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QUESTION: In patients with upper gastrointestinal symptoms presenting for investigation of dyspepsia, is treatment based on a urea breath test for Helicobacter pylori alone as effective as endoscopy and urea breath testing?
Design
Randomised {allocation concealed*}†, unblinded,* controlled trial with 1 year of follow up.
Setting
A gastroenterology clinic in Glasgow, UK.
Patients
708 patients (mean age 37 y, 53% men) who were referred by their general practitioners for investigation of upper gastrointestinal symptoms. Exclusion criteria were age >55 years, nonsteroidal anti-inflammatory drugs, or sinister symptoms. Follow up was 83%.
Intervention
Patients were allocated to endoscopy plus the noninvasive 14C-urea breath test (n=352) or the breath test alone (n=356) for determination of H pylori status. Patients were informed of their status after the test, and patients with positive results were prescribed a 7 day course of H pylori eradication treatment with omeprazole, 20 mg twice daily; clarithromycin, 250 mg 3 times daily; and amoxicillin, 500 mg (or metronidazole, 400 mg) 3 times daily.
Main outcome measures
Change from baseline on the Glasgow Dyspepsia Severity Score (GDSS). Secondary outcomes were use of medical resources, patient assessment of the procedures, and safety.
Main results
Analysis was by …
Footnotes
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Source of funding: NHS Executive Research and Development Technology Assessment Programme.
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For correspondence: Dr K McColl, Western Infirmary, Glasgow, UK. K.E.L.McColl{at}clinmed.gla.ac.uk
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Abstract and commentary published in ACP Journal Club
↵† Information provided by author.