Background: Treatment of patients with dyspepsia and chronic gastritis without H. pylori infection remains unsatisfactory. The aim of this study was to determine the effect of bismuth subsalicylate (Gastrobismol ®) on symptoms and gastric histology in this group of patients.

Methods: Patients with dyspepsia and chronic H. pylori negative gastritis by CLO test ® were randomly assigned to receive bismuth subsalicylate or placebo. After four weeks of treatment, three outcomes were analyzed (1) the change from baseline in severity of dyspeptic symptoms (as assessed by the Leeds Dyspepsia Questionnaire), (2) patients’ global assessment of efficacy using the proportion of patients without symptoms, proportion of patients with improvement, and proportion of patients who remained unchanged or who deteriorated, and (3) endoscopic appearance and gastric histology.

Results: Forty-five patients were entered and 42 completed the trial (21 patients in the bismuth subsalicylate group and 21 in the placebo group. There was no difference between the two groups in terms of symptom disappearance, total symptoms severity scores, and epigastric pain at the end of treatment. Dyspeptic symptoms of regurgitation, belching and early satiation in the bismuth subsalicylate group were significantly improved from baseline, however, when compared with the placebo group. There was no difference in endoscopic appearance and gastric histology, but gastric body inflammation was significantly decreased in the bismuth group (p=0.04).

Conclusion: Administration of bismuth subsalicylate in patients with dyspepsia and chronic H. pylori negative gastritis was of benefit with regard to regurgitation, belching and early satiation symptoms as well as decreased inflammation of the gastric body mucosa.