| Objective1.Explore the onset time of "Shugan Tiaoshen" acupuncture in the treatment of mild depression through the psychological evaluation scale.2.Use Attention Network Test(ANT)and Psychomotor Alert Task(PVT),event-related potential and dynamic cerebral blood flow automatic regulation monitoring technology to evaluate the effects of acupuncture on cognitive neurological function in the mild depression from behavioral and effector perspectives,respectively.Methods1.Study 1:Characteristics of cognitive neural function in young people with first episode of mild depressionYoung subjects aged 18 to 35 years with mild depressive episode were recruited and matched with healthy young adults.Attention Network Test(ANT)and Psychomotor Vigilance Task(PVT)were used to measure the effects of alertness,orientation,control and alertness response time in cognitive function.The latent periods of MMN,N1,P2,P3 and the amplitude of P3 of the event-related potentials of the two groups were collected.The Gain,Phase and Coherence signals at extremely low frequency(0,02-0.07Hz),low frequency(0.07-0.20Hz)and high frequency(0.2-0.5Hz)were collected by dynamic dynamic cerebral blood flow automatic regulation(DCA)monitoring.To explore the changes of cognitive and neurological function in young people with first episode of mild depression.2.Study 2:Study on the onset time of acupuncture in treating first mild depressionA randomized controlled trial was set up,and the subjects were divided into the "Shugan Tiaoshen"acupuncture group(hereinafter referred to as the "Shugan Tiaoshen group")and the non-meridian and non-acupoint group by simple random computer method.Fifty-four cases(18-44 years old)were included,including 28 cases in the group of "Shugan Tiaoshen",and 26 cases in the group of non-meridian and non-acupoint.Implement single blind,only blind subjects;Blind method was used to evaluate the efficacy of scale evaluation,event-related potential detection,dynamic cerebral blood flow automatic regulation monitoring,etc.(1)Intervention grouping"Shugan Tiaoshen" groupAcupointselection:Baihui(DU20),Yintang(EX-HN3),Hegu(LI4),and Taichon g(LR3)points.Operation:0.25×25mm filiform needle and filiform needle acupuncture were used.After disinfection,insert the needle vertically into the depth of 10-12mm,lifting and twisting the needle in order to "De Qi",After acupuncture,the patient was instructed to take a deep breath through the nose and retain the needle for 30 minutes.Perform the needle for 1min every 10min.Non-meridian and Non-acupoint groupAcupoint selection and operation:The patient was placed in supine position,and the skin at the acupoints was routinely disinfected.0.25×25mm flim-needle was used to puncture 1-2mm until the needle was upright on the non-meridian non-point.The needle was left for 30 minutes without manipulation during the period of needle retention.The course of treatment was the same as the experimental group.(2)Observation cycle:1 time a day for a total of 2 weeks of treatment.80%completion was a valid case.All patients entered Depression-related disorders specialist clinic for follow-up 2 weeks after the observation.(3)Evaluation index:Main Outcomes:Early improvement rate on the 3rd day of treatment:The percentage reduction rate of the total score of Hamilton Depression Scale-17(HAMD-17)compared with the baseline decreased by 25%or more.Secondary outcome:?Response rate on the 3rd,1st,10th,and 2nd weekend;(The percentage reduction rate of the total score of Hamilton Depression Scale-17(HAMD-17)compared with the baseline decreased by 50%or more.)?HAMD-17;?Beck Depression Self-Assessment Questionnaire(BDI-13);?Comprehensive Social Support Scale(PSSS);?90 Symptom List(SCL-90);?Safety outcome:Adverse events/adverse reactions during the intervention period.(4)Timing of evaluationBefore the intervention,on the 3rd day of the intervention,the 1st week of the intervention,the 10th day of the intervention,and the 2nd week of the intervention,the two groups were evaluated by professional psychological testers who passed the consistency test to evaluate HAMD-17;BDI-13 was self-evaluated daily during the intervention;PSSS and SCL-90 were evaluated before and 2 weeks after the intervention.3.Study 3:Effect of Acupuncture on Cognitive Nerve Function of Subjects with First Episode of Mild DepressionThe test groups and subjects are the same in Study 2.The event-related potential,ANT,PVT,and dCA data were collected at two time points before the intervention and 2 weeks after the intervention to evaluate the effect of acupuncture intervention on cognitive nerve function for 2 weeks.4.StatisticsThe psychological evaluation table data of this study adopted the principle of Intent-to-Treat Population(ITT)--statistical analysis was performed on all the cases that meeted the