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ORIGINAL ARTICLE
Year : 2023 | Volume
: 9
| Issue : 1 | Page : 81-93
Traditional chinese medicine pattern classification and herbal medicine for COVID-19: A comparative study of data from different sources
Zhen Gao1, Ying-Ying Liu2, Ye-Meng Chen3, Jing-Cheng Dong1
1 Department of Integrative Medicine, Huashan Hospital; Institute of Basic Theory and Application, Institutes of Integrative Medicine, Fudan University, Shanghai, China
2 Department of Geriatrics and Retired Cadre, Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
3 Dean's Office, New York College of Traditional Chinese Medicine, Mineola, NY, USA
Correspondence Address:
Prof. Jing-Cheng Dong
Department of Integrative Medicine, Huashan Hospital, Fudan University, Shanghai 200433
China
Source of Support: None, Conflict of Interest: None
DOI: 10.4103/2311-8571.351792
Background: Traditional Chinese medicine (TCM) plays a crucial role in the prevention and control of coronavirus disease 2019 (COVID-19). Objective: The study aimed to reveal the distribution characteristics of COVID-19 TCM syndrome types and syndrome elements and the law of TCM treatment and medication. Methods: The TCM diagnosis and treatment protocol for COVID-19 and clinical research data were obtained through network retrieval, and Revman 5.3 and SPSS 23.0 were employed to analyze the composition of TCM syndromes and the situation of TCMs in meta and frequency. Results: The top three TCM syndromes of COVID-19 included damp-heat accumulation in the lung pattern, damp abundance due to spleen deficiency, and epidemic toxin invading the lung pattern, while the syndrome elements were dampness, heat, and toxin. Gypsum fibrosum, Pogostemonis herba, and Armeniacae semen were identified as the commonly used drugs. Different syndrome elements were identified at lung disease location: Forsythiae fructus, Glycyrrhizae radix, and Armeniacae semen can be used for “wind;” Glycyrrhizae radix, Armeniacae semen, and Scutellariae radix can be used for “Heat;” Armeniacae semen, Sheng Gypsum fibrosum, and Ephedrae herba can be used for “Toxin;” Ephedrae herba, Armeniacae semen, and Atractylodis rhizome can be used for “Damp;” Magnoliae officinalis Cortex, Ephedrae herba, and Zingiberis Rhizoma recens can be used for “cold;” and Armeniacae semen, Gypsum fibrosum, Ephedrae herba, and Lepidii/Descurainiae semen can be used for “epidemic.” Conclusion: The establishment of a treatment scheme based on the classification of disease syndrome elements should be considered for sudden infectious diseases, such as COVID-19. Pogostemonis herba, Armeniacae semen, Gypsum fibrosum, and Glycyrrhizae radix should be considered as effective drugs from TCM for the treatment of COVID-19.
Keywords: COVID-19, diagnosis and treatment protocol for COVID-19, syndrome, syndrome element, traditional Chinese medicine, traditional Chinese medicine syndrome investigation
Traditional Chinese medicine (TCM) is a general designation for the medicines derived from all ethnic groups in China, including Han medicine and other ethnomedicine in China. TCM is a medical and pharmaceutical system that reflects the country's understanding of life, health, and diseases. Accordingly, TCM is rich in history and has unique theories and technical methods. Critical cases of coronavirus disease 2019 (COVID-19) often lead to fatality.[1] Early detection of COVID-19 is thus necessary, and active comprehensive intervention should be administered to patients with mild, common, and severe COVID-19 to prevent advancement to critical stage. TCM has had important contributions to the prevention and treatment of COVID-19. After numerous clinical studies, several effective prescriptions represented by “Three Drugs and Three Prescriptions” have been screened out.[2] From January 15, 2020, to March 4, 2020, the National Health Commission of the People's Republic of China (NHC) issued a total of seven editions of “diagnosis and treatment protocol for COVID-19” (DTP). The name of the disease was changed from “pneumonia caused by the novel coronavirus” to “COVID-19.” Clinical manifestations and case definitions of COVID-19 were continuously refined, and the diagnosis process has been optimized and simplified. According to the DTP issued by the NHC, all regions have formulated a TCM diagnosis and treatment protocol for COVID-19, with focus on treatment in specific regions based on the local COVID-19 disease condition, climate characteristics, and varied physical conditions of patients.
