Daneshmend 1992.

Methods	Large multicentre (two centres) double blind RCT.
Participants	Country: UK. Included 1147 participants (578 on PPI; 569 on control treatment). PU 43.9%; oesophageal varices 2.5% of total. Excluded severe bleeding (that required surgery) and bleeding that developed in patients.
Interventions	1. Omeprazole 80 mgs IV immediately, then 3 doses of 40 mg IV at eight‐hourly intervals, then 40 mg oral every 12 hours for 101 hours or until surgery, discharge, or death. 2.Identical regimen with mannitol. Post‐intervention drug treatment at discretion of physician. Initial endoscopic treatment at discretion of endoscopist (received by a minority of high risk participants).
Outcomes	40‐day mortality; rebleeding; surgery; stigmata of recent haemorrhage at index endoscopy; number of participants requiring blood transfusion. First three outcomes also reported by peptic ulcer site.
Notes	Only a few of the high‐risk participants with PU received initial endoscopic treatment. Timing of assessment of rebleeding and surgery not clear.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	The treatments were randomized in blocks of 10. No further description of sequence generation provided by authors.
Allocation concealment?	Unclear risk	No report from the authors on the methods to use adequate concealment.
Blinding? All outcomes	Low risk	Authors report that this study was double blind and that mortality assessors were blinded, but does not report who else was blinded. Authors also report that the appearances of study treatment and placebo were identical.
Incomplete outcome data addressed? All outcomes	Low risk	Initially 1154 participants randomised. Authors reported 4 participants were not given the study treatment ( one omeprazole group and three placebo group) and in 3 the treatment given could not subsequently be clearly identified. Hence 1147 were successfully randomised (578 in omeprazole group and 569 to placebo group) Authors clearly reported protocol violations in 98 participants, (62 participants were prescribed concomitant H2RA, 18 more than 12 hours after admission, 3 were under age or pregnant). Authors have also reported Intention to treat and per protocol analysis separately. The results for each of the outcomes were comparable between the two analyses.
Free of selective reporting?	Low risk	No evidence of imputation or last observation carried forward.
Free of other bias?	High risk	Authors do not describe whether length of stay ended by discharge or death. Authors do not describe in detail the criteria for requirement of repeat endoscopy offered for participants with rebleeding.