Garrido 2002.
Methods | Randomised trial, not double blinded | |
Participants | Participant characteristics • Number randomly assigned (n = 85) • Age (years): 63.1 (mean) • Sex (male/female): 50/35 • Duodenal/gastric ulcer: 27/58 • Forrest group: Ia/Ib = 25, IIa = 52, IIb = 8 | |
Interventions | Interventions • Primary intervention: epinephrine injection vs epinephrine injection and polidocanol injection • Medical treatment: not specified • Second‐look endoscopy: no • Epinephrine volume: not specified | |
Outcomes |
Outcomes assessed
Rebleeding rate
• Mortality criteria: not specified
• Bleeding criteria: haematemesis or fresh melena • Emergency surgery (assessed for whole group, but no separate data for the n = 85 cases randomly assigned) |
|
Notes | Spanish language report | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Study authors did not explain sequence generation Comment: unclear |
Allocation concealment (selection bias) | Unclear risk | Study authors did not explain allocation concealment Comment: unclear |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not done Criteria: 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 | Unclear risk | It is unclear whether n = 340 participants were randomly assigned or only the n = 85 reported in this publication who were treated endoscopically. Reporting of outcomes and numbers in each group at each time point is unclear, for example, 3 participants died as a result of haemorrhage, but it is not clear which therapy they received |
Selective reporting (reporting bias) | Unclear risk | It is unclear whether all outcomes were reported |