Soriano 1992.
Methods | Data collection: 08/89 to 06/91. Exclusion from analysis: underwent surgery, or died within 24 hs after admission. Follow‐up period: up to four weeks. | |
Participants | Spain Hospitalised cirrhotic patients with upper gastrointestinal haemorrhage, without infection or treatment with antibiotics in the previous two weeks. Etiology of bleeding: oesophageal varices, gastric haemorrhage, peptic ulcers, and others. Initial infection assessment: chest X‐ray, white blood cell count, urine/blood/ascites culture. Source of bleeding determined by endoscopy scheduled within four hs after enrolment. Emergency sclerotherapy performed for patients bleeding from varices. Child‐Pugh class A/B/C: 40/55/24. | |
Interventions | Experimental: oral norfloxacin 800 mg/day during seven days. Control: no antibiotic prophylaxis. |
|
Outcomes | Prevent bacterial infection. | |
Notes | Authors were contacted for the first version of this review. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | The sequence was generated using a table of random numbers. |
Allocation concealment? | Unclear risk | No information provided. |
Blinding? All outcomes | High risk | Not a blinded trial. |
Incomplete outcome data addressed? All outcomes | Low risk | Reassons for missing data are based on the violation of the protocol and are balanced across the groups. |
Free of selective reporting? | Low risk | The report include all the expected outcomes. |
Free of other bias? | Low risk | The trial appears to be free of other sources of bias. |
Intention to treat analysis? | High risk | The exclusion of the patients was based on an exclusion rule. |
Sample calculation? | High risk | No sample calculation procedure. |