Table 1.
Summary of randomised controlled trials included in review of proton pump inhibitors in treatment of bleeding ulcers
Treatments
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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.