The safety and efficacy of tripotassium dicitrato bismuthate (De‐Nol) maintenance therapy in patients with duodenal ulceration

SUMMARY Seventy-one patients whose duodenal ulcers had healed after a 4-week treatment period with tripotassium dicitrato bismuthate (TDB) were randomly allocated to receive maintenance treatment with either one TDB swallow tablet nocte (equivalent to 120 mg Bi2 O3) or an identical placebo. During 12 months of follow-up, no side-effects were reported by TDB-treated patients, blood bismuth levels did not rise above discontinuation threshold concentrations (> 50 μg/L in the first 6 months, or > 100 μg/L in the second 6 months), and there were no adverse effects on haematological or biochemical indices. Ulcer relapse was significantly less in TDB-treated patients (P < 0.025). Cumulative relapse rates at 6 and 12 months were 51% and 66%, respectively, for placebotreated patients and 26% and 31%, respectively, for those who received TDB. It is likely that TDB is a safe and effective maintenance treatment for patients with duodenal ulcer disease.