KAIM
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Kaammppoo,, A
Accuuppuunnccttuurree aanndd IInntteeggrraattiivvee M
Meeddiicciinnee
INTERNATIONAL INSTITUTE OF HEALTH AND HUMAN SERVICES,
BERKELEY
Volume 8, Number 1 ･ Spring 2013

Editorial

Clinical Practice Guidelines including Acupuncture
Hitoshi Yamashita

Japanese Acupuncture - Current Research

Japanese Traditional Medicine Text (7) – Orthopedic Disorders, D Acupuncture Research for Stiff Shoulders
Tomokazu Kikuchi

Kampo Medicine - Current Research

Clinical Experience for Functional Sterility, Complicated with Irregular Menstruation and Anovulatory Cycle, Administrated of Saireito
Takeshi Nakayama

Clinical Report 1 (Acupuncture)

Safety and Effects of Acupuncture Treatment Using Filiform Needles for Hemodialysis Patients
Hinata Sakuraba, Hiroshi Kondo, Shuichi Katai, Tomomasa Moriyama, Hiroaki Kinoshita, Takashi Ishizu and Aki Hirayama

Clinical Report 2 (Kampo Medicine)

Cornelia de Lange Syndrome with Recurrent Pneumonia
Hideaki Yamaguchi

Conference Report

The 3rd JSAM International Symposium on Evidence-based Acupuncture- Evidence of the Effectiveness of Acupuncture for Headache Hitoshi Yamashita

ISSN:1559-033X

College Logos
We believe it is necessary to create a new way of thinking
for the total understanding of "Life, Survival, and Health".
We decided to coin the world "Lifence" to express this.
Lifence means the combination of life sceince and medicine
as well as other disciplines such as health science, psychology,
ethics, etc.
Our college logos symbolizes the above.
The ripple effect represents the ocean and the birth of life.
The rainbow colored sphere represents a safe environment
and a barrier to protect us from negative influences.
The picture by Leonardo da Vinch represents a balanced
body and health.
Completing our logos is a ring which represents the unity ofspace fulfilling the total meanings of lifence.

―

The Journal of
Kampo, Acupuncture andIntegrative Medicine(KAIM)
Research on Theory, Practice and Integration

Volume 8, Number 1 ･ Spring 2013

EXECUTIVE EDITOR

Shuji Goto
Chairman, GOTO College ofMedical Arts & Sciences

TA B L E O F C O N T E N T S

Tokyo, JapanASSOCIATE EDITORS
Shuichi Katai

1 Editorial
Clinical Practice Guidelines including Acupuncture
Hitoshi Yamashita

Ibaraki-ken, Japan

Hiromichi Yasui
Tokyo, JapanEDITORIAL STAFF

Akihiro Souma
Hiromi Sasaki
Hiroshi Tsukayama
Hitoshi Yamashita
Junko Okubo
Kazunari Ozaki
Kengo Nakata
Masayuki Kashima
Naoya Ono
Noboru Mitsuhata
Sayaka Toda
Takao Namiki
Toshiaki Makino
Toshihiro Togo

PUBLISHER

Shuji Goto
International Institute of Health andHuman Services, Berkeley
2550 Shattuck Avenue, Berkeley
California 94704-2724, U.S.A.

2 Japanese Acupuncture - Current Research
Japanese Traditional Medicine Text (7) – Orthopedic Disorders, D Acupuncture Research
for Stiff Shoulders
Tomokazu Kikuchi

6 Kampo Medicine - Current Research
Clinical Experience for Functional Sterility, Complicated with Irregular Menstruation andAnovulatory Cycle, Adinistrated of Saireito
Takeshi Nakayama

12 Clinical Report 1 (Acupuncture)
Safety and Effects of Acupuncture Treatment Using Filiform Needles for Hemodialysis
Patients
Hinata Sakuraba, Hiroshi Kondo, Shuichi Katai, Tomomasa Moriyama, Hiroaki Kinoshita,
Takashi Ishizu and Aki Hirayama

19 Clinical Report 2 (Kampo Medicine)
Cornelia de Lange Syndrome with Recurrent Pneumonia
Hideaki Yamaguchi

20 Conference Report
The 3rd JSAM International Symposium on Evidence-based Acupuncture- Evidence of the Effectiveness of Acupuncture for Headache Hitoshi Yamashita

MISSIONTo disseminate peer-reviewed information on the use of acupuncture and herbs, and integration with western
medicine, based on research from an international perspective; thereby stimulating further research, applicationof documented therapeutic measures; and facilitating dialogue among health care practitioners worldwide.

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)KOTARO PHARMACEUTICAL introduced in 1957 the world's first Kampo extract
preparations on the market. Later, in 1967, six of our preparations could be covered in Japanfor the first time by the health insurance and after 1976 more than 100 of our preparations
were used in hospitals and clinics. Now it is half a century since we put our Kampo extract
preparations on the market and believe, we made a major contribution to this industry.
In the future we intend to continue working in accordance with our company motto: "Still better
Kampo for still more people" and provide pharmaceutical products of still higher quality.

Origin of the company's name
The company was named "KOTARO" by its
founder Taro Ueda with reference to his birthplace. Close to the ancient city of Nara. Kotaro
is the name of an enormous sheer cliff, 700 m
wide and about 200 m high. Mr. Ueda felt anaffection rising to the heavens for this cliff andthus made it the company's name.

KOTARO PHARMACEUTICAL CO., LTD.
5-23 Nakatsu 2-Chome, Kita-ku, Osaka 531-0071, JAPANURL: http://www.kotaro.co.jp

