• Yi-Chia Lee, Tsung-Hsien Chiang, Han-Mo Chiu, Wei-Wen Su, Kun-Ching Chou, ChenSam Li-ShengSLSchool of Oral Hygiene, College of Oral Medicine, Taipei Medical University, Taipei City, Taiwan., Amy Ming-Fang Yen, FannJean Ching-YuanJCDepartment of Health Services Administration, College of Public Health, China Medical University, Taichung City, Taiwan., ChiuSherry Yueh-HsiaSYDepartment of Health Care Management and Healthy Aging Research Center, Chang Gung University, Taoyuan County, Taiwan.Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsi, Shu-Lin Chuang, Yi-Ru Chen, Shih-Dian Chen, Tsung-Hui Hu, Yi-Jen Fang, Ming-Shiang Wu, Tony Hsiu-Hsi Chen, Yen-Po Yeh, and Collaborators of Taiwan Community-based Integrated Screening Group.
• Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei City, Taiwan.
• JAMA. 2024 Nov 19; 332 (19): 164216511642-1651.

ImportanceEffects of screening for Helicobacter pylori on gastric cancer incidence and mortality are unknown.ObjectiveTo evaluate the effects of an invitation to screen for H pylori on gastric cancer incidence and mortality.Design, Setting, And ParticipantsA pragmatic randomized clinical trial of residents aged 50 to 69 years in Changhua County, Taiwan, eligible for biennial fecal immunochemical tests (FIT) for colon cancer screening. Participants were randomized to either an invitation for H pylori stool antigen (HPSA) + FIT assessment or FIT alone. The study was conducted between January 1, 2014, and September 27, 2018. Final follow-up occurred December 31, 2020.InterventionInvitation for testing for H pylori stool antigen.Main Outcomes And MeasuresThe primary outcomes were gastric cancer incidence and gastric cancer mortality. All invited individuals were analyzed according to the groups to which they were randomized.ResultsOf 240 000 randomized adults (mean age, 58.1 years [SD, 5.6]; 46.8% female), 63 508 were invited for HPSA + FIT, and 88 995 were invited for FIT alone. Of the 240 000 randomized, 38 792 who were unreachable and 48 705 who did not receive an invitation were excluded. Of those invited, screening participation rates were 49.6% (31 497/63 508) for HPSA + FIT and 35.7% (31 777/88 995) for FIT alone. Among 12 142 participants (38.5%) with positive HPSA results, 8664 (71.4%) received antibiotic treatment, and eradication occurred in 91.9%. Gastric cancer incidence rates were 0.032% in the HPSA + FIT group and 0.037% in the FIT-alone group (mean difference, -0.005% [95% CI, -0.013% to 0.003%]; P = .23). Gastric cancer mortality rates were 0.015% in the HPSA + FIT group and 0.013% in the FIT-alone group (mean difference, 0.002% [95% CI, -0.004% to 0.007%]; P = .57). After adjusting for differences in screening participation, length of follow-up, and patient characteristics in post hoc analyses, an invitation for HPSA + FIT was associated with lower rates of gastric cancer (0.79 [95% CI, 0.63-0.98]) but not with gastric cancer mortality (1.02 [95% CI, 0.73-1.40]), compared with FIT alone. Among participants who received antibiotics, the most common adverse effects were abdominal pain or diarrhea (2.1%) and dyspepsia or poor appetite (0.8%).Conclusions And RelevanceAmong residents of Taiwan, an invitation to test for HPSA combined with FIT did not reduce rates of gastric cancer or gastric cancer mortality, compared with an invitation for FIT alone. However, when differences in screening participation and length of follow-up were accounted for, gastric cancer incidence, but not gastric cancer mortality, was lower in the HSPA + FIT group, compared with FIT alone.Trial RegistrationClinicalTrials.gov Identifier: NCT01741363.

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