Keywords COVID-19 - TCM - clinical trial - public health emergency
Introduction
In 2019, coronavirus disease 2019 (COVID-19) broke out,[1 ]
[2 ] with a 2% case fatality rate,[3 ] causing serious damage to the health and economy of the people in the world.[4 ]
[5 ]
[6 ] Then, the World Health Organization declared COVID-19 as a Public Health Emergency
of International Concern.[7 ] In the absence of a specific drug to treat cases of severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) infection,[8 ]
[9 ] practitioners of traditional Chinese medicine (TCM) have relied on experiences and
prescriptions for preventing and treating disease outbreaks garnered from the rich
history of TCM.[10 ]
[11 ] On the basis of supportive treatment and the combination of TCM and Western medicine,
a recent study showed that the clinical cure rate of this combined approach was 33%
higher than that of a Western medicine group, and the rate of conversion from general
to severe disease decreased 27.43%, which highlights the advantages of integrating
TCM and Western medicine.[12 ]
TCM and Western medicine differ in terms of the theoretical basis and treatment norms,
such as holistic approach and syndrome differentiation and treatment in TCM.[13 ]
[14 ] The TCM approach of individualized treatment in which an individual receives specific
prescriptions that can be added or subtracted according to symptomology is incompatible
with the universal treatment scheme of Western medicine, thus posing a barrier to
the widespread application of TCM and its acceptance by the general public. Increasing
the dissemination of TCM can potentially contribute to the prevention and control
of COVID-19. In this review, we discuss the work of TCM in this regard and summarize
measures to promote the spread of TCM, which cannot only aid in the management of
this epidemic but can also serve as a reference for future public health emergencies.
Evaluation of Clinical Efficacy to Improve the Rigor of Traditional Chinese Medicine
Research
Evaluation of Clinical Efficacy to Improve the Rigor of Traditional Chinese Medicine
Research
An important barrier to the acceptance of TCM by medical professionals and the masses
is the lack of standardized evidence of its clinical efficacy.[15 ]
[16 ] Reports on this topic have mostly been limited to case reports and experience sharing.
Systematically evaluating the therapeutic value of TCM based on empirical evidence
is critical for expanding the influence of TCM.[17 ]
Overall Status of Registered Trials on Traditional Chinese Medicine for Coronavirus
Disease 2019
Since the outbreak of the COVID-19 epidemic, the number of clinical registrations
has soared, accompanied by a variety of problems in clinical trial registration. We
counted the first 100 TCM related studies registered since the outbreak. Among them,
there are 80 intervention studies on efficacy evaluation, 72 for treatment, 2 for
prevention, and 6 for rehabilitation. Among them, 58 were randomized parallel control
studies, and 68 were approved by the clinical ethics committee. The clinical trials
and specific interventions that were evaluated are listed in [Table 1 ].
Table 1
Registered clinical study of novel coronavirus pneumonia treated by TCM
Study type
Experimental design
Total number
Ethical approval
Intervention measures of TCM
Treatment
RCT
54
60/72
Chinese patent medicines: Jinyin Granule, Xuebijing injection, Liushen Pill, Jinye
Baidu Granule, Babao Dan, Shenqi Fuzheng injection, compound Houttuynia mixture, Tanreqing
Capsule, honeysuckle oral liquid, Keshuting Syrup, Xiaoer Huatan Zhike Granule, antiviral
oral liquid, Shenfu injection, Xiyanping injection, Shufeng Jiedu Capsule, Maxing
Shigan Decoction combined with Shengjiang Powder, Qingwen Baidu Drink Formula Granules,
Shenling Baizhu Powder, Zedoary Turmeric Oil Injection
TCM decoction: Qingfei Paidu Decoction, Kangguan 1, Kangguan 2, Kangguan 3, Yiqi Huashi
Jiedu Decoction, Qingfei Decoction, Baidu Dan, Jinyinhua Decoction, Maxingshigan decoction
combined with Shengjiang powder, Qingwenbaidu Decoction formula Granule, Shenling
Baizhu powder
Others: Meditation, Baduanjin, Kangfujianfei Baduancao, psychological intervention,
acupoint Qigong, moxibustion, massage, health guidance, Guixi Tiaoxin
Non-RCT
9
Continuous entry trial
3
Single arm trial
6
Rehabilitation
RCT
6
6/6
Taijiquan, Health Qigong and lung nourishing formula, psychological intervention,
TCM nursing
Prevention
RCT
2
2/2
Decoction of Chinese medicinals (without detailed scheme)
Abbreviation: TCM, traditional Chinese medicine; RCT: randomized controlled trial.
