JAM 2005,1,16-26

16Special Contribution

Report on the 1 st Japan-Korea Workshop on Acupuncture and EBM-Proposal of Clinical Trials for the Future Japan-Korea CollaborationKAWAKITA Kenji (Director of Research Division, JSAM) 1）,
JANG Jun-hyouk (Director of International Affairs, KAMS) 2）,
TAKAHASHI Norihito 1）, NABETA Tomoyuki 1）,
TSUKAYAMA Hiroshi 1）, SEO Jung-chul 2）, LEE Sang-hoon 2）,
MOON Sang-kwan 3）, TSUTANI Kiichiro 1）, TANZAWA Shohachi 1）1）The Japan Society of Acupuncture and Moxibustion (JSAM)
2）Korean Acupuncture and Moxibustion Society (KAMS)
3）Korean Oriental Medical Society (KOMS)

Abstract
The first Japan-Korea workshop on acupuncture and EBM was held on June 4, 2004 at Chiba in the 53 rd
annual scientific meeting of the JSAM. The purpose of this workshop was to exchange the experiences ofclinical researches on acupuncture and moxibustion therapies, and to find out the issues and their solutions fordeveloping the excellent clinical research to establish strong evidence. The final purpose was to develop a
protocol for the collaborative work between both countries.
Drs. Kawakita (JSAM) and Jang (KAMS) chaired the workshop. Three speakers from Japan (Drs Takahashi,
Nabeta , and Tsukayama) and three Korean speakers (Drs Seo, Lee and Moon) presented their data on theclinical researches of acupuncture, moxibustion and bee-venom injection. After their paper presentations,various issues were discussed on their research methodology for establishing more strong evidence ofacupuncture. We got interesting new findings and understood various issues for conducting clinical researches
especially RCT.
Although we could not develop a protocol for the collaborative research in this workshop, it was very
fruitful workshop as the first step for the future Japan-Korea collaborative clinical study. The most important
product of this workshop was we could understand each other and we confirmed the necessity of the futurecollaborative clinical research on acupuncture.
Key words: Japan-Korea Workshop, EBM (evidence-based medicine), acupuncture and moxibustion, electroacupuncture, RCT (randomized controlled trial), sham acupuncture, bee venom injection, protocol
Ⅰ．Background of this workshop
Japan and the Republic of Korea have graduallydeveloped their own legislative and educational
systems on acupuncture and moxibustion. Little
information, however, has been exchanged between
two countries. Rapid increase of information andpersonnel exchange in various fields between two
countries, after World Cup Game in 2002, inparticular, has promoted the information exchanges
in the field of acupuncture and moxibustion.
Formal letter from Dr. Won-Chul Lee, thenPresident of Korean Oriental Medical Society(KOMS) was sent to Dr. Shohachi Tanzawa, thenCorresponding author Kawakita Kenji
Meiji University of Oriental Medicine, Hiyoshi-cho, Funai-gun, Kyoto 629-0392, Japan
E-mail: k_kawakita@meiji-u.ac.jp

KAWAKITA Kenji, et al

President of Japan Society of Acupuncture andMoxibustion (JSAM) in June 2002. Since thenseveral activities was conducted between two
countries1) . On 6 June 2003, Preparatory Meetingof "Japan-Korea Workshop on Acupuncture andEBM" was held in conjunction with 52 nd Annual
Conference of JSAM at Takamatsu. Simultaneously,
to encourage joint activities, a memorandum of understanding (MOU) among JSAM, the Korean
Acupuncture and Moxibustion Society (KAMS) and
KOMS was developed and formally singed on 14
February 2004 at Seoul2) . Based on such numerous
efforts of the JSAM, KAMS and KOMS members,
the first Japan-Korea workshop on acupuncture and
EBM was held at Chiba on 11 June 2004.

17

Ⅱ．Purpose of this workshop
As the first step of the Japan-Korea collaborationof clinical trials in the future, this workshop wasplanned firstly to exchange the experiences ofclinical researches on acupuncture and moxibustion
therapies, and secondly to find out the issues andtheir solutions for developing an excellent clinicalresearch for the strong evidence. The final purpose
was to develop a protocol for the collaborative
work but it might be premature to discuss at thisstage, however these three purposes were scheduled
then the workshop was started

Table 1． List of speakers and titles of their presentations
Speaker

Organization Title of Paper

1

Takahashi N

JSAM

Results obtained from multi-center RCTs on the common cold and issues to be solved.

