| ObjectiveBy using randomly controlled clinical studying method,and comparing with sham acupuncture group,the study will evaluate the early efficacy of soothing-liver and regulating-mentality integrated acupuncture plan in the treatment of patients with mild depression and explore the antidepressant effect of soothing-liver and regulating-mentality integrated acupuncture plan in the early treatment.MethodsAccording to the Chinese classification and diagnostic criteria for mental disorders 3rd Edition(CCMD-3),sixty seven patients with depression recruited from acupuncture clinic and psychosomatic disease department of Guangdong Provincial Hospital of traditional Chinese medicine were randomly divided into soothing-liver and regulating-mentality group(34 cases)and sham acupuncture group(33 cases)by using SPSS25.0 software from July 2019 to December 2020.Treatment planOperation1.Soothing-liver and regulating-mentality group Points:Acupuncture:GV20,GV29,LI4,LR3,CV12,CV10,CV6,VC4.Exquisite moxibustion:BL17,BL19.Needle-Embedding Therapy:BL15,BL18.Positioning standard:refer to the 2006 national standard of the People’s Republic of China(GB/T 12346-2006)Names and localization of acupoints.Acupuncture:The patient was in supine position,fully exposing the skin.After the selected points were disinfected with iodine volts,GV20 and GV29 were acupunctured at an angle of 30 °to the skin,and the other points were punctured directly.According to the patient’s age,weight and physical strength,the depth of acupuncture was determined.The needle was retained for 30 minutes after getting Qi.Exquisite moxibustion:After the acupuncture treatment,the patient was placed in the prone position to fully expose the skin of BL17 and BL19 on the back.The moxa cone with a diameter of 2mm*a height of 3 mm on the bottom surface was placed on the point coated with Wanhua oil and ignited with thread incense.The moxa cone can be take away when the patient feels slight burning pain or skin flushing.2 per each points.Needle-Embedding Therapy:The patient continued to take the prone position and fully exposed the skin of BL15 and BL18.After routine disinfection of points,clamp the handle of wheat grain type intradermal needle with forceps,puncture the points horizontally along the subcutaneous direction from the outside to the spine,insert all the 5mm body of intradermal needle,leave the handle outside the skin,first stick a 5*5mm medical adhesive tape between the handle and the skin,and then cover the handle and the needle body with a 15*15mm medical adhesive tape,and ask the patient to take it off after 2 days.2.Sham acupuncture groupPoints and Positioning standard:Same as Soothing-liver and regulating-mentality group.Acupuncture:The patient was in supine position,fully exposing the skin.After routine disinfection,1cm2*1cm plastic foam was applied to the surface of the point,and 1 inch flat headed needles were pierced directly through the plastic foam pad to the skin.The needle was retained for 30 minutes.Exquisite moxibustion:After the acupuncture treatment,the patient was placed in the prone position to fully expose the skin of BL17 and BL19 on the back.The moxa cone with a diameter of 2mm*a height of 3 mm on the bottom surface was placed on the point coated with Wanhua oil.The thread incense come near the moxa cone,but it does not ignite,then takes the moxa cone away.2 per each points.Needle-Embedding Therapy:The patient continued to take the prone position and fully exposed the skin of BL15 and BL18.After routine disinfection of points,a 5*5mm medical adhesive tape was affixed to the points,and then the blunt scalp internal needle was placed on the adhesive tape.The tip of the needle was flush with or slightly beyond the edge of the medical adhesive tape,but it did not penetrate the skin.Finally,the intradermal needle was covered with a 15*15mm medical adhesive tape,and retained for 2 days.The patients can remove them by themselves.Course of treatmentThe treatment cycle was 4 weeks,3 times a week,a total of 12 times.Evaluation time and indexHAMD-24 and QIDS-SR16 were evaluated before treatment,1 week after treatment.2 weeks after treatment and at the end of treatment.SF-12 was evaluated before treatment and at the end of treatment.The adverse reactions and side effects during the study were recorded.StatisticsSpss25.0 statistical software package was used to establish the database for data cleaning,checking and statistical analysis.Chi square test was used to compare the count data,rank sum test was used to compare the rank data,and measurement data were described by mean± standard deviation.T test was used for data that met the normality test and homogeneity test of variance.Independent sample t test was used for inter group comparison,and paired t test was used for intra group comparison.If the normality and homogeneity of variance are not satisfied,rank sum test is used.Repeated measurement data were analyzed by repeated measurement analysis of variance.Results1.BaselineThere were 67 patients in this study,including 5 cases of shedding and 62 cases of effective cases.There were 32 cases of soothing-liver and regulating-mentality group and 30 cases of sham acupuncture group.There were no significant differences(P>0.05)in age(P=0.893),gender(P=0.537),educational background(P=0.970),course of disease(P=0.236),HAMD-24 score(P=0.189),QIDS-SR16 score(P=0.640),SF-12 physical health score PCS(P=0.966)and SF-12 mental health score MCS(P=0.602)between the two groups before