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Original Article
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Volume 339:1875-1881 December 24, 1998 Number 26
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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

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ABSTRACT

Background It is uncertain whether treatment of Helicobacter pylori infection relieves symptoms in patients with nonulcer, or functional, dyspepsia.

Methods We conducted a double-blind, multicenter trial of patients with H. pylori infection and dyspeptic symptoms (moderate-to-very-severe pain and discomfort centered in the upper abdomen). Patients were excluded if they had a history of peptic ulcer disease or gastroesophageal reflux disease and had abnormal findings on upper endoscopy. Patients were randomly assigned to seven days of treatment with 20 mg of omeprazole twice daily, 1000 mg of amoxicillin twice daily, and 500 mg of clarithromycin twice daily or with omeprazole alone and then followed up for one year. Treatment success was defined as the absence of dyspeptic symptoms or the presence of minimal symptoms on any of the 7 days preceding the 12-month visit.

Results Twenty of the 348 patients were excluded after randomization because they were not infected with H. pylori, were not treated, or had no data available. For the remaining 328 patients (164 in each group), treatment was successful for 27.4 percent of those assigned to receive omeprazole and antibiotics and 20.7 percent of those assigned to receive omeprazole alone (P=0.17; absolute difference between groups, 6.7 percent; 95 percent confidence interval, –2.6 to 16.0). After 12 months, gastritis had healed in 75.0 percent of the patients in the group given omeprazole and antibiotics and in 3.0 percent of the patients in the omeprazole group (P<0.001); the respective rates of H. pylori eradication were 79 percent and 2 percent. In the group given omeprazole and antibiotics, the rate of treatment success among patients with persistent H. pylori infection was similar to that among patients in whom the infection was eradicated (26 percent vs. 31 percent). There were no significant differences between the groups in the quality of life after treatment.

Conclusions In patients with nonulcer dyspepsia, the eradication of 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, Meath–Adelaide 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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