Effect of omeprazole and amoxicillin plus metronidazole on the eradication of Helicobacter pylori and the healing of duodenal ulcer: comparison with a historical control.
OBJECTIVE
To test the hypothesis of equivalence of an omeprazole 7-day triple therapy without subsequent acid suppression and a historical ranitidine 12-day triple therapy (recruiting phase 1989-91) with subsequent acid suppression in their effect on the eradication of Helicobacter pylori (H. pylori) and the healing of duodenal ulcer.


METHODS
Seventy-seven patients with H. pylori-positive duodenal ulcers received a 7-day treatment with amoxicillin 750 mg tid and metronidazole 500 mg tid. Additional omeprazole 20 mg or 40 mg once daily was given to 39 and 38 of the patients, respectively. Endoscopy was performed before treatment and four weeks after cessation of therapy.


RESULTS
The cumulative intention-to-treat (ITT) H. pylori-eradication rate was 66% (51/77) as compared to 89% (46/52) for the historical control (p < 0.05). The corresponding ulcer healing rates were 90% (69/77) and 92% (48/52). Primary metronidazole resistance (PMR) had escalated from 10% to 27% within 6 years resulting in eradication rates of 84% for sensitive and 19% for resistant strains (p < 0.001). PMR could be demonstrated in 45% of all female, but only in 17% of the male patients (p < 0.05). In the patients with H. pylori eradication, the ulcers healed in 98% (50/51) as compared to 73% (19/26) in those with persistent infection (p < 0.005). Analysis based on the presence of PMR showed ulcer healing rates of 95% (53/56) for sensitive and 76% (16/21) for resistant strains (p < 0.05). Improvement of pain also showed a significant correlation with successful eradication. H. pylori-eradication, healing and symptom relief were similar in the omeprazole 20 mg and 40 mg groups.


CONCLUSIONS
The effect of amoxicillin plus metronidazole plus antisecretory agent on the eradication of H. pylori has decreased markedly during the past 6 years due to the escalation of PMR. Doubling of the omeprazole dose does not affect outcome. Cure of the infection as well as metronidazole susceptibility enhance duodenal ulcer healing and symptom relief. Acid suppression following a successful 1-week anti-HP therapy is not required for duodenal ulcer treatment.
Schütze
K
K
Medical Department I, Hanusch Hospital, Vienna, Austria.
Hentschel
E
E
Hirschl
A M
AM
D000293:Adolescent; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage*; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage*; D010406:Penicillins / Q000008:administration & dosage*; D011899:Ranitidine / Q000008:administration & dosage
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D010406:Penicillins; D008795:Metronidazole; D000658:Amoxicillin; D011899:Ranitidine; D009853:Omeprazole