Abstract

The Rome criteria have been the most widely used criteria for defining dyspepsia. The Rome III criteria have divided functional dyspepsia into postprandial distress syndrome (PDS), characterized by postprandial fullness and early satiation, and epigastric pain syndrome (EPS), characterized by epigastric pain or burning.1 PDS and EPS are thought to have different pathophysiology, so these 2 syndromes might have different responses to medication, allowing a more rational approach to drug discovery and development. In the present study, Vakil et al2 evaluated the Rome III criteria for functional dyspepsia taking into consideration of the degree of symptom overlap between the 2 subtypes, PDS and EPS. In addition, the proportion of patients with gastroesophageal reflux disease (GERD) who met the criteria for PDS and/or EPS was also evaluated to determine if these subtypes have value in separating GERD and functional dyspepsia in clinical practice. Primary care patients with one or more upper gastrointestinal symptoms at least twice a week for a month or longer were enrolled and underwent esophageal endoscopy and 24-hour pH-metry. GERD was defined as the presence of at least one of the following: reflux esophagitis, pathological esophageal acid exposure, and positive symptom association probability ≥ 95% for association of symptoms with acid reflux. Functional dyspepsia was defined by the absence of GERD and peptic ulcer disease on investigation, and PDS and/or EPS were diagnosed according to the Rome III criteria. Of the 336 study participants, 9 had peptic ulcer disease and were excluded from the study. One hundred and eighty-nine patients were diagnosed with GERD and 159 (84%) of them also met the criteria for PDS and/or EPS: 36 (19%) had PDS alone, 42 (22%) had EPS alone and 81 (43%) met the criteria for both PDS and EPS. The remaining 138 patients had upper gastrointestinal symptoms with normal endoscopy, pH-metry, and symptom association probability results, consistent with the presence of functional dyspepsia. Of these patients, 130 (94%) met the criteria for PDS and/or EPS: 13 (10%) had PDS alone, 31 (24%) had EPS alone, and 86 (66%) had both PDS and EPS. Heartburn and/or regurgitation were the predominant symptoms (most or second most bothersome symptoms reported on physician-administered symptom assessment) in 90 (57%) of 159 GERD patients with concomitant PDS and/or EPS, and in 39 (30%) of 130 functional dyspepsia patients with PDS and/or EPS (P < 0.0001). In multivariate analysis, PDS is not predictive of functional dyspepsia vs. GERD (OR, 1.120; 95% CI, 0.657-1.911); EPS is a weak predictor of functional dyspepsia (OR 2.910; 95% CI, 1.596-5.306). In summary, there was considerable overlap between PDS and EPS in patients with functional dyspepsia. The distinction of functional dyspepsia into the subgroups of PDS and EPS may not be effective in clinical trials or clinical practice. New strategies are required for the classification of functional dyspepsia.

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