| Methods |
Randomisation sequence: method not described. A blocked list was generated.
Concealment: sealed, opaque envelopes.
Treatment completed as per protocol in all patients.
Follow‐up: 28 days.
Lost to follow‐up: none.
Intention‐to‐treat analysis: yes. |
| Participants |
: alcohol 67%.
Exclusion: bleeding not from oesophageal varices; patients already under vasoactive therapy or with EVS in the previous seven days. |
| Interventions |
EVS: 2 to 3 ml intravariceal injections of ethanolamine oleate, in a single session.
Control: continuous iv infusion of somatostatin 250 µg/h for five days, after initial iv bolus of 250 µg. |
| Outcomes |
Immediate (10 to 20 min) control of bleeding on endoscopy.
Five‐day re‐bleeding.
28‐day mortality. |
| Notes |
Need of transfusions was an entry criterion, but criteria to define the need of transfusions were not reported. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Unclear |
| Allocation concealment? |
Low risk |
Adequate |
