|MODERN RESEARCH ON CHINESE MATERIA MEDICA
|Year : 2016 | Volume
| Issue : 4 | Page : 6-28
The evolutional development of traditional chinese medicine (TCM) outside the chinese mainland: Challenges, training, practice, research, and future development
School of Pharmacy & Biomolecular Sciences, Liverpool John Moores University, L3 3AF, UK; The National Institute of Complementary Medicine, Western Sydney University, NSW 2560, and Faculty of Science, University of Technology, Sydney, NSW 2007, Australia
|Date of Submission||15-Jul-2016|
|Date of Acceptance||24-Aug-2016|
|Date of Web Publication||10-Sep-2020|
School of Pharmacy & Biomolecular Sciences, Liverpool John Moores University, L3 3AF, UK; The National Institute of Complementary Medicine, Western Sydney University, NSW 2560, and Faculty of Science, University of Technology, Sydney, NSW 2007
Source of Support: None, Conflict of Interest: None
This overview has provided an account of evolutional changes of an experience-based traditional medical practice of traditional Chinese medicine (TCM) towards modernisation to keep up with recent advances in analytical and biomedical sciences, and information technology, which may help readers to understand why applying biomedical research methodology to TCM modernisation, while maintaining the experience-based concepts, principles and heritage of TCM’s personalised health and medical approaches in balancing body’s functions with physical and mental harmony when facing environmental changes, can contribute to gain global appreciation and acceptance of TCM in healthcare. It is envisaged that such future development and integration with biomedicine-based main-stream medicine (MSM) in practice will provide valuable medical care in the development of future personalised health and medicine as well as TCM product development.
Keywords: Evolution of MSM & TCM, Challenges, Training, Practice, Research, Integrative development
|How to cite this article:|
Chan K. The evolutional development of traditional chinese medicine (TCM) outside the chinese mainland: Challenges, training, practice, research, and future development. World J Tradit Chin Med 2016;2:6-28
|How to cite this URL:|
Chan K. The evolutional development of traditional chinese medicine (TCM) outside the chinese mainland: Challenges, training, practice, research, and future development. World J Tradit Chin Med [serial online] 2016 [cited 2023 Dec 1];2:6-28. Available from: https://www.wjtcm.net/text.asp?2016/2/4/6/294719
| Introduction|| |
This paper describes the author’s research paths from pharmaceutical to integrative approaches in basic and clinical research of main-stream medicine (MSM) initially, then Traditional Chinese Medicine (TCM). Through these long and winding paths of working in academic institutes, government bodies and hospitals, in both the northern and southern hemispheres over the past years, the author has collectively summarised his experience of the evolution to the present-day medicine through literature publications and own research outcomes. With this knowledge and experience collated over the decades, some recommendations are provided in this overview the best way forward to steer the global role of TCM in healthcare in the 21st century.
The initial part of the overview deals with short accounts on the development of both MSM and TCM in order to understand their contributions in treating human diseases from evolution of ethnic culture and philosophy. The different views of TCM in the West during the mid-1990s that stimulated a debate on ‘For and Against’ of its role in health amongst the public, academia and legal bodies is a mile-stone for a closer look of TCM in terms of quality, safety and efficacy at large since that period.
The recent advances of technology in biomedical sciences are consequential to the human genome project, and analytical/ instrumental sciences that allow imminent measurement of events occurring in cell/organ programming, and computational sciences that provide databases of both biomedical and analytical parameters for further elucidation and determination of research outcomes, have collectively and indirectly brought the two vastly dissimilar medical concepts to another debate of ‘For and Against’ in personalised integrative healthcare.
A large number of currently used pharmaceutical medicines are obtained from medicinal plants or natural sources. The development of current practice and pharmaceutical medicines in MSM has a comparatively short history: medieval medicine initiated in Europe into a science-based discipline dates back less than 200 years. This rapid rate of success depended mainly on the advancement of physical sciences and techno- logy. Many pharmaceutical medicines were introduced initially via activity-screening from extracts of medicinal plants and phytochemical isolation and subsequently followed by chemical synthesis of the isolated active compounds. With the help of chemical synthesis and fitting novel chemical entities into quantitative structure-action analysis (QSAR)-models or protein-enzyme models a series of chemical analogues can be screened for new drug development. The successful discovery and development of penicillin (1928-1945), which has been coined as a milestone in 20th century pharmaceutical chemistry, has stimulated introduction of many pharmaceutical drugs during the 1960s, therapeutic armament to develop and improve MSM in the developed countries worldwide, while the developing and under-developed countries/regions have relied on their own ethnic/traditional medicines mainly from medicinal plants even nowadays.
In recent years the pharmaceutical industry has produced fewer new agents for treatment of chronic diseases related to metabolic syndromes (cardiovascular complications, diabetes, obesity), rheumatoid arthritis, aging-related degenerative disorders such as Alzheimer diseases, dementia, Parkinson’s diseases and other high burden diseases such as various cancers, infectious diseases caused by drug-resistant microbial infections and others through sexual contacts or contaminated blood such as hepatitis and related carcinomas and HIV. Among many factors the root causes of few new drugs are: relentless health economics pressure; increasing regulatory hurdles; immature state of knowledge and molecular reduc- tionism and management reductionism & diseconomies of scales. Such approach to identify small molecules for drug development becomes more and more expensive. Most national health systems worldwide have suffered from the burden of high cost of pharmaceutical medicines in both primary care and secondary care since the 1990s. [Table 1] briefly summarises the key events of evolution and progress of pharmaceutical medicines in OM from ancient time to the future.
|Table 1: The Evolution of Main Stream Medicines in Europe and Other Developed Countries (Modified from ref.).|
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| The Keeping of the 5000 Years Old TCM in Line with Advances in Science and Technology|| |
TCM as one of the oldest medical traditions since 2800 BC has been practised to maintain health and treat diseases in the Chinese communities and recently adopted by others worldwide. [Table 2] concisely summarises the historical development of TCM since ancient times. Nowadays, Chinese materia medica (CMM) and proprietary products of TCM composite formulae (PCM), acupuncture and related medical manipulation (Tuina and related physical therapies), together with life styles (consuming CMM functional foods, practising Taichi, or Qigong meditation) are often used in TCM practice, coexisting with MSM in China and some regions in the Far East. Though used by the public on their own accord, TCM has not been recognised officially in some regions such the European Union and North America as part of the healthcare system run by main stream MSM practice. Such circumstance has delayed the development of traditional medicine in these regions in comparison with that in Australia, Japan (as kampo medicine), Korea (as oriental medicine) and some European countries. The non-recognition can be considered as obstacles for delay in the development and modernisation of TCM in general worldwide.
|Table 2: The Evolution of Traditional Chinese Medicine (TCM) towards Integrative Healthcare (Modified from ref)|
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Meanwhile, two unrelated phenomena in medical progresses were observed: Firstly, the population in the well- developed countries have turned to complementary and alternative medicines (CAM) and TCM has been one of the key CAM disciplines attracting most attention as evidenced by a recent overview on a 2010-2015-2025 survey and prediction®. Secondly, the human genome programme completed in 2003 has introduced significant advancement of biomedical and analytical technology to further the understanding of the nature of ill-health and offered new hopes to the big pharmaceutical organisations to develop new medicines based on functional genomics, proteomics and systems biology/ medicine for treatments of diseases. Indirectly such advances of biomedical and analytical technology may have also influenced the development of TCM and offered opportunity for modernisation to keep up with such advances, which help to convert an experience-based practice towards evidence- based medical practice in order to play a role to integrate into main stream medicine while maintaining its traditional holistic principles for maintaining good health.
