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 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.


CONCLUSIONS
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.
de Leest
Helena T J I
HT
Department of Rheumatology, VU University Medical Center, Amsterdam, The Netherlands. m.deleest@vumc.nl
Steen
Kirsti S S
KS
Lems
Willem F
WF
Bijlsma
Johannes W J
JW
van de Laar
Mart A F J
MA
Huisman
A Margriet
AM
Vonkeman
Harald E
HE
Houben
Harry H M L
HH
Kadir
Sylvana W
SW
Kostense
Piet J
PJ
van Tulder
Maurits W
MW
Kuipers
Ernst J
EJ
Boers
Maarten
M
Dijkmans
Ben A C
BA
D000368:Aged; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D017291:Clarithromycin / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D010437:Peptic Ulcer / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology*; D013997:Time Factors; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole