chinese medicinal materials and their interface with western medical concepts

18
Journal of Ethnopharmacology 96 (2005) 1–18 Review Chinese medicinal materials and their interface with Western medical concepts Kelvin Chan Research and Development Division, School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Hong Kong SAR, PR China Received 7 April 2004; received in revised form 21 August 2004; accepted 3 September 2004 Available online 28 October 2004 Abstract Chinese medicine (CM), one of the oldest continuously surviving traditions, has been practised to maintain good health and treat diseases in the Chinese communities and recently by other ethnic groups worldwide. Chinese medicinal materials (Chinese materia medica, CMM) and proprietary CM products (PCM), acupuncture and related physical therapies, as well as special life styles are often used together in the practice, co-existing with orthodox medicine (OM) in China and some regions in the Far East. Increasing uses of CMM have created both skepticism and support of CM practice that have been the major debate since the successful randomised clinical trial of the 10-CM herbs prescription in relieving atopic eczema was published in 1992. Available in the West, some CMM are supplied with wrong species or wrong named herbs that possess liver and kidney toxicity and some PCM adulterated with OM drugs. These do not give CMM the right reputation and recognition. These problems have been due to lack of recognition and regulation of the profession, qualified practitioners, quality-controlled CMM products and evidence-based clinical studies. Though practised widely, CM was not recognised officially in some regions such the EU and North America as part of the healthcare system run by western OM practice. Such circumstance has delayed the development of CM in these regions including Hong Kong comparing with that in Australia, Japan (As Kampo medicine), the UK, some European countries, and the USA. It can be considered as obstacles for proper development of CM in general. This paper addresses these key issues and attempts to propose ways for future research and development for CMM. The impact will certainly be modernisation in every aspect of CMM to cope with the fast growing demand in quality medicines in the 21st century. Several major areas are listed for discussion. © 2004 Elsevier Ireland Ltd. All rights reserved. Keywords: Chinese medicine; Chinese materia medica; Proprietary Chinese medicinal products; Impact in the West; Future development Contents 1. Introduction ............................................................................................................ 2 1.1. The integrative or complementary approach of Chinese medicine with orthodox medical practice in some Far East regions. . 2 1.2. The influence of traditional Chinese medicine in orthodox medical practice in the West .................................. 4 2. Frequent enquiries and concerns of Chinese medicines in the West .......................................................... 4 2.1. A scientific understanding of the toxicity of Chinese materia medica ................................................... 5 2.1.1. The lack of understanding how CMM should be prescribed ................................................... 5 2.1.2. The art or science of processing crude CMM before use ...................................................... 6 2.1.3. The need for novel approaches towards best use of potent Chinese medicines ................................... 6 2.2. Documenting interactions between Chinese materia medica with pharmaceutical drugs .................................. 6 Tel.: +852 3411 5303; fax: +852 3411 5317. E-mail address: [email protected]. 0378-8741/$ – see front matter © 2004 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.jep.2004.09.019

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Page 1: Chinese medicinal materials and their interface with Western medical concepts

Journal of Ethnopharmacology 96 (2005) 1–18

Review

Chinese medicinal materials and their interface withWestern medical concepts

Kelvin Chan∗

Research and Development Division, School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Hong Kong SAR, PR China

Received 7 April 2004; received in revised form 21 August 2004; accepted 3 September 2004Available online 28 October 2004

Abstract

Chinese medicine (CM), one of the oldest continuously surviving traditions, has been practised to maintain good health and treat diseasesin the Chinese communities and recently by other ethnic groups worldwide. Chinese medicinal materials (Chinese materia medica, CMM)and proprietary CM products (PCM), acupuncture and related physical therapies, as well as special life styles are often used together in the

ated both-CM herbsor wrongtation andcontrolledch the EUnt of CM intries, and

attempts toto cope

C

. . 2ions . . 24

4556

66

practice, co-existing with orthodox medicine (OM) in China and some regions in the Far East. Increasing uses of CMM have creskepticism and support of CM practice that have been the major debate since the successful randomised clinical trial of the 10prescription in relieving atopic eczema was published in 1992. Available in the West, some CMM are supplied with wrong speciesnamed herbs that possess liver and kidney toxicity and some PCM adulterated with OM drugs. These do not give CMM the right repurecognition. These problems have been due to lack of recognition and regulation of the profession, qualified practitioners, quality-CMM products and evidence-based clinical studies. Though practised widely, CM was not recognised officially in some regions suand North America as part of the healthcare system run by western OM practice. Such circumstance has delayed the developmethese regions including Hong Kong comparing with that in Australia, Japan (As Kampo medicine), the UK, some European counthe USA. It can be considered as obstacles for proper development of CM in general. This paper addresses these key issues andpropose ways for future research and development for CMM. The impact will certainly be modernisation in every aspect of CMMwith the fast growing demand in quality medicines in the 21st century. Several major areas are listed for discussion.© 2004 Elsevier Ireland Ltd. All rights reserved.

Keywords:Chinese medicine; Chinese materia medica; Proprietary Chinese medicinal products; Impact in the West; Future development

ontents

1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.1. The integrative or complementary approach of Chinese medicine with orthodox medical practice in some Far East reg1.2. The influence of traditional Chinese medicine in orthodox medical practice in the West. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. Frequent enquiries and concerns of Chinese medicines in the West. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.1. A scientific understanding of the toxicity of Chinese materia medica. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.1.1. The lack of understanding how CMM should be prescribed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.1.2. The art or science of processing crude CMM before use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.1.3. The need for novel approaches towards best use of potent Chinese medicines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.2. Documenting interactions between Chinese materia medica with pharmaceutical drugs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

∗ Tel.: +852 3411 5303; fax: +852 3411 5317.E-mail address:[email protected].

0378-8741/$ – see front matter © 2004 Elsevier Ireland Ltd. All rights reserved.doi:10.1016/j.jep.2004.09.019

Page 2: Chinese medicinal materials and their interface with Western medical concepts

2 K. Chan / Journal of Ethnopharmacology 96 (2005) 1–18

3. A world-wide need for future development and modernisation of Chinese medicine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73.1. Education and practice aspects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.1.1. Hong Kong Baptist University (HKBU). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73.1.2. The Chinese University of Hong Kong (CUHK). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73.1.3. The University of Hong Kong (HKU). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

3.2. Research and development aspects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83.2.1. Failure of conventional R&D approaches to fully use CMM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83.2.2. Action plan for the modernisation of Chinese medicine in Mainland China. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

3.3. The research and development of Chinese medicine in Hong Kong. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103.3.1. Directions of R&D for CMM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103.3.2. Developing SOP for control on quality, safety and efficacy of CMM and products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

3.4. Commercial and international aspects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123.4.1. The mission possible. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123.4.2. Aims and goals of the Hong Kong model. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

4. Conclusion on the global impact of Chinese materia medica in healthcare. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134.1. The advantage of integration of Chinese medicine into mainstream healthcare. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

4.1.1. The German experience. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134.1.2. The NHS experience in the UK. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134.1.3. Training and professionalism in Chinese medicine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

4.2. The role of Hong Kong in linking East and West for Chinese medicine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144.3. Good practices for development of Chinese medicinal products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144.4. Modern screening methodology and analytical technology for CMM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154.5. R&D of dosage forms for convenient and efficient delivery of CMM and IPR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

4.5.1. The development of new dosage forms for CMM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154.5.2. The development of concentrated granules of CMM for CM prescription use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

4.6. Open-mindedness between the practice of OM and CM for better healthcare. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

1. Introduction

Chinese medicine (CM) is a complex and holistic sys-tem of medical practice with its own philosophy, diagnosis,treatment systems and pharmacology. It considers the humanbody in relation to its own natural, physical and social envi-ronment. The practice of CM involves physical therapy (non-medication) using acupuncture, moxibustion and related dis-ciplines such asTuina MassageandQi Gongand chemicaltherapy using Chinese medicinal materials (CMM) of animal,mineral and plant origin in the form of decoctions of com-bined CMM or related proprietary products. As most of themare from plants, medical books on CMM, throughout the ages,have conveniently referred to them as ‘Ben Cao’ (Herbal-ism). Several authors and editors have written or translatedhistoric accounts and bibliography of Chinese medicine andphilosophy in the English language (Chan, 1995). Orthodoxmedicine (OM), introduced in the early 1900s to China whenshe was exposed to western influence, has made a very impor-tant impact on treatment of diseases in China, while Chinesemedicine (CM) has been the mainstream for healthcare since2800 BC (Chan, 2002a).

Chinese herbal medicine (the ultilisation of CMM for pre-venting and treating diseases), an integral part of the tradi-tional Chinese medicine (CM) and has played an important

role in the medical care of Chinese people over the past sev-eral thousand years. It is the generalisation and summationof the experiences of traditional CM practitioners and schol-ars and this is long-term struggle against diseases in the pastthroughout Chinese history. Its development has evolved into,based on the culture and philosophy of balancing body func-tions in relation to its environmental conditions, a medicalsystem through repeated tests and verification in clinical prac-tice. The theories involved may not be easily interpreted interms of those trained in orthodox medicine.

