Prospective control study of efficacy and influencing factors of a ketogenic diet on refractory epilepsy in children.

Background: To investigate the efficacy of the ketogenic diet (KD) and anti-epileptic drugs (AEDs) on children with refractory epilepsy (RE), and to analyze the effects of gender, therapeutic time, age, type of epilepsy syndrome, number of epileptic seizure types, and number of AEDs on the efficacy of the KD. A prospective, non-randomized, controlled cohort study was used and a total of 200 children with RE who were hospitalized in the Department of Pediatric Neurology, Children's Hospital of Chongqing Medical University from November 2015 to December 2020 were divided into a KD group and AEDs only group according to their parents' wishes.

Methods: Children in the KD group were treated with a classical KD in addition to the AEDs, while in the AEDs group, the original AEDs were continued and could be adjusted according to the clinical seizure types and other conditions. The effects of gender, therapeutic time, age, type of epilepsy syndrome, number of epileptic seizure types, and number of AEDs on the efficacy of the KD were analyzed.

Results: In the KD group, the efficacy was 79.41%, 79.59%, 81.05%, 81.11%, 77.01%, and 78.75%, at 3, 6, 9, 12, 18, and 24 months, respectively. In the AEDs group, the efficacy was 59.18%, 60.42%, 59.78%, 59.55%, 59.30%, and 53.01% at 3, 6, 9, 12, 18, and 24 months, respectively. After 3, 6, 9, 12, 18, and 24 months of treatment, a statistically significant difference in the effective rate between the KD group and the AEDs group was seen (P<0.05). Chi-square test was used to analyze the effects of gender, therapeutic time, age, type of epilepsy syndrome, number of epileptic seizure types, and number of AEDs on the efficacy of the KD, and the results showed no statistical significance (P>0.05).

Conclusions: KD therapy reduces the frequency of seizures in children with RE compared with AEDs alone. In the KD group, the gender, therapeutic time, age, type of epilepsy syndrome, number of epileptic seizure types, and number of anti-epileptic drugs had no significant effect on the efficacy of the KD diet.