Methodological Study On The Guidance Of Hypertension Disease Combined With Traditional Chinese Medicine

Hypertension is of high prevalence in clinical scenario. According to the report,"2012’ China cardiovascular disease", this disease affects a population reached of260million, which means one out of five Chinese adults suffers from hypertension. Traditional Chinese medicine(TCM) treatment for hypertension appeared in the1930s. It plays an significant role in fighting the disease. Even with the great efforts of Chinese and western medicine, and with the development in drug industry, prevention and control of hypertension is stilled confronted with problems. Target organ damage and related disease, like coronary heart disease, stroke, end-stage renal disease severely damage the health of the patients. Standardizing the TCM treatment and research about hypertension has a great value in developing TCM prevention and treatment, improving the prognosis of hypertension and enhancing the quality of life of hypertension patients.Objects1.Established the construction, classification and evaluation of current evidence system of TCM clinical practice, based on systematically researching the guidelines and expert consensus.2.Research the evidence-based clinical guideline as well as the quality evaluation. Establish the standard, technology process and notice for TCM clinical practice of primary hypertension disease-syndrome combination.3.Explore the feasibility of evidence classification, evaluation standard, developing method and technology process founded by this study to develop the hypertension disease-symptom TCM clinical practice guidelines.MethodTheoretical study:study on the TCM clinical features and characteristics, discusses the composition, classification and evaluationof the body of evidence of TCM clinical practice guidelines,, using evidence classification principle of evidence-based guidelines to make the evidence evaluation and recommendation standard of TCM clinical practice guidelines.Literature survey:Search and analyze the related literatures according to different topics, focused on literatures from domestic study, the United States national institutes of health, Oxford evidence-based center, Canada international evidence-based medical research organizations and other institutions. Related topics include related guidelines and standards, exchange of evidence and quality evaluation of literatures. Collect, analyze and study the literature concerning hypertension related theory, clinical syndrome, diagnosis and treatment and other relative areas.Clinical trials:Conduct the inventory survey of the manifestations features of400hypertension patients in Beijing. Determine the scope of the syndrome in the guideline. A randomized blinded placebo-controlled clinical trials was firstly performed to evaluate the safety and effectiveness of this guideline.95clinical cases were included. Guideline study:Develop the initial edition of TCM clinical practice of primary hypertension disease-syndrome combination based on the technology formed in this study.Results1.Divide the TCM clinical guidelines into evidence can be divided into traditional theory evidence and research evidence. The sources of TCM clinical guidelines are clinical research and traditional TCM articles. Involvement of clinical aspects and relevance to clinical practices are criterion of adoption. Research evidences can be incorporated into modern research methods classification, which include case report, clinical summary, clinical observation, clinical trials, expert consensus and so on. traditional theory evidence represents theory closely related to clinical and transfer of traditional technology, traditional theory evidence is the critical source of TCM evidence-based guideline. It includes all TCM literatures over the TCM history and mordern summary of TCM experience.2. Traditional theory evidence emphasize the transfer throughout the medical history. Evidence in a continuous transfer is of the highest level of evidence system. The level increases as the stability of the diagnosis and treatment’s historical transferring strengthens, and thus those evidence is regarded as a higher recommendation. Modern evidence-based guidelines and recommendation grading system should be used to evaluate the research evidence. The final step is to summarize the recommendation from traditional theory evidence and research evidence. Research evidence has a higher priority. The overall recommendation strength equals to the higher level of the two evidences. If traditional theory evidence has a recommendation strength of level B, and research evidence is of level C, than the overall recommendation level is B. If research evidence contradicts the traditional theory evidence, the strength research evidence is used as the overall recommendation strength.3. Through the literature research and the clinical study of400cases hypertension patients, the preliminary extend of hypertension clinical practice guideline is determined. After the study of9large clinical trials or case reports, we included three symptom as main content of this guideline:Hyperaction of liver-yang, yin-deficiency and yang-excess, phlegmatic hygrosis flourishing syndrome. To increase the understanding of TCM symptom distribution of hypertension, thus to ascertain the extent of the line, we investigated400hypertension patients about their symptoms. The key words turns out to be YangKang(endogenous fire, endogenous wind), blood stasis, phlegmatic hygrosis. Deficiency syndrome mainly includes Yin deficiency and Qi deficiency. According to literature study and preliminary clinical trial, we determined to take Hyperaction of liver-yang, yin-deficiency and yang-excess, phlegmatic hygrosis flourishing syndrome as major content.4. Formulate the TCM diagnosis and treatment plan for three main symptoms: Hyperaction of liver-yang, yin-deficiency and yang-excess, phlegmatic hygrosis flourishing syndrome. The basis of the plan is the case summary in hypertension out-patient services. A randomized blinded controlled clinical trials was performed to evaluate the safety and effectiveness of this guideline.95patients of hypertension Grade1-2were included in the formal research. The results are listed below: experiment group had a blood pressure(BP) decrease of12/7mmHg compared to the BP before treatment, while the average BP decline of the control group was8/3mmHg(P<0.05), treatment using TCM syndrome differentiation provided an obvious antihypertensive effect; Experiment group had a BP control rate of65.31%, while the control group39.13%; the symptoms resolving rate was65.31%in experiment group and50.00%in control group(P<0.05); there was no statistical difference in safety index between the two group. The results revealed the effectiveness of TCM syndrome differentiation treatment against Grade1-2hypertension.5. On the basis of all above, we developed the TCM treatment of hypertension clinical practice guidelines using the established method and decided extend. Seven recommendations were put forward and analyzed. Recommendation strength was confirmed to form the first draft of the TCM treatment of hypertension clinical practice guidelines (including seven recommendations). We have conducted a access on the guidelines. ConclusionsThis study established method on classifying and evaluating evidence determining recommendation strength and developing evidence-based guideline. The method meets the need for develop disease-symptom TCM clinical practice guidelines.The innovation of this study(1)Putting forward evidence classification according to the characteristics of the evidence of TCM literature, divided it into two categories, evidence theory heritage and research evidence, and respectively formulate evidence evaluation standard; The guidelines recommend strength standard was made up with the basis of evidence classification, It both comply with the transmission characteristics of TCM theory, and meet the needs of the evidence-based guidelines for research.(2)According to the development plan, research and theory of inheritance of evidence evidence evaluation standard, recommended strength completed preliminary hypertension disease clinical diagnosis and treatment of traditional Chinese medicine combined disease and guide the development of the work, put forward including the name of disease, syndrome and its diagnosis, treatment, seven recommendations and the level of evidence and strength of recommendations.