| ObjectiveDepression and insomnia remain one of the world’s major public health burdens,and acupuncture has been proven to be an effective treatment.To evaluate the therapeutic effect and safety of the acupuncture protocol of soothing the liver and regulating the mind with the treatment of depressive insomnia through clinical randomized controlled trial,and to provide experimental basis for clinical treatment of the disease,we designed this research.MethodsThrough the acupuncture clinic of Guangdong Provincial Hospital and self-media(We Chat.etc.)to recruit volunteers,64 patients were selected,and a simple randomized experimental controlled trial was conducted.By using SPSS 20.0 software,the patients were divided into 2 groups according to 1:1.Among the treatment group and the control group,there are 32 patients in each one.The evaluators and data analysts were blinded.Acupoint location refers to the 2006 national standard of the People’s Republic of China(GB/t12346-2006)Name and Location of Acupoints.The DU20、EX-HN3、LI4、LR3、SP6、HT7、N-HN54 were selected.The points of Intradermal needle are BL15、BL18 and BL44、BL48 alternately.A total treatment was 8 weeks,2 times a week,every time for 30 minutes,every treatment interval≥24 hours,4 weeks for 1 course of treatment,a total of 2 courses of treatment,complete 14 times or more can be counted into the effective cases,each stay needle 30 minutes.The follow-up period was 4 weeks.The Insomnia Severity Index Scale(ISI),Pittsburgh Sleep Quality Index(PSQI),Hamilton Depression scale(HAMD-17)and Symptom Checklist 90(SCL-90)were observed before and after treatment.Adverse reactions and side effects were recorded during the study.ResultsThe experiment included a total of 64 patients,6 cases were fallen off,of which the treatment group shedding 2 cases,control group shedding 2 cases,follow-up fell off 2 cases.In order to maintain the integrity of the original data set and prevent bias,the intentional principle(ITT)was used to analysis data.(1)Baseline comparison:there was no difference between the general data of the two groups of patients,such as age,course of disease,occupation,education level,etc.(P>0.05);There was no difference in baseline of ISI、PSQI、HAMD-17、SCL-90 before treatment.(2)ISI:Compared with pre-treatment,both groups of treatments can reduce ISI score,and improve the sleep status(P<0.05),the two groups have different efficacy,the curative effect of the Treatment Group is better than the control group(P<0.05).Both groups recovered during follow-up,and the control group rebounded significantly compared to the treatment group,and the above results suggested that the treatment group might be more effective in reducing the patient’ s ISI score,and the effect was longer than the control group(P<0.05).(3)PSQI:the PSQI score of both groups decreased compared to pre-treatment,the insomnia of patients was improved,but the decrease of the treatment group was more obvious than the control group,there was a difference between the two groups(P<0.05);Both groups recovered during follow-up,and the control group rebounded significantly compared to the treatment group,and the above results suggested that the treatment group might be more effective in reducing the patient’s PSQI score,and the effect was longer-lasting than-the control group(P<0.05).(4)HAMD-17:HAMD-17 scores decreased in both groups compared to pre-treatment,and both patients experienced an improvement in depression,but the decrease in the treatment group was significantly compared to the control group,with differences between the two groups(P<0.05).Both groups recovered during follow-up,the control group rebounded significantly,the above results suggest that the treatment group may be more effective to reduce HAMD-17 score,and the effect is longer-lasting than the control group(P<0.05).(5)SCL-90:After treatment,the SCL-90 score of the two groups both decreased compared to the pre-treatment,but there was no difference between the two groups of treatment(P>0.05).The SCL-90 score of both groups rebounded in follow-up,and there was no significant difference between the two groups of treatments(P>0.05).(6)Efficiency results:the total efficiency after treatment in the treatment group and the control group was 91.6%,65.6%respectively.The total effective rate of the treatment group were significantly higher than that of the control group(P<0.05).The total efficiency of the follow-up in the treatment group and the control group was 87.5%and 46.9%respectively,which had statistical significance(P<0.05).(7)Safety comparison:In this study,1 patient in the treatment group developed small hematoma,which was absorbed after 2 days.1 patient had a small scleroma in the Pinhole,which disappeared after 3 days;No other side effects and adverse events such as fainting or broken needles occurred,the incidence of adverse events was 3.12%.ConclusionThe acupuncture protocol of soothing the liver and regulating the mind is effective and safe in improving depressive and insomnia symptoms in patients with depressive insomnia,especially the improvement of insomnia symptoms is more accurate,and the incidence of adverse events is less. |