Helicobacter pylori eradication treatment does not benefit patients with nonulcer dyspepsia

OBJECTIVES: The aim of this study was to assess the still controversial rol e of treatment of Helicobacter pylori (H. pylori) infection in patients wit h nonulcer dyspepsia. METHODS: We conducted a double-blind, randomized, placebo-controlled, multi center trial comparing the efficacy of 7 days of eradication treatment (lan soprazole 15 mg b.i.d., amoxicillin 1 g b.i.d., and clarithromycin 500 mg b .i.d.) with a control treatment (lansoprazole 15 mg b.i.d. and placebo) in H. pylori-infected patients with nonulcer dyspepsia. C-13 breath tests were performed at baseline and during followup. We assessed patient symptoms, h ealth status (based on the SF-12 questionnaire), patient satisfaction. drug consumption, health care consultation behavior, and absenteeism related to dyspepsia over a 1-yr period. RESULTS: A total of 74 patients randomized to eradication treatment and 70 patients randomized to placebo were compared. The rate of eradication of H. pylori infection was 75% in the active treatment group and 4% in the place bo group (p < 0.005). The symptom score improved to a similar extent in the group receiving active treatment (-4.0; 95% CI = -5.0 to -3.0) and placebo (-3.6; 95% CI -4.5 to -2.7). Treatment response was not related to the sev erity or duration of initial symptoms or to the severity of gastritis on hi stology. Quality of life scores were comparable at 12 months. There was no significant difference in dyspepsia-related absenteeism or satisfaction wit h management of NUD. Patients receiving active treatment were more likely n ot to have had to use any dyspepsia treatment over the 12 months (60.8%. vs 44.3%; p = 0.047). CONCLUSIONS: This study did not demonstrate any substantial benefit of curi ng H. pylori infection in patients with nonulcer dyspepsia. The study adds further evidence that H. pylori is not the main pathogenetic or therapeutic target in these patients. (C) 2001 by Am. Coll. of Gastroenterology.