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. 2005 Mar 12;330(7491):568. doi: 10.1136/bmj.38356.641134.8F

Table 1.

Summary of randomised controlled trials included in review of proton pump inhibitors in treatment of bleeding ulcers

Treatments
Design No of patients Endoscopic signs Proton pump inhibitor Control Outcomes reported Comments
Brunner13 Germany Single centre, open, randomised after endoscopy 39 Oozing Omeprazole IV bolus Ranitidine IV bolus + infusion Mortality, surgery 19 were inpatients at time of bleed; 49% had gastric ulcer; no initial endoscopic haemostatic therapy
Daneshmend14 UK Two centre, double blind, randomised before endoscopy 503* Excluded severe bleeding requiring surgery Omeprazole IV bolus then orally Placebo Mortality, rebleeding, surgery Excluded inpatients developing bleeding
Michel15 France Multicentre, double blind 75 Spurting, oozing, NBVV, adherent clot Oral lansoprazole Oral ranitidine Mortality, rebleeding, surgery Timing of randomisation unclear
Perez-Flores16 Spain Single centre, open 81 Oozing, NBVV, adherent clot Omeprazole IV bolus then orally Ranitidine IV bolus then orally Mortality, rebleeding, surgery Timing of randomisation unclear; not all high risk patients received endoscopic haemostatic therapy
Lanas17 Spain Single centre, open, randomised after endoscopy 51 Oozing, NBVV, adherent clot Omeprazole IV bolus Ranitidine IV bolus Mortality, rebleeding, surgery No initial endoscopic haemostatic therapy
Villanueva18 Spain Single centre, open, randomised after endoscopy 86 Spurting, oozing Omeprazole IV bolus then orally Ranitidine IV bolus then orally Mortality, rebleeding, surgery 16% had onset of bleeding as inpatient
Cardi19 Italy Single centre, randomised after endoscopy 45 Oozing Omeprazole IV bolus + infusion Ranitidine IV bolus + infusion Mortality, surgery Level of blinding unclear; all patients had duodenal ulcer; no apparent initial endoscopic haemostatic therapy
Hasselgren20 Sweden, Norway Multicentre, double blind, randomised after endoscopy 322 Spurting, oozing, NBVV, adherent clot Omeprazole IV bolus + infusion Placebo IV bolus + infusion Mortality, surgery Trial stopped prematurely because of concerns over higher mortality in proton pump inhibitor than control group; only patients aged >60 included; not all high risk patients received endoscopic haemostatic therapy
Khuroo21 India Single centre, double blind, randomised after endoscopy 220 Spurting, oozing, NBVV, adherent clot Oral omeprazole Oral placebo Mortality, rebleeding, surgery No routine endoscopic haemostatic therapy; excluded patients with severe bleeding or terminal illness
Labenz22 Germany Single centre, randomised after endoscopy 40 Spurting, oozing, NBVV, adherent clot Omeprazole IV bolus + infusion Ranitidine IV bolus + infusion Rebleeding (within 24 hours) Degree of blinding unclear
Lin23 Taiwan Single centre, open, randomised after endoscopy 52 NBVV Omeprazole IV bolus Cimetidine IV bolus Rebleeding No initial endoscopic haemostatic therapy
De Muckadell24 Denmark, Holland, France Multicentre, double blind, randomised after endoscopy 265 Spurting, oozing, NBVV, adherent clot Omeprazole IV bolus + infusion Placebo IV bolus + infusion Mortality, surgery Terminated prematurely after interim analysis pooled with parallel study (Hasselgren et al20)
Corragio25 Italy Multicentre, randomised after endoscopy 73 Spurting, oozing, NBVV, adherent clot Oral omeprazole Ranitidine IV bolus Mortality, rebleeding, surgery Degree of blinding unclear
Lin26 Taiwan Single centre, open, randomised after endoscopy 100 Spurting, oozing, NBVV Omeprazole IV bolus + infusion Cimetidine IV bolus + infusion Mortality, rebleeding, surgery
Lau27 Hong Kong Single centre, double blind, randomised after endoscopy 240 Spurting, oozing, NBVV Omeprazole IV bolus + infusion Placebo IV bolus + infusion Mortality, rebleeding, surgery
Javid28 India Single centre, double blind, randomised after endoscopy 166 Spurting, oozing, NBVV, adherent clot Oral omeprazole Oral placebo Mortality, rebleeding, surgery
Sheu29 Taiwan Single centre, randomised after endoscopy 175 Spurting, oozing, NBVV, adherent clot, clean base Omeprazole IV bolus Ranitidine IV bolus Mortality, rebleeding, surgery Degree of blinding unclear
Kaviani30 Iran Two centre, double blind, randomised after endoscopy 149 Spurting, oozing, NBVV Omeprazole IV bolus then orally Placebo IV bolus then oral omeprazole Mortality, rebleeding, surgery
Desprez31 France Single centre, randomised after endoscopy 76 Oozing, NBVV, adherent clot Omeprazole IV bolus then orally Ranitidine IV bolus + infusion then orally Mortality, rebleeding, surgery Degree of blinding unclear; no apparent initial endoscopic haemostatic therapy; only available as abstract
Fried32 Switzerland, Germany Multicentre, open, randomised after endoscopy 113 Spurting, oozing, NBVV, adherent clot Pantoprazole IV bolus + infusion Ranitidine IV bolus + infusion Mortality, rebleeding Only available as abstract
Duvnjak33 Croatia Single centre, randomised after endoscopy 62 Spurting, oozing, NBVV, adherent clot Pantoprazole IV bolus Ranitidine IV bolus Rebleeding Only available as abstract; degree of blinding unclear

NBVV=non-bleeding visible vessel.

*

503 patients had endoscopic confirmation of bleeding from peptic ulcer from total cohort of 1147 patients with upper gastointestinal tract bleeding.