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Rank order of success favors longer duration of imidazole-based therapy for Helicobacter pylori in duodenal ulcer disease: a randomized pilot study

Chaudhary A, Ahuja V, Bal CS, Das B, Pandey RM, Sharma MP

Helicobacter, 2004

Abstract

BACKGROUND: Studies on eradication therapy in developing countries have shown a success rate of 70-85%, which is suboptimal. Duration of therapy may be an important factor dictating eradication success in such regions.

AIMS: The study was undertaken to evaluate the effect of increasing the treatment period on eradication of Helicobacter pylori in duodenal ulcer disease.

METHODS: A randomized trial was carried out in which 64 consecutive H. pylori-infected patients with duodenal ulcer disease were enrolled. The patients were randomized to one of the three trial arms. Therapy consisted of lansoprazole 30 mg twice a day (b.i.d.), amoxycillin 1 g b.i.d. and tinidazole 500 mg b.i.d. The treatment period was 1 week in group I, 2 weeks in group II and 3 weeks in group III. At inclusion, patients underwent endoscopy and the presence of H. pylori was documented by a positive urease test and C14 urea breath test. Four weeks after completion of eradication therapy, the patients were subjected to repeat endoscopy to assess ulcer healing and tests for H. pylori infection.

RESULTS: Sixty-four patients (55 male and nine female; mean age 35.5 years) were enrolled in each group. The H. pylori eradication rate for group I (1 week of therapy) was 47.6%, that for group II (2 weeks of therapy) was 80%, and that for group III (3 weeks of therapy) was 91.3% (p =.003). The ulcer healing rates were 71.4, 80 and 95.6% in groups I, II and III, respectively (p =.09).

CONCLUSIONS: The 3-week regimen…

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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.

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