Disease research primarily aims to determine the diagnosis and then the treatment methods and efficacy evaluation criteria, and finally provide accurate feedback. Therefore, we carried out a comparative study of COVID-19 symptom description of traditional Chinese and modern medicine.[3] The characteristics of TCM syndromes and syndrome elements were analyzed based on a COVID-19 clinical survey. The medication characteristics based on a single-case study were discussed, and a comprehensive comparative analysis of DTP across the country was performed to summarize the TCM syndrome characteristics of the disease, reveal the TCM medication characteristics of COVID-19 based on syndrome element classification, and provide a reference for the treatment of “a group treated with one prescription” for the disease. On May 25, 2020, local time, the World Health Organization revealed that epidemiological studies demonstrated the susceptibility of many people to the disease. Accordingly, if the virus existed, it could infect humans, regardless of the temperature and month. Further, if people were in close contact with each other, the epidemic would proceed. Currently, the pandemic is still rampant. Further, there are no specific drugs available to treat COVID-19. Hence, countries must not only aim to prevent another peak of the current epidemic but also prevent the next wave. The effect of TCM in preventing and treating COVID-19 must thus be explored to provide a reference for the control of the world pandemic.
Data and MethodsInclusion of literature
TCM-DTP protocols from various regions of the country were collected from the websites of regional health committees or TCM societies, including PubMed, ClinicalKey, Cochrane, “COVID-19 Scientific Research Achievements Academic Exchange Platform (http://medjournals.cn/2019NCP/index.do),” the China National Knowledge Infrastructure, “COVID-19 Special Research Achievements Network First Platform (OA) (cajn.cnki.net/gzbd/brief/Default.aspx),” in English or Chinese, and “(COVID-19) and (Chinese medicine)” were used as part of the search strategy. Data up to May 1, 2020, were included in the analysis. Two researchers independently screened the literature and recorded the information related to diagnosis and treatment.
Data collection and processing
Based on the extraction table, TCM syndrome classification, therapeutic principles and methods, prescriptions, and other contents were included and standardized. The syndrome elements were extracted according to the Differentiation of Syndrome Elements.[4] Disease nature syndrome elements and disease location syndrome elements were also extracted. The “three prescriptions” of the “three prescriptions and three drugs” were Qingfei Paidu decoction (QPD), Xuanfei Baidu Formula (XBF), and Huashi Baidu Formula (HBF). The clinical summary analysis selected clinical research based on a single-case analysis (herein referred to as a single-case study) [Figure 1]. For meta-analysis, all included trials met the following selection criteria: a prospective, cross-sectional, and retrospective study on the composition of TCM syndrome types. The exclusion criteria were as follows: case report, academic discussion, ideas, methods, reviews, duplicate publications, and lack of data on the composition ratio of the syndrome in TCM. For the meta-analysis, the checklist of the Agency for Healthcare Research and Quality[5] was used to assess the quality and bias risk of the included studies.
Figure 1: Flow diagram of the study. Notes: TCM: Traditional Chinese medicine, XBF: Xuanfei Baidu Formula, ATC: Administration of Traditional Chinese Medicine or Association of Chinese Medicine in various regions of China, DTP: TCM Diagnosis and Treatment Protocols for COVID-19, HDTP: Regularity and Characteristics of Prescriptions and Herbs use based on Diagnosis and Treatment Protocols for COVID-19, SHL: “On cold damage and miscellaneous diseases” (”Shang Han Lun”), SMD: Shegan Mahuang Decoction, XCD: Xiao Chaihu Decoction, WLP: Wu Ling Powder, MXD: Ma Xing Shi Gan Decoction, MYD: Ma Xing Yi Gan Decoction, TXD: Tingli DaZao Xiefei Decoction, QJYF: Prescriptions worth a Thousand in Gold for Every Emergency (”Bei Ji Qian Jin Yao Fang”), QJW: Qianjin Weijing