Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent ; Child ; Child, Preschool ; Female ; Humans ; Male ; Double-Blind Method ; Drugs, Chinese Herbal/therapeutic use* ; Tic Disorders/drug therapy* ; Treatment Outcome

This study aims to comprehensively evaluate the clinical value of Shaoma Zhijing Granules(SZG), Changma Xifeng Tablets(CXT), and Jiuwei Xifeng Granules(JXG) in the treatment of children with tic disorder with the method of rapid health technology assessment(RHTA), which is expected to serve as a reference for medical and health decision-making and clinical rational use of drugs in children. To be specific, relevant articles were retrieved from eight databases and three clinical trial registry platforms. After the quality evaluation, rapid assessment was carried out from the dimensions of disease burden and unmet needs, technical characteristics, safety, efficacy and economy, and the results were analyzed and presented descriptively. A total of 22 articles(1 in English, 21 in Chinese) were screened out: 18 randomized controlled trials(RCTs) and 4 clinical controlled trials(CCTs). Among them, 5 were about the SZG(all RCTs) and 9 were on CXT(6 RCTs and 3 CCTs). The rest 8 focused on JXG(7 RCTs and 1 CCT). Moreover, the overall risk of bias for 94.40% RCTs was evaluated as "some concerns" and only one(5.60%) had high risk of bias. In terms of quality, the 4 CCTs scored 5-6 points(<7 points), suggesting low quality. SZG alone or in combination with tiapride has obvious advantages in improving traditional Chinese medicine syndromes and tic symptoms compared with tiapride alone, with the average daily cost of CNY 79.44-119.16. Compared with conventional western medicine or placebo, CXT alone or in combination with conventional western medicine can improve the total effective rate and alleviate tic symptoms, and the average daily cost is CNY 22.50-67.50. JXG alone or in combination with conventional western medicine can effectively relieve tic symptoms compared with conventio-nal western medicine or placebo, with the average daily cost of CNY 82.42-164.85. The adverse events related to the three Chinese patent medicines mainly occurred in the digestive, respiratory, and nervous systems, all of which were mild. In general, SZG, CXT, and JXG are effective for children with tic disorder. They have been approved to be used in this field, of which SZG was approved in 2019, with the most up-to-date research evidence and high-quality RCT in Q1 journals. However, the comparative analysis of the three was affected by many factors, which should be further clarified. Based on the large sample data available in multiple dimensions, a comprehensive comparative evaluation of the three Chinese patent medicines should be carried out, thereby highlighting the advantages and disadvantages of them and serving a reference for rational clinical use and drug supervision.
Humans ; Child ; Drugs, Chinese Herbal/therapeutic use* ; Nonprescription Drugs/therapeutic use* ; Technology Assessment, Biomedical ; Tiapride Hydrochloride/therapeutic use* ; Tics/drug therapy* ; Tic Disorders/drug therapy* ; Medicine, Chinese Traditional

OBJECTIVETo investigate the difference in the efficacy between clonidine transdermal patch and haloperidol tablets in the treatment of moderate to severe tic disorders in children.

METHODSA total of 134 children with moderate to severe tic disorders were randomly divided into clonidine group (n=70) and haloperidol group (n=64). The clonidine and haloperidol groups were treated with clonidine transdermal patch and haloperidol tablets respectively, and the treatment lasted for 8 weeks in both groups. The Yale Global Tic Severity Scale (YGTSS) was used to evaluate the conditions of the children before and after treatment, and the adverse events during the treatment were recorded.

RESULTSThe haloperidol group had a significantly better treatment outcome than the clonidine group after one week of treatment (P<0.05); the treatment outcome showed no significant difference between the two groups after 3, 5, and 8 weeks of treatment (P>0.05). The clonidine group had significantly less reductions in the motor tics, vocal tics, and function impairment scores and total score of YGTSS than the haloperidol group after one week of treatment (P<0.05); there were no significant differences in YGTSS score reductions between the two groups after 3, 5, and 8 weeks of treatment (P>0.05). The clonidine group had a significantly lower overall incidence of adverse events than the haloperidol group (8% vs 37%; P<0.01).