This overview addresses these key issues and attempts to propose ways for future research and development for TCM into the 21st century. The impact will certainly be modernisation in every aspect of the disciplines to cope with the fast growing demand in quality medicines while maintaining the traditional principles of TCM health holism. Several major areas, which are essential for global development of TCM, are listed for discussion.
| Challenges Towards Diverging Opinion on TCM in the 1990s|| |
1. Lack of understanding of TCM principles in health and disease
The holistic approaches of TCM in diagnosis and treatment of diseases and maintaining good health is in contrast to that of MSM. Practice of MSM is based on modern anatomy, molecular cell biology and is characterised by a reductionist approach in analysis and diagnosis of health and diseases. As TCM was established long before the advent of modern science, involving validation and experiences gained over thousands of years, it represents an area of medicine that is more experienced-based with the environmental and philosophical approaches than based on conventionally scientific aspects. Although TCM has played an indispensable role in maintaining the health of people in China and several Asian regions, its value remains largely unproven according to biomedical sciences and many existing systematic reviews or meta-analyses are often inconclusive due to the less stringent clinical design not related to MSM criteria for randomised clinical trials (RCT). This deficiency has led to criticism domestically and internationally. Reasons for underdeveloped TCM research during this period are manifold, including subjective and personalised TCM diagnosis, which is often incompatible with the conventional RCT methodology for clinical research; the complexity and wide diversity of herbal medicines and diseases; as well as the difficulty of choosing correct controls for complex herbal remedies prepared from CMM and acupuncture, etc. Furthermore, lack of research funding and a worldwide shortage of qualified researchers outside the Chinese mainland who understand both TCM and modern biomedical technologies should never be underestimated. These situations have been improved recently as more scientists and practitioners have taken interest to find out how TCM works in their quests for evidence endeavours.
2. Observations on the increasing appreciation and scepticism of TCM
In the west increasing uses of Chinese medicines have created both acceptance and scepticism of TCM practice that have initiated a major debate in medical cycles since the successful randomized clinical trial on the use of ten prescription CMMs on atopic eczema was published in 1992. Quite separately during this similar period a chronic renal disease was observed in a group of otherwise healthy Belgian women who had ingested a slimming regimen that included a wrong species of CMM, Guang Fangji (Aristolochia Fangchi Radix) containing aristolochic acid instead of Han Fangzi (Stephania Tetrandra Radix). Over time, approximately 100 of these women developed chronic renal insufficiency due to the toxic effects of aristolochic acid. Furthermore available in the market, often found are CMM products adulterated with pharmaceutical drugs and wrongly supplied crude CMM causing liver and kidney toxicity. These unprofessional practices from commercial organizations do not give TCM the right reputation and recognition. It is emphasized that legal regulatory agencies should set up harmonized monographic standards for CMM and regulatory control over the import and export of natural or herbal products to ensure safety of the public who consume these products. Further information will be considered in subsequent texts on this issue.
3. The requirement of expertise and leadership to implement improvement
The advancement of internet access message on CAM is freely available to the public. As such there is the growing demand for and promotion of traditional and herbal medicines including TCM products in countries within Europe and in North America. Adverse effects and health risks exist with the use of TCM in a western environment by persons often unfamiliar with the underlying medical traditions. A recent review indicates several key points concerning usage status of TCM in a survey conducted by experts in the European Union (See Box 1). Therefore, such requirements and resources on professional experts and leadership which determine the quality of practice and standardised TCM medications and non-pharmacological interventions are the pre-requisites before one can assess the safety and efficacy of TCM treatment and prevention of diseases in regions outside China. Global collaboration is one of the ways to look at evidence-based practice of TCM and for integration into healthcare systems worldwide.
| Medical Training & Research of TCM Outside China in the 2000s|| |
1. The inclusion of complementary & alternative medicine in MSM
The reductionist and specialisation approach in diagnosis and treatment of diseases in conventional MSM has been questioned as inappropriate for holistic care for patients by experts who are involved in medical curriculum. Since the early 2000s the medical schools in the USA reviewed that although evidence-based medicine remains an important part of medical education, 123 of the 125 Association of American Medical Colleges required students to take at least one complementary/alternative medicine (CAM) course in the academic year. Such changes have been brought about by the patients’ desire for alternative therapies, as nearly 40% of American adults had used some forms of CAM, from nutrition and mental relaxation to acupuncture, magnet therapy, and foreign healing systems like traditional Chinese medicine and Indian ayurveda. Medical schools in other regions have also encouraged similar approaches, indicating there is an increasing interest of CAM. Future practice of MSM may embrace and encourage a holistic approach to practice that incorporates patient involvement in self healthcare, prevention and lifestyle interventions. In most international CAM conferences we have observed that TCM participation in key themes mainly focuses on acupuncture, qigong/taichi for the benefit of well-being and pain relief with few clinical studies of TCM formulae while research outcomes in assessing quality, safety and clinical efficacy of TCM herbal products in CAM conferences are not plentiful. In general, TCM as a CAM discipline is considered the most widely used CAM worldwide,. On the other hand, most international conferences of TCM have included a good mix of all 5 disciplines mentioned earlier.
2. The reason for inclusion of biomedical science in TCM curricula
Patients may be at risk from a delay in seeking medical advice for a serious medical condition that is not appropriately treated by complementary therapies. Therefore the practitioner should be competent to recognise the need of knowledge in both TCM and MSM practice. Professionalism and regulations are needed to protect the public.
A consultant paediatrician, who led the clinical trial of a 10 CMM-decoction mixture in treatment of atopical eczema in children and published positive outcomes in 1992, commented:
“Those unfamiliar with Chinese medicine should be aware that, in present-day China, it is regarded as perfectly normal for TCM practitioners to prescribe Western-type licensed pharmaceutical products alongside acupuncture and herbal therapies. There is no rigid separation of Western-type medicine and TCM as outsiders might imagine, and the training of TCM practitioners has for several decades included substantial amounts of basic Western medical science including anatomy, physiology and pathology. Likewise, those training in China in Western-type medicine are taught the theories of TCM. The result is considerable cross-fertilisation between these 2 disciplines, despite their superficially exclusive natures. This has been very much to the benefit of patients, who are not infrequently treated simultaneously by both types of practitioner. During my own visits to China I saw this collaboration occurring in many areas of medicine, but perhaps most effectively in the treatment of auto-immune diseases such as systemic lupus erythematosus and derma- tomyositis, which are common in China, and in the symptomatic care of patients dying of liver failure, also common in China, and of terminal malignant disease. “.
During the 1990s, such medical experts and professionals equipped with both medical disciplines were not plentiful in the west including UK and other regions. If there is the desire of using TCM in the healthcare system in any developed countries there should be training courses that produce practitioners of TCM with good quality and professionalism to safeguard the public interests and their health. This is to check on those who are not qualified and to eliminate unprofessional practice. In most European countries the interest groups of acupuncture and TCM herbalism started more formal training of CM on the initial running of and updating seminars. The earliest group seminars were run during the late 1950s and early 1960s. In recent years, many of the established acupuncture colleges in the UK (also in Australia and the USA) have introduced courses in TCM herbalism. Most of these institutes run part-time courses, mainly in the evenings and weekends, of varying years of duration with certificates and diplomas on graduation. An independent survey on overall situation of TCM practice in UK indicated that available training courses, offered by private schools/institutes, were mainly on part-time basis. [Table 3] provides a summary indicating most of the private schools/institutes offered part-time programmes for TCM or acupuncture training, as surveyed by Jin and co-workers.
|Table 3: TCM full time (FT) and part-time (PT) courses run by institutes in UK during the 1990s (Updated from Jin et al., 1995).|
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3. Training of professionals in TCM outside the Chinese mainland
3.1 The United Kingdom (UK) experience:
In 1995 the author was conferred Churchill Fellow, which provided funding for him to take on the project “Critical Assessment of Traditional Chinese Medicine in the East”. This project enabled him to visits key TCM universities/institutes in Beijing, Shanghai, Nanjing, Chengdu and Guangzhou in China, Tokyo and Toyama in Japan, Hong Kong, and Taichung and Taipei in Taiwan to investigate the then development of TCM academic programmes and research and build up networking with key institutes.
