| ObjectiveWe evaluated the efficacy of intradermal thumbtack needle and shame intradermal thumbtack needle on subthreshold depression and the effect of intradermal thumbtack needle on the attention network of subthreshold depressed subjects by using subjective scales and classical psychological paradigms as evaluation indicators.MethodsUsing a randomized controlled trial,61 subthreshold depressed subjects who met the inclusion criteria were recruited as study subjects at the outpatient clinic of Guangdong Provincial Hospital of Traditional Chinese Medicine and the School of Psychology of South China Normal University,and the study subjects were randomly divided into the intradermal thumbtack needle group(31 cases)and the comfort group(30 cases)according to a 1:1 ratio using the PEMS 3.2 software package.1.Acupuncture point selection schemeOption 1:Heart Shu point,Liver Shu point,Ju Que point,ear points:alternating left and right heart and liver.Option 2:Shen dang point,Hun Men point,Hatsuo,ear points:alternating left and right heart and liver.The two groups of acupuncture point protocols were used alternately,and the acupuncture points were positioned with reference to the National Standard of the People’s Republic of China(GB/T12346-2006)"Name and Positioning of Acupuncture Points" and the National Standard of the People’s Republic of China(GB/T 13724-2008)"Name and Positioning of Ear Points".2.OperationIntradermal thumbtack needle group:the above-mentioned dorsal acupoints and auricular points were taken,routinely sterilized and then disposable sterile snap needles were taken and applied to the acupoints,and the needles were left in place for 2-3 days.A sterile 0.20 × 1.5mm snare needle(Seirin(?) PYONEX;Seirin Corporation,Shizuoka,Japan)was used for the dorsal acupoints,and a sterile 0.20 × 0.6mm snare needle was used for the ear points.Comfort group:the operation was the same as that of the intradermal needle group,using a comfort snap needle(Seirin(?) PYONEX;Seirin Corporation,Shizuoka,Japan),without the needle tip piercing the skin.3.Duration of treatmentThe total duration of treatment was 6 weeks,and subjects received the intervention twice a week,more than 48 hours apart,with intradermal needles left in place for 2 days.4.Evaluation time points and indicatorsA total of 4 time points were selected as the evaluation time points:before the intervention,at the 3rd week of intervention,after the intervention and after 1 month of follow-up.The PHQ-9,SF-12,and GAD-7 scores were used to observe the differences in efficacy between and within groups at the four time points,and the experimental paradigms ANT and PVT were used to record the differences in attention network and vigilance attention between and within groups at the first three time points,in addition to recording the adverse effects and side effects.5.Statistics and data analysisThe SPSS 20.0 statistical package was used to create a database for data cleaning,verification and statistical analysis.Among them,the count data were analyzed and compared using the chi-square test.In the measurement data,if they conformed to normal distribution and the variances were flush,they were statistically described as mean plus or minus standard deviation(x±s)and t-test was used(where independent sample t-test was used for comparison between groups and paired t-test was used for comparison before and after within groups).If they did not conform to normal distribution,they were statistically described by quartiles((?)(P25,P50,P75)),and the Kruskal-Wallis rank sum test was used,and the Wilcoxon rank sum test was used for two comparisons within groups,and the Mann-Whitney rank sum test was used for two comparisons between groups.Repeated-measures ANOVA was used for measurement data at multiple time points,and multivariate ANOVA was used for comparison between groups at each time point.All tests were performed using two-sided tests with significant differences α=0.05.ResultsA total of 61 cases were recruited in this study,31 in the intradermal needle group and 30 in the consolation group,with 0 shedding in the intradermal needle group and 4 in the consolation group,for an overall shedding rate of 6.56%.1.BaselineThere was no significant difference in demographic data between the two groups,including age(P=0.112),gender(P=0.729)and educational level(P=0.070).Before treatment,there was no significant difference between two groups in PHQ-9 questionnaire(P=0.105),SF-12 in PCS(P=0.698)and MCS(P=0.058)dimension and GAD-7 scale(P=0.0.212).Compared two groups in ANT experimental paradigm in average accuracy(P=0.102),the ALE(P=0.749),ORI(P=0.995),EC(P=0.773)and PVT experimental in average accuracy(P=1.000)and RT(P=0.113)before treatment,there was no significant difference.The two groups of patients had a neat baseline and were comparable.2.PHQ-9 scoreThere were statistical differences between the two groups before and after intervention(P<0.001).Repeated measurement analysis of variance was conducted for PHQ-9 scores at each time point of the two groups of subjects,and it was found that the evaluation time point had statistically significant differences in PHQ-9 scores(P<0.001),while grouping factors has no statistical difference in PHQ-9 scores(P>0.05),and the two has an interaction effect(P<0.001).The score reduction rate analysis was performed on the participants of the two groups at the 3rd week of treatment,the end of treatment and the follow-up for 1 month,and there were statistical differences between the two groups at the above time points(P<0.001).The score of PHQ-9 scale in intradermal thumbtack needle group decreased significantly after intervention.The results showed that subjects in both groups showed significant improvement in PHQ-9 scale evaluation,and the intradermal needle group was better than the placebo group.3.SF-12 scoreThere were two dimension.In terms of PCS dimension,there was statistical difference in intradermal thumbtack needle group before and after the intervention(P<0.05),while there was no difference in shame intradermal thumbtack needle group(P>0.05).In the terms of