Symptomatic benefit from eradicating Helicobacter pylori infection in patients with nonulcer dyspepsia

Background The eradication of Helicobacter pylori infection is beneficial i n patients with gastric or duodenal ulcers. The value of eradicating the in fection in patients with dyspepsia and no evidence of ulcer disease is not known. Methods We performed a randomized, placebo-controlled trial comparing the e fficacy of treatment for two weeks with 20 mg of omeprazole orally twice da ily, 500 mg of amoxicillin three times daily (with 500 mg of tetracycline t hree times daily substituted for amoxicillin in patients allergic to penici llin), and 400 mg of metronidazole three times daily (160 patients) with th at of omeprazole alone (158 patients) for resolving symptoms of dyspepsia i n patients with H. pylori infection but no evidence of ulcer disease on upp er gastrointestinal endoscopy. Symptoms were assessed with the Glasgow Dysp epsia Severity Score, with resolution of symptoms defined as a score of 0 o r 1 in the preceding six months (maximal score, 20). One year later the pat ients were assessed to determine the frequency of the resolution of symptom s. Results One month after the completion of treatment, 132 of 150 patients (8 8 percent) in the group assigned to receive omeprazole and antibiotics had a negative test for H. pylori, as compared with 7 of 152 (5 percent) in the group assigned to receive omeprazole alone. One year later, dyspepsia had resolved in 33 of 154 patients (21 percent) in the group given omeprazole a nd antibiotics, as compared with 11 of 154 (7 percent) in the group given o meprazole alone (95 percent confidence interval for the difference, 7 to 22 percent; P<0.001). Among the patients in the group given omeprazole and an tibiotics, the symptoms resolved in 26 of the 98 patients (27 percent) who had had symptoms for five years or less, as compared with 7 of the 56 patie nts (12 percent) who had had symptoms for more than five years (P = 0.03). Conclusions In patients with H. pylori infection and nonulcer, or functiona l, dyspepsia, treatment with omeprazole and antibiotics to eradicate the in fection is more likely to resolve symptoms than treatment with omeprazole a lone. (N Engl J Med 1998;339:1869-74.) (C) 1998, Massachusetts Medical Soci ety.