In December 2019, the first case of coronavirus disease-2019 (COVID-19) was reported in Wuhan, China.1 Since then, COVID-19 has become a global pandemic. The lung is the main target organ, but reports also show the damage involving the heart,2 skin,3 blood vessels and blood cells,4 liver,5 neurons,6 and kidney.7 Thromboembolic events are also a complication, especially in critical cases.8 So far, the consensus from the field of traditional Chinese medicine (TCM) practitioners about this disease is: it is a plague; and the etiological factors include cold and dampness. If the pathological factors cannot be resolved at the early stages, they may result in blockage of Qi, collapse of Yin and Yang and eventually death. Its brief mechanism is generally recognized as: the cold and dampness invade through the nose and/or mouth, and accumulate in the lung. When the cold and dampness are transformed into heat, normal functions of the lung and heart will be damaged significantly, thus the disease would progress into the severe stage. If the heat persists, it may ultimately lead to damage of almost all organs. In China, TCM has contributed significantly to the treatment of COVID-19, integrated with modern imaging systems, hospital facilities, pharmaceutical drugs, and other conventional western medicine treatments. Over 90% of patients have been treated with TCM as an integrative therapy in China,9 and multiple reports indicated a beneficial outcome of adding TCM.10 However, TCM is not widely used in the hospital system of America. This present minireview/commentary summarizes the experiences of TCM field in the management of COVID-19 combined with conventional western medicine, lessons from the United States, and proposes suggestions to change the current situation.
2 TCM etiology, pathology, and treatment principle
According to the characteristics of COVID-19, it is diagnosed as a “dampness−toxin pestilence,”11 and divided into five stages: mild, moderate, severe, critical, and recovery. For mild cases, the TCM pattern is cold−dampness invading the lung or damp−heat retaining in the lung. The treatment principles are to remove cold and dry dampness, or to clear heat and resolve dampness. For moderate cases, the pattern is toxic-dampness invading the lung or cold-dampness blocking the lung. The treatment principles are to dry dampness and remove toxins, or to dry dampness and remove cold. For severe cases, the pattern is pestilence toxin blocking the lung or heat in both Qi and blood. The treatment principles are to eliminate dampness and remove toxin or to clear heat in both Qi and blood. As for the critical cases, the pattern is internal blockage and external collapse. The treatment principles are to open blockage and revitalize Yang.12,13 Dampness, instead of cold or wind invasion, is the main pathogenic factor.14 Patients of the mild, moderate, severe or critical stages can be recovered completely or left with some complications. In the recovery stage, the TCM pattern is Qi deficiency of the lung and spleen, or deficiency of Qi and Yin. The treatment principles are to, tonify Qi of the lung and spleen, or tonify Qi and Yin.15
The disease starts at the lung and eventually affects multiple organs if the plague is not controlled. Figure 1 demonstrates the interactions of the lung and other organs according to TCM theory. Organs in the figure are a combination of conventional western medicine anatomy and concepts from TCM theory.
3 Clinical reports of TCM and COVID-19
Reported clinical studies have suggested that TCM treatment plays a significant role in alleviating clinical symptoms, decreasing the time of hospitalization, reducing the overall fatality rate, and providing other beneficial outcomes when combined with conventional western medicine.16 One systemic review and meta-analysis searched six electronic databases (PubMed/MEDLINE, Cochrane Library, ScienceDirect, Google Scholar, Wanfang Data, and China National Knowledge Infrastructure), collected randomized controlled trials (RCTs) from peer-reviewed journals and non-reviewed publications, and adopted strict standards to satisfy the quality of analysis. They finally included seven original studies, comprising a total of 732 adults, for a meta-analysis. They found that comparing to the standard care, integrating TCM can improve the symptom and sign score, inflammation marker and manifestation of lung CT scan.17 Here we selected some representative clinical reports, whose dosage form includes patent TCM and TCM formula, disease severity ranges from mild and moderate cases to severe/critical cases, to show the safety and efficacy of TCM combined with conventional western medicine.
