Maintenance therapy with colloidal bismuth subcitrate in duodenal ulcer disease.

Various investigators have reported that relapses after healing of duodenal ulcers with colloidal bismuth subcitrate (CBS, De-Nol) occur less frequently than after healing with H2-antagonists. To date, treatment with CBS has been limited to 8 weeks. After a volunteer study showed that prolonged administration of CBS did not cause safety problems, a trial was undertaken in which the effects of additional maintenance CBS treatment with 120 mg of CBS daily is compared with placebo. Interim results showed that after 6 months endoscopically confirmed relapse occurred in 5 (38.5%) of the 13 patients as compared to 12 (80%) of the 15 placebo-treated patients (p = 0.05). Besides 3 cases of transient constipation, no side effects, neurological, biochemical or hematological changes were observed.