Decoction, CMED: Traditional Chinese Medicine Extract Database, HZ: Hu Zhang (Polygoni Cuspidati Rhizoma Et Radix), MBC: Ma Bian Cao (Verbenae Herba), TCD: Taohe Chengqi Decoction, DEFD: “Differentiation of Epidemic Febrile Diseases” (”Wen Bing Tiao Bian”), TP: “Treatise on Pestilence” (”Wen Yi Lun”), DYD: Da Yuan Decoction, PBT: “Prescriptions of the Bureau of Taiping People's Welfare Pharmacy” (”Taiping Huimin Heji Ju Fang”), HZP: Huoxiang Zhengqi Powder, CWO: “Cure a wood to correct” (”yi lin gai cuo”), HCD: Huangqi Chifeng Decoction, SHD: “Effective Formulae Handed Down for Generations” (”Shi Yi De Xiao Fang”), YPF: Yu Ping Feng Powder, CIT: Clinical Individualized Treatment of TCM, SCS: Single-case Clinical Studies, QPD: Qingfei Paidu Decoction, XBC: Xuan Bai Chengqi Decoction, HBF: Huashi Baidu Formula, HCCM: Regularity and Characteristics of Prescriptions and Herbs use based on Classical Chinese Medicine, PEEF: Regularity and Characteristics of Prescriptions and Herbs use based on Clinical Practice, Patient Efficacy Evaluation and Feedback after treatment, HBTG: The same Regularity and Characteristics of Prescriptions and Herbs use between Two Groups, HATG: The same Regularity and Characteristics of Prescriptions and Herbs use among Three Groups. FMS: Frontline medical staff ETD: Experienced TCM doctorsStatistical methods
The TCM syndromes and syndrome elements data were analyzed through a meta-analysis of uncontrolled binary data based on RevMan5.3.[5],[6] The DTP published by local health committees and TCM administration were searched, and the frequency or composition was analyzed and compared with the “three prescriptions” and single-case studies of the “three prescriptions and three drugs” using SPSS 23.0 (IBM Corp., Armonk, NY, USA) to prove the clinical value of the research results.
ResultsAccording to the accessibility of network information resources, 33 DTP issued by 29 provincial health committees or Chinese Medicine Associations in China, including those of Beijing, Tianjin, Hebei, Shanxi, Mongolia, Heilongjiang, Jilin, Liaoning, Shanghai, Jiangsu, Zhejiang, Anhui, Fujian, Jiangxi, Shandong, Henan, Hunan, Guangdong, Guangxi, Qiong, Sichuan, Guizhou, Yunnan, Tibet, Shaanxi, Gansu, Qing, and Ningxia, were included in this study. Further, 23 TCM syndrome investigation studies and 25 TCM single cases reports were included.
Traditional Chinese medicine syndromes and meta-analysis based on a clinical survey of COVID-19 in different areas
Methodological quality assessment
The selected articles were assessed to determine methodological quality. The quality score of each study is presented in [Table 1]. One study had high quality and 22 studies had moderate quality. There were no articles with a low-quality rating [Table 1].
Table 1: Quality control of the selected studies according to the criteria of the Agency for Healthcare Research and QualityTraditional Chinese medicine syndromes and meta-analysis
Based on an epidemiological survey, more TCM syndromes of COVID-19 exist in different regions of China than those listed in DTP. Such finding reflects the difference between diagnosis and treatment protocol and clinical practice to a certain extent. A total of 24 studies were included, and the TCM syndromes of COVID-19 were summarized into 30 categories after combination. Based on a meta-analysis of the TCM syndrome types with more than 10 cases reported in the study, the following combined incidence of COVID-19 was found for each TCM syndrome type: 45% (95% confidence interval (CI) [0.35, 0.62]), damp-heat accumulation in the lung pattern (DHL); 48% (95% CI [0.38, 0.58]), damp abundance due to spleen deficiency (DSD); 47% (95% CI [0.10, 0.85]), epidemic toxin invading the lung pattern (ETL); 31% (95% CI [0.21, 0.42]), damp-toxin constraint in the lung pattern (DTL); 31% (95% CI [0.26,0.36]), heat-toxin constraint in the lung pattern; 28% (95% CI [0.10,0.45]), deficiency of both Qi and Yin pattern; 28%(95% CI [0.17, 0.39]), cold-damp constraint in the lung pattern (CDL); 25%(95% CI [–0.18, 0.69]), heat-damp invading the lung pattern; 22% [95% CI (0.10, 0.34]), damp-toxin blocking the lung pattern; 14% [95% CI (0.07, 0.21]), and lung-spleen qi deficiency pattern (LSD)[Table 2].