The reported outcomes of the Churchill Fellowship were announced national-wide and had indirectly initiated the establishment of the very first university degree course in Europe: The author, while working at the Ministry of Health in Abu Dhabi as Director of the Zayed Complex for Herbal Research & Traditional Medicine, was appointed Visiting Professorship at Middlesex University (MU) in London and was involved in engineering partnership between MU with Beijing University of TCM to launch the full-time degree course. Box 2 summarises key ethos of the programme.
The London-Beijing course was eventually started in 1997, and since then several other institutes and universities in the UK have also offered accredited degree courses in TCM linked with TCM universities in China. It has survived the test of time and now developed post graduate training for OM qualified professionals. [Table 4] summarises the currently available foundation and post-graduate courses of TCM available in the UK. There is improvement in providing academically sound human resources of TCM in UK.
|Table 4: Current Full-time (FT) and (part-time) accredited TCM courses offered in UK under the UK Association of TCM.|
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However, at present the UK government via the Department of Health published the Report on the Regulation of Herbal Medicines and Practitioners, which has not agreed to grant Statutory Regulation (SR) for herbal medicines and practitioners as registered health professional alliance to medicine. It recommends continuing the voluntary Professional Statutory Authority (PSA) to accredit herbal practitioners since 2000 recommended for the House of Lords’ Science and Technology Select Committee, some 15 years ago. Such decision indicates the herbal profession is not recognised as part of the health profession and has created a collective rebuttal action from the education, practitioners and industry sectors. Currently some of the full-time courses for TCM degree courses are not on offer, most probably due to the lack of demand from the public. This may reflect the unfavourable decision of the UK government on not granting Statutory Registration Authority to Herbal Medicine. (See details depicted in Box 3 below):
3.2 The Australia experience:
TCM has an established history in Australia and has expanded rapidly in recent years. The practice was introduced into Australia at the time of gold rush period as early as 1850’s. At the Ballarat town of Victoria, a tourist spot where the history of gold mining is maintained, the old clinic of TCM called Bao Kan Tang is one of the major attractions. This reflects the significance of TCM in health care in the early history of Australia.
However, the practice of TCM struggles to find its place as a complementary medicine in Australia, despite the fact that around 30% of all complementary medicine consumers use TCM. Over the last decade: Two in three people use complementary medicine each year, with the complementary medicine industry being worth $1.5-2.5 billion per annum. Of those who took complementary medicine, around 27% used TCM. Although there has been many research groups formed across the nation and umbrella institutions such as the National Institute for Complementary Medicine, there has not been any major changes to encourage an ‘integrative’ approach to healthcare for the benefit of the Australian public. In 2012, Australia is the first country outside China who initiated registration of all qualified TCM practitioners, supported by standards, codes and guidelines. With this recognition of the profession, it would be an enormous advantage to provide an R&D direction for integrating the available well-tried experience-based TCM paradigm with the increasingly advanced MSM paradigm. Yet, only anecdotal records of success using TCM treatment for diseases that have not been cured successfully by MSM have been reported. In the public there had been sceptics advocating against the use of complementary medicine due to limited scientific evidence.
1) The first country outside China formalised the registration of TCM. From 1 July 2012 onwards, TCM practitioners must be registered under the Australia national registration and accreditation scheme with the Chinese Medicine Board of Australia, which is one of the 14 Boards answerable to the Australia Health Practitioner Regulatory Agency (AHPRA; http://www.ahpra.gov.au/National-Boards.aspx), and meet the Board’s Registration Standards, in order to practise in Australia. The AHPRA has the legal power to approve or disapprove these courses in TCM including acupuncture,
Chinese herbal medicine, and a combination of both disciplines. (http://www.ahpra.gov.au/Education/Approved- Programs-of-Study/Inactive-Programs-of-Study.aspx). At present there are nine different institutes (universities as well as colleges) throughout the country provide accredited/ approved basic bachelor degree courses. Some of these institutes also provide opportunities for graduates and qualified TCM practitioners to study higher/post-graduate level degrees. Most of these degree courses also provide placement training with TCM universities in China.
2) The Joint Chair in TCM Program in New South Wales State (NSW):(http://sydney.edu.au/china_studies_centre/ china_express/issue_4/features/The-JCTCM-Programme-in- NSW.shtml; accessed on 15th June 2016). To address some of the above issues, an agreement between The University of Sydney (USyd), Western Sydney University (WSU) and the NSW former Department of State and Regional Development (DSRD), now the Office of Science Research (OSR), was initiated in 2008. The Chair had been a strategic appointment whereby the holder of the Chair should provide national leadership in TCM research and develop synergistic TCM research programs at USyd and WSU. The program is jointly funded, for a period of five years, by DSRD, USyd and the WSU, and the projects are supported through the Faculty of Pharmacy at USyd and the National Institute of complementary Medicine at WSU. A high level Project Plan was developed by the Joint Chair in early 2010 and identified strategic research priorities in TCM development under the Joint Chair programme (See Box 4):
The JCTCM programme, though challenging, complex and diverse in collaboration, has successfully achieved to provide research and training direction for future human resources, particularly with partners in China. The programme has hosted a variety of TCM related public lectures, seminars, workshops and delegations during the course of the program, and participated in national TCM forums, all contributing to the development of the science and evidence-based aspects of TCM education, future and practice as well as establishing potential collaborations between national and international partners. During the period of the JCTCM programme, notably the following key projects had been carried out (See Box 5).
3.3 The Hong Kong experience:
This has been an example of gradual development TCM practitioners into an accredited and registrable profession over the years. The Hong Kong Special Administrative Region (HKSARg) in China was a British colony from 1842 to July 1997 under the Treaty of Nanjing signed by the then Qing Dynasty. Most of Hong Kong residents (Over 90%) are of Chinese origin and have close economic and cultural relations with the the Chinese mainland throughout the period. TCM as an integral part of the Chinese culture has been widely used within the Hong Kong Chinese community for a long time despite western MSM being the main stream in medical care. HKSARg is also an important trade centre port/centre of TCM related products including CMM due to her close economic relationship with the Chinese mainland and Chinese communities overseas. The open policy of the Chinese mainland since the 1980s has created many key trading channels. While China is the main producer and exporter of CMM, Hong Kong is the most important first destination of this import and re-export trade. Over the past decade, after returning to the motherland, HKSARg has been one of the most influential regional communities in terms of economic and technological development and growth and has been ranked as the world’s freest economy many years running, and it remains presently the first of the world’s top 5 leading financial centres. This does help to promote global appreciation of the culture, practice and service of TCM outside China.
1) CM in Hong Kong during colonial period. During this period, TCM was not recognised as part of the healthcare system in Hong Kong though R&D towards quality control, toxicology and pharmacology had been set up by the Chinese Materia Medica Research Centre (CMMRC) at the Chinese University of Hong Kong since the early 1980s, which has now been re-developed to the highly recognised Institute of Chinese Medicine. The then HK Government appointed a Working Party on Chinese Medicine (August 1989 to October 1994) to review the practice and use of Chinese medicine in Hong Kong and advised measures that should be taken to promote the proper use and good practice of Chinese medicine. Consequently, a Preparatory Committee on Chinese Medicine (April 1995-March 1999) was established to make recommendations to the government on the promotion, development and regulation of Chinese medicine in Hong Kong. The Committee recommended a statutory body be set up to regulate the practice, use and trading of Chinese medicine; a system of accreditation and regulation which includes registration, examination and discipline of Chinese medicine practitioners be established with transitional arrangements for existing practitioners; and a control mechanism, through systems of registration, licensing and labelling be set up to regulate the manufacture, distribution, retail and import and export of Chinese medicines. Regarding the future development of Chinese medicine, the Preparatory Committee recommended full-time undergraduate courses in Chinese medicine be developed and made available in Hong Kong; scientific researches and developments in Chinese medicine be encouraged and supported; and Chinese medicine be included into Hong Kong’s medical and healthcare system on a gradual basis.