1.1. The integrative or complementary approach ofChinese medicine with orthodox medical practice insome Far East regions

Since 1949, the government in China has re-addressed theimportance of traditional Chinese medical (CM) practice forthe nation’s healthcare programmes in parallel with ortho-dox medicine (OM). The organisation that is responsible forpublic health that encompasses CM, OM, medical appara-tus, scientific research and education is the State Council,which empowers the Ministry of Public Health (MPH) to bein charge of these disciplines. The MPH provides two uniquehealth systems in China. About 60% of healthcares are pro-vided by OM and 40% by CM. Provision of OM and CM

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K. Chan / Journal of Ethnopharmacology 96 (2005) 1–18 3

medications is the responsibility of the State PharmaceuticalAdministration (SPAC) and the State Administration of Tra-ditional Chinese medicine (SATCM), respectively. The Gov-ernment’s policy of integration of the two health providersinto one system reflects that about 80% of medications usedin the rural areas are estimated to be Chinese materia medica(CMM) and related products. One of the reasons is that CMMproducts are more economical, provide an important meansof cost saving to the Government. The SATCM, while con-trolling the practice of traditional CM, monitors all academiccourses of CM in universities and colleges. At present thereare seven universities of Chinese medicine in the whole coun-try with one college of similar standard academic status ineach of the provinces. There seven universities are located atBeijing, Chengdu, Heilongjiang, Guangzhou, Nanjing, Shan-dong and Shanghai. In each of the 23 provinces, three majormunicipalities (Beijing, Shanghai and Tianjin), and five au-tonomous regions there is at least one research institute ofCM which is linked with local CM hospitals for manufactur-ing, practice, education and research of various disciplinesof CM. Most hospitals are equipped with both orthodox andCM pharmacies. Some hospitals have integrated departmentswith specialists in both CM and orthodox medicine. Patientscan choose either treatment. In orthodox hospitals, CM out-patient departments are available for consultation. The sup-p arec 2)i nc-t ov-e ngt s aree und-i itoro ons,a oada toresi bothp ionst PHv bep tiono ions(

eri-c n them stillp eopleh rovedt rtic-u res-s lieveC es.Y anyh causet asD s

membranaceusand other related species), Gouqizi (FructusLycium Barbarum), Renshen (Radix Panax ginseng), etc.,which many Taiwanese families use in cooking soups andstews particularly in winter seasons. Moreover, women af-ter giving birth, patients after major surgical operations andthe elderly would consume CMM herbs to recuperate theirstrength. It was only until the early 1990s that virtually allhealthcare OM or CM was private, either paid for directly bythe individual or through insurance schemes that cover bothOM and CM treatment. During the late 1980s the Taiwanesegovernment decided to rationalise the quality and standard ofCM practice and CMM products by setting up a special na-tional examination to screen the existing CM practitioners fortheir competence of practice and control on quality of CMMmedications. The control on the quality of the CM practi-tioners and the manufacturing and provision of the CMMproducts is the Special Committee of Traditional Chinesemedicine under the administrative power of the ExecutiveYuan (Council) of the Ministry of Health in Taipei. Beforethe national examination most of the CM practitioners obtaintheir experience from generations before them although somewere properly trained at the only CM College in Tai Chung.After passing the special examination with 18 months prac-tice training at the China Medical College in Taichung all theolder generation of CM practitioners can practise under then n canc MMp ringP ,1

n ont oryo De-p adei ari-o cts.T ersh GrantC archa ed-i lwayst % oft tiona enttR un-b sses,i OMa con-s rtainc takent gu-l cts(

ivedt ith

ly of crude CMM and manufacturing of CM productsontrolled by the ‘Provisions for New Drug Approval’ (199ssued by the MPH via the SATCM. The most important fuions of the SATCM are: (1) to develop and implement Grnment policy for the industry, including medium to lo

erm plan and annual plan, (2) to ensure the regulationnforced, (3) to handle financial management including f

ng projects relating to industrial development, (4) to monverall production of CMM medicaments and preparatind (5) to develop the profiles of the CM industry abrnd international co-operation. Pharmacies and drug-s

n local areas provide the over-the-counter (OTC) sale ofroprietary Chinese medicines (PCM) and OM medicat

o the public according to regulations set up by the Mia the SATCM. Most CM remedies and OM drugs canurchased as OTC without a prescription with the excepf substances containing specific addictive or toxic actChan et al., 2002) Table 3.

In Taiwan, after the Second World War and under Aman influence, the practice of orthodox medicine has beeain stream of healthcare, although traditional CM wasractised and used by some of the populace. But as pave become wealthier and the access to OM has imp

here has been a continued drift away from CM. This is palarly obvious among the young, who now have higher pure from jobs. Many of those in their 20s and 30s beM treatment is too slow to get them well from illnesset the trading of CMM products and raw herbs in merbal shops has maintained good business. This is be

he vast majority of the turnover is for tonic herbs suchanggui (Radix Angelica sinesis), Huangqi (Radix Astrgalu

ew national health scheme. Presently, patients in Taiwahoose to be treated by OM or CM practitioners. Many Croduct manufacturers in Taiwan have Good Manufacturactice guidelines for production of PCM products (Chan996; Chen et al., 2002).

In Hong Kong, there has not been any legal restrictiohe practice of traditional CM throughout the whole histf the British colonial period. Since the early 1990s, theartment of Health of the Hong Kong Government have m

nitiatives by organising Working Parties, consisting of vus professionals, to look at the regulation of CM produhe rationalisation of the qualification of CM practitionas been started since 1995. Recently, the Researchouncil has given substantial amount of funding for resend development of CM in Hong Kong even though biom

cal science research and other physical sciences have aaken the lion’s share of the research funding. About 70he patient population has enjoyed their own self-medicand over 50% consult private CM practitioners to supplem

heir speedy need for recovery from illnesses (Working Partyeport, 1991). In the Report, which was set out to obtainiased observation of how patients respond to their illne

t is interesting to note that, major problems were withnd CM have rarely been reported. CM practitioners areulted much less often than OM doctors and only on cehronic diseases or desperate cases. Children are rarelyo CM practitioners. There is strong support for legal reation for CM practitioners and recently, for CMM produChan, 1996; Chan and Yeung, 2002).

In Japan, orthodox medical doctors who have receraining in Kampo medicine (an oriental medicine w

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4 K. Chan / Journal of Ethnopharmacology 96 (2005) 1–18

modified CM approaches) can prescribe Kampo treatmentand medications of CM composite formulae. Research anddevelopment of Kampo medicinal products has been very ad-vanced in particular the areas of composite formulae used inancient Chinese prescriptions. Many patients have consultedKampo practitioners as part of their healthcare programmes(Chan, 1996; Terasawa, 2002).

1.2. The influence of traditional Chinese medicine inorthodox medical practice in the West

The public and the medical profession in the West haveexpressed both interests and concerns on the use and practiceof traditional CM. The successful controlled trial of a tradi-tional CM composite prescription consisting of 10 herbs inthe form of an aqueous decoction, in the treatment of atopiceczema that has been resistant to orthodox treatment, has cre-ated greater interest and attention on the use of CM herbs andtreatment in Britain (Rustin and Poulter, 1996). At present,the quality, efficacy, and safety of these traditional treatmentsand medicines is uncertain in the West. It will be interestingand useful to note as background information how traditionalCM practice has been initiated in Europe, to compare withthe progress of this discipline in the Far East and to forecastits future development in health care.

CMh urn-i om-p t ona eani orek est.J tisht tionw tud-i ethi-c unc-t ionals ly. Atp latedC s ofa osto s ord r ofC oun-c shA ionsi ain-t ce ofC

ori-e urep y thee turet inlyi id-

Table 1World-wide influence of Chinese medicine-as of 2003.07.01

Establishment of CM organisations/clinics reaches 130 countries or regions.Australia set up regulatory control over practice of CM and CM products.Legalisation of CM practitioners in Singapore and Thailand.Admission of acupuncture into insurance scheme in Germany and USA.Over 13800 CM clinics registered in Australia, Canada, France, and UK.About 12000 acupuncturists received their licenses in the USA.The Minister of Health announced that China signed memoranda of

agreement with developed countries on health matters including CM.The national commitment on establishment of informatics helps promotion

and trade of CMM and related PCM products.Over 10000 tons of PCM exports were recorded.

1990s (Jin et al., 1995). Although acupuncture has been themain practice of CM in these clinics for pain relief and otherchronic illnesses, most practitioners also prescribed CMMherbal prescriptions with instructions for preparing decoctionor proprietary CMM products. These products are mainlysupplied by two to three major CM import and re-exportherbal companies, importing from various sources abroadwith no legal restriction at present. Evidently patients havetaken these preparations as part of their treatment. No studyhas been reported for the likely herb–drug interactions. Re-ports on toxicity of CMM treatment have been mainly con-cerned with certain CMM products that cause liver and kidneytoxicity with occasional cases of heavy metal intoxication ap-peared in the literature and national news (Graham-Brown,1992). Several cases of toxicity of Chinese herbal Medicinal(CHM) herbs have been related to the use of wrong herbs(Atherton et al., 1993). On the academic side, currently twouniversity courses are being run in acupuncture in the UK. A5-year-course with similar curriculum as that of CM univer-sities in China has been launched in one of the new Britishuniversities, in response to public demand on quality of suchmedical practice. However more comprehensive systems tocontrol both the practice and products may be necessary inthe West in order to gain confidence of CM (Lee and Chan,2002).

vel-o( nca -t tak-i ettyh

esem

2m

cine( ntive

Early knowledge of acupuncture and traditionalebalism in European culture was mainly through ret

ng merchants of the Dutch and English East India Cany. Willem ten Rhyjne compiled the first European texcupuncture in 1683. In the late 19th century, with Europ

nfluence in the Far East, China and Indo-China, much mnowledge of acupuncture percolated through to the W.M. Church in 1821 published the first extensive Briext of acupuncture. The British Acupuncture Associaas founded in 1961 by a group of practitioners who s

ed acupuncture in need for adequate educational andal standards. Subsequently the British College of Acupure was set up in 1964 and other schools and professocieties were set up in the 1970s, 1980s and recentresent there are five registers of acupuncture and reM herbalism and eight schools offering part-time coursecupuncture and CM herbalism in various parts of UK. Mf them offer 2–4 years part-time courses with certificateiplomas on graduation (Jin et. al., 1995). The Registehinese Herbal Medicine and the recently established Cil for Acupuncture (from the previous Directory of Briticupuncturists in 1982) with five professional associat

n 1994 indicated the profession’s intention to work to main common standards of professionalism in the practiM in the UK.The number of privately run schools of CM or related

ntal medicine, mainly involved with tuition of acupunctractice, has increased from 1985 to more than 10 barly 1990s. The number of CM clinics with acupunc

herapy has also increased rapidly in major UK cities, man London, from 600 to nearly approximately, 1000 by m

Quite separately, the development of CM in other deped countries such as Australia (Li et al., 2002), GermanyLiao et al., 2002), Japan (Terasawa, 2002), some Europeaountries (Sterchx et al., 2002), the United Kingdom (Channd Lee, 2002) and the USA (Hui et al., 2002) has taken a no

iceable step. It is evident that the possibility of patients’ng CMM medications and OM drugs for treatment is prigh in the future.