Volume 8, Number 1 | Spring 2013

Editorial
Clinical Practice Guidelines including Acupuncture
The NICE Guidelines (UK) for low back pains and headaches provide information about
acupuncture, as is well known, but evidence-based clinical practice guidelines published in Japan havealso begun to contain such information in recent years. As of 2013 at least, seven guidelines in Japan
provide information about acupuncture. Among these, a grade of recommendation of A or B is given toacupuncture for low back pain, fibromyalgia, chronic headache (excluding tension-type headache, which
is given a C grade of recommendation), and tennis elbow. A grade of recommendation of C is given to
facial paresis and non-odontogenic toothache, and D is given to alopecia areata (acupuncture should not
be performed). Such information about acupuncture is supposedly based on systematic reviews or metaanalyses of randomized controlled trials (RCTs), but in reality,there are some guidelines in which
judgments have not been properly drawn out. For example, compared to the NICE guidelines, Japaneseguidelines for tennis elbow overestimates acupuncture, as the grade of recommendation is based on the
old Cochrane systematic review, while the guidelines for tension-type headache underestimates
acupuncture. With respect to alopecia areata, its grade of recommendation goes against the guidelines’
definition of recommendation grade to begin with, and is self-contradictory.
Thus, although clinical practice guidelines that deal with acupuncture treatment also exist in Japan,
they are not yet sufficiently reliable. Why is this so? One reason is perhaps the absence of any committeethat is well-versed in acupuncture treatment and aptly suited to preparing guidelines on the treatment ofvarious diseases. Unlike drug therapy, clinical practice and RCT for acupuncture is complex and unique,so it is difficult for those who are not familiar with this difference to determine the grade ofrecommendation of acupuncture treatment. Sham acupuncture is frequently regarded as a control in
relation to acupuncture treatment, but it actually differs from a placebo in an RCT of a drug, as it hascertain specific effects. Another problem is that clinical practice guidelines in Japan mostly refer to RCTsof TCM acupuncture, due to the lack of sufficiently examined and publishedevidence of Japanese
acupuncture treatment.
The fair evaluation of acupuncture treatment in clinical practice guidelines requires the participationof specialists who have knowledge of the characteristics of acupuncture practice and research. Whencompiling guidelines on diseases for which evidence of acupuncture treatment is gradually being
accumulated, an open framework that invites the participation not only of physicians but also
acupuncturists is thought to be instrumental to producing even fairer guidelines. Toward this end, it isimportant that acupuncture clinicians and researchers make greater efforts to more widely disseminate
and raise awareness of the differences between acupuncture studies and pharmaceutical studies.

Hitoshi Yamashita, Lic. Ac., Ph.D.
Professor, Graduate School of Health Sciences
Morinomiya University of Medical Sciences, Osaka, JapanThe Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

1

Volume 8, Number 1 | Spring 2013

Japanese Acupuncture - Current Research
Japanese Traditional Medicine Text (7) – Orthopedic
Disorders, D Acupuncture Research for Stiff Shoulders

Tomokazu Kikuchi

Center of Oriental Medicine
Saitama Medical University Hospotal

The 2010 National Lifestyle Survey1) found that
Stiff Shoulders were the number one complaint for

presents with organic disease symptoms, if there are
no objective shoulder stiffness findings, it is labeled“Psychogenic Shoulder Stiffness”. In this paper, we
will be discussing shoulder stiffness that is not theresult of critical changes due to diseases orconditions that cannot be confirmed as neurologicalabnormalities.
1. Pathophysiology of Stiff Shoulders

women and the number 2 complaint for men, with

Until recently, the pathophysiology of stiff

more than 90% of the population having had

shoulders has been categorized as follows: instability

experience with the condition. However, medicallyof the cervical intervertebral discs, local tension in

speaking, Stiff Shoulders are a subjective complaint

the sympathetic nervous system and additionally,

with no clear definition. Further, in 2004, a study forcirculatory disorders influencing the nerves andorthopedic“StiffShouldermuscles. On the other hand, as for neck pain, causes

subjective

physicalhave been hypothetically explained as due excessive

symptoms including muscle tension and stiffness

muscle stimulation causing excessive tension in(Korikan) extending from the neck to the scapularintervertebral joints, cervical discs or nerve roots as

area, characterized by a sense of pressure andthey relate to referred pain. Additionally, it is often

dullness, but presented no clear definition ofthought that shoulder stiffness is a condition with

objective findings. Stiff shoulders are often said to bemostly non-specific symptoms involving a viciousa uniquely Japanese symptom but epidemiologicalcycle of pain compounded by additional psychologicalcomparisons between the United States and Europe

and sociological factors2).

Research

physicians
Project”2)

calledfoundfor [neck pain] and [stiff shoulders] found these
symptoms distributed within and between different
age groups and across gender lines. On the other
hand, according to a National Survey (multiple
answers possible) of people who sought treatment for
stiff shoulders 24.6% went to hospitals, 20.1% went
toclinics

and

59.6%

went

to

acupuncture,

moxibustion and massage practitioners. Clearly alarge proportion of the population are receiving
treatment from Acupuncture, Moxibustion and
Massage.

Classical

Oriental

Medicaltheorydescribes damage by cold in the neck, shoulders,
upper back leading to stiffness and pain.
Within the field of Pain Clinics, stiff shoulder isdivided into three categories. The first has no clear
pathology and is referred to “Essential Shoulder
Stiffness”. The second type may arise from spinal
disorders or underlying shoulder disorders and isreferred to as “Symptomatic Shoulder Stiffness”.
Finally, regardless of whether or not the patient2

2. Acupuncture Treatment for Stiff Shoulders
With the exclusion of the psychological andsociological background attached to stiff shoulders,the functional abnormalities seen in the sympathetic
nervous system, circulatory disorders influencing
the muscles and nerves begin to form a clearer
clinical picture. For the purposes of Acupunctureand Moxibustion treatment, keeping in mind thepossibility of stimulating the subcutaneous tissues,
we can anticipate effects in the skin, muscles, fascia,
intervertebral joints and the peripheral nerves. It
has been estimated that the effects of acupuncture
are due to improved circulation in muscles andnerves 3) and may be due to normalization of theautonomic nervous system mediated by higher levelsof the central nervous system. The principle areas
for stimulation are along the back of the skull,
trapezius muscles of the neck and head and semispinalis muscle of the head (UB10, GB20), the

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

Volume 8, Number 1 | Spring 2013

insertions of the Sternocleidomastoid and theinvestigate which tissues will be stimulated beyond

Splenius muscles of the head (GB12), on the uppertheportion if the Trapezius (GB21), muscles that cross

Additionally, the problem now is that, even if shamalong the inter-scapular area (UB43), also, areas ofacupuncture is used as a placebo control, it has been

the Splenius and the Scapulae Levator and theshown to have a physiological stimulus. From now,insertion of the Splenius at the superior border of the

we must investigate the causes of Shoulder Stiffness,

scapula (SI14). Common methods of stimulation

how to conduct acupuncture to stimulate specificinclude embedded needles, manual stimulation oftissues and to grasp how this stimulation effects thefiliform needles, and electro-acupuncture. It isdisease process.

necessary to pay careful attention to the patient’s
condition and level of pain so that the stimulation
can be appropriately adjusted.

superficial

pre-determinedacu-point.