2) TCM in Hong Kong after return to China. After 1st July 1997, the policy for the future development of Chinese medicine was enshrined in the Basic Law of the Hong Kong Special Administrative Region. Article 138 of the Basic Law provides that “… the Government of the HKSARg shall, on its own, formulate policies to develop western and traditional Chinese medicine and to improve medical and health services”. The then Secretary for Health, Welfare and Food (Now reorganised as Food and Health Bureau) conducted a public consultation on the development of Chinese medicine in the HKSARg in November 1997 to solicit public opinions. Based on the Preparatory Committee’s recommendations and public views collected in the consultation, the Chinese Medicine Bill was introduced into the Legislative Council in February 1999 and was passed in July the same year (http:// www.cmchk.org.hk/eng/main_deve.htm; accessed on 30th June, 2016).
From 1998 onwards full-time degree courses in Chinese Medicine were set up in three different local public universities recognised by the Government University Grant Council (HKUGC), though there were private colleges of TCM providing part-time courses in the past. There are presently three Schools of Chinese medicine offering fulltime (5-years foundation plus clinical internship) undergraduate degrees courses and par-time masters/postgraduate course at the Chinese University of Hong Kong (http://www.scm.cuhk.edu.hk/), Hong Kong Baptist University (http://scm.hkbu.edu.hk/en/home/index.php) and the University of Hong Kong (http://www.scm.hku.hk/). All undergraduate courses follow similar academic structure to those specified by the State Administration of Traditional Chinese Medicine in Beijing and placement/internship training in their respective teaching out-patient clinics and key TCM university hospitals in Beijing, Chengdu, Guangzhou, Nanjing, Shanghai, and Shenzhen. All courses are taught in three spoken languages when necessary (Cantonese, English and Putonghua) with biomedical curricula taught in English. The graduates have now fully integrated in services either in private practice or at the outpatient- clinics of public hospitals in the 18 districts and hospitals run by non-government organisations. The Hong Kong government University Grant Council has also provided research funding to help research and development of TCM since the mid-1990s.
In the early 2000s Hong Kong Department of Health launched the quality assurance programme on the Hong Kong Chinese Materia Medica Standards “HKCMMS” to develop standards for commonly used CMM in phases to ensure the safe use and the quality of CMM. The then Chief Executive highlighted in his 2009 Policy Address the importance of expediting the setting of standards for CMM commonly used in Hong Kong. It is in this context that the Department of Health embarked on the extension of CMM coverage to about 200 by 2012. The 2011/12 Policy Address of the Chief Executive had reaffirmed the government’s commitment to the establishment of standards for CMM. Recently the “Hong Kong Chinese Materia Medica Standards (HKCMMS) Volume 7” was launched in June 2015; seven editions of the HKCMMS covering standards for a total of 236 CMM have been published. The research and development works of HKCMMS are done by institutes from local and overseas universities and the Chinese mainland regulatory/testing institutes, and research outcomes are deliberated and overseen by the International Advisory Board (IAB) consisting of 23 local and international renowned experts. The IAB gives advice on the principles, methodologies, parameters and analytical methods for the development of HKCMM standards. It also decides the contents of the HKCMMS, selects the research institutions to take up the research and laboratory work, and determines the target medicinal plants. The IAB usually meets once per 12 to 18 months to evaluate and endorse the research results. The overall guided principles are summarized in Box 6. (http://cmd.gov.hk/html/eng/ index.html, accessed 30th June, 2016) 3) The future development of TCM in Hong Kong. In the 2016 HKSARg government policy address, in response to the requests from the academia, industry sector, and TCM community together with the encouragement of the Nobel Prize in Medicine received by Tu You-You’s research outcome on QingHaoSu, the HKSAR Government has been implementing the recommendations from Chinese Medicine Development Committee in phases: a) the launch of the Integrated Chinese-Western Medicine Pilot Project as new initiative Chinese medicine services by the Hospital Authority; b) the planning and establishment of a testing centre for Chinese medicines to be administered by the Department of Health on top of the completing the compilation of Hong Kong Chinese Materia Medica Standards for CMM commonly used in Hong Kong, and will launch a pilot study on the standard setting for Chinese medicines decoction pieces; c) personnel training and professional development, research and development for the Chinese medicines industry; and d) reserving a site to develop a Chinese medicine hospital. This has been a change for the good of TCM in Hong Kong after the 1997 return to motherland. (http://www.policyaddress.gov.hk/2016/eng/ p232.html; access 30th June 2016)
| Advance of Analytical, Biomedical and Computational Technology|| |
The holistic integrity of CMM combination contained in the proprietary Chinese herbal medicines (PCM), which creates a challenge in establishing quality assessment and control of standards of the starting materials (crude materials and decoction pieces) and the standardization of finished herbal drugs because no single chemical marker component is contributing to the total efficacy of the herbal prescription.,
Analysis of complex mixtures of TCM products depends heavily on instrumental and chemical analysis technology, which has been the key driving force for nearly all practical measurements in modern physical and medical sciences. Separation technology is an essential component in phyto- chemical analysis of ingredients in medicinal plants The introduction of unique hyphenated-chromatographic instruments coupled with sophisticated computer technology has allowed analysts to measure the chemical contents of extracts from herbal mixtures,. These analytical armaments have indeed provided analytical scientists to investigate complex mixtures in the phytochemical elucidation of ingredients in CMM as characteristics in a single CMM or mixtures in the finished products.
1. Application of chemometric analysis on chromatographic finger printing
This analytical approach has enabled the generation of chromatographic fingerprints, which represent a rational approach for the quality assessment of TCM products. Thus, chromatographic fingerprinting analysis of herbal medicines has contributed a comprehensive qualitative approach for the purpose of species authentication, evaluation of quality, and ensuring the consistency and stability of herbal drugs and their related products. The pragmatic comprehensive chromatographic fingerprinting analysis can disclose the detectable ingredients composition and concentration distribution under quantifiable operational conditions and therefore provide real-time quality information. However, this cannot entirely solve the holistic actions of the composite formulae or decoction pieces prescribed for treatment. It may leave a “grey” entity at the primary stage Nevertheless, consecutive studies will be required to develop feasible technology to measure activity and improve the reliability of quality assessment and transparency of TCM products. Chemical fingerprinting pattern alone cannot reflect entirely the quality assurance of the composite/ complex mixture products, bioactivity index to confirm the safety and mechanisms of action is needed before large scale of clinical studies for efficacy, is conducted as shown by the following example of Phytomic QC.
2. Linking chemical and biological fingerprints of CMM as quality assurance
Recently, Tilton and co-workers using finger-printing technology and gene-expression monitory, worked on the quality assessment of a TCM composite formula (Huang Qin Tang) which was developed as an product with intellectual property protection known as PHY906, consisting of four distinct CMMs: the roots of Scutellaria baicalensis Georgi. (Huang- qin), Glycyrrhiza uralensis Fisch. (Gancao) and Paeonia lactiflora Pall. (Baishao), and the fruit of Ziziphus jujuba Mill (Dajao), which has been documented for nearly 1800 years for treating common gastrointestinal distress, including diarrhoea, abdominal spasms, fever, headache, vomiting, nausea, extreme thirst, and subcardiac distention. In addition to traditional pharmacopoeia analyses, such as heavy metal tests, microbial tests, pesticide residues, a multi-faceted approach, Phytomics QC, integrates (1) high resolution chemical fingerprint focusing on liquid chromatography/ mass spectrometry (LC/MS); (2) bioresponse fingerprint with genomics technology on differential cellular gene expression; (3) animal pharmacology for in vivo validation and (4) a sensitive, quantitatively comparison method.
