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Gut 2008;57:723-724; doi:10.1136/gut.2007.139923
Copyright © 2008 BMJ Publishing Group Ltd & British Society of Gastroenterology.

Commentaries

Pitfalls in designing trials of functional dyspepsia: the ascent and demise of itopride

Sander J O Veldhuyzen Van Zanten

Correspondence to:
Dr S Veldhuyzen van Zanten, Division of Gastroenterology, University of Alberta, Zeidler Ledcor Centre, Edmonton, Alberta T6G 2X8, Canada; vanzanten@ualberta.ca

The first 150 words of the full text of this article appear below.

The publication in this issue of Gut (see page 10.1136/gut.2007.132449) of the results of the clinical trial programme evaluating itopride in functional dyspepsia (FD)1 needs to be applauded on two counts:

  • Axcan Pharma, the sponsor of the study for conducting this comprehensive clinical trial programme.
  • Gut for publishing data that are important despite the overall disappointing results of the studies.

Over the last 15 years, definite progress has been made in the design, execution and data analysis of FD treatment trials. The efficacy of a limited number of treatment options has also been established. There is evidence that proton pump inhibitors (PPIs), and to a lesser extent H2 receptor antagonists (H2RAs), are efficacious in a proportion of FD patients.25 Importantly, the presence of heartburn appears to be a predictor of response.2 As a result, there is debate as to whether this is due to the inclusion of . . . [Full text of this article]


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Relevant Article

Itopride in functional dyspepsia: results of two phase III multicentre, randomised, double-blind, placebo-controlled trials
N J Talley, J Tack, T Ptak, R Gupta, and M Giguère
Gut 2008 57: 740-746. [Abstract] [Full Text] [PDF]

This article has been cited by other articles:

  • van Zanten, S. V. (2009). Review: fibre, antispasmodics, and peppermint oil are all effective for irritable bowel syndrome. Evid. Based Med. 14: 84-84 [Full Text]  

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