| Objective1.A meta-analysis was conducted to investigate the effectiveness and safety of thumbtack needle combined with traditional Chinese medicine(TCM)vs pure traditional Chinese medicine in treating patients with Tic Disorder(TD).2.To evaluate the effect of thumbtack needle combined with Jingxinzhidong decoction compared with pure Jingxinzhidong decoction in treating patients with TD by conducting a randomized clinical trial.MethodMeta-analysis:We searched relevant randomized controlled trial studies in the following databases from their inception to December 31,2020:China National Knowledge Infrastructure(CNKI),the Chinese Biomedical Literature Database(CBM),Wan-Fang Database,Chinese Scientific Journal Database(VIP database),and PubMed.Two reviewers independently screened the obtained trials,RevMan V.5.4 software from the Cochrane Collaboration was used for data synthesis.Randomized clinical trial:The participants were TD children in the outpatient department of professor FeiHan.TD children who met the inclusion and exclusion criteria were randomly assigned into two groups through simple randomization method.The treatment group was treated with thumbtack needle combined with Jingxinzhidong decoction for 12 weeks,and the control group was treated with pure Jingxinzhidong decoction for 12 weeks.Severity of disease was assessed using the Yale Comprehensive Tic Severity Scale(YGTSS)score,and the effect of treatment was assessed using the reduction of YGTSS score.Liver and kidney function tests and urine routine test were carried out before and after treatment to ensure the safety of study.Data analysis was performed using the statistical software SPSS 26.0.Data were presented as mean(standard deviation)when it conformed to normal distribution,data that do not conform to normal distribution were presented by median and interquartile range.The enumeration data were presented by number and percentages.Two independent sample t test and two dependent sample t test were used to analyze data that conformed to normal distribution,non-parametric tests were used to analyze data that do not conform to normal distribution.chi-square test or Fisher’s exact test was used to compare enumeration data.The results were considered statistically significant different when P≦ 0.05.Following the inclusion of participants,the YGTSS score was assessed by professional physicians.The case report forms were carefully filled in and were preserve well.Follow-up visits were conducted timely.Suitable statistical methods were chosen to analyze the data.ResultMeta-analysis:A total of 8 studies(473 participants)were included in this meta-analysis,including 238 participants in the thumbtack needle combined with TCM group and 235 participants in the TCM group.The result showed that there was no significant statistical difference between thumbtack needle combined with TCM treatment and pure TCM treatment in terms of response rate(RR=1.13,95%CI[0.99,1.30],P=0.07>0.05).There were too few studies evaluated the change in YGTSS score,adverse events,long-term efficacy and other outcome measurements in the included studies to make a systematic analysis on these measurements.Randomized clinical trial:70 eligible participants with TD were randomly assigned to the thumbtack needle combined with Jingxinzhidong decoction group or the pure Jingxinzhidong decoction group.3 participants lost to follow up(1 in the thumbtack needle combined with Jingxinzhidong decoction group and 2 in the pure Jingxinzhidong decoction group).34 participants in the thumbtack needle combined with Jingxinzhidong decoction group and 33 participants in the pure Jingxinzhidong decoction group were included in the final data analysis.There were 28 boys and 6 girls in the thumbtack needle combined with Jingxinzhidong decoction group,and 27 boys and 6 girls in the pure Jingxinzhidong decoction group,no statistically significant difference was observed(p>0.05).Moreover,no statistically significant differences were observed in two groups in terms of age,severity of TD,overall score and sub-score of YGTSS scale(P>0.05)except for the complexity score of motor tic(P=0.01<0.05).The effect of two groups was evaluated according to the reduction rate of YGTSS score.The result showed that in the thumbtack needle combined with Jingxinzhidong decoction group,5 patients(14.71%)achieved clinical control,12 patients(35.29%)had significant effect,14 patients(41.18%)had mild effect,and 3 patients(8.82%)had no effect,the number of effective people was 31,the effective rate was 93.94%.In the pure Jingxinzhidong decoction group,3 patients(9.09%)achieved clinical control,4 patients(12.12%)had significant effect,20 patients(60.61%)had mild effect,and 6 patients(18.18%)were ineffective.The number of effective people was 27,and the effective rate was 81.82%.Compared with the pure Jingxinzhidong decoction group,the proportion of subjects that achieved clinical control or significant effect was higher in the thumbtack needle combined with Jingxinzhidong decoction group,and ineffective patients were fewer,effective rate was higher(P=0.025,<0.05).The severity of disease was alleviated and YGTSS scores were decreased in both groups after treatment,but no statistically significant differences were observed between two groups(P>0.05).No adverse event was reported in both groups.Conclusion:Meta-analysis:The meta-analysis showed that there was no significant statistical difference between thumbtack needle combined with TCM treatment and pure TCM treatment in terms of response rate.However,as low quality of the included studies may lead to publication bias and information bias,multicenter RCTs with large-scale and long-term follow-up are required to provide more evidence in the future.Randomized clinical trial:1.Both thumbtack needle combined with Jingxinzhidong decoction treatment or pure Jingxinzhidong decoction treatment can alleviate the severity of disease and decrease the YGTSS scores in patients with TD.2.Compared with pure Jingxinzhidong decoction treatment,thumbtack needle combined with Jingxinzhidong decoction can improve the effective rate,reduce the number of patients who do not respond to treatment,and increase the proportion of patients that achieve clinical control or significant effect.3.No adverse event was observed in both pure Jingxinzhidong decoction group and thumbtack needle combined with Jingxinzhidong decoction group.The safety of both groups is good and worthy of clinical promotion. |
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