4. Characteristics of Shoulder Patients and ClinicalStatusCompared to Westerners’ “Stiff Neck Pain“,

3. Acupuncture and Moxibustion Treatment for Stiff

Japan’s stiff shoulders represent deeper psycho-

Shoulders–The Condition of Research Abroadsocial stress. Japan’s Historical and Cultural

We performed a literature review of clinical trials

background are thought to have been influential inon the effectiveness of Acupuncture and Moxibustion

the development of this uniquely Japanese shoulder

Therapy for Stiff Shoulders conducted by foreign

stiffness. The consensus is that Japanese culture

researchers.「PubMed」was used as the dedicatedavoided, as much as possible, descriptions of

Data Base for the literature review.

psychological symptoms that appeared, instead,included[neck

stiffness],pain],[shoulder[neck

Key Words

disorders],

stiffness],[neck[acupuncture],focus was placed on their physical representation. To
betterunderstandtheclinicalefficacyof[moxibustion], [randomized controlled trial]. We are

Acupuncture treatment for Stiff Shoulders wereporting on basic research and original content

conducted a Literature Search. Using a database ofstandards. Our exclusion criteria eliminated reviews

prominent Medical School Journals including theand commentaries from this report. We found 23

following keywords: Stiff Shoulders, Neck Pain,

reports that could be included. Evaluation methods

Acupuncture,included mostly VAS scores, NDS and SF-36 wereControlled Trials. The search provided 4 appropriate

also seen here and there. The most common type ofreferences. Nakajima5) compared a local pain relief

control was a “no treatment” control group, placebo

injection group with an acupuncture group. Reported

control (non-meridian acu-points or skin stimulation

results showed that for neck pain, acupuncturegroups).TENS groups and massage groups were also

treatment was more effective in the short term andused as comparative control groups. Compared to theover the long run, so compared to other treatment“noacupuncture

methods, acupuncture was more effective. Nabeda ettreatment could be accepted as a valid treatment

al. compared the superficial needle only andmethod. However, when compared with placebos orretaining needle after the needling sensations at theother treatment-type controls, the point of view

tender point, no difference was found within andabout acupuncture efficacy was not unified. Thisbetween groups after 1, 2, 3 weeks. Furuya et al., 7)

paper is targeted to non-specific shoulder problems

investigated using 0.6mm embedded needles and(stiffness); as there are a variety of locations andplacebo type embedded needles (using just thecauses of shoulder pain (work related, postureprotective tape), comparing the baseline to post-

related,stimulation

treatment”

etc.).

acupuncture

control

Althoughisgroups,thearea

3-dimensional,

treated byfewreports

Moxibustion,

readings

and

and

3

days

Randomized

after

the

stimulation, they found that the subjects with true

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

3

Volume 8, Number 1 | Spring 2013

embeddedneedlesexperienced

significant

5. Future Prospects

improvement. Further, comparing positive andRather than treat stiff shoulders as simply anegative results of a load test on the cervical spine,

symptom, we consider it necessary to assess thewhile groups testing intervertebral joints and discs

exact background factors to grasp underlying

demonstrated no changes is test results, it was

disease processes and clarify which tissues are being

reported that in test groups for muscles and fascia,

over-stimulated by life style factors and which areas

test changes were effectively confirmed. On the otherneed to be treated to return the body to normal

hand, Ito et al.8) used a Trigger Point (TP)function. We suggest performing comparative trials,

Acupuncture

group

and

a

Standardized

Acupuncture group, comparing these to shamacupuncture, after the treatment they reported that
only the TP group’s VAS scores dropped significantly.
Because the research subjects were students andfacultymembers,

consideredtoa“volunteer

bias”

certaindegree.

shouldbe

However,

acupuncture treatment for stiff shoulders bytreating muscles and fascia was found to be highly
useful compared to treating with TP or the cervicalspine.

if possible, by separating subjects into specificgroups based on their personal reports, clinicalfindings and discrepancies between these. For
example, dividing subjects into groups with personal
pain reports (specific pain in a localized area) thatcoincide with clinical findings or a group with pain
(non-specific pain) that conflicts with clinical finding.
These subgroups with shoulder stiffness complaints
could then be compared using tests that provide
reproducible results (such as localized pressure painat specific points of the joint, range of motion andmuscle strength tests). Concerning evaluation
methods, beyond the VAS pain indicator, QOL scaleswith multi-faceted questions and possible responses
should be used. We have already been developing a

Table 6: The change of acupuncture before and after with SF
─36 and WAI by acupuncture treatment

non-specific task score/ protocol based on Furuya etal.’s work with embedded needles for VDT workers
with non-specific shoulder pain. So for subjects with

BeforeAfter
1 month

P value

Mental Component Score

51.3±6.3

53.1±5.8<.0001

measures to clarify the usefulness of acupuncture forPhysical Component Score

44.0±10.047.2±8.5<.0001

improving work effectiveness9,10) and align the

Physical functioning

53.6±6.4

54.0±6.4.5998

treatment with background factors that may be

Role physical46.4±10.6

48.9±7.0.0167

causing shoulder pain (Table 6). On the other hand,

Bodily pain

42.4±9.0

48.9±9.0＜.0001the most significant problem has become using

Vitality

48.5±9.0

50.5±8.0.0714“sham”

General health perceptions

44.7±10.1

46.7±9.2.1286

Social functioning

50.5±9.7

50.7±7.4.9709

Role emotional48.9±9.749.1±9.4.8434

an acupuncture point has been shown to activate

Mental health47.2±9.1

48.9±8.0.1134

Polymodal receptors in the epidermis, so using

Work ability index

36.1±6.5

37.4±5.7.0058

normal filiform needles (豪鍼) for sham needling was

Wilcoxon lunk sine test, n=61, mean±S.D.

shoulder pain, we used VAS and QOL (SF-36)

acupuncturewhenestablishingthecomparison groups for acupuncture. So far only
embedded needles have been considered appropriate
because even the mere application of a guide tube toconsidered unrealistic. At present, comparison withother treatments and acupuncture stimulation site

4

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

Volume 8, Number 1 | Spring 2013selection methodologies, acupuncture RCTs should
be used to investigate the specific effects of background factors on shoulder pain. In the future,
multifaceted evaluation results should be used todetermine what back ground factors contribute tostiff shoulders, Acupuncture RCTs should becompared with other treatments and point selection
methodology should be investigated to achieve
specific effects.
References
1)

MinistryofHealth,

Labor

and

Welfare:Overview of the national livelihood Census,
2006, 2007.
2)

Kenji Takagishi et al.: Research Project on theShoulder (2004-6). Japan Society of Orthopedic
Surgery 82(10): 901-911, 2008

