title: Regular-dose versus high-dose omeprazole in peptic ulcer bleeding: a prospective randomized double-blind study.
abstract: BACKGROUND
  It has been suggested that profound acid inhibition along with endoscopic therapy might prevent rebleeding and reduce mortality in patients with peptic ulcer bleeding. The aim of the study was to test the possible equivalence of a high dose and the regular dose of omeprazole in peptic ulcer bleeding.
  
  
  METHODS
  We performed a prospective randomized double-blind study involving 142 patients with acute peptic ulcer bleeding (Forrest classification I-II: spurting or oozing bleeding, non-bleeding visible vessel, clot and black base). One-hundred-and-two (71.8%) patients received endoscopic treatment (adrenaline injection and/or heater probe) in pre-entry. Patients were randomly assigned to receive the regular dose of omeprazole intravenously (20 mg once a day for 3 days, i.e. 60 mg/72 h) or a high dose of omeprazole (80 mg bolus + 8 mg/h for 3 days, i.e. 652 mg/72 h). Rebleeding, surgery and death were the outcome measures.
  
  
  RESULTS
  Six (8.2%) of the 73 patients receiving the regular dose of omeprazole and 8 (11.6%) of the 69 patients receiving the high dose of omeprazole rebled (P = 0.002 for equivalence, equivalence limit 0.15). Three (4.1%) of the former patients and 5 (7.2%) of the latter group underwent surgery. Four (5.5%) patients in the regular-dose and 2 (2.9%) in the high-dose group died within 30 days.
  
  
  CONCLUSIONS
  Under the defined tolerance limits, the regular dose of omeprazole is as successful as a high dose in preventing peptic ulcer rebleeding.
authors.affiliation: Dept. of Surgery, Kuopio University Hospital, Finland. Marianne.Udd@hus.fi
authors.forename: M
authors.initials: M
authors.lastname: Udd
authors.forename: P
authors.initials: P
authors.lastname: Miettinen
authors.forename: A
authors.initials: A
authors.lastname: Palmu
authors.forename: M
authors.initials: M
authors.lastname: Heikkinen
authors.forename: E
authors.initials: E
authors.lastname: Janatuinen
authors.forename: P
authors.initials: P
authors.lastname: Pasanen
authors.forename: R
authors.initials: R
authors.lastname: Tarvainen
authors.forename: M V
authors.initials: MV
authors.lastname: Kairaluoma
authors.forename: M
authors.initials: M
authors.lastname: Lohman
authors.forename: H
authors.initials: H
authors.lastname: Mustonen
authors.forename: R
authors.initials: R
authors.lastname: Julkunen
mesh_terms: D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000150:complications; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage* / Q000627:therapeutic use; D010438:Peptic Ulcer Hemorrhage / Q000188:drug therapy* / Q000517:prevention & control; D011446:Prospective Studies; D013276:Stomach Ulcer / Q000150:complications
chemical_list: D000897:Anti-Ulcer Agents; D009853:Omeprazole