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:
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| 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 |
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| 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 |
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| 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 |