A Preliminary Study on Legitimacy Identification Standards for Unconventional Treatment Technologies in Traditional Chinese Medicine

LIU D-Hu,CAO Shu-Hu

a.Hunan University of Chinese Medicine,Changsha,Hunan 410208,China

b.Hunan Ruijie Law Firm,Changsha,Hunan 410007,China

Keywords

Traditional Chinese medicine(TCM)

Unconventional treatment

Medical fault

Identification

ABSTRACT

Compared with western medicine with objective and standardized theories,traditional Chinese medicine(TCM)places more emphasis on subjective thinking.Moreover,there are several academic schools under TCM,and ancient secret prescriptions and proven prescriptions play important roles in TCM treatments.However,the drugs used by some academic schools and some ancient secret prescriptions and proven prescriptions often contradict mainstream theories,and some TCM treatment methods do not significantly conform to the methods that are considered safe by the Chinese Pharmacopoeia(2015 edition),medical textbooks and other canonical books.Despite the long history and abundant successful experiences of TCM treatments,controversies regarding these unconventional treatment technologies,specifically when these breach the safety standards of treatment,exist considering that several medical adverse effects are observed when performing these unconventional treatments.In view of this,distinguishing “welldefined technological breakthrough” from “medical fault” is considered necessary.This study discusses the issue and raises constructive suggestions on the corresponding identification standards for unconventional treatment strategies in TCM.

1 Introduction

Technological identification is the most difficult issue in medical disputes as hospitals and patients often argue on the legitimacy of the medical practice,and adjudicators can hardly make a judgment over such technological issues considering their insufficient medical expertise.Hence,they only rely on technological identification.At present,technical identification of medical accidents and forensic identification of medical faults are both valid.Despite the differences in identifiers and identification procedures,these two methods focus on the same issue,that is,whether the medical practice is legitimate and whether medical faults exist.

The identification of medical faults is simple and intuitive in western medicine.If a medical practice is against the laws and regulations,treatment routines,or conventions,it can be considered as an illegal medical fault.However,a problem exists when this identification standard is applied to traditional Chinese medicine(TCM).For example,the conventional dosage of Asari Radix Et Rhizoma(Xi Xin,細辛)is 1 - 3 g according to theChinese Pharmacopoeia(2015 edition)[1].There has always been an old saying that the dosage of Asari Radix Et Rhizoma(Xi Xin,細辛)should not exceed 5 g.However,in the treatment of the COVID-19 epidemic,the general Chinese medicine compound prescription Qing Fei Jie Du(Lung-clearing and Detoxifying)Decoction recommended by the National Administration of Traditional Chinese Medicine for clinical treatment was publicly questioned by some scholars because the dosage of Asari Radix Et Rhizoma(Xi Xin,細辛)reached 6 g[2].The use of 6 g Asari Radix Et Rhizoma(Xi Xin,細辛)in a single prescription of “Qing Fei Jie Du Decoction” has been questioned,while the use of 10 g of it in other prescriptions is not uncommon in clinical practice[3].To identify the legitimacy of such medical practices in TCM that deviate from conventional and standard treatments,strict identification rules,distinguishing intentional and reasonable technological innovation from real medical faults,should be established to comprehensively understand the origin and academic innovation of some TCM cultures.Simultaneously,it is absolutely impossible to allow doctors to overstep treatment routines and to disregard medical faults because of technological breakthroughs[4].

Compared with western medicine,TCM owns more academic schools,some theories of which even contradict with each other.There are also several ancestral secret prescriptions,folk prescriptions and proven prescriptions without legitimate theoretical basis in TCM.Therefore,even an expert in TCM may establish an unjust identification if he/she holds different academic views while failing to understand the complexity of the TCM theoretical system or if he/she sticks to identify TCM medical faults considering technological identification in western medicine while refusing to listen to academic explanation and defense of the identified party.

This study will discuss the legitimacy standards of unconventional treatment technologies in TCM.

2 Distinctiveness of Legitimacy Standards of Unconventional Treatment Technologies in TCM

TCM and western medicine are two significantly different medical treatment approaches used to understand,diagnose and treat several diseases.The former is significantly abstract to be proven easily,while the latter is specific because it is based on modern scientific studies[5].Thus,the fault identification standards in western medicine are simple and intuitive,while those in TCM are complicated and susceptible to several factors.For identifiers,their thinking modes of medical fault identification should vary because there are hardly specific identification standards in the TCM’s empirical-science-oriented theoretical system compared to the western medicine system with clear and intuitive criteria of right and wrong.In this way,a good identifier must be not only authoritative in this field but tolerant to other views.

