[A prospective, open, controlled and randomised study of clobazam versus carbamazepine in patients with frequent episodes of Rolandic epilepsy].
BACKGROUND
To date no controlled, randomised studies with flexible dose regimens have been conducted in children with rolandic epilepsy, and therapy is therefore still empirical.


OBJECTIVE
To evaluate the effectiveness and safety of clobazam (CLB) compared with that of carbamazepine (CBZ) in rolandic epilepsy.


METHODS
A prospective, open, controlled and randomised study was carried out to compare CBZ and CLB in children with rolandic epilepsy with a follow-up over a two-year period. A random sample of 45 patients was taken and 38 of them finished the study. A flexible dose regimen was indicated. Control of seizures, academic performance, behaviour, adherence to treatment, parents' degree of satisfaction and side effect profiles were all evaluated.


RESULTS
Both drugs were equally effective at controlling seizures (94.1% of patients with CLB and 100% of those with CBZ were free of seizures on ending the study; p = 0.26). CLB controlled seizures earlier (33.3 +/- 45 days versus 48.2 +/- 72.3; p < 0.05) and had fewer side effects than CBZ (side effects appeared in three patients with CLB and in eight of those on CBZ; p = 0). In two of the patients taking CBZ, the seizures got worse and a series of cognitive-behavioural complications also appeared.


CONCLUSIONS
CBZ is an effective drug in rolandic epilepsy, but it may be associated with exacerbation of seizures as well as with cognitive-behavioural impairment. CLB in monotherapy seems to be an effective and better tolerated drug in this kind of epilepsy.
Andrade
R
R
Instituto Nacional Neurologia y Neurocirugia de Cuba, Ciudad de la Habana, Cuba. arletygarcia@infomed.sld.cu
García-Espinosa
A
A
Machado-Rojas
A
A
García-González
M E
ME
Trápaga-Quincoses
O
O
Morales-Chacón
L M
LM
D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use*; D002220:Carbamazepine / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002653:Child Behavior Disorders / Q000139:chemically induced; D002675:Child, Preschool; D000078306:Clobazam; D003072:Cognition Disorders / Q000139:chemically induced; D019305:Epilepsy, Rolandic / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D016896:Treatment Outcome
D000927:Anticonvulsants; D001569:Benzodiazepines; D000078306:Clobazam; D002220:Carbamazepine