Influence of Helicobacter pylori eradication therapy on the occurrence of gastrointestinal events in patients treated with conventional nonsteroidal antiinflammatory drugs combined with omeprazole.
OBJECTIVE
To evaluate the effect of eradication treatment of Helicobacter pylori and the influence of H. pylori status on the incidence of gastrointestinal (GI) events in rheumatic patients receiving longterm conventional nonsteroidal antiinflammatory drug (NSAID) therapy combined with omeprazole.


METHODS
Patients (n = 919) requiring longterm NSAID therapy entered this multicenter, open label, parallel group study. H. pylori positive patients were randomized to receive either eradication therapy (omeprazole 20 mg bid, amoxicillin 1 g bid, and clarithromycin 500 mg bid for 7 days) or no therapy. Both these groups and the H. pylori negative patients were given omeprazole, 20 mg once daily, along with NSAID for the study duration (5-8 weeks). Treatment failure (primary outcome variable) was defined as the occurrence of severe GI event (symptomatic ulcer, bleeding, perforation) or dyspepsia leading to discontinuation of NSAID therapy, unscheduled consultation, or upper GI tract endoscopy.


RESULTS
Treatment failure was recorded in 9/294 (3.06%) infected patients receiving eradication therapy, 8/219 (3.65%) infected patients receiving omeprazole alone, and 5/391 (1.28%) H. pylori negative patients (p > 0.05). H. pylori eradication did not appear to influence the incidence and severity of dyspeptic symptoms in infected patients.


CONCLUSIONS
Our results do not support the use of H. pylori eradication therapy in rheumatic patients receiving conventional NSAID along with omeprazole.
Bannwarth
Bernard
B
Department of Rheumatology, Groupe Hospitalier Pellegrin, Bordeaux, France. bernard.bannwarth@u-bordeaux2.fr
Dorval
Etienne
E
Caekaert
Agnes
A
Barthelemy
Philippe
P
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000150:complications / Q000188:drug therapy; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004347:Drug Interactions; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005753:Gastric Mucosa / Q000187:drug effects / Q000382:microbiology; D005773:Gastroscopy / Q000379:methods; D016481:Helicobacter Infections / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects* / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage* / Q000009:adverse effects; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D017211:Treatment Failure; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D009853:Omeprazole