Kawakita Kenji, et al.. Japanese Acupuncture and Moxibustion, 2007; Vol.3(1): 12-25

Special Contribution

Report of the 3rd Japan-Korea Workshop on Acupuncture and EBM－Protocol development for the acupuncture trial on the osteoarthritis of
the knee－

KAWAKITA Kenji (Director of Research Department, JSAM)1)
JANG Jun-Hyouk (Director of International Affairs, KAMS)2)
TAKAHASHI norihito1), SHICHIDOU Toshiyuki1), ITOH Kazunori1), SUMIYA Eiji1)
FURUYA Eiji1), YAMASHITA Hitoshi1), TSUKAYAMA Hiroshi1), HAHN Seo-Kyung3)
PARK Hi-joon4), LEE Seung-Deok2), KIM Yong-Suk4)
1) The Japan Society of Acupuncture and Moxibustion (JSAM)
2) Korean Acupuncture and Moxibustion Society (KAMS)
3) Medical Research Collaborating Center, Seoul National University Hospital, Seoul
National University College of Medicine
4) Korean Oriental Medical Society (KOMS)
Abstract
The 3rd Japan-Korea Workshop on Acupuncture and EBM was held at Kanazawa on 16 June. From Korea team,
4 papers were presented. Dr. Hahn introduced a new approach of data analysis on series of n-of-1 trials using theBayesian statistics. It offered important information for the future n-of-1 trials. Dr. Park clearly demonstrated thesignificance of various sham devices proposed and stressed the importance of research questions when we choose
the control intervention in RCT. Dr. Lee reported the results of survey in Korean Medical Doctors (KMD) for theirpoint selection and techniques to the distal and local points. Dr. Kim presented the results of face to face survey on
the KMD with 28 items for acupuncture treatment on the knee osteoarthritis(OA). Finally, a draft of protocol was
introduced by Dr. Kim. The title was "multi-center, a randomized, single blinded, two arms, parallel-group study tocompare the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' inKorean and Japanese patients with knee osteoarthritis (Phase IV)".
From Japan team, 7 speakers presented their comments and proposals on the protocol. Dr. Takahashi introduced
several issues regarding n-of-1 trials and pointed out the importance of obtaining generalizability from n-of-1 trials.
Dr. Shichidou pointed the importance of research design, selection of outcome measures and reduction of biases.
Dr. Itoh presented the results of point selection for the knee OA based on the literature survey. Dr. Sumiya introduced several differences between KMD and Japanese acupuncturists based on the questionnaire used in KMD
survey. Dr. Furuya demonstrated a result of press tack needle and its sham device on shoulder stiffness. Dr. Yamashita introduced the results of literature survey regarding adverse events occurred by acupuncture on knee OA. Dr.
Tsukayama stressed the importance of responsibility of Institutional Review Board (IRB) for the conduction ofclinical trials. After various issues were discussed, the need of continued meeting for final protocol development
was agreed, and then the workshop was closed.
Key words: acupuncture, RCT, individualized treatment, Knee OA, Japan-Korea collaboration

Corresponding author: Kawakita Kenji
Department of Physiology, Meiji University of Oriental Medicine, Hiyoshi-cho, Nantan-shi, Kyoto 629-0392, Japan

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Ⅰ．Brief history of the workshop
Little information has been exchanged between Korea
and Japan in spite of their geographical closeness andsimilar traditional basis on acupuncture and moxibustion.
However, after 2002, the need for mutual understanding
and exchange has gradually increased in the acupuncture
and moxibustion research field.
A formal letter from Dr. Won-Chul Lee, then President of Korean Oriental Medical Society (KOMS) was
sent to Dr. Shohachi Tanzawa, the former President ofJapan Society of Acupuncture and Moxibustion (JSAM)
in June 2002. Since then several activities has been conducted between the two countries. On 6 June, 2003, a
preparatory meeting of Japan-Korea Workshop on Acupuncture and EBM was held in conjunction with the52nd Annual Conference of JSAM at Takamatsu. Simultaneously, to encourage joint activities, a memorandumof understanding (MOU) among the JSAM, the Korean
Acupuncture and Moxibustion Society (KAMS) and the
KOMS was developed and formally singed on 14 February, 2004 at Seoul. Based on such numerous efforts of
the JSAM, KAMS and KOMS members, the first JapanKorea workshop on acupuncture and EBM was held at
Chiba on 14 June, 2004.
At the Chiba meeting, KAMS and JSAM made several
agreements and the most important item among themwas 'to make a small research group for real joint research in the future'. Based on that agreement, acupuncture researchers from both countries made a 'small working group' and an informal workshop held in Fukuoka,
2005. The 'small working group' met again at the 2nd
Korea-Japan workshop on acupuncture and EBM on 22
October, 2005, which was held in conjunction with the13th International Congress of Oriental Medicine(ICOM) at Daegu in Korea.

