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. 2023 Jul 19;2023(7):CD011585. doi: 10.1002/14651858.CD011585.pub2

Habib 2016.

Study characteristics
Methods Randomised, open‐label clinical trial
Participants This trial assessed the effects of rifaximin plus lactulose versus lactulose alone in 22 participants with cirrhosis and an acute episode of hepatic encephalopathy, grade II‐IV.
There were 61 participants in each group.
Age (mean ± SD) years
  • Rifaximin plus lactulose 50.0 ± 2.3

  • Lactulose only 52.0 ± 2.8


Proportion of men (%)
  • Rifaximin plus lactulose 48

  • Lactulose only 45


Aetiology of cirrhosis
  • Not reported

Interventions Intervention: rifaximin tablet 550 mg twice daily plus lactulose 30 ml thrice daily
Control: lactulose 30 ml thrice daily
Co‐intervention: none
Duration of treatment: likely 7 days
Outcomes Neuropsychiatric assessment
Mental status: West Haven criteria
No information provided on the criteria used to determine treatment response
Inclusion period August 2014 to February 2015
Outcomes included in meta‐analyses Hepatic encephalopathy
Country of origin Single centre in Pakistan
Notes Publication status : full paper
Vested interests bias: no information provided
Additional information: no contact details provided in the article
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Patients were randomly allocated to one of the two groups on lottery basis". P 38
Allocation concealment (selection bias) Unclear risk No information provided on allocation concealment.
Blinding of participants and personnel (performance bias)
All outcomes High risk No mention of blinding as trial conducted open‐label.
Blinding of outcome assessment (detection bias)
All outcomes High risk See above
Incomplete outcome data (attrition bias)
All outcomes High risk Duration of follow‐up is not reported. No data on mortality, adverse events or attrition reported.
Selective reporting (reporting bias) High risk Duration of follow‐up is not reported. The predefined outcome is reported for all participants.
Other bias Low risk No other bias detected.
Overall bias assessment (mortality) High risk Mortality is not reported.
Overall bias assessment (non‐mortality outcomes) High risk High risk of selective reporting, performance and detection bias