Phytomics Similarity Index (PSI) has been developed by the joint efforts of Yale University and PhytoCeutica, Inc. team to assure the quality consistency of different manufactured batches of PHY906. This kind of multi-faceted technology, trade-marked as “PhytomicsQC” is not only good for the quality control of such medicines, but also useful for the discovery of new indications or the development of new formulations. In addition to GMP conditions applied during production, good quality control analyses should include both chemical fingerprints and biological fingerprints of botanicals.
Over a ten-year period of development, the multiplex technology “Phytomics QC” has been used to show batch-to- batch consistency of PHY906 production. Advanced clinical trials are ongoing to demonstrate the effectiveness of PHY906 as an adjuvant therapy for cancer patients undergoing chemotherapy. PHY906 has eventually been approved by the Food and Drug Administration (FDA) to carry out Stage II-clinical trials.
| The Challenge on Future Development of TCM Outside the Chinese mainland|| |
1. Good Practices of TCM Research in the Post-genomic Era (GP-TCM)
The European Commission under its 7th Framework Programme (FP7) funded the project coined as ‘Good Practice’ in TCM Research in the Post-genomic Era (GP-TCM), which assembled over 200 scientists and clinicians from 112 institutes in 24 countries (including nine non-European countries, see [Figure 1]) in collaboration and discussion, who had been actively involved in various disciplines in TCM research and TCM practice and active in clinical research, who took part during the period from May 2009 to October 2012. This consortium coordinated, met and deliberated how best to collect and review the published research data available from reliable journals, texts and reports over the good practice of TCM researches in 10 Work-packages covering quality, safety & toxicology, in vitro, in vivo laboratory methods, clinical research in TCM including acupuncture, and regulatory aspects of TCM and herbal products.
|Figure 1: Distribution of GP-TCM members within and beyond the EU. (A) Fifteen EU member states were involved in GP-TCM. They were Austria, Belgium, Denmark, Estonia, Finland, Germany, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Romania, Spain, Sweden and the UK, as highlighted by red dots. (B) Nine non-EU countries were involved in GP-TCM, including Australia, Burkina Faso, Canada, China, D.R. Congo, Norway, Russia, Thailand and the USA, also highlighted by red dots. [Ref: 38].|
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1.1 The formation of the FP-GP-TCM and GP-TCM Research Association
The consortium of GPTCM had provided a comprehensive review report submitted to the European Commission and published 20 peered review papers in the 2012 issue of Journal of Ethnopharmacology, volume 140, which are fully accessible to the public as an information dissimilation process,,,,,,,,,,,,,,,,,,.
Readers will find these 20 papers useful as they summarise reliable aspects of TCM research and practice since the post- genomic era and offer advice for future research and practice directions. Subsequently this consortium has been evolved in April 2012 to become the Good Practice in TCM Research Association (GP-TCMRA), which has continued the coordinating function of networking and collaboration with the aim of meeting annually, alternating in Europe and Asia, to exchange progress of TCM research work with global scientists and practitioners. (http://www.gp-tcm.org/). The comprehensive reports of the FP7-funded project can be accessed using the following website below: http://cordis. europa.eu/result/rcn/57511_en.html, accessed 30th June, 2016)
1.2 The outcomes of the GP-TCM project
The outcomes of this European funded project have been to achieve the objectives stated in the 10 work-packages described above, to approach and connect the multiplicity of expertise in working on TCM research and practice. It reflects the crucial continuing action is needed to expand networking, cross-cultural research collaboration and open- mindedness for scientific innovation and investigations that link the practice of TCM to the maintenance of good health and treatment of diseases. The key outcome of the EU coordination project has been the formation of the Good Practice in TCM Research Association (GP-TCMRA), which was established on 16th April, 2012 in Leiden, the Netherlands. Box 7 summarises other key future actions for TCM development. (http://www.gp-tcm.org/2012/04/about- association/, accessed on 30th June 2016).
2. The demand of good quality herbal materials for prescribing and manufacturing
Materia medica and herbal products, referred as botanicals in North America, are essential phytomedicines for nearly 80% of the world population particularly in developing countries, where traditional medicine often depends upon. Problems and difficulties arise in the quality assurance of herbal products due to unidentified chemical entities with unknown bioactive components. The uncertainty of how Chinese herbal medicine works, the safety and the incidents of adverse effects of substituted herbs have urged the authorities in some countries to ban use of certain Chinese herbal medicinal (CHM) products containing potent CMM. For examples the use of Ephedra Herba and Aconitii radix and related species are banned from even very experienced TCM practitioners to prescribe in Australia, Northern America, UK and other countries in Europe. Ephedra herba is a commonly prescribed CMM often in combination with other CMM in composite formulae (Fufang) while Aconitii radix, a very potent but useful CMM (when properly used) can only be prescribed by very experience TCM practitioners. In the 2000s, the Food and Drug Administration (FDA) in the USA, after reports of several deaths of misuse as weight-reduction or unsupervised use of over the counter supplements containing Ephedra herba, implemented a complete ban on the CMM (http://umm.edu/health/medical/altmed/herb/ephedra). Such an action does affect the practice of TCM as practitioners do not have access of this CMM for prescribing purposes.
3. Regulatory monographic standards of CMM in various pharmacopoeias
3.1 The Chinese Pharmacopoeia (CP, The Pharmacopoeia of the PRC)
The CMM monographs play a key role in the quality assurance of CMM for TCM practitioners prescribing herbal formulae (Fufang) to patients and TCM manufacturing industry as raw materials for their production of TCM products. One way of giving guidelines to ensure the supply of quality-ensured CMMs is to spell out monographic requirement assurance of herbs and herbal products. The monographic standard of a CMM as laid down in the Pharmacopoeia People’s Republic of China (Chinese Pharmacopoeia, CP) is the minimum requirements for all assays and analytical limit tests for each of the CMM included in the CP. These include the characteristics as described in Box 8.
3.2 The European situation for non-TCM herbal drugs
In the EU there are monographs issued for all of them in common use. The Commission E in Germany has produced standard monographs for controlling herbal medicines. The European Scientific Cooperative on Phytotherapy (ESCOP) was founded in 1989, consisting of 14 European countries, as an umbrella organisation representing national herbal medicine or phytotherapy associations across Europe, especially in their discussions with European medicines regulators. ESCOP has commissioned the writing of standards provides state-of-the-art reviews (monographs) of the therapeutic use of leading herbal medicinal products, based on the latest evidence and on leading expertise across Europe. Recently an App for Apple and Android devices summarising over 100 ESCOP monograph is available to provide the uses, safety and quality standards of many European phytomedicines. With quality of herbal medicinal products assured the efficacy of them can be assessed by RCT before licenses can be issued. (http://escop.com/, accessed 30th June, 2016). ESCOP has the advisory role but the monographs are not legally binding with regulatory agency in Europe; they serve as reference purposes in that if the herbal products manufactured according to the quality standards laid down in the ESCOP the agency can grant clinical trial certificates for clinical studies before registration for as legal herbal medicines in the country concerned.
3.3 The European consideration on TCM drugs for inclusion in the EP
The increasing availability of imported CMM and related products from China in European countries recorded approximately US$ 12 million over the last few years. They do not fall in the same category of European herbal medicines. As such quality control is considered an important aspects to guarantee the safety use of TCM products by the European Directorate for Quality Medicines & Healthcare (EDQM). The EDQM is an organisation that protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for medicines and their safe use. These standards are recognised as a scientific benchmark world-wide. The European Pharmacopoeia provides a legal and scientific reference for the quality control of medicines. It is legally binding in 37 member states that have signed the Convention on the elaboration of a European Pharmacopoeia. In addition, the observers of the European Pharmacopeia Commission (including 7 European and 17 non-European countries) benefit from the European experience in work-sharing and harmonisation and have access to the scientific work in the quality control of medicines. For such guarantee on quality of medicines dedicated to human use the European Medicines Agency (EMA) collaborates closely with EDQM. (http:// www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_ networks/general/general_content_000574.jsp&mid=WC0b01 ac0580789733; accessed on 30th June, 2016).