2

Seo J-CKAMS

Is it possible to apply placebo auricul acupuncture to Korean? -The effect of placebo
auricular acupuncture through single-blind method and randomized controlled trial

3

Nabeta T

JSAM

Results obtained from RCT of acupuncture on the shoulder stiffness and issued to besolved.

4

Lee S-H

KAMS

Randomized controlled double blind study of bee-venom therapy on rheumatoid arthritis

5

Tsukayama H

JSAM

An experience in conducting multi-center RCT of electro-acupuncture on the low backpain and issues to be solved.

6

Moon S-K

KOMS

Antispastic effect of electro-acupuncture and moxibustion in stroke patients

Figure 1. Survival analysis of the results of acupuncture on the CCD data.
Kaplan Meier test was done. CCD (common cold diary; digital data was available, yes or no).

KAWAKITA Kenji, et al

18

Table 2.

Summary of the results of GLM analysis
CCD

CCQ

centerCox(preventive)

Cox(curative)

GLM
GLM
GLM
（whole period） （treatment period） （sex）

GLM(whole period)

note

A

n.s.

n.s.

P=0.198
Sex*day：P=0.022

P=0.053
inversionm＞f

P=0.035

ACP＜cont

B

P=0.0705

P=0.0097

P=0.001
sex：P=0.021

P=0.010m＞fP<0.001

ACP＞contCn.s.

P=0.0059

P=0.360

P=0.071m＞f

P=0.029

ACP＞cont

D

n.s.

n.s.

P=0.945

P=0.907
Sex*day：P=0.007

m＞f

P=0.643

n.s.

E

n.s.

n.s.

P=0.644
Sex*day：P=0.000

m＞f

P=0.218

n.s.

Ⅲ．The contents of workshop: presentation of
papers from Japan and Korea.
The first Japan-Korea workshop on acupunctureand EBM was held at Chiba conference hall on 11
June, 2004. Over 20 members of the KAMS and
KOMS also joined to the workshop. For
convenience of the Japanese members of JSAM
and students of acupuncture schools, slides for thepresentation were prepared in English and Japanese.
They were simultaneously presented on the screen.
List of speakers and titles are summarized in Table
1.
Topics of the 1 st paper and raised issues
Dr. Takahashi reported summary of a series of
RCTs conducted by the EBM working-group of theresearch department of JSAM. The purpose of thisstudy was to evaluate the effectiveness ofacupuncture on the common cold symptoms. The
main outcome measure was the symptoms ofcommon cold questionnaire. Intervention was
manual needling to the throat with de-chi. Nontreatment group was set as the control.
Figure 1 shows the effect of acupuncture oncommon cold dialy (CCD) by Kaplan- Meieranalysis, and more survivals exist in theacupuncture group during treatment period (14days). Table 2 shows the summary of results ofacupuncture manipulation on the common cold
questionnaire (CCQ). A significant acupuncture
effects on CCQ was obtained by GLM (generallinear model) analysis, however there were alsosignificant inter-center and sex differences.
The results of multi-ceter RCT of the indirectmoxibustion to the neck or subcutaneous needlingas more regulated interventions than the needle manipulation. The results did not clearly show the effectiveness of these interventions.
Several issues were pointed out. The subjects were
the students of the acupuncture schools, and thecontrol group was no-treatment. A significant intercenter difference of effectiveness was also apparent.
Based on these experiences of the multi-center
RCT, application of n-of-1 trials on the acupuncture
research was proposed as a useful individualized
experimental design.
It is worth considering for the future experimental
design for the patient-oriented and order-madeacupuncture therapy (see ref 9).
Topics of the 2 nd paper and raised issues solved.
Dr. Seo reported on the issue on the placebo intervention for the acupuncture RCT. The placebo
needle he developed was a blunt tip with shortlength, which could not be penetrated into the skin.
The random allocation was well planned andperformed, and the sensations elicited by auricularneedling by the real and placebo needle weresimilar. The warmth, fullness, pain, activity andradiating sensations were provoked, however theincidence was less in the placebo group (Figure 2).
Discrimination of real and placebo needle was statistically significant, that is, placebo needle did notwork well (Table 3).
On the other hand, he suggested that theKAWAKITA Kenji, et al

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Figure 2. Comparison of acupuncture sensations elicited by real and placebo needle.