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Ⅱ． Purpose and themes of the workshop
The purpose of this workshop was to develop a protocol of clinical trial of acupuncture on knee osteoarthritis(OA) for the Korea-Japan collaboration of clinical
trials in the future. For the purpose, this workshop consisted of three themes. First, the Korean team presented
four papers related to the development of protocol, andthen, a draft of the protocol of clinical trials of acupuncture on knee OA was proposed by Korean team. Second,
based on the proposed protocol, questions and commentsin each item were performed by the Japanese team. Finally, researchers of both countries discussed the development of more valid protocols.
Ⅲ．Contents of the workshop
The 3rd Japan-Korea workshop on acupuncture and
EBM was held at Kanazawa on 27 June, 2006. Thirteen
members of the KAMS and KOMS joined the workshop
and about 30 members of the JSAM audience
participated. All of the presentations were prepared in
English, even though both members had several
difficulties in understanding of complicated discussions
in each theme. One of the aims of the agreement was toimprove English presentation and discussion skills of theresearchers in both countries. At the beginning of theworkshop, the chairpersons, Dr. Kawakita (JSAM) and
Dr. Jang (KAMS), briefly introduced by themselves,then the presidents of JSAM (Prof. Yano) and KAMS(Prof. Choi) made opening greetings.
Speakers and their titles of presentation are listed inTable 1. Five presentations from Korean team including
proposal of a protocol of J-K collaboration of clinical
trial and 8 presentations of comments from Japanese
team on the draft protocol. In the general discussion,
several issues were discussed and finally both Japan and
Korea members agreed with the necessity of further
meeting for the development of the protocol in near
future.
1. Presentation of papers from the Korean team
Topics of the 1st paper
Dr. Hahn briefly reported an 'acupuncture for tinnitus:
analysis of N-of-1 trials'. The aim of this study was toexplore patient perceived benefits of acupuncture fortinnitus. The design was controlled N-of-1 trials, withtwo phases A and B. Primary outcome measures were
the Daily Diary records relates to four tinnitus symptoms; loudness of tinnitus, pitch of tinnitus, number ofwaking hours affected and quality of sleep. Secondary
outcomes were Tinnitus Handicap Inventory (THI) andMeasure Your Outcome Profile (MYMOP). Patients
received a course of 10 acupuncture treatments over a 2week period. Daily Diary entries related to the four tinnitus symptoms, THI, MYMOP were recorded at pretreatment and post-treatment.
A hierarchical Bayesian model was used to combine

