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

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.

The Role of Gastrointestinal Microbiota in Functional Dyspepsia: A Review

“…It not only affects the life and work of patients, but also brings economic pressure to patients and national medical services. According to the Rome IV diagnostic criteria, FD refers to the presence of the above symptoms, but no gastrointestinal organic or structural lesions explained by gastroenteroscopy, ultrasound, computed tomography, gastrointestinal barium meal examination and other examinations ( Wei et al, 2020 ). Clinically, FD can be divided into epigastric pain syndrome (EPS), postprandial distress syndrome (PDS), and EPS-PDS overlap group.…”

Rome Foundation Clinical Diagnostic Criteria for Disorders of Gut-Brain Interaction

“…As the Rome criteria became more established over time for research, clinicians began to debate their use for clinical practice. [19][20][21][22][23] One example is related to the change in criteria for IBS from Rome III to Rome IV. The new criteria increased the specificity of the diagnosis at the expense of its sensitivity and identified a patient group with more severe disease, and the prevalence of IBS in the global study dropped by 50%.…”

“…28 The discrepancy between the Rome research criteria and clinical diagnoses became even more prominent with the publication of the Rome IV criteria, where changes in specific parameters compared to Rome III made the diagnosis less prevalent and defined a population with more severe disease. [20][21][22][23][24]29 In addition, the extent to which doctors are familiar with and apply the Rome diagnostic criteria is not clear. This is particularly important because patients with DGBI are treated at multiple levels of care, including gastroenterologists, family physicians, internists, surgeons, and others.…”

Evaluation of QOL in Patients with Dyspeptic Symptoms Who Meet or Do Not Meet Rome IV Criteria

“…It has been reported that only about half of the patients visiting hospitals meet the Rome criteria [ 10 ] in a real-world clinical setting. Recent reports in Asia also indicate that the Rome criteria for FD is suitable only in certain cases [ 11 , 12 , 13 , 14 , 15 , 16 ], meaning there are many dyspeptic patients who do not meet the Rome criteria, which we call non-FD patients in this study.…”