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Randomized Clinical Trial: Esomeprazole, Bismuth, Levofloxacin, and Amoxicillin or Cefuroxime as First-Line Eradication Regimens for Helicobacter pylori Infection

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Abstract

Background

The eradication of Helicobacter pylori infection remains a challenge, especially in the patients unsuitable to take penicillin. Cephalosporin has the potential to replace amoxicillin for H. pylori eradication.

Aims

To compare the effectiveness, safety, and compliance of amoxicillin- and cefuroxime-containing quadruple regimens in treatment-naïve patients.

Methods

In this open-label randomized control study, 400 patients with H. pylori infection were divided into amoxicillin-containing (esomeprazole 20 mg twice/day, amoxicillin 1000 mg twice/day, levofloxacin 500 mg once/day, and bismuth 220 mg twice/day for 14 days) or cefuroxime-containing (esomeprazole 20 mg twice/day, cefuroxime 500 mg twice/day, levofloxacin 500 mg once/day, and bismuth 220 mg twice/day for 14 days) quadruple therapy groups. The safety and compliance were assessed 1–3 days after eradication. Urea breath test was performed 8–12 weeks after eradication to determine treatment outcome.

Results

The baseline data including antibiotic resistance were well matched between the two groups. The eradication rates between amoxicillin- and cefuroxime-containing quadruple therapy groups were not significantly different [intention-to-treat analysis: 83.5% (95% confidence interval 78.3–88.7%) vs. 81.0% (75.5–86.5%), P = 0.513; modified intention-to-treat analysis: 90.3% (86.0–94.6%) vs. 88.5% (83.9–93.2%), P = 0.586; per-protocol analysis: 91.6% (87.5–95.7%) vs. 89.8% (85.3–94.3%), P = 0.560]. The incidence of adverse effects (18.4 vs. 20.1%, P = 0.678) and compliance (94.7 vs. 94.2%, P = 0.813) were also similar. Variate analyses showed that antibiotic resistance and poor compliance were the independent risk factors for eradication failure.

Conclusions

Esomeprazole, bismuth, levofloxacin, and amoxicillin or cefuroxime achieved similar and relatively satisfactory cure rates, safety, and compliance in first-line H. pylori eradication. Cefuroxime may be a good alternative medicine for eradication instead of amoxicillin for the patients unsuitable to take penicillin.

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Acknowledgments

The study was supported by the National Science & Technology Pillar Program of twelfth Five-Year Plan in China (2012BAI06B02) and the key laboratory for Helicobacter pylori infection and upper gastrointestinal diseases in Beijing (No. BZ0371). The sponsor of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.

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Author notes

  1. Wei Fu and Zhiqiang Song have contributed equally to this work.

Authors and Affiliations

  1. Department of Gastroenterology, Peking University Third Hospital, No 49, North Garden Road, Haidian District, Beijing, 100191, China

    Wei Fu, Zhiqiang Song, Liya Zhou, Yan Xue, Yu Ding, Baojun Suo, Xueli Tian & Li Wang

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  1. Wei Fu
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  2. Zhiqiang Song
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  3. Liya Zhou
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  8. Li Wang
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Contributions

WF contributed to the clinical studies and experimental studies. ZS contributed to the study concept, study design, clinical studies, and manuscript writing. LZ contributed to the study concept, study design, clinical studies, and manuscript editing. YX contributed to the clinical studies. YD contributed to the experimental studies. BS contributed to the clinical studies. XT contributed to the clinical studies. LW contributed to the clinical studies. All authors approved the final version of the manuscript.

Corresponding author

Correspondence to Liya Zhou.

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The authors declare that they have no conflicts of interest in the submission of this manuscript.

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Fu, W., Song, Z., Zhou, L. et al. Randomized Clinical Trial: Esomeprazole, Bismuth, Levofloxacin, and Amoxicillin or Cefuroxime as First-Line Eradication Regimens for Helicobacter pylori Infection. Dig Dis Sci 62, 1580–1589 (2017). https://doi.org/10.1007/s10620-017-4564-4

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  • DOI: https://doi.org/10.1007/s10620-017-4564-4

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