Figure 1. Comparison of RCT, N-of-1 and Bayesian model

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the results from the individual patients to obtain estimates of the population and individual patient treatment
effects, incorporating random variations at both levels(between patients and within patients).
Prof. Hahn presented about N-of-1 single case design
first and explained Hierarchical Bayesian meta-analysis.
Finally, methods, outcome measure, results were presented.
The results obtained are very clear. Primary outcome
measures of 4 items were clearly reduced by acupuncture treatment. According to her presentation, this approach has two kind of potential advantages. One ispopulation benefits: Data can be accumulated as part ofeveryday practice and may induce better representationof "effectiveness" in usual clinical setting. The other ispatient benefits: Better understanding of patient variability and ability to predict individual responses.
Usefulness of research design of N-of-1 trials in theindividualized treatment such as acupuncture has been
well recognized11,2), however, its lack of generalizability
is always severe issue of discussion. In the present presentation she clearly demonstrated a possible solution ofsuch problem (Figure 1). However, in the discussion,
importance of consideration for auto-correlation of timeseries data was pointed out.
Topics of the 2nd paped
Dr. Park presented the issue of "sham needles: proper
placebos for acupuncture research?". Randomized, dou-ble-blind, placebo-controlled trials are generally considered as the best tool to separate the 'specific' and the'unspecific' or 'placebo' effects of a therapy. If the intervention is a drug, the 'specific' component is the pharmacologically active agent while the placebo is an inert
substance. The issue becomes more complicated if thetherapy under test is a complex physical intervention
such as physiotherapy, chiropractic manipulation, or
acupuncture. Because of complex situation, there is avariety of sham techniques that have been used in clinical trials of acupuncture3,4). Figure 2 summarizes various
sham interventions used in the clinical trials.
A validated sham acupuncture device has a greater
placebo effect on subjective outcomes than oral placebo
pills. Streitberger & Kleinhenz introduced a placebo
needle into acupuncture research in 1998. The needle is
not fixed inside the copper hand. Its tip is blunt, andwhen it touches the skin pricking sensation is felt by thepatient, simulating the puncturing of the skin. The needle
moves inside the handle, and appears to be shortened.
In a cross-over experiment with 60 volunteers theytested whether needling with the placebo needle feels
any different from real acupuncture. Of 60 volunteers,
54 felt a penetration with acupuncture and 47 felt it withthe placebo. 34 felt a dull pain sensation (De-qi) withacupuncture and 13 with the placebo.
Park et al.3) designed a placebo needle (Park shamneedle: PSD) similar to Streitberger's5). They used aflange and guide tube to place the needle instead of aplastic ring covered with plastic sheet in Streitberger's

Figure 2. Types of placebo techniques used in acupuncture RCTs

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placebo needle. In a credibility study, PSD is indistinguishable from real needles and cannot elicit De-qi sensation. In another 2 credibility studies to experienced
subjects, the results were different. But, it seems to becapable to use it as sham needle for blinding in acupuncture RCTs.
Fink et al.6) designed modified Streitberger's shamneedle which uses a sponge instead of a plastic ring covered with plastic sheet. In a validation study of 68 patients with tension-type headache, patients unable todiscriminate sham from real acupuncture and 84% of
patients felt De-qi while 34% of the sham group did.
Effectiveness of acupuncture for various conditions wastested using these needles in 10 RCTs. They have beenadequately validated and usually successful in achieving
patient-blinding. However, the results from the RCTs so
far support the skeptics who believe that the clinicaleffects of acupuncture are no more than a placebo response.
She pointed out several disadvantages to sham needle
as follows: needling technique is significantly interfered,accurate point location is difficult or almost impossible,
and attaching the device to keep the needle in place istime consuming and may lessen the effect of verum
treatment. The device is not applicable to all acupuncture points. Finally, she emphasized that appropriatenessof controls depends on "what your research question is?"Topics of the 3rd paper
Dr. Lee reported similarities and differences in the selection criteria and technique between local and distal
acupuncture points in Korean medical doctors (KMD). It
is very important to select the adequate acupuncture
points, needling technique and other factors related toacupuncture stimulation. Figure 3 summarizes various
factors which may influence the clinical efficacy of acupuncture treatment.
He tried to investigate and characterized perceptionsof acupuncture point selection, especially similarities
and differences between the distal and local points in theexperts of KMD. He designed a self-administered questionnaire and performed during the annual acupuncture
conference of KAMS. 91 (79.8%) of 114 subjects were
responded and 88 (77.2%) respondents were analyzed.
In the survey, KMDs recognized that disease of locomotor system (27.7%), regional disease (26.0%), sprain /contusion / trauma (14.0%) is effective conditions to
select the local points. On the other hand, they usually
select distal points in meridian disorder (19.0%), Zangfu viscera disease (18.6%), non-regional disease (17.7%),
etc. In a symptom of indeterminate origin (30.2%) and

Figure 3. Factors influencing effectiveness of acupuncture

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chronic disorders (25.4%), they recognized that selectionof local points is ineffective. Erroneous syndrome differentiation (41.4%) was understood to be the most ineffective condition to select distal points. In the survey, theyusually select local points in the case of response points
such as pres sure pain and follow the western medicine
diagnosis.
However, in the case of selecting distal points, mostly
they followed traditional theory of meridian (88%). Thissurvey implies the real acupuncture practice may bedifferent from those of reported in the research papers.
Topics of the 4th paper
Dr. Kim reported a face-to-face survey of Korean oriental medical doctors: How do they prescribe the acupuncture points for knee osteoarthritis patients? Thissurvey was performed for the development of new clinical research design suitable for the individualized proce-

Table 2.

