Millimeter Hg Up and Down： Who has the final say in the diagnostic criteria of hypertension？ The dispute between the old and new guides？
"Every time the diagnostic method or standard of a disease changes, it is decided by the industry or society. The Health and Health Commission is a management and decision-making body. With the deepening of diagnosis and application in the industry, the National Health and Health Commission has made adjustments according to the actual health economics. "
"The current dispute mainly lies in clinical standards and subsequent medical economics issues, which is equivalent to the dispute of school views."
On November 13th, "Clinical Practice Guide of Hypertension in China" was released, and it was recommended to lower the diagnostic standard of hypertension to 130/80 mmHg. On November 13th, the Clinical Practice Guideline for Hypertension in China (hereinafter referred to as "Clinical Practice Guideline"), which was jointly formulated by the National Cardiovascular Center, the Chinese Medical Doctor Association, the Hypertension Professional Committee of the Chinese Medical Doctor Association, the Cardiovascular Branch of the Chinese Medical Association and the Hypertension Professional Committee of the Cross-Strait Medical and Health Exchange Association for two years, was released. It is recommended that the diagnostic standard for hypertension be lowered from 140/90 mmHg to 130/80 mmHg.According to the People’s Daily Health Client, Professor Han Yaling, academician of China Academy of Engineering and General Hospital of Northern Theater, delivered a speech at the press conference that day, pointing out that the clinical practice guideline was issued under the guidance of National Health Commission.
According to the data of the national hypertension survey conducted in China from 2012 to 2015, if the diagnostic standard of hypertension is lowered to ≥130/80mmHg, the prevalence rate of hypertension among adults over 18 years old in China will double, from 23.2% to 46.4%. One in every two adults over the age of 18 is hypertensive; Nearly 70%-80% of people over 55 suffer from hypertension. At that time, it was predicted that the number of patients with hypertension in China would increase by 245 million, from 245 million to 490 million. According to the data of the seventh national census, it is estimated that the number of patients with hypertension in China will increase by more than 300 million.
However, "at present, the state has not adjusted the diagnostic criteria for adult hypertension." On the evening of November 15th, National Health Commission released a message saying that regarding the diagnostic criteria of hypertension, the publicity and education points, prevention and treatment guidelines and clinical pathways issued by the national health administrative department in 2005, 2010 and 2017 were all clear: the diagnostic criteria of adult hypertension were that the blood pressure exceeded 140/90mmHg for three times on the same day.
A debate about clinical benefits and social costs has begun, and clinical practice guidelines have aroused different voices of support and opposition in the medical field. What is the background of the release of clinical practice guidelines, whether it is suitable for the characteristics of China population, and what impact will it bring? 澎湃 Science and Technology reporter interviewed a hypertension expert who participated in the formulation of the guidelines. He said that the new guidelines started from the perspective of China, a country with a high incidence of cardiovascular and cerebrovascular diseases, and moved forward the "prevention before disease" barrier, which included the idea of "national health". "But this does not mean that the time for drug prevention and control has also moved forward."
Professor Liu Lisheng, director of Beijing Hypertension Association Research Institute and former president of the World Hypertension Association, recently told the industry from the media "medical field" that there is no high-quality evidence that drug treatment will achieve obvious benefits when blood pressure is in the range of 130 ~ 139 mmHg/80 ~ 89 mmHg.
澎湃 Science and Technology reporter tried to contact the sponsor and chief expert of this clinical practice guideline, Professor Cai Jun from the National Cardiovascular Center, Fuwai Hospital of China Academy of Medical Sciences, and Professor Liu Lisheng who clearly expressed "opposition" in this debate, but no response was received. Professor Liu Lisheng told the 澎湃 technology reporter: "National Health Commission has clearly replied and will not be interviewed for the time being."
ⅮⅮ‣ Science and Technology reporter noted that "Clinical Practice Guide of Hypertension in China" will be officially published in the 11th issue of chinese journal of cardiology in 2022 on November 24th. This paper belongs to the project of Disease Prevention and Control Bureau of National Health and Wellness Committee (T2021-ZC02) and the fund project of Medical and Health Science and Technology Innovation Project of China Academy of Medical Sciences (2021-I2M-I-007).
However, before the clinical practice guidelines appeared, China had the Guidelines for the Prevention and Treatment of Hypertension in China. Taking the revised edition in 2018 as an example, the participating institutions of China Hypertension Prevention and Control Guide include: Hypertension Union (China), Cardiovascular Branch of Chinese Medical Association, Hypertension Branch of China Association for the Promotion of International Exchange of Health Care, Hypertension Branch of China Geriatrics Association and Hypertension Professional Committee of Chinese Medical Doctor Association. Professor Liu Lisheng served as the chairman of the revision committee of Guidelines for Prevention and Treatment of Hypertension in China, and Professor Wang Jiguang of Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine served as the deputy chairman. Cai Jun participated in the work of the writing committee.