Problems Exposed by Registered Traditional Chinese Medicine Trial Information
Several issues have undermined the rigor of registered TCM trials. First, the basic
concepts of placebo and randomization are unclear in some studies.[18 ] One trial even used boiled water as a placebo. Some of the conducted trials were
not registered or did not strictly adhere to ethical standards. For example, in one
study, the control group did not receive any treatment. Second, there are significant
variations in the primary and secondary outcome measures. For example, some studies
used C-reactive protein as an inflammation-related indicator, whereas others used
procalcitonin, cytokines, and other markers ([Fig. 1 ]), making it difficult to compare the results of different trials. Third, with the
exception of Chinese patent medicines and Qingfei Paidu decoction, the details of
most TCM interventions are unclear, and specific syndrome differentiation, prescriptions,
and dosage are not reported, which hinders the sharing of clinical data.[19 ] Fourth, outcome evaluation of most clinical studies includes only biological indicators,
while TCM-associated syndromes have been omitted,[20 ] with the result that certain TCM resources have been squandered. Last, most studies
have not monitored adverse reactions and toxic effects of TCM treatment. Thus, the
safety of TCM remains undetermined.
Fig. 1 Interaction of inflammation-related indicators between registered TCM studies of
new coronary pneumonia. (A ) Collaborative relationship of four indicators among studies. (B ) Quantitative relationship of four inflammation indicators. Abbreviations: CK: cytokines;
CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; PCT, procalcitonin.
Suggestions on Improving the State of Traditional Chinese Medicine Clinical Research
The emergence of the new coronavirus epidemic has posed a major public health challenge.
For the clinical value of TCM to be widely accepted, trials must be designed so that
they adhere to the principles of evidence-based medicine and are guided by professional
methodological teams to avoid wasting resources. Low-quality research not only exacerbates
the problem of resource shortage but also undermines the quality of TCM clinical research.
We propose that government administrative departments organize clinical trial evaluations,
tighten the checks of clinical trial registration and ethics committees, and focus
research efforts. Research groups should increase cooperation and the sharing of clinical
data and follow standardized trial protocols to facilitate data integration and follow-up.[18 ] At the same time, TCM-associated syndromes and the advantages and outcome measures
of TCM must be more clearly defined to modernize this practice and enhance its value.[19 ]
Transforming Decoctions into Chinese Patent Medicines
Transforming Decoctions into Chinese Patent Medicines
Chinese patent medicines have played an important role in the management of COVID-19
according to the Diagnosis and Treatment Plan for Pneumonia Infected by New Coronavirus .[21 ]
[22 ]
[23 ]
[24 ]
[25 ]
[26 ] Chinese patent medicines were crazily purchased in previous epidemics include “Banlangen
Event” for SARS and “Shuanghuanglian Oral Solution Event” for New Coronal Pneumonia.[27 ] The willingness of the masses to purchase these Chinese patent medicines during
public health crises demonstrates that they can be readily disseminated.
Chinese Patent Medicines Can Increase the Age Range of Traditional Chinese Medicine
Users
We used the Baidu Index to evaluate the level of interest of Baidu users in Chinese
patent medicines and traditional decoctions recommended for the prevention and treatment
of COVID-19 during the epidemic by using the Target group index (TGI). We searched
four classic decoctions (Qingfei Paidu Decoction, Guizhi Decoction, Mahuang Decoction,
and Maxing Shigan Decoction) and five Chinese patent medicines (Xiyanping + Xiyanping
injection, Lianhua Qinghuo Capsule + Lianhua Qingwen granule, Qingkailing oral liquid + Qingkailing
Capsule + Qingkailing granule, Shuanghuanglian oral liquid + Shuanghuanglian granule
and Huoxiang Zhengqi Pill + Huoxiang Zhengqi water + Huoxiang Zhengqi oral liquid).
