Gastroenterology

Gastroenterology

Volume 163, Issue 1, July 2022, Pages 154-162.e3
Gastroenterology

Original Research
Full Report: Helicobacter pylori
Effect of Helicobacter pylori Eradication on Gastric Cancer Prevention: Updated Report From a Randomized Controlled Trial With 26.5 Years of Follow-up

https://doi.org/10.1053/j.gastro.2022.03.039Get rights and content

Background & Aims

Helicobacter pylori infection is considered as the most important risk factor in the pathogenesis of gastric cancer. This study aims to evaluate the long-term effects of H pylori eradication treatment on the incidence and mortality of gastric cancer among a high-risk population.

Methods

This prospective, randomized, placebo-controlled trial was conducted in a high-risk area in southern China in July 1994. A total of 1630 asymptomatic, H pylori–infected individuals were randomly assigned to receive standard triple therapy for H pylori eradication (n = 817) or placebo (n = 813), and were followed up until December 2020. The primary outcome was incidence of gastric cancer. Total and cause-specific mortalities were the secondary outcomes.

Results

During 26.5 years of follow-up, 21 participants (2.57%) in the treatment arm and 35 (4.31%) in the placebo arm were diagnosed with gastric cancer. Participants receiving H pylori treatment had a lower incidence of gastric cancer compared with their placebo counterparts (hazard ratio [HR], 0.57; 95% CI, 0.33–0.98). More obvious risk reduction was observed among those without premalignant gastric lesions (HR, 0.37; 95% CI, 0.15–0.95) and those without dyspepsia symptoms at baseline (HR, 0.44; 95% CI, 0.21–0.94). Furthermore, compared with 32 cases of gastric cancer observed among 527 participants with persistent H pylori infection in the placebo group, only 16 were identified in 625 subjects with successful eradication in the treatment group (HR, 0.46; 95% CI, 0.26–0.83). However, there were no statistically significant differences for any mortality end points between the 2 groups.

Conclusions

Eradication of H pylori might confer a long-term protection against gastric cancer in high-risk populations, especially for infected individuals without precancerous gastric lesions at baseline.

Section snippets

Study Participants and Study Design

This is an updated report of a randomized, placebo-controlled trial conducted in Changle of Fuzhou, Fujian Province, China, in July 1994, with an extended follow-up time up to 26.5 years. Details of the study design, including eligibility criteria, number of enrolled participants, treatment arms, and results of 7.5-year follow-up of this trial have been published previously.16 Briefly, a total of 2423 eligible healthy participants aged 3565 years were recruited from 7 local villages and each

Results

During a maximum follow-up duration of 26.5 years, a total of 56 cases of gastric cancer were diagnosed. Table 1 shows the crude incidence rates of gastric cancer by baseline participant characteristics. Statistically significant differences were noted between groups by age, sex, daily smoking status, green tea consumption frequency, and histopathology findings.

Discussion

In this prospective, randomized, placebo-controlled trial, a significant protective effect of H pylori eradication on the risk of gastric cancer was found, and the effects were consistent by tumor subsite (cardia vs noncardia) or by follow-up duration. However, the favorable effects were only evident among those without precancerous gastric lesions and those without dyspepsia symptoms at baseline. The most significant risk reduction was noted among participants with successful eradication as

Acknowledgments

The authors thank the residents for participating in the trial; the administrative staff Zuxia Zhang, Lici Chen from Changle Center for Disease Prevention and Control, for the assistance with the study during the trial period; the gastroenterologists Fenglin Chen and Hao Chen, and nurses Mingtan Hou and Qingqing Zu from the Affiliated Union Hospital of Fujian Medical University for their assistance in gastroscopic examination in this study.

CRediT Authorship Contributions

Lingjun Yan, PhD (Conceptualization: Equal; Formal

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    Conflicts of interest The authors disclose no conflicts.

    Funding This study was supported by High-Level Talents Research Start-Up Project of Fujian Medical University, China (XRCZX2017035 and XRCZX2020034); Technology Development Fund from Fujian Province, China (2019L3006). The funding sponsor was not involved in the study design or in the collection, analysis, and interpretation of data.

    Author names in bold designate shared co-first authorship.

    Authors share co-first authorship.

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