Efficacy and safety of the ketogenic diet in Chinese children.

OBJECTIVE: To evaluate the efficacy and safety of the ketogenic diet (KD) treatment of refractory childhood epilepsy in China and determine which children are more likely to respond. METHODS: Between 2004 and 2011, we prospectively enrolled 317 children with refractory epilepsy for the KD treatment in Shenzhen Children's Hospital and followed up for at least a year. Outcome was measured by seizure frequencies before and after the diet, change in anticonvulsant use and adverse effects. We also evaluated influences of different variables (starting age, duration of epilepsy and underlying conditions) on the outcome. RESULTS: Intent-to-treat analysis showed that after 3, 6 and 12 months, 62.8%, 42.0% and 24.3% remained on the diet, 35.0%, 26.2% and 18.6% showed >50% seizure reduction, including 20.8%, 13.6% and 10.7% seizure free, respectively. Starting age may influence efficacy. The ≥10 age group showed worse response than the <10 age group, though the difference was statistically significant (p=0.039) at 3 month only. Other variables such as duration of epilepsy at the start of the diet, seizure types and aetiologies showed no significant influence on efficacy. Frequently reported complications included GI disturbance, food refusal and hypoproteinaemia. CONCLUSIONS: The KD is a safe and efficacious therapy for intractable childhood epilepsy in Chinese children. The influence of age on efficacy is worth further investigation.