White Paper AGA: Functional Dyspepsia.

Functional dyspepsia remains a major challenge for clinicians with no approved drugs available in the Western World. In October 2016, a meeting was held in Washington, DC, sponsored by the American Gastroenterological Association's Center for Diagnostics and Therapeutics, which included members of the Food and Drug Administration (FDA) and the pharmaceutical industry, experts in FD, and representatives of patient organizations. This white paper summarizes our current status, progress with a validated patient reported outcome instrument in functional dyspepsia, future directions and needs.

Clinical Rationale for Confirmation Testing After Treatment of Helicobacter pylori Infection: Implications of Rising Antibiotic Resistance.

Helicobacter pylori (H pylori) infection is one of the most common chronic bacterial infections worldwide. International guidelines recommend H pylori eradication in several scenarios: patients with peptic ulcer disease, patients who have had endoscopic resection of early gastric cancer, and patients with a gastric mucosa-associated lymphoid tissue lymphoma (MALToma). There is variability among the guidelines for other conditions.

Systematic review of patient-reported outcome instruments for gastroesophageal reflux disease symptoms.

Gastroesophageal reflux disease (GERD) symptoms are best assessed using patient-reported outcome (PRO) instruments. Guidance on developing well-defined and reliable instruments that capture optimal information from the patient's perspective was recently published by the US Food and Drug Administration and the European Medicines Agency. The aim of this systematic review was to identify and evaluate existing PRO instruments for GERD symptoms with regard to regulatory requirements.

Arbaclofen placarbil in GERD: a randomized, double-blind, placebo-controlled study.

Objectives: It has been shown that arbaclofen placarbil (AP) inhibits reflux in gastroesophageal reflux disease (GERD) following single oral dosing. This study evaluated the efficacy and safety of AP over 4 weeks in subjects with symptomatic GERD.

Methods: One hundred fifty-six subjects with heartburn and/or regurgitation ≥3 days/week and either no history of taking proton pump inhibitors (PPIs naive, n=58) or at least partial symptom response to PPI therapy (PPI responsive, n=98) were enrolled in this randomized, double-blind, placebo-controlled trial.

Will the history and physical examination help establish that irritable bowel syndrome is causing this patient's lower gastrointestinal tract symptoms?

Context: Many individuals experience lower gastrointestinal tract symptoms, most commonly attributable to functional conditions. These individuals are frequently diagnosed with irritable bowel syndrome (IBS) based on their symptoms; however, some may require additional testing or referral to specialists before this diagnosis is made.

Objective: To systematically review the literature of the accuracy of individual symptoms and combinations of findings in diagnosing IBS.

A second-order simulation model of the cost-effectiveness of managing dyspepsia in the United States.

Background: The "gold-standard'' evidence of effectiveness for a clinical practice guideline is the randomized controlled trial (RCT), although RCTs have a limited ability to explore potential management strategies for a chronic disease where these interact over time. Modeling can be used to fill this gap, and models have become increasingly complex, with both dynamic sampling and representation of second-order uncertainty to provide more precise estimates. However, both simulation modeling and probabilistic sensitivity analysis are rarely used together.

Symptom response and healing of erosive esophagitis with proton-pump inhibitors in patients with Helicobacter pylori infection.

Objectives: The aim of this article is to determine the severity of esophagitis and the response to treatment with proton-pump inhibitors in patients with and without evidence of Helicobacter pylori infection.

Methods: This retrospective analysis evaluated data collected in a randomized, double-blind clinical trial that assessed the efficacy and safety of once-daily esomeprazole 40 mg (n = 2,624) versus lansoprazole 30 mg (n = 2,617) for up to 8 wk in the treatment of reflux-associated erosive esophagitis. At baseline, erosive esophagitis was graded using the Los Angeles (LA) classification; serologic testing for H.

Dysphagia in patients with erosive esophagitis: prevalence, severity, and response to proton pump inhibitor treatment.

Background & Aims: Dysphagia is considered an alarm symptom, raising the question of stricture or malignancy. We sought to determine the prevalence and severity of dysphagia in patients with uncomplicated erosive esophagitis and its response to therapy.

Methods: A total of 11,945 patients with endoscopically confirmed erosive esophagitis (Los Angeles grades A-D) participated in 5 double-blind, randomized, clinical trials evaluating the efficacy of up to 8 weeks of treatment with either once-daily esomeprazole 40 mg (n = 5068), esomeprazole 20 mg (n = 1243), omeprazole 20 mg (n = 3018), or lansoprazole 30 mg (n = 2616).

Minimizing recurrent peptic ulcer hemorrhage after endoscopic hemostasis: the cost-effectiveness of competing strategies.

Objectives: Controversy exists regarding the optimal strategy to minimize recurrent ulcer hemorrhage after successful endoscopic hemostasis. Our objective was to evaluate the cost-effectiveness of competing strategies for the posthemostasis management of patients with high risk ulcer stigmata.

Methods: Through decision analysis, we calculated the cost-effectiveness of four strategies: 1) follow patients clinically after hemostasis and repeat endoscopy only in patients with evidence of rebleeding (usual care); 2) administer intravenous proton pump inhibitors (i.

Comparison of inter- and intraobserver consistency for grading of esophagitis by expert and trainee endoscopists.

Background: This study evaluated intra- and interobserver variability in the endoscopic scoring of esophagitis by using two grading schemes, the Los Angeles and Hetzel-Dent scales.

Methods: Three hundred twenty-five endoscopic photographs of esophagitis or healed esophagitis were randomly displayed twice to 9 endoscopist evaluators (4 experts, 5 trainees) by means of a CD-ROM. Evaluators scored each photograph by using both classification schemes.

Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis.

Objectives: Esomeprazole, the S isomer of omeprazole, has been shown to have higher healing rates of erosive esophagitis than omeprazole. This study compared esomeprazole with lansoprazole for the healing of erosive esophagitis and resolution of heartburn.

Methods: This United States multicenter, randomized, double blind, parallel group trial was performed in 5241 adult patients (intent-to-treat population) with endoscopically documented erosive esophagitis, which was graded by severity at baseline (Los Angeles classification).