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

Elfert 2016.

Methods Randomised clinical trial
Participants Country: Egypt
Period of recruitment: 2014
Number randomised: 262
Postrandomisation dropouts: 0 (0%)
Revised sample size: 262
Mean age (years): 54
Females: 120 (45.8%)
Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): not stated
Ascites with low protein: not stated
Primary prophylaxis: 0 (0%)
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
Exclusion criteria:

  • previous allergy to quinolones

  • recent gastrointestinal bleeding

  • hepatocellular carcinoma or other neoplasias that could shorten life expectancy

  • people who had already taken antibiotics

  • recent intake of quinolones in the last 6 weeks

  • HIV infection

  • hepatic encephalopathy

  • pregnant and lactating women
Interventions Participants randomly assigned to 2 groups.
Group 1: norfloxacin (n = 131)
Further details: norfloxacin 400 mg daily for 6 months
Group 2: rifaximin (n = 131)
Further details: rifaximin 400 mg TDS for 6 months
Outcomes Outcomes reported: all‐cause mortality; proportion of people with serious adverse events; number of serious adverse events per participant; proportion of people with any adverse events; proportion with spontaneous bacterial peritonitis (as per definition).
Follow‐up (months): 6
Notes Trial name/trial registry number: NCT02120196
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: "Eligible patients were randomized using a computer random number generator."
Allocation concealment (selection bias) Low risk Quote: "Sequentially numbered, opaque, sealed 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 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