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Traditional Chinese medicine (TCM) is one of the ancient healing practices with a history of more than 2,500 years and unique theories that has been making great contributions to human healthcare. It includes Chinese herbal medicine, food therapy, acupuncture, moxibustion, massage (
Currently, rigorous “totality of evidence” of the classic formulas of TCM that includes chemical standardization, biological assays, experimental studies, and clinical trials is receiving increasing attention from modern medicine. Several paradigms in the clinical and translational research efforts on the classic formulas of TCM, such as
Clinical evidence and advances in translational research in Classic Formula of TCM.
| Classic formula of TCM | Disease | Components | TCM efficacy | Pharmacological mechanism | Author’s comments | TCM classification | Additional explanation | References |
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Masked hypertension | Rhizoma Gastrodiae ( |
Calming the liver, suppressing wind, clearing heat, promoting blood circulation, and tonifying the liver and kidney. | Inhibiting sympathetic activity and renin-angiotensin-aldosterone system, blocking L-type calcium channels, improving the vasomotor function, and reducing inflammatory reactions. | The randomized, placebo-controlled trial of 251 participants showed that |
Classic formula of TCM, and Chinese patent medicine |
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Chronic heart failure | Astragalus Membranaceus ( |
Invigorating |
Increasing myocardial contractility, cardiac output, and renal blood flow, reducing ventricular wall thickness and heart index, lowering levels of angiotensin II and aldosterone, and alleviating ventricular remodeling | A multicenter, randomized, double-blind, placebo-controlled study of 512 patients with chronic heart failure demonstrated that |
Chinese patent medicine |
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Impaired glucose tolerance | Astragalus Membranaceus ( |
Tonifying qi and yin, clearing away heat, and promoting salivation. | Regulating the metabolism of glucose and lipid, improving insulin sensitivity, alleviating inflammatory injury, and regulating oxidative stress. | A randomized, double-blind, placebo-controlled trial of 420 patients with impaired glucose tolerance demonstrated that treatment with |
Chinese patent medicine |
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Type 2 diabetes | Pueraria Lobata ( |
Clearing away heat and dampness. | Improving insulin resistance, inhibiting intestinal inflammatory response, promoting intestinal mucosal repair, antioxidant stress, protecting islet β cells, and improving glucose and lipid metabolism. | A randomized, double-blind, controlled trial of 187 patients with type 2 diabetes demonstrated that |
Classic formula of TCM |
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Functional constipation | Hemp Seed ( |
Moistening the intestines, clearing away heat, promoting |
Improving defecation function and peptic protease activity. | A randomized, double-blind, double-dummy, controlled trial of 291 patients with functional constipation identified that |
Classic formula of TCM, and Chinese patent medicine |
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Irritable bowel syndrome | Saposhnikovia Divaricata ( |
Tonifying spleen, smoothing liver, dispelling dampness, and stopping diarrhea. | Anti inflammation, regulating immune function, mood and liver lipid metabolism, and improving intestinal hypersensitivity. | A randomized, double-blind, placebo-controlled trial of 116 patients with irritable bowel syndrome demonstrated that Chinese herbal medicine is effective in the management of symptoms related to irritable bowel syndrome. | Classic formula of TCM |
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H1N1 Influenza | Ephedra ( |
Clearing away heat and toxic material, and relieving the exterior syndrome. | Inhibiting bacteria, antiviral, anti-inflammatory, anti-allergic, antipyretic, and analgesic. | A prospective, nonblinded, randomized, controlled trial of 410 patients with laboratory confirmed H1N1 influenza identified that |
Classic formula of TCM |
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Coronavirus disease 2019 | Forsythia suspensa ( |
Clearing plague and detoxifying, promoting lung, and purging heat. | Broad spectrum antiviral, antibacterial and anti-inflammatory, reducing fever, relieving cough, resolving phlegm, and regulating immune. | A multicenter, prospective, randomized controlled trial including 284 patients with Covid-19 identified that the recovery rate, median time to symptom recovery, time to recovery of fever, fatigue and coughing, the rate of improvement in chest computed tomographic manifestations and clinical cure were significantly improved when compared to usual treatment. | Chinese patent medicine |
