Seo Jung-Chul, et al.. Japanese Acupuncture and Moxibustion, 2007; Vol.3(1): 4-11

Special Contribution

Report on the 2nd Japan-Korea Workshop on Acupuncture and EBM-Recent development of clinical trial on musculoskeletal diseaseSEO Jung-Chul1)
KAWAKITA Kenji (Director of Research Division, JSAM)2)
JANG Jun-Hyouk (Director of International Affairs, KAMS)1)
KAZUNORI Itoh2), URYU Noriko, LEE Seung-Deok1)
KIM Sung-Chul1), KIM Yong-Suk3)
1) Korean Acupuncture and Moxibustion Society (KAMS)
2) The Japan Society of Acupuncture and Moxibustion (JSAM)
3) Korean Oriental Medical Society (KOMS)
Abstract
The second Japan-Korea workshop on acupuncture and evidence-based medicine (EBM) was held on 22 October,2005 at Daegu, Korea in the 13th International Congress of Oriental Medicine (ICOM). The objective of this workshop was to exchange the experiences of clinical researches on acupuncture and moxibustion treatments, and tofigure out the issues and solutions for the advanced good clinical research to establish rigorous evidence.
Drs. Kawakita (JSAM) and Jang (KAMS) chaired the workshop. Two speakers from Japan (Drs. Kawakita andItoh) and two Korean speakers (Drs. Lee and Kim) presented their data on the clinical researches of acupuncture
and moxibustion. After their slide presentations, various issues were discussed in terms of their research methodology for the establishment of stronger evidence on acupuncture and moxibustion. We had new interesting findings
and understood various issues and their solutions for performing clinical researches.
The most crucial product of this workshop was that we could figure out each other more than ever and we agreed
the necessity of the future collaborative clinical studies on acupuncture and moxibustion. This workshop was very
fruitful as the step for the future Japan-Korea collaborative clinical research. We expect an excellent discussion inthis meeting to contribute to the development of clinical research on acupuncture in the future.
Key words: Japan-Korea Workshop, acupuncture, moxibustion, RCT (randomized controlled trial), EBM (evidence-based medicine)

Ⅰ．Background of this workshop
Acupuncture therapy has been highly recognized by
the WHO for its effectiveness, and many profound researches have been conducted on it in the United Statesand European countries since several decades ago. Theinterest towards Oriental Medicine is growing all overthe world. Particularly acupuncture is receiving more
spotlights because it is the most leading field of Oriental
Medicine at the present.
Now we face a new task of "Evidence Based Medicine". The world science society requires us to show not
only classical prescriptions and experiences but also
scientific evidences. More and more scientists are inter-

Corresponding author: Kim Yong-Suk
Kyunghee University, College of Oriental Medicine, Hoegi-dong, Dongdaemoon-gu, Seoul 130-701, Korea
E-mail: akys@hanmail.net

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ested in investigating the mechanism of acupuncture andmoxibustion.
Korea and Japan share a long history and abundant
experiences concerning acupuncture. We have been
exchanging updated information through various meetings, formal and informal. Oriental Medical doctors in
Korea and Japan have reserved the knowledge about theunique acupoints and remarkable skills, and recently put
their efforts on the clinical research.
Ⅱ．Purpose of this workshop
As the second step of the Japan-Korea collaboration ofclinical trials in the future, the first purpose of this workshop was to exchange the experiences of clinical researches on acupuncture and moxibustion therapies, andsecondly to find out the issues and their solutions fordeveloping the excellent clinical research to establish
strong evidence.
Ⅲ．The contents of workshop: presentation ofpapers from Japan and Korea
The second Japan-Korea workshop on acupunctureand EBM was held at Daegu EXCO, Korea on 22 October, 2005. Over 30 members of the JSAM, KAMS andKOMS joined to the workshop. The slides for the presentation were prepared in English. List of speakers andtitles are summarized in Table 1.

Topics of the 1st paper and raised issues
Dr. Itoh reported trigger-point acupuncture treatmentof chronic low back pain (n=18) and neck pain (n=20) in
elderly patients. The patients (age range: 65-81 years),with non-radiating back or neck pain for at least six
months, were allocated into one of two groups over 12weeks. Each group received two phases of acupuncturewith an interval between them and outcome measures
were pain intensity by Visual Analogue Scale (VAS) andRoland Morris Questionnaire. The standard acupuncturegroup received treatment at traditional acupuncture
points, while the other groups received treatments on
trigger-points. The trigger point acupuncture therapy
was more effective than standard acupuncture therapy on
chronic low back pain and neck pain in the aged patientsas shown in Figure 1 and 2. He suggested that triggerpoints might be more effective in the treatment of low
back and neck pain. But there was not sufficient statistical data so we could not fully support this. In addition,
deep or superficial needling to trigger-points was required to be studied.
Topics of the 2nd paper and raised issues solved
Dr. Kawakita reported the effect of indirect moxibustion on the elderly patients of osteoarthritis of the kneeby sham controlled clinical trial (real=16, sham=14).
Firstly he invented a new sham moxibustion and implemented the physical characteristics between warm (real)

