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

Assem 2016.

Methods Randomised clinical trial
Participants Country: Saudi Arabia and Egypt
Period of recruitment: 2014–2015
Number randomised: 239
Postrandomisation dropouts: not stated
Revised sample size: 239
Mean age (years): 57
Females: 63 (26.4%)
Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): 56 (23.4%)
Ascites with low protein: not stated
Primary prophylaxis: 239 (100%)
Alcohol‐related cirrhosis: not stated
Viral‐related cirrhosis: 222 (92.9%)
Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): not stated
Other causes for cirrhosis: 17 (7.1%)
Treated for ascites in addition to antibiotics (e.g. albumin or diuretics): not stated
Exclusion criteria:
  • people with resolving ascites for 1 month after diuretic therapy

  • uncontrolled diabetes mellitus

  • liver malignancy

  • organic renal disease

  • HIV infection

  • known hypersensitivity to planned drugs

Interventions Participants randomly assigned to 3 groups.
Group 1: rifaximin + norfloxacin (n = 79)
Further details: rifaximin 550 mg BD orally for 1 month, alternating with norfloxacin 400 mg OD for 1 month, total duration 6 months
Group 2: norfloxacin (n = 78)
Further details: norfloxacin 400 mg OD orally for 6 months
Group 3: rifaximin (n = 82)
Further details: rifaximin 550 mg BD orally for 6 months
Outcomes Outcomes reported: all‐cause mortality; number of any adverse events per participant; proportion with spontaneous bacterial peritonitis (as per definition); 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) Low risk Quote: "Enrolled patients were randomly allocated to three groups by using consecutively numbered, computer‐generated envelopes."
Allocation concealment (selection bias) Low risk Quote: "Enrolled patients were randomly allocated to three groups by using consecutively numbered, computer‐generated envelopes."
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "Open‐label"
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "Open‐label"
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: appeared some people were excluded from some outcomes, but information not clear.
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