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Clinical Research

Potential roles of Helicobacter pylori treatment, body mass index and waist circumference in the causation of erosive esophagitis: a randomized clinical trial (HEROES-GERD)

Subjects

Abstract

Background

In recent decades, the prevalence of gastroesophageal reflux disease (GERD) and obesity has been increasing while Helicobacter pylori infection has been decreasing.

Objective

To evaluate if H. pylori treatment, excess body weight and other anthropometric measurements are associated with incident erosive esophagitis, as a secondary objective of a trial which tested the efficacy of treatment of H. pylori on the symptoms of functional dyspepsia.

Subjects/methods

Upper gastrointestinal endoscopy and anthropometric assessments were performed, at baseline and after 12 months, in H. pylori positive patients with functional dyspepsia who had no baseline reflux symptoms or esophagitis. Patients were randomly assigned to receive omeprazole, amoxicillin, and clarithromycin (antibiotic group; n = 201) or omeprazole plus placebo (control group; n = 203). The primary outcome was the incidence of esophagitis 12 months after randomization, according to treatment groups, and the association of BMI and other anthropometric measurements.

Results

Four hundred and four patients were included (mean age, 46.1 years; 78.7% women). The 12-month follow-up endoscopic esophagitis rates for the antibiotic and control groups were 10.9% (22/201) and 9.4% (19/203), respectively (p = 0.60). The number needed to harm was 67. Baseline anthropometric measurements were performed in 94% (380/404) of patients. The 12-month follow-up esophagitis rates for overweight and normal body weight patients were 13.6% (29/213) and 6.0% (10/167), respectively (p = 0.015); rates for patients with and without increased baseline waist circumference were 15.4% (24/156) and 6.7% (15/224), respectively (p = 0.006). Following logistic regression, only the combination of increased baseline body mass index and waist, but not H. pylori treatment, was independently associated with new-onset esophagitis (OR 2.88; 95% CI: 1.28–6.45).

Conclusions

Excess body weight and concomitant increased waist circumference, but not H. pylori treatment, predicts new-onset esophagitis.

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Data availability

The data that support the findings of this study are available from the corresponding author on request.

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Acknowledgements

We are grateful to our study participants. The investigators thank Aché Laboratórios Farmacêuticos for unrestricted donation of the study drugs and the gastroscope.

Funding

The study drugs and a gastroscope, used to perform the endoscopies during the study, were obtained through unrestricted donation from the Aché Laboratórios Farmacêuticos SA, São Paulo, Brazil.

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Authors and Affiliations

Authors

Contributions

Conception and design: FM, LEM, GBS, CFMF, PSVR; acquisition, analysis or interpretation of data: all authors; drafting of the article: FM, RVCP, DS, CFMF, NJT, LEM, TCM; critical revision of the article: all authors; final approval of the article: all authors; provision of study materials or patients: FM, TCM, LRB, PSVR, LL, NFT; statistical expertise: FM, LEM, RVCP, DS, NJT, TCM; obtaining of funding: FM, LEM; administrative, technical, or logistic support: FM, LEM, TCM, LRB, PSVR, LL, NFT; collection and assembly of data: FM, LEM, GBS, CFMF, PSVR. All authors read and approved the final version of the paper.

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Correspondence to Felipe Mazzoleni.

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Mazzoleni, F., Mazzoleni, L.E., de Magalhães Francesconi, C.F. et al. Potential roles of Helicobacter pylori treatment, body mass index and waist circumference in the causation of erosive esophagitis: a randomized clinical trial (HEROES-GERD). Int J Obes 44, 147–158 (2020). https://doi.org/10.1038/s41366-019-0391-3

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