Analysis on the distinguishing features of traditional Chinese therapeutics and related statistical issues

Traditional Chinese medicine(TCM)is one of the rarely existing ancient traditional medicines that hold systematic theories as well as preventative and therapeutic methods for diseases in practice.From the 1950s,such research methods as mathematics,statistics,and data mining(DM)have been gradually introduced to TCM studies,making it more scientific.Meanwhile,the distinct features of TCM theories and diagnostic-model have constantly challenged the methodology of statistics.This paper introduces the following scientific features of traditional Chinese therapeutics:1)its goal is to balance the functions and conditions of human body;2)it emphasizes on holism and individualization;3)it stresses the longitudinal regulation and evaluation mode,which is a circle of syndrome diagnosis,treatment and evaluation;4)the interventions of TCM are abundant,compound and natural;and 5)humanistic thought is everywhere.Some statistical problems are raised based on these features.First,complex statistical methods that can analyze subjective indexes and latent variables,multidimensional and multistage data,non-equilibrium designed studies,and longitudinal data are required.Second,comprehensive evaluation on multiple-target mechanism has been brought in by combination treatment.Third,there is a need to analyze how humanity and related cultural factors may influence the effect of interventions.Thus,promoting implemented studies of statistics as well as carrying out the TCM scientific propositions have become the common expectations of both TCM and modern medicine.

Characteristics and Advantages of Traditional Chinese Medicine in the Treatment of Acute Myocardial Infarction

Objective: To obtain epidemiological data on Traditional Chinese Medicine (TCM) therapeutic status of acute myocardial infarction (AMI) and to determine TCM characteristics and advantages to improve the level of TCM prevention and treatment of AMI. Methods: Clinical epidemiology methods were used to register and survey the TCM therapeutic status of hospitalized AMI patients. In 2001, the Chinese Association of Integrative Medicine surveyed the therapeutic status of 3308 AMI patients hospitalized in 30 hospitals in Beijing and Shanghai from 2000-2001. The Beijing Collaborative Study Group on Therapeutic Status of Acute Myocardial Infarction (the Study Group) then conducted a 10-year-long register survey on hospitalized AMI patients in Third-grade A-Level TCM hospitals in Beijing. After 2002, the Study Group further surveyed the treatment conditions of AMI-hospitalized patients in 10 Second-grade A-Level TCM hospitals. The therapeutic status in 8 Third-grade A-Level Western medicine hospitals was surveyed in 2001 and 2005 as a control. In 2008, in cooperation with the China Association of Chinese Medicine, the Study Group further performed a survey at 26 Third-grade A-Level TCM hospitals nation-wide. Approximately 5000 cases were investigated to obtain authoritative data on the therapeutic status of AMI patients in TCM hospitals in China. Results: We found that Chinese herbal intravenous preparations may be beneficial in reducing the mortality of AMI. Major complications of AMI, such as heart failure and arrhythmia, were significantly less during the 10-year survey period. The mortality of hospitalized AMI patients showed a decline. TCM treatment was helpful for AMI patients in improving their quality of life. Ten-year dynamic monitoring showed that the ability to perform reperfusion and to use drugs appropriately, as well as an effort to carry out the Clinical Guidelines has made great progress in TCM hospitals. However, TCM hospitals still have some problems in treating AMI, including a lack of standardized TCM syndrome diagnosis, the need for syndrome differentiation and treatment standardization, and clinical skills in reperfusion and standardized drug treatment still need to be further improved. Compared with AMI patients in Western medicine hospitals during the same period, those in TCM hospitals had the following characteristics: they were admitted to hospital later; they were older when they had a heart attack; there were more females, they had more problems in their medical history, and they had more concomitant illnesses and complications. Therefore, the demographic baseline data were significantly different between AMI patients in TCM hospitals and those in Western medicine hospitals. This indicated that patients in TCM hospitals were more critical than those in Western medicine hospitals. Conclusions: TCM has special advantages in treating AMI. TCM hospitals are making continuous progress in standardized treatment of AMI, but further improvement is still required. AMI patients in TCM hospitals have some special characteristics, and their condition may be more critical. Further clinical research on TCM treatment of AMI is required.

Prognostic analysis of transarterial chemoembolization combined with a traditional Chinese herbal medicine formula for treatment of unresectable hepatocellular carcinoma

Background Transarterial chemoembolization （TACE） is the most widely used primary treatment for unresectable hepatocellular carcinoma （HCC） due to its survival benefit, though its clinical effect is still far from satisfactory. Jiedufang （JDF） granule preparation is a commonly used Chinese herbal medicine formula for HCC. The aim of this study was to evaluate the effect of combined therapy with TACE and JDF granule preparation in treatment of unresectable HCC on survival. Methods A retrospective study of TACE was performed in 165 patients with unresectable HCC who were admitted between January 2002 and December 2007 in Changhai Hospital, Shanghai, China. Of the 165 patients, 80 patients （study group） received combined therapy consisting of TACE and a long-term maintenance treatment with oral JDF granule preparation, and the remaining 85 patients （control group） received TACE alone. The survival rates of both groups were calculated by the Kaplan-Meier method. Factors possibly affecting survival were assessed by multivariate analysis in the Cox proportional hazard model, such as maximum tumor size, number of lesions, portal vein invasion, and etc. Results The median overall survival was 9.2 months （95% CI： 6.94-11.46） in the study group versus 5.87 months （95% CI： 4.21-7.52） in the control group. In the study group,survival rates of the 1-, 2- and 3-year follow-up were 41.2%, 18.4%, and 9.6%, respectively. Significant independent prognostic factors identified by the Cox regression analysis were as follows： serum hepatitis B surface antigen （HBsAg） （P=0.014）, maximum tumor size （P=0.027）, number of lesions （P 〈0.001）, portal vein invasion （P 〈0.001）, and the therapy model （P=-0.006）. Conclusion Combination therapy of TACE and JDF granule preparation may significantly prolong survival of patients with unresectable HCC.