Table 1summarises the ‘world-wide influence of Chinedicine as of 2003.07.01’.

. Frequent enquiries and concerns of Chineseedicines in the West

In the West, the practice of traditional Chinese mediCM) is comparatively new. As a consequence, substa

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K. Chan / Journal of Ethnopharmacology 96 (2005) 1–18 5

Table 2Frequent enquiries and concerns of Chinese medicines

What is known about the quality, safety, and efficacy of the Chinesemedicinal materials (CMM) products used?

Do CMM products have to pass through the same strict legislativeprocedures as pharmaceuticals?

What is professionalism of CM practitioners who diagnoses and prescribesCM treatments?

What do professionals in the West know about acupuncture and CMproducts and are they aware that their patients’ using a dual approach ofOM and CM at the same times? Problems of interactions between CMMand pharmaceutical drugs?

Why are composite mixtures prescribed in CM prescriptions?How to obtain guaranteed good quality herbs and Proprietary Chinese

medicines (PCM) products?

clinical practice and research in the field is fairly limited. Pub-lished information in the areas of complementary/alternativemedicine undoubtedly illustrates the increasing interests andconcerns over the use and practice of CM in the West amongthe public of developed and developing countries. In particu-lar, the practice of acupuncture as part of CM has been on thetop of the list of complementary/alternative medicine amongthose practiced in these countries, but not accepted officiallyinto the main stream of the healthcare system. On the otherhands, as mentioned in Section1 above, in China, Japan aswell as some countries and regions in the East, the use andpractice of CM have been included as part of the healthcaresystem together with orthodox medicine (OM). Apart fromthe difference of tradition, training, regulation as well as cul-ture, there is also a definite gap in the knowledge of Chinesemedicine between East and West; in particular in the under-standing of how CM uses medicinal plants for treatment.

Both acceptance and skepticism on the usefulness of Chi-nese medicine (CM) in healthcare exist among orthodox med-ical practitioners in the West. In some developed countriesthere has been a rapid growth of interest in acupunctureand Chinese herbalism. This interest has lead to increasingresearch into acupuncture, but not into Chinese medicinalmaterials (CMM). Research to date in the West has beenmostly initiated by practitioners of CM/Chinese materia med-i wor-t aredb theE ualitys

con-c dly

TS aterials(

T tage

HAM

T

there are conflicting views over a practice that is not fully un-derstood through principles and philosophy of conventionalmedical practice. The following sections have been set out togive a personal assessment from scientific reasoning on theexperience accumulated in the use of CMM, their toxicityand quality issues.

2.1. A scientific understanding of the toxicity of Chinesemateria medica

The popularity of using Chinese medicinal materials, oth-erwise known as Chinese materia medica (CMM), and relatedproducts in both sides of the Atlantic may have been due tothe well-known double-blind randomised clinical trial on thesuccessful use a decoction of 10 CMM crude herbs to re-lieve atopic eczema that was resistant to orthodox medical(OM) treatment (Sheehan and Atherton, 1992). Over the pastdecade several news-catching episodes in developed commu-nities indicated adverse effects, sometimes life threatening,allegedly arisen consequential to taking of over-the-counter(OTC) herbal products or traditional medicines from vari-ous ethnic groups. It was pointed out that adulteration wasresponsible for epidemic severe kidney damage (De Smet,1992) in Belgium where the herb Fangji (Stephaniatetrandra) was substituted by the nephrotoxic Guangfangji( ors

etsi 7E robialc al ma-t n oft xinsm icalt rugsc rers.A l andi andh rces(

2p

g ofu i.e.a t int st oft (Fu-F mix-t ilinga ingt rallyi ade‘ M).S fac-t imi-

ca rather than orthodox medical professionals. It is notehy to point out some of the most common concerns shy the professionals in the orthodox medical circles inast and the West have been the assessment of the qafety, and efficacy of CMM.

Table 2summarises the frequently asked questionserning the practice of CM and the use of CMM. Admitte

able 3urvey on the natural substances used as Chinese medicinal m

CMM) (ref. Chan and Yeung, 2002)

ype of Chinese material medica No. of item Percen

erbs 11020 86.8%nimals 1590 12.5%inerals 84 0.7%

otal 12694 100%

,

Aristolochia fangchi) as a powder mixed with OM drugs flimming (But et al., 1996).

Fake CMM were certainly identified in the herbal markn developed countries (Jin et al., 1995; Yu et al., 1995, 199).xcessive or banned pesticides, heavy metals and micontaminants may be related to the source of these herberials, under contaminated environment during cultivatiohese plant materials. Chemical and other biological toay come from unfavorable storage conditions or chem

reatment during storage. The presence of orthodox dan be related to unprofessional practice of manufactudvances of science and technology in both biomedica

nstrumental analysis help to obtain more informationence quality control over medications from natural souChan, 2003).

.1.1. The lack of understanding how CMM should berescribed

These observations indicate that there is a lackinnderstanding how CMM should be utilised properlyccording to the practice of the disciplines as set ou

he philosophy and science of Chinese medicine. Mohese CMM are incorporated as composite prescriptionsang) that contain three to as many as 30 herbs. The

ure is often prepared as an aqueous decoction by boll the CMM ingredients in an amount of water accord

o the Chinese medicine requirement and consumed ommediately. Other types of preparations are ready-mZhong Cheng Yao’ (proprietary Chinese medicines, PCome of the well-known prescriptions have been manu

ured into proprietary OTC products in dosage forms, s

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6 K. Chan / Journal of Ethnopharmacology 96 (2005) 1–18

lar to those of orthodox medicinal products that are conve-nient for patient use. Noticeable problems are those involvedwith quality control of these products (Chan, 2002c). Well-known Fu-Fang often contain potent or poisonous CMMwhich are listed in a compendium (Xu and Chan, 1994).Yet after correct processing of crude forms using ancientprocedures as described in the Pharmacopoeia of the PRChina, these poisonous CMM are often included with otherCMM in composite herbal prescriptions for patient use.Apparently some of the poisonous actions can be counter-acted by the presence of other herbs or by the method ofpreparation.

2.1.2. The art or science of processing crude CMMbefore use

All CM herbs are processed or prepared from fresh aftercollection with appropriate procedures before use. The pro-cessing, apart from cleaning and preserving purposes, has re-moved or reduced the toxic components in the unprocessedcrude herbs which when taken alone will cause fatal effects.Certain processing changes the effects of some herbs. For ex-ample, rawRadix Rehmanniaeis mainly used to purge heat,or cool the blood and promote the generation of body fluids.But, Radix Rehmanniae Preparata, after processing treat-ment, has a warm property and becomes especially effectivef ectso -d ct. Ift haven spe-c ions(

2o

reat-m ands he bi-o s areu iso-l anics vities( asa eparef im att s forp m-p icalp oachw ededa sed.T lopedc ly ori blicc

2.2. Documenting interactions between Chinese materiamedica with pharmaceutical drugs

Nowadays people are more informed, via the Internet,about medical products and knowledgeable about matters re-lating to their health and in curing and preventing illnesses.With the increasing popularity of complementary medicine,the public would take health products that contain usuallyunknown chemical entities, such as Chinese materia medica(CMM) and products, herbs of other sources, and productsused in homeopathy and aromatherapy products. There willbe a rise in the potential for adverse herb–drug reactions.Therefore studying these disciplines will become importantaspects of the healthcare in the coming 21st century (Chan,2000a, 2000b, 2002b). In orthodox medical (OM) practicethe incidence of drug–drug interactions has been the con-cern for clinicians treating patients on multiple drug regi-mens. The greater the number of drugs the patient takes thegreater the likelihood that adverse reactions may result (Liand Jurima-Romert, 1997). Fugh-Berman (2000)reviewedliterature with 65 references that reported concurrent use ofherbs may mimic, magnify, or oppose the effects of phar-maceutical drugs.Chan (2000e)pointed out that the futureprofessional should be knowledgeable on their patients’ med-ications and be aware of possible OM and CM treatment in-t nallyo witho e ofi Ben-e taint dC

lit-e rac-t ctionsa s ora d inp fg uctsa peara ucho inci-d ofes-s enta-t er canb peri-m reenc ps ofO witho ed tos arma-c evedu e ofO us-i tive

or enriching blood. After processing the therapeutic efff some herbs will be enhanced. For example,RhizomaCoryalisprocessed with vinegar has a greater analgesic effe

he supplied herbs in the market of developed countriesot been processed properly toxicity will be present, eially so when used alone without composite prescriptChan, 2002c).

