| 1.BackgroundPostpartum depression(PPD)is one of the most common mood disorders,of whom depressive symptoms attack between 4 weeks to 12 months after birth.PPD is a subtype of depression,with the same diagnostic standard.Diagnostic standard includes that the same core symptoms occur in the same two weeks,and the core symptoms contain depression,loss of sense of interest,lack of pleasure,the disturbance of sleep and appetite,attention deficits,psychomotor disorders,fatigue,feeling sense of guilt and unworthiness,and suicidal attempts.In China,the incidence of postpartum depression is about 18～35%.PPD not only weakens the social and physical function in patients,it also affects the normal growth and development of the baby and family stability.PPD protracts maternal postpartum recovery time,and some women can’t bear the neonatal nurse daily activities,other even lose their ability to care for themselves.The pathogenesis of postpartum depression is very complex,and it is currently believed that it is mainly related to sex hormones,neurotransmitters,genetic inheritance,neuroimmunity,and social psychological factors.Pharmacy therapy of PPD mainly includes tricyclic antidepressants,Serotonin reuptake inhibitors,serotonin-norepinephrine reuptake inhibitors.Patients with PPD,in postpartum period,often need to lactate,so the use of oral antidepressant is more cautious.The lower dosage,low acceptance of oral antidepressants and poor compliance affect the efficacy of treatment.Acupuncture excels at its security and acceptance,so it can become potential therapy of PPD.According to nowadays researches the acupuncture’s curative effect of depression is remarkable.But to affirming the curative effect of acupuncture of PPD still lacks of high quality clinical research.Hence the curative effect of acupuncture and moxibustion treatment of PPD is still uncertain.To summarize our traditional medical literature,women after delivery often loss a great amount of qi and blood,resulting in PPD.Pathogenesis mainly for liver depression and qi stagnation,deficiency of both qi and blood,heart spirit deprived of nourishment,qi depression transforming into fire.Due to blood loss,qi collapses,so the body down the abnormal.This study intends to compare the clinical efficacy of electro-acupuncture and sham electro-acupuncture combined with psychotherapy in the treatment of mild and moderate PPD,so as to clarify the clinical efficacy of electro-acupuncture in the treatment of PPD.2.ObjectiveTo evaluate the clinical effect of electro-acupuncture combined with psychotherapy in the treatment of mild and moderate postpartum depression.3.MethodsThis study was designed as a prospective,randomized,placebo controlled clinical study.All subjects in this clinical trial were outpatients of Acupuncture and Moxibustion Hospital of China Academy of Chinese Medical Sciences and Beijing Obstetrics and Gynecology Hospital affiliated to Capital Medical University from March 2019 to January 2021.All the patients who met the inclusion criteria signed the informed consent before inclusion.After inclusion,the subjects were randomly assigned to the electro-acupuncture group and the sham electro-acupuncture group in a ratio of 1:1 by simple random method,with 29 cases in electro-acupuncture group and 18 cases in sham electro-acupuncture group,a total of 47 cases.Patients in both groups received basic treatment:supportive psychotherapy,45 to 60 minutes once a week for 6 weeks,for 6 sessions.In the electro-acupuncture group,the selected acupoints include Baihui,Yintang,Anmian,Xinshu,Geshu,Ganshu and Shenshu.After obtaining qi,electrodes of the electro-acupuncture apparatus would be connected to the needle handle at Baihui and Yintang acupoints respectively.The density wave was selected with a frequency of 2Hz～100Hz,and the therapy lasts 20～30 minutes.The electro-acupuncture group selected the non-acupoint area of Baihui,Yintang,Anmian,Xinshu,Geshu,Ganshu and Shenshu acupoints.Needles would be punctured shallowly without obtaining qi.The needles handle of Baihui and Yintang acupoints would be connected to the electrode of the electro-acupuncture apparatus respectively,without electrifying,the therapy lasts 20～30 minutes,twice a week for 6 weeks.Specialized staffs were in charge of evaluation,data collection,input and analysis.The primary outcome measure were the difference between the 17 items of Hamilton Depression Scale before and after treatment,and the overall response rate.Secondary efficacy measures were the difference between the baseline period and the end of treatment with the Self-Rating Depression Scale,the Self-Rating Anxiety Scale,Edinburgh Self-Rating Postpartum Depression Scale,and the Barking Maternal Function Scale.The measurement nodes were at the time of enrolment(baseline),2nd week of treatment,4th week of treatment,and the end of treatment of treatment(6th week).4.Result4.1 Baseline dataThe data of patients in electro-acupuncture group and sham electro-acupuncture group,like the course of the disease,age,delivery method,culture level,the scores of Hamilton’s 17-item