Kampo Medicine, Where should we go?

Transcription

1 ICMCM Conference 2011 Milestone of Chinese Medicine Development Kampo Medicine, Where should we go? ( 漢方薬 我們應走向何方?) Executive Director & General Manager Toshiki Okubo

2 Herbal Medicine Tug-of-War!?

3 We have a good relationship with our partner in China.

4 Today s Topics 1. What is Kampo Medicine? The first began in the culture exchange. 2. Rethinking Kampo medicine Side effects of Xiao-Chaihu-Tang ( 小柴胡湯 ) 3. A Long Way Needs Us to walk? We share the same goal, however, 4. Kracie s business. In the field of traditional medicine, and

5 1. What is Kampo Medicine? Before introducing Kampo medicine, let s flash back to the history of culture exchange between Japan and China. Through the history, we could get a hint of how to promote and step up traditional medicine modernization and globalization. Han 漢 Sui, Tang, Song 隋 唐 宋 Shanghan Lun Jingkui Yaolue 傷寒論 金匱要略 Introduction Jin-Yuan Four major Schools ( 金元四大家 ) Development & Creation KOHOHA( ( 古方派 ) GOSEIHA( ( 後世派 )

6 SHOSOIN ( 正倉院 ), the ancient repository for an 8 th century herb collections from China Magolia Bark ( 厚朴 ) Cinnamon Bark ( 桂皮 ) Gardenia Fruit ( 山梔子 )

7 Ancient Chinese medicines began to be called Kampo medicines in 18 th century! Western medicine was introduced into Japan by the Portuguese around 1590, and then Japanese leadership adopted a policy of national isolation ion soon after the Portuguese and Spanish incursion. However, the trade and interchanges with the Dutch was just allowed in As a result, Dutch physicians and medical works were introduced d in Japan. Thus, the term Rampo ( 蘭方 ), meaning Holland method which was used to describe the Dutch medicine. On the other hand, ancient Chinese medicines was therefore called Kampo ( 漢方 )because it came from ancient China Han Dynasty( 漢代 ). Meji-Restoration ( 明治維新 ) Meji governments repressed traditional culture 15-18th 19 th Mid-20 th early Western medicines Kampo medicines Decline of Kampo medicines Rise of Western medicines

8 Kampo medicines is in the limelight again in post-war II economic boom! The establishment of the Japan society for oriental medicine (JSOM) in 1950, marks the arrival of traditional medicines new era. And with rapid economic growing, more and more people began to recognize the importance of self medication, and side effects of Western medicines ines also have more people paid attentions to traditional medicines again. Under these backgrounds, Kampo medicines were officially integrated into modern healthcare system in Japan and national health insurance available s The Japan Society for Oriental Medicine (JSOM) established. 210 Kampo formulae as Over-the-Counter (OTC) drugs. 82 Kampo formulae as prescription drugs About new 50 Kampo formulae are added to OTC kampo.

9 From 1980 s to 1990 s is the growing period of Kampo Medicine. millions of JPY Xiao-Chai-Hu-Tang( 小柴胡湯 ) Shock 200, ,000 Total Ethical (prescription drugs) OTC (non-prescription drugs) 120,000 80,000 40,

10 Top 10 in 1992 Total Production Value of Kampo Preparations: JP Xiao-Chai-Hu-Tang 小柴胡湯 Bu-Zhong-Yi-Qi-Tang 補中益気湯 Ba-Wei-Di-Huang-Wan 八味地黄丸 70 billion Jia-Wei-Xiao-Yao-San Xiao-Qing-Long-Tang 加味逍遥散小青竜湯 Da-Chai-Hu-Tang 大柴胡湯 Dang-Gui-Shao-Yao-San 当帰芍薬散 160 billion Chai-Hu-Gui-Zhi-Tang 柴胡桂枝湯 Gui-Zhi-Fu-Ling-Wan 桂枝茯苓丸 Ge-Gen-Tang 葛根湯

11 2. Rethinking Kampo Medicine since Xiao-Chaihu-Tang( 小柴胡湯 ) s Shock The Xiao-Chaihu Chaihu-Tang-induced side effects of interstitial pneumonia were reported largely by mass media in Japan and attracted more attentions tions to the safety & quality of Kampo medicine. Moreover, the effective evidence of Kampo medicine was also asked. Therefore, 1) How to keep the quality equal and stable is a very important task; 2) Drug information and education for doctor and pharmacist appears ars to be more important. Good information and education will help clinical doctors use correctly Kampo medicine. 3) The most important while the most difficult is how to verify the efficacy of Kampo medicine. Kampo Medicine Equality Safety Efficacy 1. Quality Control 2. Information & Education 3. Reevaluation

12 2.1. History of Kampo Quality Control in Manufacture 1970 s Kampo prepraration, maily granules were launched into market Government-driven research on QC of Kampo medicine started Published a notification on how to build QC in manufacture. The concept Standard decoction ( 標準湯剤 ) was presented out, and at least 2-3 chemical constituents asked to use as chemical makers for controlling the quality of Kampo preparations in manufacture Self-imposed GMP Guidelines for ethical Kampo preparations. Self-imposed GMP Guidelines for OTC Kampo preparations National Quality standard for 6 Kampo extracts was built for the first time. Six Kampo formulae extracts Listed in the Japanese Pharmacopoeia (XV) for the First Time.