Table 2: Traditional Chinese medicine syndromes and the meta-analysis (patients ≥10 in one study)Disease location related to the lung: Traditional Chinese medicine syndrome elements and meta-analysi
A total of 21 studies were included and the combined incidence of COVID-19 for the TCM syndrome elements was as follows: 38% (95% CI [0.32, 0.45]), dampness; 34% (95% CI [0.27, 0.41]), heat; 22%(95% CI [0.16, 0.28]), toxin; 17% (95% CI [0.11, 0.24]), cold; 9% (95% CI [0.05, 0.13]), plague; 7% (95% CI [0.02, 0.12]), sputum; 4% (95% CI [0.03, 0.05]), wind; 2% (95% CI [–0.01, 0.05]), blood stasis; and 2% (95% CI [–0.01, 0.05]), warms [Table 3].
Table 3: Traditional Chinese medicine syndrome elements and the meta-analysisRecommended herb frequency for different traditional Chinese medicine syndromes of COVID-19 based on each diagnosis and treatment protocol
Epidemic toxin blocking the lung pattern
The results are shown in [Table 4]. According to the recommended frequency, the top five rankings were Sheng Shi Gao (Gypsum fibrosum) (95.65%), Xing Ren (Armeniacae semen) (95.65%), Ting Li Zi (Lepidii/Descurainiae semen) (86.96%), Ma Huang (Ephedrae herba) (82.61%), and Da Huang (Rhei Radix et Rhizoma) (78.26%).
Table 4: Recommended herb frequency for different Traditional Chinese medicine syndromes of COVID-19 (Top 30)Internal blockage and external desertion pattern
According to the recommended frequency, the top five rankings were Hei Shun Pian (Aconiti Radix lateralis praeparata) (95.45%), Ren Shen (Ginseng Radix) (90.91%), Shan Zhu Yu (Corni Fructus) (90.91%), Mai Dong (Ophiopogonis Radix) (18.18%), and Wu Wei Zi (Schisandrae Fructus) (18.18%).
LSD
According to the recommended frequency, the top five rankings were Fu Ling (Poria) (100%), Sha Ren (AmomiFructus) (100%), Huang Qi (Astragali Radix) (93.33%), Fa Ban Xia (Pinellinae Rhizoma Praeparatum) (93.33%), and Chen Pi (Citri reticulatae Pericarpium) (93.33%).
Deficiency of both Qi and Yin
According to the recommended frequency, the top six rankings were Mai Dong (93.75%), Gan Cao (Glycyrrhizae radix) (81.25%), Nan Sha Shen (Adenophorae Radix) (68.75%), Wu Wei Zi (56.25%), Tai Zi shen (Pseudostellariae Radix) (43.75%), Bai Zhu (Atractylodis macrocephalae Rhizoma) (43.75%), and Chen Pi (43.75%).
Cold-damp constraint in the lung
According to the recommended frequency, the top five rankings were Ma Huang (100%), Sheng Jiang (Zingiberis Rhizoma recens) (100%), Cang Zhu (Atractylodis Rhizoma) (90%), Huo Xiang (Pogostemonis Herba) (90%), and Chen Pi (90%).
Damp constraint in the lung pattern
According to the recommended frequency, the top five rankings were Xing Ren (100%), Ma Huang (80%), Yi Yi Ren (Coicis Semen) (80%), Huang Qin (Scutellariae Radix) (80%), and Gan Cao (80%).
Wind-heat invading lung pattern
According to the recommended frequency, the top seven rankings were Jin Yin Hua (Lonicerae Japonicae Flos) (100%), Lian Qiao (Forsythiae Fructus) (100%), Niu Bang Zi (Arcth Fructus) (100%), Gan Cao (100%), Jie Geng (Platycodonis Radix) (66.67%), and Xing Ren (66.67%).
Damp-heat accumulation in the lung
According to the recommended frequency, the top five rankings were Gan Cao (88.89%), Huang Qin (77.78%), Xing Ren (66.67%), Cao Guo (Tsaoko Fructus) (55.56%), Hou Po (Magnoliae officinalis Cortex) (55.56%), Cang Zhu (55.56%), and Lian Qiao (55.56%).
Damp-toxin constraint in the lung
According to the recommended frequency, the top five rankings were Xing Ren (100%), Ma Huang (80%), Huang Qin (80%), Huo Xiang (6%), Fu Ling (60%), and Gan Cao (100%).
Heat-toxin accumulation in the lung pattern
According to the recommended frequency, the top five rankings were Ma Huang (100%), Xing Ren (100%), Sheng Shi Gao (100%), Gan Cao (80%), Huang Qin (60%), and Da Huang (60%).