.1.3. The need for novel approaches towards best usef potent Chinese medicines

The priority of research on natural products-related tent, in particular herbal products, is to ensure quality,

afety of the end products used by patients. In general, tlogically active chemical compounds of these productnknown even though other known, chemical entities are

ated from the herbs. Single compounds isolated from orgolvents are either too toxic or have decreased or no actiChan, 1995). Most traditional medicinal herbs are usedqueous decoctions or as aqueous-ethanolic extracts pr

rom the mixtures. Therefore research projects should ahe development of approach towards to set up guidelinerocessing crude CMM for their inclusion in Fu-Fang (coosite prescriptions) using modern analytical and biologrocedures for ensuring their safe use. This type of apprill generate future references that are desperately nes recognition if these potent or poisonous CMM are uhis is because regulatory departments in most deveountries have already taken actions to limit the suppmport into their markets as a means to protect the puonsumers.

d

eractions as they may be given both treatments intentior unintentionally and possibly taken both medicationsr without informing the practitioner. The consequenc

gnorance will lead to adverse reactions in most cases.ficial outcomes of intentional combined use will ascer

he advantages of proper integrative treatment (Cheung anhan, 2000).Some drug interactions that have been listed in the

rature are neither meaningful nor helpful for clinical pice since they are not relevant, because some interare theoretically possible based on in vitro investigationnimal experimentation that may not have been studieatient situation (Chan, 2000a). Clinically there is a lack oood documentation of interactions between CMM prodnd OM drugs in the West. When adverse reactions aps a result of taking CMM products simultaneously, sbservations have been referred to as the cause of theents. It is necessary to have a joint effort between prionals of OM and CM to set up research and documion schemes in this area (Chan, 2000g). Observed adverseactions that have been reported in clinical situationse studied and confirmed using properly designed exents. It is feasible to set up laboratory protocol to sc

ommonly prescribed CMM products against those grouM drugs with potential adverse effects when combinedther substances. Many in vivo animal models can be uscreen drug interactions between herbs and drugs. Phokinetic and pharmacodynamic correlation may be achising these in vivo models. Pharmacokinetic clearancM drugs in presence of CMM products can be studied

ng in vivo model. The data obtained are useful qualita

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K. Chan / Journal of Ethnopharmacology 96 (2005) 1–18 7

guidelines for clinical studies (Chan et al., 1995b; Lo andChan, 1995).

To equip the practitioners spotting the likely interactionsbetween CMM and pharmaceutical drugs, both CM and OMprofessionals need to acquire background knowledge on us-ing these two types of highly unrelated concepts of medicaltreatments. Some introductory information on CM principlesof using CMM and their prescriptions have been made avail-able (Chan, 2000c, 2000d). Proper professional training andaccumulating experience of both OM and CM practice in theuse of two different types of medications will undoubtedly benecessary for patient care in an integrative approach ((2000f).

3. A world-wide need for future development andmodernisation of Chinese medicine

Chinese materia medica (CMM) and their manufacturedproducts, together with physical treatments using acupunc-ture and related medical massage (Tuina), play an importantrole in the prevention and treatment of diseases in China andsome other countries, apart from orthodox medicinal (OM)pharmaceutical drugs. Without exception all medicinal prod-ucts used for treatment of diseases in human and animalsshould have proven quality, safety and efficacy. Problemsa nceo ta ndp cts,t fes-s dingd ces,q od-e hi-n sandso in or-d ndZ

ide,t einga nesem tice.T de-s work-a

3

hesea andO strya ongK ent(

ca-t and

has not recognised CM training of any kind as a professionalqualification. Since there was no registration system for theCM practitioners and no regulation of CM practice, it is anatural consequence that there was no system of accreditingCM courses or schools at all before regulations were put intopractice.

In the 1950s, private schools offered part-time (mainlyevening and/or week-end) courses of varying formats, rang-ing from short interest courses to better-structured under-graduate and post-graduate courses (qualifications not recog-nised by government) over periods of several years. QualifiedCM professionals from Mainland China set up some of theseprivate schools since the early 1950s. Students attending therealso included OM graduates and practitioners. Some of thesegraduates are well qualified to train future professionals inthe integrative practice of OM and CM. More than half of theactive CM practitioners recorded recently claimed that theyhad received their training in Hong Kong. Representatives ofCM profession recognised these courses as they are ‘makingvaluable contribution to training of practitioners’ (WorkingParties, 1991).

The publicly funded tertiary institutions did not involvethemselves in CM education or training until the early 1990son a part-time course basis. Only in the late 1990s full-timedegree courses of CM were offered. Currently three univer-s reet prac-t

3de-

v ce( ittedt firstr HongK un-c greep che-l thefi r ofP ents.

de-s hi-n egreec f theP se ofB nc-t h-n n byt ands

3sity

o beenr nese

nd difficulties have been identified in the quality assuraf all herbal products when registered as medicines (Chan el., 1999). Due to the high demand of CMM for compourescriptions and OTC functional food and health produ

here is a shortage of supply of CMM. To cope with unproional practices in various aspects concerning CMM traifferent guidelines will be required in assuring the souruality, professionalism and regulatory control. Thus mrnisation, but maintaining the principles of practice, of Cese medicine that has been practised in China for thouf years has been on the national agenda since 1995er to benefit healthcare world-wide (Chan, 2002a; Chan aou, 2002).

As the demand of CMM has been increasing world-where is a global interest to assure good quality CMM bvailable and for professionals in various areas of Chiedicinal practices to provide good quality medical prac

o implement such concepts the following sections willcribe some directions that have taken place and otherble proposals for future development.

.1. Education and practice aspects

The role-players, who can develop and implement tspects, are practitioners and professionals of both CMM disciplines, universities, health authorities, CM indund clinics or hospitals. To illustrate such a concept the Hong model is described to indicate areas for developm

Chan and Yeung, 2002).The Hong Kong Government did not include CM edu

ion into the public education system until the late 1990s

ities are offering full-time degree, part-time diploma/degype courses, some of which are refreshing courses foritioners.

.1.1. Hong Kong Baptist University (HKBU)The University’s new School of Chinese medicine has

eloped the first-in-Hong Kong full-time Bachelor of ScienHonours) in Chinese medicine programmes and admhe first batch of 30 students in September 1998. It is theecognised degree programme in Chinese medicine inong by the funding organisation, University Grant Coil. The programme has been structured to a dual derogramme of Bachelor of Chinese medicine; and Ba

or of Science (Honours) in Biomedical Science. In 2001rst (recognised by the University Grant council) Bacheloharmacy in Chinese medicines was offered to 15 studThe School of Continuing Education of HKBU has

igned from a 4-year part-time Professional Diploma of Cese Medicine course since 1997 to a 5-year part-time dourse in Chinese medicine. Upon completion, holder orofessional Diploma may transfer to the degree courachelor of Health Science (Chinese Medicine) in conju

ion with the University of Royal Melbourne Institute of Tecology in Australia. These part-time courses are now ru

he School of Chinese Medicine to improve the qualitytandard of professionalism.

.1.2. The Chinese University of Hong Kong (CUHK)In the early 1990s the Extramural School of the univer

ffering continuous education to the public at large hasesponsible for setting up part-time programmes on Chi

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8 K. Chan / Journal of Ethnopharmacology 96 (2005) 1–18

Medicine. The university opened a degree course of Bachelorof Chinese Medicine in 1999/2000 academic year with firstintake of 15 students. The course involves service teachingfrom academics in universities of Chinese medicine in theMainland.

3.1.3. The University of Hong Kong (HKU)Since 1991, the university has been offering part-time

programmes on Chinese Medicine in its School of Pro-fessional and Continuing Education (SPACE) over a widerange of courses covering the following areas. A 4-yearDiploma of Traditional Chinese Medicine course was offeredin 1997/1998. The course was then changed to run by creditunit system and expandable to a 6-year Bachelor of Tradi-tional Chinese Medicine degree course in 1998/1999. Stu-dents may enroll for either course depending on own qual-ifications and choice. On CM Pharmacy, a 3-year Diplomain Pharmaceutical Management in Chinese Medicine courseand a 4.5-year Bachelor of Pharmacy in Chinese medicine de-gree course has also been established. Two diploma courseson acupuncture, namely, Diploma in Clinical Acupuncture(designed for western medicine practitioners) and Diplomain Acupuncture and Moxibustion (designed for working CMpractitioners) are available. A 2.5-year Master of Tradi-tional Chinese Medicine (Acupuncture and Moxibustion)c inesem og-n Or-t ition-e

fullyt d de-v turem thep

3

tho-d hasn elop-m t oft h thea odoxm ns ofC ucedt Plano hash alityc pro-p theM in-i hi-n inis-t e ofN

The aims of the Plan have mainly been to modernise andinternationalise various aspects of Chinese medicine basedon inheriting and carrying forward the advantages and dis-tinguishing features of the traditional system of healthcare.The Plan will fully utilise the methodology and measures ofmodern sciences, draw lessons and experiences from interna-tional standards and regulations on materia medica, in orderto develop Chinese herbal products that can compete and en-ter the international medicinal markets. The Plan has startedsince 1995 and aimed to increase the share of the world mar-ket from the then 3% to 15% in 10–15 years’ time. Otherareas of modernisation include:

• Provision of training programmes of various CM profes-sionals to strengthening the modernisation programmes.

• Linking with overseas universities for the development oftraining courses and degrees programmes, and researchcollaboration for Chinese medicine.

• Development of the frame work for harmonisation ofregulations for control of registration of Chinese herbalmedicines, including all aspects of ‘Good Practices’ suchas good agricultural practice (GAP), good sourcing prac-tice (GSP), good laboratory practice (GLP), good manu-facturing practice (GMP), and good clinical trial practice(GCTP) for Chinese medicines.

• Establishing key national institutes and high quality cor-andlud-

fes-s theys entlyi andd ora-t t ofH d ex-p icinesl

3u

andd emi-c ined.U suc-c icals,e ing-hs striesi ork-i n ofp turals rgets( sms)w hesec cals

ourse was launched for degree holders of either Chedicine or orthodox medicine, or practitioners with recised qualifications. There is also a Diploma in TCM

hopaedics and Traumatology course designed for practrs.

It is encouraging that the government has committedo support and recognise that the training, research anelopment of CM are important procedures for the fuodernisation and internationalisation of CM along sideromotion of developing the CM industry.

