Theophylline-induced behavior change in children. An objective evaluation of parents' perceptions
B. Bender and H. Milgrom
Department of Pediatrics, National Jewish Center for Immunology and Respiratory Medicine, Denver, CO 80206.
OBJECTIVE--To evaluate children who take theophylline for the presence of
behavioral side effects and to determine whether the beliefs about these
side effects held by their parents are supported by their own observations.
DESIGN--A double-blind, placebo-controlled, randomized, crossover protocol.
Under both study conditions the children completed tests that measured
their attention, impulsivity, memory, activity level, and mood, while the
parents rated their behavior. PATIENTS--The subjects were 8- to 12-year-old
children with asthma whose parents had observed adverse behavioral side
effects while the children were taking theophylline. Among cited side
effects were impulsivity, hyperactivity, altered mood, and impaired
attention. RESULTS--No differences related to treatment could be detected
from the parent questionnaires or from six of nine scores of the
psychological evaluation of the children. The children, however, made fewer
attention errors and showed a mild increase in anxiety and hand tremor of
the dominant hand while they were receiving theophylline. All mean changes
were small. No significant relationship was found between theophylline
concentrations in the serum and degree of change in mood or attention.
Eleven of 42 participants were disqualified for noncompliance during the
study. CONCLUSION--Parental beliefs about the side effects experienced by
their children are not supported by their own observations performed
through a blinded protocol. These results are in conflict with reports of a
high incidence of adverse behavioral side effects attributed to
theophylline therapy.