Theoretical conflicts among different academic schools are usually not observed in TCM.However,such contradiction phenomena are not avoided or are regarded as barriers against academic development by the TCM academia,but are considered as reasonable.As such,schools of Chinese medical theory have always been designed as the core curricula of TCM higher education.Since the existence of academic schools is considered as reasonable and factional views are not denied considering their deviation from the mainstream theories,it is evidently inappropriate to mechanically identify those seem-tobe medical malpractices of other schools based on the mainstream theories.

Huoshen School’s use of Aconiti Lateralis Radix Praeparata(Fu Zi,附子)is a typical example of unconventional medication.As prescribed inChinese Pharmacopoeia,the conventional dosage should be 3 - 15 g considering its certain toxicity.However,doctors of Huoshen School use over 50 g per dose[6],which is far beyond what is specified inChinese Pharmacopoeia.Because of their heavy toxicity,the prescribed dosage of Aconiti Radix Cocta(Zhi Chuan Wu,制川烏)and Aconiti Kusnezoffii Radix Cocta(Zhi Cao Wu,制草烏)inChinese Pharmacopoeiaare 1.5 - 3 g,and 0.3 - 0.6 g for Strychni Semen(Ma Qian Zi,馬錢子)[1].However,senior famous TCM doctors prescribe a dosage that is ten times higher than the prescribed dosage for these Chinese medicines,which surprisingly result in positive clinical effects[7].

The above mentioned treatment technologies,which are evidently beyond specifications of drug use inChinesePharmacopoeiaand which deviate from mainstream academic theories,are defined to be unconventional.If we identify such technologies,which may have caused injuries,with the thinking mode and the theoretical standard of technological identification in western medicine,the conclusion must be bad for doctors.In this way,the Huoshen School’s use of an overdose of drugs will lose its legitimacy,and schools such as the Huoshen School or the Gongxia School are bound to close.Over time,the TCM will ultimately lose its excellent traditions as academic schools are eliminated one by one.Consequently,the TCM will lose its significance.

Medical faults refer to malpractices of doctors who fail to perform the duty of care.In western medicine,medical practices violating routines of treatment and nursing are considered as “faults”.However,in TCM,the application of unconventional treatment technologies based on special theories and experiences of academic schools is a deliberate and well-defined conduct rather than a fault arising from the negligence of the duty of care.Therefore,while the unconventional treatment technologies of some TCM academic schools seem to violate the routines,they are definitely not subjective “faults”.

3 Legitimacy Identification of Unconventional Treatment Technologies

As previously mentioned,unconventional treatment technologies in TCM can be specialties of some academic schools.Certainly,they may also be malpractices of doctors.How to distinguish natures of such practices is the focus of this study.The orthodox theories inChinesePharmacopoeia,textbooks and authoritative journals are certainly identification standards for medical practices.Furthermore,what else can justify unconventional treatment technologies so as to distinguish them from medical malpractices?

This study summarizes the common unconventional treatment technologies according to actual clinical medical situations and discusses the legitimacy standards to distinguish between “well-defined academic breakthrough” and “subjective malpractice”.

3.1 Identification standards of unconventional treatment technologies based on academic school theories

There must be relevant literature to support the theories of academic schools.However,some schools use radical methods or an overdose of high toxicity drugs,which is dangerous to some extent.For example,the Huoshen School uses an overdose of Aconiti Lateralis Radix Praeparata(Fu Zi,附子),and the Gongxia School uses an overdose of Rhei Radix Et Rhizoma(Da Huang,大黃)[8].Therefore,it is insufficient to merely have theoretical support,and a certain quantity of successful medical cases is required.Most of the healthcare workers who use an overdose of high toxicity drugs and achieve positive clinical effects by surprise are commended worldwide.However,according to a popular Chinese saying,nothing is given without a disadvantage in it;a good curative effect is possibly accompanied with certain toxic and side effects.It is more like a science game where doctors cannot ensure gains or losses at the very beginning.Therefore,bad effects,if present,cannot be attributed to the doctors.

The literature should be taken as quoted evidence to identify the legitimacy of unconventional treatment technologies of academic schools.An academic school cannot be established without mass literature,such as ancient medical books,papers and news reports.Since we allow the existence of academic schools,we have to recognize the legitimacy of their practices.It is not scientific or ethical to merely lavishly commend the positive clinical effects without tolerating the negative effects of a technology.If an unconventional treatment technology is supported by a significant literature of an academic school and its application is based on the school’s theories and experiences,then it should be identified as legitimate.

This study suggests that a treatment technology should be identified as a legitimate technological breakthrough if it meets the following conditions:first,the technology is supported by well-known theories of academic schools,and second,the technology does not involve high risk or patients explicitly agree to use the technology after being informed of the risks.Otherwise,the technology should be considered as a medical fault.

