ONE-WEEK THERAPY WITH OMEPRAZOLE, CLARITHROMYCIN AND METRONIDAZOLE ORORNIDAZOLE, FOLLOWED BY 3 WEEKS TREATMENT WITH OMEPRAZOLE, ERADICATESHELICOBACTER-PYLORI EQUALLY AND HEALS DUODENAL-ULCER

Objective: To estimate and compare the efficacy of `triple' 1-week reg imens omeprazole, clarithromycin and a nitroimidazole (metronidazole o r ornidazole) followed by omeprazole, for an additional 3 weeks, on He licobacter pylori eradication and duodenal ulcer (DU) healing, in a co untry with a high resistance rate of H. pylori to metronidazole. Desig n: Open, prospective, two-centre study. Methods: Patients older than 1 8 years with active duodenal ulcer (DU), diagnosed by endoscopy and fo und to be infected with H. pylori (modified Giemsa stain and CLO test, Delta West, Australia), were included in the study. Three triple-drug regimens, given for 7 days, were used. (1) omeprazole (Om) 20 mg once a day, plus clarithromycin (Cl) 250 mg twice daily, plus ornidazole ( Or) 500 mg twice daily (O1COr); (2) Om 20 mg twice daily, plus Cl 250 mg twice daily, plus Or 500 mg twice daily (OCOr); and (3) Om 20 mg tw ice daily, plus Cl 250 mg twice daily, plus metronidazole (M) 500 mg t wice daily (OCM). Two hundred and three consecutive H. pylori-positive patients were included in the study, randomly assigned as follows: 50 patients (group A1: 32 men, 18 women, age 23-77 years) on O1COr; 47 p atients (group A2: 29 men, 18 women, age 27-77 years) on OCOr; and 106 (group B: 71 men, 35 women, age 18-83 years) on OCM. Ulcer healing an d H. pylori eradication were assessed endoscopically, 8-9 weeks after the start of treatment. H. pylori was considered eradicated if both hi stology and rapid urease test (six biopsies, antrum-body) were negativ e. Results: Eleven patients were lost to follow-up; 192 patients were analysed. Group A1: 48; group A2: 44; group B: 100. `Per-protocol' ana lysis: H. pylori eradication, 90-93% (P = 0.901); ulcer healing, 90-98 % (P = 0.300). 'Intention to treat' analysis: H. pylori eradication, 8 5-88% (P = 0.887); ulcer healing, 86-91% (P = 0.657). Compliance was e xcellent, no serious side effects were observed and no patients withdr ew due to side effects. Conclusions: No differences were observed in t he H. pylori eradication and the healing rate among the groups. It see ms that twice daily omeprazole is no better than single daily dosage a nd that ornidazole is as effective as metronidazole. In addition, in t he studied population which is believed to have a high prevalence of m etronidazole resistance, all the regimens used were effective.