A prospective randomized comparative trial showing that omeprazole prevents re-bleeding in bleeding peptic ulcer patients after successful endoscopic therapy

A blood clot at a peptic ulcer is unstable in a low pH environment. Omeprazole (OME) may prevent re-bleeding by elevating intragastric pH in bleeding peptic ulcer patients. In this study, we assessed the influence of OME and cimetidine (CIM) on 24 hours intragastric pH and to determine their ability to prevent re-bleeding after having achieved initial hemostasis in patients with active bleeding or non-bleeding visible vessels (NBVV). METHODS: Between Nov. 1995 and Jun. 1996, 100 bleeding peptic ulcer patients (spurting/oozing /NBVV: 21/13/66) who had obtained initial hemostasis with heater probe thermocoagulation (n=69) or multipolar electrocoagulation (n=31) were enrolled in the trial Fifty received OME and the same number received CIM randomly. In the CIM group, CIM was given 300 mg intravenous (i.v.) bolus followed by 1200 mg continuous infusion daily for three days. Thereafter, CIM was given 400 mg per os twice daily for two months. In the OME group, OME was given 40 mg i.v. bolus followed by 160 mg continuous infusion daily for three days. Thereafter, OME was given 20 mg per os once daily for two months. A pH meter (Gastrograph Mark III, Solothur, Switzerland) was inserted in each patient's fundus under fluoroscopic guidance after the i.v. bolus of CIM or OME. The outcome of measure was the re-bleeding rate, volume of blood transfused, numbers of surgery performed and the mortality rates of the two groups. RESULTS: The mean intragastric pH rose to 6 one hour after the initial bolus of OME in the OME group; it persisted around this value for the rest of 24 hours. In the CIM group, the mean intragastric pH rose to 4 one hour after the initial bolus of CIM and persisted around 4.5-5.5 for the rest of 24 hours. By day 3 and 14 there were fewer rebleeding episodes in the OME group than in the CIM group (0, 2 vs 8, 12, p<0.01, p<0.01). There was a tendency for the OME group to have a lower volume of blood transfused (median, range: 0, 0-2500 ml) as compared with that of the CIM group (0, 0-5000) (0.05<p<0.1). The length of hospital stay (days, median, range; OME: 7,3-27; CIM: 6,3-31), numbers of surgery performed (OME:0, CIM:0) and mortality rates (OME:2, CIM:0) of the two groups were not statistically different. CONCLUSIONS : Intravenous OME 40 mg bolus followed by 160 continuous infusion daily can elevate intragastric pH remarkably and prevent re-bleeding in patients with peptic ulcer bleeding after initial hemostasis has been achieved. It should be used routinely in these patients after successful endoscopic therapy.