, Volume 51, Issue 1, pp 89-98

Clinical Outcomes of Eradication of Helicobacter pylori in Nonulcer Dyspepsia in a Population with a High Prevalence of Infection: Results of a 12-Month Randomized, Double Blind, Placebo-Controlled Study

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Abstract

Ninety-one Helicobacter pylori-positive patients with nonulcer dyspepsia were randomized to receive either lansoprazole, amoxicillin, and clarithromycin or lansoprazole and placebo. A validated questionnaire assessed dyspeptic symptoms at baseline and at 3, 6, and 12 months. Endoscopies and biopsies were performed at baseline and at 3 and 12 months. There was an overall trend, although not statistically significant, for a benefit of H. pylori eradication. Of the patients in the antibiotics group, 16 of 46 (35%) had symptomatic improvement, versus 9 of 43 (21%) in the control group (P = 0.164). In a secondary analysis, it was found that of the patients without endoscopic gastric erosions, 15 of 34 (44%) in the antibiotics group and 5 of 33 (15%) of controls had symptomatic improvement (P = 0.015). Helicobacter pylori eradication did not prove to be clinically beneficial, although a tendency to symptomatic benefit was detected. Further studies are necessary to confirm the implications of endoscopic gastric erosions in these patients.

Abbott Laboratórios do Brasil Ltda. donated the drugs used in this clinical trial. The Research Incentive Fund (FIPE) and the Graduate Research Group at Hospital de Clínicas de Porto Alegre provided editorial support. No member of the research team received any remuneration to conduct this study.