Eradication of Helicobacter pylori does not reduce the incidence of gastroduodenal ulcers in patients on long-term NSAID treatment: double-blind, randomized, placebo-controlled trial

Helena T.J.I. de Leest, Kirsti S.S. Steen, Willem F. Lems, Johannes W.J. Bijlsma, Mart A F J van de Laar, A. Margriet Huisman, Harald Erwin Vonkeman, Harry H.M.L. Houben, Sylvana W. Kadir, Piet J. Kostense, Maurits W. van Tulder, Ernst J. Kuipers, Maarten Boers, Ben A.C. Dijkmans

    Research output: Contribution to journalArticleAcademicpeer-review

    42 Citations (Scopus)

    Abstract

    Background: Helicobacter pylori and nonsteroidal antiinflammatory drugs (NSAIDs) are the major causes of gastroduodenal ulcers. Studies on the benefit of eradication of H. pylori in NSAID users yielded conflicting results. Objective: To investigate whether H. pylori eradication in patients on long-term NSAIDs reduces the incidence of gastroduodenal ulcers. Methods: Patients on long-term NSAID treatment and who are H. pylori positive on serologic testing, were randomly assigned to either H. pylori eradication (omeprazole, amoxicillin, and clarithromycin) or placebo. Primary endpoint was the presence of endoscopic gastric or duodenal ulcers 3 months after randomization. Results: One hundred sixty-five (48%) of a total of 347 patients were on gastroprotective medication. At endoscopy, gastroduodenal ulcers were diagnosed in 6 (4%) and 8 (5%) patients in the eradication and placebo group, respectively (p = .65). During follow-up of 12 months, no symptomatic ulcers or ulcer complications developed. No significant differences were found in the development of gastroduodenal erosions, dyspepsia, or in quality of life. Conclusion: H. pylori eradication therapy in patients on long-term NSAID treatment had no beneficial effect on the occurrence of ulcers, erosions, or dyspepsia. Ulcer rates in both study arms are remarkably low, in both patients with and without gastroprotective therapy.
    Original languageUndefined
    Pages (from-to)477-485
    JournalHelicobacter
    Volume12
    Issue number5
    DOIs
    Publication statusPublished - 2007

    Keywords

    • non-steroidal
    • stomach ulcer
    • duodenal ulcer
    • anti-ulcer agents
    • anti-inflammatory agents
    • Helicobacter pylori
    • IR-71299
    • METIS-243928

    Cite this