Abstract
Background/Aims
Gastroesophageal reflux disease (GERD) is a common medical condition, frequently refractory to medical therapy. Nickel is a leading cause of allergic contact dermatitis. Although nickel is widely found in foods, the effect of nickel on GERD is unknown. This pilot study sought to evaluate the effect of a low-nickel diet on GERD and determine if epicutaneous patch testing to nickel could predict responsiveness to a low-nickel diet.
Methods
This prospective, single-site pilot study recruited 20 refractory GERD patients as determined by GERD Health-Related Quality of Life (GERD-HRQL) scores. All patients had epicutaneous patch testing for nickel and were then instructed to follow a low-nickel diet for 8 weeks regardless of patch test results. GERD-HRQL was recorded at baseline and following 8 weeks of a low-nickel diet. Demographic and clinical data associated with GERD and nickel allergy were recorded. A Wilcoxon signed-rank test and nonparametric analysis of longitudinal data were run to determine statistical significance in pre- and post- GERD-HRQL scores in nickel patch test–positive and negative groups.
Results
Nearly all (19/20 [95%]) participants reported reduced GERD symptoms after 8 weeks on a low-nickel diet. Mean total GERD-HRQL, regurgitation, and heartburn scores declined (27.05 ± 16.04, 11.45 ± 6.46, 10.85 ± 8.29). Participants with positive vs. negative patch testing to nickel responded equivalently to a low-nickel diet.
Conclusions
A low-nickel diet improves GERD symptoms, but responsiveness to a low-nickel diet does not correlate with epicutaneous patch testing to nickel.
Trial registration
ClinicalTrials.gov number: NCT03720756
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Funding
Research reported in this publication was supported by the National Institute of General Medical Sciences of the National Institutes of Health under the West Virginia Clinical Translational Science Institute Award Number 5U54GM104942-04. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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All authors have contributed to and approved the final version of the manuscript. The respective roles of each author are the following: A.Y.: patient recruitment, data analysis, and drafting the manuscript; R.H.: study design and patient recruitment; M.M.: patient recruitment; E.G.: data analysis and critical revision of the manuscript for valuable intellectual content; W.F.: statistical analysis; R.C.: literature review and critical revision of the manuscript for valuable intellectual content; Z.Z. and S.G.: study concept, design, patient recruitment, and critical revision of the manuscript for valuable intellectual content.
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AY, RH, MM, EG, WF, RC, ZZ, and SG declare that they have no conflict of interest. All authors had access to study data and approved the final manuscript.
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The study was performed in accordance with the Helsinki Declaration of 1975, as revised in 2000 and 2008 concerning human rights, and the authors followed the policy concerning informed consent as shown on Springer.com. The study was conducted after obtaining proper ethical clearance from the institutional ethics committee.
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The study protocol was approved by the West Virginia University institutional review board.
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Senior author Swapna Gayam, MD, accepts full responsibility for the conduct of the study, has had access to the data, and controls the decision to publish.
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Yousaf, A., Hagen, R., Mitchell, M. et al. The effect of a low-nickel diet and nickel sensitization on gastroesophageal reflux disease: A pilot study. Indian J Gastroenterol 40, 137–143 (2021). https://doi.org/10.1007/s12664-020-01090-3
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DOI: https://doi.org/10.1007/s12664-020-01090-3