| Methods |
Randomisation sequence: blocked computer‐generated list.
Concealment: sealed, opaque envelopes.
Treatment completed as per protocol in all patients.
Follow‐up: 42 days, no patients lost.
Intention‐to‐trat analysis: yes.
Two patients excluded because of serious protocol violation. |
| Participants |
Country: Spain.
Cirrhotic patients with endoscopy‐proven variceal bleeding.
Exclusion: recent sclerotherapy or band ligation; bleeding from fundal varices; other concomitant bleeding sources. |
| Interventions |
EVS: intra‐paravariceal injection of either 5% ethanolamine or 1% polidocanol, single session.
Terlipressin: iv injections of 2mg/4h until control of bleeding (48 hours max) and 1 mg/4h thereafter for 5 more days. |
| Outcomes |
48‐hour failure to control bleeding.
Re‐bleeding within five days after initial control.
42‐day re‐bleeding and death. |
| Notes |
Randomised trial 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 |
