Suzuki 2018.

Study characteristics
Methods	Randomised, evaluator blinded clinical trial
Participants	This trial assessed the effects of rifaximin versus lactitol in 172 people with cirrhosis and an acute episode of hepatic encephalopathy, grade I or II. There were 84 participants in the rifaximin group and 87 in the lactitol group. Age (median (range)) years Rifaximin 66 (39 to 76) Lactitol 64 (28 to 74) Proportion of men (n: %) Rifaximin 43/84 (51.2) Lactitol 46/87 (52.9) Aetiology of cirrhosis (n: %) Rifaximin Hepatitis B 10(12.0) Hepatitis C 31 (37.3) Alcohol 18 (21.7) Other 24 (28.9) Lactitol Hepatitis B 9 (10.7) Hepatitis C 30 (35.7) Alcohol 24 (28.6) Other 21 (25.0)
Interventions	Intervention: rifaximin tablets 400 mg thrice daily Control Intervention: lactitol 6‐12 g thrice daily Co‐intervention: none Duration of treatment: 14 days
Outcomes	Neuropsychiatric assessment PSE Sum/Index: mental status (West Haven criteria), asterixis, NCT‐A and B, and digit symbol test, blood ammonia, EEG mean frequency
Inclusion period	2013 to 2015
Outcomes included in meta‐analyses	Mortality, adverse events, health‐related quality of life, hepatic encephalopathy, blood ammonia
Country of origin	A total of 37 investigatory sites in Japan
Notes	Publication status: full paper Vested interests bias: trial conducted under the auspices of ASKA Pharmaceutical Co. Ltd; a company employee was a co‐author Additional information: the published report included data not only from the 14‐day randomised comparison of rifaximin versus lactitol but also from a 10 week roll‐over study of rifaximin treatment alone. Only the randomised trial was included in the analyses. Authors were contacted on 20 March 2018 for further information on improvement in the hepatic encephalopathy; they were further contacted on 11 April 2021 for data on non‐serious adverse events and length of hospital stay; still awaiting response.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised in a 1:1 ratio using a web assignment system
Allocation concealment (selection bias)	Unclear risk	No mention of allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding of participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinded outcome assessment stated in report
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants accounted for in report. All participants who had completed at least one dose of the investigational drug and underwent at least one efficacy evaluation were included in the statistical analysis.
Selective reporting (reporting bias)	Low risk	No reporting bias detected
Other bias	Low risk	No other bias identified
Overall bias assessment (mortality)	Low risk	Although the study was not double‐blind, this is unlikely to affect mortality outcomes.
Overall bias assessment (non‐mortality outcomes)	High risk	One or more domains classified as 'high' risk of bias