Theophylline-induced behavior change in children. An objective evaluation of parents' perceptions.
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.