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Randomized Controlled Trial Comparative Study Clinical Trial
Significant increase in eradication rates of Helicobacter pylori infection with two consecutive dual therapies (omeprazole and amoxycillin or omeprazole and clarithromycin). A randomized study in 450 Spanish patients.
- J A Moreno, J M Pajares, C Santander, P Carpintero, C Hermida, S Lara, and R García Grávalos.
- Gastroenterology Department, Hospital de la Princesa, Madrid, Spain.
- J. Gastroenterol. 1996 Nov 1; 31 Suppl 9: 48-52.
AbstractHelicobacter pylori infection is associated with peptic ulcer disease and chronic gastritis, and eradication of the microorganism markedly reduces the recurrence of peptic ulcer. However, a major problem is the choice of a treatment that is effective, has high eradication rate, and is well tolerated by patients. We evaluated the eradication of H. pylori infection in patients with chronic gastritis (CG), duodenal ulcer (DU), and gastric ulcer (GU) after two dual therapies (omeprazole with either amoxycillin or clarithromycin). Of 450 patients initially included in the study, 207 had CG, 187 DU and 56 GU, and all presented with H. pylori infection. Diagnosis was made from endoscope examination, biopsy samples, rapid urease test and 13C-urea breath test (UBT). H. pylori infection was considered to be present when two of the tests had positive results. All patients were randomized to one of two regimens: (A) omeprazole (20 mg b.i.d.) plus amoxycillin (750 mg t.i.d.) or (B) omeprazole (40 mg b.i.d.) plus clarithromycin (500 mg t.i.d.). The duration of each of the regimens was 2 weeks. Fifty-eight patients who showed H. pylori infection after the first treatment (27 with CG, 24 with DU, and 7 with GU) were allocated to a second therapy. H. pylori eradication was assessed by UBT, 6 weeks after the end of the therapies; positive values were those higher than 5 delta units. A second consecutive dual therapy of omeprazole plus an antibiotic (amoxycillin or clarithromycin) not used in the first therapy improved on the eradication rates obtained with the first regimen. The overall eradication rates were also higher, but no significant differences were found between amoxycillin and clarithromycin. The best results were obtained in those patients with GU.
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