Helicobacter pylori eradication and standardized 3-month omeprazole therapy in functional dyspepsia

Abstract

OBJECTIVES: The role of Helicobacter pylori in functional dyspepsia remains unclear. This study evaluated the long term consequences for symptoms and quality of life in patients with H. pylori–positive functional dyspepsia after H. pylori eradication therapy with a standardized 3-month omeprazole treatment. METHODS: A total of 151 H. pylori–positive patients with functional dyspepsia were randomized to receive either eradication therapy or placebo-antibiotics. The initial medication was administered in a double-blinded fashion.In addition, to standardize acid suppression, every patient received omeprazole therapy for the first 3-month period. Dyspeptic symptoms were evaluated by a questionnaire every 3 months, and quality of life was measured by a validated RAND 36-item health survey 1.0 questionnaire at the beginning of the study and after 12 months of follow-up. As the main outcome measure, the scores of patients who had received H. pylori eradication therapy and omeprazole were compared with those who received placebo and omeprazole during the 12 months of follow-up. RESULTS: A total of 136 patients completed the 1-yr follow-up. In all, 77 patients received eradication therapy and 74 patients remained as controls. After 12 months, the mean reduction in the dyspepsia score was 28.8% in patients with H. pylori eradication therapy and 21.7% in the control group. The reduction of dyspepsia was significant ( p < 0.0001) in both groups compared to baseline value, but no statistically significant differences in changes of dyspeptic symptoms or in quality of life were demonstrated between the H. pylori eradication therapy group and controls after 1 yr. In both patient groups, regurgitation ( p < 0.001) and heartburn ( p < 0.01) revealed relapse after cessation of 3-month omeprazole treatment. CONCLUSIONS: No clear differences in symptoms or in quality of life were found between patients treated with H. pylori eradication therapy and omeprazole compared with patients receiving placebo and omeprazole after 1 yr. Regardless of H. pylori status, omeprazole treatment reduced heartburn and regurgitation. The placebo effect on the symptoms of functional dyspepsia and on quality of life was marked.