[Efficacy of colloid bismuth subcitrate (De-Nol) in gastropathies induced by nonsteroid anti-inflammatory drugs: an open controlled 4-week trial].

OBJECTIVE

To evaluate efficiency of colloid bismuth subcitrate (CBS) in gastropathies induced by nonsteroid anti-inflammatory drugs (NSAID).

METHODS

45 patients with rheumatic diseases (RD) taking NSAID with gastric and/or duodenal up to 1 cm in size or multiple (more than 10) gastric mucosa erosions detected at esophagogastroduodenoscopy were randomized into two groups. Patients of group 1 (n = 30) received CBS (240 mg twice a day + amoxicillin 2 g/day and furozolidon 400 mg/day--subgroup 1a, n = 10 or CBS monotherapy in the same dose--subgroup 1b, n = 20). Patients of group 2 (n = 15) received ranitidine 150 mg twice a day. Older women, RA patients, patients with gastric ulcer prevailed. H. pylori was detected in 73.3 and 90% patients, respectively. Dispepsia and heartburn occurred in 90 and 93.3%, respectively. The efficacy was assessed after 4 weeks of therapy.

RESULTS

Healing of ulcers and erosions were achieved in 22 of 26 patients of group 1 (84.6%) and in 7 of 14 (50%) of group 2 (p = 0.036, chi-square). After therapy dyspepsia persisted in 4 patients of group 1 and 9 patients of group 2. Side effects were in 3 patients on CBS. Untiulcer effect did not differ between the subgroups (88.8 and 82.4%, respectively) and was effective in 6 of 7 HP-negative patients (85.7%) and in 8 of 10 HP-positive patients (80%).

CONCLUSIONS

De-Nol is effective in NSAID-induced gastropathies. Its action is not related with influence on HP.