The Working Party of TCM (WPTCM) was created in 2008 by the Pharmacopeia Europa (Ph Eur) Commission at the EDQM to oversee the elaboration of new Ph Eur TCM herbal drug monographs based on pre-existing monographs published in the Pharmacopoeia of the People’s Republic of China (Also so known as Chinese Pharmacopoeia, CP). Recently, it was announced by the Chairman of the WPTCM at the International Summit of Future TCM held in Zhijiang on 29th May 2016 that 66 monographs of CMM, out of a total of 186 herbal drugs, have been included in the European Pharmacopoeia; targeting up to 300 monographs in the future. (http://www.chinanews.com/jk/2016/05-29/7887169. shtml; accessed on 30th June, 2016).
Evidently, there exist different aspects of the details in the deliberation of monographs between the EP and CP as indicated by the authors. This is a good indication of the progressive cooperation in drafting pharmacopoeia monographs for Chinese materia medica between China and EU to focus on good quality of starting materials for TCM products in the future market of the European sector. There remains further harmonization can be achieved on the standardisation of CMM, the starting herbal materials for TCM prescription use and possibly for future manufacturing of TCM products.
3.4 The North America sector and other regional progress in drafting herbal monographs
Quite separately other institutes in the North America sector such as the American Herbal Council, which provides critical information for the American Herbal Pharmacopoeia, have also included herbal monographs on TCM materials with the help of colleagues in China and other countries focusing on TCM and other traditional medicines giving critical reviews on TCM herbal materials as quality assured monographs. These monographs represent the most comprehensive and critically reviewed body of information on herbal medicines in the English language, and serve as a primary reference for academicians, health care providers, manufacturers, and regulators. It is a non-government run organisation, hence the PDF of the monographs can be purchased online. (http:// www.herbal-ahp.org/, accessed on 30th June, 2016). On the other hand the Herbal Medicines Compendium (HMC), published by the U.S. Pharmacopeial Convention (USP), is a freely available, online resource that provides standards for herbal ingredients used in herbal medicines. Standards are expressed primarily in monographs, containing general information; these include: the definition of the herbal ingredient relative to the monograph title and then follows with a specification. The specification contains tests for critical quality attributes of the herbal ingredient and includes analytical test procedures and acceptance criteria for specified tests. USP’s HMC employs validated analytical procedures for the tests specified in its monographs, using state-of-the-art analytical techniques and allied reference materials. Additional analytical methods and approaches may be referenced in general chapters, which also are available online. Some of the key experts on TCM monographs from the CP in China also serve as USP Council Experts, which is the body that makes the organization’s scientific and standards-setting decisions. When coupled with sound registration processes and manufactured according to suitable Good Manufacturing Practices, standards in HMC can become an important part of the safety net that helps ensure access to good quality herbal medicines. http:// hmc.usp.org/about/about-the-herbal-medicines-compendium, accessed 30th June, 2016
3.5. Herbal monographs related to TCM from other countries and regions
Countries and other regions have their own pharmacopoeia focusing on required standards for herbal medicines and products available in their communities. Some of these regulations also cover TCM products. An overview the regulations of Chinese materia medica in various countries and regions indicated there are wide variation of requirements for the quality control on herbal products,. Box 9 summarises some of the key agencies, which provide standards in their national pharmacopoeia on herbal materials. The overview also suggests that the fast growing demand worldwide for traditional medicines calls for harmonised monographic standards to safeguard quality and safety of herbal products to the public.
4. Global view on adverse reactions and interactions of TCM with pharmaceutical drugs
Traditional medical systems such as TCM have been used with accumulated experience, and refined over a long period of recorded clinical use, and include well-defined formulary of processing and combination of CMM according to the individual patients’ constitutions to maximise efficacy and minimise toxicity. In general, such selection of CMM perceived as harmless, some do exhibit low level or non- symptomatic toxicity and indeed many toxic herbs showing adverse drug reactions (ADRs) have been identified only via painful experience or serendipity; some incidents of wrong supply of intended material exist as in the case of aristolochia species. Because of the vast amount of herbal medicines and related products on the worldwide market and the variability of regulatory control of herbal products in different regions together with poor budgets or support available for herbal research; relatively few reports on the basic scientific assessment of herbal products appear in the literature or official reports from regulatory agencies. Serious ADR events regarding TCM mainly concern those CMM such as Aconitum species, which are used very rarely in countries outside China because they are banned from the market and for prescribing. But these potent CMMs are restricted to experienced-based prescribing by registered TCM practitioners.
4.1 An overview on adverse drug reactions to TCM
In a recent overview on adverse drug reactions (ADRs) to traditional Chinese medicines, it was pointed out that the safe use of CMM and products in traditional Chinese medicine (TCM) practice conventionally relies on correct pharmacognostic identification, good agricultural and manufacturing practices based on pharmacopoeia standards and rational/correct CMM combinations with TCM-guided clinical prescribing. The experience-based principles on using prescribed formulae of several CMM may not absolutely ensure safety without assurance of proper supply of the herbal materials for detailed toxicological investigations when compared with development of new pharmaceutical drugs. Clinically observed toxicity reports remain as guidance for gathering toxicological evidence, though essential as pharma- covigilance, but are recognised as late events for ensuring safety and can be considered for future awareness and prevention. (See Box 10).
A separate expert opinion paper on issues of ADRs methodology focused on the toxicity of herbal medicines appears in the Science magazine, which provides guidance on researching ADRs: “Recent advances in functional-omics and bioinformatics now allow the investigation of efficacy and toxicity at systems levels. The modulation of multiple pathways and end-points induced by numerous components can be determined, to enable the elucidation of mechanisms of action and potential threshold behavior for the mixtures. When developed and validated for use on herbals, these methods will enhance the detection of insidious toxicities, providing the necessary background information for effective extended pharmacovigilance of specific herbal medicines. In vivo classical tools are still a cornerstone for toxicological evaluation, but appear ill-suited to study multi-component and variable herbal mixtures”.
4.2 Dealing with combined use of TCM and pharmaceutical drugs in healthcare
Due to the advances of multimedia to provide information on health and disease matters, the public are more aware or informed, mainly via the Internet, about health and medical products. People become more knowledgeable about matters relating to their health conditions and well-being in curing and preventing illnesses. The author has taken on the task of publishing a comprehensive review, based on previously published text book and current literature, on the topic of interactions between conventional pharmaceutical drugs (PD) and TCM products while focusing on the harmful or beneficial effects of such combined intake with examples from reported clinical studies and interpretation of possible mechanisms of actions. It is feasible to set up laboratory protocol to screen commonly prescribed CMM products against those groups of PD with potential adverse effects when combined with other substances. Many in vivo animal models can be used to screen drug interactions between herbs and drugs. Pharmacokinetic and pharmacodynamic correlation may be achieved using these in vivo models. Pharmaco- kinetic clearance of PD in presence of CMM products can be studied using in vivo models. The data obtained are useful qualitative guidelines and reference alerts for clinical practice in integrative medicine involved TCM and MSM, but they are not considered as clinically relevant in actual patient care unless the patient’s response involved life-threatening danger or irreversible damage. In most literature reports, when ADRs arisen due to TCM-PD interactions or other complementary medicines alone, supportive measures are carried out while the suspected interacting TCM or PD are withdrawn and close observations on patient’ s clinical conditions are monitored. Accumulation of individual cases of TCM-PD interactions from clinical observations will provide information for further laboratory confirmation. In general PD-PD or TCM-PD interactions may produce enhanced drug effect that is synergistic; the outcomes of interactions may be beneficial or harmful can be classified as:
- Major: if life-threatening or permanent damage occurs;
- Moderate: if additional treatment is required; or
- Minor: if the therapeutic outcome is unnoticeable or not affecting desired therapy goals.
