Clinical Study On The Treatment Of Chronic Heart Failure With Syndrome Differentiation

Objective1.This study was designed to detect the distribution characteristics about Traditional Chinese Medicine syndrome elements in chronic heart failure(CHF)patients due to coronary heart disease to offer references for clinical treatments based on syndrome differentiation.2.The purpose of this study was to evaluate the efficacy and safety of TCM in the treatment of chronic heart failure according to syndrome elements with randomized controlled clinical study objectively.Materials and Methods1.Case observation table was designed to collect 924 CHF patients in 17 TCM hospitals,and descriptive statistical analyses of 915 patients,syndrome elements were studied to detect the distribution characteristics.2.In this study,we used a multicenter,randomized,double-blind,parallel and placebo-controlled study design.We have collected 220 CHF patients caused by coronary heart disease(CHD)in seven tertiary hospitals of Chinese medicine.According to the Stratified Random Act stratification factors in the center,a few blocks of 4,we usd SAS software to generate random digital code.Patients were randomly divided into two groups,namely treatment group(conventional medicine + Chinese herbal medicine according to syndrome elements)and the control group(conventional western medicine + placebo).We observed the echocardiography,TCM symptom score,NYHA functional classification,the stop or reduction rate of drugs,SF-36 questionnaire condensed condition,and safety evaluation at baseline,14 and 28 days.We analyzed all data with SPSS17.0 statistical software.The population to analysis included intention to treat and per-protocol patients.Safety analysis of patients was about intention to treat population.Results(?)Distribution characteristics of TCM syndrome elements in CHF patients caused by CHD1.Distribution of syndrome elementsThe main disease names of CHF patients in TCM were thoracic obstruction,congestive heart failure,heart palpitations,gasp syndrome,edema.The main syndrome elements were qi deficiency,blood stasis,water retention,yin deficiency,phlegm turbidity and yang deficiency.The main syndrome elements were qi deficiency(63.64%),blood stasis(72.73%),yin deficiency(45.45%)and phlegm turbidity(27.27%)in 11 CHF patients with NYHA I.The main syndrome elements were qi deficiency(77.73%),blood stasis(76.52%),phlegm turbidity(28.34%)and yin deficiency(27.53%)in 247 CHF patients with NYHA ?.The main syndrome elements were blood stasis(80.71%),qi deficiency(79.59%),phlegm turbidity(35.06%),yin deficiency(21.34%)and yang deficiency(20.59%)in 539 CHF patients with NYHA ?.The main syndrome elements were qi deficiency(78.81%),blood stasis(74.58%),retained fluid(57.63%),yang deficiency(29.66%),phlegm turbidity(29.66%)and yin deficiency(27.12%)in 118 CHF patients with NYHA ?.2.The combinations of syndrome elementsThere were single to six syndrome element combinations,combined with two,three or four syndrome elements were the most common combinations.Qi deficiency was the most common syndrome in single type,accounting for 34.62%.Qi deficiency combined with blood stasis was the top combination,accounting for 56.79%.Qi deficiency and blood stasis combined with water retention was the top three syndromes combination,accounting for 25.55%.Qi deficiency and blood stasis and water retention combined with yin deficiency syndrome was the top four syndromes combination,accounting for 23.77%.3.The analysis between syndrome elements and related factorsWith logistic regression analysis using binary and logistic stepwise regression analysis,we found that qi deficiency had a positive correlation with cardiac arrhythmia(P<0.05).Yang deficiency had a positive correlation with NYHA functional classification(P<0.05),and a negative correlation with the history of myocardial infarction(P<0.05).Yin deficiency had a positive correlation with cardiac arrhythmia(P<0.05),and a negative correlation with the history of myocardial infarction(P<0.05).Blood stasis had a positive correlation with the history of myocardial infarction(P<0.05).Water retention had a positive correlation with NYHA functional classification,the history of myocardial infarction and diabetes diseases(P<0.05).Phlegm turbid had a postive correlation with hyperlipidemia(P<0.05).