It is reported that the 2022 revised edition of Guidelines for Prevention and Treatment of Hypertension in China will be officially published at the end of this year, and Professor Liu Lisheng is still the chairman of the revision committee.
In 2020, the National Health and Wellness Commission appointed the Clinical Epidemiology and Evidence-based Medicine Branch of the Chinese Medical Association to update the Guiding Principles for Formulating/Revising Clinical Diagnosis and Treatment Guidelines in China, which was published in the Chinese Medical Journal on March 15th this year. The guiding principle clearly points out that the formulation of guidelines should follow more rigorous, standardized and objective methods and processes. It is required that the guideline makers explain the basic information, background, formulation methods, evidence, recommendations and related steps of the guideline, which further increases the scientificity and transparency of the guideline formulation process.
Some experts suggested that the guidelines need to invite clinical pharmacy, nursing, medical technology, evidence-based medicine experts, health economics experts and even patient representatives to discuss what kind of diagnosis and treatment measures are really best for patients.
A clinician from a top-three hospital in Shanghai told 澎湃 Technology, "The standards need to be revised based on high-quality clinical research data. This guide should be made, not published. It cannot be a guide with different intentions and concerns. " Focusing on this dispute about lowering the threshold of hypertension, the doctor said, "After the adjustment, there will be 250 million new patients in China, which will bring a series of problems in the future, so we must not be too hasty."
Another cardiologist in Shanghai’s third-class hospital told the 澎湃 science and technology reporter: "The diagnosis of hypertension is not decided by the Health and Health Commission. The national diagnostic criteria for diseases are more used for the management and charging of single diseases. Therefore, National Health Commission said: The guidelines and consensus issued by professional organizations, trade associations and individuals are the research results of experts, not the national standards for disease diagnosis. Every time the diagnostic method or standard of a disease changes, it is decided by the industry or society. The Health and Health Commission is a management and decision-making body. With the deepening of diagnosis and application in the industry, the National Health and Health Commission has made adjustments according to the actual health economics. "
Does the lowering of the standard mean that the treatment is advanced?
In the last century, the famous Framingham study in the United States set the threshold of hypertension as 160/95mmHg, which made people realize that hypertension is a disease that needs to be prevented and treated. With the deepening of research, the threshold of hypertension has been adjusted to 140/90mmHg, and 130/80mmHg-140/90mmHg belongs to normal high blood pressure, which also needs attention and has become an international clinical consensus.
In 2017, the American Heart Association/American Heart Association (ACC/AHA) took the lead in breaking through the convention and lowered the diagnostic standard of hypertension to 130/80mmHg. 130~139/80~89 mmHg is grade 1 hypertension and ≥140/90 mmHg is grade 2 hypertension. However, the European Society of Cardiology (ESC/ESH) and the International Society of Hypertension updated the guidelines in 2018 and 2020 respectively, and both still used the diagnostic criteria of 140/90 mmHg. In 2022, the World Health Organization Guidelines for Drug Treatment of Adult Hypertension recommended drug treatment for high-risk people with systolic blood pressure of 130-139mmHg, while non-high-risk people did not recommend drug treatment.
Once the American guide was published, it caused a heated discussion in the medical field in China. The main questions are whether the active classification and treatment concept of hypertension in the United States is applicable to China population, and there is still a lack of large-scale clinical investigation on the number of people within the two thresholds and their cardiovascular disease risks.
In this regard, the research team in anzhen hospital gave some answers. They analyzed the data of more than 20 years’ follow-up of 21,441 residents over 35 years old who had no cardiovascular disease in many provinces of China. The study showed that among the young and middle-aged people aged 35-59, the risk of cardiovascular disease increased significantly in those with blood pressure of 130-139/80-89 mmHg. Compared with those with blood pressure less than ＜120/80 mmHg, their risk of cardiovascular disease increased by 78%, the risk of coronary heart disease increased by 77% and stroke increased. This study, published in 2018, supports the importance of early blood pressure control among young and middle-aged people.
Professor Zhao Dong from Beijing anzhen hospital, a participant in the above research, pointed out in the press conference of Clinical Practice Guide on November 13th that "most people with blood pressure levels of 130~139 mmHg and/or 80~89 mmHg are young and middle-aged, and lowering the diagnostic criteria reflects the concept of moving forward the defense line and strengthening the initial prevention."
"The new guidelines (Guidelines for Clinical Practice of Hypertension in China) actually pay more attention to making people realize the importance of preventing hypertension. In fact, in essence, the new guidelines did not move forward to start the boundary of hypertension drug treatment, it just moved forward to prevent hypertension drugs. " A hypertension expert who participated in the formulation of the guide told the 澎湃 technology reporter.
