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

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 lon...

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Bibliographic Details
Published in:Helicobacter (Cambridge, Mass.) Mass.), 2007-10, Vol.12 (5), p.477-485
Main Authors: De Leest, Helena T.J.I., Steen, Kirsti S.S., Lems, Willem F., Bijlsma, Johannes W.J., Van De Laar, Mart A.F.J., Huisman, A. Margriet, Vonkeman, Harald E., Houben, Harry H.M.L., Kadir, Sylvana W., Kostense, Piet J., Van Tulder, Maurits W., Kuipers, Ernst J., Boers, Maarten, Dijkmans, Ben A.C.
Format: Article
Language:English
Subjects:
Aged
Amoxicillin - therapeutic use
Anti-Bacterial Agents - therapeutic use
anti-inflammatory agents
Anti-Inflammatory Agents, Non-Steroidal - adverse effects
Anti-Inflammatory Agents, Non-Steroidal - therapeutic use
anti-ulcer agents
Anti-Ulcer Agents - therapeutic use
Clarithromycin - therapeutic use
Double-Blind Method
Drug Therapy, Combination
duodenal ulcer
Female
Helicobacter Infections - complications
Helicobacter Infections - drug therapy
Helicobacter Infections - epidemiology
Helicobacter Infections - microbiology
Helicobacter pylori
Helicobacter pylori - drug effects
Humans
Incidence
Male
Middle Aged
non-steroidal
Omeprazole - therapeutic use
Peptic Ulcer - complications
Peptic Ulcer - drug therapy
Peptic Ulcer - epidemiology
stomach ulcer
Time Factors
Treatment Outcome
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Summary: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.
ISSN:1083-4389
1523-5378
1478-4041
DOI:10.1111/j.1523-5378.2007.00543.x