- Bender BG,
- Ikle DN,
- DuHamel T,
- Tinkleman D
The objective of study was to determine the psychological side effects of theophylline and beclomethasone in asthmatic children.
Multicenter, randomized, double-blind, parallel-group study in which 102 asthmatic children were assigned to one of two treatments, beclomethasone three times daily, or theophylline twice daily. At baseline, 1 month, and 1 year, parents completed standardized behavioral questionnaires while children received psychometric testing of attention, concentration, memory, learning, and problem-solving.
There was no consistent difference in treatment effects between the two drugs. There were two significant treatment-by-period results that were discordant; one suggested slightly improved attention in the theophylline group, while the other indicated slight advantage in attention scores in the beclomethasone group. There were numerous significant period results indicating that behavior and cognitive test performance improved over a 1-year period regardless of the treatment.
Neither theophylline or beclomethasone should be removed from consideration because of concern for significant psychological side effects. Although there is a possibility that a subset of asthmatic children, particularly preschoolers, may be at risk for medication induced changes, there are no controlled studies to prove this. Parental misconceptions of medication side effects often occur because of temporary effects that occur at the initiation of treatment or because they erroneously associate the effects of the chronic illness, asthma, with the medications.
This study was conducted in children 6 to 17 years of age and thus cannot speak to the effects in preschoolers; however, it is refreshing to note that the behavioral side effects of theophylline and beclomethasone were not significant and that behavioral side effects were more likely to be associated with the asthma. These results would suggest that treatment of asthma resolved the apparent behavioral effects of asthma, rather than creating behavioral side effects. This is further support for effective treatment of asthma, from a behavioral standpoint, and verifies the safety of theophylline and beclomethasone as medications for asthma therapy with regard to learning and behavior.