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ObjectiveTo systematically collect， analyze， and evaluate the randomized controlled trials （RCT） of Chinese patent medicine combined with western medicine in the treatment of hypertension， map the evidence， and provide reference for the future clinical research and formulation of guidelines and policies. MethodThe relevant articles were retrieved from China Biology Medicine disc， China National Knowledge Infrastructure （CNKI）， VIP， Wanfang Data， PubMed， Embase， and Cochrane Library with the time interval from inception to December 31， 2022. The RCT of Chinese patent medicines combined with western medicine in the treatment of hypertension were included. The research characteristics and methodological quality were analyzed and evaluated. ResultA total of 330 RCTs of treating hypertension with Chinese patent medicines combined with Western medicine were included in this study， all of which were published in Chinese. These RCTs involved 88 Chinese patent medicines and 37 788 patients， and 46% of RCT had the sample size ≥100 patients. Eighty-seven percent of RCT showed the study period within 3 months. All the interventions in the RCTs were Chinese patent medicine + western medicine vs western medicine. Among the evaluation indicators， blood pressure， response rate， TCM syndrome score， endothelial cell function， and safety were mainly concerned. In terms of methodological quality， most articles did not mention the generation of random sequences， allocation concealment， or blinding method. The blinding evaluation of outcomes showed low risks of bias， and there was insufficient information to judge whether there was selective bias or other bias. ConclusionThere were many Chinese patent medicines used in combination with western medicine in the treatment of hypertension， and they were mainly taken orally. The existing RCT had problems such as small sample size， unclear clinical value positioning， imperfect design failing to reflect the value of Chinese patent medicines， unreasonable measurement indicators， and non-standard measurement methods. Future research should solve the above problems， improve the research quality， value， and authenticity， and enhance the reliability and extension of evidence.
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ObjectiveTo evaluate the quality of research and evidence related to antihypertensive Chinese patent medicines combined with western medicines for the treatment of hypertension， synthesize and update the evidence， form expert consensus， and provide evidence for clinical decision-making. MethodThe databases of China National Knowledge Infrastructure （CNKI）， WanFang Data Knowledge Service Platform （WanFang）， Vip Chinese Science and Technology Journal Database （VIP）， Chinese Biomedical Literature Service System （Sinomed）， National Library of Medicine （PubMed）， Cochrane Library， Web of Science， and US Clinical Trials Registry were searched for randomized controlled trials of antihypertensive Chinese medicine combined with western medicine for the treatment of hypertension from database construction to July 31， 2022. The quality of the literature was evaluated using the bias risk assessment tool in Cochrane Handbook 6.3. Evidence synthesis of main outcome indicators was performed using R software. The Grading of Recommendations Assessment， Development， and Evaluation profiler （GRADEprofiler） 3.6 was employed to evaluate the quality of evidence. Expert consensus was formed based on the Delphi method after two rounds of voting. Result64 pieces of literature were included， and the results of literature quality evaluation and risk of bias showed that 70.31% （45/64） of the studies indicated some risks， and 29.69% （19/64） indicated high risks. Compared with conventional western medicines， the combination of Chinese patent medicines with western medicines can significantly lower systolic pressure （SBP） and diastolic pressure （DBP）， increase the effective rate of antihypertensive， reduce the incidence of adverse reactions， endothelin-1， and traditional Chinese medicine syndrome scores. Egger's test showed that Songling Xuemaikang capsules reduced SBP and DBP. Tianma Gouteng granules reduced SBP and DBP and increased the effective rate of antihypertensive， and Xinmaitong capsules reduced SBP and increased the effective rate of antihypertensive， without significant publication bias. Songling Xuemaikang capsules increased the effective rate of antihypertensive， and Xinmaitong capsules decreased DBP， with significant publication bias. The results of the GRADE evidence quality evaluation showed that most evidence was at grades B and C. Finally， four strong recommendations and 14 weak recommendations were formed. ConclusionCompared with conventional western medicines for the treatment of hypertension， antihypertensive Chinese patent medicines combined with western medicines have advantages in reducing blood pressure and improving drug use safety， but they are mostly weak recommendations in terms of efficacy， and more high-quality evidence is needed.
