Post hoc analysis and claims of superiority in the excel trial

[...]the conclusion is based on one post hoc exacerbation analysis performed during the last of three 8-week intervals, whereas seven other analyses of exacerbations showed no significant difference between treatments. Guidelines state that the minimum period for assessing exacerbations should be 6...

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Bibliographic Details
Published in:Respiratory medicine 2007-03, Vol.101 (3), p.681-682
Main Authors: Naya, Ian P, Andersson, Tomas L.G
Format: Article
Language:English
Subjects:
Albuterol - analogs & derivatives
Albuterol - therapeutic use
Androstadienes - therapeutic use
Asthma
Asthma - drug therapy
Bronchodilator Agents - therapeutic use
Budesonide - therapeutic use
Drug Combinations
Drug Therapy, Combination
Ethanolamines - therapeutic use
Fluticasone-Salmeterol Drug Combination
Formoterol Fumarate
Humans
Medical research
Pulmonary/Respiratory
Studies
Treatment Outcome
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Summary:[...]the conclusion is based on one post hoc exacerbation analysis performed during the last of three 8-week intervals, whereas seven other analyses of exacerbations showed no significant difference between treatments. Guidelines state that the minimum period for assessing exacerbations should be 6 months.3 These guidelines also suggest that changes in concomitant therapy, e.g. exacerbation treatment, can make outcomes less reliable over time. [...]it is essential for all data from the point of randomisation to be incorporated in any exacerbation rate.
ISSN:0954-6111
1532-3064
DOI:10.1016/j.rmed.2006.10.025