| ObjectiveConduct randomized controlled trials,to evaluate the efficacy and safety of fine moxibustion in the treatment of depression-related insomnia.Methods1.Case source.Mild to moderate depression-related insomnia patients were recruited from March 2018 to October 2019 in the acupuncture clinic of Guangdong Hospital of traditional Chinese Medicine and Wechat platform.2.Random grouping and blind method.Using the method of simple randomization,according to the proportion of 1:1,they were divided into two groups:Jing-moxibustion group(n=35)and shame moxibustion group(n=35).Only the researchers knew the group of single-blind design.3.Intervention measures.(1)Jing moxibustion group.Acupoint selection:AB two sets of acupoints,alternately selected.Group A:bilateral BL13,bilateral BL15,bilateral BL17,bilateral BL19,bilateral BL20,bilateral BL23;Group B:bilateral BL42,bilateral BL44,bilateral BL47,bilateral BL48,bilateral BL52,GVI1,GV4.Basis for acupoint positioning:the textbook of the Twelfth five-year Plan for higher Education of traditional Chinese Medicine published by China traditional Chinese Medicine Publishing House,9th edition of Meridian and Acupoint Studies,ISBN:9787513209144.Operation:apply a little Wanhua oil on the acupoint,knead the moxa into a sand cone,the diameter of the bottom circle is about 2mm,the cone is 3mm high,prepare the burning incense,ignite the velvet,the incense ash in the process is caught with a small plate,when the patient feels burning pain,change the moxa column immediately,2 strong in each hole.(2)shame moxibustion group.Acupoints were selected as the same essence moxibustion group.Operation:the process is basically the same as that of the fine moxibustion group,the only difference is that the oil on the surface of the acupoint needs to be soaked in 2/3 of the moxa column volume to ensure that the moxa column burns to about 1/3 to extinguish automatically,and the patient will not feel temperature change or burning sensation.(3)course of treatment and follow-up.Course of treatment:twice a week,2 times treatment interval 2 days,8 times as a course of treatment,a total of one course of treatment.The interval between the two treatments is between 48 and 72 hours.The follow-up time was 30 days after the end of treatment.(4)Evaluation indexMain outcome measures:Pittsburgh Sleep Index scale(PSQI),Hamilton Depression scale(HAMD-24).Secondary outcome indicators:depression factor(SCL-90),quality of life questionnaire(SF-36),adverse events and side effects in symptom Checklist 90(SCL-90).(5)Evaluation time point.Before entering the group,after the end of treatment,1 month after the end of treatment.(6)Statistical method.The analysis database is established by SPSS 22.0 statistical software,and the statistical analysis of the data is completed by conforming to the scheme set according to the principle of intentionality.Shapiro-Wilk test method was used to test normality and Levene method was used to test the homogeneity of variance.when the measurement grouping data were in accordance with normal distribution,the description was expressed by mean and standard deviation,and independent sample t-test was used to compare groups before and after treatment.Nonparametric test was used for non-normal and uneven variance,Mann-Whitney rank sum test was compared between groups,median and quartile were used to describe measurement data,constituent ratio and frequency were used to describe distribution law of binary classification data.Chi-square test or exact probability method was used for inter-group comparison.The depression factor scores of PSQI,HAMD-24,SF-36 and SCL-90 in the two groups were compared at different time points.When the data were in accordance with normal distribution,the general linear model-repeated measurement analysis of variance(ANOVA)was used,and when the data did not conform to normal distribution,repeated measurement ANOVA-generalized linear model equation,P<0.05.There was statistical difference.Results1.Baseline comparison.During the baseline period,there was no difference in gender,age,course of disease,education level,acupuncture treatment,PSQI score,HAMD-24 score,SCL-90 depression factor score,SF-36 score between the two groups,but there was comparability between the two groups.2.PSQI score result.(1)intra-group comparison.Compared with before treatment,the PSQI score in the Jing-moxibustion group decreased at the end of treatment and follow-up for 1 month,and the difference was statistically significant(P<0.001),while in the shame moxibustion group,the PSQI score was lower at the end of treatment and 1 month follow-up,which was statistically significant(P<0.001).