| Methods |
Randomised trial, not double blinded |
| Participants |
Participant characteristics
• Number randomly assigned (n = 200)
• Age (years): 54.5 (mean)
• Sex (male/female): 138/58
• Duodenal/gastric ulcer: 117/75
• Forrest group: Ia = 62, Ib = 134 |
| Interventions |
Interventions
• Primary intervention: epinephrine injection (n = 99) vs epinephrine injection plus sodium tetradecyl sulphate (n = 101)
• Medical treatment: ranitidine 50 mg/6 h intravenously
• Second‐look endoscopy: yes
• Epinephrine volume: not specified |
| Outcomes |
Outcomes assessed
Rebleeding rate, surgery rate, hospital stay, transfusion requirements and mortality
• Mortality criteria: hospital mortality
• Bleeding criteria: fresh hematemesis or melena plus shock or fall in haemoglobin > 2 g/dL
|
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random number list generated by computer |
| Allocation concealment (selection bias) |
Low risk |
Sealed and numbered envelopes |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Quote: (abstract p 611): "After the procedure the patients were transferred to the surgical gastroenterology ward and were treated by surgeons who were unaware of the mode of treatment"
Criteria: blinding was incomplete, as it is virtually impossible in studies on endoscopic treatment. Review authors believe that this did not introduce significant bias |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No missing outcome data: 200 participants were randomly assigned. Outcomes were presented for all those randomly assigned, including details of n = 4 who were excluded after randomisation and those lost to follow up (n = 13) or who did not return for follow‐up to determine ulcer healing 4 weeks after discharge |
| Selective reporting (reporting bias) |
Low risk |
The published report includes all expected outcomes, including those that were prespecified |
