1. Evidenced Based Journal Club – 20th June 2007
A brief overview of:
Banu et al, Side effects of phenobarbital and carbamazepine in childhood epilepsy: randomised controlled trial
BMJ, doi: /bmj BE
Dr Roland Morley

2. Goals of Study COPYRIGHTED IMAGE
Is phenobarbital associated with more behavioural side effects than carbamazepine?
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3. Study Structure COPYRIGHTED IMAGE Double blind RCT
Children’s hospital in Bangladesh
12 month follow up
Intention to treat analysis
Comparison of behaviour before and after treatment
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4. Inclusion COPYRIGHTED IMAGE COPYRIGHTED IMAGE
n=108 recruited by referral
Children with “active epilepsy”:
≥2 generalised tonic-clonic, partial (focal) or 2ndry generalised seizures in last 12 months
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5. Exclusion Absence, myoclonic or severe malignant epilepsy
Major motor and cognitive impairments
Current treatment with antiepileptics

6. General Assessment History Examination – CNS and general
Multi-disciplinary developmental:
including psychological and IQ
EEG

7. Behavioural Assessment
Participants ≤ 2 years:
Bayley scale of infant development
Participants >2 yrs to 3 yrs 11 mths:
Richman behavioural assessment questionnaire
Participants > 5 years:
Connors’ rating scale

8. Classification of Participants
International League Against Epilepsy research guidelines to classify patients:
Symptomatic
Without other impairment
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9. Randomisation Blinded researcher to physician by telephone:
Oral Phenobarbital (once a day):
Starting dose 1.5mg/kg OD
Increased to 3mg/kg OD at 2 weeks
Titrated until seizures controlled or max dose 4mg/kg Vs
Oral Carbamazepine (in 2 divided doses) :
Starting dose 5mg/kg
Increased to 16mg/kg at 2 weeks
Titrated until seizures controlled or max dose 20mg/kg

10. Follow Up 2 weeks, 1 month, 3 months, 6 months, 1 year:
“depending on therapeutic response and travel”
Compliance assessed
Uncontrolled / intolerant of treatment:
Switch to new drug
Remove from behaviour outcome analysis

11. Outcomes Behaviour “Seizure remission”: Drug Efficacy
No seizures in last quarter of 12 month follow up
Drug Efficacy
Time to first seizure
Time to withdrawal from treatment due to side effects
Date of last follow up

12. Behaviour Change COPYRIGHTED IMAGE At 1 year follow up: No Change
Improved
Deteriorated:
Acceptable to parents
Unacceptable to parents
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13. STUDY HEADLINE RESULTS

14. Behavioural difference within treatment groups
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Neither drug shows significant deterioration in behaviour at 1 year
2-5 age group shows significant improvement

15. Behavioural difference between treatment groups
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No significant difference between treatments

16. Seizure Remission - No seizures in last quarter of 12 month follow up
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Mean time without seizures:
Phenobarb = 102 days
Carbamaz = 74 days

17. No Correlation between behavioural problems and variables at one year
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18. Appendix
Slides for reference now follow for discussion

19. Flow Through Trial
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20. Demographics
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21. Demographics
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22. Outcome by drug
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