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


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

In This Article


Demographic Data

There were 48 males and 54 females. In each group 39% of patients had failed more than one course of eradication therapy. The distribution of gender, mean age, number of previous failed treatment and endoscopic diagnosis were listed in Table 1 , and were similar in both groups. All patients were previously treated initially with triple therapy. The initial treatment was amoxil, clarithromycin and proton pump inhibitor (PPI) in 61% and was amoxil, metronidazole and PPI in 30% of subjects. Information related to the duration of treatment was not collected, but it was mostly 7 days in local practice. For those 40 subjects with more than one previous eradication therapy, the second-line therapy was still mostly triple therapy of another antibiotic combination. Only 13 of these 40 subjects had received quadruple therapy previously. As illustrated in Figure 1, there were 28 and 74 patients with and without previous history of levofloxacin, respectively. Fifty-one were randomized into EBAL and 51 into EBMT. All patients completed follow-up and returned for the 13C-urea breath test at week 12. However, five and three patients in EBAL and EBMT, respectively, failed to complete at least 75% of study drugs. These patients were excluded from PP analysis.

Figure 1.

Flow chart of the study patients. LT, levofloxacin triple therapy; ITT, intention-to-treat; PP, per-protocol.

Eradication of Helicobacter Pylori

According to the ITT analysis at week 12, H. pylori eradication was achieved in 37 of the 51 patients in EBAL group and 45 of the 51 patients in EBMT group ( Table 2 ). The ITT eradication rates of EBAL and EBMT were 73% and 88%, respectively (P = 0.046). The PP eradication rates of EBAL and EBMT groups were 78% and 94%, respectively (P = 0.030). Among patients who had only one course of previous eradication therapy, the ITT eradication rates of EBAL and EMBT were 84% and 87%, respectively (P = 0.718). For those who had failed more than one course of eradication therapy, the ITT eradication rate was statistically lower for EBAL than EMBT (56% vs. 90%, P = 0.013). For those with previous history of levofloxacin triple therapy, the eradication rates of EBAL and EMBT were 71% and 93%, respectively (P = 0.139). As the number in this subgroup was small, the power was insufficient to detect a difference.

Side Effects and Compliance

Most subjects experienced some side effects during therapy. There were only 14 and 12 of 51 subjects in EBAL and EBMT, respectively, without reported side effects. However, only five (10%) patients in each group failed to complete the whole 7-day treatment. The rates of side effects and withdrawal of treatment between both groups were similar. In all subjects who had taken the treatment for 3 days or less, there were failures of H. pylori eradication no matter which treatment regimen was taken. Except one patient, intolerance to side effects was the cause of all premature treatment withdrawal. This subject belonged to EBAL group and treatment was stopped because of acute attack of gallstone colic, which was probably not a result of the eradication therapy. Side effects leading to early withdrawal of treatment included nausea, vomiting, diarrhoea, dizziness and rash. All symptoms resolved afterwards. There was no mortality or major morbidity recorded in the study.


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