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and sham moxibustion (Figure 3). Moxibustion treatments were done two times per week for three weeks.
Acupuncture points around the knee joint bilaterally(ST34, SP9, SP10, GB33, LV8) were used. Both VAS
and Western Ontario and McMaster Universities osteoarthritis index (WOMAC) scores showed improvement in both groups, but a significant reduction wasfound only in real group (Figure 4). No change was observed in physical examination in both groups. These
data demonstrated the real moxibustion is more effective

than sham intervention for the pain relief of osteoarthritis of the knee. But the importance of heat-sensitive afferent inputs in both acupuncture and moxibustion
treatment was suggested.
Topics of the 3rd paper and raised issues solved
Dr. Lee reported the comparison of superficial anddeep acupuncture in the treatment of ankle sprain by aprospective randomized single-blind study in 23 ankle

Figure 1. Effect of standard acupuncture and trigger-points treatments on low back pain
Trp : Trigger point accupuncture therapy
SA : Standard acupuncture therapy

Figure 2. Effect of standard acupuncture and trigger-points treatments on neck pain

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sprain patients. In superficial acupuncture group, theneedle was introduced in the skin at a depth of 2 mm,
whereas in deep group the needle was placed deeply into
muscular tissue or the articular capsule at a depth morethan 15mm. The treatment was planned for duration of 1week, 3 times. Although at the end of the treatment there
was no evidence of significant statistical differences
between the two different groups, pain reduction (VAS)
was greater in the group treated with deep acupuncture(Table 2, 3). He suggested that deep stimulation has abetter analgesic effect when compared with superficial
stimulation in pain reduction, but the other outcome
measures such as bearing weight, pressure threshold do
not support his suggestion.
Topics of the 4th paper and raised issues solved
Dr. Kim reported a pilot study of acupuncture treatment for the degenerative knee arthritis on the evidence
based medicine. In pragmatic acupuncture treatment

Figure 3 Warm and sham moxibustion devices

Figure 4 Time course of pain magnitude between Warm and sham moxibustion

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group (n=20) we used 3 liver meridian points (LI 3, 4, 7)
for the patients with medial knee joint pain, 2 stomach
meridian points (ST 35, 36) for the patients with middle
knee joint pain, and 3 gall bladder meridian points (GB33, 34, 43) for the patients with lateral knee joint pain,we added to LI 2 point using reduction method if patients have knee edema. We used the acupuncture points
of BL34, SP9, ST35, S36, BL60, GB39, SP6, and KI3
using the reinforcement-reduction method in standardization acupuncture treatment group (n=17). Primary
outcomes were WOMAC pain and function scores at 4,8, and 14 weeks. Secondary ones were consisted of100mm VAS, ROM (Range of Motion) using Goniometer, and pain threshold using pressure algometer. In
comparison of outcomes there were no significant statistical differences between the pragmatic and standardization acupuncture treatment group (Table 4, 5). He aimed
to investigate whether the pragmatic acupuncture treatment provides more effective pain relief than treatmentusing the same acupuncture point to the all patients, but
it was pointed out that there were two many study arms.

Ⅳ．General discussion
After slide presentations, various issues were discussed on their research methodology for the establishment of stronger evidence on acupuncture andmoxibustion. To clarify the purpose of the study is avery important issue especially in collaborative research.
Therefore, in 2nd Japan-Korea workshop on acupunctureand EBM, we decided musculoskeletal disease as anadequate target disease for the clinical research.
Dr. Itoh reported the trigger point acupuncture therapy
was more effective than standard acupuncture therapy on
chronic low back pain and neck pain in the aged patients.
But it was pointed out that it unfair to select fixed acupuncture points only in standard acupuncture therapy
group. Some researchers insisted if individualized acupuncture points were selected in acupuncture therapy
group or fixed points were selected in trigger point acupuncture therapy, the results would be different.
In the research area of Oriental Medicine, moxibustion
research is not so much, especially clinical trial of

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moxibustion is rare. Participants applauded Dr.
Kawakita's sham moxibustion as a creative sham device
in moxibustion research. Dr. Kawakita reported an analgesic effect of warm moxibustion and he suggested thattemperature of warm moxibustion is essential for theanalgesic effect. But no apparent difference between thewarm and sham moxibustion on the results of physicalexamination (excursion of knee joints, heat and ballottement of patella). We could not make a conclusionfrom the present data because the experimental period
might be too short and the assessment in categoricalscales (improve, no change and worse) was not so sensitive. Therefore, quantitative evaluation will be required.
In Japan superficial stimulation acupuncture is prevalently used in clinics with good results. Dr. Lee suggested that deep stimulation has a better analgesic effectwhen compared with superficial stimulation in pain reduction, however, the other outcome measures such as
bearing weight, pressure threshold do not support hissuggestion. Dr. Lee's findings are controversial in this
aspect and need to be discussed.

