Alvarez 2005.
| Methods | Randomised clinical trial | |
| Participants | Country: Brazil Period of recruitment: 1999–2001 Number randomised: 57 Postrandomisation dropouts: not stated Revised sample size: 57 Mean age (years): 48 Females: 19 (33.3%) Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): not stated Ascites with low protein: 28 (49.1%) Primary prophylaxis: 35 (61.4%) Alcohol‐related cirrhosis: 20 (35.1%) Viral‐related cirrhosis: not stated Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): not stated Other causes for cirrhosis: 37 (64.9%) 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: sulfamethoxazole + trimethoprim (n = 25) Further details: sulfamethoxazole 160 mg + trimethoprim 800 mg daily for 5 days a week (duration not stated, but probably until follow‐up Group 2: norfloxacin (n = 32) Further details: norfloxacin 400 mg daily for 5 days a week (duration not stated, but probably until follow‐up) |
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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) 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: information not available |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: information not available |
| 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 |