Items of Questionnaire

dures because survey can reflect real common clinicalpractice.
Four professors of the Oriental Medical College and
10 resident doctors of the Oriental Medical Hospitaldeveloped the questionnaires which consist of 28 items(Table 2). Seventy two KMDs who preferred to answer
the remote acupuncture prescription at previous telephone survey responded the entire questionnaires which
took ten to fifteen minutes to complete. In the survey,
Korean medical doctors preferred to use the five shu
acupuncture points, especially 'hyung' or 'shu' points, on
the contra-lateral side of lesion and that the first target
organ is the liver. Five element points theory was mainly
based on 'Nanjing' and 'Hwangdi Nejing'. The De-qi
sensation of both doctor and patients were emphasized.
This study showed that Korean medical doctors prefer
to follow the Korean traditional acupuncture methods
respecting the old classic principles. And these results
can guide to develop advanced clinical trial protocols

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more closely to real acupuncture practice.
2. Proposal of a protocol from the Korean teamDr. Kim from the Korean team proposed a draft of the
protocol. The title was "multi-center, a randomized,
single blinded, two arm, parallel-group study to compare
the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' in Korean
and Japanese patients with knee osteoarthritis (Phase
Ⅳ)".
This protocol plans to include 126 subjects and divided into two arms. 126 volunteers with knee osteoarthritis will be recruited from the community andthen randomized to one of the two study arms in a ratioof 1:1. One arm participants will receive individualized
acupuncture twice a week, the other arm participants
will receive standardized acupuncture twice a week.

Figure. 4. Outline of the protocol.

Each patient will participate in this study for a maximumof 8 months. The study consists of a screening visit,baseline assessment visit (day 1), a treatment period(week 3-week 9), and a six month follow-up visit (week35). The total duration of the study will be approximately one and half years and will include a total of
twelve study visits.
Assessment of pain and function of the knee joint willtake place at the baseline and at the 26 week (6 months)
interval throughout the follow-up period. The primaryobjective of this protocol was to determine whether individualized acupuncture provides greater pain relief compared with standardized minimal acupuncture in patientswith osteoarthritis of the knee. Therefore, the primary
outcome measure is participant pain rating based on a
100mm VAS.
The secondary objective included four items. First, todetermine if individualized acupuncture has more

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change in pain, stiffness, physical function of the knee
(WOMAC) compared to standardized minimal acupuncture at 6 weeks and 6 months. Second, to determine if
individualized acupuncture increases average quality oflife (SF-36) compared to standardized minimal acupuncture at 6 weeks and 6 months. Third, to determine if
individualized acupuncture increases average joint function (LFI score) compared to standardized minimal acupuncture at 6 weeks and 6 months. Fourth, to determine
if individualized acupuncture increases average physicalfunction (HAQ) compared to standardized minimal acupuncture at 6 weeks and 6 months.
Thus, the secondary outcome measures are Western
Ontario McMaster Questionnaire (WOMAC), Quality ofLife (SF-36), Lequesne Functional Index (LFI) score,and physical function was evaluated by the Health assessment Questionnaire (HAQ).
The scheme of this study is shown in Figure 4.
3. Comments on the proposed protocol and discussion from Japan team1) Comments on the research design-1
Dr. Takahashi commented on the issue of clinical trial
design. In his presentation 'N-of-1 trials for the individualized therapy on the knee pain', he proposed to use then-of-1 design for the Japan-Korea cooperated clinical
trial for acupuncture and moxibustion treatment of knee