Table 3.

Ability to differentiate real and placebo acupunctureRealacupuncture

Placeboacupuncture

Total

Thinking it as the real

26

10

36

Thinking it as the placebo

10

26

36

uncertain

12

12

24

Total

48

48

96

(P=0.0008, chi-square test)

Table 4. Ability to differentiate real and placebo acupuncture for naiveand experienced acupuncture recipients
Correct

Incorrect

Uncertain

Total

Naive

9

6

8

23

Experienced

17

4

4

25

Total

26

10

12
(P=0.128,48
chi-square test)

KAWAKITA Kenji, et al

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Figure 3. Suppression of VAS of the neck and shoulder pain by repetitive acupuncture treatment in volunteers.
VAS: visual analogue scale

Table 5.

Assessment of blinding answers to the question "How did you feel when
the acupuncture needle was inserted?" in acupuncture (AG) and sham (SG) groups.
Inserted to muscle

not penetrated skin

Could not discriminate

AG

11

4

2

SG

9

6

2

No significant difference between AG and SG was found (chi-square=0.6, P=0.74)

experiences of acupuncture therapy affect on thediscrimination of the real and placebo. Table 4shows that the experienced group detected the real
one more accurately than those of acupuncturenaive patients, although the difference was not
significant.
Based on the literatures of placebo research in theforeign countries, he also pointed out a possibilityof the racial difference. These results were
important to select the placebo intervention andsubjects in acupuncture research. Expression of theplacebo needle was a matter of discussion as shamintervention has been more common term as thetrue placebo acupuncture is impossible theoretically.

Topics of the 3 rd paper and raised issues solved.
Dr. Nabeta reported the RCT conducted on thestudent volunteers who have complaint of pain andstiffness in the neck and shoulder. Repetitive
application of manual acupuncture, inserted to themuscle and sparrow pecking technique used, to thetender points of neck and back once in a week for
3 weeks produced cumulative effects as shown in
Figure 3. In the previous trials, the minimum
acupuncture was shown to be inadequate as control
intervention as it actually worked. Then uniquesham acupuncture was considered and statisticallysignificant effects were detected compared with thebaseline but not between the groups.
The procedure of gesture of needling was

KAWAKITA Kenji, et al

21

Figure 4. Effects of bee venom injection on pain and HAQ of the arthritis patients
HAQ: health assessment questionnaire

Figure 5. Effects of bee venom injection on ESR and CRP of the arthritis patients
ESR: erythrocyte sedimentation rate CRP: C-reactive protein.

successfully blinded as shown in Table 5, however
it was pointed out that these sham procedure wasapplicable only on the back where the subjects
could not see. The subjects of this RCT werestudent volunteers in Japanese acupuncture school
and they were familiar with acupuncture sensations,so the success of masking by the present shamprocedure is meaningful. However, the volunteer
bias was an important factor, so the results should
be analyzed and discussed carefully. Importance ofthe selection of adequate stimulating points (tender

point) was also stressed.
Topics of the 4 th paper and raised issues solved.
Dr. Lee reported a clear effect of BVI (beevenom injection) on the patients of rheumatoid
arthritis. BVI was applied to the acupuncture points
nearby the major joints (twice a week for 8
weeks), and control intervention was saline
injection to the same points. Random allocation
was sufficiently done, and the results clearly

KAWAKITA Kenji, et al22

indicated that the BVI improved the tender joint
count, swollen joint count, morning stiffness, pain(VAS), HAQ, ESR and CRP. The effects of BVI
on VAS and HAQ were shown in Figure 4. Thoseof ESR and CRP values in laboratory examinations
were summarized in Figure 5. The effects increased
with time of treatments, so it was very interesting
to know the after-effects of the BVI.
The procedure was shown to be very useful forthe arthritis patients, however, it is not applicablein Japan. Japanese acupuncturists are not allowed touse the drug injection for their treatment. This wasa big difference in the acupuncture related medical
system between Japanese and Korea.

Table 6.

