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Observational Study
. 2020 Dec;11(12):e00278.
doi: 10.14309/ctg.0000000000000278.

Rome III, Rome IV, and Potential Asia Symptom Criteria for Functional Dyspepsia Do Not Reliably Distinguish Functional From Organic Disease

Zhongcao Wei  1 , Qian Yang  1 , Qi Yang  2 , Juan Yang  2 , Xinxing Tantai  1 , Xin Xing  1 , Cailan Xiao  1 , Yanglin Pan  3 , Na Liu  1 , Jinhai Wang  1
Affiliations
Observational Study

Rome III, Rome IV, and Potential Asia Symptom Criteria for Functional Dyspepsia Do Not Reliably Distinguish Functional From Organic Disease

Zhongcao Wei et al. Clin Transl Gastroenterol. 2020 Dec.

Abstract

Introduction: Although the Rome criteria were created primarily for research purposes, it was an important question whether the Rome criteria can distinguish organic dyspepsia from functional dyspepsia (FD). We evaluated the accuracy of the Rome IV criteria in identifying patients with FD and compared the differences between the Rome IV, Rome III, and potential Asia criteria in identifying patients with FD.

Methods: In this cross-sectional study, we analyzed data from patients who met the inclusion and exclusion criteria from March 2018 to January 2019 at 2 tertiary hospitals.

Results: A total of 600 patients were enrolled in this study, including 381 individuals met the Rome IV criteria for FD, 438 individuals met the Rome III criteria for FD, and 525 individuals met the potential Asia criteria for FD. The Rome IV criteria identified patients with FD with 67.3% sensitivity and 38.4% specificity, and the positive and negative likelihood ratios of FD identified by Rome IV criteria were 1.09 (95% confidence interval 0.97-1.24) and 0.85 (95% confidence interval 0.67-1.08), respectively. There was no significant difference in the area under Rome IV, Rome III, or potential Asia criteria receiver operating characteristic curves in identifying FD (P > 0.05).

Discussion: The Rome IV criteria were no better than the Rome III or potential Asia criteria in identifying FD and were not helpful in identifying patients with FD. Hence, although the Rome criteria remain useful for defining patients with FD for inclusion into clinical treatment trials, they should not be used for diagnosing FD.

Trial registration: ClinicalTrials.gov NCT03479528.

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Conflict of interest statement

Guarantor of the article: Zhongcao Wei, MD.

Specific author contributions: Zhongcao Wei, MD, and Qian Yang, MD, contributed equally to this work. Z.W., Y.P., J.W., and N.L.: designed the research. Z.W., Qian Yang, Qi Yang, and J.Y.: performed the research. X.T., X.X., and C.X.: contributed analytic tools. Z.W. and Qian Yang: analyzed the data. Z.W., Y.P., J.W., and N.L.: wrote the paper. All authors finally approved the manuscript.

Financial support: None to report.

Potential competing interests: None to report.

Trial registration: The Rome IV part of our study was registered at ClinicalTrials.gov (number NCT03479528).

Figures

Figure 1.
Figure 1.
Endoscopy results for all participants. Among the 600 patients who underwent upper gastrointestinal endoscopy, there were 349 patients with chronic gastritis, 185 patients with gastric erosion, 16 patients with gastric ulcer, 13 patients with duodenal ulcer, 12 patients with Barrett's esophagus, 9 patients with gastric cancer, 7 patients with esophageal cancer, and others.
Figure 2.
Figure 2.
Functional dyspepsia (FD) according to Rome IV, Rome III, and potential Asia criteria. In the 196 patients diagnosed with true FD according to the reference standard, 132 met the Rome IV criteria for FD, 154 met the Rome III criteria for FD, and 167 met the potential Asia criteria for FD; among 404 patients who were not diagnosed with true FD according to the reference standard, 249 met the Rome IV criteria for FD, 284 met the Rome III criteria for FD, and 358 met the potential Asia criteria for FD. Ns, no significance; *P < 0.05.
See this image and copyright information in PMC

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