One-day Quadruple Therapy Compared With 7-day Triple Therapy For Helicobacter Pylori Infection

One-day Quadruple Therapy Compared With 7-day Triple Therapy For Helicobacter Pylori Infection

Lara L F; Cisneros G; Gurney M; Van Ness M; Jarjoura D; Moauro B; Polen A; Rutecki G; Whittier F

Archives of Internal Medicine

2003

2003-09

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 retreated 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.

clarithromycin; cure; duodenal-ulcer disease; eradication; follow-up; General & Internal Medicine; nonulcer dyspepsia; peptic-ulcer; proton-pump inhibitor; term; united-states; urea breath test

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2079-2084

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