| 1.Research backgroundThe incidence rate of depression is 4.4%,and the lifetime prevalence rate is 10.8%,seriously endangering human physical and mental health.Commonly used clinical antidepressants mainly serotonin recycling inhibitors(SSRIs),serotonin and norepinephrine recycling inhibitors(SNRIs),its early adverse reactions such as dizziness,nausea,vomiting,and slow onset,mostly 2～8 weeks,a large number of patients due to early adverse reactions and lag and affect treatment.Reports of modern traditional Chinese medicine treatment of depression are also constantly appearing.Traditional Chinese medicine compound has good advantages in the treatment of mild and moderate depression.At present,many studies have proved that the separate use of traditional Chinese medicine decoction for mild-to-moderate depression has definite effect and few adverse reactions.Based on the main pathogenesis of the heart-spleen deficiency,establish the Jianpi Jieyu decoction.The composition of Astragalus 30g,Dangshen 12g,Angelica 12g,Fu Shen 30g,Wild jujube kernel 15g,Bupleurum 10g,Albizzia bark 20g,Gardenia 10g.The early clinical practice of this party found that the healthy spleen and depression can improve the symptoms of depression,lack of joy,fatigue and other symptoms in patients with mild and moderate depression,and no obvious adverse reactions were seen in clinical observation.This study adopted a randomized controlled research method,using the positive drug paroxetine as a control,to evaluate the efficacy and safety of healthy spleen depression in the treatment of mild to moderate cardiosplenic depression,which provided a reference for the treatment of depression in traditional Chinese medicine.2.Clinical study2.1 objectiveTo evaluate the efficacy and safety of the Jianpi Jieyu decoction in treating patients with mild-to-moderate depression and heart-spleen deficiency.2.2 methodThis study using stratified randomized control method,meet the inclusion criteria of mild-to-moderate depression and heart-spleen deficiency patients with 140 cases,including control group and 70 cases,all study subjects from May 2017-December 2019 in China Xiyuan hospital academy of traditional Chinese medicine sciences encephalopathy(100 cases)and Botou hospital of traditional Chinese medicine encephalopathy(40 cases).Patients with mild-to-moderate depression with heart-spleen deficiency were randomly divided into TCM group and control group.The TCM group was given the Jianpi Jieyu decoction orally,and the control group was given paroxetine orally.The primary efficacy measure was the change in the Hamilton Depression Scale-17(HAMD-17)score from baseline to 6 weeks of treatment.Secondary efficacy measures were effective rate(reduction of HAMD-17 score at 6 weeks versus 50%at baseline)and changes in Hamilton Anxiety Scale(HAMA)and TCM symptom score scores.HAMD-17,HAMA and TCM were evaluated at the baseline,on the fourth and sixth weekend;the adverse effects were recorded by the side reaction scale(TESS).SPSS26.0 software is used for statistical analysis.The measurement data is expressed in mean ± standard deviation.If it conforms to the normal distribution,it is tested by t-test,and if it does not conform to the normal distribution,the rank sum test is used.The counting data describes the frequency and percentage,and the chi-square test is used.P≤0.05 indicates that there is a statistical difference.2.3 result2.3.1 General data analysisA total of 140 patients with mild-to-moderate heart-spleen deficiency depression met the inclusion criteria,70 in the Jianpi Jieyu decoction group and 70 in the paroxetine group.Among them,9 cases of paroxetine group shedding,the shedding rate was 12.8%.There was no significant difference between age,sex,nature of work,family genetic history(P>0.05).2.3.2 Baseline analysisThere was no significant difference between the two groups in total HAMD-17 score,each factor score of HAMD-17,total HAMA score,TCM symptoms points,and disease severity(P>0.05).2.3.3 Efficacy outcomes2.3.3.1 The primary outcomeThe change of HAMD-17 score from baseline to weekend 6 was-(10.19±4.0)in the TCM group and-(10.56±3.65)in the control group,with no significant difference(P>0.05).2.3.3.2 Secondary outcomes2.3.3.2.1 