Figure 5. Comparison of RCT and n-of-1 trials

pain. The reason is that RCT is difficult to recruit
enough subjects in the same time and difficult to manage
many subjects with many institutions.
He showed the difference of RCT and integrates N-of1. Then, he questioned whether meta-analysis of various
N-of-1 trials can be generalized?(Figure 5).
In addition, he pointed out problems in N-of-1 trials.
N-of-1 trial may incline toward the patient who is likely
to be effective (selection bias). Therefore, we have torecruit a patient so that there may be no deviation. Another problem is that we need methods to integrating theresult of the trials for an individual and to generalization.
Statistics may be a solution. Finally, he concluded that if
problems were solved using N-of-1 trials may be released from the difficulty which manages many patientssimultaneously. Furthermore, more clearly curative effect of acupuncture and moxibustion may be discovered.
2) Comments of research design-2
Dr. Shichidou showed his expertise about RCT designing and planning order for the Korea/Japan joint research
as research adviser. He explained four items about research design and planning order such as examination inquestionnaires, planning control group, feasibility, anddata analysis methods.
Regarding examination in questionnaire, he mentioned
three important things. First, we have to consider thequestionnaire and scale. That means we have to pretest

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the reliability (reproducibility) and validity of the questionnaire. Second, we must choose and use the scales(ratio, interval, ordinal, nominal) accurately. Third, if we
use a translated oversea questionnaire, we need to conduct a reliability/validity test as well. It is very common
to use an oversea questionnaire, however, we should
concern about the fact that it is made under different
culture. And we have to confirm its frequency and reliability and validity test in foregoing papers.
WOMAC, VAS, SF 36, etc. are used for pain/function
scale of the knee OA in the foregoing research. For example, the gonarthritis questionnaire made by Japan
Orthopedic association (JOA) has no reliability and validity test. Now, JOA is making new score named JKOM.
About planning control group, he introduced several
sham acupuncture and research papers which used it.
Feasibility is also important in the research. Adequate
number of subjects, adequate technical expertise, affordable in time and money, manageable in scope are essential items for feasibility. Data analysis methods are emphasized by as well.
Finally, he wanted to touch other important items suchas randomization, allocation concealment, treatment
term & frequency, eligibility criteria. But he could not

Figure 6. Frequency of use on treatment point

because of shortage of presentation time.
3) Point selection-1
Dr. Itoh reported point selection in the references ofknee OA research. In the evaluation of the efficacy ofacupuncture, important parameters were the stimulation
site, intensity and modality of stimulation of the points.
For the assessment of stimulation site, one can indicate
certain variable, numbers of stimulation sites, and thelocation of stimulation sites. On the other hand, the location of the stimulating site in the knee OA patients was a
traditional acupuncture point around the knee in mostprevious studies.
The main aim of this study was to review the widelyused and effective stimulation sites of the knee OA in
the recent clinical trials. He used Medline (from 1996 to2005) as a search database and search terms;'acupuncture' and 'moxibustion', 'osteoarthritis of knee','knee arthritis' or 'knee pain'. The search was also limited
to 'humans' and 'English'. On the other hand, he searched
the references of each paper. As the result of literature
survey, VAS and WOMAC were the most frequently
used outcome measures and ST36 (足三里) and SP9 (陰陵泉) were the most frequently used acupuncture points.

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Figure 6 summarizes the number of papers which usedeach acupuncture point listed. ST36 was the most frequent choice among the papers searched.
On the other hand, he calculated effect size of each
paper as well. Effect size is the change in endpoint divided by standard deviation (SD). However, it was notpossible to calculate formal effect size, because few
authors reported standard deviation. In the effect size
calculated, WOMAC was used in 7 papers and theireffect size was the biggest. HSS (Hospital special surgery knee score) used in 2 papers, and the effect size was
the second. VAS used in 5 papers and the effect size was
the third. In the effect size of treatment points, ST34 (梁丘) was the biggest, ST35 (犢鼻), GB34 (陽陵泉), SP9(陰陵泉), LR3 (太衝) were about the same each other,and it should be noticed that it also varied with the control interventions.
In conclusion, SP9 (陰陵泉), GB34 (陽陵泉), EXLE4 (外膝眼), ST35 (犢鼻), ST36 (足三里) were more
useful and effective points than the other points fortreatment of the knee OA.
4) Point selection-2
Dr. Sumiya reported the problems of questionnaire
survey using Korean prototype. His title was "The prob-