repetitive measure analysis of variance,evaluation time point had statistically significant differences in PCS score(P<0.05),while group factors on PCS score results had no statistical difference(P>0.05),and both do not have interaction(P>0.05),In terms of score reduction rate,the PCS dimension comparison before and after the intervention in the two groups had no statistical difference(P>0.05);In terms of MCS,there were statistically significant differences in MCS between the intradermal thumbtack needle group and the sham intradermal thumbtack needle group before and after treatment(P<0.001).In terms of repetitive measure analysis of variance,there was a statistical difference in MCS score at the evaluation time point(P<0.001),while there was no statistical difference in MCS score in the grouping factors(P>0.05),and these two had an interaction effect(P<0.05).In terms of score reduction rate,there were statistical differences in MCS score reduction rate between the two groups at the 3rd week of treatment,the end of treatment and the follow-up for 1 month(P<0.05),and the score of MCS dimension of the participants in intradermal thumbtack needle group decreased significantly after intervention.The results showed that the intradermal needle group had improvement in the PCS dimension,but the efficacy was not significant,while the placebo group had no improvement;in the MCS dimension,both groups had significant improvement,and the intradermal needle group had better efficacy than the placebo group.4.GAD-7 scoreIntra-group comparison results showed that both of intradermal thumbtack needle group(P<0.001)and shame intradermal thumbtack needle group(P<0.002)had a statistical difference.Repeated measures analysis of variance results showed that the evaluation time point(P<0.001)and grouping factors(P<0.05)had statistical differences on the GAD-7 score,and the two had an interactive effect(P<0.001).In terms of score reduction rate,there was no statistical difference between the two groups at the 3rd week of treatment(P≥0.05),and there was statistical difference at the end of the intervention and at the 1-month followup(P<0.05).The score reduction rate of GAD-7 in the intradermal thumbtack needle group decreased significantly after the intervention.The results showed that subjects in both groups showed significant improvement in the evaluation of the GAD-7 scale,and the intradermal needle group was better than the placebo group.5.ANT paradigmThere were three dimension.In the terms of alertness effect,intra-group comparison before and after intervention showed statistical difference in intradermal thumbtack needle group(P<0.05),but no statistical difference in shame intradermal thumbtack needle group(P>0.05).Repeated measures analysis of variance showed that there were significant differences between the evaluation time point and the grouping factors on the alertness effect(P<0.05),and the two factors had an interactive effect(P<0.05).In terms of score reduction rate,there was statistical difference in the alertness effect at the third week of treatment and at the end of treatment(P<0.05).In terms of orientation effect,before and after intervention there was no statistical difference of both two groups(P>0.05).Repeated measures analysis of variance results showed that there was no significant difference between the evaluation time point and grouping factors on the orientation effect(P>0.05),and there was no interaction between the two factors(P>0.05).There was no statistical difference in the reduction rate of orientation effect at each time point(P>0.05).In terms of executive control effect,before and after intervention,there were statistically significant differences in intra-group comparison of both two group(P<0.05).Repeated measures analysis of variance indicated that there was a statistical difference in the evaluation time point on the effect of executive control(P<0.001),but there was no statistical difference in the grouping factors(P>0.05),and there was no interaction between the two factors(P>0.05).There was no statistical difference in the score reduction rate of executive control effect at each evaluation time point(P>0.05).The results showed that the intradermal needle group showed improvement in the vigilance and executive control effects,but the latter efficacy was not significant,and there was no statistical difference in all three aspects in the placebo group.6.PVT paradigmIntra-group comparison showed that there was no statistical difference in RT of theintradermal thumbtack needle group(P>0.05),while there was statistical difference in RT of the shame intradermal thumbtack needle group(P<0.05).In the analysis of variance of repeated measurements,there was no significant difference in the evaluation time point and grouping factors on RT(P>0.05),and there was no interaction between the two(P>0.05).In terms of score reduction rate,there was no statistically significant difference in score reduction rate between the two groups at the third week of treatment(P>0.05),but at the end of treatment,the difference was statistically significant(P<0.05).The results showed that the intradermal needle group had an improvement in the PVT paradigm,while the difference in the placebo group was not statistically significant.7.The effective rateThe total effective rate at the end of treatment was 93.55%and 69.23%for the intradermal thumbtack needle group and the comfort group,respectively,with statistically significant differences.This indicates that the overall efficacy of the intradermal thumbtack needle group was better than that of the comfort group.Conclusion1.Intradermal thumbtack needle therapy can effectively improve the depressive mood,anxiety,and mental health of the subthreshold depression population and improve the overall quality of life.2.Intradermal thumbtack needle therapy can improve the alertness effect in the attention network of subthreshold depressed people and improve vigilant attention,but it has no significant effect on the orientation effect and executive control effect. |
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