Traditional Chinese medicine has a history of more than 2, 000 years and has been widely used in clinical practice. However, due to the lack of a reliable scientific basis, the role of traditional Chinese medicine in the prevention and treatment of coronary artery disease is not clear. At present, the existing randomized controlled trials about traditional Chinese medicine for coronary artery disease have defects, small sample sizes, and different results, so it is difficult to make a clear conclusion on the actual advantages and disadvantages of traditional Chinese medicine. In this review, the efficacy and safety of traditional Chinese medicine in the prevention and treatment of coronary artery disease were systematically evaluated through randomized controlled trials, most of which were double-blind trials. We reviewed 17 randomized controlled trials that included a total of 11, 726 coronary artery disease patients. The methodological quality of the trials was generally high, with nine (52.94%) having a modified Jadad score of 7 and only three (17.65%) having a modified Jadad score of <3. There are 16 trials (94.12%) reporting safety; the safety of traditional Chinese medicine seems not to be inferior to that of mimetic, placebo, or western medications. Moreover, the results from 17 randomized controlled trials (100.00%) showed that traditional Chinese medicine can be applied as a complementary and alternative method to the primary and secondary prevention of coronary artery disease, and only six trials (35.29%) described adverse cardiovascular events specifically. However, it is necessary to assess the safety and efficacy of traditional Chinese medicine in treating coronary artery disease with long-term hard endpoints.
In recent years, due to various reasons, such as an aging population, the number of cardiovascular diseases has risen sharply (1–3). Mortality related to cardiovascular diseases is also rapidly escalating worldwide and brings a great threat to global health (4). Either incidence or mortality of coronary artery disease (CAD) accounts for a large part of cardiovascular diseases (5–7). In the United States, CAD accounts for more than two-thirds of all cardiovascular diseases, and almost half of Americans have at least one risk factor (8). In Europe, cardiovascular mortality was higher in middle-income countries where it accounted for a greater proportion of potential years of life lost compared with high-income countries (9). Situations in Asian countries are not better than in western countries (10). Most countries in Asia are experiencing the challenges from CAD, with the mortality rate varying from 103 to 366 per 100, 000 adult populations (11). In the clinic, CAD is often mainly divided into stable CAD (SCAD, namely, chronic myocardial ischemia syndrome) and acute coronary syndrome according to the latest clinical practice guidelines, and the treatment is mainly based on lifestyle management, medical treatment (including conventional western medications and Chinese medicine), and revascularization (12). Despite the use of medical treatment and revascularization, there is still much room for improving efficacy and reducing adverse reactions (13).
Traditional Chinese medicine (TCM), mainly from the East, has shown its idiographic ascendancy in the prevention, therapeutic effect, rehabilitation, and healthcare of diverse diseases (14–16). The evidence-based application of TCM keeps a foothold in China and other Asian countries, and with the popularity of TCM in the East, it is increasingly accepted and used by other countries in the world (17, 18). TCM doctors often prescribe a personalized mixture of herbs, characterizing holistic view and syndrome differentiation, to a patient (16). Thus, TCM opens new perspectives for the discovery and development of relevant drugs since it is a more systemic approach to preventing and treating diseases (16), resulting in a rethinking of the importance of TCM (19). So far, more and more randomized controlled trials (RCTs), which are taken to be the gold standard of testing efficacy and safety of therapies for a wide spectrum of diseases and for informing therapeutic guidelines (20), about TCM for CAD have been issued their results. These reliable results not only spur the modernization of TCM but also bring us stronger confidence in the management of CAD. However, we have to admit that RCTs of TCM were carried out relatively late, and these RCTs use surrogate endpoints, have small sample sizes, short follow-up, and diverse outcomes. Here, we critically evaluate the efficacy and safety of TCM in patients with CAD with available evidence from RCTs.
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Two reviewers (BL and NG) searched PubMed, comprising more than 32 million citations for biomedical literature from MEDLINE, Life Science journals, and online books, through the National Center for Biotechnology Information, U.S. National Library of Medicine, for particular RCTs comparing the efficacy and safety of TCM in patients with CAD with language limited to English.
Inclusion criteria for RCTs: (1) Participants with definite diagnoses of CAD, including stable angina, unstable angina, myocardial infarct (MI), SCAD, and coronary artery bypass grafting, made with accepted western medicine methods. (2) The efficacy and/or safety of TCM were assessed. The assessment indicators included, but were not limited to, hard endpoints and surrogate endpoints, such as Chinese medicine syndrome, 6-min walking test, ultrasound echocardiography, serum markers, hemodynamic examination, side effects, and cardiovascular mortality. All clinical indicators were compared with no intervention or placebo, or western medications.
