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Ethics of placebo controlled studies of inhaled steroids for COPD
  1. D L Hahn1
  1. 1Dean Medical Center, East Clinic, 1821 S Stoughton, Road, Madison, WI 53716, USA; dlhahn@wisc.edu

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The meta-analysis by Sutherland et al1 of the effect of inhaled corticosteroids on the progression of airflow limitation in patients with chronic obstructive pulmonary disease (COPD) found a small improvement in forced expiratory volume in 1 second (FEV1) of −7.7 ml/year (95% CI −14.2 to −1.3) which is similar to the results of the meta-analysis performed by Highland et al2 (−5 ml/year (95% CI −11.2 to 1.2)) using a very similar data set. The meta-analyses employed slightly different study selection criteria and analytical techniques, and questioned the clinical significance of such small differences in FEV1. The selected primary studies suffered from potential drop-out bias and significant selection bias, in that almost all of the studies subjected to these meta-analyses excluded patients with a bronchodilator response.2 Studies of asthma and COPD as separate entities are limited because asthma and COPD (observed in cross section) represent a continuum,3 and the small number of available prospective observations indicates that asthma and COPD are sometimes different clinical manifestations of the same underlying aetiology evolving over time.4 Given all the uncertainties, questions and limitations, Highland et al2 concluded (correctly in my opinion) that “additional studies are needed …

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