3)

Tomokazu Kikuchi et al.: Effect of electroacupuncture stimulation on circulation to thetrapezius muscle─ 99mTcO4 ─A study using theclearance method. Kampo Medicine 61(6): 834839, 2010

4)

Satoshi Yamaguchi: Effects of Acupuncture
Treatments: Trends in Research Findings. The
Journal of the Japanese Society of Balneology,
Climatology and Physical Medicine58 (4): 232240, 1995

5)

Miwa Nakashima et al.: Study on acupuncture forneck pain by a randomized, controlled trial withlocal injection. Journal of Japan Society of
Acupuncture and Moxibustion 57(4): 491-500, 2007
6) Tomoyuki Nabeta et al. Randomized controlled
pilot study of acupuncture on neck stiffness.
Journal of the Japan Society of Acupunctureand Moxibustion; 47(3): 173–81, 1997
7) Eiji Furuya, et al.: The Effects of Thumbtack
Needling on Upper Back Muscle Stiffness,
Journal of Japan Society of Acupuncture andMoxibustion, 52 (5): 553-561, 2002.
8) Kazunori Ito et al.: Trigger point acupuncture
trials on University students with shoulder
stiffness─A Questionnaire Survey from theresults of Acupuncture Clinical trials. Journal ofJapan Society of Acupuncture and Moxibustion
56(2): 150-157, 2006
9) Rika Suzuki et al.: Effects of Acupuncture for
VDT workers (1) Influence on Neck, Shoulder
Stiffness and Eye Strain. Journal of Japan
Society of Acupuncture and Moxibustion 60(5):829-836, 2010
10) Tomokazu Kikuchi et al.:Effects of
Acupuncture for VDT workers (2) Influences on
QOL and Work Productivity and Comfort.
Journal of Japan Society of Acupuncture andMoxibustion 61 (1): 51-58, 2011

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

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Volume 8, Number 1 | Spring 2013

Kampo Medicine - Current Research
Clinical Experience for Functional Sterility, Complicatedwith Irregular Menstruation and Anovulatory Cycle,
Administrated of Saireito
Takeshi Nakayama
Department of Obstetrics and Gynecology,
Shizuoka Kosei Hospital[Abstract]
Kampo therapy for sterility is often used as single
or adjunctive agent medicated with a western
medicine, for primarily treating the functional
abnormalities such as anovulation. Typically, thechiefpatternsofadministrationaretokishakuyakusan, unkeito, and other agents that
improve blood deficiency. Many researches havebeen reported concerning their efficacy in treatmentof sterility. In recent years, however, many patterns
other than the type of blood deficiency may bepresent due to food satiation and the stress-relateddisease. Thus, newer approaches of Kampo therapy
adapted for the modern age would be necessary forthe treatment of sterility.
Therefore, we tried administrating saireito, aformulation to treat Qi stagnation and fluid
retention, for patients with sterility complicatedwith irregular menstruation or anovulatory cycle. Its
excellent efficacy was demonstrated by assessmentof changes in sex hormonal levels, the recovery rateof menstrual cycle, and the rates of ovulation andpregnancy before and after the oral administration.
Since saireito has ever exerted the alleviating effecton stress in some cases in addition to the improving
effect on ovarian function, it is estimated to be aneffective administration for patients with sterility
accompanied with the menstrual irregularity or the
anovulatory cycle.
Key words: Primary Sterility, Saireito, Irregular
Menstruation, Anovulatory Cycle

6[Introduction]
Saireito is a combination formula made up of
shosaikoto and goreisan for the treatment of
stagnation of liver Qi and fluid disturbance. It is
supposed to have endogenous steroid hormone-likeactions and inhibits platelet aggregation and its
effects for the treatment of gestational edema andhabitual abortion have been confirmed in the field ofobstetrics and gynecology. Recently it has reportedly
shown to be effective for polycystic ovary syndrome
and is therefore expected to be an effective
therapeutic drug for the treatment of abnormal
endocrine metabolism.
In infertility patients, the presence of "Qi" disorder
like Qi depression or Qi stagnation has been pointed
out. Moreover, the metabolic syndrome has developed
into a social problem, so there are not many cases
which blood deficiency is the predominantly major.
Therfore, we tried saireito in patients with functional
sterility complicated by irregularities of menstruation
or ovulation disorders. We examined variations infemale hormone concentrations, menstrual cycle,
variations in ovulation ratio and the occurrence ofpregnancies associated with the internal use ofsaireito to determine whether saireito is an effective
drug for the treatment of infertility.
[Methods]
During the period from January 2008 until December
2011, we prescribed saireito extract granules (Kracie)
8.1 g/bid before the meals after obtaining a sufficient
informed consent for 24 (average age 34.7±4.5 years)out of 89 patients who visited our clinic with thedesire to have children and presented with irregularmenstruation like oligomenorrhea or amenorrhea andwere diagnosed to suffer from ovulation disorders orfunctional sterility. Patients with organic factors likemyoma uteri or the like female factors or else male
factors were excluded. Each individual patientunderwent oriental medical examinations to establish
the disease pattern that were subsequently analyzed,
but prescribed saireito regardless of the pattern. For
this reason the formula may possibly have have been
administered for off-label use. The ethics committeeof our clinic discussed the issue and approved, that in

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

Volume 8, Number 1 | Spring 2013

cases of apparent deviation from the pattern patientsin question were excluded from the study. Bloodexaminations
wereperformed
beforetheadministration, 4 and then 8 weeks later between the
5th to 7th day after onset of the menstruation and thevariations in the measured LH, FSH, LH/FSH,
testosterone values examined. Also, any variations in
the menstrual cycle and the occurrence of ovulations
before and after the administration of saireito wereconfirmed with reference to the basal bodytemperature. Establishment of pregnancies was later
confirmed by the delivery.

The occurrence of adverse events related to theinternal use was also investigated. We attempted at
the same time also to make a comparative study
pertaining to Qi, Blood and Water including all
infertility patients, those treated with saireito as wellas the patients in whom pregnancies occurred after
treatment with saireito.
[Results]
The 24 infertility patients presenting with irregularmenstruation were treated with saireito. In 15 ofthese patients a recovery of the menstrual cycle could
be observed (menstrual cycle improvement ratio 63%).
Also, based on the basal body temperature ovulations
were observed in 14 of the patients with anovulatory
cycles and among these ovulation was definitely
established in 9 patients (ovulation ratio 64%).

