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. 2010 Jul 7;2010(7):CD005415. doi: 10.1002/14651858.CD005415.pub3

Hawkey 2001.

Methods Multicentre (two centres) double blind RCT.
Participants Country: UK. 414 participants in total (102 on PPI; 103 on placebo; 103 on tranexamic acid; 106 on tranexamic acid plus PPI). PU 42.4%; 3.9% oesophageal varices 2.5% of total. Excluded severe bleeding (that required immediate surgery).
Interventions 1. Lansoprazole 60 mg orally (start), followed by 30 mg plus dummy medication four times daily for four days. 2. Placebo ‐ double dummy technique. 3.Tranexamic acid 2g orally (start), followed by 1g orally plus dummy medication four times daily for four days. 4.Tranexamic acid and lansoprazole ‐ both active drugs as above for four days. Post‐intervention drug treatment not mentioned. Initial endoscopic haemostatic treatment offered for participants with active bleeding.
Outcomes 30 day mortality; 30 day surgery; rebleeding (timing unclear); stigmata of recent haemorrhage at index endoscopy; number of participants requiring blood transfusion.
Notes For the current meta‐analysis we included only group 1 (lansoprazole alone) as active treatment group and group 2 (placebo) as control group. participants that received tranexamic acid or the combination of PPI and tranexamic acid were not included. Timing of assessment of rebleeding not clear.
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk Authors report no method for sequence generation.
Allocation concealment? Unclear risk Authors report no method for allocation concealment.
Blinding? 
 All outcomes Low risk Authors mention double blind, double dummy comparison.
Incomplete outcome data addressed? 
 All outcomes Low risk Authors provide a clear disposition of participants at each stage after randomisation. Of the 414 participants enrolled, 55 not endoscoped. Of the 298 endoscoped, 61 were not Gi bleed. 248 participants were eligible and 50 not eligible for further evaluation due to protocol violations (39 more than 72 hours after start of bleeding, 9 more than 8 hours from 1st dose to endoscopy, 2 participants with no trial data). 20 further participants were not evaluable (14 participants missed 2 or more doses, 4 endoscopy received before trial treatment, 3 prohibited drugs during trial and 1 previously in trial). The authors also report the withdrawals and dropouts within each treatment group.
Free of selective reporting? Low risk No evidence of selective reporting.
Free of other bias? High risk Authors report the decision to offer repeat endoscopy for rebleeding was left to the discretion of treating physician and do not describe in detail the criteria for requirement of repeat endoscopy.