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Chemotherapy-induced gastrointestinal toxicity | Scutellaria Baicalensis ( |
Clearing away heat, and reliving diarrhea and pain. | Regulating immunity, inhibiting bacteria, anti-inflammatory, and anti-cancer. |
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Classic formula of TCM |
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Return of spontaneous circulation after in-hospital cardiac arrest. | Red ginseng ( |
Revive the yang for resuscitation, tonifying qi, and preventing exhaustion. | Improving heart failure, anti myocardial ischemia-reperfusion injury, anti arrhythmias, anti shock, improving myocardial energy metabolism and microcirculation, protecting endothelial cells, improving hemodynamics, and regulating blood pressure. | A prospective, randomized, controlled clinical study of 1,022 patients demonstrated that |
Chinese patent medicine |
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Owing to challenges in modern drug research and development such as improving investments and preventing the decline of drug approval, scientists have focused their attention on natural herbs and the classic formulas of TCM to create promising drugs and drug candidates. Derivatives from natural products have been widely used as cornerstones in Western medicine, such as aspirin, digitalis, and paclitaxel. Recently, natural herbs and the classic formulas of TCM-oriented new drug development model have achieved significant breakthroughs, including artemisinin and dihydroartemisinin for malaria (
Given the difficulty of retrieving original literature in Chinese as well as the poor methodological quality of the original clinical trials, such as high risk of bias, unclear reporting of outcome measures, lack of preregistration in an international database, lack of high-level clinical recommendation evidence, and insufficient data reports on the toxicology, pharmacological effects, and adverse effects, several classic formulas of TCM have been regarded as a “mystery” to modern science. Accordingly, more clinical and experimental data are warranted to verify their application values.
A total of 43 papers were received under this Research Topic, out of which eight papers were accepted for publication. The original research articles and reviews in this Research Topic cover a wide range of medical conditions, including essential hypertension, contrast-induced nephropathy after percutaneous coronary intervention, hepatocellular carcinoma, lung cancer, doxorubicin-induced cardiotoxicity, DNCB-induced atopic-dermatitis-like skin lesions, and heat stroke.
Two papers elaborate on the clinical applications of the classic formulas of TCM for cardiovascular diseases.
Three papers clarify the clinical efficacies and mechanisms of the classic formulas of TCM for tumor-based diseases.
Additionally,
In recent times, steadily increasing amounts of evidence have shown that the classic formulas of TCM have important clinical value in the treatment of various conditions, including chronic and infectious diseases. Findings under this Research Topic can significantly promote comprehension of the therapeutic efficacies and potential protective mechanisms of the classic formulas of TCM. Thus, this Research Topic encompasses exploration of new clinical evidence and novel approaches in the application of the classic formulas of TCM to the treatment of various diseases, paving the evidence-based path for the future.
PW: writing–original draft, and review and editing. WC-sC: writing–review and editing. DY: writing–review and editing. YZ: writing–review and editing. XX: writing–original draft, and review and editing.
The authors declare that financial support was received for the research, authorship, and/or publication of this article. This work was supported by the Central High Level Traditional Chinese Medicine Hospital Clinical Research and Achievement Transformation Ability Enhancement Project (Nos. HLCMHPP2023081 and CZ30981), National Natural Science Foundation of China (No. 82174101), Beijing-Tianjin-Hebei Basic Research Cooperation Special Project (No. J230037), Joint Research and Development Project of China Science and Technology Development Center for Chinese Medicine (No. CXZH202301), Young Elite Scientists Sponsorship Program by CACM (No. 2019-QNRC2-A02), Scientific and Technological Innovation Project of China Academy of Chinese Medical Sciences (No. CI 2021A03804), and Fundamental Research Funds for the Central Public Welfare Research Institutes (Nos. ZZ14-YQ-023, ZZ11-073, and ZXKT21017).
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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