Table 1: List of patients who became pregnant
Age

BMI

Gravidity

ParityAbortion

Menstrual cycle

Menstrual(before)(after)cycle

OvulatiOvulation

Durationon(after)until(before)PCOS

pregnancy(Cycle)
4

No

Yes

3

Yes

Yes

Yes

2

No

Normal

No

Yes

4

No

Oligomenorrhea

Normal

No

Yes

3

No

0

Oligomenorrhea

Normal

Yes

Yes

6

No

1

3

Oligomenorrhea

Normal

Yes

Yes

7

No

1

1

3

Oligomenorrhea

Normal

No

Yes

2

No

20.7

1

1

1

Oligomenorrhea

Normal

Yes

Yes

6

No

32

18

0

0

0

Oligomenorrhea

Normal

No

Yes

5

Yes

11

34

23.6

0

0

0

Oligomenorrhea

Normal

Yes

Yes

4

No

12

34

19.3

0

0

0

Oligomenorrhea

Oligomenorrhea

Yes

Yes

6

Yes

13

37

17.4

0

0

0

Oligomenorrhea

Oligomenorrhea

No

Yes

12

No

14

40

24.9

0

0

0

Oligomenorrhea

Oligomenorrhea

No

Yes

4

No

15

37

21

2

1

1

Oligomenorrhea

Normal

Yes

Yes

3

No

16

39

39

2

2

0

Oligomenorrhea

Normal

Yes

Yes

7

No

1

33

26.6

1

1

0

Oligomenorrhea

Normal

No

2

28

17.5

1

0

0

Oligomenorrhea

Normal

No

3

34

19.9

0

0

0

Oligomenorrhea

Normal

4

34

20.1

0

0

0

Oligomenorrhea

5

42

28.4

2

1

1

6

33

22.6

0

0

7

40

21.1

5

8

31

21.8

9

24

10

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

Yes

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Volume 8, Number 1 | Spring 2013

Among the 24 infertility patients pregnancies
occurred following treatment with saireito in 16
women (pregnancy rate 67%, see Table 1).
Treatment duration with saireito until establishmentof pregnancies was on the average 4.9±2.5 weeks.
Moreover, while 6 out of the 24 patients werediagnosed with Polycystic Ovary Syndrome (PCOS),
pregnancies occurred in 3 of those patients(pregnancy ratio 50%). A breakdown of the outcomein the 16 women who got pregnant showed ongoing
pregnancies in 14 (87%) women and spontaneousabortion in 2 (13%). The delivery in those women, who
actually gave birth was uneventful for both motherand child, considered to be also due to the fact, thatthe children had simultaneously been medicated andobvious anomalies were not observed.
Regarding fluctuations in the gonadotrophic hormone
levels the LH values before, 4 and 8 weeks
respectively after the administration were 7.1±4.8,
5.5±2.8 and 4.7±1.1 mIU/ml. While the LH
concentration tended to be both before and after theadministration low, significant differences were notobserved. The LH/FSH ratio was 0.88±0.62, 0.62±0.27
and 0.55±0.13 respectively and decreased significantly
before and afer the administration.(P<0.05). No
significant differences were observed in FSH andtestosterone levels (Figure 1).

Adverse events associated with the internal use
included the occurrence of mild diarrhea, vomiting
and similar symptoms of gastroenteritis in one
patient (4.2%), but these were alleviated bydiscontinuing the medication. Otherwise, including
clinical laboratory tests, no problematic side effects
were observed.
Examination of Qi, Blood and Water during the visitsof the 89 infertility patients showed Qi deficiency in
31 cases (35%), Qi stagnation in 39 (44%), Blooddeficiency in 50 (56%), Blood stagnation in 31 (35%)
and Water stagnation in 26 (29%) patients. Regarding
the 24 patients treated with saireito 9 (38%)
presented with Qi deficiency, 10 (42%) with Qi
stagnation, 13 (54%) Blood deficiency, 10 (42%) Bloodstagnation and 8 (50%) with Water stagnation.
Among the 16 women in whom a pregnancy occurred 6(38%) presented with Qi deficiency, 6 (38%) with Qi
stagnation, 8 (50%) Blood deficiency, 7 (44%) Bloodstagnation and 7 (44%) with Water stagnation (Table 2).
Table 2: Patterns in infertility patients and patientstreated with saireito

All
infertility
patients(89
patients)
Patients
treatedwithsaireito(24
patients)
Patients
treatedwithsaireito inwhomapregnancy
occurred

Figure 1: Fluctuations in hypophyseal hormones
associated with the administration of saireito

8

Qi

Qi

Blood

Blood

Water

deficiency

stagnation

deficiency

stagnation

stagnation

31/89

39/89

50/89

31/89

26/89

(35%)

(44%)

(56%)

(35%)

(29%)

9/24

10/24

13/24

10/24

8/16

(38%)

(42%)

(54%)

(42%)

(50%)

6/16

8/16

8/16

7/16

7/16

(38%)

(50%)

(50%)

(44%)

(44%)

[Discussion]
The factors responsible for female infertility canbroadly be classified into functional and organic
disorders. Disorders of tubal patency, intrauterine
disorders, peritubal adhesion, myoma uteri,endometriosis etc. can be mentioned as organic

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

Volume 8, Number 1 | Spring 2013

anomalies, but the progress in assisted reproductive
technology (ART） and fiberscopic surgery have led toremarkable improvements in therapeutic results1).
While progress in recombinant preparations andgonadotropin therapies allowed to achieve higher
ovulation ratios in cases of functional anomalies, thepregnancy ratio has not markedly changed andconditions like ovarian hyperstimulation syndrome(OHSS) and multiple pregnancies cannot be avoided.
The results of infertility treatment have improved
remarkably, but there are still some infertility
patients whose cause is unknown, and even if theinfertility treatment with ART is performed, there aremany patients who have difficulty getting pregnant
because of infertility2). Among oriental medical
concepts regarding infertility the "kidneys" arethought to control reproduction, so that the condition
is considered to be based on menstrual anomalies due
to "kidney deficiency"2). However, the condition isoften influenced by multiple factors like anemia andchilling correlated to "Blood deficiency", "Bloodstagnation" caused by circulatory insufficiency,
stress-induced mental conditions like "liver
depression and Qi stagnation", "disorders of the
body's fluid metabolism" due to disorders of pelvic
blood flow etc., which often are present in various
combinations (Figure 2). Some reports state, that
abdominal or tongue examinations showed in actual
clinical practice a close correlation of liver depression
and Qi stagnation, "Blood stagnation" and "disordersof the body's fluid metabolism" with infertility, so that
Bupleurum preparations or drugs for overcoming
Blood stagnation are effective2). Regarding the"pattern" of infertility a study conducted in 1989
showed that approximately 65% of the cases
presented with a deficiency pattern, while excess
patterns were reportedly found in less than 10%.
Regarding anomalies of Qi, Blood and Water "Qi
deficiency" was reported found in 32%, "Qistagnation" in 37%, "Blood deficiency" in 61% and"Blood stagnation" in 22% respectively3). For thisreason formulas for the treatment of "Blooddeficiency": Tokishakuyakusan and unkeito were
frequently chosen and there are multiple reports on
their effects in the treatment of infertility4,5).

