Medium- or high-dose omeprazole plus amoxicillin eradicates Helicobacter pylori in gastric ulcer disease.
OBJECTIVE
To compare the efficacy of two omeprazole/amoxicillin regimens concerning Helicobacter pylori eradication, ulcer healing, pain relief, and safety in patients with gastric ulcer disease.


METHODS
In a prospective, single-blind, single-center study, 70 patients with active, H. pylori-positive (histology and/or culture) gastric ulcers were randomly treated with either omeprazole 20 mg b.i.d. plus amoxicillin 1 g b.i.d. (group I; n = 35) or with omeprazole 40 mg b.i.d. plus amoxicillin 1 g b.i.d. over 2 wk, followed by full dose ranitidine for another 4 wk. Patients were investigated clinically and endoscopically prior to treatment and after 6 wk, including the assessment of H. pylori status by means of urease test, specific culture, and histology.


RESULTS
Patients of group I and II had similar demographic and clinical characteristics. Three patients were lost to follow-up. The overall proportion of H. pylori eradication was 88.1% (group I, 91.2%; group II, 84.8%, p = NS). The ulcer healing rate was 79.1% after 6 wk, 92.5% after 10 wk, and 100% after 6 months, without a statistically significant difference between the study groups. Complete pain relief occurred after a median of 2 days (group I) and 1.5 days (group II, p = NS), respectively. Six patients (9.0%) complained of side effects that led to discontinuation of amoxicillin treatment in three patients (4.5%).


CONCLUSIONS
Omeprazole plus amoxicillin is a highly effective and well-tolerated therapy regimen to eradicate H. pylori from the gastric mucosa of patients with gastric ulcer disease. In addition, the results clearly suggest that medium- and high-dose omeprazole schedules are equally effective with regard to bacterial eradication, ulcer healing, pain relief, and safety in gastric ulcers. Thus, medium- and not high-dose omeprazole plus amoxicillin should be the treatment regimen of first choice to eradicate H. pylori in gastric ulcer disease.
Labenz
J
J
Department of Internal Medicine, Elisabeth Hospital, Essen, Germany.
Rühl
G H
GH
Bertrams
J
J
Börsch
G
G
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage*; D011446:Prospective Studies; D013276:Stomach Ulcer / Q000188:drug therapy / Q000382:microbiology*
D000658:Amoxicillin; D009853:Omeprazole