Yim 2018.
| Methods | Randomised clinical trial | |
| Participants | Country: South Korea Period of recruitment: not stated Number randomised: 124 Postrandomisation dropouts: 12 (9.7%) Revised sample size: 112 Reasons for postrandomisation dropouts: not stated Mean age (years): not stated Females: not stated 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: 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:
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| Interventions | Participants randomly assigned to 2 groups. Group 1: ciprofloxacin (n = 57) Further details: ciprofloxacin 750 mg weekly for 12 months Group 2: norfloxacin (n = 55) Further details: norfloxacin 400 mg daily for 12 months Additional details: none of baseline characteristics were extracted as the outcomes were presented for 55 vs 57 participants, but the baseline characteristics were described for 62 participants in each group. |
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| Outcomes | Outcomes reported: all‐cause mortality; number of serious adverse events per participant; liver transplantation; proportion with spontaneous bacterial peritonitis (as per definition) Follow‐up (months): 12 |
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| Notes | Trial name/trial registry number: NCT01542801 Attempted to contact authors in November 2018, but received no replies. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The randomization table was generated by a statistician (SSK) using the nQuery Advisor program." |
| Allocation concealment (selection bias) | Low risk | Quote: "Centralized web‐based interactive response system." |
| 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 | Unclear risk | Comment: there were postrandomisation dropouts and it was unclear whether these were related to outcomes. |
| 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 |
AIH: autoimmune hepatitis; BD: twice daily; n: number of participants; OD: once daily; PBC: primary biliary cirrhosis; PSC: primary sclerosing cholangitis; TDS: three times daily.