March 29, 2001New England Journal of Medicine
Preventing Recurrent Upper Gastrointestinal Bleeding in Patients withHelicobacter pyloriInfection Who Are Taking Low-Dose Aspirin or Naproxen
Key result
For H. pylori patients with prior GI bleeding, eradication therapy equaled omeprazole in aspirin users (1.9% vs 0.9%), but omeprazole was superior in other NSAID users (4.4% vs 18.8%; P=0.005).
Why the study?
Does omeprazole prevent recurrent upper gastrointestinal bleeding better than H. pylori eradication in patients with H. pylori infection taking low-dose aspirin or naproxen?
Population
400 patients with H. pylori infection and a history of endoscopy-confirmed upper gastrointestinal bleeding…
Comparison
Omeprazole 20 mg daily for six months. vs One week of H. pylori eradication therapy…
Design
RCT, randomly assigned separately
Follow-up
6 months
Authors
Discussion
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Implication
Omeprazole preferred over eradication alone for naproxen users with prior bleed; extends NSAID-specific gastroprotection evidence in H. pylori patients.
Study Design
Type
RCT (n=400)
Blinding
Placebo-controlled
Randomization
randomly assigned
Structured PICO
Does omeprazole prevent recurrent upper gastrointestinal bleeding better than H. pylori eradication in patients with H. pylori infection taking low-dose aspirin or naproxen?
P
Population
400 patients with H. pylori infection and a history of upper gastrointestinal bleeding taking low-dose aspirin or other NSAIDs, followed for 6 months.
I
Intervention
Omeprazole 20 mg daily for six months.
C
Comparator
One week of H. pylori eradication therapy (bismuth subcitrate 120 mg, tetracycline 500 mg, metronidazole 400 mg, all four times daily) followed by placebo for six months.
O
Outcome
Recurrent upper gastrointestinal bleeding during the six-month period.hard clinical
Main Result
Effect estimate: Absolute difference 1.0% (95% CI -1.9 to 3.9)
Absolute Event Rate: 1.9% vs 0.9%
In patients with H. pylori and prior GI bleeding, omeprazole is equivalent to H. pylori eradication for preventing recurrent bleeding in those taking low-dose aspirin, but superior in those taking naproxen.
Cite This Study
Chan et al. (2001) conducted an RCT in Helicobacter pylori infection and history of upper gastrointestinal bleeding (n=400). H. pylori eradication therapy vs. Omeprazole 20 mg daily was evaluated on Recurrent bleeding during the six-month period (aspirin users) (Absolute difference 1.0%, 95% CI -1.9 to 3.9). For H. pylori patients with prior GI bleeding, eradication therapy equaled omeprazole in aspirin users (1.9% vs 0.9%), but omeprazole was superior in other NSAID users (4.4% vs 18.8%; P=0.005).