| ObjectiveTo evaluate the efficacy and safety of electro-acupuncture based on Soothing Liver Qi and Regulating Spirit Theory in depression related insomnia,and to provide a reference for the clinical treatment of depression-related insomniaMethodsThrough the acupuncture clinic of Guangdong Provincial Hospital of Traditional Chinese Medicine and recruiting subjects from the media/We Chat public platform.In this randomized controlled trial,a total of 60 volunteers that conforming to the inclusion criteria are randomly assigned to one of two groups by SPSS17.0 software,there were 30 cases in the treatment group and 30 cases in the control group.Both groups received soothing-liver and regulating-mentality acupuncture treatment,while the treatment group added electro-acupuncture.Patients in both groups will receive normal needle acupuncture on 12 acupoints,including Taichong(LR30),Hegu(L114),Sanyinjiao(sp6)Anmian(Extra),Shenmen(H7),Baihui(DU20),and Yintang(EX-HN3).The only difference is that the treatment group added electro-acupuncture in Baihui and Yintang.Patients take the appropriate position.After disinfection points,choose 1-inch needle(0.30×25mm)acupuncture,the needle penetrated the skin sufficiently to reach the required depth,then manipulate the needles to elicit de qi.Ratain the needles for 30 min,with a uniform lift twisting until de qi,then connecte the electrode of electro acupuncture instrument to the needle handle of Baihui,Yintang and bilateral Hegu and Taichong.Electro-acupuncture parameters:Density wave,2/15Hz,current intensity 0.lma-1.Oma,the patient tolerance for the maximum degree.The whole course of treatment was 20 times,a total course of treatment was required,patients received treatment 2 times a week(two consecutive treatment interval ≥72 hours),the enrolled cases were completed at least 80%within 10 weeks.Efficacy indicators and efficacy evaluation:The efficacy evaluation time points were set before treatment,after the end of treatment and 4 weeks after the end of treatment,Pittsburgh Sleep Index(PSQI),Hamilton Depression Scale(HAMD),Baker Depression ScaleThe efficacy evaluation time points were set before treatment,after the end of treatment and 4 weeks after the end of treatment,Pittsburgh Sleep Index(PSQI),Hamilton Depression Scale(HAMD),Baker Depression Scale(SDS)were the rating scales.Statistical analysis:The data obtained by SPSS19.0 software processing,which count data expressed as a percentage,while the corresponding differences between groups for chi-square test or Fisher exact probability method;measurement data by means of standard deviation means,within the group The results of paired t-test comparison,analysis of variance between groups or rank sum test(non-normal distribution and variance),repeated measures of variance analysis.Statistical test using the significance level of a =0.05 two-sided test.Results1.A total of 60 subjects were enrolled in this study,including 30 in the treatment group and 30 in the control group.2.There was no statistical difference between the treatment group and the control group in the basic data such as age,sex and education before treatment,the same statistical result in depression and insomnia score,suggesting that two groups could be compared and analyzed at baseline.3.PSQI scoreIn-group comparison:Compared with pre-treatment,the total score of both groups decreased to a certain extent.At the 10th and 14th week after treatment,the scores of the treatment group showed obvious difference compared with before treatment(P<0.001),and the control group also decreased(P<0.05),the difference was statistically significant.Compared with the 10th weekend,there was no significant difference between the 14th weekend scores(P>0.05).Comparison between groups,the PSQI score were compared by single factor analysis of variance at the end of treatment,the difference between two groups is no statisticance.At the 14th week after treatment,the PSQI score had no significant difference(P>0.05).4.HAMD scoreIn-group comparison:HAMD scores decreased after treatment in both groups.At the end of treatment and 4 weeks after the end of follow-up results showed that compared with the pre-treatment,the two groups of patients with a certain degree of decline in the score,and the treatment group at the 10th and 14th week scores were reduced(P<0.01)The differences were statistically significant.However,compared with the results at the end of the tenth weekend,we can see that the scores on the 14th weekend have increased,but there is no statistical difference between the results(P>0.05).Compared with the pre-treatment,the scores of the 10th and 14th week of the control group decreased to a certain extent(P<0.01),and there was significant statistical difference.Compared with the tenth weekend scores,we can see that the scores at the 14th weekend were basically the same,there was no statistical difference(P>0.05).Comparison between groups:After 10 weeks of treatment,the total score of HAMD in both groups was compared and analyzed by rank sum test.The overall comparison result was:Z=-2.534,P<0.05.The difference was statistically significant.After 4 weeks of treatment,the HAMD total score was compared by rank sum test,Z=-1.839,P>0.05.The difference was not statistically significant.5.SDS scoreComparisons within groups:The SDS scores of both groups decreased after treatment.The treatment group at the end of treatment and 4 weeks after the end of follow-up results showed that compared with before treatment,patients with SDS scores have a certain extent,there was a statistical difference.Compared with the 10th weekend,the 14th weekend had some improvement,but the difference was not statistically significant(P>0.05).Compared with before treatment,the score of the control group decreased to a certain extent at the 10th and 14th week(P<0.01),and there was a significant statistical difference.Compared with the end of the 10th week,the score of the 14th weekend had a certain increase,but there was no statistical difference(P>0.05).Comparison between groups:After 10 weeks of treatment,the SDS scores of the two groups were compared by the single factor analysis of variance,the overall comparison results:F = 6.018,P<0.05.The difference was statistically significant.Four weeks after the end of treatment,SDS total scores showed:F = 2.624,P>0.05.The difference was not statistically significant.6.Effective rateAfter treatment,the total effective rate was 66.7%in the treatment group and 56.7%in the control group.The cure rate,effective rate and effective rate in the treatment group were(P<0.05)The total effective rate was 53.3%in the treatment group and 43.3%in the control group.The cure rate,effective rate and effective rate in the treatment group were(0%,6.67%,46.7%)and the control group(0%,6.67%,36.7%);after testing,P>0.05,there was no significant difference between the two groups.7.Adverse eventsThere is no adverse events records during the study.ConclusionElectro-acupuncture based on Soothing Liver Qi and Regulating Spirit Theory could improve the sleeping quality and depressive symptoms of patients with Depression related insomnia,the effect is same as non-electro acupuncture,while in improving the state of depression,the effect is better. |
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