Randomized control study on two different protocols of ketogenic diet for refractory epilepsy in children / 中国小儿急救医学

ABSTRACT

Objective To assess the efficacy and safety of two different protocols of ketogenic diet (KD)-eating on demand or eating at regular intervals for refractory epilepsy in children.Methods Sixty children with refractory epilepsy were randomly divided into eating on demand group (n =30) and eating at regular intervals group (n =30) by random number table method.After taking the whole amount of KD,the capillary blood ketone and glucose level and urine ketone were monitored every 6 hours in 72 continuous hours.Seizure frequency and onset time were recorded.Antiepileptic efficacy and diet tolerability of the two groups were evaluated on 4 weeks,12 weeks,24 weeks and 48 weeks after initiating the diet.Adverse effects were monitored.Results After treatment of 4 weeks,the complete seizure remission rates of eating on demand group and eating at regular intervals group were 33.3％ (10/30) and 30.0％ (9/30) respectively,which suggested a comparable efficacy for two groups (P ＞ 0.05).The day when KD started to work was averaged (6.18 ± 2.42) d and (8.63 ± 2.63) d respectively.The group of eating on demand showed a faster onset of action (P ＜0.05).After treatment of 12 weeks,24 weeks and 48 weeks,complete seizure remission rates of eating on demand group were 30.0％ (9/30),34.8％ (8/23) and 36.8％ (7/19) respectively;the eating at regular intervals group were 33.3％ (10/30),30.4％ (7/23) and 44.4％ (8/18) respectively.The two groups had no significant difference (P ＞ 0.05).One year later,the treatment retention rates of the two groups were 63.3 ％ (19/30) and 60.0％ (18/30) respectively.There was no significant difference (P ＞ 0.05).The adverse effects mainly including transient gastrointestinal symptoms and metabolic disturbances were mostly tolerable and curable.Conclusion The two different protocols of KD-eating on demand and eating at regular intervals are both effective and well-tolerated for refractory epilepsy in children.While protocol of eating on demand is more easier to achieve ketotic state and the effect is more quickly,so it can be more easily received by children.Therefore in clinical practice,we can choose flexible eating time according to children's eating habits,which can improve the therapeutic compliance.