BISMUTH SUBSALICYLATE SUPPRESSION OF HELICOBACTER-PYLORI IN NONULCER DYSPEPSIA - A DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL

Gastritis caused by Helicobacter pylori (HP) is common in patients wit h nonulcer dyspepsia (NUD), but an etiologic relationship between the histologic lesion and clinical symptoms is unproven. HP is inhibited b y bismuth subsalicylate (BSS), a traditional remedy for dyspeptic comp laints. The aim of this study was to assess the short- and long-term e ffects of BSS on HP, gastritis, and symptoms in patients with NUD. One hundred twenty-six patients with NUD who were shown to be infected wi th H. pylori (HP+) were enrolled. There was a two-week placebo run-in Period to eliminate placebo responders. Fifty patients remained sympto matic and were randomly assigned to therapy with either BSS liquid or a matching placebo. EGD, biopsy, and clinical evaluations were perform ed at entry, at week 5 (end of therapy), at week 9 (four weeks after t herapy), or at time of symptomatic relapse. Twenty-seven patients rece ived placebo and 23 patients received BSS. BSS suppressed H. pylori in 15/23 patients (65%) and eradicated it in one patient, whereas the pl acebo had no effect on H. pylori. Gastritis improved during therapy wi th BSS but relapsed by week 9. There was no significant change in leve l of dyspeptic symptoms during or after treatment, although one month after the end of treatment, the patients in the BSS group consistently had lower symptom scores and fewer symptomatic days for all symptoms measured. The study confirms that BSS given for three weeks suppresses but does not usually eradicate H. pylori. Such short-term suppression of H. pylori heals gastritis but does not result in clinical improvem ent.