Blazing of both qi and ying pattern
According to the recommended frequency, the top rankings were Sheng Shi Gao (100%), Zhi Mu (Anemarrhenae Rhizoma) (100%), Di Huang (Rehmanniae Radix) (100%), Shui Niu Jiao (Bubali Cornu) (100%), Chi Shao (Paeoniae Radix rubra) (100%), Xuan Shen (Scrophulariae Radix) (100%), Lian Qiao (100%), Dan Pi (Moutan Cortex) (100%), Huang Lian (Coptidis Rhizoma) (100%), Zhu Ye (Phyllostachys nigrae Folium) (100%), Ting Li Zi (100%), and Gan Cao (100%).
Based on the analysis of 11 TCM syndromes of COVID-19, the Chinese medicines recommended to treat more than one type of TCM syndrome were Gan Cao (10/11), Xing Ren (9/11), Sheng Shi Gao (9/11), Fu Ling (8/11), Ban Xia (Rhizoma Praeparatum) (8/11), and Lian Qiao (8/11); followed by Ting Li Zi (7/11), Cang Zhu (7/11), Huo Xiang (7/11), Chen Pi (7/11), Huang Qin (7/11), Gan Lu Gen (Phragmitis Rhizoma) (7/11), and Yi Yi Ren (Coicis Semen) (7/11). The herbs suitable for more than 6 types of syndromes included Ma Huang (6/11), Cao Guo (6/11), Bing Lang (Arecae Semen) (6/11), Hou Po (6/11), Chi Shao (6/11), Jie Geng (6/11), and Chai Hu (Bupleuri Radix) (6/11).
Recommended herb for different traditional Chinese medicine syndrome elements of COVID-19 based on each diagnosis and treatment protocol
By decomposing wind-heat invading lung, heat-toxin accumulation in the lung, DTL, DHL, damp constraint in the lung, CDL, and epidemic toxin blocking the lung into disease nature syndrome elements, the suitable herbs for these disease syndrome elements were identified as: (1) Gan Cao, Lian Qiao, Xing Ren, Jie Geng, and Huang Qin, which can be used as basic herbs when the disease syndrome elements of COVID-19 are wind, heat, toxin, dampness, cold, or plague; (2) Jin Yin Hua, Gan Lu Gen, Chai Hu, Sang Ye (Mori Folium), and Chan Tui (Cicadae Periostracmu), which are used to treat the disease syndrome elements of wind, heat, toxin, dampness, and plague; (3) Ma Huang, Sheng Shi Gao, Gua Lou (Trichosanthis Fructus), Chuan Bei Mu (Fritillariae Cirrhosae Bulbus), and Huo Xiang, which are used to treat the disease syndrome elements of heat, toxin, dampness, cold, or plague; (4) For different disease syndrome elements, the herbs, Lian Qiao, Gan Cao, Xing Ren, and Jie Geng, were found to be suitable for “wind.” Gan Cao, Xing Ren, Huang Qin, and Lian Qiao were suitable for “hot.” Xing Ren, Sheng Shi Gao, Ma Huang, and Ting Li Zi were suitable for “toxin.” Ma Huang, Xing Ren, Cang Zhu, Cao Guo, Huo Xiang, and Hou Po were suitable for “dampness.” Hou Po, Ma Huang, and Sheng Jiang were suitable for “cold.” Xing Ren, Sheng Shi Gao, Ma Huang, and Ting Li Zi were suitable for “plague [Table 5].”
