Hasan 2018.

Study characteristics
Methods	Randomised, double‐blind, placebo‐controlled clinical trial
Participants	This trial assessed the effects of rifaximin plus lactulose versus lactulose plus placebo in 91 people with cirrhosis admitted to hospital with an acute episode of hepatic encephalopathy, grade I‐IV. There were 45 participants in the rifaximin plus lactulose group and 46 in the placebo plus lactulose group. Age (mean ± SD) years Rifaximin plus lactulose 44.7 ± 10.6 Placebo plus lactulose 45.0 ± 10.1 Proportion of men (n: %) Rifaximin plus lactulose 36 (80.0) Placebo plus lactulose 38 (82.6) Aetiology of cirrhosis (n: %) Rifaximin plus lactulose group Alcohol 42 (93.3) Other aetiologies not reported Placebo plus lactulose group Alcohol 39 (84.8) Other aetiologies not reported
Interventions	Intervention: rifaximin 400 mg 3 times daily with lactulose 15 ml 3 to 4 times daily titrated to produce 3 to 4 loose stools per day Control intervention: placebo tablets three times daily plus lactulose 15 ml 3 to 4 times daily titrated to produce 3 to 4 loose stools per day Co‐interventions: both groups received supportive measures such as intravenous antibiotics and enemata as indicated, but the number requiring these measures was not provided. Duration of therapy: until recovery of hepatic encephalopathy or for a maximum of 10 days
Outcomes	Neuropsychiatric assessment Mental status: West Haven criteria Improvement was defined as any reduction in encephalopathy grade and worsening as any increase in encephalopathy grade.
Inclusion period	Not stated
Outcomes included in meta‐analyses	Mortality, hepatic encephalopathy
Country of origin	Single centre in Bangladesh
Notes	Publication status: full paper Vested interests bias: no information provided Additional information: authors contacted for further information on the aetiology of cirrhosis in the participants, inclusion period, conflicts of interest, blinding status, handling of incomplete outcomes, and data on our secondary outcomes. The request was made on 9 April 2021, response received on 12 April 2021 directing us to the online study site (www.japi.org/n3n5o506k424r4/f3j5v50694j4y4/v2c4).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomised using a 1:1 allocation ratio using block randomisation in variable block sizes.
Allocation concealment (selection bias)	Low risk	Interventions were allocated in a sealed, coded packet containing a bottle of rifaximin or placebo.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The study was conducted double‐blind; the participants received the interventions in a coded, sealed packet.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The study was conducted double‐blind; the participants received the interventions in a coded, sealed packet.
Incomplete outcome data (attrition bias) All outcomes	High risk	The authors did not report how missing outcome data were dealt with. In the assessment of outcomes, the percentages reported do not match with the total number of participants allocated to each group; it seems as though 2 from the rifaximin group and 6 from the lactulose group were lost to follow‐up.
Selective reporting (reporting bias)	High risk	All outcomes stated in the methodology were reported; however there are discrepancies in the number of participants randomised and the number for whom results are provided; we could not identify a clinical trial registry entry in order to compare with the study protocol.
Other bias	Low risk	No other bias detected
Overall bias assessment (mortality)	High risk	Incomplete outcomes, attrition bias
Overall bias assessment (non‐mortality outcomes)	High risk	One or more domains were classified as 'high risk'.