treatment.2.HAMD-24 scoreAt the end of treatment,HAMD-24 scores of the two groups were decreased compared with those before treatment.Comparison between groups:After one week of treatment,there was significant difference between the soothing-liver and regulating-mentality group and the sham acupuncture group(P=0.024);After two weeks of treatment,the scores of the soothing-liver and regulating-mentality group were significantly lower than those of the sham acupuncture group,and there were significant differences between the two groups(P=0.006);At the end of treatment,the score of the soothing-liver and regulating-mentality group was significantly lower than that of sham acupuncture group(P=0.000).Intra group comparison:After one week,two weeks and the end of treatment,the scores of the soothing-liver and regulating-mentality group were significantly different from those before treatment(P<0.01);After one week,two weeks and the end of treatment,the scores of sham acupuncture group were significantly different from those before treatment(P<0.01).The results showed that the scores of HAMD-24 in the soothing-liver and regulating-mentality group and the sham acupuncture group were significantly improved,and the improvement effect of the soothing-liver and regulating-mentality group was better than that of the sham acupuncture group.3.QIDS-SR16 scoreAt the end of treatment,the QIDS-SR16 scores of the two groups were lower than those before treatment.Comparison between groups:After one week of treatment,the QIDS-SR16 scores of the soothing-liver and regulating-mentality group and the sham acupuncture group decreased compared with those before treatment,and there was significant difference between the two groups(P=0.036);After two weeks of treatment,both groups showed the downward trend,and there was a significant difference between the two groups(P=0.016);At the end of treatment,both groups showed a downward trend,and there was a significant difference between the two groups(P=0.024).Intra group comparison:After one week,two weeks and the end of treatment,the scores of the soothing-liver and regulating-mentality group were significantly different from those before treatment(P<0.01);After one week,two weeks and the end of treatment,the scores of sham acupuncture group were significantly different from those before treatment(P<0.01).The results showed that the scores of QIDS-SR16 in the soothing-liver and regulating-mentality group and the sham acupuncture group were significantly improved,and the improvement effect of the soothing-liver and regulating-mentality group was better than that of sham acupuncture group.4.SF-12 scoreAt the end of treatment,SF-12 scores of the two groups showed an upward trend.Comparison between groups:At the end of treatment,PCS scores of the soothing-liver and regulating-mentality group and the sham acupuncture group increased compared with those before treatment,and there are no significant differences between the two groups(P=0.693);MCS scores of the two groups increased compared with those before treatment,with no significant differences between the two groups(P=0.392).Intra group comparison:The scores of PCS in the soothing-liver and regulating-mentality group at the end of treatment were significantly different from those before treatment(P=0.011).Compared with the MCS score before treatment,the difference was statistically significant(P=0.000).The scores of PCS in the sham acupuncture group at the end of treatment were significantly different from those before treatment(P=0.016).Compared with the MCS score before treatment,the difference was statistically significant(P=0.000).The results showed that the SF-12 scores of the soothing-liver and regulatingmentality group and the sham acupuncture group were significantly improved,and the improvement degree of the two groups was similar.5.EfficiencyAfter two weeks of treatment,the total effective rate was 87.50%in the soothing-liver and regulating-mentality group and 70.00%in the sham acupuncture group,and there were significant differences between the two groups(P<0.01);At the end of treatment,the total effective rate was 90.63%in the soothing-liver and regulating-mentality group and 66.67%in the sham acupuncture group,and there were significant diferences between the two groups(P<0.01).The results showed that the curative effect of the soothing-liver and regulating-mentality group was better than that of the sham acupuncture group after two weeks of treatment and at the end of treatment.6.Shedding rateIn this study,67 subjects were included,including 34 cases in the soothing-liver and regulating-mentality group,33 cases in the sham acupuncture group,and 5 cases of shedding.The total shedding rate is 7.46%.There were 2 cases of shedding in the soothing-liver and regulating-mentality group,with a shedding rate of 5.88%,and 3 cases of shedding in the sham acupuncture group,with a shedding rate of 9.09%.7.Adverse reactionsNo treatment-related adverse reactions were reported during this study.ConclusionThe soothing-liver and regulating-mentality acupuncture integrated acupuncture plan can significantly improve the depressive symptoms and quality of life of patients with mild depression.In terms of improving depressive symptoms,the soothing-liver and regulating-mentality acupuncture integrated acupuncture plan can take effect after one week of treatment,and the curative effect is significantly better than that of sham acupuncture. |
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