According to its introduction, the new guidelines point out that when the patient’s blood pressure is 130~139/80~89mmHg, it is necessary to first make 90 days of therapeutic lifestyle changes, such as low salt and sugar in diet. After that, if the blood pressure has not been lowered, consider drug intervention. And if it is accompanied by other diseases such as kidney, it needs direct intervention in drug treatment, which is called "intensive hypotension" academically.
Which is more important, clinical benefit or cost?
It is worth mentioning that in May this year, the Taiwan Province Cardiology Society and the Taiwan Province Hypertension Society (TSOC/THS) also updated the Guidelines for Hypertension in Taiwan Province, suggesting that the family self-test blood pressure should be ≥130/80 mmHg as the diagnostic standard for hypertension, which is mainly based on the results of two tests from SPRINT in the United States and STEP in Chinese mainland.
SETP trial is a multicenter randomized controlled trial led by Professor Cai Jun from National Cardiovascular Center and Hypertension Center of Beijing Fuwai Hospital of China Academy of Medical Sciences. He is also the initiator and chief expert of this clinical practice guide.
In this study, 60-80-year-old hypertensive patients in China were randomly divided into two groups, and the systolic blood pressure targets of the two groups were set at 110-< 130 mm Hg (intensive blood pressure reduction) or 130-< 150 mm Hg (standard blood pressure reduction) respectively. Last year, the research results were announced: compared with the standard antihypertensive group, intensive hypotension can reduce the risk of major cardiovascular complex outcomes by 26%, acute coronary syndrome by 33%, stroke by 33% and acute uncompensated heart failure by 73%. And that risk of serious adverse events of the patient is not increase. This shows that antihypertensive therapy can significantly reduce the relative risk of cardiovascular disease in elderly hypertensive patients.
However, most people in the range of 130 ~ 139 mmHg/80 ~ 89 mmHg are young and middle-aged, and the evidence is not clear whether they can benefit from drug treatment. Professor Liu Lisheng said recently that there is no high-quality evidence that drug therapy will achieve obvious benefits when blood pressure is in the range of 130 ~ 139 mmHg/80 ~ 89 mmHg.
Professor Wang Jiguang, director of Shanghai Institute of Hypertension and Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine, also pointed out in an interview with the First Financial Reporter, "So far, no published randomized controlled clinical study at home and abroad has confirmed that it can benefit from antihypertensive drugs for non-high-risk patients with blood pressure of 130-139/80-89mmHg, and no study has confirmed the safety of drug treatment for this group of people."
According to a report published in China in May this year, a CHINOM study of China population found that taking antihypertensive drugs could not reduce the risk of cardiovascular and cerebrovascular diseases (none of the three antihypertensive drugs could) among non-high-risk individuals aged 45-79 years in China, and it might even bring a harmful trend. The results of CHINOM research are being compiled and published.
Accordingly, Wang Jiguang believes that lowering the diagnostic criteria of hypertension is not in line with the national conditions of hypertension control in China, and will greatly increase the disease burden of hypertension prevention and control in China.
Professor Cai Jun said in an interview with "Clove Garden Cardiovascular Time", "Although in the short term, patients’ medication costs increase, in the long term, patients’ cardiovascular-related serious complications (such as myocardial infarction, heart failure and stroke) are greatly reduced, and the overall cost is reduced. And with the current medical insurance policy and the wide coverage of national collection, the cost of medication for hypertensive patients can be controlled within 100 yuan for one year, and the country will not bear more economic burdens. "
Zhao Dong also believes that lifestyle intervention for people with 130-139 mmHg and/or 80-89 mmHg and starting antihypertensive drug therapy when non-drug therapy fails are important window periods to reduce the adverse consequences of hypertension, which is "cost-effective on the whole."
"Early diagnosis and early treatment is the initial heart of the guide." Professor Li Yuming, deputy dean of TEDA International Cardiovascular Hospital and director of the National Cardiovascular Disease Management Capability Assessment and Improvement Project (CDQI) Hypertension Center, also told the reporter of the technology, "Blood pressure exceeding 130mmHg is already a great health risk, and our cardiovascular doctors know very well that if it exceeds this standard, we must find a way to get down, and we cannot stop doing it because it is difficult."
Who is in charge of the national diagnostic criteria?
"At present, the state has not adjusted the diagnostic criteria for adult hypertension." On November 15th, National Health Commission announced that regarding the diagnostic criteria of hypertension, the publicity and education points, prevention and treatment guidelines and clinical pathways issued by the national health administrative department in 2005, 2010 and 2017 were all clear: the diagnostic criteria of adult hypertension were that the blood pressure exceeded 140/90mmHg for three times on the same day.
According to the 2018 edition of "Guidelines for the Prevention and Treatment of Hypertension in China", hypertension is defined as: without using antihypertensive drugs, the blood pressure in the clinic is measured three times on the same day, with systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg. According to the level of elevated blood pressure, hypertension is further divided into three levels. Blood pressure is a normal high value when it is 80 ~ 89 mmHg/130 ~ 139 mmHg.
