Integrate Acupuncture Plan For The Somatic Symptoms In Patients With Depression:a Real-World Study

ObjectivesTo estimating and integrating the effectiveness and safety of integrate acupuncture plan,and to value their improvement of living quality while treating depression patients.According to the real-world study and contrast between paroxetine as control.MethodsSource of casesThe research was design as the real-world study.All the 72 patients who is suffering from depression up to standard came from the outpatient department of Guangdong Hospital of TCM.In order to meet their actual needs and subjective wishes,the patients were divided into acupuncture group（32 cases）and drug treatment group（40 cases）.Treatments1.integrative treatment group1.1 The prescription:acupuncture:LI4,L3,S20,S22;abdomen acupuncture:RN12,RN10,RN6,RN4,ST24;moxibustion:BL17,BL21,directly moxibustion by twice for each acu-point.;intradermal acupuncture:BL20 and BL15.1.2 Syndrome differentiation treatment of TCM:A)stagnation of liver qi:basic intervention with no increase.B)qi depression transforming into fire:add pricking collateral blood therapy:take the bilateral BL20and BL15C)phlegm stagnation:Moxibustion on RN12 for twice more and intradermal needle in BL13.D)heart-spleen deficiency:Moxibustion on ST36 and additional intradermal needle in BL22.E)heart-kidney imbalance:Moxibustion on KI1 and additional intradermal needle in BL25F)heart-gallbladder disorder:Moxibustion on GB45 and additional intradermal needle in BL211.3 Acu-piont destination:refer to<nomenclature and location of acupuncture points>which is the National standards of the People’s Republic of China published in 2006（GB/T12346-2006）.1.4 Operation:refer to<Standardized manipulations of acupuncture and moxibustion>which is the National standards of People’s Republic of China published in 2008（GB/T21709.4-2008）.Patient in the supine position,use the performer and finger skin after disinfection,acupoints in three quick into a needle,needle into the depth depends on the acupuncture point parts,body fat,each meridian;much air twisting retaining needle for 30 minutes,the whole tell patients with nasal breathing air.Tell patients take a break after a needle,without discomfort told the patient prone position,four flower hole skin local with purple flower oil,then put the bottom diameter 2 mm x height of 3 mm moxa wick paste on it,since their cutting-edge lit,with joss stick in local skin flush,burning pain remove and replace the other ai wick,2 per hole a bit strong.Dry the moxibustion after finishing with cotton swab.After disinfecting the skin of both sides of the heart and liver,the needle was inserted into the acupoint skin with forceps.Cover and paste in the direction of the needle from the end of the needle.The intervention was performed twice a week for more than 48 hours.8 times（4 weeks）for one course.There were two courses of treatment.2.control groupParoxetine hydrochloride was used in the control group,and the initial dose was 20mg Po qd.After 2-3 weeks,the dose could be increased by 10mg per week according to the patient’s reaction.The daily maximum was not greater than 50mg.The total courses were8 weeks.Times of evaluations and indications.The study used the SCL-90 symptom scale,Hamilton depression scale（HAMD）and SF-36 living quality score to compare the variation within groups and between groups in curative effects before the first treatment,by the end of the 1^st course of treatments,by the end of the 2^nd course of treatment,and one month after the end of treatments.At the same time,we recorded the adverse reactions and side effects in the study.statisticalSelect the appropriate statistical analysis method according to the nature of clinical trial data（measurement data,categorical data and grade data）.Analyze categorical data by chi-square test or the exact probability method.Using t test to analyze the measurement date after normality test and f test.Analyze the variation between different time points in the group by repeated measures analysis of variance.Results1.baselineComparative analysis before acupuncture group and drug group treatment indicated that:between age（P=0.717）,gender（P=0.223）,marital status（P=1.000）,the course of the disease（P=0.184）,family history（P=1.000）,allergic history（P=0.453）,the classification of traditional Chinese medicine（P=0.053）,SCL-90 dimension of somatization（P=0.713）,dimension of depression（P=0.700）,HAMD scores（P=0.091）and SF-36 measurement（P=0.692）,there was no obvious difference between all the two-groups patients.They are comparable.2.SCL-90 score.At the end of the treatments,the SCL-90 scale of somatic dimension and depression dimension showed a decrease trend within two groups of patients.The scores of somatization and depression of the patients with drugs showed an upward trend during the follow-up period,while the acupuncture group were generally unchanged.Compare within groups:somatization levels:Analysis of variance of repeated measures indicated that there was a statistically significant difference in time dimension（P<0.01）and in group dimension（P<0.01）respectively.there