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The ketogenic diet for the treatment of childhood epilepsy: a randomised controlled trial

Neal, EG; Chaffe, H; Schwartz, RH; Lawson, MS; Edwards, N; Fitzsimmons, G; Whitney, A; (2008) The ketogenic diet for the treatment of childhood epilepsy: a randomised controlled trial. Lancet Neurology , 7 pp. 500-506.

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Abstract

Background The ketogenic diet has been widely and successfully used to treat children with drug-resistant epilepsy since the 1920s. The aim of this study was to test the effi cacy of the ketogenic diet in a randomised controlled trial. Methods 145 children aged between 2 and 16 years who had at least daily seizures (or more than seven seizures per week), had failed to respond to at least two antiepileptic drugs, and had not been treated previously with the ketogenic diet participated in a randomised controlled trial of its effi cacy to control seizures. Enrolment for the trial ran between December, 2001, and July, 2006. Children were seen at one of two hospital centres or a residential centre for young people with epilepsy. Children were randomly assigned to receive a ketogenic diet, either immediately or after a 3-month delay, with no other changes to treatment (control group). Neither the family nor investigators were blinded to the group assignment. Early withdrawals were recorded, and seizure frequency on the diet was assessed after 3 months and compared with that of the controls. The primary endpoint was a reduction in seizures; analysis was intention to treat. Tolerability of the diet was assessed by questionnaire at 3 months. The trial is registered with ClinicalTrials.gov, number NCT00564915. Findings 73 children were assigned to the ketogenic diet and 72 children to the control group. Data from 103 children were available for analysis: 54 on the ketogenic diet and 49 controls. Of those who did not complete the trial, 16 children did not receive their intervention, 16 did not provide adequate data, and ten withdrew from the treatment before the 3-month review, six because of intolerance. After 3 months, the mean percentage of baseline seizures was signifi cantly lower in the diet group than in the controls (62·0% vs 136·9%, 75% decrease, 95% CI 42.4–107.4%; p<0·0001). 28 children (38%) in the diet group had greater than 50% seizure reduction compared with four (6%) controls (p<0·0001), and fi ve children (7%) in the diet group had greater than 90% seizure reduction compared with no controls (p=0·0582). There was no signifi cant diff erence in the effi cacy of the treatment between symptomatic generalised or symptomatic focal syndromes. The most frequent side-eff ects reported at 3-month review were constipation, vomiting, lack of energy, and hunger. Interpretation The results from this trial of the ketogenic diet support its use in children with treatment-intractable epilepsy.

Type: Article
Title: The ketogenic diet for the treatment of childhood epilepsy: a randomised controlled trial
UCL classification: UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Pop Health Sciences > UCL GOS Institute of Child Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Pop Health Sciences > UCL GOS Institute of Child Health > ICH Developmental Neurosciences Prog
URI: http://discovery.ucl.ac.uk/id/eprint/1356445
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