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

• 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
• ISSN: 1083-4389; 1523-5378; 1478-4041
• DOI: 10.1111/j.1523-5378.2007.00543.x

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.