Efficacy analysis of HAMD-17The total effective rate of the Chinese medicine group was 60%,the clinical cure rate was 45.71%,and the control group was 5 7.38%and 34.43%,respectively.There was no statistically significant difference between the total effective rate and clinical cure rate of the two groups(P>0.05).There was a statistically significant difference between the two HAMD-17 scoring groups at the weekend of the drug treatment(P<0.05).After 2 weeks of medication,the change value of HAMD-17 score in the Chinese medicine group was-(4.33±3.79),and the change value of HAMD-17 score in the Western medicine group was-(3.03±2.29).The difference was statistically significant(P<0.05)in comparison between the two groups of HAMD-17 score decline values.There was no statistically significant difference between the hamd-17 scoring values at the 4th and 6th weekend of treatment(P>0.05).There was no statistically significant difference between the two groups comparing the decline in HAMD-17 scores at 4 and 6 weeks of administration(P>0.05).The HAMD-17 scores of the two groups were significantly different from baseline to week 2,week 4,and week 6 of treatment(P<0.0001).The two groups of HAMD-17 factors were treated for 6 weeks and the change value group,and the difference was not statistically significant(P>0.05).The difference between the two groups of HAMD-17 factors in each field was compared with the pre-treatment group for 6 weeks(P<0.0001).2.3.3.2.2 Efficacy analysis of HAMAThe total efficiency of the TCM group was 91.43%,the clinical cure rate was 20%,and the control group was 90.16%and 8.2%respectively.Compared with the total efficiency and clinical cure rate of the two groups,the difference was statistically significant(P>0.05).Group comparison of HAMA score values at baseline,treatment week 2,4,and 6 was not statistically significant(P>0.05).HAMA scores varied significantly from baseline to comparisons within the group at week 2,week 4,and week 6 of treatment(P<0.0001).There was no statistical significance between the two groups at 2,4 and 6 weeks when the drug was used(P>0.05).The change of HAMA score from baseline to weekend 6 was-(8.06±3)in the TCM group;control group was-(7.93±3.48),There was no statistically significant difference(P>0.05).2.3.3.2.3 Analysis of total points of TCM symptomsThe baseline change of TCM symptom integrals from the Chinese medicine group to the 6th weekend was-(11.37±5.07),and the change value of The Western medicine group was-(11.87±6.01),and the difference in the decrease in TCM symptom integrals between the two groups was not statistically significant(P>0.05).There was no significant difference between the two groups of TCM symptom integration treatment for 2 weeks,4 weeks and 6 weekends(P>0.05).The differences between the two groups before and after 6 weeks of treatment were statistically significant(P<0.05).2.4 Clinical Overall Impression Table(CGI)analysisThe severity of disease,total efficacy and treatment effect were analyzed,and the difference was not significant(P>0.05).2.5 Safety evaluationFrom baseline to weekend 6,both groups showed no abnormalities in blood routine,urine routine,stool routine,liver and kidney function,and electrocardiogram.After 6 weeks of treatment,the incidence of adverse effects was 22.86%in the control group and 7.14%in the TCM group,there was a significant difference in the incidence of adverse reactions between the two groups(P<0.05).3.Conclusions(1)The efficacy of The Jianpi Jieyu decoction in improving with mild-to-moderate depression and heart-spleen deficiency is comparable to that of the antidepressant paroxetine.(2)The early efficacy of The Jianpi Jieyu decoction in improving with mild-to-moderate depression and heart-spleen is better than paroxetine.(3)The Jianpi Jieyu decoction can improve the anxiety symptoms associated with mild-to-moderate depression and heart-spleen.(4)The incidence of adverse reactions in the treatment of mild-to-moderate depression and heart-spleen with The Jianpi Jieyu decoction is significantly lower than that of paroxetine.(5)The Jianpi Jieyu decoction prescription medication compliance is better than paroxetine. |
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