Figure 2: Pathology in modern infertility patients(personal proposal)

Qi deficiency

Qi stagnation

Water
stagnation

Anxiety, insomnia, loss ofappetite

Irritability

Edema, obesity,
anomalies ofdischarge

Blood
deficiency

Dietary
weight loss

StressAnemia, xerosis cutis
Circulatory
insufficiency
Blood Dysmenorrhea,
stag- Circulatory failure
nationDysmenorrhea,
ovulation disorder

Saireito is a combination formula composed ofshosaikoto and goreisan that includes 12 crude drugs
and is designed to alleviate stagnation of liver Qi anddisorders of the body's fluid disturbance. The originaltext in the "Shi yi de xiao fang 世医得効方）(Effective
Formulas from Generations of Physicians " by Wci
Yi‐Lin (危亦林 1277-1347) says "very effective forcuring wind damage, summerheat damage andmalaria" and the formula was mainly used for
conditions associated with inflammation. Asada
Sohaku's text "Futsugo Yakushitsu Hokan" contains
the passage: "This formula is used for people with ashosaikoto pattern to alleviate feelings of distressaccompanied by excessive thirst combined withdiarrhea. It is particularly effective for summerheat
epidemics.", describing the symptoms of theshosaikoto pattern. Main indications are nephrotic
syndrome, chronic nephritis and similar renal
diseases, chronic hepatitis etc. where a mild degree of
edema is observed, heat stroke and the like acuteforms of enteritis, exudative otitis media, habitual
headache as well as a combination with steroid
hormones (to reduce dose or alleviate side effects).
Regarding the mechanism of action it has beenreported to stimulate the hypothalamus – hypophysis– adrenal system, while Glycyrrhizae Radix inhibits
the cholesterol metabolism in the liver and reportedly
increases steroid production6). In the field of obstetrics
and gynecology saireito is used for the gestational

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

9Volume 8, Number 1 | Spring 2013edema associated with habitual abortion, and usedespecially often during pregnancy. Saireito
administered as a treatment of habitual abortion has
been reported to be safe for the fetus even during fetalorgan period7). It is therefore presumed to be one ofsafe therapeutic drugs for patients desiring to havechildren. Recently multiple reports describing cases
in which pregnancies have been established throughtreatment with saireito have been published8,9). We
therefore conducted this study based on theassumption, that saireito is an effective formula forthe treatment of infertility.
When 24 patients complaining of infertility associatedwith menstrual irregularities were treated withsaireito, pregnancies were established in 16 of thesepatients (67%) within a period of 4.9±2.5 weeks. In 9(64%) out of 14 patients in whom anovulatory cycles
were observed, ovulations were confirmed based on
the basal body temperature. In former reports about
Kampo treatment for infertility tokishakuyakusan
led to an ovulation ratio of 44% and a pregnancy ratioof 22%, while Unkeito similarly led to an ovulation
ratio of 50-60% and a pregnancy ratio of 18%10). Thus,
compared to the aforementioned Blood deficiency
improving formulas, saireito achieved even higher
ovulation and pregnancy ratios. Comparing the levelsof the gonadotrophic hormones before and afteradministration showed a decreasing tendency for LH
values and moreover a decrease in the LH/FSH ratio
Saireito
probablystabilizes
the(P<0.05).
gonadotrophic hormone balance, thereby possibly
enabling an effective action at hypophseal hormone
levels. Regarding PCOS the number of cases was few
with only 6 patients, but in 3 (50%) of those apregnancy was established. Thus, establishment ofpregnancies was observed in a comparatively highnumber of cases treated with saireito.
Generally, clomifene citrate or gonadotropin
preparations are used for in the field of infertility
therapy as the therapeutic drug for the treatment ofovulatory disorders. Yet, since they might cause thedevelopment of OHSS besides their other effects,
multiple pregnancies could develop in case of
superovulation. For these reasons the benefits of
Kampo therapy with its fewer side effects is currently

10

reconsidered. Some reports point out, that in modern
society the pathology of infertility patients suggests a
strong psychosomatic correlation, which bestows
great importance on healing "Qi" anomalies with the
Kampo therapy11). In particular "liver depression and
Qi stagnation" and "disorders of the body's fluid
metabolism" are frequently observed pattern in
infertility patients, so that saireito, designed to healstress or obesity seems to the indicated for the"pattern" of modern infertility patients. In practice
Murata's report in 1989 found that 32% of thepatterns were "Qi deficiency", 37% "Qi stagnation",
61% "Blood deficiency" and 22% "Blood stagnation"3),while the current study revealed 35% of the patterns
to be "Qi deficiency", 44% "Qi stagnation", 56% "Blooddeficiency" and 35% "Blood stagnation", indicatingthat the portion of "Qi stagnation" and "Bloodstagnation" has increased as compared with former
reports, which in turn is possibly correlated to thelarger number of established pregnancies throughtreatment with saireito. Moreover, the effectivenessof saireito for the treatment of PCOS has recently also
been confirmed12,13). PCOS is an endocrine disorderassociated with irregularities of menstruation or
polycystic ovaries, hyperandrogenemia or increased
secretion of LH. The pathology suggests, based on thepresence of obesity or insulin resistance, a correlation
with the metabolic syndrome14). This may lead toovulatory disorders and thus frequently be correlated
to the pathology of infertility, so that saireito
presumably is beneficial for infertility patients
suffering from complication with PCOS.
It is well known that tokishakuyakusan or unkeito
are used as Kampo therapy for infertility and theiruse is by now general practice. In recent years thenature of the infertility "pattern" is possibly changing,so that for infertility patients in whom these formulas
do not lead to the establishment of pregnancies, atherapy based on Kampo diagnosis is adopted when it
seems to be necessary to choose a more suitable
formula. Verification of the effectiveness of saireito stillneeds further study, but for modern infertility patientsand complicating menstruation irregularities orovulatory disorders saireito can be considered to be one
effective formula.

