A blinded, crossover study of the efficacy of the ketogenic diet.
Despite over 80 years of use, the ketogenic diet (KD) has never been tested in a blinded manner. Twenty children with intractable Lennox-Gastaut syndrome (LGS) were fasted 36 h and then randomized to receive the classic KD in conjunction with a solution containing either 60 g/day of glucose or saccharin. Parents and physicians were blinded to both the solution composition and level of ketosis. A crossover to the KD with the alternate solution occurred following the sixth day and a repeat fast. A 24-h electroencephalography (EEG) was obtained at baseline and after each arm. After administration of the solution, there was moderate evidence of a reduction in parent-reported seizures between the glucose and saccharin arms, with a median difference of 1.5 seizures per day (p = 0.07). There was no reduction in the number of EEG-identified events, with a median reduction of 7 events per day (p = 0.33). Ketosis was not completely eliminated in the glucose-added arm.
Freeman
John M
JM
Departments of Neurology and Pediatrics, The John M Freeman Pediatric Epilepsy Center, Baltimore, Maryland, USA.
Vining
Eileen P G
EP
Kossoff
Eric H
EH
Pyzik
Paula L
PL
Ye
Xiaobu
X
Goodman
Steven N
SN
D020155:3-Hydroxybutyric Acid / Q000652:urine; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D055423:Diet, Ketogenic; D004311:Double-Blind Method; D004569:Electroencephalography; D004831:Epilepsies, Myoclonic / Q000178:diet therapy* / Q000652:urine; D004829:Epilepsy, Generalized / Q000178:diet therapy* / Q000652:urine; D005260:Female; D005950:Glucose Solution, Hypertonic / Q000008:administration & dosage; D006801:Humans; D007223:Infant; D007659:Ketones / Q000652:urine; D008297:Male; D012439:Saccharin / Q000008:administration & dosage; D013577:Syndrome
D005950:Glucose Solution, Hypertonic; D007659:Ketones; D012439:Saccharin; D020155:3-Hydroxybutyric Acid