requirements of the program,were randomly grouped,and had completed at least one evaluation to evaluate the total treatment effect.The last observation carried forward(LOCF)method was used to fill in missing data.When the measurement data met the conditions of normality and homogeneous variance,it was described as the mean ± standard deviation,and when it didn't meet the conditions,it was expressed as the median.Counting data was represented by example composition ratio and rate.Two independent sample t test(or Mann-Whitney U test)was used for comparison between two groups,paired t test(or Wilcoxon paired signed rank test)was used for comparison within groups before and after intervention,and repeated measurement data at multiple time points was used for repeated measurement.Analysis of variance;Chi-square test(or Fisher's exact probability method)was used for comparison of rates between groups.The composition ratio between groups was compared using 2×C table or 3×C table chi-square test.The statistical test adopted a two-sided test,and the significance level of the difference was ?=0.05.P<0.05 indicated a statistical difference.Normal data adopted bivariate correlation Pearson correlation coefficient,and non-normal data adopted Spearman rank correlation coefficient analysis.For the objective index data,in order to better quantify the actual changes,missing values were not entered,and all significance tests were performed with pairwise missing values,?=0.05.ResultsStudy 1(1)Compared with healthy young people,the alertness effect of the Attention Network Test was statistically different between the two groups(P=0.006).The alertness of young and depressed subjects was higher than that of healthy young people;There was no statistical difference in MMN latency,N1 latency,P2 latency,and P3 latency(P>0.05).There was a statistical difference in P3 amplitude between the two groups(P=0.029).The amplitude of P3 wave in young and depressed subjects was lower than that of healthy young people;The left and right brain phase values(Phase)of dynamic cerebral blood flow automatic adjustment low frequency state(LF)were lower than healthy young people(P<0.05),(2)The phase of the very low frequency state(VLF)(r=-0.2 61,P<0.05)and low frequency state(LF)(r=-0.255,P<0.05))was negatively correlated with the HAMD-17.Study 2(1)Baseline resultsA total of 54 patients were enrolled,46 of which completed 80%of the treatment,and 8 of them fell off.Among them,there were 2 cases in the "Shugan Tiaoshen" group and 6 cases in the "non-meridian and non-acupoint" group.The general data of the two groups of subjects at baseline,such as age,gender,occupation,education,life events,and social support,were compared by chi-square test or analysis of variance.There was no statistical difference between the two groups(P>0.05);Before intervention,the HAMD-17 and BDI-13 scales were not statistically different between the two groups(P>0.05),and it can be considered that the two groups were comparable before treatment.(2)Early-onset rate on the third dayOn the third day of intervention,the early onset rate was 96.42%in the "Shugan Tiaoshen"group and 61.53%in the "non-meridian and non-acupoint" group.The "Shugan Tiaoshen"group was better than the "non-meridian and non-acupoint" group with statistical differences(P<0.05).(3)Response rate at each time point on the 3rd day,1st weekend,10th day,and 2nd weekend of the interventionOn the 3rd day,the response rate was 42.9%in the "Shugan Tiaoshen" group,and 30.8%in the "non-meridian and non-acupoint" group.At the end of the first week,the response rate was 82.14%in the "Shugan Tiaoshen" group and 69.23%in the "non-meridian and non-acupoint" group.On the 10th day,the response rate was 85.7%in the "Shugan Tiaoshen" group and 73.1%in the "non-meridian and non-acupoint" group.At the end of the second week,the response rate was 89.28%in the "Shugan Tiaoshen" group,and 69.23%in the "non-meridian and non-acupoint" group.At all time points,the "Shugan Tiaoshen" group was higher than the control group,indicatied that the "Shugan Tiaoshen" group reached a response earlier.There was no statistical difference between the groups(P>0.05).