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ObjectiveTo evaluate the effect of antihypertensive and lipid-regulating Chinese patent medicine combined with conventional Western medicine in the treatment of hypertension with dyslipidemia. To carry out the evidence synthesis of clinical research and provide evidence-based evidence support for clinical decision-making. MethodThe databases including China National Knowledge Infrastructure （CNKI），Wanfang Data Knowledge Service Platform （WF），VIP，SinoMed，Embase，PubMed，Web of Science （WOS），and the Cochrane Library were searched for randomized controlled trials （RCT） of all listed Chinese patent medicines in the treatment of hypertension with dyslipidemia from the establishment of the databases to April 15，2023. The literature was screened and extracted，and the risk of bias tool 2.0 （RoB2） was used to assess the quality and risk of bias of the methodology. Revman 5.4.1 software was used to analyze the outcome indicators. Grading of Recommendations Assessment，Development and Evaluation （GRADE） was applied to assess the quality of evidence formed by clinical research data. The inclusion and recommendation of Chinese patent medicines in the National Drug Catalogue for Basic Medical Insurance，Work-related Injury Insurance and Maternity Insurance （2022） and domestic guidelines and consensus were searched to form a bubble chart. ResultA total of 15 studies were included. The evaluation of the methodological quality of each study showed that the risk of bias stemmed from the lack of blinding and allocation concealment，and low sample size. The comprehensive analysis of clinical studies showed that Dengzhan Shengmai capsules combined with rosuvastatin and amlodipine besylate，Yindan Xinnaotong capsules combined with simvastatin and levamlodipine tablets，Xiaoshuan Tongluo capsules combined with nifedipine controlled release tablets and pravastatin sodium tablets，Xinshubao capsules combined with atorvastatin calcium tablets and irbesartan，Wenyading capsules combined with enalapril，and Jiangzhining tablets combined with conventional Western medicines were all superior to conventional Western medicines used in the control group in improving systolic blood pressure （SBP），diastolic blood pressure （DBP），cholesterol （TC），triglyceride （TG），low density lipoprotein cholesterol （LDL-C），and high density lipoprotein cholesterol （HDL-C）. There was no significant difference in the incidence of adverse reactions between the two groups. The GRADE evaluation of the main outcome indicators showed that the evidence quality of SBP and incidence of adverse reactions was graded as B，that of DBP as C，and that of total TC，TG，LDL-C，and HDL-C as D. The evaluation of Chinese patent medicines covered by medical insurance and recommended by guidelines and consensus showed that Yindan Xinnaotong soft capsules，Dengzhan Shengmai capsules and Xiaoshuan Tongluo capsules belonged to class B drugs of medical insurance，and were recommended for 7，6 and 3 times in the guidelines and consensus，respectively. ConclusionCompared with simple medicine treatment，Chinese patent medicine combined with conventional Western medicine has more advantages in improving blood pressure and blood lipid，and shows higher safety. Among them，Yindan Xinnaotong soft capsules，Dengzhan Shengmai capsules and Xiaoshuan Tongluo capsules have stronger clinical applicability and economy. All the trials included in this article adhered to the principle of randomization and reported the outcome measures. However，the quality of evidence in related clinical studies was low. In terms of trial design，large-sample，multi-center，blinded randomized controlled trials based on the consolidated standards of reporting trials （CONSORT） statement are still needed for comprehensive trial designs and reporting，to further improve the GRADE quality evaluation and guideline formulation under the guidance of evidence-based medicine，so as to provide higher quality evidence-based research evidence for clinical decision-making.