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

Volume 8, Number 1 | Spring 2013

[Conclusions]
The internal use of Saireito for the treatment ofinfertility complicated by menstruation irregularities
or ovulatory disorders has led in many patients to anormalization of the menstrual cycle or theestablishment of pregnancies. Apart from improving
ovarial function, saireito also alleviates the stressassociated with infertility treatment and is therefore
considered a possibly effective formula for thetreatment of infertility.

10. Toshiyuki Yasui: Practical lectures to learn
Kampo therapy from experts; menstrualirregularities,
femaleinfertility.
ClinicalObstetrics and Gynecology; 2008; 62: 1061-1066
11. Takashi Kano: Infertility as a psychosomatic
disorder in medical care. Psychosomatic
medicine; 2009; 49: 1171-1176
12. Atsushi Sakai: Investigations of the usefulness ofSaireito for the treatment of polycystic ovary
syndrome. Clinical Obstetrics and Gynecology;
2000; 54: 1330-1333[References]
1. Satoshi Hayakawa: Usefulness of Kampo
therapy for the treatment of infertility．Journalof Clinical and Experimental Medicine; 2003;
204: 1011-1014
2. Naohisa Ushiroyama: The role of Kampo therapy
in the treatment of infertility. Obstetrical and
Gynecological Therapy; 2001; 83: 45-50
3. Takaaki Murata: Introduction into Kampo
therapy in obstetrics and gynecology; Kampo andinfertility. Obstetrical and Gynecological
Therapy; 1989; 58: 693-702
4. Toshihiro
Aono:
Effectivenessof
tokishakuyakusan for the treatment of infertility.
Progress in the research into Kampo therapy inthe field of obstetrics and gynecology; 1995; 12:52-57
5. Masao Igarashi: Effects of unkeito andtokishakuyakusan for the treatment ofinfertility; in particular ovulatory disorders andluteal insufficiency．Kampo Igaku 1985;9:85-88
6. Izumi Iwai: Influence of saireito on the
hypothalamus – hypophysis – adrenal system inrats. Hormones and Clinic; 1992; 40: 745-748
7. Masanori Iwaki: Safety of saireito in thetreatment of infertility. Prog Med 1999; 19: 19691971
8. Tsuyoshi Nakayama: Therapeutic possibilities ofsaireito in the treatment of infertility. Prog Med
2010; 30: 14-15
9. Four cases in which a combination therapy withsaireito led to pregnancies: Toshitake Moriyama.
Medicine and Pharmacology; 2011; 66: 123-128

13. Machi Okamoto: Effects of saireito on theovarian function of patients with polycystic
ovary syndrome. Reprod Med Biol 2010; 9:
191-195
14. Rotterdam

ESHRE/ASRM-Sponsored

PCOS

Consensus Workshop Group: Revised 2003
consensus on diagnostic criteria and long-term
healthrisks

relatedtopolycystic

ovary

syndrome. Fertil Steril 2004; 81: 19-25.

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

11

Volume 8, Number 1 | Spring 2013

Clinical Report 1 (Acupuncture)
Safety and Effects of Acupuncture Treatment Using
Filiform Needles for Hemodialysis Patients
Hinata Sakuraba1), Hiroshi Kondo1), Shuichi Katai2),
Tomomasa Moriyama2), Hiroaki Kinoshita1,2),
Takashi Ishizu3) and Aki Hirayama1)
1) Center for Integrative Medicine, Tsukuba University ofTechonology, Tshukuba, Japan,
2) Faculty of Health Sciences, Tsukuba University ofTechnology, Tsukuba, Japan,
3) Department of Nephrology, Tsukuba Central Hospital,
Ushiku, Japan

1. Introduction
The number of dialysis patients in Japan in 2010
was 300,000 and continues to grow1). Many patientson hemodialysis often suffer from various conditions
like amyloidosis induced arthralgia or pruritus ofunidentified etiology, hemodialysis induced fatigue
etc.2). It has been pointed out, that since the patientsare complaining of the above mentioned physicalsymptoms, their Quality of Life (below abbreviated
QOL) is worse than that of healthy persons3,4). Manyof the listed symptoms can be treated withmedications physicians prescribe, but often theachieved improvements are not satisfactory, so thatmany of the staff members in charge of thehemodialysis treatment agonizes over how to treat
these conditions5). Complementary and Alternative
Medicine (below CAM) has received much attention
for possible solutions it may provide and thus a"Study meeting for Research into Maintenance of
Hemodialysis Patients with Complementary andAlternative Medicine" approved by the JapaneseSociety for Dialysis Therapy (JSDT) has been held6).
During this study meeting various results of CAM
treatments have been reported, where many reports
dealt with acupuncture treatment as a representative
form of CAM. Acupuncture treatment has in Japan along history as a therapy form and is both extremely
popular and well known7). It is also one of the few
therapies of which a national qualification isapproved. Our investigation reported many
hemodialysis staff and hemodialysis patients

12

interested acupuncture therapy2,5,8).
Several reports both abroad and in Japan deal withthe effect of acupuncture treatment for hemodialysis
patients. Abroad effects related to the improvement ofpruritus, erectile dysfunction, gastroparesis havebeen reported9,10,11). On the other hand, in Japan
Okuno et al. used 0.6 mm press needles (Pyonex,
SEIRIN Co., Ltd., Shimizu, Japan12)) for thetreatment and reportedly achieved alleviation of pain
and improvements of the QOL13).
Okuno et al. also used similar press needles for acrossovercomparative
study
and
reported
effectiveness for intractable pruritus in hemodialysis
patients14). Moreover, regarding case reports dealing
with the use of filiform needles for the treatment ofcomplications in hemodialysis patients Kasuya et al.
reported effectiveness for lumbar spinal canalstenosis and Sakaguchi et al. for the treatment ofintermittent claudication respectively15,16). However,in a systematic review of acupuncture treatment of
hemodialysis patients published in 2010 only 6
relevant reports were analyzed and moreover nopositive results could be deduced from studies withlarger number of case reports17). In other words, while
reports pertaining to acupuncture treatment of
hemodialysis patients can be found worldwide, there
are only few studies guaranteeing a certain quality
level. Also, the number of publications itself still
remains rather low.
We observed during the performance of our study
using filiform needles for the treatment many cases,
where those had been effective. In this study we
examined for the first time in Japan the safety andeffectiveness of the use of filiform needles inacupuncture treatment of hemodialysis patients atthe bedside.
2. Methods
1) Subjects
Subjects of the present study were hemodialysis
outpatients at the T.C. Hospital Dialysis Center in
Ushiku city of Ibaraki prefecture. A questionnaire
was performed prior to the study and 3 of the patients
requesting acupuncture treatment included as
subjects (Table 1). On that occasion the hemodialysis

