Perfusion Nutrient Load Test Combined With 2dus in Assessment of Proximal and Distal Gastric Emptying in Healthy Subjects and Functional Dyspepsia Patients

Background: Clinical trials and regulatory agencies rely on the ROME III criteria for definition of functional dyspepsia (FD) and require exclusion of patients with GERD from entry into FD clinical trials.Aim: To determine the overlap between Rome III FD and GERD in unselected primary care patients with frequent upper GI symptoms.Methods: Unselected primary care patients (n=336) with upper GI symptoms were studied in Western Europe and North America.Patients were included if they had upper GI symptoms at least 2 days/ week the month before inclusion and at least 3 days/week of at least mild intensity the week before inclusion.Patients were required not to use proton pump inhibitors within 2 months of inclusion.All patients underwent blinded evaluation by a primary care doctor and a gastroenterologist separately.Patients were interviewed using a list of 19 pre-specified upper GI symptoms.Following this, all patients underwent upper endoscopy and 48 hour pH testing using the wireless Bravo pH system placed 6 cm above the endoscopically measured squamo-columnar junction.GERD was defined as presence of reflux esophagitis on endoscopy (LA grades A-D) and/or pathologic distal esophageal acid exposure, ie an esophageal pH <4 for at least 5.5% of the 24 hours.FD was defined by the Rome III criteria including the absence of GERD and peptic ulcer disease.Results: Among the FD (n=153)/GERD (n= 181) patients evaluated, 30/35% reported 1-5 upper GI symptoms, 42/45% reported 6-10 symptoms and 28/21% reported 11-19 symptoms.The most common, overlapping symptoms between FD and GERD were bloating, belching and epigastric pain.Regurgitation was absent in patients with FD who had no heartburn but was very common (74%) in patients with FD who had heartburn.The prevalence/patterns of dyspeptic symptoms in FD, with and without concomitant heartburn, and in GERD, with heartburn, are shown in the Table .Conclusions: 1.The Rome III criteria for functional dyspepsia (FD) do not reliably distinguish between FD and GERD. 2. Substantial overlap between FD and GERD requires new strategies for trial design in upper GI disorders other than GERD and suggests the need for further exploration of FD definitions.Prevalence of dyspeptic symptoms in FD, with or without heartburn, and in GERD, with heartburn 1122