A Randomized Controlled Study Of The Efficacy,Safety And Compliance Of Integrated Traditional Chinese And Western Medicine In Patients With Community Depression Disorder

Objective:This study investigated the effective protocols for combining Chinese and Western medicine in the treatment of patients with depressive disorders in the community based on the effectiveness and safety of Traditional Chinese medicine(TCM),Western medicine treatment,and combined Chinese and Western medicine treatment,as well as patient compliance with treatment.To explore the correspondence between the Western clinical symptom clusters of depressive disorders and the syndrome pattern of TCM.Methods:310 patients with community depressive disorder were randomly divided into Western medicine group,TCM group and combined Chinese and Western medicine group,receiving escitalopram or duloxetine alone,Shugan Jieyu Capsules alone and combined with Shugan Jieyu Capsules escitalopram or duloxetine,respectively,for 8 months.The Montgomery-Asberg Depression Rating Scale(MADRS),Hamilton Depression Scale(HAMD),and Hamilton Anxiety Inventory(HAMA)were used at baseline,weekends 4,8,12,16,24,and 32 to assess the condition;adherence was assessed by the Morisky Medication Adherence Questionnaire(MMAS-8),calculating the shedding rate;and using the side effect scale(TESS),and adverse event record form to assess safety.Results:1.There was a significant difference in treatment outcome between the western medicine group,the TCM group and the combined Chinese and western medicine group in the first phase(8 weeks)(χ2=19.27,P<0.001).Among them,the efficacy of the combined Chinese and Western medicine group differed significantly from that of the Western medicine and TCM groups(χ2=12.03,P=0.002;χ2=14.86,P=0.001),and the cure rate and effective rate were higher in the Chinese and Western medicine group.The HAMD reduction rate and HAMA reduction rate in the first stage combined Chinese and Western medicine group were the highest among the three groups(P=0.001,P=0.012).2.There was a significant difference in the overall change of MADRS,HAMD and HAMA scale scores in the combined Chinese and Western medicine group in the three stages compared with the Western medicine group and the TCM group(P<0.05),and the scale scores in the combined Chinese and Western medicine treatment group decreased more rapidly and converged to 0 more quickly.3.The older patients in the Western medicine group had a lower rate of HAMD score reduction than the younger patients(P<0.05),and the older patients in the combined Western and Chinese medicine group had a higher rate of HAMD score reduction than the Western medicine group(P<0.05).4.The combined Chinese and Western medicine group was negatively correlated with the shedding rate,and the first onset,unprovoked onset,duration of disease,unmarried,lower education and longer time of receiving treatment were positively correlated with the shedding rate of patients.The differences in the incidence of adverse reactions and TESS scores among the three groups were not significant.5.Syndrome of liver stagnation and spleen deficiency was positively correlated with the blocking factor and the sleep disorder factor;the anxiety/somatization factor score was positively correlated with the breakdown of heart-kidney interaction syndrome;the heart-spleen deficiency syndrome was positively correlated with the weight factor and negatively correlated with the blocking factor score;the liver-gallbladder dampness-heat syndrome was negatively correlated with the sleep disorder factor;and the heart and gallbladder qi deficiency syndrome was negatively correlated with the blocking factor.The results of this study suggest that:1.The combined treatment of Chinese and Western medicine for depressive disorder patients in the community is more effective than combining Western medicine alone followed by TCM or combining Western medicine alone followed by Chinese herbal medicine,which can control disease symptoms faster and stabilize the disease,and can achieve clinical cure earlier;patients treated with combined Chinese and Western medicine have higher compliance,which is conducive to patients’ longterm prognosis,and there is no increase in adverse effects and good safety.2.The implementation of combined Chinese and Western medicine treatment in the community has unique advantages.This study found that combined Chinese and Western medicine treatment has better efficacy for elderly patients with depressive disorders,and patients with depressive disorders in the community are mainly elderly,and giving targeted Chinese medicine treatment based on consideration of the underlying disease can improve the survival quality of patients with depressive disorders in the community.3.Correlation analysis between Western clinical symptom clusters and TCM syndrome pattern:The higher the blocking factor and sleep disorder factor score,the higher the likelihood of the TCM diagnosis of liver stagnation and spleen deficiency Syndrome.The higher the anxiety/somatization factor score,the higher the likelihood of the TCM diagnosis of heart-kidney interaction breakdown syndrome.The higher the weight factor score and the lower the blocking factor score,the higher the likelihood of diagnosis of heart-spleen deficiency syndrome in TCM.Patients with a low sleep disorder factor are more likely to be diagnosed with liver-gallbladder dampness-heat syndrome.The lower the obstructive factor score,the more likely the patient will be diagnosed with heart and gallbladder qi deficiency syndrome.