A NEW QUADRUPLE THERAPY FOR THE ERADICATION OF HELICOBACTER-PYLORI - EFFECT OF PRETREATMENT WITH OMEPRAZOLE ON THE CURE RATE

To elucidate whether pretreatment with omeprazole decreases the cure r ate of Helicobacter pylori infection with a new quadruple therapy, and thus, whether this pretreatment should not be used in clinical practi ce, we conducted a randomized trial. Ninety patients with chronic pept ic ulcer disease and nonulcer dyspepsia, with biopsy-proven H. pylori infection were randomly assigned to the two following regimens: Group 1 (n = 45) received omeprazole 20 mg once daily for 2 weeks (days 1-14 ), and 500 mg amoxicillin granules and 250 mg metronidazole thrice dai ly, and roxithromycin 150 mg twice daily for 1 week (days 8-14), Group 2 (n = 45) received the same antibiotic treatment as group 1 for 1 we ek (days 1-7), in addition to omeprazole treatment for 2 weeks (days 1 -14). Four weeks after the treatment ended, endoscopy was repeated, wi th two biopsy specimens each taken from the antrum and the corpus (tot al of four specimens) for a urease test, histological analysis, and cu lture to establish cure of infection. A patient was regarded as cured only if all three methods gave negative results for H, pylori. In the intention-to-treat analysis, 42 of 45 patients (93.3%; 95% confidence intervals [CI], 81.7%-98.6%) in group 1 were cured compared with 43 of 45 patients (95.6%; 95% CI, 84.9%-99.5%) in group 2. In the per-proto col analysis, the corresponding figures were 42/44 (95.5%; 95% CI 84.5 %-99.4%) and 43/44 (97.7%, 95% CI 88.0%-99.9%). There were no signific ant differences in the cure rate between the two groups on either anal ysis. All patients, except for one who had an allergic reaction, compl eted the treatment regimens. Fifty to sixty percent of the patients ha d no side effects while the rest had mild to moderate side effects. Th e new quadruple therapy consisting of omeprazole, amoxicillin, metroni dazole, and roxithromycin appears suitable for use in clinical practic e, as the cure rate was 95% and no severe side effects were observed. Pretreatment with omeprazole did not reduce the cure rate for this new quadruple therapy.