Helicobacter Pylori Treatment with Alternative Drugs: Good and Cheap for Developing Countries Furazolidone-Based Treatment- Omeprazole, Furazolidone and Tetracycline Open-Label Trial in A Developing Country: Why Not?

Abstract

Objective: To analyze eradication rate and evaluate collateral effects of an existing alternative dosage, comprised of Omeprazole, tetracycline and furazolidone for 7 days in patients with gastric and/or duodenal ulcers and first-degree relatives of family members with a diagnosis of gastric cancer with positive study for Helicobacter pylori (H. pylori) and treatment-naive. Design and location: The out patients from the Clinic of the Gastroenterology Department of the ABC Medical School, Santo Andre, SP-Brazil. Patients and methods: Study including treatment-naive patients with a duodenal or gastric ulcer or first-degree relatives of family members with a diagnosis of gastric cancer with a positive study for H. pylori confirmed by non-invasive: breath test (C 13), or serology (IgG) or invasive: Rapid Urease Test or gastric histology by biopsy obtained of upper gastro duodenal endoscopy (UGE). The medication schedule: Omeprazole 20mg TID (before meals) plus Tetracycline 500mg TID (after meals) and Furazolidone 200mg TID (after meals) for 7 days. Diagnostic tests for eradication rates were performed 90 days after the treatment. Adverse effects were considered as: light, mild or severe, and include: nausea, vomiting, rush, headache. Results: 85 patients were included in the study of which 55 completed the treatment. 95% of the patients had an adequate adherence to the treatment. 49% of the patients analyzed by protocol had at least one side effect, with the most common being nausea (24%) and there was no statistical difference between the relation of side effects and lapse of treatment for H. pylori. 5% (3 patients) interrupted the treatment. The eradication rate per protocol (PP) was 96% (95%CI: 84% to 100%) for patients who completed the treatment. Conclusion: The therapy based on Omeprazole, tetracycline and furazolidone in the dosages proposed represents a good and low-cost alternative to the first-line therapy to eradicate infection by H. pylori in treatment-naive patients in a developing country.