Effect of omeprazole and amoxicillin plus metronidazole on the eradicationof Helicobacter pylori and the healing of duodenal ulcer: Comparison with a historical control

BACKGROUND/AIMS: To test the hypothesis of equivalence of an omeprazole 7-d ay triple therapy without subsequent acid suppression and a historical rani tidine 12-day triple therapy (recruiting phase 1989-91) with subsequent aci d suppression in their effect on the eradication of Helicobacter pylori (H. pylori) and the healing of duodenal ulcer. METHODOLOGY: Seventy-seven patients with H. pylori-positive duodenal ulcers received a 7-day treatment with amoxicillin 750mg tid and metronidazole 50 0mg tid. Additional omeprazole 20mg or 40mg 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% wit hin 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 femal e, but only in the 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 PIMP showed ulcer healing rates of 95% (5 3/56) for sensitive and 76% (16/21) for resistant strains (p<0.05). Improve ment of pain also showed a significant correlation with successful eradicat ion. H. pylori-eradication, healing and symptom relief were similar in the omeprazole 20mg and 40mg groups. CONCLUSIONS: The effect of amoxicillin plus metronidazole plus antisecretor y agent on the eradication of H. pylori has decreased markedly during the p ast 6 years due to the escalation of PMR. Doubling of the omeprazole dose d oes not affect outcome. Cure of the infection as well as metronidazole susc eptibility enhance duodenal ulcer healing and symptom relief. Acid suppress ion following a successful 1-week anti-HP therapy is not required for duode nal ulcer treatment.