4.3 Harmful effects of TCM-PD interactions
Patients often self-medicate themselves with various health products and over-the-counter medicines apart from prescribed pharmaceutical drugs (PD). Some of those non-prescribed products may have doubtful quality control and contain harmful additives or unchecked ingredients such as pharmaceutical drugs; thus their usefulness is in doubt. The increasing popularity world-wide of using traditional Chinese medicines (TCM) and related over-the-counter (OTC) functional products has raised concerns over their concomitant use with PD and the consequential adverse effects. In most cases the alleged causes of ADRs are linked with herbal sources, although the authorised information on the interactions between TCM-PD is not plentiful in the literature. Most pharmaceutical drug-drug- interactions are related to interference of the pharmacokinetics and pharmcodynamics of the drugs taken simultaneously; thus prescribers should be aware of multiple drug treatment regimes and unintentional co-administration or self-administration. Some of the interactions can be predicted to avoid or changed to other treatment regime, from the properties (pharmacological and physic-chemical as well as pharmacokinetic characteristics). Those that cannot be predicted can be considered as the dynamic interactions at receptors or enzymes systems not clear or idiosyncratic outcomes related to the patient’s constitution or disease status (Both MSM and TCM aspects). Key guiding principles on dealing with available information during treatment period are listed in Box 11.
4.4 Beneficial effects of TCM-PD interactions
Experience of integrated MSM and TCM medical practice in China has provided experience of, since the 1950s through experience of practice and recorded case studies, beneficial treatment observations and outcomes with probable explanation or possible mechanisms of interactions between TCM and PD, although more experimental research and clinical evidences are needed to confirm such observations with significant evidence accepted by the MSM circle. This is partly because the MSM gold standard of randomised clinical trials (RCT) is not entirely applicable in the individualised approaches for treatment in CM practice in personal medicine. These case studies were abstracted from medical journals published in China and have been translated into English and edited by the author and co-worker for presentation in the text. The tentative categories of case studies, which illustrate synergy effects of treatment consequential to co-administration of PD and CM medications are summarised in Box 12.
Many other examples of clinical cases and larger clinical trials have been published in Chinese languages and a review published in 2005 summarises systematically in English language the CMM’s role to function as key TCM drugs augmenting the beneficial contribution to the mechanisms as beneficial agents in the treatments indicated.
Under these circumstances, there is an urgent need to compile such database. The future professionals in health and medical care should be knowledgeable or aware of what their patients have been taking or given. In actual practice the patients may receive both treatments intentionally or unintentionally, with or without the awareness of the practitioner. In these situations a reliable database for interactions between TCM- PD will be extremely useful for consultation when integrative TCM-PD treatment problems appear or during emergency situations. Their combining of medications may be involved with possible outcomes of adverse reactions or beneficial effects. Such a database will be welcomed by both practitioners of TCM/herbal medicines and MSM practitioners in the emerging trend of integrative medicine.
5. Integrative science and medicine in future global clinical development of TCM
To promote TCM to be accepted globally into mainstream medicine and healthcare systems, it is important that up-to- date science and technology can be implemented to interpret the basis of TCM diagnosis and treatment and the assurance of the quality, safety and efficacy of TCM products and treatment modalities. Previous sections on the advances of analytical, biomedical and computational aspects of technology are equipped for the purposes of modernisation in assurance and control of the quality and safety of CMM. Innovative development of methodology to provide evidence of mechanisms of actions in pre-clinical studies of TCM composite formulae (Fufang, consisting of multiple CMMs) and their efficacy in clinical trials as well as TCM treatment approaches require further consideration.
5.1 Linking systems approaches in MSM and TCM principles
The systems biology approach to MSM, recently adopted into biomedical fields, offers the potential to investigate if the principles can be applied to integrate with TCM. The systems biology approach of patient profiling using modern genomics, proteomics and metabolomics technologies, is a perfect match for the systems diagnosis in TCM. Integration of these approaches may reveal different groupings or sub-phenotypes of patients, which require individualised treatments. Moreover, knowledge about the biological mechanisms behind the personalized herbal formulas used in TCM is expanding through modern herbal chemical and genomic profiling techniques,.
Both TCM and MSM science describe life as a complex, dynamic, non-linear system. As OM scientists discovered the non-linear behaviour of cytokine networks, TCM practitioners and scientists have recognized non-linear patterns in how symptoms change in patients. The fractal properties of the arteries, lungs and heart rate resemble the fractal thinking in TCM. In both sciences, life is considered a self-balancing system for organisation of body functions that is far from equilibrium. Systems thinking can build the cultural, philosophical and scientific bridges that are necessary to share understanding between the two sciences. By studying tools and techniques developed in both the TCM and MSM medical systems, new insights will emerge that are necessary to heal the patient, under his environment and the world he lives in,.
5.2 Progress of biomedical and clinical studies in TCM
In a 2010 review on the situation of clinical trials of TCM in the past decade, including systematic reviews and meta- analyses on TCM clinical trials either focusing on the treatment of diseases with TCM principles approaches or focusing on one TCM herbal product, on TCM studies either with randomization controlled trial (RCT) methodology or general observation, the authors observed, from the first systematic review of TCM clinical research published in 2002, to more clinical trials have also been published internationally, and, which has consequently increased the number of systematic reviews (SRs) and meta-analysis of TCM clinical trials.
The authors of the 2010 studies summaries the following key points of their observations (Box 13):
5.3 The Health-Related Quality of Life (HRQOL) Instrument for TCM research: ChQOL
It is acceptable that Quality of Life (QOL) indicators are often used as secondary outcome indicators in many clinical studies in conventional MSM. However, the efficacies of TCM treatment using conventional QOL have not been particularly evident in TCM studies. There is a general impression among TCM practitioners that the currently available QOL instruments may not be sensitive enough to detect the health changes that are regarded as important in treatment using TCM. For examples, in TCM diagnosis and treatment regimens, appetite and digestion, routine of urination and bowel, facial and lips colour, spirit in the eyes and adaptation to climates and seasons are very important indicators of health status under the TCM’s diagnosis. However, these indicators are usually not included in common health related QOL (HRQOL) measure. Through the development of Chinese medicine based QOL (ChQOL) it is feasible to assess patient-reported outcomes (PROs), generated from ChQOL instrument administered to patients before and after treatment intervention, as a measure of treatment efficacy. PROs include not only health status and quality of life but also reports on the satisfaction with the treatment and care, the adherence to prescribed regimens when directly related to end-result outcomes. Further treatment-related decisions are based on a combination of objective and PROs subjective parameters. The PROs concept is actually similar to one of the four diagnostic methods in TCM: “Interrogation”, which has been used since the beginning of TCM, and is a very effective diagnostic and evaluation method in TCM.
The development of the Chinese quality of life (ChQOL) instrument based on the diagnosis and treatment of TCM, has allowed us to investigate its application to record patients’ feedback as patients’ reported outcomes (PROs) after the intervention of TCM treatment or receiving TCM prescription containing mixtures of Chinese materia medica (CMM) or proprietary Chinese medicines (PCM). The opportunity of recording objective and subjective outcome indicators such as biomarker, PROs & HRQOL, and TCM practitioners’ treatment records, respectively can also be applied to the evidence- base approaches for assessing TCM treatment efficacy on individual patient cases. This instrument can be a bridge that integrates TCM with conventional MSM and healthcare to assess the efficacy of TCM treatment. The ChQOL instrument has been applied to study patients with congestive heart failure and RCT panel studies of PCM of products containing multiple CMM as a health product, in patient suffering from hepatitis, in metabolic syndrome and asthma. The evidence level of case report and panel study will be improved and ascertained by applying innovative analysis with modern informatics processing technologies. These new approaches will be more suitable for case reports and panel studies and may pave the way for ascertaining TCM principles of holistic approaches to diagnosis and treatment of diseases and individualized treatment for patients.
