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A Randomized Controlled Trial of Test-and-Treat Strategy for Helicobacter pylori
Clinical Outcomes and Health Care Costs in a Managed Care Population Receiving Long-term Acid Suppression Therapy for Physician-Diagnosed Peptic Ulcer Disease
James E. Allison, MD;
Leo B. Hurley, MPH;
Robert A. Hiatt, MD, PhD;
Theodore R. Levin, MD;
Lynn M. Ackerson, PhD;
Tracy A. Lieu, MD, MPH
Arch Intern Med. 2003;163:1165-1171.
Background Guidelines recommend Helicobacter pylori (HP) testing and treatment for patients with a history of peptic ulcer disease (PUD), assuming that PUD has been documented and that successful HP eradication would eliminate the need for further therapy and medical utilization.
Methods An open-label, randomized controlled trial in a managed care setting evaluated the clinical outcome and costs of an HP test-and-treat (T & T) strategy in 650 patients receiving long-term acid suppression therapy for physician-diagnosed PUD. Patients were randomized to T & T for HP (n = 321) or to usual care (n = 329). Outcome measures included presence and severity of PUD symptoms, use of acid-reducing medication, and acid-peptic–related health care costs during 12-month follow-up.
Results Only 17% of study participants had PUD confirmed by radiography or endoscopy; only 38% of the T & T group tested positive for HP. At 12 months, patients in the T & T group were less likely to report ulcerlike dyspepsia or use of acid-reducing medication; however, 75% of the T & T group used acid-reducing medication during the second half of the 12-month follow-up. In the 12 months after randomization, the T & T group had higher total acid-peptic–related costs than the usual care group.
Conclusions Most patients receiving long-term acid suppression therapy for physician-diagnosed PUD in community practice settings are likely to have HP-negative, uninvestigated dyspepsia. Routine testing and treating for HP will not reduce acid-peptic–related costs and have only a modest (though statistically significant) effect in reducing clinical symptoms and use of acid-reducing medications.
From the Division of Research, Kaiser Permanente Medical Care Program, Northern California Region, Oakland (Drs Allison, Hiatt, Levin, and Ackerson and Mr Hurley); University of California, San Francisco General Hospital Campus (Dr Allison); Department of Gastroenterology, Kaiser Permanente Medical Center, Walnut Creek, Calif (Dr Levin); and Department of Ambulatory Care and Prevention, Harvard Pilgrim Health Care and Medical School, Boston, Mass (Dr Lieu). Dr Hiatt is now with the University of California, San Francisco. The authors have no relevant financial interest in this article.
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