Sodium cromoglicate: an ineffective drug or meta-analysis misused?

Sodium cromoglicate (SCG) has been available since around 1970 for the treatment of asthma and other allergic disorders in both adults and children. It has been approved for use around the world. Over the period of its development, a number of different formulations were introduced. In 1999, a systematic review of SCG use in childhood asthma was carried out and reported initially as a poster. Further systematic reviews and papers followed from the same authors and finally a Cochrane Collaboration review was published in 2003. All concluded that SCG was ineffective in paediatric asthma. Both the British Thoracic Society Guidelines for the treatment of paediatric asthma and the Model List of Essential Drugs of the WHO now reflect these conclusions. This paper looks carefully at the conclusions of these systematic reviews and raises concerns about the interpretation of the results. These failed to take adequate account of the changes with time in both the formulations used and the age groups examined, and also failed to take adequate note of the totality of information available over all end-points. One primary end-point was based on only four out of the 24 studies included in the review. Rather than having no effect, it is demonstrated that a considerable body of evidence favours SCG compared to placebo and, far from being ineffective, the drug appears to be effective particularly in older children. This article replaces a previously published version. DOI: 10.1002/pst.258.