Rolachon 1995.
| Methods | Randomised clinical trial | |
| Participants | Country: France Period of recruitment: 1991–1993 Number randomised: 60 Postrandomisation dropouts: not stated Revised sample size: 60 Mean age (years): 55 Females: 28 (46.7%) Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): not stated Ascites with low protein: 60 (100%) Primary prophylaxis: 53 (88.3%) Alcohol‐related cirrhosis: 55 (91.7%) Viral‐related cirrhosis: 1 (1.7%) Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): 2 (3.3%) Other causes for cirrhosis: 2 (3.3%) Treated for ascites in addition to antibiotics (e.g. albumin or diuretics): not stated |
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| Interventions | Participants randomly assigned to 2 groups. Group 1: ciprofloxacin (n = 28) Further details: ciprofloxacin 750 mg/week orally for 6 months Group 2: no active intervention (n = 32) 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); length of hospital stay 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" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Double‐blind … 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 the outcomes assessed adequately. |
| Other bias | Low risk | Comment: no other bias noted |