TCM has been reported to improve the overall cure rate. In a multicenter, prospective, RCT, Lian Hua Qing Wen Capsules (连花清瘟胶囊), a patent Chinese medicine, significantly improved the recovery rate of patients with COVID-19 (91.5% vs. 82.4%) compared to the conventional western medicine alone. Similar positive results were also observed with chest computed tomography results (83.8% vs. 64.1%) and the clinical cure rate (78.9% vs. 66.2%).18 Furthermore, TCM also alleviated symptoms such as fever, cough, fatigue, and loss of appetite more rapidly.19
Tian et al. enrolled 721 mild and moderate COVID-19 patients, including 430 Han Shi Yi Formula (寒湿疫方) users (HSYF group) and 291 non-users (control group). They observed that no cases in the exposed group but 19 (6.5%, P < 0.001) cases in the control group advanced to severe disease. After propensity score matching (PSM), none of the Han Shi Yi Formula users but 7 (4.7%, P = 0.022) non-users progressed to the severe stage. They concluded that Han Shi Yi Formula can significantly reduce the advancement to the severe stage in cases of mild and moderate COVID-19.20 The same team also used the method of propensity score matching in a 1:1 ratio and enrolled 156 Chinese herbal medicine (CHM) users and 156 non-users. All-cause mortality was observed in 13 CHM users and 36 non-users, indicating the fatality risk of CHM users was reduced by 82.2% compared to non-users.21
A multicenter, RCT conducted at four medical centers took a total of 111 severe/critical patients and randomly assigned them to receive Shen Huang Granule (参黄颗粒剂) as the SHG group twice a day for 14 days with standard care, or to receive standard care alone as the control group. The reports showed that the overall fatality was decreased from 75.9% (41/54) in the control group, to 38.6% (22/57) in the SHG group. Interestingly, the ventilation rate in the SHG group was 0, but in the control group was 58.8% (10/17).22 This report is important since it is the first report focusing on severe/critical cases at the very beginning of the pandemic with dramatically reduced fatality and rates of mechanical ventilation.
The TCMs of Jin Hua Qing Gan Granule (金花清感颗粒), Lian Hua Qing Wen Capsule/Granule, Xue Bi Jing Injection (血必净注射液), Qing Fei Pai Du Decoction (清肺排毒汤), Hua Shi Bai Du Formula (化湿败毒方), Xuan Fei Bai Du Formula (宣肺败毒方), were renowned and broadly reported for their good efficacies and safety, and were named “three medicines and three formulas” collectively. To save space, we summarize their representative clinical reports, and other TCM mentioned in the above paragraphs in Table 1.
Table 1 -
Summaries of clinical reports of treating COVID-19 with TCM
||Name of TCM
||Type of study
||Lian Hua Qing Wen capsule
||Prospective multicenter open-label randomized controlled trial
||Lian Hua Qing Wen Capsule + SC
||Mild to moderate
||Recovery rate and time
||Xuan Fei Bai Du Decoction
||Randomized clinical trial
||Xuan Fei Bai Du Decoction + SC
||Mild to severe
||Disappearance rates of major symptoms
||Han Shi Yi Formula
||Retrospective cohort study
||Han Shi Yi Formula + SC
||Mild to moderate
||The proportion to severe status
||Ma Huang Liu Jun Tang
||Retrospective cohort study
||Ma Huang Liu Jun Tang + SC
||Severe to critical
||Shen Huang Granule
||Randomized controlled multicenter trial
||Shen Huang Granule + SC
||Severe to critical
||Overall improvement rate and mortality
||Jin Hua Qing Gan granule
||Randomized controlled trial
||Jin Hua Qing Gan Granule + SC
||Suspected and confirmed cases, mild
||Clinical symptoms, disease aggravation rates
||Xue Bi Jing Injection
||Randomized controlled trial
||Xue Bi Jing Injection + SC
||Recovery rate and inflammation marker
||Qing Fei Pai Du Decoction
||Single-center, retrospective, observational study
||Qing Fei Pai Du Decoction + SC
||Moderate to critical
||Hua Shi Bai Du Formula
||Unblinded, cluster-randomized clinical trial
||Hua Shi Bai Du Formula + SC
||Recovery or aggravation rate
COVID-19: coronavirus disease-2019; SC: Standard Western medicine care; TCM: traditional Chinese medicine.