lems in carrying out the questionnaire in Japan, which
had carried out in Korea". He used the similar questionnaire that carried out by Korea team, but it was slightly
modified in order to adjust for the present acupuncture
treatment style in Japan. The questionnaires were justsent to 1,000 members that were chosen randomly fromabout 6,000 registered members of the Japan Society ofacupuncture & Moxibustion by computer.
Regarding questionnaire used in Korea, he found several issues to be modified. In Japan at present, there are
4 main acupuncture and moxibustion treatment styles.
They are treatments based on 1) western medicine, 2)
traditional Chinese medicine, 3) meridian and 4) eclectic
style. However, many acupuncturists using the Western
medicine style do not understand the reinforcing andreducing manipulations and arriving qi as well. Moreover, acupuncturists who do not know about the theory of
meridians and collaterals or the theory of Yin and Yang
organs are not rare.
The treatment effect of acupuncture and moxibustion
on the osteoarthritis might be influenced by the degreeof seriousness of knee OA symptoms, however, the Japanese acupuncturists can not legally allowed to diagnose
the patients as having knee OA. And now in Japan,
acupuncturists are prohibited to use pricking and cup-

Figure 7. The degree of shoulder stiffness using VAS

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ping therapy causing hemorrhage on the law. Thesesituations of Japanese acupuncturists make it difficult to
conduct the survey using the same questionnaire with
Korean team. The results of this survey will be collected,
analyzed and reported in near future.
5) Intervention-1
Dr. Furuya of the Tokyo therapeutic institute reported"The effect of press tack needle (PTN) treatment on
shoulder stiffness". Shoulder stiffness is defined as unpleasantness and a strained trapezius muscle. This symptom is improved by a rubbing or slight pressure, andfrequently treated with acupuncture and moxibustion. It
is caused by psychological, physical and social factors.
Shoulder stiffness is caused by a reduction of pain
threshold and is related to autonomic nerve dysfunction
as well. Before treatment, he did a physical examination
for the differential diagnosis of other disease such as
herniated nucleous pulposus, thoracic outlet syndrome,
etc. PTN is used for the purpose of pain reduction or
prolongation of the effects of regular acupuncture andmoxibustion treatment. For example, PTN is used forrelaxation of shoulder stiffness in chronic symptoms.

However, there are few reports that inspected the effectiveness of PTN itself 4).
Therefore, this study was planned to inspect curative
effect of PTN. A change of subjective symptoms after
PTN treatment was compared with that of sham needle
using volunteers with shoulder stiffness. This study was
designed as a randomized controlled trial (RCT). Fifty
six volunteer subjects who aware of shoulder stiffness
were treated with 0.6mm length PTN for 3 days. The
subjects were the staff and students of Tokyo Therapeutic Institute.
The number of the volunteers reporting awareness ofshoulder stiffness after 3 days decreased from 28 to 12 in
the PTN group and from 25 to 23 in the sham group(p<0.01). As shown in Figure 7, VAS value of shoulder
stiffness decreased immediately (p<0.05) after PTN
treatment and it continued and increased 3 days later(p<0.01). These results suggested that PTN treatment on
the tender points improved shoulder stiffness. The shamdevice of PTN used in this study seems to be very excellent for its purpose. The Japanese team has planned to
conduct a RCT using real PTN and sham PTN, however,
the efficacy of PTN alone on the symptoms of knee OA

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has not known, so an exploratory study should be conducted using n-of-1 research design.
6) Outcome measures
This presentation was performed in the session of general discussion because of the shortage of time. Pleaserefer to the general discussion for the detailed comments
about this issue.
7) Safety of acupuncture to the knee OA
Dr. Yamashita, the chief investigator of the Committee
for Safe acupuncture in JSAM, presented his report"Safety of acupuncture for knee OA".
He mentioned that there are four published case reports on acupuncture adverse events in treating knee
OA7). The reported adverse events were acupuncture
mycobacteriosis, pseudoaneurysm of the popliteal artery,necrotising fasciitis, and candida arthritis of the knee.
Regarding these reports, however, two questions may
arise; "How often does it happen?" and "Is a causal relationship well established?". Since case report is in low
level in the hierarchy of clinical evidence, he reported areview of safety information from acupuncture RCTs on
knee OA. He searched in PubMed and Igaku Chuo Zassi(Japan Centra Revuo Medicina) as a data base. Search
keywords are "acupuncture, electroacupuncture, osteoar-

