Screening for Helicobacter pylori to Prevent Gastric Cancer
Authors: Lee Yi-Chia , Chiang Tsung-Hsien , Chiu Han-Mo , Su Wei-Wen , Chou Kun-Ching , Chen Sam Li-Sheng , Yen Amy Ming-Fang , Fann Jean Ching-Yuan , Chiu Sherry Yueh-Hsia , Chuang Shu-Lin , Chen Yi-Ru , Chen Shih-Dian , Hu Tsung-Hui , Fang Yi-Jen , Wu Ming-Shiang , Chen Tony Hsiu-Hsi , Yeh Yen-Po ,   Collaborators of Taiwan Community-based Integrated Screening Group, Lin   Jaw-Town , Wu Chun-Ying , Liou Jyh-Ming , Luo Jiing-Chyuan , Chang Chun-Chao , Lee  Chia-Long , Chen Kuan-Yang , Shyu Rong-Yaun , Chang Chi-Yang , Chiu Cheng-Tang , Lin Chun-Che , Chang Chi-Sen , Chen Chi-Yi , Chou Chu-Kuang , Sheu Bor-Shyang , Yang Yao-Jong , Cheng Hsiu-Chi , Chang Wei-Lun , Kuo Hsin-Yu , Sheu Ming-Jen , Hsu Ping-I , Wu Deng-Chyang , Kuo Chao-Hung , Chuah Seng-Kee , Bair Ming-Jong , Yi Chih-Hsun , Yao Yu-Chin , Chang Kai-Wen , Shih Li-Chen , Yu Hsu-Fang , Wang Hsiao-Chi , Yeh Hui-Yun , Hsu Chen-Yang 
Published: September 2024

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