(4)HAMD-17? There was no significant difference in the total score of HAMD-17 at each time point between the "Shugan Tiaoshen" group and the "non-meridian and non-acupoint" group,and there were differences from the baseline on the third day of intervention.?Comparison between groups of each factorAnxiety somatization symptom factor:The two groups were evaluated at each time after baseline in the "Shugan Tiaoshen" group than the "non-meridian and non-acupoint",but there was no statistical difference between the two groups(P>0.05);Sleep disturbance factor:As the intervention course progressed,the measured value gradually decreased.The scores on the 3rd,10th,and 14th days of the "Shugan Tiaoshen"group were lower than those of the "non-meridian and non-acupoint",but there was no statistical difference(P>0.05);Blocking factor:There was no statistical difference between the two groups at each time point(P>0.05);Cognitive impairment factor:There was a statistical difference between the two groups on the 14th day of intervention(P=0.032).?Overall analysis of repeated measurement of each factor:Anxiety somatization factor:Compared with the baseline,the scores of anxiety somatization symptoms on the 10th and 14th days improved statistically(P<0.05),indicated that acupuncture intervention had improved anxiety somatization factors from the 10th day More obvious,the difference was 3.143(95%CI:1.276-5.010);Sleep disturbance factor:Compared with the baseline,the sleep factor was statistically different from the 3rd day,the difference was 1.357(95%CI:0.581-2.133)and lasted to 14 days.Blocking factor:Compared with the baseline,the improvement on the 7th day of the treatment period was statistically different(P<0.05),and the difference was 1.286(95%CI:0.052-2.519),and compared with the baseline on the 10th day,On the 14th day,the difference continued to be statistically significant(P<0.05);Cognitive impairment factor:Compared with the baseline,the change from intervention to day 7 showed a significant difference and was statistically significant(P=0.030),with a difference of 1.429(95%CI:0.145-2.712).And with the progress of treatment,the 10th and 14th days continued to improve compared with the baseline and there was a statistical difference(P<0.05).(5)BDI-13?Comparison between groupsThere was no statistical difference between the two groups at various time points during the baseline period and seven days after the intervention(P>0.05);?The overall analysis result of repeated measures It indicated that there is a significant difference between the baseline and the baseline at the beginning of the intervention to 5 days and is statistically significant(P=0.003),the difference was 5.071(95%CI:2.141-8.002),as the intervention progressed,it continued to improve on the 6th and 7th day and was statistically different from the baseline(P<0.05).(6)Perceived Social Support Scale(PSSS)The total scores of family support,extra-family support,and support in the comprehension social support score of the "Shugan Tiaoshen"group increased after treatment compared with the scores before treatment,and the difference was statistically significant(P<0.05).Although the scores of the three groups in the "non-meridian non-acupoint" group were slightly higher than those before treatment,the difference was statistically significant(P>0.05).(7)List of 90 symptoms(SCL-90)The scores of the factors in the "Shugan Tiaoshen" group were lower after 2 weeks of intervention than before the intervention,and the difference was statistically significant(P<0.05).In the "non-meridian non-acupoint" group,the scores of psychotic,other,positive items,and the number of positive factors were lower than the scores before treatment,and the difference was statistically significant(P<0.05),and there was no statistically significant difference before and after cofactor intervention(P>0.05).Study 3(1)The values of vigilance and executive control in the "Shugan Tiaoshen" group were lower than those before the intervention,and there was a statistical difference(P<0.05);The executive control in the "non-meridian non-acupoint" group was lower than those before the intervention,There was a statistical difference(P<0.05);there was no statistical difference in PVT response(RT)between the two groups and pre-post(P>0.05).(2)The two groups of event-related potential components,the phase(LPhase)values of the left brain(Red)and right brain(Green)under the low frequency automatically adjusted by dynamic cerebral blood flow,there was no statistical difference before and after the intervention(P>0.05).Conclusion(1)The first episode of mild depression in young people has impaired cognitive function and automatic adjustment of dynamic cerebral blood flow.It shows high alertness,the P3 amplitude decreases,and the phase value decreases.Automatic adjustment of dynamic cerebral blood flow is related to the degree of depression.(2)The "Shugan Tiaoshen" acupuncture therapy(DU20,EX-HN3,LI4,LR3)can take effect on the third day,and is characterized by the earliest improvement of sleep disorders,and a higher response appears within 1 week.After 2 weeks of treatment,the PSSS and SCL-90 scores were significantly improved,the alertness of cognitive functions,the efficiency of executive control were improved,and the event-related potentials and dynamic cerebral blood flow autoregulation function did not change significantly. |
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