Table 5: Recommended herb frequency for different Traditional Chinese medicine syndrome elements of COVID-19 (Top 30)Comparison of high-frequency recommended herbs for COVID-19 traditional Chinese medicine syndromes and syndrome elements based on diagnosis and treatment protocols and clinical practice
(1) Among the herbs suitable for six or more TCM syndromes and five or more syndrome elements, Gan Cao, Sheng Shi Gao, Huo Xiang, Xing Ren, Ma Huang, Ban Xia, Chen Pi, Huang Qin, and Chai Hu appeared in QPD. In addition, Fu Ling was identified as a suitable herb for six or more TCM syndromes. (2) Among the herbs suitable for six or more TCM syndromes and five or more syndrome elements, Gan Cao, Sheng Shi Gao, Huo Xiang, Xing Ren, Ma Huang, Ting Li Zi, Cang Zhu, and Gan Lu Gen appeared in XBF. In addition, Yi Yi Ren was identified as a suitable herb for six or more TCM syndromes. (3) Among the herbs suitable for six or more TCM syndromes and five or more syndrome elements, Gan Cao, Sheng Shi Gao, Huo Xiang, Ma Huang, Xing Ren, Ban Xia, Ting Li Zi, Cang Zhu, and Cao Guo appeared in HBF. In addition, Fu Ling, Hou Po, and Chi Shao were identified as suitable herbs for six or more TCM syndromes. (4) Among the herbs suitable for six or more TCM syndromes and five or more syndrome elements, Gan Cao, Sheng Shi Gao, Huo Xiang, Xing Ren, Ban Xia, Huang Qin, Chai Hu, Cang Zhu, Gan Lu Gen, Jie Geng, and Lian Qiao appeared as high-frequency herbs used in single-case clinical studies (patient use rate above 15%). In addition, Fu Ling and Hou Po were identified as suitable herbs for six or more TCM syndromes, while Jin Yin Hua and Chuan Bei Mu were identified as suitable herbs for five or more syndrome elements. (5) Gan Cao, Sheng Shi Gao, Huo Xiang, Ma Huang, Xing Ren, Ban Xia, Chen Pi, Huang Qin, Chai Hu, Ting Li Zi, Cang Zhu, Gan Lu Gen, Dou Kou (Amomi Fructus Rotundus), Cao Guo, Bing Lang, Jie Geng, and Lian Qiao were identified as other suitable herbs for six or more TCM syndromes and five or more syndrome elements. (6) For herbs used in QPD, Gan Cao, Sheng Shi Gao, Huo Xiang, Xing Ren, Ban Xia, Huang Qin, Chai Hu, Fu Ling, Gui Zhi (Cinnamomi Ramulus), Bai Zhu, and Zhi Shi (Aurantii Fructus immaturus) appeared as high-frequency herbs used in single-case clinical studies. For herbs used in XBF, Gan Cao, Sheng Shi Gao, Huo Xiang, Xing Ren, Cang Zhu, Gan Lu Gen, and Qing Hao (Artemisiae Annuae Herba) appeared as high-frequency herbs used in single-case clinical studies. For herbs used in HBF, Gan Cao, Sheng Shi Gao, Huo Xiang, Xing Ren, Ban Xia, Cang Zhu, Fu Ling, and Hou Po appeared as high-frequency herbs used in single-case clinical studies. (7) The herbs used in QPD, XBF, and HBF that are suitable for six or more TCM syndromes and five or more syndrome elements and were also identified as high-frequency herbs used in single-case clinical studies were Huo Xiang, Xing Ren, Sheng Shi Gao, and Gan Cao [Table 6].
Table 6: Comparison of the high-frequency recommended herbs for COVID-19 Traditional Chinese medicine syndromes and syndrome elements based on diagnosis and treatment protocols and clinical practice Discussion COVID-19 is an acute respiratory infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Fever, dry cough, and fatigue are the main clinical manifestations of COVID-19. Most patients with this disease have mild clinical symptoms and a good prognosis. However, some patients with severe disease rapidly progress to acute respiratory distress syndrome and experience septic shock.[30] Similar to SARS-CoV, SARS-CoV-2 uses angiotensin-converting enzyme II (ACE2) as its receptor. ACE2 is widely distributed in the lung, heart, kidney, gastrointestinal tract, and other organs.[33],[34] TCM is composed of closely linked technical and cultural levels.[35] As there is no clear evidence to support the key therapeutic role of a specific drug, TCM allows doctors to exploit previous diagnosis and treatment experience for the treatment of new acute infectious diseases, thereby aligning with the clinical practice of modern medicine. Modern medicine summarizes the norms and principles of compassionate use. For example, compassionate use, as stipulated by the U.S. Food and Drug Administration, refers to scenarios where patients suffering from serious or life-threatening diseases utilize unlicensed test drugs outside clinical trials when they cannot be treated using existing drugs or those selected for clinical trials.[36] Importantly, doctors, especially experienced doctors, can write a prescription based on previous “fragmentary” knowledge or evidence. This prescription not only aims to target the main pathogenic changes in patients but also considers non-symptomatic factors, such as age, region, and constitution in patients.[37]
Many types of meta-analyses based on cross-sectional study without control dichotomy data are available. These meta-analyses include single rate meta-analysis, which is commonly used to determine prevalence rate, detection rate, awareness rate, mortality rate, and infection rate.[38] In this study, this approach was applied to analyze the frequency of COVID-19 syndromes. Consequently, DHL, DSD, and ETL were identified as frequent TCM syndromes of the disease. The frequency of the first two syndromes was approximately 50%. The lung was identified as the disease location, and dampness, heat, and toxin were identified as the disease syndrome elements.
