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

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:
  • people with Grade I ascites


Exclusion criteria:
  • history of oesophageal bleeding

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
Outcomes None of the outcomes of interest were reported.
Follow‐up (months): 6
Notes Trial name/trial registry number: NCT01904409
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: "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