Executive Director & General Manager

ToshikiToshiki OkuboOkubo

KampoKampo Medicine, Where should we go?Medicine, Where should we go?

““Milestone of Chinese Medicine DevelopmentMilestone of Chinese Medicine Development””ICMCM Conference 2011ICMCM Conference 2011

（漢方薬、我們應走向何方？）

“Herbal Medicine Tug-of-War”!?

We have a good relationship with our partner in China.

Today’s Topics

1. What is Kampo Medicine?

3. A Long Way Needs Us to walk ?

2. Rethinking Kampo medicineSide effects of Xiao-Chaihu-Tang ((小柴胡湯小柴胡湯））

The first began in the culture exchange.

We share the same goal, however,…

4. Kracie’s business.In the field of traditional medicine, and…

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.

1. What is Kampo Medicine?

IntroductionIntroduction Development & CreationDevelopment & Creation

“Shanghan Lun” “Jingkui Yaolue”「傷寒論」「金匱要略」

“Jin-Yuan Four major Schools”（金元四大家）

Sui, Tang, Song隋、唐、宋

Han漢

KOHOHAKOHOHA（古方派）（古方派）GOSEIHAGOSEIHA（後世派）（後世派）

Cinnamon Bark （桂皮）

SHOSOIN (正倉院）, the ancient repository for an 8th century herb collections from China

Magolia Bark (厚朴 ) Gardenia Fruit (山梔子)

Ancient Chinese medicines began to be called “Kampo medicines” in 18th century!

Decline of Decline of KampoKampo medicinesmedicines

15-18th

Western medicine was introduced into Japan by the Portuguese aroWestern medicine was introduced into Japan by the Portuguese around 1590, und 1590, and then Japanese leadership adopted a policy of national isolatand then Japanese leadership adopted a policy of national isolation soon after theion soon after thePortuguese and Spanish incursion. However, the trade and interchPortuguese and Spanish incursion. However, the trade and interchanges with the anges with the Dutch was just allowed in 1639. Dutch was just allowed in 1639. As a result, Dutch physicians and medical works were introduceAs a result, Dutch physicians and medical works were introduced in Japan. Thus, d in Japan. Thus,

the term the term RampoRampo ((蘭方蘭方) , meaning ) , meaning ““Holland methodHolland method”” which was used to describe which was used to describe the Dutch medicine. On the other hand, ancient Chinese medicinesthe Dutch medicine. On the other hand, ancient Chinese medicines was thereforewas thereforecalled called KampoKampo ((漢方漢方））because it came from ancient China Han Dynastybecause it came from ancient China Han Dynasty（（漢代漢代). ).

KampoKampo medicinesmedicinesWestern medicinesWestern medicines

19th Mid-20th early

MejiMeji--RestorationRestoration((明治維新）明治維新）

MejiMeji governments repressed traditional culturegovernments repressed traditional culture……

Rise of Rise of WesternWestern medicinesmedicines

Kampo medicinesis in the limelight again in post-war II economic boom!

1950 1970’s

The Japan Society for Oriental Medicine (JSOM) established.1950…

210 Kampo formulae as Over-the-Counter (OTC) drugs.

82 Kampo formulae as prescription drugs.

1975…

1976…

The establishment of the Japan society for oriental medicine (JSThe establishment of the Japan society for oriental medicine (JSOM) in 1950, OM) in 1950, marks the arrival of traditional medicinesmarks the arrival of traditional medicines’’ new era. new era. And with rapid economic growing, more and more people began toAnd with rapid economic growing, more and more people began to recognize the recognize the

importance of self medication, and side effects of Western medicimportance of self medication, and side effects of Western medicines also have ines also have more people paid attentions to traditional medicines again. more people paid attentions to traditional medicines again.

Under these backgrounds, Under these backgrounds, KampoKampo medicines were officially integrated into medicines were officially integrated into modern healthcare system in Japan and national health insurance modern healthcare system in Japan and national health insurance available.available.

About new 50 Kampo formulae are added to OTC kampo.2011.4…

From 1980’s to 1990’s is the growing period of Kampo Medicine.

76

40,000

80,000

120,000

160,000

200,000

77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 00

TotalEthical (prescription drugs)OTC (non-prescription drugs)

Xiao-Chai-Hu-Tang（小柴胡湯）’ Shockmillions of JPY ¥

Top 10 in 1992

葛根湯Ge-Gen-Tang2.0

桂枝茯苓丸Gui-Zhi-Fu-Ling-Wan2.2

柴胡桂枝湯Chai-Hu-Gui-Zhi-Tang2.3

当帰芍薬散Dang-Gui-Shao-Yao-San2.5

大柴胡湯Da-Chai-Hu-Tang2.6

小青竜湯Xiao-Qing-Long-Tang2.8

加味逍遥散Jia-Wei-Xiao-Yao-San3.7

八味地黄丸Ba-Wei-Di-Huang-Wan4.4

補中益気湯Bu-Zhong-Yi-Qi-Tang4.7

小柴胡湯Xiao-Chai-Hu-Tang44.0

¥ 160 billion

¥ 70 billion

Total Production Value of Kampo Preparations: ¥ JP

12

345

67

8910

2. Rethinking Kampo Medicine since Xiao-Chaihu-Tang（小柴胡湯）’ s Shock

1. Quality Control 3. Reevaluation

Safety

Kampo Medicine

EfficacyEquality

2. Information & Education

The XiaoThe Xiao--ChaihuChaihu--TangTang--induced side effects of interstitial pneumonia were induced side effects of interstitial pneumonia were reported largely by mass media in Japan and attracted more attenreported largely by mass media in Japan and attracted more attentions to the tions to the safety & quality of safety & quality of KampoKampo medicine. Moreover, the effective evidence of medicine. Moreover, the effective evidence of KampoKampomedicine was also asked. Therefore, medicine was also asked. Therefore,

1) How to keep the quality equal and stable is a very important 1) How to keep the quality equal and stable is a very important task;task;2) Drug information and education for doctor and pharmacist appe2) Drug information and education for doctor and pharmacist appears to be more ars to be more

important. Good information and education will help clinicalimportant. Good information and education will help clinical doctors use doctors use correctly correctly KampoKampo medicine. medicine.