Topics of the 5 th paper and raised issues solved.
Dr. Tsukayama introduced conducting process ofthe first multi-center randomized controlled trial(RCT) of acupuncture for lumbago in Japansupported by "Foundation for Training and
LicensureExaminationIn
Anma-MassageAcupressure, Acupuncture and Moxibustion" Thestudies were planned as a model case of multicenter acupuncture RCT in Japan by theFoundation and were performed at clinical facilitiesin 4 universities or colleges in Japan from 1995
until 1999. The studies consisted of two trials. The
trial I (1995-1996) failed to conduct uniform multicenter RCT. The protocol was implemented into

Requirement for conducting multi-center trial

・Clear concepts which are really accepted and shared by all of the working group member
are needed in acupuncture multi-center trial.
・ Top-down model need powerful leadership, clear strategy and incentive forresearchers.
・Training of clinical trial is needed.
・Spontaneous commitment to study group is desirable.
・Conducting RCT need a lot of cost.
・Financial support is needed to conduct multi-center RCT in multi-disciplinary collaboration
・Multidisciplinary collaboration is recommended
・Clinical trial expert
・Clinical medicine expert
・Bio-statistics expert
・Acupuncture researcher
・Clear definition of the role and responsibility of each working group member were neededin multi-center trial

Table 7. Requirement for conducting multi-center trial
・Concept of quality control is useful in multi-center trial
・Monitoring for allocation, research setting and implementation process in each institutions (monitor)
・Trial coordination in each institution (coordinator)
・Data management (data manager)
・Concealed allocation (independent controller)
・Requirement in trial design-Appropriate acupuncture procedure should be based on・Pre-existing evidence
・Review of standard texts
・Research of usual practice in reality-Outcome measurements should be validated in each language
・Difficulty of patient recruitment from outpatient of acupuncture clinic has not been solved
in Japan.
・Collaborations with conventional medical system
・Advertising of patients recruitment
・Consideration for the ethical issue
・An approval from ethical committee

KAWAKITA Kenji, et al

Figure 6. Changes of MAS after the first treatments
MAS: modified Ashworth scale
EA: additive specific electro-acupuncture to specific points for spasticity.
Mox: additive moxibustion to specific points for spasticity.
control: routine acupuncture treatment

Figure 7. Changes of MAS according to treatment period
See Fig. 6 for abbreviations

Table 8. Issues to be solved for the future collaboration of Japan-Korea clinical research
1. Validity of RCT for Future Study
2. Methods of Random Allocation
3. Selection of Control Intervention
4. Necessity of Placebo or Sham Interventions
5. Selection of Outcome （Subjective, Objective）
6. Calculation of Sample Size
7. Like-hood of Multi-Center RCT in Japan and Korea
8. Difference of Medical System between Japan and Korea
9. Choice of Target Disease for the Future Study
10. Financial Support

23

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KAWAKITA Kenji, et al

different procedure by each institution and thenumber of subject recruited did not reach thetarget.
In the trial II (1996-1999), the Foundation asked
the trial expert to lead the study process. The
concept of quality management on RCT was
introduced into the trial II, and the role and responsibility of each working group member had beenclearly defined. These attempts led the trial successfully and a uniform multi-center RCT was able
to be conducted among institutions. Electroacupuncture was examined and control intervention
chosen was real TENS in the trial II. Both interventions were applied twice a week for 2 weeks (4treatments). Subjective pain intensity tended todecrease with time by both interventions, and nodifference was detected between the groups. Basedon the experiences of multi-center RCT on
lumbago, he proposed several issues for the future
clinical research (Table 6,7)
The clear concepts in management and specificpurpose of RCT are required and those should bewell-understood by all the members participated in
the project. Regarding the intervention, appropriate
acupuncture procedure should be chosen based on
the pre-existing evidence, review of standard
textbooks and usual practical reality. Patient
recruitment and setting of the entry criteria,
resolution of ethical issues and financial support arealso important. These issues were pragmaticallyvery important for the future collaborative activitiesof acupuncture research.
Topics of the 6 th paper and raised issues solved.
The last speaker was Dr. Moon. He showed clear
results of anti-spastic effect of acupuncture on the
stroke patients. He compared the effects of additive
EA, additive moxibustion for the spasticity androutine acupuncture treatment for the stroke.
Routine acupuncture was used as the control intervention. Both specific treatments were done every
two days (8 times during 15 days). Results werevery clear. Immediately after the EA the MAS(modified Ashworth scale) value was improved
only in the additive EA group significantly (Figure6), and the effect of additive EA group continued
and the best improvement was obtained at the endof treatment session (Figure 7).
The control setting is very important issue ofdesign of a protocol. In his study, the routine
acupuncture treatment was chosen as the control

