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

Wahib 2014.

Study characteristics
Methods Randomised, open‐label clinical trial
Participants This trial assessed the effects of rifaximin versus lactulose in 50 people with cirrhosis and an acute episode of hepatic encephalopathy, grade I‐III.
There were 25 participants in each group.
Age
  • Not reported


Proportion of men
  • Not reported


Aetiology of cirrhosis
  • Hepatitis C (100%)

Interventions Rifaximin: rifaximin 400 mg thrice daily
Control intervention: lactulose 30 ml thrice daily
Co‐interventions: daily enemata in both groups
Duration of treatment: 7 days
Outcomes Neuropsychiatric assessment
Modified PSE Sum/Index: mental state (West Haven Criteria), asterixis, NCT‐A, venous blood ammonia
Inclusion period Not reported
Outcomes included in meta‐analyses Mortality, hepatic encephalopathy, blood ammonia
Country of origin Single centre in Egypt
Notes Publication status: full paper
Vested interests bias: no information provided
Additional information: authors contacted on 11 April 2021 for further information on participant and study characteristics, conflicts of interest, randomisation methods, allocation concealment, blinding status, trial registry status, clarification on missing outcomes, and data on both our primary and secondary outcomes; still awaiting response.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Participants were classified into two groups: no mention of randomisation.
Allocation concealment (selection bias) High risk No mention of randomisation; open‐label trial.
Blinding of participants and personnel (performance bias)
All outcomes High risk No mention of blinding in journal article.
Blinding of outcome assessment (detection bias)
All outcomes High risk No mention of blinding in journal article.
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants accounted for in journal article; no deaths reported.
Selective reporting (reporting bias) High risk No prespecified outcomes; no information provided on side effects; trial not registered in trial database.
Other bias Low risk No other bias detected.
Overall bias assessment (mortality) Low risk All participants alive at the end of the study.
Overall bias assessment (non‐mortality outcomes) High risk High risk of selection, detection, performance, and reporting bias; no information on side effects of treatment.