Exclusion criteria for RCTs: (1) The sample size was <50. (2) The follow-up duration was <2 weeks. (3) RCTs only reported symptomatic changes without any objective measurements.
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When studies or data duplication were found, only the latest or most complete studies were included. We assessed the trials' methodological quality using the modified Jadad score scale. Two reviewers (BL and NG) extracted the data and assessed quality independently. Any disagreements were resolved by discussion. Extracted information was summarized on standardized reporting forms (Table 1). Although we only included RCTs, which means methodological heterogeneity is acceptable, the clinical heterogeneity is so substantial that we cannot aim to perform a meta-analysis pooling the results.
Stable angina is a common symptom of stable CAD (13). The researchers conducted an RCT to assess the efficacy and safety of Wufuxinnaoqing Soft Capsule (五福心脑清胶囊), which has been widely applied to angina for about 30 years, for chronic stable angina (in line with blood stasis syndrome in TCM). It is concluded that Wufuxinnaoqing Soft Capsule could decrease angina attacks and nitroglycerin consumption, relieve angina severity degree, and effectively reduce the blood stasis syndromes after a 12-week treatment, and it was safe during the follow-up (21). Another double-blind RCT of 187 patients with angina after the percutaneous coronary intervention was conducted to confirm the efficacy and safety of Shenzhu Guanxin Recipe (参术冠心方), and the results showed a larger reduction in angina pectoris score, TCM symptom score, and Seattle Angina Questionnaire score in patients given Shenzhu Guanxin Recipe from pretreatment to 12-month follow-up assessment. Again, the data showed that the safety of Shenzhu Guanxin Recipe was acceptable (22). A phase IV double-blind, randomized, and placebo-controlled study conducted at 12 centers in China indicated that after 4-week treatment with Guanxinshutong Capsule (冠心舒通胶囊), the quality of life was substantially improved, and the number of angina attacks and the consumption of short-acting nitrates were significantly reduced (23). Both of these studies were based on the premise of standard western medication treatment with TCM, and there was no positive control group, so the study on Shengjie Tongyu Granule (升解通瘀颗粒) was born. In this study, Tongxinluo Capsule (通心络胶囊), which is clinically recognized as the effective drug in treating angina (25, 37–39), was used as a positive control drug to study the effect of Shengjie Tongyu Granule for angina. The results showed that the angina score and TCM score of the two groups were all significantly improved after the treatment, but there was no statistical significance in comparison between groups, suggesting that Shengjie Tongyu Granule can effectively improve the clinical symptoms of patients with angina, with the curative effect similar with Tongxinluo Capsule (24).
Unstable angina is a clinical manifestation between exertive stable angina pectoris and acute MI and sudden death. Sixty patients with unstable angina were randomly assigned to two groups to determine the efficacy of add-on therapy of Xin'anning Nasal Drop (心安宁滴鼻剂) for unstable angina, and the results indicated the rapid relief effect of Xin'anning Nasal Drop (40). Another RCT divided a total of 90 unstable angina with blood stasis syndrome in TCM after successful percutaneous coronary intervention population into three groups [Xuefu Zhuyu Capsule (血府逐瘀胶囊) group, Shengmai Capsule (生脉胶囊) group, and placebo group]. After 4 weeks of treatment with corresponding medications, patients in the Xuefu Zhuyu Capsule group had better efficacy on clinical symptoms and signs and blood stasis syndrome scores, and health-related quality of life in those populations compared with those in other groups (26). Sun and his colleagues conducted an RCT that included 72 patients with unstable angina to demonstrate that the treatment of Danhong Injection (丹红注射液) for 2 weeks can reduce homocysteine, high sensitivity C-reactive protein, and N-terminal pro-brain natriuretic peptide of patients with unstable angina (27).
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Nearly 5, 000 Chinese patients who experienced a previous MI and average low-density lipoprotein cholesterol levels at baseline were assigned to placebo to Xuezhikang (血脂康) to test the effects of Xuezhikang on lipoprotein and cardiovascular endpoints. After a 4.5-year therapy,
Nearly 5, 000 Chinese patients who experienced a previous MI and average low-density lipoprotein cholesterol levels at baseline were assigned to placebo to Xuezhikang (血脂康) to test the effects of Xuezhikang on lipoprotein and cardiovascular endpoints. After a 4.5-year therapy,
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