CONCLUSIONSClonidine transdermal patch and haloperidol are both effective in the treatment of moderate to severe tic disorders in children. The clonidine transdermal patch, despite slow action, has comparable efficacy and fewer adverse effects compared with haloperidol.

Child ; Child, Preschool ; Clonidine ; administration & dosage ; Female ; Haloperidol ; therapeutic use ; Humans ; Male ; Severity of Illness Index ; Tic Disorders ; drug therapy ; Transdermal Patch

OBJECTIVETo investigate the mRNA expression of dopamine receptor D2 (DRD2) and dopamine transporter (DAT) in peripheral blood lymphocytes before and after treatment in children with tic disorder (TD).

METHODSRT-PCR was used to measure the mRNA expression of DRD2 and DAT in peripheral blood lymphocytes before and after treatment in 60 children with TD. The correlations between mRNA expression of DRD2 and DAT and the severity of TD were analyzed. Sixty healthy children served as the control group.

RESULTSBefore treatment, the children with TD had a significant increase in the mRNA expression of DRD2 and DAT compared with the control group (P<0.05). After 3 months of treatment with oral aripiprazole, the mRNA expression of DRD2 decreased significantly (P<0.05), while that of DAT showed no significant changes in children with TD. In the children with moderate or severe TD, the mRNA expression of DRD2 was positively correlated with Yale Global Tic Severity Scale (YGTSS) score (P<0.05). In the children with moderate TD, the mRNA expression of DAT was positively correlated with YGTSS score (P<0.05).

CONCLUSIONSIn children with TD, the mRNA expression of DRD2 in peripheral blood lymphocytes can be used as one of the indicators for diagnosing TD, assessing the severity of TD, and evaluating clinical outcomes.

Adolescent ; Child ; Child, Preschool ; Dopamine Plasma Membrane Transport Proteins ; genetics ; Female ; Humans ; Lymphocytes ; metabolism ; Male ; RNA, Messenger ; blood ; Receptors, Dopamine D2 ; genetics ; Tic Disorders ; drug therapy ; metabolism ; mortality

OBJECTIVETo evaluate the clinical efficacy and safety of aripiprazole in the treatment of childhood tic disorders (TD) by a meta analysis.

METHODSA systematic search for randomized controlled trials (RCTs) on the efficacy and safety of aripiprazole in the treatment of childhood TD that were published between January 2000 and August 2014 was conducted. A Meta analysis on the selected RCTs was conducted using Review Manager 5.2 software.

RESULTSSix RCTs involving 551 TD patients were enrolled. There were no significant differences in the efficacy between aripiprazole and traditional drugs for treatment of TD either by the end of follow-up visit or at 2 weeks, 4 weeks and 8 weeks after treatment. The subgroup analysis results indicated that aripiprazole had the same efficacy for the treatment of TD as traditional drug haloperidol. Aripiprazole had a lower incidence of extrapyramidal reactions than haloperidol (P<0.05), but the overall incidence of side effects of aripiprazole was not lower than traditional drugs for treatment of TD.

CONCLUSIONSThe available evidence suggests that aripiprazole has the same curative effect in the treatment of childhood TD compared with the traditional drugs. However, it is difficult to draw a firm conclusion that aripiprazole is a safer drug in the treatment of childhood TD.