thritis, knee, gonalgia and gonarthrosis", and search
limits are "randomized controlled trial", and he found 11
papers which reported adverse events in acupuncture
RCTs.
Table 3 summarizes the adverse events reported in theliteratures8-13). There were some adverse events such as
joint swelling, bruising and small hematoma. Several
subjective symptoms were dizziness, nausea and numbness, but it did not significantly differ and their incidences were quite low. Finally he recommended twothings for establishing safety information on adverse
events in acupuncture RCTs. First, calculate each event's
incidence (frequency). Second, classify the events
caused by acupuncture with avoidability and severity.
8) Ethical issues to be considered
Dr. Tsukayama presented "Ethical consideration on
conducting and publishing randomized controlled trial".
He introduced ethical standards and international guidelines for ethics in the biomedical field14).
There are three ethical standards in the biomedical
field, which is the Nuremberg Code (1947), Helsinki
declaration (1964) and the Belmont Report (1974). The
Belmont Report is ethical principles and guidelines forthe protection of human subjects of research and stand-24
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ards for Institutional Review Board. Also, there are threeinternational guidelines for ethics in biomedical field as
follows. (1) Good Clinical Practice guidelines (GCP) aredeveloped by International Committee on Harmonization (ICH), (2) International ethical guidelines for biomedical research involving human subjects is developed
by Council for International Organization of Medical
Sciences (CIOMS) and (3) Uniform requirements formanuscripts submitted to biomedical journals: writingand editing for biomedical publication made by the international committee of medical journal editors.
He used most of his time to introduce important thing
about Institutional Review Board/Independent Ethics
Committee (IRB/IEC) in ICH/GCP. Table 4 summarizes
the responsibilities of IRB/IEC closely related to theprotocol development for the clinical trials. These issues
are also important to develop a final protocol and actual
conduction of clinical trials.
IV．General discussion
During the general discussion session, question fromthe floor was not allowed because we need much time to
discuss about the protocol which already presented by
Korean team.
Because shortage of time, Dr. Shichidou asked several
questions as a representative of the Japanese team as
they had another workshop for discussion of the protocol.
VAS is used as the primary outcome measure andsecondary outcome measures are WOMAC, Quality ofLife (SF-36), Lequesne Functional Index (LFI) score,and physical function was evaluated by the Health assessment Questionnaire (HAQ). He suggested that
WOMAC includes pain, stiffness and physical function
items, so it is better to use WOMAC. Other measures are
not necessary. In case of contradictory results obtained
among the outcome measures, it is very difficult to explain the results. Repeated measurements of similar
items in different questionnaires may also induce severe
statistical errors. Another important point he mentioned
was issues of individualized and standard interventions15). In the protocol, de-qi is required in the individualized intervention, whereas no de-qi in the standard
group. There are two factors included in the interventions, the location difference of acupuncture points andinduction of de-qi or not. If we got the significant result
among the two groups, we have no idea which is thecause of the results. This is also important issue to beconsidered.
Finally all of members of both countries agreed to reconsider the protocol based on the discussion today, andto have a next meeting in the near future.
Appendix
All six speakers kindly agreed to exhibit their slides tothe members of the JSAM, KAMS and KOMS for promoting the clinical research in both countries. It is allowed for the personal use only, so please do not use forother purposes. You can see these slides at the homepages of the JSAM, KAMS and KOMS soon.
References
1) Jackson A, MacPherson H, Hahn S. Acupuncture fortinnitus: a series of six n=1 controlled trials. Complement Ther Med. 2006; 14: 39-46.
2) Takahashi N, Clinical trial of acupuncture using nof-1 RCT. J Japan Society of Acupuncture andMoxibustion. 2005; 55(3): 363 (in Japanese).
3) Park J, White A, Stevinson C, Ernst E, James M.
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