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

Maria Bomme; Jane Møller Hansen; Mette Wildner-Christensen; Jesper Hallas; Ove B Schaffalitzky de Muckadell

doi:10.1016/j.cgh.2017.06.006

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

Clin Gastroenterol Hepatol. 2017 Nov;15(11):1715-1723.e7. doi: 10.1016/j.cgh.2017.06.006. Epub 2017 Jun 9.

Authors

Maria Bomme¹, Jane Møller Hansen², Mette Wildner-Christensen³, Jesper Hallas⁴, Ove B Schaffalitzky de Muckadell²

Affiliations

¹ Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark; Institute of Clinical Research, University of Southern Denmark, Odense, Denmark. Electronic address: maria.bomme@rsyd.dk.
² Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark; Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
³ Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark.
⁴ Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.

PMID: 28606845
DOI: 10.1016/j.cgh.2017.06.006

Abstract

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.

Keywords: Dyspepsia; Helicobacter pylori Screening; Peptic Ulcer Disease; Randomized Controlled Trial.

Publication types

Randomized Controlled Trial

MeSH terms

Adult
Aged
Dyspepsia / epidemiology*
Female
Follow-Up Studies
Health Facilities / statistics & numerical data
Helicobacter Infections / complications*
Helicobacter Infections / diagnosis*
Helicobacter Infections / drug therapy
Humans
Incidence
Male
Mass Screening / statistics & numerical data*
Middle Aged
Peptic Ulcer / epidemiology*
Prevalence
Prospective Studies
Quality of Life
Surveys and Questionnaires

Associated data

ClinicalTrials.gov/NCT02001727