| ObjectiveDiabetes combined with depression is a constantly occurring disease in contemporary Chinese society.At present,a lot of research have been taken separately on diabetes or depression,however,little has been taken on both of them and the curative effect was not satisfying.The purpose of this study is to evaluate the clinical efficacy of Professor Fan Guanjie' s"Varialbe-stable and Sequential Eight Methods" on the treatment of diabetes combined with depression,planning to explore a cure for physical and mental health.This study tries to improve the clinical efficacy of traditional Chinese medicine and would make great ef-forts to comprehend Professor Fan's academic ideology and way of thinking,by frequently enlarging horizon and enhancing innovation awareness.MethodsThis study adopted research methods of clinical prospective randomized controlled trials,with diabetes and depression patients in Department of endocrinology of Guangdong Province Traditional Chinese Medical Hospital outpatient and ward from June in 2014 to March in 2016 as the research objects.Ninety cases were averagely divided into the treatment group and the control group.Both of the groups were given basic therapy and health education.Besides,the treatment group was given traditional Chinese medicine guided by the "Varialbe-stable and Sequential Eight Methods",according to the syndrome characteristics of subjects.The control group was given Zuo Luofu(Sertraline Hydrochloride Tablets,50mg QD).Both of the two groups experienced twelve weeks of intervention.Tests were taken before and after the intervention,including fasting blood glucose(FPG),two hour postprandial blood glucose(2hPPG),glycosylated hemoglobin(HbAlC),fasting insulin(FINS),total cholesterol(TC),triglyceride(TG),low density lipoprotein(LDL-C),high density lipoprotein(HDL-C),free T3(FT3),free T4(FT4),thyroid stimulating hormone(TSH),C reactive protein(CRP),insulin resistance index(HOMA-IR),traditional Chinese medicine syndrome score,Hamilton Depression Scale(HAMD)score and diabetes specific quality of life scale(DSQL)score,and the changes of traditional Chinese medicine syndrome.All statistical tests were under bilateral inspection,and a P value less than or equal to 0.05 indicated statistical differences.The measurement data of both groups used average increasing or reducing standard deviation for statistical description.T test was selected to compare the measurement data between the two groups(If data were not normal distribution or missing variance,nonparametric test would be applied instead).Dichotomous data of both groups were recorded in proportion and rate and the results of comparison between the two groups were calculated by Chi-square or fisher test.The ranked data in both groups were calculated by nonparametric test.ResultsIn the course of the study,ninety diabetes and depression patients in Department of endocrinology of Guangdong Province Traditional Chinese Medical Hospital outpatient and ward were equally divided into the treatment group and the control group.The results are detailed as follows:1.Comparison of baseline data:The general data of the two groups were compared before the study,including gender structure,age,age structure,marital status,smoking and drinking state,BMI,duration of diabetes,diabetic complications,concurrent diseases,the observation index score,score of HAMD,DSQL,TCM syndrome.There were no remarkable differences between the two groups(P>0.05).Baseline data were balanced and comparable.2.Clinical curative effect evaluation(1)Blood Glucose index:After treatment,the two groups' data of FPG,2hPPG,HbAlC were lower than before,the differences were prominent(P<0.01).After treatment,there were no observable differences between the two groups(P>0.05).(2)Insulin indicators:After treatment,the levels of FINS in the two groups were increased,but of no obvious difference compared with those before treatment(P>0.05).After treatment,the levels of HOMA-IR in the two groups were significantly lower than before treatment,and the differences were apparent(P<0.01).After treatment,there were no prominent differences between the two groups(P>0.05).(3)Blood lipid index:After treatment,the levels of TC,TG,LDL-C in the treatment group were lower than before treatment,the differences were observable(P<0.01).However,the change of HDL-C was not obvious(P>0.05).After treatment,the level of TC in the control group patients increased compared with that before treatment,and the differences were statistically notable(P<0.05).Contrarily,the change of TG,LDL-C,HDL-C were not obvious(P>0.05).After treatment,the differences of TG and TC between the two groups were prominent(P<0.05),while the diff'erences of HDL-C and LDL-C were not apparent(P>0.05).This indicated that the treatment group was superior to the control group on declining the levels of TG and TC.