Rimola 1985.
Methods | Data collection: no information provided. Exclusion from analysis: underwent surgery, or died within 24 hs after admission. Follow‐up period: up to 10 days after stopping bleeding (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 (128 patients), gastric haemorrhage ( 10 patients), peptic ulcers (8 patients). Initial infection assessment: chest X‐ray, white blood cell count, urine/blood/ascites culture. Source of bleeding determined by endoscopy scheduled within 24 hs after enrolment. Emergency sclerotherapy performed for patients bleeding from varices. Child‐Pugh class A/B/C: not reported. | |
Interventions | Experimental (non‐absorbable antibiotics):
Group Ia ‐ oral gentamicin (200mg) + vancomycin (500 mg) + nystatin (10^6 UI) every six hs, until two days after cessation of haemorrhage.
Group Ib ‐ neomycin (1 gm) + colistin (1.5 x 10^6 UI) + nystatin (10^6 UI) every six hs, until two days after cessation of haemorrhage. Control (Group II): no antibiotic prophylaxis. |
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Outcomes | Prevent bacterial infections. | |
Notes | The antibiotic therapy regimen was modified after inclusion of the first 40 patients in the experimental group because of budget constraints.
The two group of patients treated with antibiotics were combined for the purpose of this review. Authors were contacted for the first version of this review, and additional information was received. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | The sequence was generated using random number table. |
Allocation concealment? | Low risk | Adequate, this item keeps as the first review. |
Blinding? All outcomes | High risk | Not a blinded trial. |
Incomplete outcome data addressed? All outcomes | High risk | The proportion of missing outcomes is not balanced among the groups. |
Free of selective reporting? | Low risk | The report include all the expected outcomes. |
Free of other bias? | High risk | The antibiotic therapy regimen was modified after inclusion of the first 40 patients in the experimental group because of budget constraints. |
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. |