13 Cutting-edged manufacture equipments, technology & software control system used in Kampo manufacture

14 Kinds of OTC Kampo Preparations Others, 5.1% Tablets, 55.7% Granules, 39.2% Cited from Fuji-Keizai Market Survey (2007)

15 National Quality Standard for Kampo Fromula Extracts are released for the first time in (JP15 th ) Supplement I (2) Supplement II (3) 2011 (JP16 th ) 1. Ge-Gen-Tang Extract 2. Chai-Ling-Tang Extract 3. Jia-Wei-Xiao-Yao-San Extract 4. Bu-Zhong-Yi-Qi-Tang Extract 5. Ling-Gui-Zhu-Gan-Tang Extract 6. Da-Huang-Gan-Cao-Tang Extract 7. Gui-Zhi-Fu-Ling-Wan Extract 8. Ban-Xia-Hou-Pe-Tang Extract 9. Ba-Wei-Di-Huang-Wan Extract 10. Niu-Che-Shen-Qi-Wan Extract 11. Zhen-Wu-Tang Extract 葛根湯柴苓湯加味逍遥散補中益気湯苓桂朮甘湯大黄甘草湯桂枝茯苓丸半夏厚朴湯八味地黄丸牛車腎気湯真武湯 Other 11 Total 22 Total 30 kinds of Kampo formulae are planed to be listed in JP

16 2.2. Promoting Research & Education Governments Universities & Institutes Kampo Medicine Academic Organizations Industries

17 Registration & Certification Systems for Kampo Specialists (Doctor & Pharmacist) The Japanese Society of Oriental Medicine Since 1990 Since people (2008) The Japan Pharmacists Education Center The Japanese Society of Pharmacognosy Since 2000 Since people (2008)

18 Academic Publications & Magazines on Kampo Medicine

19 2.3. Efficacy Reevaluation of Kampo Medicine 1990 A Working Group was established. ----for studying the Clinical Evaluation Method of Kampo Preparations 1991 Eight Kampo Formulae were specified for reevaluation by Health Ministry. Xiao-Chai-Hu-Tang 小柴胡湯 Shao-Yao-Gan-Cao-Tang 芍薬甘草湯 Xia-Qing-Long-Tang 小青竜湯 Huang-Lian-Jie-Du-Tang 黄連解毒湯 Da-Huang-Gan-Cao-Tang 大黄甘草湯 Gui-Zhi-Jia-Sho-Yao-Tang 桂枝加芍薬湯 Liu-Jun-Zi-Tang 六君子湯 Bai-Hu-Jia-Ren-Sheng-Tang 白虎加人参湯 1997 Three Kampo Formulae verified as effective for the indication specified. Xiao-Chai-Hu-Tang Xia-Qing-Long-Tang Da-Huang-Gan-Cao-Tang 小柴胡湯 小青竜湯 大黄甘草湯 Chronic hepatitis Allergic rhinitis Constipation 1998 To establish an original evaluation method is necessary?!

20 Evidence-based medicine (EBM) is everything? Evidence level Meta-analysis Double blind-rct (DB-RCT) Randomized control trial (RCT) Case control study Case series Case report

21 An Effort to promote evidence-based medicine (EBM) in Kampo

22 NBM may make for Kampo understanding! As while we are making hard effort to promote and disseminate EBM M in traditional medicine by means of modern scientific means, the approach called narrative- based medicine (NBM) is in limelight again in traditional medicine study. Because NBM approach is similar to four examination ( 四診 ) methods such as inspection & listening ( 望 ), smelling ( 聞 ), questioning ( 問 ) and palpation ( 切 ) in ancient Chinese medicine. EBM (Evidence-based Medicine) Meta-analysis NBM (Narrative-based Medicine) Narrative

23 3. A Long Way Needs Us to Walk? International standardization Multi-nation, multi-region cooperation Multi-discipline, cross-discipline cooperation New approaches Database, evidence

24 4. Kracie s Business

25 Promotion video (4 41 )

26 Thank you for your kind attention! 感謝各位的耐心聆聴!