3.2 Identification standards of unconventional treatment technologies based on secret prescriptions and proven prescriptions

Article 39 of theLaw of the People’s Republic of China on Traditional Chinese Medicineregulates that “The state shall take measures to support the review,research,and utilization of academic thoughts and treatment experiences of ancient TCM documents and famous TCM experts as well as folk TCM technical methods.The state encourages organizations and individuals to donate TCM documents,secret prescriptions,proven prescriptions,treatment methods and technologies with the value of scientific research and clinical application.”[9]It can be observed that secret prescriptions and proven prescriptions dispersed in and kept by various communities are also important components of TCM,which are recognized and encouraged by law.Despite their lack of corresponding theoretical support and their deviation from mainstream theories,these prescriptions may achieve good effects in medical practice.“Qualification system of TCM physicians with specialty in medical skills”under theLaw of the People's Republic of China on Traditional Chinese Medicineis mainly set up for such talents.The law legitimizes the qualification of TCM physician with specialty; hence,medical skills they specialize in should also be allowed to deviate from mainstream theories.If unconventional treatment technologies are required while conducting such skills,we should also understand it.

This study suggests that a treatment technology should be identified as a legitimate technological breakthrough if it meets the following conditions:first,the origin of secret prescriptions and proven prescriptions can be traced back,and second,the technology does not involved high risk or patients explicitly agree to use the technology after being informed of the risks.Otherwise,the technology should be considered as a medical fault.

3.3 Identification standards of unconventional treatment technologies from ancient medical books and cases

TCM is considered as significantly important.Apart from the orthodox mainstream theories,discovered folk prescriptions,and proven prescriptions,in the vast number of ancient books,several mysteries need to be investigated,sorted out and performed forward.For example,Prescriptions for Fifty-two Diseases(Wu Shi Er Bing Fang,《五十二病方》)is the earliest extant literature of medical prescriptions in China,in which therapies for 52 diseases and over 280 medical prescriptions are recorded.Under the circumstance where there were no guiding TCM systematic theories or referential identification methods,doctors treated diseases with empirical prescriptions proven by long-term practice[10].Thus,clinical trial of treatment technologies from ancient medical cases is a significantly normal way to pass down TCM.However,the ancient medical books contain both the good and the bad as well as the conventional and the unconventional.There is no harm of applying conventional treatment technologies into clinical practice,but some other unconventional treatment technologies should be taken seriously.It is evidently imprudent to use an overdose of toxic drugs without the support of successful cases.

This study suggests that the use of technologies without evident damaging effects in ancient medical books and cases should be considered as reasonable technological exploration and application; however,unauthorized use of unconventional technologies,which results in injuries considering the doctors’insufficient clinical practice,should be considered as a medical fault.

4 Conclusions

Articles 40 and 50 of theLaw of the People’s Republic of China on Traditional Chinese Medicineregulate that “The state shall establish and improve the scientific and technological innovation system,evaluation system and management mechanism commensurate with TCM features and promote TCM scientific and technological progress and innovation.The state shall strengthen the construction of the TCM standard system and formulate standards and revise in a timely manner the technical requirements that shall be unified according to TCM features ...The state shall promote the establishment of an international TCM standard system.” In line with this,it can be observed that the construction of the TCM standard system and the TCM evaluation system has been put on the track to becoming a rule of law.However,unlike western medicine,TCM has a different thinking mode,which is highly critical rather than observant to routines,and consists of a lot of schools.TCM has always held to an old adage that “using medicine is like dispatching soldiers”,meaning that an army arrangement is as changeable as the shape of water,since it is a military strategy to defeat enemies by a surprise action.Thus,it is difficult for the unique TCM thinking mode to flourish in today’s society where standardization and legalization prevail.This is also the problem TCM must face up to now.In this case,the TCM industry should spare no efforts to make this ancient discipline accepted and understood while adapting to the society.The evaluation standards,if established,should comply with industrial characteristics of TCM to further promote the development of the TCM industry.

This study discusses and studies the legitimacy identification of unconventional treatment technologies in TCM and raises the identification standards for several common situations.The study aims to help identification experts distinguish “well-defined medical breakthrough” from “medical fault” and to provide legal support for special and innovative TCM treatment technologies to boost the sound development of the TCM industry.However,additional studies are required considering that this study is incomplete and has insufficient details,and the identification standards proposed in this study are based on the authors’own ideas only to pave the way for upcoming researchers.The implementation of these standards first requires the consensus of the whole industry,and subsequently,the authorities or industrial associations can thoroughly assess these standards.

Acknowledgements

We thank for the funding support from the Hunan Provincial Situation Advisory Project(No.2013ZZ5).

Competing Interests

The authors declare no conflict of interest.