Effects And Safety Of Acupuncture For Chronic Tic Disorder:A Randomized Controlled Trial

Background:Tic Disorder(TD)is a chronic neurological disorder characterized by motor tics or vocal tics,mostly seen in school-age children.The prevalence in China is increasing year by year,and Chronic tic Disorder(CTD)accounts for 1.2%of the cases.Currently,the treatment of this disease is still dominated by medication,which has serious adverse effects.And cognitive behavioral therapies such as Habit Reversal Training(HRT)are not yet popular in China,and more and more parents in China are turning their attention to Traditional Chinese Medicine(TCM)treatment.Acupuncture therapy is highly preferred due to its high international acceptance and safety without side effects.However,there is a lack of high-quality studies on acupuncture for CTD,and there is a gap in international clinical randomized controlled studies with comfort acupuncture as a control,resulting in the effectiveness of acupuncture for CTD yet to be proven by more adequate evidence.CTD is a neuropsychiatric disease,often accompanied by psychological behavioral problems,often sensitive and introverted personality,high mental stress,and easy parental anxiety.The supervisor’s years of clinical research found that the symptoms of children with CTD are related to the heart and brain.According to the clinical experience of our acupuncture department and the research summary of our supervisor for many years,we established the treatment principle of "tranquilizing the heart and calming the mind,and combining the disease with the illness".Based on this,this study was designed as a prospective,randomized controlled study to observe the effectiveness and safety of acupuncture in the treatment of CTD,to provide highquality research evidence for the treatment of CTD in Chinese medicine,and to provide a safe and effective treatment method for children with CTD.Objective:To clarify the clinical effectiveness and safety of acupuncture in treatment of chronic tic disorder by comparing the differences between two groups,acupuncture was treatment group and minimal acupuncture in control group.Methods:.Forty patients with chronic tic disorder will be selected and divided into two groups with 20 patients in each group in prospective randomized controlled study design,respectively using Yale Global Tic Severity Scale(YGTSS)as the main efficacy index as well as Clinical Global Impression Scale(CGI)and Gilles de la Tourette Syndrome-Quality of Life Scale for Children and Adolescents(C&A-GTS-QOL)to evaluate the improvement of acupuncture therapy on symptoms and quality of life of CTD patients.Adverse events during treatment will be recorded to clarify the safety of acupuncture therapy.Statistical analysis was performed using SPSS 26.0 with a two-sided validity test,and p<0.05 was considered statistically significant.The mean± standard deviation was used to describe the measurement data that satisfied normal distribution,and the median and interquartile spacing were used to describe those that did not satisfy normal distribution;paired t-test was used to compare the difference in efficacy within two groups,and independent sample t-test was used to compare the difference in efficacy between two groups;Multiple repeated-measures analysis of variance was used for trend analysis of change.The number of cases and percentages were used to describe the counting data,and the χ2 test or Fisher’s exact probability method was used to compare the changes before and after treatment between groups.Results:1 Acupuncture therapy can improve YGTSS,YGTSS-TTS,CGI-S,CGI-I and C&AGTS-QOL as well as the minimal acupuncture(p<0.05),even is better than the minimal acupuncture in YGTSS,YGTSS-TTS,CGI-S(p<0.05),indicating that the acupuncture is better in improving tic symptoms and severity of disease than the minimal acupuncture.2.There was no significant difference between acupuncture and minimal acupuncture in improvements before 8 weeks treatments(p>0.05).But at the end of treatment and at follow-up,the acupuncture treatment group is more effective(p<0.05),indicating that the long-term effect of the acupuncture treatment group is better and that the effect can be maintained until 12 weeks post-treatment.3.The difference between acupuncture and minimal acupuncture in improving the CGI-I was not significant(p>0.05),indicating that acupuncture was not better than minimal acupuncture in improving the efficiency.4.The difference between acupuncture and minimal acupuncture in improving the C&A-GTS-QOL was not significant(p>0.05),indicating that acupuncture was not better than minimal acupuncture in improving the quality of life.5.The difference between acupuncture and minimal acupuncture in improving the GTS-QOL-Psychological,Physical,Cognitive,Obsessive was not significant(p>0.05),indicating that acupuncture was not better than minimal acupuncture in improving the quality of life in terms of psychosocial,physical and activities of daily living,cognitive impact and obsessive-compulsive.6.The safety of acupuncture in the treatment of chronic tic disorder is good,with no significant adverse effects.Conclusions:This study preliminarily shows that acupuncture has a certain improvement and safety on patients with chronic tic disorder.