There is no evidence for a difference in antiepileptic efficacy between phenobarbital and any other compared AED , yet no evidence for absolute efficacy .
No convincing evidence exists for an excess of behavioural adverse effects , over other AEDs , attributable to phenobarbital .
Masked studies of phenobarbital in childhood epilepsy have shown no significant differences in behavioural or cognitive adverse effects compared to other AEDs .
This is in contrast to the excess of such adverse effects reported in studies open to observer bias .
However , the one finding of reduction in cognitive ability associated with phenobarbital treatment for febrile convulsions remains a concern .
INTRODUCTION : Against a background of concern about the safety of new pharmaceutical products , there has been renewed interest in one of the oldest antiepileptic drugs ( AEDs ) , phenobarbital .
Although still in widespread use in developing countries , its popularity has slipped in Western countries over the past century , partly because of controversy about its adverse effect profile .
This critical review examines the evidence supporting its effectiveness and its associated behavioural adverse effects for febrile convulsions and childhood epilepsy .
Randomised comparative monotherapy trial of phenobarbitone, phenytoin, carbamazepine, or sodium valproate for newly diagnosed childhood epilepsy
BACKGROUND The medical treatment of childhood epilepsy is largely influenced by clinical trials in adult patients . We know of only one r and omised comparative trial ( of two drugs ) in newly diagnosed childhood epilepsy . We have undertaken a long-term , prospect i ve , r and omised , unmasked , pragmatic trial of the comparative efficacy and toxicity of four st and ard antiepileptic drugs used as monotherapy in children with newly diagnosed epilepsy . METHODS Between 1981 and 1987 , 167 children aged 3 - 16 years , who had had at least two previously untreated tonic-clonic or partial seizures , with or without secondary generalisation , were r and omly allocated treatment with phenobarbitone , phenytoin , carbamazepine , or sodium valproate . The protocol was design ed to conform to st and ard clinical practice . Efficacy was assessed by time to first seizure after the start of treatment and time to achieving 1-year remission . FINDINGS The overall outcome with all four drugs was good . 20 % of children remained free of seizures and 73 % had achieved 1-year remission by 3 years of follow-up . We found no significant differences between the drugs for either measure of efficacy at 1 , 2 , or 3 years of follow-up . The overall frequency of unacceptable side-effects necessitating withdrawal of the r and omised drug was 9 % . This total included six of the first ten children assigned phenobarbitone ; no further children were allocated this drug . Of the other three drugs , phenytoin ( 9 % ) was more likely to be withdrawn than carbamazepine ( 4 % ) or sodium valproate ( 4 % ) . INTERPRETATION Our data will inform choice of drug and outcome with four of the st and ard drugs available for newly diagnosed tonic-clonic or partial seizures with or without secondary generalisation in children
There is no evidence for a difference in antiepileptic efficacy between phenobarbital and any other compared AED , yet no evidence for absolute efficacy .
No convincing evidence exists for an excess of behavioural adverse effects , over other AEDs , attributable to phenobarbital .
Masked studies of phenobarbital in childhood epilepsy have shown no significant differences in behavioural or cognitive adverse effects compared to other AEDs .
This is in contrast to the excess of such adverse effects reported in studies open to observer bias .
However , the one finding of reduction in cognitive ability associated with phenobarbital treatment for febrile convulsions remains a concern .
INTRODUCTION : Against a background of concern about the safety of new pharmaceutical products , there has been renewed interest in one of the oldest antiepileptic drugs ( AEDs ) , phenobarbital .
Although still in widespread use in developing countries , its popularity has slipped in Western countries over the past century , partly because of controversy about its adverse effect profile .
This critical review examines the evidence supporting its effectiveness and its associated behavioural adverse effects for febrile convulsions and childhood epilepsy .