Ginés 1990.
| Methods | Randomised clinical trial | |
| Participants | Country: Spain Period of recruitment: 1987–1989 Number randomised: 80 Postrandomisation dropouts: not stated Revised sample size: 80 Mean age (years): 58 Females: 26 (32.5%) Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): not stated Ascites with low protein: not stated Primary prophylaxis: 0 (0%) Alcohol‐related cirrhosis: 46 (57.5%) Viral‐related cirrhosis: not stated Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): not stated Other causes for cirrhosis: 34 (42.5%) 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: norfloxacin (n = 40) Further details: norfloxacin 400 mg daily (duration not stated, but probably to end of follow‐up) Group 2: no active intervention (n = 40) 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); 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 | Low risk | Quote: "Double‐blind, multicenter, placebo‐controlled study… Each patient's assigned drug was known only by the pharmacy." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Double‐blind, multicenter, placebo‐controlled study… Each patient's assigned drug was known only by the pharmacy." |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: information not available |
| Selective reporting (reporting bias) | Low risk | Comment: protocol not available, but authors reported mortality and adverse events adequately. |
| Other bias | Low risk | Comment: no other bias noted |