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Evidence summaries

Ketotifen for Asthma in Children

Ketotifen alone or in combination with other interventions appears to improve control of asthma and wheezing in children with mild and moderate asthma, with sedation and weight gain as minor side effects. Level of evidence: "B"

A Cochrane review [Abstract] 1 included 26 studies with a total of 1,826 subjects, age range 4 months to 18 years. Ketotifen was given between 10 and 32 weeks. The proportion of children able to reduce or stop their bronchodilator use within 12 to 16 weeks of treatment was significantly higher in the ketotifen group (relative risk 2.39, 95% CI 1.64 to 3.48) based on four trials; this result was statistically significant in a subgroup of two trials with well described and adequate method of blinding. Statistically significant beneficial effects of ketotifen were also observed in the following secondary outcomes: efficacy evaluated by physician (10 trials) and parents/patients (7 trials), asthma symptom score (4 trials), asthma exacerbations (2 trials), and reduction in use of oral steroids (4 trials). However, sub-group analyses of trials with well described and adequate method of blinding was only significant for the outcome asthma symptom score and non-significant for the remaining secondary outcomes. Reported side effects were more frequent in the ketotifen group than in the placebo group (sedation: 21% vs 12%, weight gain: 27% vs 17%, respectively).

Comment: The quality of evidence is downgraded by study quality (inadequate or unclear allocation concealment and reporting).

    References

    • Schwarzer G, Bassler D, Mitra A, Ducharme FM, Forster J. Ketotifen alone or as additional medication for long-term control of asthma and wheeze in children. Cochrane Database Syst Rev 2004;(1):CD001384 [Review content assessed as up-to-date: 20 May 2010]. [PubMed]

Primary/Secondary Keywords