.2. Research and development aspects

The practice of Chinese medicine, co-existing with orox medicine introduced in the early 1900s, in Chinaever been stopped throughout the history of the devent of healthcare in China. However, the improvemen

his form of healthcare has not been keeping pace witdvance in science and technology and that of the orthedicine. The recent increase of interests and concerM practice in the West has indirectly hastened and ind

he already planned national decision to implement the ‘f Modernisation of Chinese medicine’. Such decisionelped to cope with the increasing demand of good qurude materials and finished products. The recent ‘Plan’osed in general by 15 ministries in China, was led byinistry of Science and Technology, jointly with the M

stry of Health, the State Administration of Traditional Cese Medicine (SATCM), the State Food and Drug Adm

ration (SFDA), and the National Foundation Committeature Science, etc. (Chan and Zou, 2002).

porations for co-ordinating the national developmentmodernisation of all aspects of Chinese medicine, incing practice and research of acupuncture.

Thus when considering the R&D programmes that proionals in Hong Kong and other regions are targeting,hould have a good knowledge of what are being run presn Mainland China. Programmes should be innovativeo not create duplication. There should be mutual collab

ion. The HKCMMS project launched by the Departmenealth has received help and collaboration from mainlanerts and academics of various aspects of Chinese med

ocally and internationally.

.2.1. Failure of conventional R&D approaches to fullyse CMM

Plenty of information in the literature on researchevelopment in the search and screening for new chal entities from Chinese medicinal plants can be obtanfortunately such attempts have not produced manyessful leads for development of orthodox pharmaceutxcept the well-known artemisinin isolated from the Qaosu herb (Chan, 1995; Chan et al., 1999). Traditionally, re-earch institutes in China and other pharmaceutical indun developed countries focus most R&D programmes wng on plant materials towards the conventional isolatioure chemical entities. These new compounds from naources are then screened for activities on biological taenzymes or receptor systems, interfering micro-organihose modulation is implicated in a particular disease. Tonventional attempts fail to isolate or identify lead chemi

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K. Chan / Journal of Ethnopharmacology 96 (2005) 1–18 9

for synthesis of analogues from well-known medicinal plants.One of the many reasons for this failure is that the researchapproach for orthodox screening and synthesis of compoundsis not suitable for all medicinal plants, which have been tra-ditionally proven, possessing therapeutic efficacy when usedaccording to the traditional ways of using combination ofherbs. On the other hand, clinical trials on the efficacy oftraditional herbal remedies have supported the introductionof some natural products for use as medicines or functionalfood worldwide. Examples of these are: cranberry juice fortreatment of urinary retention, Garlic extracts for reducinghigh blood pressure and cholesterol, ginger preparations formotion sickness and post-operative nemesis, Zemaphyte@

(a CM composite prescription containing 10 CM plants) fortreatment of severe atopic eczema and related skin disordersthat are resistant to orthodox treatment, tea-tree oil for acne,valerian for treatment of anxiety, St. John’s Worts (Hyper-icum), and feverfew for migraine prophylaxis.

The author has indeed proposed in various scientific andprofessional meetings and publications to set up a new strat-egy and approach for screening the efficacy of CMM (Chan,1995; Chan et al., 1995a) in the mid-1990s.Scheme 1il-lustrates a strategy that provides a screening procedure thatallows the data for use in quality assurance assessment, pre-diction for selection of further screening of activities andr ces.A then-t

3m

ortsh siumo wash ects.K ndp sitivea of thep

3 pew

• sort-re-

• lop-

• ing

• pts;cy,ide

ffi-pri-nd

Scheme 1. Quality evaluation protocol for Chinese medicinal materials(CMM) and herbal products (Chan, 2002d).

low in side-effects), and “3 Eases” (easy to store, easy totake along and easy to use).

• Apply modern technology used for orthodox pharmaceuti-cals in the R&D of dosage forms development of Chineseherbal products. It should be mentioned that the design ofnew dosage forms should be in keeping with the charac-teristics of Chinese herbal products.

3.2.2.2. Establishing framework structures for R&D of Chi-nese herbal products.

• Absorb the advantages of modern physical, chemical, andcomputer sciences and information in order to set up ef-ficient, accurate and rapid methodologies for the isolationof effective components from Chinese crude herbs.

• Establish standardised laboratory models for evaluatingmethodologies and providing indices suitable for pharma-cological screening of Chinese medicinal plants.

ecognition purposes as finger printings for future referendatabase for each of the extracts of appropriately au

icated CMM can be kept as reference.

.2.2. Action plan for the modernisation of Chineseedicine in Mainland ChinaTo implement the modernisation plan nationwide eff

ave been called upon. In 1998, an International Sympon the Modernisation of Traditional Chinese medicineeld in Nanjing on July 10–12 to consider various aspey officials from the 15 ministries gave their viewpoints alans. Overseas Chinese nationals contributed with popproaches and ideas. The followings summarise somelans for action and implementation (Zou, 1998).

.2.2.1. Policy on R&D of Chinese herbal products to coith the market-needed.

Screen and evaluate herbal products from good asments of Chinese herbal prescriptions or formulae insponse to disease-directed needs.Explore the theory and methodology suitable for deveing Fu-Fang (herbal composite prescriptions).Concentrate on application of CM theory in developFu-Fang formulation products.Develop Fu-Fang dosage forms following earlier attemin order to obtain quality CMM medications with efficastability and good quality. It has been the aim to provproducts with ‘3 Efficiencies’ (efficiency in potency, eciency in rapid onset of actions and efficiency in approate duration); ‘3 Lows’ (low in dosage, low in toxicity a

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10 K. Chan / Journal of Ethnopharmacology 96 (2005) 1–18

• Emphasise the development, protection, and cultivation ofChinese medicinal plants by implementing GAP.

• Explore and strengthen the theoretical and methodologicalresearch on Chinese herbal toxicology.

• Strengthen the research on processing of crude Chinesemedicinal plants.

• Develop the methodology for quality control on Chinesemedicinal plant materials and manufactured products bysetting up good practices guidelines such as GAP, GSP,GLP, GMP and GCTP that should be adapted for manu-facturing of Chinese herbal medicinal products.

• Establish the evolution systems on the overall quality as-surance of Chinese herbal medicinal products, which in-clude national screening, standardisation centres, GMPcentres and GCTP centres on Chinese herbal products.

• Set up information Internet system on Chinese Medicine,by making use the Knowledge of Database Discovery(KDD), pattern recognition for medicinal plant extractsfor identification and quality assurance, etc.

3.2.2.3. Establishing technology for modern Chinese herbalindustries.

• Modernise productive technology of Chinese herbal prod-ucts.

• ion

• nese

• ssingance

• Chi-ntainin-

table

• ardsrobialcts.

3 na-t

• hi-

• inestion

• n bysti-e.

• archese

• Compile standard CM terminology in various foreign lan-guages for the promotion of knowledge exchange.

• Updating analytical information in monographs of herbalmaterials included the Chinese Pharmacopoeia to copewith new analytical technology such as finger-printingsand pattern recognition for herbal extracts.

• Promote the formation of Trans-national Corporation onnational herbal industries.

3.2.2.5. Promoting international academic exchange intraining professionals of Chinese medicine.In view of thefast development of various schools of Chinese medicine(both acupuncture and Chinese Herbal Medicine) in the West,the State Administration of TCM and other appropriate min-istries in China have launched joint training and educationalprogrammes. This approach aims to raise the standard andquality of CM practitioners and other related scientists andtechnicians in Chinese herbal products. Indirectly, this helpsto build linking bridges between East and West for betterunderstanding of the principles of Chinese medicine.

3.3. The research and development of Chinese medicinein Hong Kong

Similar to the practice of the CM profession R&D of CMw as ac GC),aa eb therp ressi f co-h g.A s orp ublicf lledi andt od-e facec cacya merm emici as ofb ing tot liner ands

rantC s ofC

g ngK M)( fC dici-n on of

Apply modern biotechnology in production and cultivatof Chinese herbs.Engineer automatic systems for processing of Chiherbal materials.Renew and update equipment and apparatus in proceof Chinese herbal materials and products in accordwith GMP.Standardise the procedures for quality assurance ofnese herbal products. Chinese herbal products cocomplex components. It is important to establish theternationally acceptable quality control standards suifor Chinese herbal products (Zou, 1998).Set up internationally acceptable quality control standon presence of heavy metals and pesticides, and micand radiation contamination in Chinese herbal produ

.2.2.4. Promoting Chinese herbal products into interional markets.

Strengthen the protection of intellectual property of Cnese herbal products.Elevate the level of patent on Chinese herbal medicby protecting the interest of technology and formulaknow-how on Chinese herbal products.Strengthen international exchange and co-operatiolaunching international links with various academic intutes and government bodies for information exchangEncourage co-operations in setting up joint reseprojects on R&D of product development on Chinherbal products.

as non-existent until the early 1990s, when there whange of attitude of the Research Grant Committee (Rnd the then Industrial Department of the Government (Channd Yeung, 2002). All major universities in Hong Kong haveen actively competing for funding from these and orivate sources. While competition is encouraging prog

n new directions, unfortunately there has been the lack oesion to collectively identify the R&D need in Hong Konpart from private funding, which may have specific aimurposes; there should be guidance and criteria from p

unding authorities to tackle various voids that can be fin by expertise from academic institutes in Hong Konghe Mainland. With concerted efforts the progress of mrnisation can be achieved effectively and rapidly toompetition abroad. Areas in assurance of safety, effind quality are the major concerns of the global consuarket as far as the CM treatment products go. Acad

nstitutes without excessive repetition should share areasic, applied and clinical research programmes accord

heir strengths and expertise. This approach will streamapid throughput of R&D outcomes that can be utilisedhared efficiently for modernisation.

The Research Grant Committee of the University Gouncil started to fund basic research in various areahinese medicine in the mid-1990s.The Innovation for Technology Commission (www.info.

ov.hk/itc/eng/technology/) and the recently set up Hoong Jockey Club Institute of Chinese medicine (HKJCIC

http://www.hkjcicm.org), provide funding for the R&D ohinese medicine related to new technology for meal products. The HKJCICM also encourages submissi

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K. Chan / Journal of Ethnopharmacology 96 (2005) 1–18 11

projects with international collaboration in product Develop-ment of Chinese medicines.

