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
Proportion of men
Aetiology of cirrhosis
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| 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 |
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| Outcomes | Neuropsychiatric assessment Modified PSE Sum/Index: mental state (West Haven Criteria), asterixis, NCT‐A, venous blood ammonia |
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| 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. |
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| 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. |