Antipsychotic Agents ; therapeutic use ; Aripiprazole ; adverse effects ; therapeutic use ; Humans ; Tic Disorders ; drug therapy

In recent years, the incidence of tic disorders has increased, and it is not uncommon for the patients to treat the disease. The pathogenesis and pathogenesis of Western medicine are not yet clear, the clinical commonly used western medicine has many adverse reactions, traditional Chinese medicine (TCM) research is increasingly valued. Based on the software of TCM inheritance assistant system, this paper discusses Ding Yuanqing's experience in treating tic disorder with Professor. Collect yuan Qing Ding professor in treating tic disorder of medical records by association rules Apriori algorithm, complex system entropy clustering without supervision and data mining method, carries on the analysis to the selected 800 prescriptions, to determine the frequency of use of prescription drugs, the association rules between the drug and digging out the 12 core combination and the first six new prescription, medication transferred to the liver and extinguish wind, cooling blood and relieving convulsion, Qingxin soothe the nerves, with the card cut, flexible application, strict compatibility.
Data Mining ; Databases, Bibliographic ; Drug Prescriptions ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; chemistry ; therapeutic use ; Humans ; Tic Disorders ; drug therapy ; Treatment Outcome

OBJECTIVETo assess the efficacy and safety of Xifeng Zhidong Tablet (XZT) in treating tic disorder children patients of internal disturbance of Gan-wind with phlegm syndrome (IDGWPS).

METHODSA stratified randomized, double-blinded, parallel control of placebo, multi-center trial was conducted in 160 subjects from 5 hospitals in China. They were randomly assigned to 2 groups, the test group and the control group, 80 in each group. Those in the test group were treated with XZT, while those in the control group were treated with placebos. The therapeutic course was 4 weeks for all. The effectiveness indicators covered main indicators and secondary indicators. Yale global tic severity scale (YGTSS) was taken as the main indicators. The amelioration of social function impairment, efficacy, single index of Chinese medical syndromes, Chinese medical syndrome efficacy as well as disappearance rate of single Chinese medical symptoms were evaluated as secondary indicators. The safety indicators included clinical adverse events, vital signs, blood/urine/stool routines, renal and liver functions, and electrocardiogram (ECG).

RESULTSAs for main indicators, the score of YGTSS decreased from 22.10 +/- 6.38 to 11.34 +/- 6.58 in the test group, while it decreased from 22.65 +/- 6.70 to 16.82 +/- 6.53 in the control group, showing statistical difference when compared with the same group before treatment (P < 0.01). Besides, the decrement was more significant in the test group after treatment (P < 0.05). As for secondary indicators, the total effective rate was 83.54% in the test group and 34.18% in the controlled group, showing statistical difference between the two groups (P < 0.05). As for social function impairment, 20,38, 16, 3, 1 case(s) in the test group were ranked as normal, minimal, mild, moderate, obvious degree, while 1, 24, 45, 7, and 0 case(s) in the control group were ranked as normal, minimal, mild, moderate, obvious degree. Better effect was obtained in the test group (P < 0.05).As for Chinese medical syndrome efficacy, it was 87.34% in the test group and 64.56% in the control group (P < 0.05). As for single index of Chinese medical syndromes, the disappearance rate of motor tics, irritability, dreaminess, abnormal tongue proper,abnormal tongue fur, and abnormal tongue pulse condition was 78.67%, 34.72%, 62.26%, 34.62%, 58.97%, and 39.74%, respectively in the test group, while they were 34.67%, 13.11%, 21.82%, 15.58%, 25.97%, and 19.48%, respectively in the control group. Better results were shown in the test group (P < 0.05). Totally 5 adverse events occurred. The incidence of adverse events was 3.75% in the test group and 2.53% in the control group.

CONCLUSIONSAfter 4 weeks of XZT treatment, the integral of YGTSS could be obviously reduced, the degree of social function impairment ameliorated, and Chinese medical syndromes improved. In addition, no adverse reaction occurred in this study.

