Bajaj 2016.
| Methods | Randomised clinical trial | |
| Participants | Country: USA and Russia Period of recruitment: not stated Number randomised: 518 Postrandomisation dropouts: 2 (0.4%) Revised sample size: 516 Reasons for postrandomisation dropouts: not stated Mean age (years): 57 Females: not stated Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): not stated Ascites with low protein: not stated Primary prophylaxis: 516 (100%) Alcohol‐related cirrhosis: 125 (24.2%) Viral‐related cirrhosis: 160 (31.0%) Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): not stated Other causes for cirrhosis: 231 (44.8%) 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 = 422) Further details: rifaximin 40–160 mg (immediate release and soluble solid dispersion) for 24 weeks Group 2: no active intervention (n = 94) Further details: placebo for 24 weeks |
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| Outcomes | None of the outcomes of interest were reported. Follow‐up (months): 6 |
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| Notes | Trial name/trial registry number: NCT01904409 Attempted to contact authors in November 2018, but received no replies. |
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| 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: "Double‐blind placebo‐controlled trial." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Double‐blind placebo‐controlled trial." |
| 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 |