TY - JOUR T1 - Design of treatment trials for functional gastrointestinal disorders JF - Gut JO - Gut SP - II69 LP - II77 DO - 10.1136/gut.45.2008.ii69 VL - 45 IS - suppl 2 AU - S J O Veldhuyzen van Zanten AU - N J Talley AU - P Bytzer AU - K B Klein AU - P J Whorwell AU - A R Zinsmeister Y1 - 1999/09/01 UR - http://gut.bmj.com/content/45/suppl_2/II69.abstract N2 - Until recently many clinical trials of functional gastrointestinal disorders (FGIDs) suffered from important weaknesses in trial design, study execution, and data analysis. This makes it difficult to determine whether truly efficacious therapies exist for these disorders. One of the important methodologic problems is the absence of validated outcome measures and lack of consensus among stakeholders on how to measure outcome. Currently much of the effort is being put into the development of validated outcome measures for several of the FGIDs. The randomized, controlled trial with parallel groups is the design of choice. In this report, guidelines are given for the basic architecture of intervention studies of FGIDs. Further studies on design issues are required to ensure the recommendations will become evidence based in the future.FGIDfunctional gastrointestinal disorderIBSirritable bowel syndromeVASvisual analogue scalesITTintention-to-treatMCIDminimal clinically important difference ER -