The Department of Health, since 2003 has started an In-ternational Advisory Board over-seeing the setting up of theHong Kong Chinese Materia Medica Standards (HKCMMS).These have been the steps over the next few years to provideinternationally recognised standards and guidelines for crudeCMM so that the trade can follow to provide quality CMMin the market (www.info.gov.hk/dh/mainser/trad.htm). Ini-tially two local universities, HKBU and CHUK, linking withthe Hong Kong Government Laboratory under the spon-sorship of Department of Health and advice and guidanceof the International Advisory Board (IAB) of HKCMMS,took on the projects of setting up validated laboratory pro-cedures to generate standards for eight CMM in 2003.Early in 2004 two other local universities, HKU and HongKong University of Science and Technology (HKUST)joined in to generate standards for 24 CMM. By 2005,there will be a total of 32 CMM with internationally ap-proved standards as reference for the trade and industryof CMM to comply with. Such directions will be the ap-proach for future quality assurance of CMM. The rest of the574 commonly used CMM will eventually been standard-ised.

Other R&D programmes to ascertain the science involvedi ven-t withM re ess a sci-e Ms usingr lin-i l ex-p sando iencea e oft

3t of

m n bei

erbala t; thei ality,e ed toa ctice( enti-fi thata

rod-u g byt tion,c n bes d ex-t ures

for manufacturing these products are needed urgently to pro-duce acceptable dosage forms for use in CM practice.

There are several advantages of this approach.

• The granules produced can be QA-guaranteed by the man-ufacturer with acceptable monographic details for identi-fication and standardisation purposes.

• Such quality medicinal products can then be used for clin-ical trials with confidence comparable to those for OMpharmaceuticals.

• Patients will no longer worry about preparing the decoc-tion themselves. Their preparations may not give consis-tent products, thus efficacy may be compromised.

• Patients will find carrying of new CMM dosage forms,comparable to those OM medications, is convenient.

• Such medicinal products, though with complicated chemi-cal compositions, can be regulated according to nationallyand internationally agreed monographs complied by ex-pertise groups consisting of government health authorities,CM herbal manufacturers, and appropriate academicians.

Secondly, a higher level of biomedical research-staff fromdifferent universities and institutes have their own expertiseto develop up-market medicinal healthcare products or medi-cations from their research programmes of CM natural prod-ucts, that have been used for centuries. These will involveu log-i ped,t med-i con-t nes,n ech-n giesc ands haver ell-u si pri-m noto x-t s form latingt cang thea mentR

thesea

• tics,

• HIV,

• cro-ese

n the principles of CM diagnoses, treatment and preion of diseases should be encouraged in conjunctionainland experts. These basic research programmes a

ential to substantiate evidence-based CM practice inntific platform. The medications manufactured from CMources should then be assessed for clinical efficacyecognised clinical investigations in line of randomised ccal trials and properly designed case studies. Traditionaerience in the successful treatment diseases over thouf years can then been proven by modern bio-medical scpproaches—‘Tradition is confirmed by Science’. Som

hese areas are illustrated as follows:

.3.1. Directions of R&D for CMMTwo levels of R&D on the progress of developmen

edicinal products from Chinese herbal materials cadentified.

Firstly, the local needs—to address local needs on hnd other natural products that are used in CM treatmen

ndustries have the duty and responsibility to ensure qufficacy and safety (QES) of these materials. They neddress the sources of CMM with Good Sourcing PraGSP), having guaranteed reference to the collection, idcation and authentication of these medicinal materialsre prescribed by CM practitioners.

In order to safeguard the QES of these medicinal pcts from natural sources, and avoid accidental poisonin

he public due to supply of wrong herbs and adulteraommonly prescribed Fu-Fang and individual herbs caupplied by reputable CM herbal manufacturers, as drieracts or granules of the decoctions. R&D on the proced

-

s

p-to-date biotechnology. Apart from general pharmacocal/toxicological screening models that we have develohere is now available expertise to develop advanced biocal testing using in vitro systems, such as tissue culturesaining cell-lines that are useful: phage lysins, anti-cytokiovel immuno–pharmacological screening and rapid biotological and microbial diagnostic tests. These technoloan be utilised for the preliminary screening of crudeubsequently refined extracts from natural products. Weecently identified and isolated active compounds from wsed CM plants such as ginseng (Panax ginseng) that posses

nduction and inhibition of angiogenesis processes usingary cell lines. The application of such knowledge willnly explain the multiplicity actions of crude CM plant e

racts but also open up new horizon of searching new leadolecular pharmacological agents to treat diseases re

o CVS, cancer, rheumatoid arthritis. Such technologyenerate future patents for the benefit of the country inreas of Natural Products Research and Clean Environesearch.Several areas can be identified to be benefitted from

pproaches:

Infectious diseases: rapid diagnostic tests, new antibioanti-virals.Immunology related disorders such as cancer,rheumatoid arthritis, etc.Application of angiogenesis research to interpret micirculation and related cardiovascular effects of Chinmedicines.Phage display technologies.

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12 K. Chan / Journal of Ethnopharmacology 96 (2005) 1–18

3.3.2. Developing SOP for control on quality, safety andefficacy of CMM and products

The role players involved are professionals from univer-sities, herbal industries, and Government regulatory bodies.Without quality products the success of any clinical inves-tigations or trials of CMM products will be compromised.Here several disciplines of expertise will be required to setup standard operating procedures (SOP) and guidelines onGAP, GSP, GLP, GMP, and GCTP. Thus herbal manufac-turers of CMM products, government regulatory body, andlegal expertise on natural products should make sure SOPhave been included in the industrial monographs for all prod-ucts to be registered as prescription only CM medications, orOTC products.

3.3.2.1. Streamline basic and applied research programmesfor CMM products.Referring to the above Section3.2, thenational plan from China for modernisation can be used asguidelines. The universities and academic institutes in HongKong should join-venture to identify and research into nichemarketable areas of health and treatment needs with localmanufacturing industries of CM products.

3.3.2.2. Input biomedical science measurements onacupuncture and CMM treatment.These areas of clinicalr ve at-t as ofC sages dies.T ts inu

3

m-i m-pt e thep ouldc r them vel-o

3in-

f ologyf iquea rofes-s icinei ax-i ntiona inte-g andq etterh top logy

(MIT) recommendations on the development of manufactur-ing industry for CM product. Various ingredients are there,what is needed is a workable and a deliverable model to set inmotions this important mission. Hong Kong needs a properand accountable organisation to ensure the delivery of ideasfrom different sectors into products and goods with assur-ances of quality, reliability and brand reputation. The devel-oped countries in the West and the new consumers in Chinaand other emerging economies demand these good qualityproducts. The followings are some of the mission that shouldlead to reality.

It was previously proposed by the Chief Executive of theHong Kong SAR that the setting up of an International Insti-tute for Development of Chinese medicines has become morepossible due to the financial support offered by the HongKong Jockey Club.

In line with the actions for national modernisation of Chi-nese medicine, the proposed model aims to provide a co-ordination role in close contacts with institutes in Main-land. The ultimate common goal has been to create oneof the national Centres of Excellency for promoting Chi-nese medicine globally in the right directions. National ef-forts in several areas should be addressed towards assuranceof quality of clinical and professional practice in CM, thelaunching of CM herbs and herbal products with good qual-i ula-t lity,s uredp

3

r dentB nd-i seda era self-s ringC omes odelt of aC hievet

• ncycineth.

• iousndts of

• har-ctsen-

llec-

esearch into mechanism of how acupuncture works haracted a lot of interest in developed countries. Other areM treatments including Qi-Gong, Tai-chi and acu-mashould also be looked into their evidence-base stuhe join effort should come from academic departmenniversities and hospitals and clinics.

.4. Commercial and international aspects

Evidence of failure and difficulty of isolating pure checal entities from single medicinal plant as potential coounds for activity screening (Chan et al., 1999) indicates

hat conventional phytochemical screenings might not bath to follow. The future R&D strategic approaches shentre on the market orientated research with the aim foanufacturing of CM products and help co-ordination depment for small and medium sized manufacturers.

.4.1. The mission possibleHong Kong provides some of the best globally reliable

rastructures for business, monetary, trading and technor local and international development. It provides a undvantage to promote and expand Chinese medicine pionally and scientifically, and to establish Chinese medn global pharmaceutical market. Therefore, in order to mmise the usefulness of Chinese medicine in the prevend treatment of diseases, a model was proposed torate education, promotion of research, manufacturinguality assurance of Chinese medicinal products for bealthcare (Chan et al., 1999). There is a big task aheadut into practice the Massachusetts Institute of Techno

ty safety and efficacy, the promotion of a workable regory system to cope with international demands on quaafety, and efficacy of crude CM herbs and manufactroducts.

.4.2. Aims and goals of the Hong Kong modelThe Model Organisation (Chan et al., 1999) should be

esponsible with complete accountability to an indepenoard of Trustee, which is formed to oversee that public fu

ng for the execution of duties by the organisation is uppropriately. After initial support from public funding ovdefinite period, subsequent development should be

upporting. Apart from generating capital via manufactuM products, joint venture projects and consultation inchould be the logical sources of revenues. A successful mo promote the co-ordination roles for the developmenthinese medicine-based industry should be set up to ac

he following goals.

To develop for Hong Kong a global Centre of Excellewith unique and stand-alone identity for Chinese mediin order to counteract misconception that CM is a myTo co-ordinate, incubate and realise ideas from varuniversities’ units on CM in Hong Kong and Mainlainto action for basic and applied research in all aspecChinese medicine.To create an international centre for co-ordination, themonisation of regulations for registration of CM produwith quality, safety and efficacy for treatment and prevtion of diseases; development for registration of intetual properties on CM product manufacturing.

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K. Chan / Journal of Ethnopharmacology 96 (2005) 1–18 13

• To set up trouble-shooting facilities for Hong Kong’s CMmanufacturing companies or small or medium sized indus-tries, which cannot afford such facilities, with due regardsfor the confidentiality of their products.

