Effect of different doses of furazolidone with amoxicillin and omeprazole on eradication of Helicobacter pylori.

BACKGROUND

Resistance to metronidazole is one of the most common reasons for Helicobacter pylori treatment failure with classic triple therapy. In contrast, the clarithromycin-based regimen is not cost-effective for developing countries. Furazolidone is a very good substitute for metronidazole and clarithromycin, but its many side-effects limit widespread use. The aim of the present study was to assess the efficacy of two different doses of furazolidone in combination with amoxycillin and omeprazole.

METHODS

A total of 123 patients with duodenal ulcer were randomized and received the following medications for two weeks. Group A: furazolidone 2 x 200 mg + amoxycillin 2 x 1 g + omeprazole 2 x 20 mg/day. Group B: furazolidone 2 x 50 mg + amoxycillin 2 x 1 g + omeprazole 2 x 20 mg/day. Control endoscopy was performed after 6 weeks and two biopsy specimens from the antrum and two from the corpus were taken for a urease test and histology. Eradication was concluded if all tests were negative for H. pylori.

RESULTS

In total, 110 patients completed the study. Four patients in group A did not tolerate the regimen on day 8 of therapy and were excluded from the study. Serious complications such as fever, and fatigue and dizziness, which occurred in the beginning of the second week of treatment (days 8-10), were more common in group A than in group B (19%, 15.9% and 14.3%, respectively, in group A vs 0% in group B). The eradication rate by per protocol analysis was significantly higher in group A than in group B (88.9%vs 67.9%, respectively, P = 0.008). However, this difference was low and not statistically significant by intention-to-treat analysis (76.2% in group A and 62.3% in group B, P = 0.09).

CONCLUSION

The regimen with a non-reduced dose of furazolidone in combination with amoxycillin and omeprazole was effective when the patients tolerated the drugs and completed the study.