intervention, and it actually worked as control intervention (no-effect produced). It is very reasonable
control intervention for the patients' benefit in theclinical trials. Comparison of routine treatment andthe additive specific acupuncture therapy may begood choice in the future clinical trials.
Ⅳ．General discussion
In Table 8, ten items were listed for the general
discussion. During the presentation of papers, someitems were referred by the speakers and discussed
among the participants.
Regarding the research design, all presenters
employed the RCT as the best design for obtaining
strong evidence. On the other hand, Dr. Takahashi
pointed out the necessity of n-of-1 clinical trial as
individualized intervention is essentially important
for acupuncture research. In the multi-center RCT
on the common cold, he found a significant intercenter difference. A uniformed intervention in eachcenter was keenly required, however it wastechnically quite difficult to standardize theacupuncture manipulation for obtaining similar
acupuncture sensation in each subject.
The necessity of random allocation of subjects in
RCT was agreed by all participants and it was
conducted in the papers presented, however theimportance of the group-comparison analysis should
be reminded.
Regarding the control intervention, non-treatment
control, sham/placebo needling, TENS were used in
the presentations. In general, importance of shamintervention in acupuncture RCT was agreed,
however the methodological difficulties of placebo
control in acupuncture were also stressed among
the researchers. Then non-treatment control was set
as the student subjects were familiar with theacupuncture sensation and easily discriminate thereal and sham acupuncture in Japanese acupuncture
school. Dr. Nabeta succeeded to develop shamacupuncture, but it had limitation that it wasapplicable only to the back. On the other hand, Dr.
Seo examined the efficacy of placebo auricularneedling and pointed out a possibility of racialdifference among United Kingdom and Korea. It
was an important issue that in both Japan and
Korea true acupuncture naive subjects were rare so
the sham acupuncture seems to be more difficult in
Asian countries than Western countries. Comparisonof routine acupuncture and additive specificacupuncture treatment used by Dr. Moon and its

KAWAKITA Kenji, et al

clear success was also important from the view
points of patient's benefit in RCT. It was also pragmatically useful for the future trials.
Sample size calculation was done in relatively
large scale RCTs in Japan. Its importance for
excluding so-called type II error in to conclude theresults obtained. In the future collaborative clinicalstudy it will be important so a preceding pilot
study will be required. To conduct a multi-center
RCT in Japan and Korea, it is very important todiscuss on the target disease and financial support
as pointed by Dr. Tsukayama.
Because of the shortage of time, we could not
discuss on the issues listed in Table 2 sufficiently
at the workshop, however, we could understand thedifferent situation of Japanese and Korean acupuncturists, and the difficulties for conducting the multicenter RCT. Bee venom injection reported by Dr.
Lee was a very attractive, however the Japanese
acupuncturists can not use it for the legal
regulation. We knew the situation of each country
and could exchange various information about theclinical research conducted in both countries.
So we wish to conclude that the first Japan-Korea
workshop on acupuncture and EBM was fruitfuland meaningful as the first step of the future collaborative clinical research between two countries.

25

western countries, and we need to find unique or
specific target for the clinical research for the
purpose of strengthening our originality in research.
If we want to stress the importance of technicalmatters of acupuncture and moxibustion developedin Korea and Japan, we should consider the use ofn-of-1 trial design or other research designs insteadof the commonly standardized RCT.
We sincerely hope the participants and readers of
this report send us their frank opinions for the next
Korea-Japan Workshop to our mail addresses.
Ⅵ. Acknowledgements
We sincerely thank to the organizing committee of
Chiba Meeting for setting this workshop, and to
Dr. Tsutani, Director of International Affair of
JSAM, and Dr. Tanzawa, President of JSAM, fortheir arrangement since last year, and to themembers of KAMS and KOMS to collaborate thisworkshop.
A part of the clinical trials conducted in Japan
were supported by the AHAKI foundation(FoundationforTraining
andLicensureExaminationinAnma-Massage-Acupressure,
Acupuncture and Moxibustion)
References

