Sidhu 2011.

Study characteristics
Methods	Randomised, double‐blind, placebo‐controlled clinical trial
Participants	This trial assessed the effects of rifaximin and placebo in 94 people with cirrhosis and minimal hepatic encephalopathy; 49 randomised to rifaximin and 45 to placebo. Age (mean (range)) years Rifaximin 52.8 (51.0 to 54.6) Placebo 54.3 (51.6 to 57.1) Proportion of men (n: %) Rifaximin 40/49 (82) Placebo 34/45 (75) Aetiology of cirrhosis (n: %) Rifaximin Alcohol 27/49 (55) Hepatitis B 0/49 (0) Hepatitis C 19/49 (39) Other 5/49 (10) Placebo Alcohol 21/45 (47) Hepatitis B 1/45 (2) Hepatitis C 20/45 (44) Other 4/45 (9)
Interventions	Intervention: rifaximin 200 mg, 2 tablets thrice daily Control intervention: placebo tablets, 2 tablets thrice daily Co‐intervention: none Duration of treatment: 8 weeks
Outcomes	Neuropsychiatric assessment Minimal hepatic encephalopathy was diagnosed if, in the absence of clinically obvious neuropsychiatric change, any 2 of 5 tests in a neuropsychometric battery, comprised of number and figure connection, picture completion, digit symbol, and block design, were beyond 2 SD of normal.
Inclusion period	December 2008 to November 2009
Outcomes included in meta‐analyses	Mortality, reversal of minimal hepatic encephalopathy; development of overt hepatic encephalopathy, adverse events, health‐related quality of life (Sickness Impact Profile)
Country of origin	Single centre in India
Notes	Publication status: full paper Vested interests bias: study drugs (rifaximin and placebo) were provided by LUPIN limited, Laxmi towers, Bandra Kurla Complex, Mumbai‐ 400051, India. Additional information: Nil
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "All patients diagnosed to have MHE were randomised into two groups (group A and B) using computer‐generated randomisation" p. 309 in journal article. Judgement: random sequence generation done
Allocation concealment (selection bias)	Low risk	Quote: "Sequentially numbered, opaque envelopes were used for treatment allocation by a coordinator, who was not investigator." p. 309 in journal article. Judgement: allocation concealment adequate
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "The participant, investigator, data‐entry operator, and statistician were blinded regarding the treatment drugs. The code was broken only after the study was complete and analysis of the results was carried out." p. 309 in journal article. Judgement: blinding adequate
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The participant, investigator, data‐entry operator, and statistician were blinded regarding the treatment drugs. The code was broken only after the study was complete and analysis of the results was carried out." p. 309 in journal article. Judgement: blinding adequate
Incomplete outcome data (attrition bias) All outcomes	Low risk	Participants lost to follow‐up, participant drop‐outs, and severe adverse events accounted for in journal article. Intention‐to‐treat analyses were performed. Outcome data adequate.
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 in all domains
Overall bias assessment (non‐mortality outcomes)	Low risk	Low risk of bias in all domains