 2014, were included in this report. No information is available on whether participants had a history of hepatic encephalopathy prior to the trial.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	As stated in correspondence with authors 19 July 2015: "Patients were randomized by computer generated numbers." Authors' judgement: probably done
Allocation concealment (selection bias)	Unclear risk	No mention of allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	High risk	As stated in correspondence with authors 19 July 2015: "No blinding, this was open labelled study."
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open‐label study
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants accounted for
Selective reporting (reporting bias)	Low risk	All relevant outcomes from trial registry reported in the letter
Other bias	Low risk	No other bias detected
Overall bias assessment (mortality)	Low risk	Mortality data reported; no participants unaccounted for
Overall bias assessment (non‐mortality outcomes)	High risk	High risk of selection, performance, detection bias