Side effects of phenobarbital and carbamazepine in childhood epilepsy: randomised controlled trial

doi:10.1136/bmj.39022.436389.BE

BMJ 2007;334:1207 (9 June), doi:10.1136/bmj.39022.436389.BE (published 4 December 2006)

Research

Side effects of phenobarbital and carbamazepine in childhood epilepsy: randomised controlled trial

Selina H Banu, clinical neurophysiologist and paediatric neurologist¹, Moshrat Jahan, primary care physician trained in childhood epilepsy¹, Umme Kulsum Koli, child psychologist¹, Saadia Ferdousi, child psychologist¹, Naila Z Khan, professor of child development and neurology¹, Brian Neville, Prince of Wales's professor of childhood epilepsy²

¹ Child Development and Neurology Unit, Dhaka Shishu (Children's) Hospital, Bangladesh Institute of Child Health, Sher-e-Bangla Nagar, Dhaka 1207, Bangladesh , ² Neurosciences Unit, UCL, Institute of Child Health, Wolfson Centre, London WC1N 2AP

Correspondence to: B Neville bneville{at}ncype.org.uk

Objective To compare the behavioural side effects associatedwith two commonly used antiepilepsy drugs—phenobarbitaland 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 requireda change of antiepilepsy drug. Side effects were compared in85 children. In the last quarter of the 12 month follow-up,71 children were seizure free after one year's treatment. Thirtytwo in the phenobarbital group and 39 in the carbamazepine grouphad no seizures in 74 and 102 days after randomisation, respectively.Ten children had increased behavioural problems, which wereunacceptable in four (one in the phenobarbital group and threein the carbamazepine group). Independent t tests, however, showedno difference between the two trial drugs.

Conclusion There was no excess in behavioural side effects withphenobarbital in children with epilepsy in a country with limitedresources.

Trial registration NCT00381537 [ClinicalTrials.gov] .

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