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Luis F. Lara, MD; Gerardo Cisneros, MD; Michael Gurney, MD; Michael Van Ness, MD; David Jarjoura, PhD; Betty Moauro, RN; Ann Polen, MEd; Gregory Rutecki, MD; Frederick Whittier, MD

Arch Intern Med. 2003;163:2079-2084.

Background  Eradication of Helicobacter pylori infection has had an impact on the treatment and recurrence rates of peptic ulcer disease and malignancies such as mucosa-associated lymphoid tissue lymphoma. Treatment options are cumbersome, expensive, and associated with side effects.

Methods  Randomized, prospective, open-labeled equivalence trial with a parallel-group design to compare eradication rates of H pylori with a 1-day, 4-drug regimen with a 7-day, 3-drug regimen. A total of 160 patients with dyspepsia and a Glasgow Dyspepsia Severity Score of at least 3 had a urea breath test labeled with carbon 14. Patients who tested positive were randomized to 1 of the 2 study groups. The study was designed to test the therapeutic equivalence of 1-day and 7-day regimens based on the percentage of H pylori eradication in each group at 5 weeks.

Results  The 1-day treatment group (n = 80) had a slightly higher eradication percentage (95%) than the 7-day group (90%). The possible inferiority of the 1-day treatment relative to the 7-day treatment, a 15% difference in the number of patients whose infection was not eradicated at 5 weeks, was rejected (P<.001; 90% confidence interval, 2.7%-11%). Both groups demonstrated a mean decrease of 7.5 points in the Glasgow Dyspepsia Severity Score. The 2 groups showed no significant differences in side effects. Patients whose treatment failed (4 in the 1-day treatment group and 7 in the 7-day treatment group) were re-treated for 10 days. One patient from the 7-day treatment group still tested positive after the second treatment.

Conclusions  The 1-day treatment proved to be statistically similar to the 7-day treatment for the eradication of H pylori in patients with dyspepsia and a positive urea breath test. Further evaluation will be necessary to determine whether the 1-day regimen is adequate for patients with peptic ulcer disease, mucosa-associated lymphoid tissue lymphoma, or gastric adenocarcinoma.

From the Wake Forest University School of Medicine, Winston-Salem, NC (Dr Lara), and the Northeastern Ohio Universities College of Medicine Affiliated Hospitals, Canton (Drs Cisneros, Jarjoura, Rutecki, and Whittier and Ms Polen). Drs Gurney and Van Ness and Ms Moauro are in private practice in Canton. The authors have no relevant financial interest in this article.

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