Lack of effect of treatment for Helicobacter pylori on symptoms of nonulcer dyspepsia.
BACKGROUND
Prior studies have yielded conflicting results on whether or not Helicobacter pylori causes nonulcer dyspepsia.


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.


RESULTS
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.


CONCLUSIONS
Patients with nonulcer dyspepsia should not routinely be treated for H. pylori, since it is not a cause of this condition in most patients.
Greenberg
P D
PD
Gastroenterology, Hepatology, and Clinical Nutrition, Medical Service, San Francisco General Hospital, and Department of Medicine, University of California, USA.
Cello
J P
JP
D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D015153:Blotting, Western; D004415:Dyspepsia / Q000188:drug therapy* / Q000382:microbiology; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013997:Time Factors; D017211:Treatment Failure
D000907:Antibodies, Bacterial; D004791:Enzyme Inhibitors; D009853:Omeprazole