(4)Inflammation index:After treatment,the levels of CRP in both groups were lower than before treatment,and the differences were distinct(P<0.01).However,there were no apparent differences between the two groups(P<0.05).(5)Thyroid function index:After treatment,there were no evident differences of FT3,FT4,TSH between the two groups compared with those before treatment(P>0.05).In addition,there were no obvious differences between the two groups after treatment(P>0.05).(6)Hamilton Depression Scale score:After treatment,HAMD scores of both groups were lower than before treatment,and the differences were clear(P<0.01).Moreover,the differences between the two groups were statistically prominent(P<0.01).This result manifested that the treatment group was superior to the control group.(7)The specific quality of life of patients with diabetes scale score:After treatment,the two groups of DSQL total score and four dimension scores decreased than before treatment,and the differences were notable(P<0.01).Furthermore,the scores of treatment group were lower than the control group in total score and dimension of physiological,psychological and treating.The differences were apparent(P<0.05),demonstrating that the improvement of the treatment group about the physical,psychological and treating dimensions were superior to those in the control group.(8)TCM syndromes:Compared with those before treatment,TCM syndrome scores were remarkably lower in both groups after treatment(P<0.01).The scores of the TCM syndrome of the treatment group were lower than those of the control group.This result showed observable differences(P<0.01),which pointed out the treatment group was superior to the control group.(9)Curative effects:the effective rate about diabetes of the treatment group was 83.3%,while 72.5%in the control group.There were no apparent differences between them(P>0.05).The effective rate about depression of the treatment group was 95.2%,while 92.5%in the control group.There were no obvious differences between them(P>0.05).The effective rate about TCM syndromes of the treatment group was 90.5%,while 60.0%in the control group.There were remarkable differences between them(P<0.01),which showed the treatment group was superior to the control group.(10)Syndrome distribution and dynamic change:patients' symptoms were usually characterized as combination of three to five Chinese medical syndrome,and showed dynamic changes.At the early phase of treatment,syndromes of the two groups appearred mostly were damp heat,liver-Qi stagnation,blood heat,vexation by heat.In the middle stage of treatment,syndromes with high frequency of occurrence in both groups were liver-Qi stagnation,damp heat,blood heat,blood stasis,Qi-Yin deficiency,kidney-Qi deficiency.At the last stage of treatment,syndromes with high frequency of occurrence in the treatment group were damp heat,Qi-Yin deficiency,while blood stasis and kidney-Qi deficiency in the control group.3.Safety abalysis:no adverse events occurred in both groups,and the safety was fine.4.Compliance and quality control:In the course of this study,the treatment group was shedding three cases,and the control group was off five cases,and the shedding rate accounted for 8.9%of the total cases.Among these cases,three were shedding because of life events,two were off due to poor curative effect,three were off result from inconvenience to come to hospital.Conclusion1.As a physical and mental illness,diabetes combined with depression is difficult to cure.This study proves that the "Varialbe-stable and Sequential Eight Methods" can lessen the levels of blood glucose and blood lipid,ameliorate insulin resistance,alleviate somatic symptoms and lower the score of HAMD.2.The incidence of diabetes and depression interact with each other because of their same core pathogenesis such as liver-QI stagnation and damp heat."Varialbe-stable and Sequential Eight Methods" regards diabetes and depression as a whole.Professor Fan pays full attention to prevention and treatment simultaneously,and explores a cure for physical and mental health.This acadamic thought realizes the spirit of TCM and its special advantages.3.In the treatment of diabetes combined with depression,the "Varialbe-stable and Sequential Eight Methods" emphasizes psychological counseling,doctor-patient interaction,and lifestyle intervention.These measures can enhance the patients' ability to adapt to society and quit depressed emotion,and can improve curative effect,relieve clinical symptoms and promote their quality of life. |
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