The term “Chinese patent medicine” was directly searched to determine the degree of
active interest in TCM. The audience of four epidemic-related traditional decoctions
was mainly persons >40 years of age (TGI > 100), with relatively little attention
paid by adults between the ages of 20 and 40 years (TGI < 100; [Fig. 2 ]). The age range of Baidu users who searched for information on the five epidemic-related
Chinese patent medicines was broader (>20 years), whereas searches of the term “Chinese
patent medicines” were more common in persons under the age of 30 years. We suggest
that interest in Chinese patent medicines can compensate for the lack of attention
to traditional decoctions in persons <40 years old and can encourage acceptance of
TCM across all age groups.
Fig. 2 The popularity of Chinese patent medicine and traditional decoction for prevention
and treatment of COVID-19 among people of all ages. The target group index (TGI) information
comes from Baidu Index, which is collected from February 7 to March 7, 2020. Bule
lines: traditional decoction; Red lines: Chinese patent medicines. When the target
group index equals 100, it represents the average level. If the TGI is higher than
100, it means that the user's attention to certain drugs is higher than the overall
level. Gray areas indicate that people are less concerned about the drug than average
(TGI < 100).
Conversion of Decoctions into Chinese Patent Medicines and Strengthening the Rationale
for Using Chinese Patent Medicines
Classic formulations are processed and concentrated for transformation into Chinese
patent medicines, which not only retain the active ingredients of the original decoction
but also eliminate the preparation time and facilitate their transport and intake,[28 ] thus making them more appealing to the public. Compared with oral forms, injectable
Chinese medicinals have a more rapid onset of therapeutic effects and are amenable
to mass production,[29 ] and their administration is more convenient. Thus, promoting the transformation
of effective formulations and dosage forms and expanding the coverage of Chinese patent
medicines can increase the widespread adoption of TCM practices. However, misuse of
these agents because of their ease of distribution must be avoided. For example, for
COVID-19, there was a blind rush by the public to purchase Shuanghuanglian oral liquid
to protect against coronavirus infection without informed guidance,[27 ] leading to cases of gastrointestinal adverse reactions. This underscores the importance
of educating the masses on the safe and appropriate use of Chinese patent medicines.
Pharmaceutical supervision departments should also increase their scrutiny of the
directions for the use of Chinese patent medicines (especially dosing for special
groups such as pregnant women and children) and more closely monitor and record adverse
reactions and drug–drug interactions[30 ]
[31 ]; this can strengthen the rationale for prescribing these medicines and enhance their
safety, while providing a reference to the masses for making informed choices regarding
treatment options.
Engaging the Masses with Low-Threshold Traditional Rehabilitation Therapy
Engaging the Masses with Low-Threshold Traditional Rehabilitation Therapy
The Guiding Recommendations for TCM Rehabilitation in the Recovery Period of New Coronavirus
Pneumonia (Trial) formulated by the State Administration of TCM describe six suitable types of TCM
for controlling COVID-19, namely, moxibustion therapy, acupoint massage, ear point
pressing beans, scraping, cupping, and acupuncture therapy, along with two traditional
exercises, namely, Baduanjin and Taijiquan ([Table 2 ]).[32 ] Traditional rehabilitation therapy, which is based on TCM theory, is a means of
improving patients' physical and mental health and quality of life not only by relieving
their physical pain and mental distress but also by increasing their confidence in
overcoming the disease.
Table 2
Traditional rehabilitation therapy and guidance recommendations in “guideline recommendations
for TCM rehabilitation in COVID-19 (Trial)”
Categories
Therapy sorts
Details
Appropriate Technology of TCM
Moxibustion
Dazhui(DU14), Feishu(BL13), Shangwan(RN13), Zhongwan(RN12), Geshu(BL17), Zusanli(ST36)
Meridian massage
Acupoint massage: Taiyuan(LU 9), Zhongfu (LU 1), Danzhong(RN 17), Shenshu(BL 23),
Dachangshu (BL 25), Zhongwan(RN 12), Feishu(BL 13), Lieque(LU 7), Zusanli(ST 36) etc.
