| Methods |
Randomisation sequence: computer‐generated list.
Concealment: sealed, opaque envelopes.
Treatment completed as per protocol in all patients.
Follow‐up: 42 days.
Lost to follow‐up: not reported.
Intention‐to‐treat analysis: not assessable. |
| Participants |
Country: Spain.
Cirrhotic patients with endoscopy‐proven variceal bleeding.
Exclusion: bleeding from gastric varices.
Alcoholic cirrhosis 71%. |
| Interventions |
EVS: intra‐paravariceal injection of 1% polidocanol (mean max volume 48 ml), single session.
Control: 48 hour continuous iv infusion of 250 µg/h of somatostatin after an initial iv bolus of 250 µg. |
| Outcomes |
48‐hour failure to control bleeding or re‐bleeding.
re‐bleeding within day two to seven.
42‐day mortality. |
| Notes |
Within a mean of nine days from admission, all surviving patients entered a randomised trial of elective pharmacological therapy versus EVS or shunt surgery.
This study was based on the Baveno consensus conferences guidelines. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Adequate |
| Allocation concealment? |
Low risk |
Adequate |