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The standardization of classification methods of Traditional Chinese Medicine(TCM) ancient books can provide a clear and reliable reference for all kinds of TCM ancient books collection units, which can also promote the sharing and utilization of TCM ancient books. We studied and investigated the classification methods of TCM ancient books in past dynasties. The standard on classification of TCM ancient books was formulated by compared with the classification table of Zhongguo Zhongyi Guji Zongmu, and referred to the classification table of Zhonghua Guji Zongmu. This standard specified three-level categories and classification principles of TCM ancient books, and mainly composed of basic categories, three-level category table, classification principles and examples, and instructions for use.
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This study was aimed to explore clinical functions of consensus-based clinical practice guidelines (CB CPGs) in traditional Chinese medicine (TCM). Under the guidance of the State Administration of TCM, 42 TCM hospitals in China had conducted a questionnaire survey for 73 CB CPGs and 2993 questionnaires had been included and analyzed. According to the category of good, general and bad, the proportion of the good in improving safety performance was 69.43%, controlling cost was 58.57%, regulating medical behavior was 55.50%, improving clinical effectiveness was 46.74%. It was concluded that the CB CPGs had played a good role in improving safety performance and controlling cost in TCM clinical practice.
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Despite a recent American Heart Association (AHA) consensus statement emphasizing the importance of resistant hypertension (RH), its control is still a challenge for conventional medicine. The Chinese herbal formula, Qutan Huayu Fang, has been used effectively to assist antihypertensive agents in blood pressure control, but its effect for RH patients is still unclear. This pilot study aims to explore the effects of taking the formula in addition to antihypertensive medication in the management of RH.
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The development, application and revision of the clinical practice guideline (CPG) in traditional Chinese medicine (TCM) are a whole thing. However, the development and revision of TCM CPGs have been influenced due to lack of TCM CPGs reporting and feedback channel. Therefore, during the TCM standardization network establish-ment, we studied the application model of TCM CPGs with spontaneous reporting network, in order to provide the ba-sis for further TCM CPGs development and revision.
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It is an urgent task to transform scientific research achievements on traditional Chinese medicine (TCM) into standard for the science and technology workers of TCM. The transformation not only improves the level of TCM standard, but also promotes the scientific research achievement on TCM into productivity. The Medium and Long-Term Strategic Development Plan for TCM Standardization issued by the State Administration of TCM of the People's Republic of China put forward reinforcement of study on method for transformation of TCM scientific research achievement into standard. Thus, this paper presented seven steps for the transformation on the basis of the TCM Standardization Regulation (trial) in order to provide some references.
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This study was based on the project prophase of expert consultation and literature consult, and aimed to analyze the medicine establishment from the perspective of traditional Chinese medicine (TCM) doctors, in order to further study the influence of medical insurance on the development of TCM. Detailed suggestions were made in or-der to promote the benign development trend of TCM and medical insurance. Questionnaire survey was used in the investigation on perceptions of TCM related with medical insurance among 253 TCM doctors in appointed medical institution of medical insurance. Data was processed with frequency statistics. The results showed that after becoming the appointed medical institution of medical insurance, the medical insurance patients have become the main service group (73.5%) of hospitals (68.4%) and incomes of TCM doctors (41.9%) have increased, which contribute to TCM hospitals of becoming bigger and stronger (63.6%). The medical insurance patients have chosen TCM treatment main-ly for its curative effect (37.9%) and safety (24.1%). The influence of reimbursement ratio in medical insurance was relatively low (1.2%). The reimbursement range of TCM medical insurance needs to be further expanded, such as Chinese medicine nosocomial preparation (90.5%), decoction preparation fee (78.3%), and etc. It was concluded that under the background of universal health coverage, medical insurance plays a more and more important role in the development of TCM. And TCM should ensure its safety and improve its curative effect through the standardization of TCM and other measures. Meanwhile, the formulation of medical security policy and medical insurance management service standards should also consider the characteristics of TCM, and encourage the service of TCM.
