| Objective: To study the efficacy and safety of traditional Chinese medicine combined with acupuncture in the treatment of attention deficit hyperactivity disorder(ADHD)in children with tic disorder(TD).Methods: All cases in this study were recruited from the pediatric encephalopathy specialist clinic of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,and children who met the inclusion criteria for TD comorbid ADHD were studied.They were randomly divided into experimental group and control group according to random number table.The experimental group was treated with self-made formula "Xifeng Zishen Decoction" combined with acupuncture,and the control group was treated with self-made formula "Xifeng Zishen Decoction".The course of treatment in both groups was 12 weeks.In the two groups,the efficacy was evaluated before treatment,2 weeks,4 weeks,8 weeks and 12 weeks after treatment,the TD efficacy assessment scale was assessed with the Yale Severity Scale(YGTSS),the ADHD efficacy assessment was assessed with the SNAP-IV parental scale,the social function assessment was assessed with the Children’s Global Assessment Scale(CGAS),the TCM symptom improvement was assessed with the TCM score scale,the safety evaluation was mainly performed to observe the liver and kidney function laboratory test indicators,and the adverse reactions were recorded.The obtained data were statistically analyzed and concluded using SPSS 25 software.Results: A total of 80 cases were included in the FAS and 72 cases in the PPS in this clinical study,including 40 cases in the FAS and 37 cases in the PPS,3 Withdrawn in the test group;40cases in the FAS and 35 cases in the PPS,5 Withdrawn in the control group.1.There were no significant differences in gender,age,disease duration,and severity of illness(YGTSS total score before treatment,SNAP-IV total score before treatment,CGAS total score before treatment,and TCM score before treatment)between the two groups(P > 0.05),which were comparable.2.After 12 weeks of treatment,the overall response rate was 54.05% and 34.43% in the control group(P < 0.05),and the overall response rate was 86.48% and 62.85% in the control group(P< 0.05);the ADHD response rate was 59.34% and 34.21% in the control group(P < 0.05),and the effective rate was 86.48% and 65.71% in the control group(P < 0.05).3.After 12 weeks of treatment,the YGTSS total score,SNAP-IV total score,TCM total score,CGAS total score,motor tic score,vocal tic score,oppositional defiance score,attention deficit score,and hyperactivity-impulsivity score in the two groups were improved compared with those before treatment(P < 0.05),and the YGTSS total score,TCM score,CGAS total score,motor tic score,vocal tic score,and attention deficit score in the test group were superior to those in the control group(P < 0.05).4.Comparison of onset time of efficacy: The median onset time of TD efficacy test group was8 weeks,and the median onset time of control group was 12 weeks(P < 0.05);the median onset time of ADHD efficacy test group was 12 weeks in the control group(P < 0.05).5.Comparison of total score and each factor score: YGTSS total score,SNAP-IV total score,TCM total score,CGAS total score,motor tic score,vocal tic score,oppositional defiance score,attention deficit score,and hyperactivity-impulsivity score will change with time(P < 0.05).After 2 and 4 weeks of treatment,there was a difference in vocal tic scores between the two groups(P < 0.05).After 8 weeks of treatment,there were differences in YGTSS total score,TCM total score,CGAS total score,and motor tic score between the two groups(P < 0.05).After 12 weeks of treatment,there was a difference in attention deficit score between the two groups(P < 0.05).6.Of the 72 children finally included in the study,liver and kidney function did not change significantly before and after treatment.A total of 3 children(1 in the test group and 2 in the control group)developed mild nausea and retching symptoms after medication,with an incidence of adverse events of 4%.Conclusion:1.Chinese medicine combined with acupuncture,simple Chinese medicine treatment of TD children with ADHD clinical symptoms have been improved;and for TD,Chinese medicine combined with acupuncture efficacy is better than simple Chinese medicine.2.2.The onset time of TD in children treated with traditional Chinese medicine combined with acupuncture is earlier than that treated with traditional Chinese medicine alone.3.In terms of improving YGTSS score in children with traditional Chinese medicine combined with acupuncture,the effect of vocal tics is better than that of motor tics.4.Traditional Chinese medicine combined with acupuncture is superior to hyperactive impulsivity in improving SNAP-IV score in children.5.Both traditional Chinese medicine and acupuncture have good safety. |