Adolescent ; Child ; Child, Preschool ; Double-Blind Method ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Male ; Medicine, Chinese Traditional ; Phytotherapy ; Placebos ; Tic Disorders ; diagnosis ; drug therapy ; Treatment Outcome

Tic disorder is a childhood neuropsychological disorder which has the characteristics of abrupt, involuntary, and repetitive stereotyped muscle movement or voice. Tourette's disorder shows a chronic prognosis, and can last for life if no medical treatment is applied. Though the tic disorder has been known for a long time, the underlying cause is still not well known. Psychotropic drugs have long been used for the tic disorder or Tourette's disorder, but few clinical studies were carried out. However, the European Society for the Study of Tourette's syndrome recently reported the clinical guideline of Tourette's syndrome and other tic disorders based on the research findings obtained so far. Also, the guideline for the evidence-based treatment was reported in Canada, and North America. By synthesizing the newly reported foreign guidelines for treatment and review articles, this study aims to investigate the psychotropic drug therapy used for the tic disorder or Tourette's disorder.
Canada ; Drug Therapy* ; Muscles ; North America ; Prognosis ; Psychotropic Drugs ; Tic Disorders ; Tourette Syndrome* ; Voice

OBJECTIVETo study the effects qufeng zhidong Simplified Recipe (QZSR) on the behavior of the tic disorder (TD) rats.

METHODSFifty male SD rats were randomly divided to the normal group, the model group, the QZSR-1 group, the QZSR-2 group, and the QZSR group, 10 in each group. Two mg/kg apomorphine (APO) was intraperitoneally injected to rats in the model group, the QZSR-1 group, the QZSR-2 group, and the QZSR group, while equal volume of normal saline was intraperitoneally injected to rats in the normal group, both once daily for 7 successive weeks. At the 4th week equal volume of normal saline was intraperitoneally injected to rats in the model group and the normal group, while corresponding medicinal liquid was intraperitoneally injected to those in the rest groups, both once daily for 7 successive weeks. At the 2nd and 4th week of intervention, rats' improvement degrees of stereotyped behavior and the open-field test were monitored, and their experimental results were analyzed.

RESULTSAt the 2nd and 4th week of intervention, when compared with those of the model group, the score of stereotyped behavior decreased, the numbers of passing-panel, straightening, and dejecta pill were reduced, and the number of grooming increased in the QZSR-1 group, the QZSR-2 group, and the QZSR group. But there was no difference among the three groups (P>0.05).

CONCLUSIONQZSR could significantly reduce APO induced stereotyped behavior scores of TD rats, improve their locomotor activities, and reinforce their adaptive faculty.

Animals ; Behavior, Animal ; drug effects ; Drugs, Chinese Herbal ; pharmacology ; therapeutic use ; Male ; Rats ; Rats, Sprague-Dawley ; Tic Disorders ; drug therapy ; psychology

OBJECTIVETo evaluate the efficacy and safety of aripiprazole in the treatment of tic disorder when tiapride is used as a control.

METHODSSixty-five children aged 6-14 years old with tic disorders were randomly assigned to two groups: aripiprazole (2.5-10 mg/d) and tiapride treatment (25- 400 mg/d). After 12 weeks treatment, the clinical efficacy was assessed by the Yale Global Tie Severity Scale (YGTSS) score and the adverse reactions were observed.

RESULTSThe YGTSS score in both groups decreased from the second week of treatment. Compared with the tiapride treatment group, the aripirazole treatment group showed a more decreased YGTSS score (29+/-13)% vs (16+/-14)%; P<0.01 by the second week of treatment. The overall effective rate in the aripiprazole and tiapride treatment groups was 91% and 84%, respectively (P>0.05) 12 weeks after treatment. There were no significant differences in the incidence of adverse reactions between the aripiprazole and tiapride treatment groups and no severe adverse events were found in either group.

CONCLUSIONSLow dose aripiprazole is safe and effective for treatment of tic disorders in children, suggesting that it represents a new valid option for the treatment of tic disorder.

Adolescent ; Antipsychotic Agents ; therapeutic use ; Aripiprazole ; Child ; Female ; Humans ; Male ; Piperazines ; adverse effects ; therapeutic use ; Quinolones ; adverse effects ; therapeutic use ; Tiapamil Hydrochloride ; adverse effects ; therapeutic use ; Tic Disorders ; drug therapy