| Methods |
Single centred, open RCT. |
| Participants |
Country: Turkey. Included 58 participants (30 omeprazole group, 28 control treatment group). |
| Interventions |
1. Omeprazole 80mg IV as soon as possible after admission, followed by 40 mg IV once a day and 100mg IV 3 times a day for 6 days. Omeprazole 20mg once a day at end of 4 weeks. 2. Rantidine 100 mg as soon as possible after admission, followed by 100 mg IV 3 times a day for 6 days. Famotidine 40mg once a day at end of 4 weeks. |
| Outcomes |
Mortality, rebleeding, stigmata of recent haemorrhage at index endoscopy, number of participants requiring blood transfusion. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Authors report no details of sequence generation. |
| Allocation concealment? |
Unclear risk |
Authors report no details of allocation concealment. |
| Blinding?
All outcomes |
Unclear risk |
Authors report no details of blinding. |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Authors provide clear disposition for all randomised participants. Among the 6 omeprazole group participants who were not endoscoped in the 1st month; one participant died of massive upper gastrointestinal haemorrhage due to end stage liver disease, two participants moved to another city and could not come to control, one participant had appendicitis and operated at control date, and two participants refused control endoscopy. For the 1st month endoscopy of ranitidine group, 20 of 28 participants(71%) were reexamined. Among the 8 ranitidine group participants who were not endoscoped in the 1st month; one participant died of pancreas carcinoma with massive upper gastrointestinal bleeding, one participant had coronary by‐pass surgery, one participant had unstable heart disease, 3 participants refused the endoscopy procedure and 2 participants with unknown reasons could not be reexamined. Authors report that these participants were omitted from the rest of the study. |
| Free of selective reporting? |
High risk |
No data regarding requirement for surgery. No data per treatment group for stigmata of recent haemorrhage. |
| Free of other bias? |
High risk |
No definition of rebleeding. Indications for surgery not stated. |