"The state has standardized procedures for the development of diagnostic standards for diseases such as hypertension. Guides, consensus, etc. published by professional organizations, industry associations, individuals, etc. are the research results of experts and are not used as national disease diagnosis standards. " The national health and health commission said.
The above-mentioned experts, who did not want to be named, said that the "Guidelines for Prevention and Treatment of Hypertension in China" was promulgated by the China Hypertension Alliance, and National Health Commission and other government departments made a decision according to the guidelines formulated by the Hypertension Alliance, and then comprehensively considered the actual situation of China. "Therefore, the consideration of hypertension standards should integrate scientific factors and actual conditions such as medical insurance, which are indispensable."
In an interview with China Business News, Wang Jiguang made it clear that the 2022 edition of "Guidelines for Prevention and Treatment of Hypertension in China" is currently being updated and is expected to be released at the end of the year. China Hypertension Union, Hypertension Branch of China Medical Care Association for the Promotion of International Exchanges, Hypertension Branch of China Geriatrics Association, National Health Commission Key Laboratory of Hypertension Diagnosis and Treatment, and Shanghai Hypertension Research Institute have jointly submitted a statement to National Health Commission, stating their position of "opposing the downward adjustment of standards" and giving relevant suggestions.
He pointed out that before the new 2022 edition of the Guidelines for Prevention and Treatment of Hypertension in China was officially released, the diagnosis, treatment and management of hypertension should still be carried out according to the guiding principles of the 2018 edition of the Guidelines for Prevention and Treatment of Hypertension in China.
At present, there are more than 1,000 clinical guidelines and expert consensus published annually in China, but the overall quality is mixed and there is a gap with international guidelines. In 2020, the National Health and Wellness Commission appointed the Clinical Epidemiology and Evidence-based Medicine Branch of the Chinese Medical Association to update the Guiding Principles for Formulating/Revising Clinical Diagnosis and Treatment Guidelines in China, which was published in the Chinese Medical Journal on March 15, 2022. The 2022 edition of the guidelines added four important contents: pre-registration, writing a plan, and managing conflicts of interest and normative reports.
Last year, the WHO Cooperation Center for Guideline Implementation and Knowledge Transformation, together with the Guideline and Standards Research Center of the Chinese Medical Association Magazine, developed the Guideline Comprehensive Rating Tool (STAR), which has incorporated nearly 2,000 medical guides and consensus. STAR also regards managing conflicts of interest as an important indicator.
It is worth mentioning that, according to the knowledge of the reporter of the technology, the methodological support units of the China Clinical Practice Guide for Hypertension, which lowered the diagnostic standard of hypertension, include: the Innovation Unit of Evidence-based Evaluation and Guide Research of China Academy of Medical Sciences, the Guide and Standard Research Center of Chinese Medical Association Magazine, the Health Data Science Research Institute of Lanzhou University, and the GRADE Lanzhou University Center. The numbers of "Registration and Writing Plan" are: International Practice Guide Registration and Transparency Platform (PREPARE), Chinese-English Bilingual Registration (IPGRP2021CN346) and Writing and Publishing Guide Plan (DOI: 10.3760/CMA.J.CN112148-2021126-01021).
"In the process of formulating the guidelines, many hospitals participated in the collection of clinical evidence, and the whole guideline also brought together the consensus of experts." The above-mentioned unnamed experts believed that although the new guidelines recommended five categories of antihypertensive drugs, involving a complicated multi-interest chain, there was no promotion from stakeholders.
Cai Jun also said that the downward adjustment of the diagnostic threshold of hypertension in this practice guide was unanimously voted by 50 top experts in the cardiovascular field in China. "Providing patients with better health education, correct ideological guidance and timely supply of collected drugs to all parts of the country are the key points in the future."
Li Yuming said that the guidelines were formulated in accordance with the standard, and were finally decided after discussion by the Chinese Cardiovascular Branch and the National Cardiovascular Center. He does not comment on the voices of various societies. "As long as they are inclusive and rational, they can all discuss each other."
"The current dispute mainly lies in clinical standards and subsequent medical economics issues, which is equivalent to a dispute of school views." A scientist engaged in basic research in Shanghai told the reporter that he also noticed the debate about hypertension. He believes that hypertension has no objection in basic scientific research.
"There is no doubt about the importance of lowering blood pressure. From a scientific point of view, it is necessary to understand the harm of high blood pressure and what is the mechanism of lowering blood pressure." There are generally international and China clinical guidelines for related diseases. The scientist said, "Generally, they follow China’s. However, (doctors) have freedom and no regulations. "
(This article is from The Paper, please download the "The Paper" APP for more original information)
Reporting/feedback