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 .
The United Kingdom Infantile Spasms Study comparing vigabatrin with prednisolone or tetracosactide at 14 days: a multicentre, randomised controlled trial
BACKGROUND Infantile spasms , which comprise a severe infantile seizure disorder , have a high morbidity and are difficult to treat . Hormonal treatments ( adrenocorticotropic hormone and prednisolone ) have been the main therapy for decades , although little evidence supports their use . Vigabatrin has been recorded to have a beneficial effect in this disorder . We aim ed to compare the effects of vigabatrin with those of prednisolone and tetracosactide in the treatment of infantile spasms . METHODS The United Kingdom Infantile Spasms Study assessed these treatments in a multicentre , r and omised controlled trial in 150 hospitals in the UK . The primary outcome was cessation of spasms on days 13 and 14 . Minimum doses were vigabatrin 100 mg/kg per day , oral prednisolone 40 mg per day , or intramuscular tetracosactide depot 0.5 mg ( 40 IU ) on alternate days . Analysis was by intention to treat . FINDINGS Of 208 infants screened and assessed , 107 were r and omly assigned to vigabatrin ( n=52 ) or hormonal treatments ( prednisolone n=30 , tetracosactide n=25 ) . None was lost to follow-up . Proportions with no spasms on days 13 and 14 were : 40 ( 73 % ) of 55 infants assigned hormonal treatments ( prednisolone 21/30 [ 70 % ] , tetracosactide 19/25 [ 76 % ] ) and 28 ( 54 % ) of 52 infants assigned vigabatrin ( difference 19 % , 95 % CI 1%-36 % , p=0.043 ) . Two infants allocated tetracosactide and one allocated vigabatrin received prednisolone .  Adverse events were reported in 30 ( 55 % ) of 55 infants on hormonal treatments and 28 ( 54 % ) of 52 infants on vigabatrin . No deaths were recorded . INTERPRETATION Cessation of spasms was more likely in infants given hormonal treatments than those given vigabatrin .  Adverse events were common with both treatments
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 .