No severe adverse events have been reported in the clinical trials of TCM in their treatment of COVID-19 so far when combined with conventional western medicine.17
4 Acupuncture in COVID-19 management
Acupuncture is the main modality of TCM in countries outside of China. In the treatment of COVID-19, it was used as adjunctive therapy to CHM. No clinical trials of acupuncture in the management of COVID-19 have been reported so far. Instead, they were mainly reported as case studies. For example, Yin et al. treated a patient with severe COVID-19, significant shortness of breath and decreased peripheral oxygen saturation (SpO2), with manual acupuncture combined with the CHM granule formula Fu Zheng Rescue Lung (扶正救肺方) and Xue Bi Jing Injection along with conventional western medicine. After acupuncture was administered, it quickly improved the patient’s breathing function, SpO2 and the heart rate recovered.27
Additionally, a 37-year-old female physician in the United States also reported a case of using acupuncture for COVID-19. This case described a New York City anesthesiologist and medical acupuncturist who was infected and confirmed to have the COVID-19 virus. She had severe symptoms of pneumonia, such as pleuritic chest pain, shortness of breath, increased respiratory rate, hypoxia, dry cough, orthostatic hypotension, and headache. She self-treated with cupping therapy at the onset of anosmia, using dry suction vacuum cup therapy (plastic, 1.5 in diameter) in the area of LU 1 bilaterally, and administered acupuncture upon onset of pulmonary symptoms using acupuncture points like Yunmen (云门 LU 2), Kongzui (孔最 LU 6), Zusanli (足三里 ST 36), Quchi (曲池 LI 11), Dazhui (大椎 GV 14), Dingchuan (定喘 EX-B1), and Chuanxi (喘息 EX-B10). All pulmonary symptoms recovered after 2 days, and eventually she made a full recovery.28
5 Lessons in America
From the above data, we can conclude that adding TCM to conventional western medicine treatments for COVID-19 patients may be promising with respect to improved treatment outcomes. Unfortunately, TCM is not widely used in the American hospital system, if any. Obviously, using the latest version of the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guidelines for all clinical trials involving TCM combined with conventional western medicine must be enforced to increase reproducibility and transparency of all findings.29 In the United States, as of May 23, 2022, there were 83,281,329 confirmed cases of COVID-19, with 1,002,173 cumulative deaths.30 The approval of medication Paxlovir did not change the clinical outcome markedly.31 If the mortality can be reduced by 82.2% as the reported result by integrating TCM into the management,21 at least 600,000 lives can be saved. Public health measures in the United States, including federal provision and coverage for two rounds of COVID-19 vaccination and later two rounds of booster shots have greatly reduced the number of hospitalizations in the United States. As of May 23, it is estimated that 69% of the US population has been fully vaccinated against COVID-19, while hospitalizations have decreased to only 4,116 ICU hospital beds needed.32 Although vaccination in the United States has greatly reduced hospitalizations and deaths from COVID-19, how to manage complications of COVID-19 is still a challenge.33 The effects of what is now formally referred to as long-lasting COVID-19 disease or long COVID is estimated to affect millions of individuals who have previously contracted COVID-19, with symptoms including fatigue, headache, dyspnea, and anosmia.34 Although there are no published randomized clinical trials using TCM for long COVID, TCM may have its greatest value in resolving symptoms and improving the quality of life, where it might be used as a stand-alone treatment. If TCM were more integrated into the healthcare system of the United States and demonstrated similar safety and efficacy as the results observed in China, then severe/critical cases and associated mortality we hypothesize would be significantly reduced. At the current time, there is only one registered clinical trial in ClinicalTrials.gov of TCM to treat mild to moderate COVID-19 in the United States. However, “The purpose of this study is (only) to document the safety of taking TCM in patients with COVID-19 and to gain information to determine whether a study with TCM can be conducted. The study will test a TCM that has been made into a granule formulation called Xuan Fei Bai Du Granulesv (宣肺败毒颗粒)” (ClinicalTrials.gov Identifier: NCT04810689). As more rigorous clinical trials of TCM continue to be registered, conducted, and published in China, we expect to see more trials of TCM formulations conducted in the United States.