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Traditional Chinese medicine (TCM) standardization serves as an important foundation of TCM modernization and internationalization, and TCM standardization strategy is the core of the subject. Recently, some developed countries and developing countries with a better economic basis have set development strategy for TCM standardization. China is at the beginning on TCM standardization strategy study. This paper explored the methods for setting TCM standardization development strategy. Firstly, strengths, weaknesses, opportunities and threats of TCM were analyzed based on SWOT method to set development tactics. On the above basis, the authors defined the total goal and stage goal under the guidance of the relevant laws and regulations. To achieve the strategic goal, priority areas were formed by literature analysis and expert inquiry method, and the safeguard measures were formulated by expert symposium. Secondly, the draft for development strategy of TCM standardization was made based on the above content. Finally, the authors revised and formed the official development strategy of TCM standardization.
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So as to explore the relationship between hypertension happen and combined phlegm and blood stasis,aswell as relations to fi ve zang-viscera,we analysis and study the related articles in literatures of past dynasties about phlegm,blood stasis with dizzy and headache,fi ve zang-viscera with dizzy and headache.We fi nd that there are relationships between phlegm and dizzy and headache,between blood stasis and dizzy and headache,between fi ve zang-viscera and dizzy and headache,as well as between phlegm,blood stasis and disorders of functions of fi ve zang-viscera.Thus,phlegm induces dizzy and headache,blood stasis induces dizzy and headache,the disorders of functions of fi ve zang-viscera cause phlegm or blood stasis,and the diseases of fi ve zang-viscera induce dizzy and headache.Therefore,the happen of dizzy and headache in hypertensive disease has direct or indirect relationships with diseases of fi ve zang-viscera,which should be noticed in clinical treatment.In clinical practices,we fi nd that in the f ive zang-viscera,the heart and kidney have the close relationship with hypertension.In literatures of past dynasties,the discuss about combined phlegm and blood stasis inducing diseases can be found,but there are no records about combined phlegm and blood stasis inducing dizzy and headache,though that is one of the most important pathological factors of hypertension happen in clinical treatment,so we should pay attention to combined phlegm and blood stasis in the treatment of hypertensive disease.
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Hypertension is a common vascular disease.The rate of deformity and mortality initiated by hypertension has been increasing year by year.The patients with hypertension will take life-long western medicine.However,Chinese Medicine does well in treating grade Ⅰand Ⅱhypertension,which can make some patients reduce and stop taking western medicine and stabilize their blood pressure.This guideline assembled all the experts' experience and expertise from Cardiopathia Committee of China Association of Chinese Medicine,which was also based on nearly thirty-year literature searching about essential hypertension home and abroad.Furthermore,we mainly classi ed TCM syndromes and made treatment principles according to our achievement in the last decade and six expert consensus conferences.Besides,some information about nursing,prevention and rehabilitation is also discussed for the sake of preventing and reducing essential hypertension and its complications,which is according to the theory of "Preventive Treatment of Disease" of Nei Jing.This article will introduce such a guideline that we want to gather di erent opinions and suggestions all over our country in order to improve curative e ect in practice.
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The Subject of heart disease in TCM is a clinic subject specially to study heart system diseases.Because of its broad contents and complex syndromes,its treatment method is gradual and should follow the principle of individual symptom characteristics.In order to improve therapeutic effects for the treatment of these diseases,Professor Shen Shaogong raises a new method of "Modular Syndrome Classification" based on numbers of clinical experiences,and as well decides whole project.In this project,"Deficiency" includes three modules,and superficiality of Excess also includes three modules.In each unit,there are 1 host symptoms and 1 concurrently symptom,as well as tongue and pulse,especially tongue.In the treatment of heart system diseases,above items can be combined according to clinical appears to form symptom-complex.This combination method is called symptoms and signs differentiation and classification method,which can not only affect the actual pathological changes of diseases objectively,but also meet to various changes of diseases actively.So this method can make differentiation accuracy relatively.