Through such integrative approaches utilizing the superiorities of both medical disciplines the future clinical research and practice will be able to provide evidence-based outcomes for TCM practice and products development.
Of particular emphasis to apply such integrative approach, it is feasible that future development of TCM products can be applied towards high burden diseases (See Box 14), which are under the top healthcare agenda in most developed regions worldwide.
6. The integrative approaches for R&D of TCM products for markets outside China
Manufacturers of TCM products are now required in China and other countries worldwide to comply with good practice in manufacturing (GMP). They need to ensure and ascertain the quality of the starting CMMs are in line with the regulatory requirement of minimum pharmacopoeia standards, with good agricultural and collection practice (GACP). Quality assurance of the starting CMMs including decoction pieces and aqueous granules for TCM practitioners’ prescribing needs is now the responsibility of manufacturers. They should be aware of and apply the advance technology indicated under the Section for Advance of Analytical Biomedical and Computational Technology for the quality and safety assurance of their products according to pharmacopoeia standards, which are the basic requirements for the initial stage for the herbal markets to satisfy the TCM practice need of prescribing.
6.1 Develop niche TCM drugs focusing on high burden diseases as future targets
Current worldwide research in drug discovery from medicinal plants involves a multifaceted approach combining botanical, phytochemical, biological, and molecular techniques. Medicinal plant drug discovery continues to provide new and important leads against various pharmacological targets including cancer, HIV/AIDS, Alzheimer’ s, malaria. Even with all the challenges facing drug discovery from medicinal plants, natural products isolated from medicinal plants can be predicted to remain an essential component in the search for new medicines.
However, for TCM manufacturers to compete with conventional pharmaceutical drugs counter-parts they should focus on niche and innovative products via specific R&D programmes with patterned products line based on TCM medicinal plants sources whether as products from single-herbal or multiple TCM formulae. They should also be knowledgeable about the patent policy and regulatory requirements for registration of herbal products in the countries or regions they aim to enter, which should be unique for survival of a very drug industry worldwide. In the recently published overview on understanding interactions of TCM-PD, it was pointed out that the areas of importance and interest in integrative approaches can focus on the high burden chronic diseases where most national health systems in developed regions experience high and escalating cost in the high burden diseases. It is feasible to include those sexually transmitted and acquired diseases consequential to contacts with contaminated blood sources or infected environments as indicated in Box 14 where both TCM and MSM practices can contribute with great successes if proper collaborations can be arranged.
6.2. Improved RCT design with TCM syndrome differentiation to stratify patient group and PROs
Disease-oriented studies using the approach of multi-indexed high-throughput technologies and systems biology analyses will be the preferred strategy for screening bio-active ingredients in the future R&D of TCM. Combining the systems biological investigations and functional “omics” to elucidate the pre-clinical mechanisms of actions of Chinese medicines/ acupuncture will ensure the identification of potential bio- markers to be associated with both Western disease concepts and TCM pattern classifications,. When these data are available they will provide information for design of future clinical studies where TCM pattern differentiation will facilitate the stratification of patient groupings before clinical trial investigations. Guidelines for RCT trials investigating TCM products should now be available to gear integrative approaches in applying stratified patient groups to increase the probability of useful outcomes. Over the past decades, increasing numbers of clinical trials on TCM treatment efficacy have emerged and we predict that there will be more RCTs with higher quality in the future to meet the needs of modern research and development, and that the quality of RCTs will be improved with the generalized RCT registration, standardization of clinical research, and the promotion of evidence-based medicine (EBM). The worldwide focus on clinical trials in TCM will continue to increase. However we are in need of modified modalities that can focus on the assessment of TCM diagnosis and treatment outcomes of the holistic and individual approach. Based on accepted and recognised models such as Interaction Rules Mining, informatics analysis of data from TCM diagnosis and treatment principles can contribute to the understanding of how the complex mixture of CMM are related to the principles of TCM formulary in treatment of diseases.
More importantly, communications between the two different medical modalities needs to be dynamic to facilitate optimal healthcare for the individual measures of treatment outcomes. Including quality of life instruments such as ChQOL or disease-specific instrument with TCM characteristics as a tool for monitoring patient-reported outcomes linked to biomedical markers is another evidence-based measurement for R&D of PCM part from measuring TCM practice treatment indicated before. The use of TCM- specific QOL instrument coincides with the fundamental initial diagnostic measurement in TCM of ‘asking questions’ which gathers information on the overall health conditions of the patient. This is the heart of personalized medicine and would offer common ground for integration. All these factors can be further linked with mathematical and computational approaches (such as chemometrics) as mentioned earlier,. The uniqueness of TCM product development at the R&D stages where novel extraction technology and quality assurance with unique pattern characteristics can provide patent rights. [Figure 2] illustrates the whole flow steps in development of patentable TCM products.
|Figure 2: A scheme proposed for future development of TCM products for high burden diseases.|
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| Concluding Remarks|| |
Applying bioinformatics technology in collecting and deciphering TCM data depends on the collective combination of knowledge from the fields of information technology, biomedical sciences, statistics, and TCM practice. Combining the strengths of each is essential to improving the quantitative analysis of TCM and broadening our knowledge of the principles that underlie its effectiveness. Continuing feedback between the scientists and practitioners in each field will help us to refine the analytical techniques used for evaluation. Good practice in bioinformatics focusing on TCM will integrate the data from various disciplines of TCM practices, R&D investigations of quality control and standardisation, mechanistic studies, ADRs reports, and regulatory requirements as well as training skills for practitioners will provide valuable information for future modernisation of TCM. The use of good quality big data for future reference and analysis will give bench-marks for improvement and adjustment in order to keep up with advances in biomedical fields.
The way forward to identify evidence-base in TCM practice requires multidisciplinary collaborations among different professionals of both MSM and TCM practices with expertise from biomedical, bioinformatics, pharmaceutical and TCM disciplines. There is still a lack of human resources to take up the integrative medical research and practice worldwide. The new wave of general practitioners should be trained in the practice and science of TCM with integrative medicine knowledge. If mainstream medical practitioners have some understanding of the principles of TCM, which is supported by scientific methodology, there would be less opposition and more acceptance of TCM practice. The creation of collaborative networks is vital to overcome these differences so that international, multi-centre clinical trials are comprehensively planned and executed. These opportunities will help define workable integrative medical models for future clinical practice settings.
Due to the advances in biomedical, chemical and computational technology, multidisciplinary approaches for investigating evidence-based aspects of TCM practice are essential. Research linking the quality control in the manufacturing of TCM products, relatively new systems biology and experience-based TCM principles is vital to interpret the holistic approach of TCM towards its integration into mainstream medicine,[69‘71]. However, to achieve these objectives, an integrative approach is crucial to connect the multiplicity of expertise. Networking, cross- cultural research collaboration and open-mindedness are needed to support the scientific innovation and investigations that link the holistic practice of TCM to the maintenance of good health and treatment of diseases. Continuing effort in combined scientific methodology and TCM practice in R&D is the key to providing new knowledge for training the newer generation of human resources in integrative medicine that involves TCM practice.
| Acknowledgement|| |
The Author declares that the presented materials have duly been referenced from literature and public websites and there is no conflict of interest with any organisations. He is currently Visiting Professor in Natural Products & TCM Research at the School of Pharmacy & Biomolecular Sciences, Liverpool John Moores University, L3 3 AF, UK and Adjunct Professor in TCM Research at the National Institute of Complementary medicine, Western Sydney University, NSW 2550 and Faculty of Sciences, University of Technology Sydney, NSW 2007, Australia.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4]
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