• Med Clin Barcelona · Feb 1999

    Randomized Controlled Trial Comparative Study Clinical Trial

    [Helicobacter pylori and digestive hemorrhage due to duodenal ulcer: the prevalence of the infection, the efficacy of 3 triple therapies and the role of eradication in preventing a hemorrhagic recurrence].

    • J P Gisbert, D Boixeda, R Aller, C de la Serna, E Sanz, C Martín de Argila, V Abraira, and A García Plaza.
    • Servicio de Gastroenterología, Hospital Ramón y Cajal, Departamento de Medicina, Universidad de Alcalá de Henares, Madrid. gisbert@meditex.es
    • Med Clin Barcelona. 1999 Feb 13;112(5):161-5.

    BackgroundTo report the prevalence of Helicobacter pylori in patients with bleeding duodenal ulcer and to verify the effect of eradication on hemorrhage recurrence. To evaluate the efficacy on H. pylori eradication and on ulcer healing of three one-week triple therapies and to compare their efficacy with that of a dual therapy.Patients And MethodsOne-hundred and eleven patients with bleeding duodenal ulcer not taking gastroerosive drugs were prospectively studied. At endoscopy, biopsies from gastric antrum and body were obtained (haematoxylin-eosin), and a 13C-urea breath test was also performed. Both diagnostic methods were repeated one month after completing one of the following treatments (randomized study): omeprazole (20 mg/12 h), amoxycillin (1 g/12 h) and clarithromycin (500 mg/12 h) (OAC, n = 27); omeprazole (20 mg/12 h), clarithromycin (500 mg/12 h) and metronidazole (500 mg/12 h) (OCM, n = 27); lansoprazole (30 mg/12 h), amoxycillin (1 g/12 h) and clarithromycin (500 mg/12 h) (LAC, n = 27); and lansoprazole (30 mg/12 h) and clarithromycin (500 mg/8 h) (LC, n = 27). The first three therapies were administered for one week, and LC for two weeks. Once eradication was confirmed no antisecretory therapy was administered. A breath test was performed in the follow-up at 6 months and at one year.ResultsThe prevalence of H. pylori infection was 97.3% (95% CI: 92-99%). Five patients were lost from the study during follow-up. The eradication efficacy (intention-to-treat) was: OAC, 89% (72-96%); OCM: 93% (77-98%); LAC, 93% (77-98%), and LC, 70% (51-84%). Overall triple therapy efficacy was higher than that of dual therapy (91% vs 70%; p < 0.05). Thirteen patients needed a 2nd or 3rd therapy, and eradication success was finally achieved in all cases. The type of therapy was the only variable which influenced on H. pylori eradication (OR: 4.5; 95% CI: 1.4-14%; p < 0.01) and H. pylori eradication was the only variable which influenced on ulcer healing (OR: 4.7; 95% CI: 1.2-19%; p < 0.05). The yearly reinfection rate was 2.8% (0.9-7.8%). No hemorrhage recurrences occurred during the one year follow-up period.ConclusionsH. pylori prevalence in bleeding doudenal ulcer is almost 100%. These patients will be spared of hemorrhage recurrence at least for one year if infection is eradicated. Therefore, eradication therapy is the therapy of choice, and maintenance therapy with antisecretory drugs is no longer needed. One-week triple therapies with a proton pump inhibitor and two antibiotics (clarithromycin plus amoxycillin or metronidazole) have a high efficacy in patients with bleeding duodenal ulcer.

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