Bg. Bender et al., NEUROPSYCHOLOGICAL AND BEHAVIORAL-CHANGES IN ASTHMATIC-CHILDREN TREATED WITH BECLOMETHASONE DIPROPIONATE VERSUS THEOPHYLLINE, Pediatrics, 101(3), 1998, pp. 355-360
Objective. Results from previous investigations that examined the psyc
hological side effects of theophylline have been inconsistent, and non
e have reported about inhaled corticosteroids. The objective of this s
tudy was to assess the relative psychological side effects of theophyl
line and beclomethasone in asthmatic children. Methods. This was a mul
ticenter, randomized, double-blind, parallel-groups study in which 102
asthmatic patients were assigned to one of two treatments: beclometha
sone three times daily or theophylline twice daily. At baseline, 1 mon
th, and 1 year, parents completed standardized behavioral questionnair
es while the children received psychometric testing of attention and c
oncentration, memory and learning, and problem-solving. Results. Altho
ugh power was sufficient to detect meaningful mean score changes, no c
onsistent differential treatment effects were observed. Two significan
t treatment-by-period interactions were discordant, with one suggestin
g slightly better attention in the theophylline group, whereas the oth
er indicated a small advantage in attention scores in the beclomethaso
ne group. Numerous significant period effects revealed that behavior a
nd cognitive test performance improved over the 1-year period, regardl
ess of treatment, and confirmed a well established practice effect res
ulting from repeated administrations of such tests. Conclusions. Neith
er theophylline nor beclomethasone should be avoided out of concern fo
r significant psychological side effects. The possibility remains that
a subset of asthmatic children may be susceptible to such medication-
induced changes; investigators have suggested that preschool children
may be at particular risk, although no controlled studies with this ag
e group have been conducted. Parental perceptions of medication side e
ffects can be influenced by temporary effects present at initiation of
treatment or by erroneous attribution of the psychological effects of
the chronic illness. Reports of psychological changes in response to
asthma medications must be addressed respectfully but objectively, wit
h due consideration of available evidence and an awareness of other po
tential explanations.