(?)Randomized controlled clinical trial1.Baseline data analysisThere was no statistical significance between two groups on basic demographic data,the basic disease condition and so on.There was no statistical significance between two groups on concomitant diseases,NYHA functional classification,western medicine treatment,the index of echocardiography,TCM syndrome score,the score of SF-36(P>0.05).2.Curative effect analysis2.1 Comparison of the efficacy of EchocardiographyAfter 14 or 28 days' treatment,left ventricular ejection fraction(LVEF)in CHM group is significantly higher than that in placebo group(P<0.001).The LVEF level was statistically significant at three time points(before treatment,14 and 28 days)in each group(^<0.001).After 28 days' treatment,FS level in CHM group was higher than that in placebo group(P<0.05).Comparison within each group:The FS level was statistically significant at three time points(before treatment,14 and 28 days)in each group(P<0.001).Per-protocol analysis suggested that the FS level of CHM group was higher than that in placebo group after 14 days' treatment(P<0.05).There were no significant difference between two groups on left ventricular end-diastolic diameter(LVEDD),left ventricular posterior wall thickness(LVPW),thickness of interventricular septum(IVS)(P>0.05),meanwhile there were no difference at three time points(before treatment,14 and 28 days)in each group(P>0.05).2.2 Comparison of the efficacy of NYHA functional classification? Comparison of the efficacy of NYHA functional classification distribution:There was significant difference on NYHA functional classification distribution between two groups after 14 or 28 days' treatment(P<0.05).?Comparison of the improved level of NYHA functional classification:The improved level of NYHA functional classification in CHM group was higher than that in placebo group after 14 or 28 days' treatment(P<0.05).?Effect analysis on NYHA functional classification in subgroups:There was no significant difference on the improved level of NYHA functional classification between CHF patients with NYHA II in two groups after 14 or 28 days' treatment(P>0.05).There was significant difference on the improved level of NYHA functional classification between CHF patients with NYHA III in two groups after 14 or 28 days' treatment(P<0.05).2.3 Comparison of the efficacy of stop or reduction rateAfter 14 day s'treatment,the stop or reduction rate of digoxin is higher than that in placebo group(P<0.05),so was that in 28 days' treatment.There was no difference between two groups on the stop or reduction rate of diuretics,?-blockers,ACEI or ARB,aldosterone receptor antagonist after 14 or 28 days' treatment(P>0.05).2.4 The efficacy analysis of symptoms and signs? The efficacy analysis of symptoms and signs score:After 14 or 28 days' treatment,the symptoms and signs core of CHM group was less than that in placebo group(P<0.001).Comparison within each group,there was statistically difference at three time points(before treatment,14 and 28 days)(P<0.05).?The disappearance rate of signs and symptoms:After 14 days' treatment,there was statistically difference on the disappearance rate of jugular vein distention,expectoration,bloating,flank pain(P<0.05).Meanwhile,per-protocol analysis suggested that there was statistically difference on the disappearance rate of nausea,vomiting and loss of appetite(P<0.05).After 28 days' treatment,there was statistically difference between two groups on the disappearance rate of fatigue,less gas lazy words,dizziness,giddiness,gasp,bloating,nausea,vomiting,rib-side distention,body weight difficulties,bitter taste,coated tougue(P<0.05).Per-protocol analysis suggested that there was statistically difference on the disappearance rate of dysphoria in chestpalms-soles,being not prostrate(P<0.05).2.5 SF-36 scale scores efficacy analysis? There was statistically difference between two groups on physical functioning score,role-physical score,bodily pain score,general health score,role-emotional score,mental health score after 14 or 28 days' treatment(P<0.001).? The baseline of vitality and social functioning scores were inconsistent between two groups(P>0.001).2.6 Safety evaluation? Compliance analysis:Except the shedding and exclusion ones,the compliance of patients in both groups were well(P>0.05).? Laboratory analysis before and after the treatment:There was no clinical meaningful variation of laboratory indicator in two groups.? Analysis of adverse event and adverse reaction:There was no statisticall difference on adverse event or adverse reaction between two groups(P>0.05).Conclusion1.Qi deficiency,blood stasis,water retention,yin deficiency,yang deficiency and sputum are the main nature syndrome elements of CHF patients caused by coronary heart disease.With the variation of NYHA functional classification,yang deificiency,blood stasis and water retention have certain variation law.Two,three,four syndrome elements are the most common combinations.The combination of qi deficiency and blood stasis are the basic of all syndrome element combinations.NYHA functional classification,the history of myocardial infarction and concomitant diseases may influence the syndrome element distribution of CHF patients.2.The result of echocardiographic index,the indicator of TCM symptom score and SF-36 questionnaire integration can be improved by the treatment of CHM according to syndrome element.NYHA functional classificaion,the disappearance rate of some symptoms and signs,the stop or reduction rate of digoxin and quality of life of patients can be improved,too.3.The treatment of CHF with CHM according to syndrome elements is effective and safe.