Published online Nov 6, 2015. doi: 10.4292/wjgpt.v6.i4.96
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
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.
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.