Ⅴ. Future issues of the workshop
We could not make up a draft of protocol for thecollaborative clinical research, however the participants might agree that it was the meaningful firststep for it. We still have many issues to be
discussed and resolved. After the workshop, several
issues for the next workshop were discussed, andwe agreed to have small meeting before the next
Korea-Japan Workshop on Acupuncture and EBM
held at Korea in October, 2005.
A regular video conference among the countries
was planed firstly, however it is still under consideration because of its technical difficulty and cost.
Now we are planning a small meeting in this fallin Korea to promote the discussion for the further
progress.
To clarify the purpose of the collaborative study
will be the most important issue.
To make strong evidence of acupuncture brought
by RCT is undoubtedly important, therefore weneed to decide an adequate target disease for theclinical research. Recently numerous clinicalresearches of acupuncture have published in

1) Tsutani K. Report of the Preparatory Meetingof "Japan-Korea Workshop on Acupuncutureand EBM" at Takamatsu in 2003. Zen Nippon
Shinkyu Gakkai Zasshi (Journal of the Japan
Society of Acupuncture and Moxibustion:
JJSAM). 2003; 53(4): 551-4. (in Japanese)
2) Tsutani K. Memorandum of understanding(MOU) of three societies Japan and Republicof Korea was signed. Zen Nippon Shinkyu
Gakkai Zasshi (Journal of the Japan Society of
Acupuncture and Moxibustion: JJSAM). 2004;
54(2): 186-90. (in Japanese)3) Tanzawa S, Kawakita K, Inoue E, Shichiou T,
Kitakoji H, Nabeta T, Sumiya E, Umeda T,
Aizawa S, Nishida A, Takahashi N, Ochi H.
Randomized controlled trials (RCTs) ofacupuncture and moxibustion in Japan at thepresent and the future issues. Journal of theJapan Society of Acupuncture and Moxibustion(JJSAM). 2003; 53:635-45. (in Japanese)4) Nabeta T, Kawakita K. Relief of chronic neckand shoulder pain by manual acupuncture totender points -A sham-controlled randomized

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KAWAKITA Kenji, et al

trial. Comp Ther Med. 2002; 10: 217-22.
5) Sakai T, Tsutani K, Tsukayama T, Nakamura
T, Kawamoto M, Kasuya D. Protocol of multicenter
randomized
controlled
trialofacupuncture with electric stimulation (AES)
versusacupuncture-like
transcutaneouselectrical nerve stimulation (TENS) for
lumbago. Journal of the Japan Society of
Acupuncture and Moxibustion (JJSAM). 1998;
48(1): 40-74. (in Japanese)
6) Lee K-M, Lee S-Y. Kim S-W, Ha I-D, Cho
G-H, Park H-J, Jung T-Y, Seo J-C, Han S-W.
Is it possible to apply placebo auricularacupuncture to Korean?-The effects of placebo
auricular acupuncture through single-blind
method and randomized controlled trial.
Journalof
KoreanAcupuncture
andMoxibustion Society. 2003; 4: 145-60. (inKorean)7) Lee S-H, Hong S-J, Kim S-Y, Yang H-I, Choi
D-Y, Lee D-I, Lee Y-H, Lee J-D. Randomized
controlled double blind Study of bee venom
therapy on rheumatoid arthritis. Journal of
Korean Acupuncture and Moxibustion Society.
2003; 12: 80-8. (in Korean)
8) Moon S-K, Whang Y-K, Park S-U, Ko C-N,
Kin Y-S, Bae H-S, Cho K-H. Antispastic
effect of electroacupuncture and moxibustion
in stroke patients. Am J Chin Med. 2003;
31(3): 467-74.
9) Kawakita K, Suzuki M, Namura K, Tanzawa
S. A proposal for a simple and useful research
design for evaluating the efficacy ofacupuncture: multiple, randomized n-of-1 trials.
J Jpn Soc Acupunt Mox -Online.11 May 2004.
(http://www.jsam.jp/english/)Appendix
All six speakers kindly agreed to exhibit theirslides to the members of the JSAM, KAMS and
KOMS for promoting the clinical research in bothcountries. It is allowed for the personal use only,
so please do not use for other purposes. You can
see these slides at the homepages of the JSAM,
KAMS and KOMS soon.