Effects Of Ketogenic Diet Therapy On The Neurobehavioral Development In Children With Global Developmental Delays

BackgroundThe incidence of GDD is about 1~3%,which is a transitional diagnosis.After 5 years of age,most of the children with GDD developmental retardation.Therefore,GDD is a major cause of children’s disability;moreover,the abnormal rate of emotional behavior is significantly higher than that of the general population,which affect the quality of life of children severely.Presently,GDD lacks specific treatments;rehabilitation therapy is the leading method.But the prolonged duration of the rehabilitation treatment,and insignificant efficacy.As a diet therapy with low cost,the ketogenic diet(KD)has become a major treatment in children with intractable epilepsy and has been widely adapted by investigators worldwide.Our previous study confirmed the efficacy and safety of KD add-on therapy in children with intractable epilepsy and found that it improved the neurobehavioral and cognitive abilities in such children.Therefore,we speculated that KD therapy could also improve the cognitive function and emotional and social behaviors in children with GDD.PurposeIn this study,on the basis of rehabilitation therapy,KD treatment was given to children with GDD.The safety and effects of KD on the neurobehavioral development of children with GDD were analyzed before and after the treatment,so as to find a safe and effective method for the treatment of GDD.MethodsThe children with GDD treatment at the Department of Rehabilitation for Children in the Third Affiliated Hospital of Zhengzhou University were enrolled from January 2016–July 2016.A total of 89 children were randomly divided into the routine treatment group and the KD therapy group.The treatment regimen of each subject was generated by a randomly assigned sequence that was placed in a sequential,sealed,opaque envelope.Among whom,37 cases were categorized in the routine treatment group and 39 in the KD therapy group and treated by comprehensive rehabilitation training for 12 months.The KD therapy group was given the modified Atkins diet.Before treatment and at 3,6,9,and 12 months after treatment,the Gesell Development Scale,Chinese version of Urban Infant-Toddler Social and Emotional Assessment(CITSEA)/Achenbach Child Behavior Checklist(CBCL),and Infant-Junior Middle School Students’ Social Life Abilities Scale(S-M scale)was evaluated in both groups.SPSS 21.0 software was used for statistical analysis.Measurement data with normal distribution use t-test for the comparison between groups.Data that did not conform to the normal distribution use Wilcoxon rank-sum test for the comparison between groups.Post-hoc test was used for the comparison of the data at different time points.,the improvement in neurobehavioral development between the two groups were compared.ResultsAt 3,6,9,and 12 months after treatment,the comparison of Gesell scores showed that the improvements in adaptability,fine movements,language,and personal socialization in the KD therapy group were superior to those in the routine treatment group(P<0.05).At 6,9,and 12 months after treatment,the Chinese version of Urban Infant-Toddler Social and Emotional Assessment(CITSEA)/Achenbach Child Behavior Checklist(CBCL)scores showed superior improvement in the KD therapy group than the routine treatment group(P<0.05).At 3 and 6 months post-treatment,the S-M scale scores showed similar improvements in both groups(P>0.05);whereas at 9 and 12 months,the improvement in the KD therapy group was superior to that in the routine treatment group(P<0.05).During the KD therapy,6 children developed diarrhea in the early stage,and 2 showed a mild weight-gain.Conclusions1.KD therapy can improve the neurobehavioral development of children with GDD,and the longer the treatment,the more obvious the improvement.2.KD therapy is relatively safe,with less adverse reactions,there is no need for termination of treatment.