Bass 2010.
| Methods | Randomised clinical trial | |
| Participants | Country: USA, Canada, Russia Period of recruitment: 2005–2008 Number randomised: 299 Postrandomisation dropouts: 0 (0%) Revised sample size: 299 Mean age (years): 56 Females: 117 (39.1%) Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): 299 (100%) Ascites with low protein: not stated Primary prophylaxis: not stated Alcohol‐related cirrhosis: not stated Viral‐related cirrhosis: not stated Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): not stated Other causes for cirrhosis: not stated 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 = 140) Further details: rifaximin 550 mg BD for 6 months or until recurrence of hepatorenal syndrome Group 2: no active intervention (n = 159) Further details: placebo for 6 months |
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| Outcomes | Outcomes reported: all‐cause mortality; number of serious adverse events per participant; proportion of people with any adverse events; number of any adverse events per participant; number of other decompensation events. Follow‐up (months): 6 |
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| Notes | Trial name/trial registry number: NCT00298038 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 | 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 |