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Side effects of phenobarbital and carbamazepine in childhood epilepsy: randomised controlled trial
Selina H Banu1, Moshrat Jahan, Umme Kulsum Koli
1Child Development and Neurology Unit, Dhaka Shishu (Children's) Hospital, Bangladesh Institute of Child Health, Sher-e-Bangla Nagar, Dhaka 1207, Bangladesh.
Insights
Phenobarbital and carbamazepine, common antiepilepsy drugs for children, showed similar behavioral side effects in a Bangladesh study. This research is crucial for epilepsy treatment in resource-limited settings.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
- Epilepsy Management
Background:
- Phenobarbital and carbamazepine are frequently prescribed antiepilepsy drugs for children.
- Understanding their behavioral side effect profiles is critical for optimizing treatment, especially in resource-limited settings.
- Limited comparative data exists on the behavioral effects of these drugs in pediatric populations in developing countries.
Purpose of the Study:
- To compare the behavioral side effects of phenobarbital versus carbamazepine in children with epilepsy.
- To assess seizure control and treatment outcomes in pediatric epilepsy patients in Bangladesh.
Main Methods:
- A prospective, randomized, controlled, single-center trial was conducted.
- 108 children (aged 2-15) with generalized tonic-clonic or partial/secondary generalized seizures were enrolled.
- Seizure control and behavioral side effects were monitored over 12 months.
Main Results:
- Of 91 children followed up for 12 months, 71 achieved seizure freedom.
- Behavioral problems were observed in 10 children; however, statistical analysis showed no significant difference between phenobarbital and carbamazepine groups.
- Six children required a change in antiepilepsy medication during the study period.
Conclusions:
- Phenobarbital does not present an excess of behavioral side effects compared to carbamazepine in children with epilepsy in resource-limited settings.
- Both drugs demonstrated efficacy in seizure control.
- The findings support the use of phenobarbital as a viable option for pediatric epilepsy management in areas with limited resources.
Objective:
To compare the behavioural side effects associated with two commonly used antiepilepsy drugs-phenobarbital and carbamazepine-in children in Bangladesh.
Design:
Prospective randomised controlled single centre trial.
Setting:
Specialist children's hospital in Dhaka, Bangladesh.
Participants:
108 children aged 2-15 with generalised tonic-clonic (n=51) or partial and secondary generalised seizures (n=57).
Main Outcome Measures:
Seizure control and behavioural side effects.
Results:
91 children were followed up for 12 months. Six required a change of antiepilepsy drug. Side effects were compared in 85 children. In the last quarter of the 12 month follow-up, 71 children were seizure free after one year's treatment. Thirty two in the phenobarbital group and 39 in the carbamazepine group had no seizures in 74 and 102 days after randomisation, respectively. Ten children had increased behavioural problems, which were unacceptable in four (one in the phenobarbital group and three in the carbamazepine group). Independent t tests, however, showed no difference between the two trial drugs.
Conclusion:
There was no excess in behavioural side effects with phenobarbital in children with epilepsy in a country with limited resources. Trial registration NCT00381537.
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