Lack of effect of treatment for Helicobacter pylori on symptoms of nonulcer dyspepsia

Background: Prior studies have yielded conflicting results on whether or no t Helicobacter pylori causes nonulcer dyspepsia. Patients and Methods: We enrolled 100 consecutive patients with nonulcer dy spepsia into a randomized, double-blind, placebo-controlled trial. Patients with peptic ulcer disease, esophagitis, hepatobiliary disease, irritable b owel disease, or predominantly reflux-related symptoms were excluded by his tory and upper endoscopy. Helicobacter pylori infection was determined by b iopsy and histologic examination. Serum H pylori IgG antibodies and CagA st atus were determined by Western blot. Enrolled patients were randomized to a 14-day regimen of omeprazole (20 mg twice daily) and clarithromycin (500 mg three times daily) or placebo. Dyspeptic symptoms were assessed by use o f a visual analog scale at baseline and at 1, 3, 6, and 12 months after tre atment. Follow-up upper endoscopy with biopsy was performed 4 weeks after t reatment. Compliance was measured by tablet counts. Results: At 1 year, the change in dyspeptic symptoms was -24.0 (95% confide nce interval, -69.0 to 21.0) in the omeprazole and clarithromycin group and -24.2 in the placebo group (95% confidence interval, -70.0 to 21.6). Furth ermore, patients with persistent H pylori infection demonstrated a greater, but not significant, improvement in symptoms (-40 +/- 144 [mean+/-SD], -65 +/- 142, -45 +/- 138, and -39 +/- 163) than those with successful eradicat ion (-26 +/- 126, -26 +/- 148, -12 +/- 126, and -25 +/- 151) at months 1, 3 , 6, and 12, respectively. Conclusion: Patients with nonulcer dyspepsia should not routinely be treate d for H pylori, since it is not a cause of this condition in most patients.