Prior studies have yielded conflicting results on whether or not Helicobacter pylori causes nonulcer dyspepsia.
Patients and Methods
We enrolled 100 consecutive patients with nonulcer dyspepsia into a randomized, double-blind, placebo-controlled trial. Patients with peptic ulcer disease, esophagitis, hepatobiliary disease, irritable bowel disease, or predominantly reflux-related symptoms were excluded by history and upper endoscopy. Helicobacter pylori infection was determined by biopsy and histologic examination. Serum H pylori IgG antibodies and CagA status 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 of a visual analog scale at baseline and at 1, 3, 6, and 12 months after treatment. Follow-up upper endoscopy with biopsy was performed 4 weeks after treatment. Compliance was measured by tablet counts.
At 1 year, the change in dyspeptic symptoms was −24.0 (95% confidence 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). Furthermore, 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 eradication (−26±126, −26±148, −12±126, and −25±151) at months 1, 3, 6, and 12, respectively.
Patients with nonulcer dyspepsia should not routinely be treated for H pylori, since it is not a cause of this condition in most patients.