• To set up training facilities for Hong Kong’s, perhapsglobal, need of professionals, technicians, dispensersspecifically required by the CM industries that other uni-versity institutes cannot offer.

• To incubate and realise environment for R&D programmesin conjunction with experts in various local university re-search departments and institutes as well as those in Main-land China on new formulation, novel composite prescrip-tion products, manufacturing procedure with GMP guide-lines.

• To provide facilities for small-scale pre-manufacturingR&D production for small and medium size industries.

• To set up functionally viable CM hospitals or clinics, sim-ilar to the one set up in Kotzting in Munich, Germany,complementing existing OM hospitals such that the publiccan have a choice for their treatment.

• The future development of healthcare tourism based onCM treatment and prevention of diseases can help to pro-mote Hong Kong’s economy and culture as well as improvethe quality of life for the public when the know more aboutthe use of CM information.

• aning

• fortiontly,

oita-ent

4m

andu uthorc ingq cineso ticeo ch.

4i

om-b M)i ns int e dev of-fi alitya for

implementation. Evidence-based assessment should be theminimal requirement for inclusion of CM into the OM mainstream practice.

4.1.1. The German experienceThe practice of integrated CM and OM in a well-

established private TCM hospital in Kotzting, near Munich inGermany, since 1991 has been a successful example of inte-grated practice. Crude CMM and products imported fromChina are authenticated and quality-controlled by Phyto-chemists at the Department of Pharmacognosy, DusseldorfUniversity and that of Munich University under the directionof Prof. Bauer and Prof. Wagner, respectively. CM practi-tioners are qualified from Beijing University of TCM. Pa-tients who fail to get cure from orthodox medicine are ad-mitted to the hospital for treatment with CM therapies (suchas acupuncture,Tuina, Qigong and CM herbs) only as a lastattempt for medical treatment. All patients are diagnosed byCM method and OM procedure before and after treatmentperiod. Several studies have been carried out on the efficacyand safety of the CM treatment in the hospital. Success ratehas been impressive (Liao, et al., 2002).

If there is evidence showing benefits of integrating com-plementary medicine into orthodox treatment, it should beallowed for patient care. Treatment of some diseases such asa as notb ronici onersl ss.S tmento tions.S d ofC atingi

4t at

t hasb e ands 83 bya ng int inici ici eenp peo-p orumt ults,o they nurs-i whom enceo ateh ing,a com-p thatt the

Taking a role of international link for CM the Institute cstart organising ICH regulations to clamp down supplyadulterated and fake CHM Products.Working with Mainland China on encouraging GAPproducing raw materials is a very much-needed direcin order to replenish shortage of CHM materials. Indirecthis approach will help preventing unnecessary expltion and is positively environmental friendly to prevextinction of natural materials.

. Conclusion on the global impact of Chineseateria medica in healthcare

Having gone through different issues it is necessaryseful to make conclusions over several areas that the aonsiders as key points for the way forward in producuality-proven, safe and evidence-based Chinese medir their proprietary products suitable for the proper pracf Chinese medicine and or integrative medicine approa

.1. The advantage of integration of Chinese medicinento mainstream healthcare

The example of practising integrative medicine by cining Chinese medicine (CM) and orthodox medicine (O

n China, developed regions in the West and other regiohe Far East can be used to assess the situation to beloped in Hong Kong where CM practice is becomingcial. Guidelines should be set to ensure adequate qund availability of practitioners and treatment methods

,

-

topic eczema, strokes, and some rheumatic diseases heen successfully cured by orthodox medicine. These ch

llnesses have been referred to Chinese medicine practitiegally or officially for treatment with considerable succeome aspects of the success have been noted for treaf skin diseases that are resistant to orthodox medicaome private proper CM acupuncture clinics with the aiM herbal proscriptions show successful cases of tre

rritable bowel syndrome that OM has fail to help.

.1.2. The NHS experience in the UKIn an UK National Health Service (NHS) environmen

he South Western Hospital in Brixton, the use of CMeen successful for treatment of pain, drug dependenctrokes. This Gateway Clinic has been set up, since 19physiotherapist who became, after subsequent traini

he UK and China, a CM practitioner. The Gateway Cls a NHS clinic with very little financial support. The Clins styled on the ‘open plan Chinese Medicine Clinic’ as sractised in China; with a large community space wherele are all treated as equals together. In this open public f

he Chinese medicine is seen for what it is and the resr failures, or reactions, are in full view. Obviously overears there have been orthodox medical practitioners,

ng professionals, and physiotherapists and administersaintain strong opinion and refuse to recognise the evidf the work being done. As time passes the political climas had to find new innovations and methods of works the allopathic model is too costly and hazardous, inlete and unpopular. The CM practitioner has commented

here is the need for a Gateway Clinic in every hospital in

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14 K. Chan / Journal of Ethnopharmacology 96 (2005) 1–18

UK and it will probably happen in the near future. The gen-eral public has welcomed the friendly and sincere attitude andthe natural flow of Chinese medicine, particularly as the re-sults have been good. All clients have benefited on some levelor another and many have resolved their health issues com-pletely and gone on to learn the Chinese systems of longevitysuch as Qi Gong, Tai-Chi, meditation and food therapy, etc.

The Hospital Authority is now acknowledging theseachievements and is at present developing strategies to utilisethese skills to obtain more financial resources to develop fur-ther the service. Recently the Gateway service has been ac-cepted into the main stream HIV Budget and so its future ismore secure than before. Previously the ‘survival’ budget hadto be bid on an annual basis (Tindall, 2002).

4.1.3. Training and professionalism in Chinese medicineThe use and practice of CM in China and other regions

and countries in the East have been established. However,modernisation and improvement will be needed to make bet-ter use of this traditional medical practice for complementingand co-existing with the well-advanced orthodox medicine.Implementing and up keeping of existing regulations for bothpractitioners and product-related treatment is also needed tosafeguard the quality of CM for providing and improvinghealthcare of the population.

t, ino alth-c , theC mpe-t stra-t osew ofes-s ber-s andp onalr

•• tion.• g

• .• ose

• tion

• y of

4C

rolef vel-o ongv tures

for business, monetary, trading and technology for local andinternational development, are available to provide presentlya unique advantage for the promotion and expansion of Chi-nese medicine.

The way forward to make better use of Chinese medicinefor healthcare of the public in a global situation will requiretremendous efforts from professionals and health officialsin China where Chinese medicine originated and those fromcountries where Chinese medicine is practised. Both East andWest have to work closely together to get the right approachfor professionalism, regulatory issues for control of qualityof practitioners, Chinese material medica and other treatmentrelated therapies. It is not a responsibility of one countryto see to the implementation of efficacy, safety and qualityof Chinese medicine. The areas for building bridges can besummarised as follows:

• International development for regulation on authenticationof Chinese medicinal plants.

• Dialogue between regulatory bodies from Chinese regula-tory authorities and those from other countries.

• Control of quality of import and export of CMM sub-stances.

• Co-ordination of GAP and GSP of CMM materials to avoidextinction of endangered species.

• Development of methodology for assessment of efficacy

• har-and

con-t heret wella inC r useo alitya edi-c hinac partf ento ongK overp thew willa inest isa-t resto entm an bea ality.

4m

es ind times

In Hong Kong and developed countries in the Wesrder to be recognised and accepted into practice in heare as part of the medical and health professional teamM practitioners have to be able to demonstrate their co

ence of practice and level of their training. The demonion of professionalism requires a concerted effort of thho are practising various roles of Chinese medicine. Prional organisations apart from self-regulating their memhip should be able to demonstrate their working ethicsrofessionalism in order to obtain national and internatiecognition by aiming at:

Maintaining and developing educational standards.Continuing professional development and modernisaBeing familiar with healthcare affairs (improving linkinvia various OM and CM professionals).Keeping with development of ethics and safety issuesBeing aware of R&D in Chinese medicine as well as thin orthodox practice.Setting up liaison mechanism with government regulaagency for better service.Helping to develop monographs or industrial formularCMM products for local then international use.

.2. The role of Hong Kong in linking East and West forhinese medicine

Hong Kong has the right ‘environment’ to take up theor building up links between East and West for future depment of Chinese medicine. This is because in Hong Karious ingredients, such as the global reliable infrastruc

of CMM products.Development of regulatory issues for the internationalmonisation of setting monographs for CMM materialsproducts.

There is great potential for Chinese medicine to makeribution for better healthcare in developed countries whe public are cared for by orthodox medical practice, ass developing regions. The integration of CM into OMhina has set positive examples. In order to make bettef CM there is a need to demonstrate the efficacy, qund safety of the discipline with more scientific and mal evidence-based studies. Modernisation of CM in Can help to make better understanding of the discipline. Arom availability of reliable CMM products, the developmf proper education and training courses for CM in Hong and countries in the West, and regulatory controlrofessional qualification and treatment products will beay forward for Chinese medicine. Such approacheslso set examples for practices of other traditional medic

hat the WHO has tried very hard to mobilse for modernion and recognition into healthcare for the 80% of thef the world population in developing countries. Treatmethods and products based on traditional medicines cccepted if they are proven with safety, efficacy, and qu

.3. Good practices for development of Chineseedicinal products

Over the past decade several news-catching episodeveloped communities indicated adverse effects, some

