| Methods |
Single centred, open RCT. |
| Participants |
Country: Poland. Included 102 participants (50 on PPI and 52 on placebo group). PU 75.5% of total; no participants with oesophageal varices (hepatic insufficiency was an exclusion criterion). |
| Interventions |
1. Omeprazole IV bolus delivery, dosing regime unclear: stated as "40 mg" or "80 mg" or "120 mg" (presumably representing total daily doses). 2. Ranitidine IV bolus delivery, dosing regime unclear: stated as "150 mg" or "200 mg" or "300‐400 mg" (presumably representing total daily doses). Unclear if participants within each treatment arm were allocated to each dosing group by a random method or not. Duration of treatment depending on continuation of bleeding. Initial endoscopic haemostatic treatment not mentioned. |
| Outcomes |
Mortality; surgery; stigmata of recent haemorrhage at index endoscopy; number of participants requiring blood transfusion. Timing of outcome assessment not clear. |
| Notes |
Timing of assessment of rebleeding not clear. Initial endoscopic haemostatic treatment not mentioned. Dosing of pharmacological treatments not clear. Rebleeding rates could be extracted because the study was designed to assess time needed for bleeding cessation. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Series of random odd and even numbers generated by the computer. |
| Allocation concealment? |
Unclear risk |
No details of allocation concealment reported. |
| Blinding?
All outcomes |
High risk |
Open study. |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Reported disposition of all randomised participants and outcomes for all participants randomised. No withdrawal or dropouts were observed during the study period. |
| Free of selective reporting? |
Low risk |
No evidence of selective reporting. |
| Free of other bias? |
Unclear risk |
Did not distinguish length of stay ended by mortality or discharge. Rebleeding not reported as an outcome although the study was designed to assess cessation of bleeding at day 5 depending on clinical and laboratory criteria. No data reported on the requirement for repeat endoscopy for persistence of bleeding. Authors did not report time of assessment of mortality. |
