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. 2020 Jan 16;2020(1):CD013125. doi: 10.1002/14651858.CD013125.pub2

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:
  • hypersensitivity or intolerability with quinolones

  • hepatocellular carcinoma beyond Milan Criteria

  • hepatic encephalopathy > stage 2

  • history of treatment with antibiotics within 2 weeks of enrolment

  • HIV infection

  • uncontrolled malignancy

  • women at child‐bearing age unwilling to use effective measures for contraception

  • pregnant or breast‐feeding women

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.
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
Notes Trial name/trial registry number: NCT01542801
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) 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.