Preliminary Study On The Benefit Comparison Of Three Treatment Regimens In The Stable Phase Of Chronic Obstructive Pulmonary Disease

ObjectiveTo evaluate the effectiveness and economic evaluation of three treatments(convention Western medicine treatment,traditional Chinese medicine treatment,and a combination of both conventional Western medicine and TCM treatments)on patients with stable chronic obstructive pulmonary disease(COPD)and then determine which treatment is the most suitable for COPD patients to reduce the acute exacerbation,improve quality of life,and lighten the disease burden of COPD patients,and provide the evidence for clinical decision-making and health policy development.MethodsA multicenter,pragmatic,randomized,controlled trial was adopted.Stable COPD patients were randomly divided into three groups:convention Western medicine treatment group(CWM group,treated with given Salbutamol,Formoterol,Salmeterol/fluticasone,respectively,according to the guidelines),traditional Chinese medicine treatment group(TCM group,treated with Bufei granule,Bu-Fei Jian-Pi granule,Bu-Fei Yi-Shen granule,and Yi-Qi Zi-Shen granule based on their corresponding TCM syndrome patterns,respectively)and combination of both conventional Western medicine and TCM treatments group(CM group,treated with traditional Chinese medicine combined with conventional western medicine).Acute exacerbation frequency,six-minute walk distance,clinical symptoms,quality of life and cost-effectiveness analysis,indicators such as liver and kidney function of three therapeutic methods were measured and analyzed by single-factor ANOVA,repeated measures ANOVA,paired t test or Wilcoxon rank sum test,and other statistical methods.Results1 Cases of withdrawal or rejection 168 patients were randomly divided into WMC group,TCM group and combined group and 56 in each group.During 6 months treatment,9 patients eliminated because of incomplete data or other causes.12 patients shed because of loss to follow-up,data lost.So 159 could be evaluated in a FAS(Full Analysis Set)analysis and 150 in a PPS(per protocol Set)analysis.2 The Base Line 159 patients have been included in analysis of curative effect.There were no significant differences in sex,nation,age,occupation,the course of disease,complications,past history six-minute walking distance(6MWD)in the three groups(P>0.05).This study is comparable.3 Efficacy and health economic evaluation3.1 Cases of acute exacerbation During the whole research,42 of patients suffered acute exacerbation with 18 in the CWM group,17 in TCM group,while 7 in CM group.The number of patients had acute exacerbation in combined group was less than CWM and TCM groups(P<0.05).There was no significant difference in the three groups in the number and duration of exacerbations before treatment(P>0.05),while there was significant difference in the three groups after treatment(P<0.05),and the CM group was less than CWM and TCM groups(P<0.05).During 6-month treatment,the number and duration of acute aggravation in CM group deceased significantly(P<0.01).There was significant difference in the CM group compared with CWM and TCM groups in the degree of acute exacerbation(P<0.05).3.2 Lung function There was no significant difference on FVC,FEV1,FEV1%of the three groups before treatment(P>0.05).These indexes were higher after treatment than before treatment(P>0.05).There was significant difference between after treatment and before treatment.on FEV1,FEV1%of the CM group(P<0.05),while no difference between CWM and TCM groups(P>0.05).3.3 Clinical symptoms The symptom scores in the three groups decreased compared with before treatment,and had time responses(P<0.05).There was significant difference in symptom scores in three groups in different time points(P<0.05),and the CM group decreased significantly compared with CWM and TCM groups(P<0.05).There was significant differences in individual symptoms,such as cough,expectoration,wheezing,chest tightness,shortness of breath and fatigue(P<0.05),while no significant differences in cyanosis score(P>0.05).3.4 MMRC MMRC in the three groups decreased after treatment compared with before,and had time responses(P<0.05).There was significant difference in different treatment times(P<0.05),and it was lower in the CM group than CWM and TCM groups(P<0.05).35 Six-minute walking distance(6MWD)After treatments,6MWD in the three treated groups were higher than before treatment,and had time responses(P<0.05).There was significant difference in 6MWD in different treatment times(P<0.05),and it was higher in the CM group than CWM and TCM groups(P<0.05).3.6 SF-36 Dynamic scoring assessent,overall self-assessment of health,social function,and assessment,emotional impact on the role of mental health,psychological assessment,total physical health scores increased in the three groups,and had time responses(P<0.05).There was significant difference among three groups in different time points and it was higher in the CM group than CWMand TCM groups(P<0.05).There was no significant difference among three groups in somatic pain score(P>0.05).3.7 CAT The total integral of CAT in the three treated groups decreased significantly after treatment compared with before,and had time responses(P<0.05).There was significant difference in CAT in different treatment times(P<0.05),and it was lower in the CM group than CWM and TCM groups(P<0.05).3.8 COPD-PRO The integral of clinical symptoms,satisfaction of health condition,treatment effect and the total integral of PRO in the three treated groups decreased and had time responses(P<0.05).There was significant difference in PRO in different treatment times(P<0.05),and it was lower in the CM group than CWM and TCM groups(P<0.05).3.9 ESQ-COPD The integral of capacity for life and work,clinical symptoms,effect of therapy,convenience of therapy,whole effect domain and the total integral of ESQ in the three treated groups increased after treatment and had time responses(P<0.05).There was significant difference in different treatment times(P<0.05),and it was higher in the CM group than CWM and TCM groups(P<0.05).3.10 Health Economic Evaluation The average treatment cost in CWM,TCM and CM group was 17289.72,19298.99 and 21818.1 RMB respectively,and there was significant difference in the three treated groups(P<0.05).The cost of per unit effect in CM group is 4544.25 RMB,which was less than CWM(7697.20)and TCM(7980.89)groups.Compared with CWM and TCM groups,the CM group just appends 3624.08,3861.39 Yuan respectively for one extra Unit effect.Conclusions1 The three treated groups(CWH group,TCM group and CM group)all have good efficacy,which can reduce the number and duration of exacerbations,improve clinical symptoms(cough,expectoration,chest distress,short of breath),and improve quality of life and treatment satisfaction of the patients.However,compared with CWH group and TCM group,CM group has better efficacy in alleviating the clinical symptoms,reducing acute exacerbations,increasing exercise tolerance and quality of life for COPD patients.2 Compared with CWH group and TCM group,the CM group just need append 3624.08,3861.39 RMB respectively for one extra unit effect.3 According to clinical efficacy and cost-effectiveness analysis,the combination of both conventional Western medicine and TCM treatments is the optimal treatment of patients.