| Methods |
Single centre double blind randomised controlled trial. |
| Participants |
Setting: Hongkong, Asia, 631 participants randomised (314 in the PPI group and 317 in the placebo group) 187 participants with Peptic ulcer disease in the PPI group and 190 in the placebo group. 3.8% participants with variceal bleed. Excluded long term aspirin users and participants with continued shock requiring emergency surgery. |
| Interventions |
Intravenous omeprazole 80mg at randomisation and continuous infusion at 8mg/hour until endoscopy. Intravenous placebo 80mg bolus followed by infusion 8mg/hr until endoscopy. participants with high risk stigmata requiring endoscopic treatment were treated with PPI 8mg/hour infusion for 72 hours followed by 8 weeks of oral omeprazole 40mg. Omeprazole based standard Helicobacter eradication treatment for 7 days used as appropriate. |
| Outcomes |
30 day mortality, rebleeding, surgery, proportion of participants requiring endoscopic therapy, length of hospital stay and mean units of blood transfusion reported according to treatment group. Stigmata of haemorrhage reported only in peptic ulcer disease participants. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Consecutive participants randomised according to computer generated random numbers in blocks of 20. |
| Allocation concealment? |
Low risk |
Sealed packs generated centrally in the pharmacy and sent to the wards with lowest numbered pack to be opened by the resident treating the participant. |
| Blinding?
All outcomes |
Low risk |
Participants and all investigators were blinded to the treatment groups. |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Clear reporting of disposition of participants at each stage of the study. |
| Free of selective reporting? |
High risk |
Stigmata of the recent haemorrhage reported only for peptic ulcer patients. The absence of this data for all randomised patients precluded the inclusion of this study from the main analysis which might have influenced the overall results for this outcome. The authors report that 5 patients in the omeprazole group excluded from analyses, (3 received the wrong diagnosis, 1 had small‐bowel obstruction, 1 had a history of total gastrectomy, 1 had cholangitis, 2 withdrew voluntarily). 2 of the 314 patients did not undergo endoscopy. Of the 319 patients in the placebo group, 2 were excluded from the analysis, 1 because of wrong diagnosis and the other withdrew voluntarily. |
| Free of other bias? |
Low risk |
In the publication the authors did not distinguish length of stay ended by mortality or discharge; however, they provided separated data when requested. |