A three-day course of intravenous omeprazole plus antibiotics for H. pylori-positive bleeding duodenal ulcer.

BACKGROUND/AIMS: This prospective trial aimed to test the efficacy of 3-day intravenous omeprazole plus antibiotics for Helicobacter pylori (H. pylori) eradication rate, and to see whether individualized response to omeprazole in intragastric pH elevation will alter the success of eradication.

METHODOLOGY: One hundred and thirty-eight cases with H. pylori-positive duodenal ulcer bleeding were randomized into four therapy groups: Group 1 (n = 32) received a 3-day course of intravenous omeprazole (80 mg loading then 40 mg q 9 am & 9 pm) plus ampicillin/salbactum (1.5 gm i.v. loading then 750 mg q 9 am, 3 pm, & 9 pm); Group 2 (n = 35) followed protocol as for Group 1 except the antibiotics were metronidazole and erythromycin (both 500 mg i.v. q 9 am, 3 pm, & 9 pm). Group 3 (n = 31) followed protocol as for Group 1 and further added with erythromycin (both 500 mg i.v. q 9 am, 3 pm, & 9 pm). Group 4 served as a control group (n = 40) receiving oral dual therapy after leaving the emergency room (omeprazole 20 mg and amoxycillin 1 g bid x 2 weeks). In each case, three gastric biopsies were done for total histologic density of H. pylori (THPD) (range: 0-15) before, 1 day and 6 weeks after completion of therapy. Except for the control group, the 24-hour ambulatory intragastric pH meter (MIC Inc, Gastrograph Spark III, Swiss) was inserted as possible on the 2nd day of therapy.

RESULTS

The 3-day intravenous regimens achieved high clearance rates of H. pylori (Group 1: 93.8%; Group 2: 93.9%; Group 3: 100%). The eradication rates of H. pylori in Groups 1-4 were 43.8%, 57.1%, 58.1%, and 72.8%, respectively. In Groups 1-3, the H. pylori-eradicated cases had lower pre-treatment THPD than non-eradicated cases (6.01 vs. 9.24, p < 0.001). Among 72 cases with pH meter insertion, the percentage of intragastric pH > 5.3 during 24-hour was not different among 35 H. pylori non-eradicated and 37 eradicated cases (78.7 vs. 76.7%, p > 0.05).

CONCLUSIONS

The 3-day intravenous regimens may achieve clearance of H. pylori quickly. However, they were not so effective for eradication, especially in cases with higher bacterial loads. The interindividual response to omeprazole in intragastric pH elevation under the study dosage had insignificant variations to alter the success of eradication.