Objective: Furazolidone, an old but cheap antibiotic, was shown to be a good alternative to metronidazole in triple therapy for Helicobacter pylori eradication in areas where metronidazole resistant bacteria are common, but randomized studies are lacking. Aim: A randomized controlled trial to determine the efficacy and safety of furazolidone compared to metronidazole in classic quadruple therapy for eradication of H. pylori infection in duodenal ulcer patients. Methods: Patients with endoscopically proven duodenal ulcer and positive urease test were randomized to receive ranitidine 300 mg, amoxycillin 1000 mg and bismuth subcitrate 240 mg b.d, with either furazolidone 200 mg b.d (RABF), or metronidazole 500 mg b.d. (RABM) for 2 weeks. Compliance and side‐effects were monitored and recorded by table diary. H. pylori eradication was assessed at least 4 weeks after the completion of therapy with 14C‐urea breath test. Results: A total of 106 patients were enrolled and 101 (59 male, 42 female, mean age=40 ± 11 years) completed the study. Endoscopic findings and demographic data were comparable in both groups. Intention‐to‐treat eradication rates were 75% and 55% (P=0.03) and per protocol eradication rates were 82 and 56% (P=0.006) in the RABF and RABM groups, respectively. Side‐effects were reported by 13 patients (27%) in the RABF group (one stopped treatment) compared to five patients (10%) in the RABM group (P=0.04). Conclusion: Quadruple therapy containing furazolidone, instead of metronidazole, results in a significantly higher H. pylori eradication rate in Iranian duodenal ulcer patients.
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.
Background: A definitive treatment for functional dyspepsia (FD), and the role of Helicobacter pylori eradication on the course of this disease are controversial. Aim: To investigate the effect of a combination of acid-suppressing and prokinetic drugs or eradication therapy on the course of H. pylori-positive FD. Method: A total of 157 patients with endoscopically-proven H. pylori-positive FD and no response to 4 weeks of antacid therapy were randomly divided into 2 groups. 84 were placed on bismuth subnitrate plus metronidazole and amoxicillin (group A) and 73 received ranitidine and metoclopramide for 4 weeks (group B). The severity of symptoms (7 items) were assessed on a 6-point categorical scale. Group B patients who failed to respond to their medication underwent eradication therapy after 3 months. All patients were followed and assessed for 9 months after the end of therapy by the same clinicians who initiated the therapy. Results: At the end of the medication period, symptom’s score decreased significantly, and to the same extent. At 3-month follow-up moderate or complete response was achieved in 27.4% (group A) and 19.2% (group B) by intention-to-treat analysis. 34 patients of group B, not responding to treatment, underwent eradication therapy and followed as group A. Eradication of H. pylori was successful in 60 of 110 controlled patients (54%). After 9-month follow-up, complete or moderate response was observed in only 30% of 60 patients in whom H. pylori had been eradicated (intention-to-treat analysis), compared to 38% in 50 noneradicated cases (p > 0.05, 95% CI: 19–43 vs. 24–52). Conclusion: Eradication therapy with bismuth compound is effective as ranitidine plus metoclopramide in a subgroup of patients with FD not responding to antacid therapy. There is no difference in improvement between patients cured or not cured from H. pylori infection. This suggests that bismuth compounds were effective in FD when used in the eradication regimen. Combination therapy with acid-suppressing drugs plus prokinetic and bismuth seems to hold promise for FD.
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