Eradication Rates of 10-day Sequential Therapy for Helicobacter pylori: Results of an 8-year Prospective Study Conducted at a Tertiary Korean Hospital

Kichul Yoon; Nayoung Kim

doi:10.4166/kjg.2019.73.2.99

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Yoon and Kim: Eradication Rates of 10-day Sequential Therapy for Helicobacter pylori: Results of an 8-year Prospective Study Conducted at a Tertiary Korean Hospital

Original Article

Alimentary Tract

The Korean Journal of Gastroenterology 2019; 73(2): 99-104.

Published online: 26 February 2019

DOI: https://doi.org/10.4166/kjg.2019.73.2.99

Eradication Rates of 10-day Sequential Therapy for Helicobacter pylori: Results of an 8-year Prospective Study Conducted at a Tertiary Korean Hospital

Kichul Yoon^1,², Nayoung Kim^1,³

¹Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.

²Department of Internal Medicine, Wonkwang University Sanbon Hospital, Gunpo, Korea.

³Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.

Correspondence to: Nayoung Kim, Department of Internal Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam 13620, Korea. Tel: +82-31-787-7008, Fax: +82-31-787-4051, nayoungkim49@empas.com

Received 1 February 2019 Revised 5 February 2019 Accepted 7 February 2019

Korean Society of Gastroenterology

(open-access):

This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background/Aims

The Helicobacter pylori (H. pylori) eradication rate of standard triple therapy is unsatisfactory in Korea, and sequential therapy (SQT) has been suggested to be a practical first-line alternative regimen. The aim of this prospective study was to document changes in annual eradication rates of SQT.

Methods

A total of 983 H. pylori-positive subjects were enrolled from 2010 to 2018 and their data were subjected to intention-to-treat (ITT) and per-protocol (PP) analysis. All subjects received 10-day sequential therapy consisting of 40 mg esomeprazole and 1 g amoxicillin b.i.d for 5 days followed by 40 mg esomeprazole b.i.d, 500 mg clarithromycin b.i.d and 500 mg metronidazole t.i.d for 5 days. The ¹³C-urea breath test, rapid urease test (CLO test®), and histology were used to confirm eradication. Compliance and side effects were also investigated.

Results

ITT and PP eradication rates of SQT were 69.9% (687 of 983) and 87.1% (657 of 754), respectively. The annual eradication rate of ITT remained consistent over the 8-year study period (p for trend=0.167), whereas PP analysis showed the eradication rate increased (p for trend=0.042). The overall adverse event rate for SQT was 41.7% (410 subjects).

Conclusions

Despite high antibiotic resistance rates in Korea, the eradication rate of SQT did not decrease over the 8-year study period.

Keywords: Helicobacter pylori, Sequential therapy, Intention to treat analysis, Per-protocol analysis

Figures and Tables

Fig. 1

Schematic of the analysis.

Fig. 2

Intention-to-treat (ITT) and per-protocol (PP) analysis of annual Helicobacter pylori eradication rate following 10-day sequential therapy. ITT eradication rates remained constant over the study period (p for trend=0.167), whereas PP eradication rates showed a significant increasing trend (p for trend=0.042).

Table 1

Baseline Characteristics

Values are presented as mean±standard deviation or n (%).

ITT, intention-to-treat; PP, per-protocol; MALT lymphoma, mucosaassociated lymphoid tissue lymphoma.

Table 2

Adverse Events

Values are presented as n (%).

^aOther symptoms include skin problems, malaise or sedation, dry mouth, dizziness, sleep disturbance, etc., percentage was calculated based on the intention-to-treat population.

Notes

^{Conflict of interest} None.

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ORCID iDs: Nayoung Kim
https://orcid.org/0000-0002-9397-0406
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