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(Journal Article) |
GASTROENTEROLOGY 2006;130:1538–1551 Design of Treatment Trials for Functional Gastrointestinal Disorders Design of Treatment Trials Committee: E. JAN IRVINE, * WILLIAM E. WHITEHEAD, ‡
M Shaw
,
NJ Talley
,
WD Chey
,
K Matsueda
ABSTRACT
This document addresses the design of trials to assess the efficacy of new treatments for functional gastrointestinal disorders (FGID), emphasizing trials in irritable bowel syndrome and dyspepsia, because most research has been undertaken in these conditions. The double-blind, randomized, placebo-controlled, parallel group trial remains the preferred design. Randomized withdrawal designs, although encouraged by the European Agency for the Evaluation of Medicinal Products, have the same potential disadvantages as a crossover design, including carryover effects, unmasking (unblinding), and overestimation of the potential benefit for clinical practice. Innovative trial designs that evaluate intermittent (on demand) treatment are likely to become more common in the future. Investigators should include as broad a spectrum of patients as