Effectiveness of Helicobacter pylori therapies in a clinical practice setting

Background: Whether eradication rates for Helicobacter pylori treatment reg imens obtained in controlled clinical trials (efficacy) can also be obtaine d in clinical practice (effectiveness) is unknown because no such trials ha ve been reported in the United States. Objectives: To determine the eradication rates of H pylori in a community p ractice setting and the effects of practice variation in the choice of trea tment regimen on patient outcome (H pylori infection cure) and cost. Methods: Between February 1 and December 30, 1996, 38 community-based gastr oenterologists in the Portland, Ore, metropolitan area enrolled a total of 250 patients infected with H pylori, as determined by endoscopic or noninva sive methods. Various therapeutic regimens aimed at eradicating H pylori we re used by the gastroenterologists, and a posttreatment urea breath test wa s used to determine H pylori infection cure. Compliance and incidental effe cts were also measured and decision analysis was used to estimate the cost of treatment. Results: The regimens used varied considerably. Patients receiving a 2- or 3-times-a-day treatment regimen were significantly more compliant (P = .01) than those receiving a 4-times-a-day regimen. Proton pump inhibitor-based triple-therapy regimens were significantly more effective than all other tr eatment regimens combined (87% vs 70%; P = .001) in eradicating H pylori. T hese proton pump inhibitor-based triple-therapy regimens were also more cos t-effective by decision analysis for a hypothetical cohort of patients with duodenal ulcer disease. Conclusions: The considerable variation in the choice of treatment regimens affects the clinical and economic outcomes of patients undergoing therapy for H pylori infection. Whether these data reflect the outcome in other com munities is unknown but should be determined. It will be necessary to deter mine if the dissemination of these data results in a reduction of practice variation and improvement in clinical and economic outcomes of patients bei ng treated for PI pylori infection in clinical practice.