A Cochrane review [Abstract] 1 included 65 studies. 56 studies (19 paediatric studies) contributed data (10 005 adults and 3 333 children); 21 studies were of high methodological quality. All study patients had mild or moderate persistent asthma and study durations varied from 4 to 52 weeks. The median dose of inhaled corticosteroids was quite homogeneous at 200 µg/day of microfine hydrofluoroalkane-propelled beclomethasone or equivalent (HFA-BDP eq).
Patients treated with anti-leukotrienes were more likely to suffer an exacerbation requiring systemic steroids (RR 1.51, 95% CI 1.17 to 1.96; 21 studies, n=6 077). Twenty eight (95% CI 15 to 82) patients must be treated with anti-leukotrienes instead of inhaled corticosteroids to cause one extra exacerbation. The magnitude of effect was significantly greater in patients with moderate compared with those with mild airway obstruction (RR 2.03, 95% CI 1.41 to 2.91 versus RR 1.25, 95% CI 0.97 to 1.61). Significant group differences favouring inhaled corticosteroids were noted in most secondary outcomes including patients with at least one exacerbation requiring hospital admission (RR 3.33, 95% CI 1.02 to 10.94; 12 studies, n=2 715), the change from baseline FEV1 (MD 110 mL, 95% CI 140 to 80; 23 studies, n=7 128) as well as other lung function parameters, asthma symptoms, nocturnal awakenings, rescue medication use, symptom-free days, the quality of life, parents and physicians satisfaction. Anti-leukotriene therapy was associated with increased risk of withdrawals due to poor asthma control (RR 2.56, 95% CI 2.01 to 3.27; 26 studies, n=7 669). Thirty one (95% CI 22 to 47) patients must be treated with anti-leukotrienes instead of inhaled corticosteroids to cause one extra withdrawal due to poor control. Risk of side effects was not different between groups.
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