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
Proportion of men (%)
Aetiology of cirrhosis
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| 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 |
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| Outcomes | Neuropsychiatric assessment Mental status: West Haven criteria No information provided on the criteria used to determine treatment response |
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| 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 |
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| 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 |