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K. Chan / Journal of Ethnopharmacology 96 (2005) 1–18 15

life threatening, allegedly arisen consequential to taking ofOTC herbal products or traditional medicines from vari-ous ethnic groups. Apart from not fully identified chemicalentities with unfamiliar mechanisms of actions, these man-ufactured OTC products may contain excessive or bannedpesticides, microbial contaminants, heavy metals, chemi-cal toxins, and orthodox drugs. The presence of orthodoxdrugs can be related to unprofessional practice of manufac-turers. Some of these environment related factors can be con-trolled by standard operating procedure (SOP) in bringing upto GAP, GLP, GSP, and GMP for producing these medici-nal products from herbal or natural sources. Without suchquality-guaranteed products any clinical studies for efficacyand safety will not be convincing. The public’s belief thatherbal and natural products are safer than synthetic medicinescan only be ascertained by putting regulatory standards onthese products that should be manufactured with good qual-ity assurance (QA) using these Good Practices. Only prod-ucts with good QA should be included in Good Clinical TrialPractice, GCTP (Chan and Zou, 2002). In Mainland China,since 1 June 2004 the government has already implementedguidelines for growing CMM with reference to the ‘Origin ofGrowth’ principles for over 70 medicinal plants in five ma-jor provinces. It is believed that with continuous monitoringthere will not be shortage of CMM for use and the stan-d orG MP;t CMt basep

4t

pec-t posi-t ighp lets Ra-m scop( MSa ofC suc-c con-v CMh mix-ti s int anda s theq offi a,1 lly-c (seeS

4.5. R&D of dosage forms for convenient and efficientdelivery of CMM and IPR

Most traditionally used herbal remedies including CMMproducts, when marketed as OTC remedies, do not havepatent (intellectual property, IP), but Trade Marks monopoly.Manufacturers who produce these products do not enjoy anymonopoly of producing them. Thus there are many brands ofthe same Fu-Fang ready-made products in the market withvarying quality, efficacy and safety (QES) problems. Thisdoes not help the image of herbal products at all. Withoutthe patent right in natural products not many pharmaceuti-cal companies would spend money to carry out R&D pro-grammes on them. This is more so for CMM products thathave been introduced for centuries. The popularity of usingCMM products in the early 1990s for the treatment of severeatopic eczema attracted tremendous attention and interest inthe use of CM herbs and CMM products in the West. OneBritish herbal manufacturer has taken on the patent right is-sues for this remedy and eventually obtained patents for thisand other herbal products (Chan et al., 1999). Yet in the ChinaMainland market there are many of the me-too products formany ancient Fu-Fang with variable quality. For example,Liu-Wei-Di-Huang Wan, that is good for nourishingYinandtonifyingKidney, is made by many manufacturers; some arew Al-l esec ereh formo rbss cap-s e for-m d by‘ form in-c uctsw

4the

d &Dp e un-d thea icinef rtantf

4C

s ex-t pan( ndq allyp thed ble,i er

ard of CMM supply will be improved. A domino effect food Practices will be resulted from GAP onwards to G

hen followed by GCTP for assessing the efficacy ofreatment using CMM products according to evidence-rotocols.

.4. Modern screening methodology and analyticalechnology for CMM

Over the past 40 years, chromatography and sroscopy have been used to study chemical comions of CM herbs. Using gas chromatography (GC), herformance liquid chromatography (HPLC), Ultra-viopectroscopy (UV), infra-red spectroscopy (IR/NIR),an spectroscopy, nuclear magnetic resonance spectro

NMR), mass spectroscopy (MS), X-ray diffraction, GC–nd HPLC–MS–MS, a lot of chemical compositionsM herbs have been isolated and identified. Theess of eventual launching new drugs using theseentional approaches has been very disappointing aserbs are mainly effective when used as composite

ures, generally known as Fu-Fang (Chan, 1995). Us-ng Chinese medicinal materials (CMM) as examplehis paper we can use modern biomedical techniquesdvance analytical technology to analyses and assesuality of CMM and natural products using conceptsngerprinting and pattern recognition (Chan et al., 1995995b) as important steps for QA of these chemicaomplex CMM and proprietary Chinese medicinescheme 1).

y

ell-known and some are small firms that copy others.egedly, nearly about 90% of the male public in the Chinommunity is taking this ancient OTC CM product. Thave been three stages of improvement for the dosagef the product, ranging from a big pill of all six crude hetored in wax to concentrated small pills and presentlyules containing concentrated extracts. Yet none of thesulations have their manufacturing processes protecte

Intellectual property Right’. Great potential is availableaking ‘trade mark’ or brand named-products in order to

rease the quality and efficacy of ready-made CMM prodith proper industrial monographs.

.5.1. The development of new dosage forms for CMMThe areas that I personally consider as important to

evelopment of patentable CMM products are to set up Rrogrammes on the new uses of Fu-Fang. Therefore, therstanding of principles behind the choice of CMM andppreciation of the need in the practice of orthodox med

or problematic diseases and disorders is extremely impoor selection of R&D programmes.

.5.2. The development of concentrated granules ofMM for CM prescription useThe development in using granules of dried aqueou

racts of CM herbs is very advanced in Taiwan and JaChan, 1996). Attention on research into efficacy, safety auality of these preparations compared with conventionrepared CM decoction should give future directions inevelopment of CM dosage forms. If results are favoura

t will be most convenient from patients’ viewpoint. Oth

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16 K. Chan / Journal of Ethnopharmacology 96 (2005) 1–18

advantages may include less risk of deterioration, simplifiedstorage and portability, elimination of the need to inspect rawherbs at the prescribing and dispensing stage, possible consis-tency of quality, ease of dispensing and administration, andfacilitation of clinical research. However major work requiredwill be to prove efficacy when compared with traditionallyprepared decoctions from composite prescriptions. Projectsbetween industrial partner and academic institutes have beenidentified and supported by the Chinese Academy for Sci-ence and Technology. The advantage of concentrated gran-ules from Fu-Fang decoctions can be identified as follows:

• Most convenient for use from patients’ viewpoint.• Less risk of deterioration.• Simplified storage and portability.• No inspection of raw herbs at the prescribing and dispens-

ing stage.• Possible consistency of quality.• Ease of dispensing and administration.• Facilitation of clinical research.

4.6. Open-mindedness between the practice of OM andCM for better healthcare

Using the Hong Kong situation as an example the well es-tablished degree in orthodox medicine (OM) was establishedi amep ch-i heg skep-t g ina n ofC thati atedo le-m dingp sted,h gula-t g theg CMp d to-w lesst aimsa an inl triald sibles pract

• out-andbe

l of

• undrs infer-

ent aspects of medical practice, can best be achieved bylaunching joint seminars, academic and professional meet-ings in order to build up the learning curves for collabora-tion.

• Educating the public on general healthcare issues shouldinclude both CM and OM aspects towards guidance oneffects and safety of dual treatments. This will eliminatethe misunderstanding and blame on either treatment whenadverse effects arise during treatment period.

• Academic and professional discussions can be focused onintegrating advantages and avoiding disadvantages of med-ical treatment and prevention of certain themes of illnessesas a mission for giving the best possible patient care. Suchexamples can be found from the well-known Kotzting Chi-nese medicine Hospital in Munich, Germany (Liao et al.,2002).

• With the common goal of assessing the efficacy of CMtreatment, whether through acupuncture or using CMMproducts, the setting up of evidence-based clinical studiesand control on quality, safety and efficacy of CM treatmentis a good opportunity for utilising open-mindedness.

• To achieve such evidence-based treatment studies, otherscientific professionals related to both CM an OM practiceswill be needed to support various aspects involving patientsmonitoring, outcome measurements. These professionals

ithuchgnisecane islsovideto be

• nta-willnte-rtinggressn be

• andld beistant

hesl ar-ncer

eliefoverughencannc-rents.

n the early 1911 in a private medical school that later becart of the University of Hong Kong. However the laun

ng of official training courses for CM in Hong Kong by tovernment was over 80 years later. Inevitably there are

icism and concerns from OM practitioners in Hong Konccepting CM practice into medical care. The situatioM practice in the Mainland and other regions such as

n Taiwan and Japan is quite different where the integrr parallel practice of CM and OM has been officially impented since the early 1950s. Concerns, misunderstanrotectionism, skepticism, and suspicions, though exiave been put aside by co-practice experience or via re

ory means throughout the past 50 years. In Hong Konovernment’s decision of regulating the qualification ofractitioners and quality of treatment products has helpeards the right direction for progress of CM. Neverthe

here is a need of open-mindedness in achieving thend objectives set up by the government’s 10 years pl

aunching CM as part of the healthcare and future indusevelopment. The followings can be discussed as posteps to achieve open-mindedness and respectable CMice.

Once the competence, quality and evidence-basedcomes of CM treatments have been demonstratedrecognised professionally and legally, there shouldenough opportunity to work towards the common goaquality service for patient care.Apart from the common Chinese cultural backgroshared between most of the OM and CM practitioneHong Kong initial understanding between the two dif

,

-

may include biomedical scientists who are familiar wboth disciplines, other paramedical supporting staff sas special nursing staff and pharmacists who can recoCM terminology as well as medications, experts whoauthenticate, identify and quantify crude CMM. Thera lack of such expertise not only in Hong Kong but ain other developed countries. Mainland China can prosome in-puts; however, their professionals may needre-orientated towards competitive overseas markets.Both CM and OM practice have their own documetion system for patient diagnosis and treatment. Itbe most valuable for future actions that if and when igrated medicine is being practised a generalised repoand documenting system can be derived such that proof treatment and adverse reactions or interactions carecorded.In desperate situations for the benefit of patient careprogress of medical science a concerted effort shoumade towards targeting chronic diseases that are resto OM with either integrated CM and OM approacor using CM to complement OM treatment. Severaeas can be identified. Treatment of certain types of cacan use CM composite herbal prescription in the rof side effects of cytotoxic drugs and helping to imprthe immuno-system that is weakened by cytotoxic dtreatment. In the prevention of bacterial resistance worthodox antibiotics are compromised CM decoctionbe co-administered. For myocardial infarction acuputure, or CM decoction with micro-circulation activities aused in conjunction with orthodox beta-blocking ageAll these and other examples have been cited.

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K. Chan / Journal of Ethnopharmacology 96 (2005) 1–18 17

All these collaborative approaches will need open-mindedness in clinical practice and biomedical research inorder to investigate the mechanisms behind how such in-tegrative treatment works. The consequence will be a newdirection for patient-care orientated development.

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macy

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