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. 2020 Jan 16;2020(1):CD013125. doi: 10.1002/14651858.CD013125.pub2

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:
  • portal hypertension with an hepatic venous pressure gradient ≥ 10 mmHg


Exclusion criteria:
  • cardiac or respiratory failure

  • invasive cancer within the past 5 years

  • infection

  • antibiotic treatment 14 days prior to inclusion

  • overt hepatic encephalopathy

  • kidney failure with serum creatinine > 200 µmol/L

  • transfusion‐requiring bleeding within 1 week prior to inclusion

  • anaemia

  • continuous abuse of alcohol with symptoms of withdrawal

  • expected survival < 3 months

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
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
Notes Trial name/trial registry number: NCT01769040
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) 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