OBJECTIVE:1.Re-evaluate the clinical efficacy of Jingning granules in treating children with attention deficit hyperactivity disorder(ADHD)who have Qi and Yin deficiency syndrome.Evaluate the improvement of Jingning granules on the core symptoms of ADHD and the safety of Jingning granules.2.Access the activity of the hypothalamic-pituitary-adrenal axis and attention network function in children with ADHD,and analyze whether there are differences in levels compared to healthy control children.3.Analyze the influencing factors of cortisol levels and attention network function in children with ADHD,and explore whether there is a correlation between the two.4.Explore the effect of Jingning granules on cortisol levels and attention network function in children with ADHD.METHODS:A total of 26 children diagnosed with attention deficit hyperactivity disorder(ADHD)in Western medicine and ADHD in Traditional Chinese Medicine(TCM)(qi and yin deficiency syndrome type)were included in this study conducted from December 2021 to February 2023 at Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine and Pediatric Department of Xiamen Traditional Chinese Medicine Hospital of Beijing University of Traditional Chinese Medicine.The legal guardians of the children all signed informed consent forms.12 patients dropped out due to factors such as the epidemic,and a total of 26 patients completed the clinical trial.Electrocardiogram,blood routine test,urine routine test,liver and kidney function test,cortisol levels,and attention network function tests,as well as the PSQ rating scale of each patient were tested at week0 and week8 of treatment,The SNAPⅣ assessment scale(Parent Version)and Traditional Chinese Medicine syndrome score were recorded at week 0,week 4,and week 8.Adverse events were promptly recorded during the treatment process.In addition,12 healthy children who were treated at the pediatric outpatient department of Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine were included in the study.Their basic information was collected,and SNAP-Ⅳ scale assessment,ANT test,and serum cortisol level detection were conducted using blood samples.Two people entered and verified the collected clinical data to ensure accuracy,and IBM SPSS 20 software was used for statistical analysis of the clinical data.RESULTS:After 8 weeks of treatment with Jingning granules in the included 26 pediatric patients,the total effective rate of disease efficacy was 80.77%,and the total effective rate of TCM syndrome efficacy was 84.62%.The SNAP-Ⅳ rating scale and Conners Parent Rating Scale(CPRS)both showed significant improvement after 8 weeks of treatment compared to before treatment(P<0.01)in children with ADHD.The various primary and secondary symptoms of the TCM syndrome scoring system also showed significant improvement after 8 weeks of treatment compared to before treatment(P<0.01).There were differences in attentional network function between children with ADHD and healthy controls,with children with ADHD showing weaker orientation and conflict network functions than healthy controls,and these differences were statistically significant(P<0.01).Children with ADHD also had weaker alerting network functions than healthy controls,and this difference was statistically significant(P<0.05),while their response time and accuracy rates were lower than those of healthy controls(P<0.01,P<0.05).There was no signifi cant relationship between gender and attentional network function.Reaction time and accuracy rates in the ANT test were related to the severity of ADHD.Alertness function was better in ADHD-C type patients than in ADHDI type patients.The morning cortisol levels of children with ADHD were lower than those of healthy controls(P<0.01),and morning serum cortisol levels in girls with ADHD were higher than in boys with ADHD(P<0.01).Cortisol levels were higher in the ADHD-Ⅰ group than in the ADHD-C group.Jingning granules significantly improved attentional network function in children with ADHD(P<0.01),increased correct response rates and reaction times(P<0.01),and effectively increased their cortisol levels(P<0.01).No adverse reactions were reported during the treatment period,and safety indicators after treatment were normal.CONCLUSIONS:Jingning granules can effectively treat the core symptoms of ADHD in children with Qi and Yin Deficiency Syndrome.Additionally,it can also improve sleep,diet,stool,night sweats,and other concurrent syndromes.Moreover,Jingning granules have been shown to significantly improve the SNAP-Ⅳ(Parents version)and PSQ scores.The cortisol level and attention network function of children with ADHD were found to be lower than those of healthy control children.However,Jingning granules have been demonstrated to significantly improve both the cortisol level and attention network function of children with ADHD.It is believed that the mechanism of action for Jingning granules may involve regulating the activity of the HPA axis in children with ADHD,thereby improving attention.Importantly,Jingning granules are a safe treatment option with higher security. |