EFFICACY AND SAFETY OF THERAPIES FOR FAPD (FAP-NOS, IBS) IN CHILDREN: PROTOCOL FOR A NETWORK META-ANALYSIS

Abstract

Introduction: Functional Abdominal Pain Disorders (FAPDs or Disorders of Gut-Brain Interaction) are chronic, debilitating conditions impacting over 250 million children and their families globally. Pediatric Abdominal Pain Disorders (FAPDs) are subcategorized into Functional abdominal pain – not otherwise specified (FAP-NOS), Irritable Bowel Syndrome (IBS), Functional dyspepsia (FD) and Abdominal Migraine (AM). There are multiple therapies that have been tested in randomized trials, but direct comparisons are rare and results heterogeneous. We present the protocol for a network meta-analysis to investigate the efficacy and safety of these treatments. The scope will be all of the sub-categories, except FD, which owing to its very different presentation and sets of treatments will be unlikely to be included in any network analysis.

Methods: Cochrane and ‘Grading of Recommendations Assessment, Development and Evaluation’ (GRADE) methodology will be followed throughout. A structured search will be run for all randomized trials with no date limits. The results will be screened in duplicate by two authors independently and disagreements solved by a third author. This will also be done for full text selection and data extraction. Risk of bias assessments will be made for each study with authors contacted for missing information. We will express outcomes as risk ratios and mean differences with 95% confidence intervals. We will perform network meta-analyses and assess the certainty of the evidence using GRADE. The primary outcomes will be treatment success, serious adverse events, frequency of pain and severity of pain.