Funded by: Health Care Insurance Board, the Netherlands; Grant Number: OG-98-22
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
Article first published online: 21 AUG 2007
Volume 12, Issue 5, pages 477–485, October 2007
How to Cite
De Leest, H. T.J.I., Steen, K. S.S., Lems, W. F., Bijlsma, J. W.J., Van De Laar, M. A.F.J., Huisman, A. M., Vonkeman, H. E., Houben, H. H.M.L., Kadir, S. W., Kostense, P. J., Van Tulder, M. W., Kuipers, E. J., Boers, M. and Dijkmans, B. A.C. (2007), 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. Helicobacter, 12: 477–485. doi: 10.1111/j.1523-5378.2007.00543.x
- Issue published online: 21 AUG 2007
- Article first published online: 21 AUG 2007
- Helicobacter pylori;
- anti-inflammatory agents;
- duodenal ulcer;
- stomach ulcer;
- anti-ulcer agents
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.