3) The most important while the most difficult is how to verify 3) The most important while the most difficult is how to verify the efficacy of the efficacy of KampoKampo medicine.medicine.

2.1. History of Kampo Quality Control in Manufacture

Kampo prepraration, maily granules were launched into market.1970’s…

1993…

Self-imposed GMP Guidelines for ethical Kampo preparations.

2006…

Self-imposed GMP Guidelines for OTC Kampo preparations.

1980-84… Government-driven research on QC of Kampo medicine started.

1985.5… 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.

1988…

Six Kampo formulae extracts Listed in the Japanese Pharmacopoeia (XV) for the First Time.

National Quality standard for 6 Kampo extracts was built for the first time.

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

Kinds of OTC Kampo Preparations

Cited from Fuji-Keizai Market Survey (2007)

Granules, 39.2%Tablets, 55.7%

Others, 5.1%

National Quality Standard for Kampo Fromula Extractsare released for the first time in 2006.

真武湯11. Zhen-Wu-Tang Extract

半夏厚朴湯8. Ban-Xia-Hou-Pe-Tang Extract

桂枝茯苓丸7. Gui-Zhi-Fu-Ling-Wan Extract

牛車腎気湯10. Niu-Che-Shen-Qi-Wan Extract

八味地黄丸9. Ba-Wei-Di-Huang-Wan Extract

大黄甘草湯6. Da-Huang-Gan-Cao-Tang Extract

苓桂朮甘湯5. Ling-Gui-Zhu-Gan-Tang Extract

補中益気湯4. Bu-Zhong-Yi-Qi-Tang Extract

加味逍遥散3. Jia-Wei-Xiao-Yao-San Extract

柴苓湯2. Chai-Ling-Tang Extract

葛根湯1. Ge-Gen-Tang Extract

2006 (JP15th)

Supplement I (2)

Supplement II (3)

Total 30 kinds of Kampo formulae are planed to be listed in JP

2011 (JP16th) ・・・

Other 11

Total 22

2.2. Promoting Research & Education

Kampo Medicine

Industries

Governments

Universities & Institutes Academic Organizations

Registration & Certification Systems for Kampo Specialists (Doctor & Pharmacist)

The Japan Pharmacists Education CenterThe Japanese Society of Pharmacognosy

The Japanese Society of Oriental MedicineSince 1990Since 1990

Since 2000 Since 2000

2755 people (2008)

1548 people (2008)

Academic Publications & Magazineson Kampo Medicine

2.3. Efficacy Reevaluation of Kampo Medicine

1990… A Working Group was established.----for studying the Clinical Evaluation Method of Kampo Preparations

1997…

1991… Eight Kampo Formulae were specified for reevaluation by Health Ministry.

白虎加人参湯Bai-Hu-Jia-Ren-Sheng-Tang六君子湯Liu-Jun-Zi-Tang桂枝加芍薬湯Gui-Zhi-Jia-Sho-Yao-Tang大黄甘草湯Da-Huang-Gan-Cao-Tang黄連解毒湯Huang-Lian-Jie-Du-Tang小青竜湯Xia-Qing-Long-Tang芍薬甘草湯Shao-Yao-Gan-Cao-Tang小柴胡湯Xiao-Chai-Hu-Tang

Three Kampo Formulae verified as effective for the indication specified.

大黄甘草湯

小青竜湯

小柴胡湯

ConstipationDa-Huang-Gan-Cao-Tang

Allergic rhinitisXia-Qing-Long-Tang

Chronic hepatitisXiao-Chai-Hu-Tang

1998… To establish an original evaluation method is necessary?!

Evidence-based medicine (EBM) is everything?

Case report

Case series

Case control study

Randomized control trial (RCT)

Double blind-RCT (DB-RCT)

Meta-analysis

Evidence le

vel

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

http://www.jsom.or.jp/medical/ebm/ere/index.html

EBM(Evidence-based Medicine)

EBM(Evidence-based Medicine)

NBM(Narrative-based Medicine)

NBM(Narrative-based Medicine)

NBM may make for Kampo understanding!

As while we are making hard effort to promote and disseminate EBAs while we are making hard effort to promote and disseminate EBM in traditional M in traditional medicine by means of modern scientific means, the approach callemedicine by means of modern scientific means, the approach called d narrativenarrative--based medicine (NBM)based medicine (NBM) is in limelight again in traditional medicine study.is in limelight again in traditional medicine study.

Because NBM approach is similar to Because NBM approach is similar to ““four examination (four examination (四診四診))”” methods such as methods such as inspection & listeninginspection & listening ((望望), ), smellingsmelling ((聞聞), ), questioningquestioning ((問問) and ) and palpationpalpation ((切切) in ) in ancient Chinese medicine. ancient Chinese medicine.

Meta-analysis Narrative

International standardization

3. A Long Way Needs Us to Walk ?3. A Long Way Needs Us to Walk ?

Database, evidence

New approaches

Multi-discipline, cross-discipline cooperation

Multi-nation, multi-region cooperation

4. Kracie’s Business

Promotion video (4’41”)

Thank you for your kind attention!Thank you for your kind attention!

感謝各位的耐心聆聴！感謝各位的耐心聆聴！感謝各位的耐心聆聴！