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Theophylline-induced behavior change in children. An objective evaluation of parents' perceptions
1Department of Pediatrics, National Jewish Center for Immunology and Respiratory Medicine, Denver, CO 80206.
Insights
This study found that theophylline did not cause behavioral side effects in children with asthma as reported by parents. Objective measures showed minimal changes, contradicting parental beliefs about the medication
Area of Science:
- Pediatric Pulmonology
- Child Psychology
- Pharmacology
Background:
- Theophylline is a medication used to treat asthma in children.
- Concerns exist regarding potential behavioral side effects of theophylline therapy.
- Parental reports of side effects like hyperactivity and inattention are common.
Purpose of the Study:
- To objectively assess behavioral side effects in children treated with theophylline.
- To determine if parental observations of side effects align with blinded assessments.
- To investigate the relationship between theophylline levels and behavioral changes.
Main Methods:
- A double-blind, placebo-controlled, randomized crossover study was conducted.
- Children aged 8-12 with asthma participated.
- Evaluations included objective cognitive/behavioral tests and parental rating scales.
Main Results:
- No significant differences in behavior were detected via parent questionnaires or most psychological tests.
- Children showed slightly improved attention but increased mild anxiety and hand tremor while on theophylline.
- No correlation was found between serum theophylline levels and behavioral changes.
Conclusions:
- Parental beliefs regarding theophylline's behavioral side effects were not supported by blinded observations.
- Objective assessments contradict commonly reported adverse behavioral effects of theophylline.
- Further research may be needed to reconcile these findings with existing literature.
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.