(2)comparison between groups.At the end of treatment and 1 month of follow-up,there was significant difference in the total score of PSQI between the two groups(P<0.001).Compared with before treatment,the decrease of PSQI score in the Jing-moxibustion group was greater than that in the shame moxibustion group.(3)the results show that.At the end of treatment and follow-up for 1 month,the PSQI evaluation of the two groups was improved compared with that before treatment,and the improvement of PSQI score in the Jing-moxibustion group was better than that in the shame moxibustion group at the end of treatment and follow-up for 1 month.3.HAMD-24 score result.(1)intra-group comparison.In the Jing-moxibustion group,the HAMD-24 score decreased at the end of treatment and follow-up for 1 month,and the HAMD-24 score decreased at the end of treatment and follow-up for 1 month in the shame moxibustion group.(2)comparison between groups.At the end of treatment and 1 month of follow-up,there was significant difference in the total score of HAMD-24 between the two groups,and the decrease of HAMD-24 score in the Jing-moxibustion group was larger than that in the shame moxibustion group compared with that before treatment.(3)the results show that.At the end of treatment and follow-up for 1 month,the HAMD-24 evaluation of the two groups was improved compared with that before treatment,and the improvement of HAMD-24 score in the Jing-moxibustion group was better than that in the shame moxibustion group at the end of treatment and follow-up for 1 month.4.SF-36 score result.(1)intra-group comparison.At the end of treatment and 1 month of follow-up,the SF-36 score of the Jing-moxibustion group was significantly higher than that of the former,and the SF-36 score of the shame moxibustion group was higher than that of the former at the end of treatment and 1 month of follow-up,the difference was statistically significant(P<0.05).(2)comparison between groups.At the end of treatment and 1 month of follow-up,there was significant difference in the total score of SF-36 between the two groups,and the increase of SF-36 score in the Jing-moxibustion group was larger than that in the shame moxibustion group compared with that before treatment.(3)the results show that.At the end of treatment and follow-up for 1 month,the SF-36 evaluation of the two groups was improved compared with that before treatment,and the improvement of SF-36 score in the Jing-moxibustion group was better than that in the shame moxibustion group at the end of treatment and follow-up for 1 month.5.SCL-90 depression factor score:(1)intra-group comparison.At the end of treatment and 1 month of follow-up,the score of SCL-90 depression factor in the Jing-moxibustion group was significantly lower than that before treatment,and the SCL-90 depression factor score in the shame moxibustion group was significantly lower than that before treatment and 1 month follow-up(P<0.05).(2)comparison between groups.At the end of treatment and 1 month of follow-up,there was significant difference in the score of SCL-90 depression factor between the two groups,and the decrease of SCL-90 depression factor score in the Jing-moxibustion group was larger than that in the shame moxibustion group compared with that before treatment.(3)the results show that.At the end of treatment and follow-up for 1 month,the evaluation of SCL-90 depression factor in the two groups was improved compared with that before treatment,and the improvement of SCL-90 depression factor score in the Jing-moxibustion group was better than that in the shame moxibustion group at the end of treatment and follow-up for 1 month.6.Efficiency.At the end of the course of treatment,the total effective rate was 88.57%in the Jing-moxibustion group and 23.33%in the shame moxibustion group,with a significant statistical difference(P<0.01),indicating that the curative effect of the Jing-moxibustion group was better than that of the shame moxibustion group.7.Shedding rate.A total of 70 patients with mild to moderate depression-related insomnia were recruited,and 5 cases fell off in the shame moxibustion group,with a loss rate of 7.14%.8.Safety evaluation.In the course of treatment,there were 3 cases of adverse reactions in the Jing-moxibustion group,there were no adverse reactions in the pseudo-essence moxibustion group,with a total incidence of 4.62%.There was no significant difference in adverse events between the two groups(P>0.05).ConclusionJing-moxibustion is effective and safe in the treatment of mild to moderate depression-related insomnia.The curative effect of the Jing-moxibustion group was better than that of the shame moxibustion group in improving sleep quality,depressive symptoms and quality of life. |
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