| BackgroundDepressive disorder is a common clinical disease characterized by persistent depression and decreased pleasure.It has been widely concerned because of its high prevalence,high recurrence rate,high disability rate,high suicide rate and heavy disease burden.According to the latest data of the World Health Organization,more than 264 million people are suffering from depression in the world.Among them,the patients with depression and insomnia are widespread.Some studies have shown that 90%of the patients with depression have insomnia symptoms.In view of the interaction between insomnia and depression,comprehensive intervention on insomnia symptoms of depressive disorder patients is bound to become an important way of depression treatment in the future.Because the pathogenesis of depressive disorder is not clear at present,in the treatment of depression combined with insomnia patients generally use symptomatic treatment,this method is easy to remain insomnia symptoms,so that the subjective psychological burden of patients increased,and then increase the risk of depressive disorder recurrence Traditional Chinese medicine in the treatment of diseases,especially in the treatment of combined diseases,is easy to play its advantages of overall adjustment,which can make up for the shortcomings of Western medicine.ObjectiveTo observe the clinical effect of tianwangbuxindan in the treatment of depression combined with insomnia(heart Yin deficiency syndrome)and compare with trazodone hydrochloride;to monitor the adverse reactions during the observation period to evaluate its safety.To explore and expand the clinical application of traditional Chinese medicine based on Tianwang buxindan in the treatment of insomnia related diseases.MethodsA single center,randomized clinical study design was used to collect patients with depression and insomnia(heart Yin deficiency syndrome)who met the acceptance criteria.According to the random number table,the patients were randomly divided into treatment group 1,treatment group 2 and control group in the proportion of 1:1:1.Treatment group 1(traditional Chinese medicine group)took Tianwang buxindan plus and minus formula,treatment group 2(traditional Chinese medicine combined with western medicine group)took Tianwang buxindan plus and minus formula and trazodone hydrochloride tablets,control group(Western medicine group):took trazodone hydrochloride tablets.The experimental period was 8 weeks,and the therapeutic effect of the experimental group and the control group were evaluated after 8 weeks.The general situation and scale scores of patients were recorded at three visit points(week 0,4 and 8),the changes of scores were observed,and the adverse reactions during the trial were recorded.The main outcome measures were Pittsburgh sleep quality index(PSQI)and Hamilton Depression Scale(HAMD)after 8 weeks of treatment,and the secondary outcome measures were TCM Syndrome Scale.After the clinical observation of all cases,spss22.0 software was used for statistical analysis of relevant data.Chi square test or variance analysis was used to measure the comparability of each group.Mean±standard deviation(x±s)was used for quantitative data(numerical variable)Or the interval between the median and the quartile is described,and the analysis of variance is used in the comparison between groups;the counting data(classified variable)is described by the number of cases and percentage,and the chi square test is used in the comparison between groups.P<0.05 showed statistical significance.The clinical effect of Tianwang buxindan was evaluated with reference to the data analysis results.ResultsFrom July 2019 to February 2020,65 cases were included in the outpatient of brain diseases department of Xiyuan Hospital,Chinese Academy of traditional Chinese medicine,including 22 cases in treatment group 1(Chinese medicine group),20 cases in treatment group 2(Chinese medicine combined with western medicine group)and 23 cases in control group(Western medicine group).In the course of the experiment,1 case in the treatment group 2(Chinese medicine combined with western medicine group),2 cases in the control group(Western medicine group),and 62 cases were included in the statistics.The statistical results showed that there was no significant difference between the treatment group and the control group in gender,age and scores of various scales before treatment(P>0.05).Main outcome indicators:PSQI scale score,comparison among three groups after 8 weeks of treatment:the difference of effective rate of three groups was statistically significant(P<0.05),the effective rate of treatment group 1(Chinese medicine group)and treatment group 2(Chinese medicine combined with western medicine group)were higher than that of control group(Western medicine group).Comparison within the group:treatment group 1(Chinese medicine group),treatment group 2(Chinese medicine combined with western medicine group)and control group(Western medicine group)were statistically significant(P<0.05).HAMD-17 scale score,after 8 weeks of treatment,there was no significant difference among the three groups(P>0.05).Comparison within the group:treatment group](Chinese medicine group),treatment group 2(Chinese medicine combined with western medicine group),control group(Western medicine group)were statistically significant(P<0.05).Secondary outcome index:TCM Syndrome Scale score,comparison among three groups after 8 weeks of treatment:the difference of effective rate of three groups was statistically significant(P<0.05),the effective rate of treatment group 1(TCM group)and treatment group 2(TCM combined with western medicine group)were higher than that of control group(Western medicine group).Comparison within the group:treatment group 1(Chinese medicine group)and treatment group 2(Chinese medicine combined with western medicine group)had statistical significance(P<0.05),while the control group(Western medicine group)had no statistical significance(P>0.05).Safety evaluation:the incidence of adverse reactions among the three groups was statistically significant(P<0.05).The incidence of adverse reactions in the control group(Western medicine group)was the highest,and the incidence of adverse reactions in the treatment group 1(Chinese medicine group)was the lowest.Conclusion1.Tianwang buxindan addition and subtraction formula can effectively improve the depression,insomnia symptoms and traditional Chinese medicine symptoms of patients with heart Yin deficiency depression and insomnia.2.Tianwang buxindan addition and subtraction formula has less adverse reactions and good safety in the treatment of depression with heart Yin deficiency and insomnia3.In terms of improving insomnia symptoms,the therapeutic effect of Tianwang buxindan plus and minus formula and Tianwang buxindan plus and minus formula combined with trazodone hydrochloride is better than that of trazodone hydrochloride alone;the therapeutic effect of Tianwang buxindan plus and minus formula on TCM syndromes is better than that of trazodone hydrochloride;the combination of Tianwang buxindan plus and minus formula and trazodone hydrochloride can reduce the occurrence of adverse reactions of patients. |
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