Ali 2014.
| Methods | Randomised clinical trial | |
| Participants | Country: Pakistan Period of recruitment: 2012–2013 Number randomised: 126 Postrandomisation dropouts: not stated Revised sample size: 126 Mean age (years): 42 Females: 66 (52.4%) Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): 126 (100%) Ascites with low protein: not stated Primary prophylaxis: not stated Alcohol‐related cirrhosis: 4 (3.2%) Viral‐related cirrhosis: 120 (95.2%) Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): not stated Other causes for cirrhosis: 2 (1.6%) Treated for ascites in addition to antibiotics (e.g. albumin or diuretics): not stated Inclusion criteria:
Exclusion criteria:
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| Interventions | Participants randomly assigned to 2 groups. Group 1: rifaximin (n = 63) Further details: rifaximin 550 mg BD for 6 months or until recurrence of hepatorenal syndrome Group 2: no active intervention (n = 63) Further details: placebo for 6 months |
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| Outcomes | Outcomes reported: all‐cause mortality; number of other decompensation events Follow‐up (months): 6 |
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| Notes | Attempted to contact authors in November 2018, but received no replies. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: information not available |
| Allocation concealment (selection bias) | Unclear risk | Comment: information not available |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Triple blind randomized placebo‐controlled trial… The patients, the investigator and the statistician did not know which patients were receiving Rifaximin and which were being given placebo." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Triple blind randomized placebo‐controlled trial… The patients, the investigator and the statistician did not know which patients were receiving Rifaximin and which were being given placebo." |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: information not available |
| Selective reporting (reporting bias) | High risk | Comment: protocol not available, and authors did not report adverse events adequately. |
| Other bias | Low risk | Comment: no other bias noted |