Lack of Effect of Treating Helicobacter pylori Infection in Patients with Nonulcer Dyspepsia
André L. Blum, M.D., Nicholas J. Talley, M.D., Colm O'Moráin, M.D., Sander Veldhuyzen van Zanten, Ph.D., Joachim Labenz, M.D., Manfred Stolte, M.D., Japie A. Louw, Ph.D., Arild Stubberöd, M.D., Asgeir Theodórs, M.D., Marie Sundin, B.Sc., Elisabeth Bolling-Sternevald, Dip.N.Ed., Ola Junghard, Ph.D., for The Omeprazole plus Clarithromycin and Amoxicillin Effect One Year after Treatment (OCAY) Study Group
Background It is uncertain whether treatment of Helicobacterpylori infection relieves symptoms in patients with nonulcer,or functional, dyspepsia.
Methods We conducted a double-blind, multicenter trial of patientswith H. pylori infection and dyspeptic symptoms (moderate-to-very-severepain and discomfort centered in the upper abdomen). Patientswere excluded if they had a history of peptic ulcer diseaseor gastroesophageal reflux disease and had abnormal findingson upper endoscopy. Patients were randomly assigned to sevendays of treatment with 20 mg of omeprazole twice daily, 1000mg of amoxicillin twice daily, and 500 mg of clarithromycintwice daily or with omeprazole alone and then followed up forone year. Treatment success was defined as the absence of dyspepticsymptoms or the presence of minimal symptoms on any of the 7days preceding the 12-month visit.
Results Twenty of the 348 patients were excluded after randomizationbecause they were not infected with H. pylori, were not treated,or had no data available. For the remaining 328 patients (164in each group), treatment was successful for 27.4 percent ofthose assigned to receive omeprazole and antibiotics and 20.7percent of those assigned to receive omeprazole alone (P=0.17;absolute difference between groups, 6.7 percent; 95 percentconfidence interval, 2.6 to 16.0). After 12 months, gastritishad healed in 75.0 percent of the patients in the group givenomeprazole and antibiotics and in 3.0 percent of the patientsin the omeprazole group (P<0.001); the respective rates ofH. pylori eradication were 79 percent and 2 percent. In thegroup given omeprazole and antibiotics, the rate of treatmentsuccess among patients with persistent H. pylori infection wassimilar to that among patients in whom the infection was eradicated(26 percent vs. 31 percent). There were no significant differencesbetween the groups in the quality of life after treatment.
Conclusions In patients with nonulcer dyspepsia, the eradicationof H. pylori infection is not likely to relieve symptoms.
Source Information
From the Division of Gastroenterology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (A.L.B.); the Department of Medicine, University of Sydney and Nepean Hospital, Sydney, Australia (N.J.T.); the Department of Gastroenterology, MeathAdelaide Hospitals, Trinity College, Dublin, Ireland (C.O.); the Division of Gastroenterology, Queen Elizabeth II Health Sciences Center, Halifax, N.S., Canada (S.V.Z.); Uni-Klinik Otto von Guericke, Gastroenterologie, Magdeburg, Germany (J.L.); the Institute for Pathology, Klinikum Bayreuth, Bayreuth, Germany (M.S.); the Department of Gastroenterology, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa (J.A.L.); the Department of Surgery, Värnamo Hospital, Värnamo, Sweden (A.S.); the Division of Gastroenterology, St. Josph's Hospital, Hafnarfjordur, Iceland (A.T.); the Departments of Clinical Research (M.S., E.B.-S.) and Statistics (O.J.), Astra Hässle, Mölndal, Sweden; and the Department of Biomedicine and Surgery, Linköping Hospital, Linköping, Sweden (E.B.-S.).
Address reprint requests to Dr. Blum at the Division of Gastroenterology, Centre Hospitalier Universitaire Vaudois, CH-1011 Lausanne, Switzerland.
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