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

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:
  • ≥ 2 episodes of overt hepatic encephalopathy


Exclusion criteria:
  • gastrointestinal bleeding

  • recent portosystemic shunt or transjugular intrahepatic portosystemic shunt

  • comorbidities such as chronic renal insufficiency or respiratory insufficiency

  • electrolyte insufficiency

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
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
Notes Trial name/trial registry number: NCT00298038
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 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