Editorial
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Pharmacol Ther. Nov 6, 2015; 6(4): 96-104
Published online Nov 6, 2015. doi: 10.4292/wjgpt.v6.i4.96
Present state and future challenges in pediatric abdominal pain therapeutics research: Looking beyond the forest
Craig A Friesen, Jennifer V Schurman, Susan M Abdel-Rahman
Craig A Friesen, Division of Gastroenterology, Hepatology, and Nutrition, Children’s Mercy Kansas City, Kansas City, MO 64108, United States
Jennifer V Schurman, Division of Developmental and Behavioral Sciences, Children’s Mercy Kansas City, Kansas City, MO 64108, United States
Susan M Abdel-Rahman, Division of Pediatric Pharmacology, Medical Toxicology, and Therapeutic Innovation, Children’s Mercy Kansas City, Kansas City, MO 64108, United States
Author contributions: All authors contributed equally to the content, writing, and revision of this manuscript; all authors had approved the final version of the manuscript.
Conflict-of-interest statement: The authors have no conflicts of interest.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Craig A Friesen, MD, Division of Gastroenterology, Hepatology, and Nutrition, Children’s Mercy Kansas City, 2401 Gillham Road, Kansas City, MO 64108, United States. cfriesen@cmh.edu
Telephone: +1-816-2343016 Fax: +1-816-8021465
Received: May 4, 2015
Peer-review started: May 6, 2015
First decision: July 10, 2015
Revised: August 8, 2015
Accepted: August 20, 2015
Article in press: August 21, 2015
Published online: November 6, 2015
Processing time: 191 Days and 20.1 Hours
Abstract

At the present time, it is nearly impossible to treat pediatric functional gastrointestinal disorders associated with pain in an evidence based fashion. This is due to the overall lack of controlled studies and, even more importantly, the complexity of the contributors to disease phenotype which are not controlled or accounted for in most therapeutic trials. In this manuscript, we review the challenges of defining entry criteria, controlling for the large number of biopsychosocial factors which may effect outcomes, and understanding pharmacokinetic and pharmacodynamic factors when designing therapeutic trials for abdominal pain in children. We also review the current state of pediatric abdominal pain therapeutics and discuss trial design considerations as we move forward.

Keywords: Pharmacogenomics; Functional dyspepsia; Abdominal pain; Irritable bowel syndrome; Therapeutic trials; Pharmacokinetics

Core tip: For abdominal pain therapeutics research to fulfill the promise of personalized medicine, there is a need to standardize trial entry criteria including validating Rome criteria as predictors of response. There is also a need to embrace complexity and recognize and control for the large number of biologic, psychologic, social, and pharmacologic factors which define each patient and may affect drug response. This approach will allow us not only to understand what treatments work for the population at large, but for the individual patient in front of us.