Skip to main content
. 2020 Jan 16;2020(1):CD013125. doi: 10.1002/14651858.CD013125.pub2

Ali 2014.

Methods Randomised clinical trial
Participants Country: Pakistan
Period of recruitment: 2012–2013
Number randomised: 126
Postrandomisation dropouts: not stated
Revised sample size: 126
Mean age (years): 42
Females: 66 (52.4%)
Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): 126 (100%)
Ascites with low protein: not stated
Primary prophylaxis: not stated
Alcohol‐related cirrhosis: 4 (3.2%)
Viral‐related cirrhosis: 120 (95.2%)
Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): not stated
Other causes for cirrhosis: 2 (1.6%)
Treated for ascites in addition to antibiotics (e.g. albumin or diuretics): not stated
Inclusion criteria:
  • ≥ 2 episodes of hepatic encephalopathy


Exclusion criteria:
  • hypersensitivity to rifamycin and its products

  • calcium level > 10 mg/dL

  • hepatocellular carcinoma

  • comorbidities such as chronic kidney disease, respiratory insufficiency, and cerebrovascular injury

Interventions Participants randomly assigned to 2 groups.
Group 1: rifaximin (n = 63)
Further details: rifaximin 550 mg BD for 6 months or until recurrence of hepatorenal syndrome
Group 2: no active intervention (n = 63)
Further details: placebo for 6 months
Outcomes Outcomes reported: all‐cause mortality; number of other decompensation events
Follow‐up (months): 6
Notes 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: "Triple blind randomized placebo‐controlled trial… The patients, the investigator and the statistician did not know which patients were receiving Rifaximin and which were being given placebo."
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Triple blind randomized placebo‐controlled trial… The patients, the investigator and the statistician did not know which patients were receiving Rifaximin and which were being given placebo."
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