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