Retrospective Cohort Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jan 28, 2023; 29(4): 692-705
Published online Jan 28, 2023. doi: 10.3748/wjg.v29.i4.692
Disease trends after Helicobacter pylori eradication based on Japanese nationwide claims and the health check-up database
Kazuhiro Mizukami, Kentaro Sugano, Tomomi Takeshima, Kazunari Murakami
Kazuhiro Mizukami, Kazunari Murakami, Department of Gastroenterology, Oita University, Oita 8795593, Japan
Kentaro Sugano, Department of Medicine, Jichi Medical University, Tochigi 3290498, Japan
Tomomi Takeshima, Milliman Inc., Tokyo 1020083, Japan
Author contributions: Sugano K contributed to the conception of the study; Sugano K, Takeshima T, and Murakami K contributed to the design of the study; Mizukami K, Sugano K, Takeshima T, and Murakami K contributed to the interpretation of data; Mizukami K and Takeshima T wrote the article; Sugano K and Murakami K critically reviewed the manuscript.
Institutional review board statement: The study was reviewed and approved for publication by the Ethics Committee of Oita University, Faculty of Medicine (No. 1692).
Informed consent statement: Informed consent was not obtained because this study used anonymized claims data.
Conflict-of-interest statement: Sugano K received lecture fees from Takeda Pharma. Inc and he is an advisor of Phathom Co. Takeshima T is an employee of Milliman Inc., which provides consulting service for biomedical companies. Mizukami K and Murakami K declare that they have no conflicts of interest.
Data sharing statement: Data will not be made available to other researchers because access to the raw data is strictly limited to authorized researchers, and the raw data and interim analysis data must be deleted after the authorized research period. Analytic methods and analysis results approved for publication by the Ministry of Health, Labour and Welfare in Japan will be made available upon reasonable request.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Kazuhiro Mizukami, MD, PhD, Associate Professor, Department of Gastroenterology, Oita University, 1-1 Idaigaoka, Hasama, Yufu, Oita 8795593, Japan. mizkaz0809@oita-u.ac.jp
Received: October 29, 2022
Peer-review started: October 29, 2022
First decision: November 14, 2022
Revised: November 28, 2022
Accepted: January 9, 2023
Article in press: January 9, 2023
Published online: January 28, 2023
Processing time: 83 Days and 11.5 Hours
ARTICLE HIGHLIGHTS
Research background

Helicobacter pylori (H. pylori) eradication therapy can prevent some diseases, including peptic ulcer disease and gastric cancer. However, potentially unfavorable effects of eradication therapy have also been reported for some diseases, such as gastroesophageal reflux disease (GERD), Barrett’s esophagus (BE), inflammatory bowel disease (IBD), allergic diseases, and metabolic diseases. Consequently, both positive and negative impacts should be considered when assessing the effects of H. pylori eradication therapy.

Research motivation

This study compared the incidence of some diseases before and after H. pylori eradication therapy in order to assess the positive as well as negative effects of the therapy. The comprehensive evaluation of these effects in Japan, where large-scale eradication therapy was commenced earlier than it was in other countries because of coverage by universal healthcare, might provide useful information for clinicians worldwide.

Research objectives

The objective of this study was to compare the incidence of some diseases, which appear to be associated with H. pylori eradication therapy, before and after the eradication in order to obtain a comprehensive overview of the treatment effects.

Research methods

This study used a Japanese nationwide health claims database, the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB; April 2009-March 2020), developed by the Japanese Ministry of Health, Labour and Welfare. The database contains almost all (≥ 95%) health insurance claims data issued in Japan as well as health check-up data for individuals who underwent specific health check-ups. Patients with a prescription for primary H. pylori eradication therapy covered by national health insurance were analyzed as those who received primary H. pylori eradication therapy. The incidences of GERD, BE, other upper gastrointestinal diseases, and IBD; the prevalence of allergic diseases and metabolic syndrome (MS); and changes in body mass index (BMI) were examined before and after primary H. pylori eradication therapy.

Research results

In total, 5219731 patients who received primary eradication therapy were identified in the database. There was no significant increase in the incidence of GERD after eradication when considering the effects of aging and the reporting period. The incidence of BE was higher in the 3-year period after eradication than in the period before eradication for all age categories. The incidence of IBD and prevalence of allergic disease were also higher after eradication. In contrast, the incidences of gastric and DUs and gastritis were decreased after eradication. Among patients with at least one entry of health check-up data (1701111 patients), the percentage of patients with MS showed a slight increase following eradication (11.0% in the year of eradication and 12.2% after 5 years). Because this study only used information recorded in the claims database, the disease incidences were based on records of the diagnoses, and it was not possible to confirm the true onset of the development of the disease. The accuracy of the records of diagnoses also affected the results of this study.

Research conclusions

To our knowledge, this is the first study to examine the effects of H. pylori eradication therapy using a large-scale database in Japan. The results suggest that there is an increase in BMI and the development of BE, IBD, allergic diseases, and MS, but not in the development of GERD, after H. pylori eradication therapy. Although the treatment can drastically decrease the incidences of gastric and duodenal ulcers and gastritis, a considerable increase in allergic diseases may cancel out these beneficial effects.

Research perspectives

A comprehensive, long-term assessment of the treatment effects, with consideration of both favorable and unfavorable effects, is necessary for evaluating the true value of H. pylori eradication therapy.