A MULTICENTER STUDY OF THE EFFICACY OF THE KETOGENIC DIET

Objective: To determine the efficacy of the ketogenic diet in multiple centers. Design: A prospective study of the change in frequency of se izures in 51 children with intractable seizures who were treated with the ketogenic diet. Setting: Patients were enrolled from the clinical practices of 7 sites. The diet was initiated in-hospital and the patie nts were followed up for at least 6 months. Patients: Fifty-one childr en, aged 1 to 8 years, with more than 10 seizures per week, whose elec troencephalogram showed generalized epileptiform abnormalities or mult ifocal spikes, and who had failed results when taking at least 2 appro priate anti-epileptic drugs. Intervention: The children were hospitali zed, fasted, and a 4:1 ketogenic diet was initiated and maintained. Ma in Outcome Measures: Frequency of seizures was documented from parenta l calendars and efficacy was compared with prediet baseline after 3, 6 , and 12 months. The children were categorized as free of seizures, gr eater than 90% reduction, 50% to 90% reduction, or lower than 50% redu ction in frequency of seizures. Results: Eighty-eight percent of all c hildren initiating the diet remained on it at 3 months, 69% remained o n it at 6 months, and 41% remained on it at 1 year. Three months after initiating the diet, frequency of seizures was decreased to greater t han 50% in 54%. At 6 months, 28 (55%) of the 51 initiating the diet ha d at least a 50% decrease from baseline, and at 1 year, 40% of those s tarting the diet had a greater than 50% decrease in seizures. Five pat ients (10%) were free of seizures at 1 year. Age, sex, principal seizu re type, and electroencephalogram were not statistically related to ou tcome. Conclusion: The ketogenic diet is effective in substantially de creasing difficult-to-control seizures and can successfully be adminis tered in a wide variety of settings.