OMEPRAZOLE-BASED DUAL AND TRIPLE THERAPY FOR THE TREATMENT OF HELICOBACTER-PYLORI INFECTION IN PEPTIC-ULCER DISEASE - A RANDOMIZED TRIAL

Objectives, it was our goal to evaluate the efficacy and safety and pa tient compliance with omeprazole-based dual and triple therapy for era dication of Helicobacter pylori in peptic ulcer disease. Materials and Methods. One hundred seventy-five consecutive patients with H. pylori infection and associated active peptic ulcer were included. H. pylori infection was assessed by rapid urease test and histological analysis . Patients were randomized among three treatments: group 1 (56 patient s): omeprazole, 20 mg bid, and amoxicillin, 1 gm bid, for 2 weeks; gro up 2 (61 patients): omeprazole, 20 mg bid, plus amoxicillin, 1 gm bid, and metronidazole, 500 mg bid, for 1 week; and group 3 (58 patients): omeprazole, 20 mg bid, plus amoxicillin, 1 gm bid, and clarithromycin , 500 mg bid, for 1 week. Ulcer healing and cure of infection were eva luated at 4 to 6 weeks after cessation of therapy. Eradication rate wa s calculated per-protocol and by an intention-to-treat analysis. Resul ts. At posttreatment endoscopy, duodenal ulcer was healed in 98.3% of patients. Eleven patients (6%) were lost to follow-up. H. pylori Infec tion was treated successfully in 55% (95% confidence interval [CI] = 4 1%-69%) of patients of group 1; 86% (95% CI = 77%-95%) of group 2 (p < .001 vs. group 1); and 93% (95% CI = 85%-100%) of group 3 (p < .001 v s. group I). On intention-to-treat analysis, eradication was 52%, 80%, and 86% in groups 1, 2, and 3, respectively. A good compliance was ob served in more than 90% of patients of all groups. Side effects were r eported by 7% of patients in group 1, 9% in group 2, and 11% in group 3. None of the patients stopped therapy because of side effects. Concl usions. Dual-therapy omeprazole-amoxicillin for 2 weeks is associated with significantly lower eradication rate than is 1-week omeprazole-ba sed triple therapies. Triple therapy is well-tolerated and produces si de effects similar to those of dual therapy. The highest cure rate of H. pylori infection was achieved with triple therapy of omeprazole, am oxicillin, and clarithromycin for 1 week.