depression scale,the Self-Rating Depression Scale,the Self-Rating Anxiety Scale,Edinburgh Self-Rating Postpartum Depression Scale,and the Barking Maternal Function Scale were no statistically significant difference(P>0.05).So two groups of baseline were comparable.4.2 The primary outcome measures4.2.1 Hamilton’s 17-item depression scale scores Intra-group comparison:The scores of the two groups at the 2nd week,4th week and the 6th week had significant statistical significance compared with the baseline data(P<0.01).The scores of the electro-acupuncture group before and after treatment were 15.46±4.13 and 6.64±4.03,respectively,and those of the sham electro-acupuncture group were 14.86±4.70 and 4.86±2.88.Comparison between groups:There was significant difference in scores between two groups at the 4th of treatment(P>0.05).But there was no difference in different values in any valuation codes between two groups.The different values of electro-acupuncture group was 8.82±3.65 before and after treatment,and the sham electro-acupuncture group was decreased by 10.00±3.96 before and after treatment.4.2.2 Overall Respose RateThe overall response rate of electro-acupuncture group and sham electro-acupuncture group were 92.86%and 100.00%respectively,and there was no statistical significance between the two groups(P>0.05).4.3 The secondary outcome measures4.3.1 The Edinburgh Self-Rating Postpartum Depression Scale Intra-group comparison:Compared with the baseline period,the scores of the electro-acupuncture group and the sham electro-acupuncture group showed statistically significance at the 4th week 6th week(P<0.01).The scores of the electro-acupuncture group before and after treatment were 17.59±4.16 and 10.18 ± 5.40,respectively,and those of the sham electro-acupuncture group were 17.28 ±4.85 and 7.86 ± 5.92,respectively.Comparison between groups:There was significant difference between two groups’ different values and scores at the 4th week of treatment(P<0.05).The different values between electro-acupuncture group and sham electro-acupuncture group before and after treatment were 7.04±6.20 and 9.21±6.05.4.3.2 Self-Rating Depression ScaleIntra-group comparison:The scores of the electro-acupuncture group at 2nd,4th,6th week of treatment showed statistically significant difference compared with the baseline period(P<0.05).There was statistically significant difference between the scores of the sham electro-acupuncture group at the 4th and 6th week of treatment and the baseline period(P<0.05),,showing statistically significant difference between scores before and after treatment(P<0.01).The scores of the electro-acupuncture group before and after treatment were 61.03±7.75 and 51.63±12.58,respectively,and those of the sham electro-acupuncture group were 55.54±9.20 and 43.79±11.43,respectively.Comparison between groups:At the 4th week of treatment,the different values of two groups were with statistical significance(P<0.05).Scores of the sham electro-acupuncture group were lower than that of the electro-acupuncture group.And the difference value of electro-acupuncture group and sham electro-acupuncture group before and after treatment were 9.40±8.83 and 11.75±10.15 respectively.4.3.3 Self-rating Anxiety ScaleIntra-group comparison:The scores of the electro-acupuncture group and the sham electro-acupuncture group at the 4th and 6th week of treatment had statistically significant differences compared with the baseline period(P<0.05).The scores of the electro-acupuncture group before and after treatment were 53.96±8.32 and 45.65±10.31,and those of the sham electro-acupuncture group were 50.89±8.90 and 43.79±8.94,respectively.Comparison between groups:There was no statistical significance in the scores and different values of the two groups at any evaluation code(P>0.05).The difference value of before and after treatment was 8.30±8.56 in the electro-acupuncture group,and 7.11±8.37 in the sham electro-acupuncture group.4.3.4 Barkin Index of Maternal FunctioningIntra-group comparison:There were statistically significant differences in scores of two groups at the end of 4th and 6th week of treatment compared with the baseline period(P<0.05).The scores of the electro-acupuncture group before and after treatment were 70.89±15.76 and 81.29±17.40,and those of the sham electro-acupuncture group before and after treatment were 78.07± 13.54 and 88.29±15.33.Comparison between groups:There were no statistically significant differences of different values and scores between two groups at any evaluation codes(P>0.05).The difference value of before and after treatment was-10.39±12.90 in the electro-acupuncture group,-10.21±12.13 in the sham electro-acupuncture group.5.ConclusionElectro-acupuncture group and sham electro-acupuncture group have significant curative effect on postpartum depression.Based on current incomplete data,there was no significant difference in the curative effect between electro-acupuncture group and sham electro-acupuncture group so far,but the final conclusion need further verification. |
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