Quadruple Therapy for Helicobacter pylori Infection

David J. Bjorkman, MD, MSPH (HSA), SM (Epid.)


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In This Article

Abstract and Introduction


A combination of bismuth subcitrate potassium, metronidazole, tetracycline, and omeprazole was safe and effective at eradicating H. pylori infection.


Eradication of Helicobacter pylori infection requires multiple-drug therapy. Given that some of the standard drugs, particularly clarithromycin, lose efficacy because of increasing antibiotic resistance, evaluation of new therapeutic regimens is essential.

To test a new four-drug regimen, European investigators conducted an industry-sponsored, noninferiority, open-label, randomized phase III trial involving 438 patients with H. pylori infection and upper gastrointestinal symptoms. Patients received either quadruple therapy (a single capsule containing bismuth subcitrate potassium, metronidazole and tetracycline, 4 times a day, plus omeprazole twice daily) for 10 days or standard therapy (omeprazole, amoxicillin and clarithromycin twice daily) for 7 days. Successful eradication of H. pylori infection was defined as negative urea breath tests at ≥28 and ≥56 days after completion of therapy.

The intent-to-treat eradication rate was higher in the quadruple-therapy group than in the standard-therapy group (80% vs. 55%; P<0.0001). Safety profiles were similar in both groups. Treatment failures in the standard-therapy group were associated with clarithromycin resistance (P<0.0001).

The authors conclude that 10-day quadruple therapy provides higher eradication rates and a similar safety profile compared with 7-day standard therapy in a European population. They further suggest that, because of the rising incidence of clarithromycin resistance, quadruple therapy should be considered as first-line therapy for H. pylori infection.


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