As stated above, another major health concern of contracting COVID-19 even in fully vaccinated and boosted individuals is long COVID. It occurs in a range from 7.5% to 41% in non-hospitalized adults, 2.3%–53% in mixed adult, 37.6% in hospitalized adults, and 2%–3.5% in mainly non-hospitalized children.35 Pilot study indicates that female sex, age, comorbidities, severity of acute disease, and obesity are related to long COVID. Nearly 50% of primary studies discovered some degree of long COVID-related social and family-life damage, long periods away from work, reduced workloads, and unemployment.36,37 This indicates that long COVID will likely have a profound public health impact, and although few reports of TCM that include acupuncture for long COVID are currently available, the evidence is emerging.38 And indeed, effectiveness is increasingly anecdotally observed in the practice of acupuncturists (personal experience and personal communication). More definitive evidence must await larger clinical trials in China and the United States, and these will certainly be forthcoming given that millions of individuals are currently suffering or will suffer from long COVID.
6 Suggestion of dialogues among associated parties
We think that TCM selectively neglected in the American hospital system is mainly due to miscommunication.
To resolve this miscommunication, a dialogue is necessary, and the World Health Organization (WHO) has set a good example. The attitude of WHO about recommending TCM for COVID-19 has always been ambiguous, but this situation has changed recently. Following a high-level policy dialogue between the Director-General of WHO and China’s National Administration of TCM (NATCM) in Geneva on January 17, 2022, WHO had a meeting of experts to evaluate the role of TCM in the treatment of COVID-19, from February 28 to March 2, 2022.39 The key findings of the Expert Meeting include but are not limited to: ①. The evidence evaluation reports applied appropriate and rigorous methodology to determine the current level of clinical evidence and safety of the studied TCM interventions used in the trials. ②. On the basis of clinically relevant outcome measures, the studied TCMs are helpful in the treatment of COVID-19, particularly in mild-to-moderate cases. ③. There are promising data to suggest that TCM is helpful in reducing the risk of progression from mild-to-moderate stages to severe COVID-19 stages. ④. Though with some limitations, the data from the selected RCTs justify further investigations in clinical trials to assess the potential benefits of selected TCMs in the treatment of COVID-19.
A similar dialogue or public hearing can happen in America. A dialogue between associated parties such as the American Society of Acupuncturists (ASA), National Institutes of Health (NIH), and Food and Drug Administration (FDA) may help to resolve the miscommunication. Indeed, a similar and successful conference was held in 1997: the NIH Consensus Development Conference on Acupuncture. The consensus of that conference stated that: “Promising results have emerged, for example, efficacy of acupuncture in adult post-operative and chemotherapy nausea and vomiting and in postoperative dental pain.” “There is sufficient evidence of acupuncture’s value to expand its use into conventional medicine and to encourage further studies of its physiology and clinical value.”40 Before this conference, in 1996, the FDA reclassified acupuncture needles for the administration of acupuncture and substantially equivalent devices of this generic type from class III (premarket approval) into class II (special controls).41 This upgrade means acupuncture needles are medical devices for “general use” by trained professionals, not “experimental” device anymore. These two milestone events laid a solid foundation for American people to enjoy the medical benefits of acupuncture. We hope this good tradition of communication among NIH, FDA, and American acupuncture field can continue.
