Effects of Community Screening for Helicobacter pylori: 13-Year Follow-Up Evaluation of a Randomized Controlled Trial

Background & Aims Helicobacter pylori eradication improves the prognosis of peptic ulcer disease (PUD), dyspepsia, and possibly gastric cancer. H pylori screening tests are accurate and eradication therapy is effective. H pylori population screening seems attractive. The aim of this study was to evaluate the long-term effect of H pylori population screening and eradication on dyspepsia prevalence and the incidence of PUD, and as secondary outcomes to assess the effect on health care consumption and quality of life. Methods At baseline in 1998 to 1999, 20,011 individuals aged 40 to 65 years were randomized to H pylori screening and eradication or a control group with no screening. Both groups received a questionnaire on dyspepsia and quality of life. Register data were obtained for all randomized individuals. Results The baseline questionnaire response rate was 63%. Of the 5749 individuals screened, 1007 (17.5%) were H pylori positive. Complete symptom data were obtained for 8658 (69%) individuals after 13 years. Dyspepsia prevalence decreased in both groups during the follow-up period, but multivariate analysis showed no effect of H pylori screening and eradication (adjusted odds ratio, 0.93; 95% confidence interval, 0.82–1.04); compared with usual care. Intention-to-treat and per-protocol analyses of register data provided similar results. H pylori screening neither reduced PUD incidence significantly (adjusted odds ratio, 0.88; 95% confidence interval, 0.70−1.11) nor did it have a beneficial effect on health care consumption. H pylori screening had no long-term effect on quality of life. Conclusions This randomized clinical trial with 13 years of follow-up evaluation, designed to provide evidence on the effect of H pylori population screening, showed no significant long-term effect when compared with usual care in this low-prevalence area. ClinicalTrials.gov identifier: NCT02001727.