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Efficacy of low-dose clarithromycin triple therapy and tinidazole-containing triple therapy for Helicobacter pylori eradication.

Author(s): Choi IJ, Jung HC, Choi KW, Kim JH, Ahn DS, Yang US, Rew JS, Lee SI, Rhee JC, Chung IS, Chung JM, Hong WS

Affiliation(s): Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Clinical Research Institute, Seoul National University Hospital, Seoul, South Korea.

Publication date & source: 2002-01, Aliment Pharmacol Ther., 16(1):145-51.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

BACKGROUND: Proton pump inhibitor-based triple therapies are recommended as the first-line treatment for Helicobacter pylori eradication. AIM: To evaluate the efficacies of low-dose clarithromycin triple therapy and tinidazole-containing triple therapy in a metronidazole resistance prevalent area and to compare the efficacies with standard triple therapy. METHODS: In a randomized, multicentre, prospective study, a total of 352 patients with duodenal ulcer or non-ulcer dyspepsia were randomly divided into three groups according to the administered regimen: OAC250 group (omeprazole, 20 mg, amoxicillin, 1000 mg, and clarithromycin, 250 mg), OAC500 group (omeprazole, 20 mg, amoxicillin, 1000 mg, and clarithromycin, 500 mg) and OTC group (omeprazole, 20 mg, tinidazole, 500 mg, and clarithromycin, 500 mg). The three groups received each regimen twice daily for 7 days. Upper gastrointestinal endoscopy was performed before and 4 weeks after treatment. H. pylori status was determined by rapid urease test and 13C urea breath test. RESULTS: The eradication rates in the OAC250, OAC500 and OTC groups were 76.2%, 65.7% and 64.8% (95% confidence interval: 67.9-84.4%, 56.7-74.8% and 55.7-73.9%), respectively, by intention-to-treat analysis (P=0.149) and 92.8%, 87.2% and 84.1% (95% confidence interval: 84.4-97.3%, 77.9-93.8% and 73.9-91.2%), respectively, by per protocol analysis (P=0.088). All regimens were well tolerated and compliance was excellent. CONCLUSIONS: Both low-dose clarithromycin triple therapy and tinidazole-containing triple therapy are effective and safe regimens for H. pylori eradication.

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