Clinical Trial: Levoflaxacin-Based Quadruple Therapy was Inferior to Traditional Quadruple Therapy in the Treatment of Resistant Helicobacter pylori Infection

Y. K. Yee; T. K. Cheung; K.-M. Chu; C. K. Chan; J. Fung; P. Chan; D. But; I. Hung; A. O. O. Chan; M. F. Yuen; A. Hsu; B. C. Y. Wong

Disclosures

Aliment Pharmacol Ther. 2007;26(7):1063-1067. 

In This Article

Methods

Patient Population

Consecutive patients, who were found to have H. pylori infection and had failed at least one course of eradication therapy in Queen Mary Hospital, Hong Kong, were recruited if they consented after explanation. Persistent H. pylori infection was confirmed either by 13C-urea breath test or rapid urease test. Exclusion criteria included subjects' refusal to consent for the study, age <18 or >70, pregnancy, history of allergy to any drug involved in the study or major medical illnesses. This study was approved by the Institutional Review Board of the Hospital Authority Hong Kong West Cluster/University of Hong Kong.

Treatment Regimen and Follow-up

Each candidate was randomized into either levofloxacin-based quadruple therapy, EBAL (esomeprazole 40 mg b.d., bismuth subcitrate 240 mg b.d., amoxicillin 1 g b.d. and levofloxacin 500 mg b.d. for 1 week) or traditional quadruple therapy, EBMT (esomeprazole 40 mg b.d., bismuth subcitrate 240 mg b.d., metronidazole 400 mg t.d.s. and tetracycline 500 mg q.d.s. for 1 week). Stratified randomization was used according to whether subjects had previous history of levofloxacin-based triple therapy or not. Treatment was given with related advice on possible side effects of therapies, importance of completing the whole course of treatment and channels to contact investigators during treatment. In the week after treatment, data related to drug compliance and side effects of treatment were also collected.

13C-urea breath test was performed 12 weeks after drug treatment. A technician, who was blinded to the assigned protocol, performed all 13C-urea breath tests. Subject was fasted for 4 h before the test and no test meal was given. After obtaining the predose breath sample, a solution with 75 mg 13C-urea powder was given to the subject orally. The second breath sample was collected at 30 min. A cut-off value of 5% was used. Samples collected were analysed by the purpose built isotope ratio mass spectrometer (Analytical Precision Products Ltd, Northwich, UK). This protocol had been validated locally with a sensitivity of 97% and specificity of 98%.[17]

Statistical Analysis

All significant tests were two-sided in a significance level of 5%. The study was designed to have 80% power to detect a 20% difference in efficacy of levofloxacin-based quadruple therapy with the assumption of 70% efficacy of traditional quadruple therapy. The original plan was to recruit a total of 124 subjects. The SPSS statistical package was used for data analysis. Chi-squared test was used for non-parametric data and t-test for continuous variables. The intention-to-treat (ITT) analysis included all subjects who had taken at least one tablet of drugs. In the per-protocol (PP) analysis, only patients who had taken 75% or more of the study drugs and attended all planned follow-up assessment were included.

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