Chung 1997.
| Methods | Randomised trial, not double blinded | |
| Participants | Participant characteristics • Number randomly assigned (n = 276) • Age (years): 58.5 (mean) • Sex (male/female): 187/89 • Duodenal/gastric ulcer: 176/87 • Forrest group: Ia = 58, Ib = 212 | |
| Interventions | Interventions • Primary intervention: epinephrine injection (n = 136) vs epinephrine injection and heat probe (n = 140) • Medical treatment: ranitidine • Second‐look endoscopy: yes • Epinephrine volume: 9.5 vs 10.1 | |
| Outcomes |
Outcomes assessed Rebleeding rate, length of hospital stay, requirement for blood transfusion, surgery rate and mortality
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| Notes | Outcomes assessed Rebleeding rate, surgery rate and mortality • Mortality criteria: hospital mortality • Bleeding criteria: not specified | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomisations took place at the time of endoscopy when actively bleeding ulcers were seen. The endoscopy nurse then opened a sealed envelope containing the treatment option, which had previously been determined by a random number list generated by a computer. Treatment was concealed from the endoscopist when the patient was admitted into the trial" (page 1308) Comment: adequate |
| Allocation concealment (selection bias) | Low risk | Quote: "Randomisations took place at the time of endoscopy when actively bleeding ulcers were seen. The endoscopy nurse then opened a sealed envelope containing the treatment option, which had previously been determined by a random number list generated by a computer. Treatment was concealed from the endoscopist when the patient was admitted into the trial" (page 1308) Comment: adequate |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not done Blinding 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: Randomisation took place at the time of endoscopy when actively bleeding ulcers were seen. 276 randomly assigned, Six patients were excluded after randomisation (n = 2 in epinephrine; n = 4 in combined therapy), as their ulcers were subsequently found to be malignant |
| Selective reporting (reporting bias) | Unclear risk | The published report includes all expected outcomes, including those that were prespecified |