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
Abstract
BACKGROUND

Helicobacter pylori (H. pylori) infection is a risk factor for many diseases, including peptic ulcer disease and gastric cancer. While H. pylori eradication therapy can prevent these diseases, potentially unfavorable effects of eradication therapy have also been reported in 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.

AIM

To compare the incidence of these diseases before and after H. pylori eradication and to comprehensively assess its effects.

METHODS

This retrospective cohort study used a Japanese nationwide health claims database (April 2009-March 2020), developed by the Japanese Ministry of Health, Labour and Welfare. The database contained almost all health insurance claims data issued in Japan, and specific health check-up data for individuals who took the check-ups. Descriptive statistics were used for the analyses. Patients who received primary eradication therapy were defined as those prescribed medi-cation for H. pylori eradication. New diagnoses, defined as incidence of upper gastrointestinal diseases and IBD, and prevalence of allergic diseases were compared before and after eradication. The incidence and prevalence of each disease were also compared between the 3-year period before eradication (from the 4th to the 2nd year prior to the year of eradication) and the 3-year period after eradication (from the 1st to the 3rd year after the year of eradication) based on the age category and calendar year and month. Changes in body mass index and proportion of patients with metabolic syndrome (MS) were examined before and after eradication.

RESULTS

We identified 5219731 patients who received primary eradication therapy. The 65-69 years age group had the greatest number of patients in both sexes. There was no significant increase in the incidence of GERD after eradication when considering the effects of aging and reporting period. However, the incidence of BE was higher in the 3-year period after eradication than in the 3-year period before eradication for all age categories (0.02%-0.10% vs < 0.01%-0.05%). The incidence of IBD and prevalence of allergic disease were also higher after eradication. In contrast, the incidence of gastric and duodenal ulcers and gastritis was reduced after eradication. In 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).

CONCLUSION

The results suggest that H. pylori eradication therapy reduces peptic ulcers and gastritis; however, it is associated with increased incidence of several other chronic diseases.

Keywords: Administrative claims; Healthcare; Allergy; Eradication therapy; Gastroesophageal reflux disease; Helicobacter pylori; Inflammatory bowel disease

Core Tip: While Helicobacter pylori (H. pylori) eradication can prevent certain diseases including peptic ulcer diseases and gastric cancer, unfavorable effects of eradication therapy have also been reported. We analyzed a Japanese nationwide health claims database containing almost all health insurance claims data to compare the incidence and prevalence of specific diseases before and after H. pylori eradication to comprehensively assess its effects. We identified 5219731 patients who received primary eradication therapy. H. pylori eradication drastically reduced peptic ulcers and gastritis but was associated with an increase in Barrett’s esophagus, inflammatory bowel disease, allergic disease, and metabolic syndrome.