Lack of effect of treating Helicobacter pylori infection in patients with nonulcer dyspepsia

Background It is uncertain whether treatment of Helicobacter pylori infecti on 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 d iscomfort centered in the upper abdomen). Patients were excluded if they ha d a history of peptic ulcer disease or gastroesophageal reflux disease and had abnormal findings on upper endoscopy. Patients were randomly assigned t o 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 o meprazole alone and then followed up for one year. Treatment success was de fined as the absence of dyspeptic symptoms or the presence of minimal sympt oms on any of the 7 days preceding the 12-month visit. Results Twenty of the 348 patients were excluded after randomization becaus e they were not infected with H. pylori, were not treated, or had no data a vailable. For the remaining 328 patients (164 in each group), treatment was successful for 27.4 percent of those assigned to receive omeprazole and an tibiotics and 20.7 percent of those assigned to receive omeprazole alone (P = 0.17; absolute difference between groups, 6.7 percent; 95 percent confid ence 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 respe ctive 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 pat ients in whom the infection was eradicated (26 percent vs. 31 percent). The re were no significant differences between the groups in the quality of lif e after treatment. Conclusions In patients with nonulcer dyspepsia, the eradication of H. pylo ri infection is not likely to relieve symptoms. (N Engl J Med 1998;339:1875 -81.) (C) 1998, Massachusetts Medical Society.