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J Gastroenterol Hepatol. 2015 Sep;30(9):1361-6. doi: 10.1111/jgh.12983.

Concomitant and hybrid therapy for Helicobacter pylori infection: A randomized clinical trial.

Author information

  • 1Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea.
  • 2Division of Gastroenterology and Hepatology, Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.
  • 3Division of Gastroenterology and Hepatology, Department of Internal Medicine, Daegu Fatima Hospital, Daegu, Korea.
  • 4Division of Gastroenterology and Hepatology, Department of Internal Medicine, Dongguk University Gyeongju Hospital, Gyeongju, Korea.
  • 5Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
  • 6Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.

Abstract

BACKGROUND AND AIMS:

This study aimed to validate the equivalence of first-line concomitant and hybrid regimens for Helicobacter pylori infection in an era of increasing antibiotic resistance. The study also aimed to assess regimen compliance.

METHODS:

H. pylori-infected patients from six hospitals in Korea were randomly assigned to either concomitant or hybrid regimens. The concomitant regimen consisted of 20 mg of esomeprazole, 1 g of amoxicillin, 500 mg of clarithromycin, and 500 mg metronidazole, twice daily for 10 days. The hybrid regimen consisted of a 5-day dual therapy (20 mg of esomeprazole and 1 g of amoxicillin, twice daily) followed by a 5-day quadruple therapy (20 mg of esomeprazole, 1 g of amoxicillin, 500 mg of clarithromycin, and 500 mg of metronidazole, twice daily).

RESULTS:

Eradication rates for concomitant and hybrid therapy were 78.6% (187/238) and 78.8% (190/241) in the intention-to-treat analysis, and 89.8% (176/196) and 89.6% (181/202) in the per protocol analysis. For both analyses, 95% confidence intervals fell within the ± 8% equivalence margin. Adherence was better in the hybrid group (95.0%) than in the concomitant group (90.1%), a difference that was borderline significant (P = 0.051). Adverse event rates were higher in the concomitant group than in the hybrid group for nausea (15.8% vs 8.8%; P = 0.028) and regurgitation (17.6% vs 10.7%; P = 0.040).

CONCLUSION:

As compared with concomitant therapy, hybrid therapy offered similar efficacy, better compliance, and fewer adverse events. Hybrid therapy could be a reasonable first-line treatment option for H. pylori in areas with high antibiotics resistance.

KEYWORDS:

Helicobacter pylori; peptic ulcer diseases; stomach; treatment and antimicrobial resistance

PMID:
25867608
DOI:
10.1111/jgh.12983
[PubMed - indexed for MEDLINE]
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