Add Shaoshang (LU 11), Chize (LU 5) if coughing, dry coughing or throat itching
Meridian massage: lung meridian of hand-Taiyin, large intestine meridian of hand-Yangming,
stomach meridian of foot-Yangming, spleen meridian of foot-Taiyin, conception meridian
and governor meridian etc.
Auricular point pressing beans
Common auricular points: Bronchus point, lung point, incretion point, Shenmen point,
occiput point, spleen point, stomach point, large intestine point and sympathy point
etc.
Scraping
Lung meridian of hand-Taiyin, large intestine meridian of hand-Yangming, urinary bladder
meridian of foot-Taiyang. etc.
Cupping
Feishu(BL 13), Gaohuang(BL 43), Pishu(BL 20), Shenshu (BL 23) and Dazhui(DU 14) etc.
Acupuncture
Commonly-used acupoints: Quchi(LI 11), Taiyuan(LU 9), Feishu(BL 13), Zusanli(ST 36),
Yinlingquan(SP 9) and Guanyuan(CV 4) etc.
Syndrome matching points: Add Geshu(BL 17), Shenshu (BL 23) and Dachangshu (BL 25)
if feeling weakness, cold-fearing and having pale tongue. Add Zhongwan(RN 12) and
Tianshu(ST 25) if having poor appetite, thin stools and pale tongue.Add Dazhui(DU
14), Dingchuan(EX-B1) and Gaohuang(BL 43) if coughing, expectorating and having pale
tongue.
Traditional exercises
Baduanjin
It is recommended to exercise once or twice a day for 10 to 15 minutes, and adjust
the intensity of exercise according to individual physical condition.
Taijiquan
It is recommended that once a day for 30–50 minutes each time.
Abbreviation: TCM, Traditional Chinese medicine.
Note: This guidance applies to the people in the recovery phase who meet the criteria
for decoupling and discharge from the COVID-19 diagnosis and treatment program. Clinicians
can refer to this guidance and give relevant treatment or rehabilitation guidance
according to the individual situation of the patient. After discharge, patients can
also adopt appropriate self-intervention methods according to this recommendation.
Promoting the Spread of Traditional Chinese Medicine Through Traditional Rehabilitation
Therapy
Appropriate techniques of TCM and traditional exercises have played an important role
in promoting TCM. The merits of the former which includes acupuncture are recognized
worldwide[33 ]
[34 ]
[35 ]; and the latter are readily accepted by the masses because of their low threshold,
time commitment, and energy consumption, and alignment with national healthcare consciousness.[36 ] COVID-19 is a test for the TCM system and a good opportunity for its promulgation.
Baduanjin, a TCM health exercise, was shown to exert a synergistic effect on the recovery
of vital energy in patients with COVID-19 by mobilizing the whole body through coordinated
movements to enhance physical strength, blood oxygenation, and immune function. In
Jiangxia Dahuashan Square Cabin Hospital, traditional Kung Fu Baduanjin and breathing
and turning exercises were widely adopted by patients and healthcare workers.[37 ] Traditional rehabilitation therapy is simple, effective, convenient, and inexpensive
and can improve malaise symptoms such as fatigue and shortness of breath in patients
with COVID-19.[38 ]
Encouraging Mass Participation in Traditional Rehabilitation Therapy
Promoting traditional rehabilitation therapy by increasing the participation of the
masses requires the joint efforts of the government, community, media, primary medical
units, health care workers, and other parties.[39 ] Government departments should strengthen guidance, improve relevant rules and regulations,
and ensure the orderly and coordinated development of traditional rehabilitation therapy
at all levels of operation from medical units to communities.[40 ] The community can adopt certain measures to advertise traditional rehabilitation
therapy such as Baduanjin that has a low threshold and can thus be readily propagated
among communities and individuals. Also, the media and journalists can actively report
the advantages of traditional rehabilitation therapy such as simplicity, convenience,
effectiveness, and low cost and thereby gradually increase the awareness of traditional
rehabilitation therapy among the masses through various media channels such as radio,
news, microblog, and the WeChat social media platform. Moreover, grassroots medical
units should be equipped with doctors trained in traditional rehabilitation therapy
who can carry out the relevant work, are knowledgeable, and contribute to the advancement
of TCM.[41 ] Health care workers should be mindful of and open to traditional rehabilitation
therapy. On the one hand, they should use it to relieve physical pain in patients;
at the same time, they should be aware of its equal importance for mental health.
