Riggio 2005.

Study characteristics
Methods	Randomised, open‐label, three‐arm clinical trial
Participants	This trial assessed the effects of rifaximin versus lactitol and rifaximin versus no intervention in preventing the development of hepatic encephalopathy in 75 people with cirrhosis, free of encephalopathy, who underwent placement of a transjugular intrahepatic portosystemic shunt (TIPS) . Two comparisons were assessed; (i) rifaximin versus lactitol; (ii) rifaximin versus placebo. Age (mean ± SD) years Rifaximin 55 ±10.8 Lactitol 60.6 ± 9 No treatment 54.9 ± 11.7 Proportion of men (n: %) Rifaximin 14 (56) Lactitol 14 (56) No treatment 21 (84) Aetiology of cirrhosis (n: %) Rifaximin Alcohol 6 (24) Other 19 (76) Lactitol Alcohol 12 (48) Other 13 (52) No treatment group Alcohol 7 (28) Other 18 (72)
Interventions	Intervention: rifaximin 400 mg thrice daily Control intervention (i): lactitol 60 grams daily in 3 divided doses Control intervention (ii): no treatment Co‐intervention: 120 ml sorbitol enema administered in the rifaximin and no treatment groups, if required Duration of treatment: 30 days or until occurrence of hepatic encephalopathy
Outcomes	Neuropsychiatric assessment Modified PSE Sum/Index: mental status (West Haven Criteria), asterixis, NCT‐A, venous blood ammonia
Inclusion period	November 1998 to September 2003
Outcomes included in meta‐analyses	Mortality, hepatic encephalopathy, adverse events, venous blood ammonia
Country of origin	Single centre in Italy
Notes	Publication status: full paper Vested interests bias: none Additional information: additional unpublished data requested from authors; response received directing to a published article
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was performed in blocks of 12 by sealed opaque envelopes." P 675, column 2, l. 61. Authors judgement: probably done
Allocation concealment (selection bias)	Low risk	Sealed opaque envelopes were used, see above. Authors judgement: Probably done
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Blindness was not considered due to the modifications in the bowel habits induced by one of the treatments." P 675, column 2, l. 62
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Blindness was not considered due to the modifications in the bowel habits induced by one of the treatments." P 675, column 2, l. 62
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants accounted for in journal article.
Selective reporting (reporting bias)	Low risk	All outcomes reported in journal article.
Other bias	Low risk	No other bias detected
Overall bias assessment (mortality)	Low risk	Low risk of bias for mortality outcomes
Overall bias assessment (non‐mortality outcomes)	High risk	High risk of performance and detection bias