Paik 2005.

Study characteristics
Methods	Randomised, open‐label clinical trial
Participants	This trial assessed the effects of rifaximin versus lactulose in 54 people with cirrhosis and an acute episode of hepatic encephalopathy, grade I‐III. There were 32 participants in the rifaximin groups and 22 in the lactulose group. Age (mean ± SD) years Rifaximin 56.2 ± 7.1 Lactulose 54.9 ± 6.6 Proportion of men (n: %) Rifaximin 24 (75) Lactulose 13 (59) Aetiology of cirrhosis (n: %) Rifaximin Hepatitis B 26 (81) Hepatitis C 3 (9.5) Alcohol 3 (9.5) Lactulose Hepatitis B 15 (68) Hepatitis C 1 (4.5) Alcohol 6 (27.5)
Interventions	Intervention: rifaximin 400 mg, 3 times per day Control intervention: lactulose 90 ml per day in divided doses Co‐intervention: none Duration of treatment: 7 days
Outcomes	Neuropsychiatric assessment Modified PSE Sum/Index: mental status (West Haven criteria), asterixis, NCT‐A, blood ammonia
Inclusion period	January 1997 to December 1998
Outcomes included in meta‐analyses	Hepatic encephalopathy, adverse events, blood ammonia concentrations
Country of origin	Single centre in South Korea
Notes	Publication status: full paper Vested interests bias: rifaximin provided by pharmaceutical company Additional information: authors contacted on 9 April 2021 for further information on aetiology of cirrhosis, participant numbers with overt hepatic encephalopathy, co‐interventions used, method of randomisation, blinding status, allocation concealment, trial registration status, and data on our primary and secondary outcomes; still awaiting response.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Using a computer‐generated sequential 3:2 block randomisation list, patients were randomised."
Allocation concealment (selection bias)	Unclear risk	No mention of allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Although this trial has a limitation due to it being an open‐label study," p. 406 in published report.
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding of outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "no patient was withdrawn from the trial due to an undue adverse effect." Judgement: all participants accounted for in published report. There is mention in the article that 64 participants started treatment, but 10 were discontinued due to meeting exclusion criteria.
Selective reporting (reporting bias)	Low risk	Published as journal article in international journal
Other bias	Low risk	No other bias detected
Overall bias assessment (mortality)	Low risk	High risk of selection, detection and performance bias, although this will unlikely affect mortality data
Overall bias assessment (non‐mortality outcomes)	High risk	High risk of selection, detection and performance bias