TCM is used as a treatment according to syndrome differentiation and is not a good choice of treatment based on disease (modern medicine) differentiation. However, it is difficult to carry out individual syndrome differentiation and treatment for all individuals with sudden infectious diseases. Thus, achieving high-level disease differentiation and treatment is of great significance with respect to the characteristics and advantages of comprehensive syndrome differentiation and treatment. Syndrome elements are less than syndromes by unit; however, if diseases are classified by syndrome elements, they are greater than syndromes. Therefore, based on decomposition of COVID-19 syndromes into syndrome elements, this study formed a new unit of disease syndrome elements to guide the classification of COVID-19 in “a group of people treated with one prescription.”
In this study, the laws embodied in the specific clinical practices could not control or predict diagnosis and treatment compared to the scientific nature of the syndrome and treatment laws conveyed by the diagnosis and treatment standards, generalized and controlled by experts. Currently, well-designed clinical trials recommend fixed medication. In contrast, case reports record the patient's condition and specific prescription medication, which reflects the characteristics of syndrome differentiation and treatment with TCM. Similarly, COVID-19 TCM “Three Drugs and Three Prescriptions” featured a wide range of applications that are effective and representative of numerous clinical trials and basic studies. Therefore, in this single-case analysis, we employed the “three prescriptions” in the “three drugs and three prescriptions” of TCM as a control to verify whether the results obtained through the analysis of syndrome types and syndrome element coverage rate have a clinical value, and whether it provides a reference for the corresponding research on COVID-19 “Syndrome Types-Syndrome Elements-Diseases-Prescriptions” to integrate traditional Chinese and Western medicine. High-frequency medication, suitable for >6 syndromes and 5 syndrome elements, was found to be consistent with the study on single-case analysis and “three prescriptions” in the “Three Drugs Three Prescriptions” of TCM. These strategies also overlap with the main drugs targeting pathogenesis of COVID-19. Therefore, the “special prescription” for COVID-19 can be preliminarily screened through syndrome types or the coverage rate of syndrome elements. However, whether the relatively simple syndrome differentiation can be used as a bridge between TCM and Western medicine remains to be investigated.
Herein, we mainly studied the guidelines issued by the National and Local Health committees. Further, the conclusions drawn must be validated using specific clinical and experimental data. Based on the characteristics of the disease, the medication of TCM syndrome elements does not consider the patient's constitution and prescription. Only the medication analysis of different disease syndrome elements of COVID-19 with lung disease location syndrome elements was included in the present study. Concurrent consideration of other disease location syndrome elements and the performance of synthesis are problems that must be further addressed. Of note, this method only considered the existing symptoms and signs of the patient. Thus, neither the symptoms and signs of the patient nor the etiology and pathogenesis of the disease, based on a combination of the symptoms and signs that the patient should not have and does not have, were considered. However, the latter is crucial to clinical syndrome differentiation and should be considered in specific clinical symptoms.
Some prior studies evaluated the efficacy and safety of TCM for the treatment of COVID-19; however, the included studies were basically randomized, controlled clinical trials or studies specifically targeting a certain Chinese patent medicine. Currently, a report that combines the analysis of the TCM DTP, a case report based on a single patient, and “three prescriptions and three drugs” has not been published; this is the entry point of this study.
Conclusion(1) The term “epidemic disease” in TCM for COVID-19 has a variety of meanings. In clinical treatment, in addition to syndrome differentiation and treatment corresponding to “one prescription for one person,” the establishment of a treatment scheme based on the classification of disease syndrome elements should be considered for sudden infectious diseases, such as COVID-19, to promote the rapid response and linkage between TCM and Western medicine. (2) Although there are numerous COVID-19 drugs, Sheng Shi Gao, Huo Xiang, Xing Ren, and Gan Cao, followed by Ma Huang and Ban Xia (Pinellinae Rhizoma Praeparatum), are the commonly used drugs.
Authors' contributions
Gao Z wrote the manuscript, and GZ and Liu YY systemically revised the manuscript for important content. All authors read and approved the final manuscript.
Financial support and sponsorship
This work was supported by Shanghai Municipal Health Commission (NO: XGYJKY2022-0307).
Conflicts of interest
There are no conflicts of interest.
References
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