COLLOID BISMUTH VERSUS FAMOTIDINE IN THE TREATMENT AND PREVENTION OF DUODENAL-ULCER RELAPSE - RESULTS OF A DOUBLE-BLIND, DOUBLE DUMMY RANDOMIZED STUDY

Fifty-three consecutive patients with active duodenal ulcer (DU) were randomly included in a double-blind, double-dummy study to test the he aling and relapsing rate of two treatment regimens: famotidine 40 mg n octe for 4-8 weeks, followed by 20 mg for 12 months after healing of t he ulcer and colloidal bismuth (CBS) (240 mg bid) for 4-8 weeks, follo wed by placebo maintenance treatment. The results of the shea term per iod confirmed the efficacy of CBS in healing DU (24/25 in CBS group an d 19/23 in famotidine group). However, the relapse rate in the CBS-tre ated group was higher (77.8% at 12 months) than in the famotidine grou p (35.7%) (p = 0.041). Only 7 patients (41.2%) were cleared from Helic obacter pylori (HP) after CBS treatment. In conclusion, the high relap se rate observed in CBS treated patients may be related to the high pe rcentage of patients with HP infection in the tested group and support the hypothesis that lack of efficacy of CBS in preventing DU recurren ce is related to its poor eradication of HP.