Strengthening Communication and Cooperation with Media to Improve Public Opinion of
Traditional Chinese Medicine
Strengthening Communication and Cooperation with Media to Improve Public Opinion of
Traditional Chinese Medicine
As an intermediary between the medical profession and general public, the media play
an important role in publicizing the effects of TCM treatments and can influence the
perceptions, emotions, and decisions of the general public.[42 ] Accurate reporting of TCM can thus aid in epidemic prevention and control, while
misinformation can cause panic and exacerbate epidemics.
Influence of False Media Reports on the Public's Opinion of TCM
There have been inaccurate news reports related to TCM in the context of COVID-19,
two of which are highlighted here. The first report that Shuanghuanglian can inhibit
the new coronavirus was published in the People's Daily (Sina Weibo topic with 2.22
billion views).[27 ] The reporter did not mention the limitations of the study, such as the effect was
observed only in vitro, resulting in a blind rush by the public to purchase and use
Shuanghuanglian in a misguided attempt to prevent SARS-CoV-2 infection. Moreover,
this led to a mass public gathering during the COVID-19 outbreak, despite the fact
that self-isolation is a better strategy to decrease the risk of infection. The second
report that the tension of patients with COVID-19 was alleviated after taking TCM
was published by the China News Network (Sina Weibo topic with 350 million views).[43 ] Huang Luqi, a researcher at the Chinese Academy of Engineering and president of
the Chinese Academy of Chinese Medical Sciences, originally stated that “the people
are in urgent need of TCM, and they are at ease under the protection of TCM.” Unfortunately,
an incorrect interpretation of this statement by the media resulted in the public
believing that TCM is no better than a placebo.
Suggestions on Strengthening Communication and Cooperation Between Proponents of Traditional
Chinese Medicine and the Media
During an outbreak, the public is highly sensitive to relevant information and any
misinformation can lead to collective irrational actions. Many people blindly listen
to rumors that could require considerable effort to address and refute.[44 ] This is detrimental not only to the management of the epidemic but also to public
confidence in the medical community.
Acceptance by and engagement of the masses is essential for expanding the influence
of TCM.[45 ] Experts in TCM should strengthen communication and cooperation with the media, validate
information on TCM from the medical and public opinion perspectives, use easy-to-understand
language in communications about TCM, and be mindful of the subject characteristics
of TCM. At the same time, the government must improve systems for monitoring and transmitting
accurate information and countering false information and provide guidance to the
public for identifying the relevant aspects of TCM.[46 ] Finally, the use of professional and precise language and responsible actions by
the media can help expand the reach of TCM.
Outlook
Since the outbreak of COVID-19, TCM has played an important role in the prevention
and control of the outbreak. However, due to the particularity of the theoretical
system of TCM and the insufficient understanding of the theoretical knowledge of TCM
by the masses, the dissemination quality and efficiency of TCM are hindered to a certain
extent, and the acceptance and recognition among the masses are reduced. It is urgent
to improve the rigor of TCM research and promote the dissemination effect, which cannot
only make TCM fully exert its efficacy and value in this global antiepidemic work,
but also promote the inheritance and innovation of TCM. We should gradually improve
the evaluation system of clinical efficacy of TCM, promote the conversion of TCM Decoction
to Chinese patent medicine, and promote low-threshold traditional rehabilitation therapy,
at the same time, strengthen communication and cooperation between the media, so as
to expand the dissemination degree and influence of TCM. By further promoting and
sharing with the world's medical workers the experience and programs of TCM in fighting
the epidemic, we can really push the inheritance, innovation, and development of TCM
to a new stage so that TCM not only plays an important role in the prevention and
control of the new coronary pneumonia epidemic but also contributes to human health.
