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

Grangie 1998.

Methods Randomised clinical trial
Participants Country: France
Period of recruitment: 1991–1993
Number randomised: 107
Postrandomisation dropouts: 0 (0%)
Revised sample size: 107
Mean age (years): 55
Females: 38 (35.5%)
Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): not stated
Ascites with low protein: not stated
Primary prophylaxis: 107 (100%)
Alcohol‐related cirrhosis: 93 (86.9%)
Viral‐related cirrhosis: 10 (9.3%)
Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): not stated
Other causes for cirrhosis: 4 (3.7%)
Treated for ascites in addition to antibiotics (e.g. albumin or diuretics): not stated
Exclusion criteria:
  • active gastrointestinal bleeding

  • hepatocellular carcinoma or other life‐threatening disease

Interventions Participants randomly assigned to 2 groups.
Group 1: norfloxacin (n = 53)
Further details: norfloxacin 400 mg daily (duration not stated, but probably to end of follow‐up)
Group 2: no active intervention (n = 54)
Further details: placebo
Outcomes Outcomes reported: all‐cause mortality; number of any adverse events per participant; proportion with spontaneous bacterial peritonitis (as per definition)
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: "Double‐blind, placebo‐controlled."
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Double‐blind, placebo‐controlled."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no postrandomisation dropouts
Selective reporting (reporting bias) High risk Comment: protocol not available, and authors did not report the outcomes assessed adequately.
Other bias Low risk Comment: no other bias noted