[Combined treatment of gastric ulcers induced by nonsteroid antiinflammatory drugs. Results of 4-week population-based controlled trial of efficacy of proton pump inhibitor combination with tripotassium bismuth dicitrate].

AIM

To study efficacy of a combination of proton pump inhibitor (PPI) and bismuth tripotassium dicitrate (BTD) in gastric ulcers (GU) induced by non-steroid anti-inflammatory drugs (NSAD) in rheumatic patients with factors affecting PPI efficacy.

MATERIAL AND METHODS

Fifty rheumatic patients entered the study (5 males and 45 females, mean age 63.5 +/- 6.2 years) with NSAD-induced GU. Criteria of participation in the study: ulcer size > 1.0 cm, 2 and more ulcers, administration of glucocorticoids (GC) and/or cytotoxic drugs. The patients were divided into two groups. Group 1 patients received omeprasol 20 mg twice a day + BTD 240 mg twice a day; group 2 patients received omeprasol alone 20 mg twice a day. The groups were matched by demographic and clinical parameters, consisted mainly of women with rheumatoid arthritis, most of the patients took GC, methotrexate or leflunamid. The result of the treatment was evaluated by the findings of endoscopic examination 4 and 8 weeks after treatment.

RESULTS

Three patients from group 1 and 2 patients from group 2 were withdrawn from the study. For 4 weeks ulcer heeling was achieved in 15 patients of group 1 (68.2%) and 8 patients of group 2 (34.8%), p = 0.038. On week 8 ulcers healed in 86.3 and 78.3% patients, respectively. Severe side effects were absent.

CONCLUSION

Combination of omeprasol with BTD stimulated heeling of NSAD-induced gastric ulcer.