Recently numerous clinical researches of acupuncture
have published in western countries, and we need to findunique acupuncture method for the clinical research tostrengthen our originality. Dr. Kim's report was based onthis consideration of pragmatic design. In comparison ofoutcomes there were no significant statistical differences
between the pragmatic and standardization acupuncture
treatment group. However, it was pointed out that results
without comparison of baseline are unmeaning. One of
the most noteworthy aspects in this workshop is growinginteresting in the individualized clinical trial than n of 1
trial that has been indicated a few problems yet to beclarified.
We need to discuss how to get rid of disadvantage of nof 1 and individualized trial method and how to develop
better method capable of answering the question in theclinical research with less defect based on establishedresearch method.
We also discussed and resolved following issues; validity of RCT for future study, methods of random allocation, selection of control intervention, necessity of

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placebo or sham interventions, selection of outcome(subjective, objective), calculation of sample size, likehood of multi-center RCT in Japan and Korea, difference of medical system between Japan and Korea, andfinancial support.
Ⅴ．Future issues of the workshop
During this workshop we could not make up acommon protocol for the collaborative clinical research.
But we had new interesting findings and understoodvarious issues and their solutions for performing clinicalresearches. The most important product of this workshop
was that we could figure out each other more than everand we agreed the necessity of the future collaborative
clinical studies on acupuncture and moxibustion. Thisworkshop was very fruitful as the step for the future
Japan-Korea collaborative clinical research and theparticipants might agree that it was the meaningful firststep for it.
We still have many issues to be discussed and solved.
Safety and ethics are two topics often not perfectly
considered by researcher during the clinical research onacupuncture. We are going to discuss these issues moredeeply at next workshop, when we will also be talking
about selection of acupuncture for the clinical researchthat was based on results of survey in Korea. After theworkshop we agreed to have a meeting again at 54th
annual scientific meeting of the JSAM which will beheld in Japan in June, 2006.
We are sure that our efforts will be historicallymeaningful in developing traditional acupuncture into anevidence based future medicine. We are expecting that
this meeting will play an important role in improving thequality of clinical research on acupuncture and theglobalization of the Oriental Medicine. We sincerely
hope the participants and readers of this report send theirfrank opinions for the next Korea-Japan Workshop to
our mail addresses.
Acknowledgements
We sincerely thank to the organizing committee ofICOM meeting for setting this workshop, and to Dr.
Dong-Suk Park, president of Korean Oriental Medical
Society and Choi Do-Young, president of Korean Acupuncture & Moxibustion Society, for their arrangement
since last year, and to the members of JSAM, KAMS

and KOMS to collaborate this 2nd Japan- Korea workshop.
A part of the clinical trials conducted in Japan weresupported by the AHAKI foundation (Foundation forTraining and Licensure Examination in Anma-MassageAcupressure, Acupuncture and Moxibustion). A part ofthe clinical trials conducted in Korea were supported bythe KIOM (Korea Institute of Oriental Medicine).
References
1) Park J-S, Kim W-Y, Baek S-T, Lee S-D, Kim K-S.
Comparison of superficial and deep acupuncture inthe treatment of ankle sprain: A randomized controlled trial-pilot study. The Journal of Korean Acupuncture and Moxibustion Society. 2004; 21(5):137-47. (in Korean)
2) Le Bars D, Dickenson AH, Besson JM. Diffuse noxious inhibitory controls (DNIC). II. Lack of effect on
non-convergent neurons, supraspinal involvement
and theoretical implications. Pain. 1979; 6(3): 30527.
3) Kim S-C, Lim J-A, Lee J-D, Lee S-K, Lee S-Y,Moon H-C, Choi S-M, Chung Y-H. A pilot study ofacupuncture treatment for the osteoarthritis of theknee joint on the EBM (Evidence Based Medicine).The Journal of Korean Acupuncture andMoxibustion Society, 2006; 23(1): 187-215. (in Korean)
4) Kim S-C, Lee J-D, Lee S-K, Lee S-Y, Moon H-C,Choi S-M, Chung Y-H. The study on the questionnaire analysis and agreement diagnosis of the same
patients using differentiation of symptoms and signs
on chronic knee joint pain including osteoarthritis ofknee joint. The Journal of Korean Acupuncture andMoxibustion Society. 2006; 23(1): 71-93. (in Korean)5) Uryu N. Effects of indirect moxibustion on the patients of knee osteoarthritis. Master thesis of Meiji
University of Oriental Medicine. (in Japanese)
6) Itoh K, Katsumi Y, Kitakoji H. Trigger point acupuncture treatment of chronic low back pain in elderly patients - a blinded RCT. Acupuncture Med.
2004; 22(4): 170-7.
7) Itoh K, Katsumi Y, Hirota S, Kitakoji H. Randomized trial of trigger point acupuncture compared withother acupuncture for treatment of chronic neck pain.
Comple Therap Med. (in press)

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Seo Jung-Chul, et al.. Japanese Acupuncture and Moxibustion, 2007; Vol.3(1): 4-11Appendix
All four speakers kindly agreed to exhibit their slides
to the members of the JSAM, KAMS and KOMS for
promoting the clinical research in both countries. It isallowed for the personal use only, so please do not use
for other purposes. You can see these slides at thehomepages of the JSAM, KAMS and KOMS soon.