Background The relation between Helicobacter pylori infectionand nonulcer dyspepsia is uncertain. We tested the hypothesisthat curing the infection will relieve symptoms of dyspepsia.
Methods We randomly assigned 170 H. pylori–infected patientswith nonulcer dyspepsia to receive twice-daily treatment with20 mg of omeprazole, 1000 mg of amoxicillin, and 500 mg of clarithromycinfor 14 days and 167 such patients to receive identical-appearingplacebos; all patients were then followed through regular visitsfor 12 months. Symptoms were scored on diary cards for sevendays before each visit. A carbon-13 urea breath test was performedat base line and repeated at 1 and 12 months, and endoscopicbiopsy was performed at 12 months to determine H. pylori status.Treatment was considered successful if the patient had onlymild pain or discomfort or none at all.
Results The rate of eradication of H. pylori infection was 90percent in the active-treatment group and 2 percent in the placebogroup at four to six weeks (P<0.001). At 12 months, therewas no significant difference between groups in the rate ofsuccessful treatment (46 percent in the active-treatment groupand 50 percent in the placebo group; relative likelihood ofsuccess with active treatment, 0.93; 95 percent confidence interval,0.73 to 1.18; P=0.56). There was also no significant differencein the rate of successful treatment at 12 months between patientswho were H. pylori–negative and those who were H. pylori–positive(48 percent vs. 49 percent). The rates of successful treatmentwere also similar when patients were analyzed according to thetype of dyspepsia (ulcer-like, reflux-like, or dysmotility-like)and changes in the quality of life. There was no significantassociation between treatment success and histologic improvementin chronic gastritis at 12 months (P=0.68).
Conclusions We found no evidence that curing H. pylori infectionin patients with nonulcer dyspepsia leads to relief of symptoms.
Source Information
From the Department of Medicine, University of Sydney, Nepean Hospital, Penrith, Australia (N.J.T.); University of Wisconsin Medical School, Milwaukee (N.V.); the Department of Family Medicine, Bethesda Hospital, Cincinnati (E.D.B.); and Oregon Health Sciences University, Portland (M.B.F.).
Address reprint requests to Dr. Talley at the Department of Medicine, University of Sydney, Nepean Hospital, Clinical Sciences Bldg., Penrith, NSW 2751, Australia, or at talley{at}pnc.com.au.
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