was a statistically significant difference between the two groups after interacting treatment with time（P<0.01）.Depression levels:Analysis of variance of repeated measures indicated that there was a statistically significant difference in time dimension（P<0.01）and in group dimension（P<0.01）respectively.there was a statistically significant difference between the two groups after interacting treatment with time（P<0.01）.Comparison between groups:at the end of the first course,there was no statistical difference between the acupuncture group and the drug group in depression and somatic dimensions（P=0.991）,（P=0.658）.At the end of the second course,there was a statistically significant difference between the acupuncture group and the drug group in somatization and depression（P<0.01）.During the 1month follow-up,there was a statistical difference between the acupuncture group and the drug group in somatization score（P<0.01）,and no statistical difference in depression dimension（P=0.099）.The results showed that both the integrated acupuncture group and paroxetine group could improve the depressive mood and somatic symptoms.The overall effect of the integrated acupuncture treatment was better than that of paroxetine.The efficacy of the two groups is similar on the depression dimension.On the somatic symptoms dimension,integration of acupuncture and moxibustion began to work after 8 treatments（4 weeks）,and the long-term curative effect is better than that of paroxetine.3.HAMD scoreAt the end of the first course of treatment,the two groups had declining scores of the simple HAMD scale than before.At the end of the second course of treatment and during the 1month follow-up,the scores of the drug group showed an upward trend while the scores of the acupuncture group continued to decline.Compare within groups:Analysis of variance of repeated measures indicated that:on time dimension there was a statistically significant difference between the two groups（P<0.01）;on group dimension there was no statistical difference between the two groups（P=0.447）;there was a statistically significant difference between the two groups after interacting group with time（P<0.01）.Comparison between groups:at the end of the first course,there was a statistically significant difference between the acupuncture group and the drug group（P<0.05）.At the end of the second course,there was no statistical difference between the acupuncture group and the drug group（P=0.122）.There was a statistically significant difference between the acupuncture group and the drug group during the 1month follow-up（P<0.01）.The results showed that both of acupuncture and paroxetine can improve the depressive state of patients according to HAMD score improvement.Paroxetine began to work in 4 weeks.But rebound phenomena was observed after withdrawal of medication.Acupuncture treatment was effective after 8 treatments（4 weeks）,and the continuous effect was better than that of paroxetine.4.SF-36 scaleTwo sets of scores showed an upward trend after the end of the first course of treatment.At the end of the second course of treatment,the score of the drug group was lower than before.The score of acupuncture group was still on the upward trend.Comparison between groups:at the end of the first and second courses,there was no statistical difference between the acupuncture group and the drug group（P=0.421）,（P=0.091）.There was a statistically significant difference between the acupuncture group and the drug group（P<0.05）.The results showed that in terms of quality of life improvement,the efficacy of integrated acupuncture was better than that of paroxetine.5.EfficiencyThe total effective rate of acupuncture group and drug group at the end of treatment was 75%and 57.5%respectively.And the total effective rate of the two groups was no statistically significance.It shows that the efficacy of integration of acupuncture and moxibustion is comparable to that of paroxetine in treating depression.6.Shedding rate72 patients were recruited in this study in total.32 in the acupuncture group and40 in the drug group.All the course of treatment Completed without shedding.7.Adverse reactionsAmong the patients in the drug group,9 patients showed nausea（22.5%）,5 patients had xerostomia（12.5%）,and 3 patients experienced dizziness（7.5%）.The results were evaluated as a common adverse reaction of paroxetine,and the trial was carried out after treatment.No adverse reactions were observed in the remaining patients.The main adverse reactions of the patients in the acupuncture group were small blisters in the acupoints,which could be relieved by themselves after 1 week,and the trial was carried out smoothly.conclusion1.Integration of acupuncture and moxibustion can effectively treat depression.Its efficacy in improving depression mood and life quality is equal to that of paroxetine.At the same time,its efficacy in improving somatization symptoms is better than that of paroxetine.2.Paroxetine obtained onset time than that of integrated acupuncture plan,while integrated acupuncture plan obtained better lasting effects than that of peroxetine.