Madrid 2001.
| Methods | Randomised clinical trial | |
| Participants | Country: Chile Period of recruitment: not stated Number randomised: 22 Postrandomisation dropouts: not stated Revised sample size: 22 Mean age (years): 58 Females: 11 (50.0%) Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): not stated Ascites with low protein: not stated Primary prophylaxis: not stated Alcohol‐related cirrhosis: 13 (59.1%) Viral‐related cirrhosis: 7 (31.8%) Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): not stated Other causes for cirrhosis: 2 (9.1%) Treated for ascites in addition to antibiotics (e.g. albumin or diuretics): not stated Inclusion criteria:
Exclusion criteria:
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| Interventions | Participants randomly assigned to 2 groups. Group 1: norfloxacin + neomycin (n = 12) Further details: norfloxacin 400 mg BD alternating with neomycin 500 mg TDS, alternating every 15 days for 6 months Group 2: no active intervention (n = 10) Further details: placebo Additional details: another group which received cisapride was excluded from the analysis |
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| Outcomes | Outcomes reported: number of other decompensation events 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 | Unclear risk | Comment: placebo used but no information about blinding provided. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: placebo used but no information about blinding provided. |
| 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 |