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The Journal of Headache and Pain
Published in: The Journal of Headache and Pain 6/2010

Open Access 01-12-2010 | Review Article

Are the current IHS guidelines for migraine drug trials being followed?

Authors: Anders Hougaard, Peer Tfelt-Hansen

Published in: The Journal of Headache and Pain | Issue 6/2010

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Abstract

In 2000, the Clinical Trials Subcommittee of the International Headache Society (IHS) published the second edition of its guidelines for controlled trials of drugs in migraine. The purpose of this publication was to improve the quality of such trials by increasing the awareness amongst investigators of the methodological issues specific to this particular illness. Until now the adherence to these guidelines has not been systematically assessed. We reviewed all published controlled trials of drugs in migraine from 2002 to 2008. Eligible trials were scored for compliance with the IHS guidelines by using grading scales based on the most essential recommendations of the guidelines. The primary efficacy measure of each trial was also recorded. A total of 145 trials of acute treatment and 52 trials of prophylactic treatment were eligible for review. Of the randomized, double-blind trials, acute trials scored an average of 4.7 out of 7 while prophylactic trials scored an average of 5.6 out of 9 for compliance. Thirty-one percent of acute trials and 72% of prophylactic trials used the recommended primary efficacy measure. Fourteen percent of the reviewed trials were either not randomized or not double-blinded. Adherence to international guidelines like these of IHS is important to ensure that only high-quality trials are performed, and to provide the consensus that is required for meta analyses. The primary efficacy measure for trials of acute treatment should be “pain free” and not “headache relief”. Open-label or non-randomized trials generally have no place in the study of migraine drugs.
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Metadata
Title
Are the current IHS guidelines for migraine drug trials being followed?
Authors
Anders Hougaard
Peer Tfelt-Hansen
Publication date
01-12-2010
Publisher
Springer Milan
Published in
The Journal of Headache and Pain / Issue 6/2010
Print ISSN: 1129-2369
Electronic ISSN: 1129-2377
DOI
https://doi.org/10.1007/s10194-010-0257-5

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