Currently, the FDA has a major separation between “conventional foods” and drug products and what it refers to as “dietary supplements.” As stated by the FDA on their website, “FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering ‘conventional’ foods and drug products, specifically under the Dietary Supplement Health and Education Act of 1994 (DSHEA).”42 TCM currently belong to the category of dietary supplements and dietary supplement ingredients, although there have been a few cases where a TCM formulation has gone through the FDA’s rigorous evaluation process of preclinical and clinical testing towards achieving approval as a drug. The successful completion of the phase II clinical trials for the TCM formulation, Compound Dan Shen Dripping Pill (丹参滴丸), approved since 1993 by the Chinese FDA (CFDA), is an example of this. Since the mechanisms and development process of CHM is substantially different from that of drug pharmacy, apparently, they do not fall into the category of drugs in the conventional western medicine paradigm, even though CHM is used in China to treat a wide variety of medical conditions. Due to the fundamental differences in diagnosis and treatment paradigms of TCM and conventional western medicine, FDA approval of any CHM formulations prescribed to diagnose, treat, cure, or prevent any disease condition must be put through the same rigorous preclinical and clinical testing done for all drug approvals in the United States. However, this does not prevent licensed TCM professionals from accredited institutions in the United States from practicing the full scope of their training in TCM in private practice, thanks to state licensure legislation (state board of medical practice or acupuncture) and exam organizations such as the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM), or California Acupuncture Board (administrating California Acupuncture Licensing Examination [CALE]).
For the moment, though, we must accept the fact that in the United States, TCM formulations are classified as “dietary supplements” by the FDA and are treated like all botanical medicines and natural products, and thus are currently regulated under the DSHEA of 1994. Under this paradigm, it is not necessary for traditional CHM manufacturers to get pre-market approval from the FDA, but they are responsible for determining that their products are made according to internationally recognized Good Manufacturing Practices (GMP), that they are safe and that their product claims are supported by some clinical evidence.
As a matter of fact, the attitude of conventional medicine system is becoming more and more friendly toward TCM. For instance, in 2019, WHO member states endorsed the eleventh revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-11). Importantly, ICD-11 now includes TCM for the first time.43 By adding a supplemental chapter 26 to the ICD-11, which now includes 150 disorders and 196 patterns that derive from the TCM paradigm; and by acknowledging that these 150 disorders and 196 patterns arise from classic concepts that are completely outside of the conventional western medicine paradigm, this bodes well for future integration of TCM into mainstream conventional western healthcare systems. One can imagine in the future United States community clinics and hospital pharmacies carrying conventional western medicine drugs but also TCM formulations, as is done in China today.44 As with any highly regulated profession, pharmacists will be key stakeholders in evaluating and communicating to the public the sourcing, quality, safety, tolerability, and efficacy of any TCM formulation, just as they are required to do with conventional western medicine drugs.
In the United States, as far as we know, the pharmaceutical companies or distributors only authorize licensed acupuncturists/Chinese medicine practitioner to order TCM concentrated granules. Given the large amount of preclinical and now clinical trials data registered and published in China, including now clinical trials on concentrated granules used to treat COVID-19 (China Clinical Trial Registry), perhaps there will be a way in the future to provide an FDA fast-track for some of the concentrated granules used in these trials with positive clinical results, and that they might be categorized as drugs to diagnose, treat, cure, and prevent disease, without having to go through the additional millions of dollars of FDA-overseen preclinical and clinical phase I, II, and III clinical trials, requiring massive duplication of time, money, and effort. Better collaboration, cooperation, alignment, and understanding between FDA-like regulatory agencies in places like China, Japan, South Korea, the United States will certainly help people to achieve better health and have more choices to combat future pandemics like COVID-19, but with substantially less mortality.
In conclusion, TCM has contributed significantly to the management of COVID-19 in this pandemic. Unfortunately, it is not widely used in the American hospital system for this battle. We think this situation is most likely caused by miscommunication. To resolve this miscommunication, we suggest a dialogue among associated parties. The good dialogue tradition among NIH, FDA and American acupuncturist field, recent improved attitude of WHO toward the role of TCM in the treatment of COVID-19, and newly addition of TCM disorders and patterns to ICD-11, all encourage a promising dialogue in America, and eventually, save more lives.
This article does not contain any studies with human or animal subjects performed by any of the authors.
Zuo-Biao Yuan drafted the manuscript. Paul S. Amieux revised the manuscript. Both authors contributed to the conception and design of the article and interpreting the relevant literature, read and agreed to the published version of the manuscript.
Conflicts of interest
The authors declare no financial or other conflicts of interest.
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