Bucci 1993.

Study characteristics
Methods	Randomised, double‐blind, double‐dummy clinical trial
Participants	This trial assessed the effects of rifaximin versus lactulose in 58 participants with cirrhosis and chronic hepatic encephalopathy. There were 30 participants in the rifaximin group and 28 in the placebo group. Age (mean ± SD) years Rifaximin 54.9 ± 2.6 Lactulose 58.3 ± 3.8 Proportion of men (n: %) Rifaximin 17 (56.7) Lactulose 13(46.4) Aetiology of cirrhosis (n: %) Rifaximin Alcohol 20 (67) Posthepatitic 8 (27) Other 2 (6) Lactulose Alcohol 17(61) Posthepatitic 10 (36) Other 1 (3)
Interventions	Intervention: rifaximin 2 tablets of 200 mg plus 10 gram sachets of placebo (sorbitol), thrice daily Control group: lactulose 10 gram sachets plus 2 tablets of rifaximin placebo, thrice daily Co‐interventions: none Duration of treatment: 15 days
Outcomes	Neuropsychiatric assessment Modified PSE Sum/Index comprises scores for: mental status (West Haven criteria), asterixis, cancelling A test, NCT‐A, EEG mean frequency, fasting venous blood ammonia
Inclusion period	Not reported
Outcomes included in meta‐analyses	Hepatic encephalopathy defined by improvement of modified PSE Sum, serious adverse events, blood ammonia concentrations
Country of origin	Single centre in Italy
Notes	Publication status: full paper Vested interests bias: trial sponsored by Alfa Wassermann Additional information: individual participants data supplied by Alfa Wassermann
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Information from Alfa Wassermann: "List, manually prepared by Alfa Wassermann Medical Department." Judgement: probably random generation
Allocation concealment (selection bias)	Low risk	Quote: "...a double‐dummy experimental design" p. 110 in published report. Judgement: participants received rifaximin + placebo or lactulose + placebo. No risk of selection bias detected.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Trial stated as double‐blind
Blinding of outcome assessment (detection bias) All outcomes	Low risk	No other biases detected
Incomplete outcome data (attrition bias) All outcomes	Low risk	All primary end points reported. No participants unaccounted for.
Selective reporting (reporting bias)	Low risk	Additional information on primary end point achieved from Alfa Wassermann (January 2013).
Other bias	Low risk	No other bias detected
Overall bias assessment (mortality)	Low risk	Low risk of bias in all domains
Overall bias assessment (non‐mortality outcomes)	Low risk	Low risk of bias in all domains