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Electronic letters published:
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Flawed study design
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Brian J Lipworth, Professor of allergy and pulmonology Asthma and Allergy Research Group,Ninewells University Hospital,Dundee
Send letter to journal:
b.j.lipworth{at}dundee.ac.uk Brian J Lipworth
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The study of Perng et al was flawed in its design because there was no comparator group taking low dose inhaled steroid alone .Thus it is entirely conceivable that in steroid naive patients with mild to moderate asthma ,with only mild airway hyperresponsiveness ,there would be a shallow dose response to budesonide ,such that the response to 400ug/day budesonide would be no different than 1200ug/day .Without demonstrating a dose response in the first instance for budesonide in these patients ,one can not exlude the distnict possibility that budesonide 400ug plus zafirlukast would have been no different than budesonide 400ug alone .Curiously the authors did not include an intial run in period prior to randomisation,when the patients could have been given 400ug/day of budesonide alone ,prior to randomisation ,in order to establish a treated baseline with which to compare the response to subsequent randomised treatments. Current guidelines clearly advocate stepping down to the lowest effective maintainence dose of inhaled steroid once initial control is acheived .In this resepct it would have been more informative to have stepped down from 1200ug to 400ug of budesonide after 6 weeks ,while at the same time stopping zafirlukast in the other group ,in order to compare the effects of budesonide 400ug alone in both groups. The author has no conflicts of interest |
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