| Research BackgroundMajor Depression (MD) is a kind of mental illness with significant and lasting depressed mood as the main feature, mainly expressed as depressed mood, loss of pleasure, thinking slowly, volitional activities decline, cognitive dysfunction and somatic symptoms. Major depression ranks fourth on the list of disorders withthe highest burden of disease worldwide, and will be the second leading cause of disease burdenworldwide by2020, according to the Global Burden of DiseaseStudy. It is expected to beranked first in high-income countries by2030. The effectiveness of newer anti-depressantsfor mild to moderate depression has recently come under question. Patients have been concerned about over-reliance onprescribed antidepressant medications and are keen to have accessto non-pharmacological treatment options.Lots of researches confirmed that the effect of acupuncture treatment on depression is remarkable, at the same time it hasless side effects.On the basis of previous research, this study preliminary exploreon the basis principle of Real World research (Real World Study, RWS), comprehensively observeand evaluate the clinical effectiveness of acupuncture treatment on depression and the quality of life of patients with depression and the correlation between the degree of depression and life events.PurposeThis study designed based on Real World Study(RWS) ideas to make sure the electroacupure’s (EA) exact clinical advantages in treating depression.Based on the efficacy confirmation of EA on depression, to detectthe effectivenessof EA on HAMD-24(via evaluating the reduce score rate of7factors of HAMD), QOL before and after treatment, to analysis the correlation between life events, QOL and depression degree. To evaluate and discover the clinical value of EA’s antidepressant effectivenesscomprehensively and extand the clinical advantages of EA. Hope to get closer to real life and offer better service for patients.MethodsResearch was conducted from March2013to March in2014in the Dongfang Hospital and the sixth Hospital of Peking University.60depression cases were collected,5cases fell off and55cases were observed actually. Patients were divided into EA group (n=32) and western medicine group (n=23)according to their intentions and intervention last for8weeks.EA group selected main point combined with some other points according to different condition, the western medicine group chooseSSRIs. Hamilton Depression Scale (HAMD-24), the Universal Quality of Life Assessment Scale (SF-36), Life Event Scale (LES), Colombia Suicide Rating Scale (C-SSRS) were evaluatedfor each patient. Follow-up was carried out at4weeks after the treatment and HAMD-24and SF-36were used to evaluate long-term efficacy.Results1EAgroup and antidepressant groupwere comparable at baseline. Distribution of gender,age and HAMD-24scores showed no significant difference (P>0.05).2After8weeks intervention, the total effective rate of EA group and antidepressant group were100%and91.3%respectively, chi-square test showed no significant difference between two groups(p=0.170>0.05).3The results of general linear model repeated measures analysis of variance (GML) for HAMD-24score on different time pointsshowed that EA group and ntidepressant group HAMD-24score at different time points were significantly different (p=0.000<0.01), the interaction between treatment and time hassignificantdifference(p=0.011<0.05), while the difference between two groups was not significantly different (p=0.078>0.05).4Inner-group comparition and inter-group comparitionbetween two groupswere carried out on7factors of HAMDrespectively via the method of GML. Inner-group comparison results showed:EA group and western medicine group’sscore of anxiety/somatization, weight, cognitive impairment, diurnal variation,retardation, sleep disorders, hopelessness factors scores hadsignificant difference at different time points (p<0.05), and anxiety/somatization, diurnal variation, sleep disorders factors had time and treatment interaction(p<0.05). Inter-group comparition showed:EA group and western medicine group’sscore of anxiety/somatization, weight, hopelessnessfactorshad significant difference (p<0.05).5The results of Clinical Global Impression Scale(CGI) score statistics indicatedthere was no significant difference at baseline (P>0.05).After eight weeks intervention, SI score in two groupshas significantly difference (P<0.05), the severity of the disease of EA group was significantly lower than the western medicine groupafter treatment. Overall efficacy of two groups (GI) was different(P<0.05), EA group wasbetter than western medicine group. Efficacy index(EI) in both groups wassignificant different (P<0.001), EA group was significantly better than thewestern medicine group.6Statistical resultsof SF-36scale showedthat both EA and western medicine could improve depression patients’QOLsignificantly (p<0.001). There was no significant difference in electric-acupuncture group and western medicine group on improving overall QOL (p>0.05).Non-parametric textwas used to evaluated scores in eight domains of QOL, the inner-group comparison (Wilcoxon test) showed that EA treatment could increase the scores of physiological functions, body pain, general health, vitality, social function, role emotional and mental health significantly (p<0.05), and western medicine could increase scores of physiology, physical function, general health, vitality, social function, role emotional and mental health significantly (p<0.05). Inter-group comparison of two groups (Mann-Whitney test) showed that scores of EA and western medicine had significant differencein physiological function, body pain and general health domains (p<0.05).GML statistical analysis showed that depression patients’QOL scores in EA group and western medicine group at different time points (before and after treatment, follow-up) were significant different (p<0.01) and there was no significant interaction (p>0.05). Comparison between two groups, QOL scores was not significantly different (p>0.05).7Life Event Scale (LES) statistics showed that there was no significant difference in the total amount of life events stimulation before and after treatment, and there was nocorrelationbetween HAMD-24scores and the reducing scores of life events stimulation (p>0.05).8Correlation analysis of QOL related factors indicated that there was significant difference between EA and western medicine in improving seven factors of HAMD-24and eight domains of SF-36before and after treatment (p<0.05). What’s more, patients’age and duration of depression also relative to the improved degree ofQOL’sdifferent domains (p<0.05). While life events stimulation had no correlation with each domains of QOL (p>0.05).9Adverse events statistics showed that the incidence of adverse events in EA group and western medicine group was significantly different (p=0.000<0.01), medicine group were significantly higher than the EA group.Conclusions:1After8weeks of intervention, both EA and5-HT antidepressantsare effective for depression and there was no significant difference between two groups.2After8weeks of intervention, EA and5-HT antidepressants could improve degree of cognitive impairment, diurnal variation, retardation and sleep disturbance significantly, and no significant difference between EA and5-HT antidepressants. EAis better than5-HT antidepressants in improvingthe degree of anxiety and depression/somatization and long-term effects are also better. So for depression patients with serious somatic symptoms, EA is better choice.3Both EA and5-HT antidepressants can improve depression patients’ QOL. EA is better than5-HT antidepressants in improvingbody pain and5-HT antidepressant is better than EA in improving physiological function. 4There was no significant correlation between life events and the degree of depression. It’s inadequate todetermine the degree of depression simply according to the amount of life events stimulation.5EA and5-HT antidepressantshave different improve degrees of corration between seven factors of HAMD-24and eight domains of SF-36. EA and5-HT antidepressants as two different interventions,can improve levels of depression and QOL differently. |
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