Kimer 2017.
| Methods | Randomised clinical trial | |
| Participants | Country: Denmark Period of recruitment: 2013–2015 Number randomised: 54 Postrandomisation dropouts: 0 (0%) Revised sample size: 54 Mean age (years): 56 Females: 9 (16.7%) Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): not stated Ascites with low protein: not stated Primary prophylaxis: not stated Alcohol‐related cirrhosis: 42 (77.8%) Viral‐related cirrhosis: 6 (11.1%) Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): 2 (3.7%) Other causes for cirrhosis: 4 (7.4%) 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 = 36) Further details: rifaximin 550 mg BD for 4 weeks Group 2: no active intervention (n = 18) Further details: placebo |
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| Outcomes | Outcomes reported: all‐cause mortality; number of serious adverse events per participant; number of any adverse events per participant; proportion with spontaneous bacterial peritonitis (as per definition). Follow‐up (months): 1 |
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| Notes | Trial name/trial registry number: NCT01769040 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) | Low risk | Quote: "Computer‐generated logarithm provided by our external data manager." |
| Allocation concealment (selection bias) | Low risk | Quote: "Computer‐generated logarithm provided by our external data manager." |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Double‐blind, randomized, and placebo‐controlled trial… All patients and personnel were blinded to the treatment." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Double‐blind, randomized, and placebo‐controlled trial… All patients and personnel were blinded to the treatment." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no postrandomisation dropouts |
| Selective reporting (reporting bias) | Low risk | Comment: protocol not available, but authors reported mortality and adverse events adequately. |
| Other bias | Low risk | Comment: no other bias noted |