NEW ONE-WEEK TRIPLE THERAPIES WITH METRON IDAZOLE FOR THE ERADICATIONOF HELICOBACTER-PYLORI - CLARITHROMYCIN OR AMOXICILLIN AS THE 2ND ANTIBIOTIC

BACKGROUND: TO compare the efficacy of two ''new'' one-week triple the rapies (with omeprazole, metronidazole and clarithromycin or amoxycill in) for the eradication of Helicobacter pylori and healing duodenal ul cer. METHODS: Randomised therapeutic trial. Eighty-eigh consecutive du odenal ulcer patients with H. pylori infection were studied. At endosc opy, biopsies from both gastric antrum and body were obtained for hist ologic study (H&E). Two different therapies were administered for one week: omeprazole (O) (20 mg b.i.d.) and metronidazole (M) (500 mg b.i. d.) associated with clarithromycin (C) (500 mg b.i.d.) (group OMC, n = 44) or amoxycillin (A) (1 g b.i.d.) (group OMA, n = 44). Endoscopy wi th biopsies was repeated one month after completing therapy, and a C-1 3-urea breath test was also performed. Compliance was evaluated by tab let count. Analysis of data: multiple logistic regression, intention-t o-treat. Eradication was defined as the absence of H. pylori by all di agnostic methods. RESULTS: Mean age (standard deviation) was 45(14) ye ars, 75% males, Distribution of variables was similar in both therapeu tic groups. Forty-two patients in each group completed the protocol. E radication was achieved in 90.5% (95% CI = 78-96%) in group OMC and in 57% (42-71%) in group OMA (p < 0.001), In the multivariate analysis t he type of therapy was the only variable which influenced on H. pylori eradication (OR = 7.1; CI = 2.2-24; p = 0.001). Ulcer healing was dem onstrated in 88% (75-95%) of patients in group OMC and in 71% (56-83%) in group OMA (p = 0.1). Ulcer healing was higher when eradication was achieved (90%; 80-95%) than in H. pylori-positive patients (50%; 31-6 9%) (p < 0.001). Eradication of H. pylori was the only variable which influenced on ulcer healing (OR = 9.3; CI = 2.8-31; p < 0.001). CONCLU SION: The ''new'' triple therapy with omeprazole, metronidazole and cl arithromycin (administered in a twice-a-day basis and only for one wee k) had an excellent efficacy for the eradication of H. pylori, signifi cantly higher than that obtained with amoxycillin instead of clarithro mycin. Both therapies achieved a high ulcer healing rate when H. pylor i was eradicated, even with omeprazole administered only for one week.