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

Volume 8, Number 1 | Spring 2013

specialist at the same center confirmed, that there
were no physical problems that would affect theperformance of the acupuncture treatment. From all
subjects a written and signed informed consent form
was obtained for this study.
Table 1 Subjects
Dialysis
history

Age

Sex

Subject 1

5 years

74

male

Subject 2

4 years

50

male

Subject 3

32 years

59

femaleSymptoms
low back pain,
numbnessofleft legnumbnessofright hand, lowback pain, pain
low back pain,
pain of bothshoulder joints,shoulderstiffnessshowed degeneration of lumbar vertebrae andosteophytes at the shoulder joint. She is currently
treated with oral medication and compresses.
2) Treatment
The treatment was performed at the bedside, while
the patients underwent their hemodialysis. Needles
were Seirin (Shimizu, Japan) disposable filiform
needles with a diameter of 0.16 mm (No. 1) and 0.18
mm (No. 2) of a length of 40 mm and 50 mm
respectively (Figure 1). The treatments were
performed by an acupuncturist with more than 10
years of clinical experience. Points were selected
depending on symptoms and conditions, patientswere in supine position (Figure 2-1), or if needling of
the back was necessary turned on their side while
watching out for the shunt (Figure 2-2). The needles
were inserted using a guide tube to a depth varying
from several millimeter to several centimeter andretained for a period between 10 and 15 minutes.

(Symptoms classified according to hemodialysis history, age andsex)

Current symptoms of the subjects are as follows.
Subject No. 1 was a 74-year old man with a dialysis
history of 5 years. Symptoms treated withacupuncture are low back pain and numbness of left
leg. The symptoms developed 5 years ago andworsened recently. At an orthopedic clinic he wasdiagnosed with lumbar spinal canal stenosis andtreated in osteopathy clinics with electricity, but thecondition did not improve. The second subject was a
50-year old man with a hemodialysis history of 4
years and treated for numbness of right hand, lowback pain and pain of the right leg. The symptoms
developed after a traffic accident in September 2008.
They were treated with oral medication andcompresses, which was not very effective. The third
subject was a 59-year old woman with a hemodialysis
history of 32 years and treated for low back pain, painof both shoulder joints and shoulder stiffness. The
symptoms developed several years ago and x-ray
examination performed at an orthopedic clinic

Magnified image of a needle tip

Filiform needle in the guiding tube

Figure 1 Disposable filiform needle

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

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Volume 8, Number 1 | Spring 2013

For the evaluation we used two different methods
depending on the subject of the assessment. First we
asked about the general condition and assessed theanswers with the 6-step Face Scale (Figure 1). The
other evaluation method was a Visual analog scale(below called VAS) where the patients assessed theseverity of the treated symptoms between a level of 0
meaning "no problem at all" and 100 meaning "worst
so far".

Figure 2-1 Treatment situation (supine position)
good
Figure 3badFace Scale

4) Incident, accident measures
There are no reports about using filiform needles for
acupuncture

treatmentofpatients

undergoinghemodialysis in Japan. For us this was a newchallenge too, so that we used past experiences as areference in an effort to avoid or suppress theoccurrence of incidents or accidents as shown in Table
3. Further, we asked the subjects to report any
Figure 2-2 Treatment situation (lateral position)

One evaluation was performed prior to the start of thestudy and after that the duration defined as a 5-weektreatment period and a following 5-week post
treatment observation period. Treatments wereadministered once a week for a total of 5 weeks.
During the post treatment observation period a totalof 5 assessments were made at a rate of once a week
(Table 2).
Table 2 Protocol
Intervention Observation

Situation

treatment resting

Period5weeksOutcome One time Every week14

treatment directly to the physicians, nurses or
dialysis staff in efforts to obtain still more detailed

3) Protocol and evaluation

Beforepossible disadvantages caused by the acupuncture

5weeksinformation.
Moreover, for the conduction of this study it was
examined and approved by the ethics committee of
the Center for East-West Integrative Medicine ofaffiliated with the Department of Health Sciences of
the Tsukuba University of Technology.
Table 3 Incident, accident measures* A sufficiently informed consent was obtained inadvance.
* Use of disposable needles based on considerations
pertaining to an easy susceptibility to infection.
* The physical condition was assessed and needlingstimulation intensity gradually increased, to avoid
acupuncture induced sudden drops in bloodpressure.

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

Volume 8, Number 1 | Spring 2013

* Physical and dialysis conditions were confirmedon the day in question prior to the treatment and incase of bad conditions the feasibility of thetreatment itself was assessed and stimulus dose
adjusted.
* No needling near visible blood vessels or shunts.
* Confirmation that the previous treatment site did
not show signs of internal hemorrhage or otheranomalies.
* Preparation of an incident report format used for
detailed documentation and data accumulation
regarding incidents.

the post treatment observation period. For subject 2
the value improved from the pretreatment value of
4.0 to 2.3 during the treatment period, but aggravated
to 2.7 during the post treatment observation period.
For subject 3 the value almost did not vary from thepretreatment value of 2.0 to 2.3 during the treatment
period and similarly 2.3 during the post treatment
observation period (Figure 4).
Figure 4 Results of the Face Scale

3. Results
First we would like to address the occurrence ofincidents and accidents. There were 3 cases (20%) outof the total of 15 treatments all three subjects received.
Regarding their nature these incidents included
internal bleeding, triggering of the alarm of thedialysis equipment during change of position andinadvertent touching the needles (retained needles)
during the acupuncture treatment by the staff while
attending to the patient. A physician took care of thesituation in any case and critical events did not occur.

Figure 5 shows the evaluation results for each

The internal bleeding occurred at a needling site at

symptom obtained with a VAS. As with the Face Scalethe shoulder joint, but the patient him/herself did notthese too are the average values obtained during thecomplain about any pain or discomfort. The alarm

5-week treatment and post treatment observation

was triggered by a change in position, turned off by aperiods. For subject No. 1 the two symptoms low backnurse and after that did not occur again. The contact

pain and numbness of the left leg, for subject No. 2 thewith a needle while attending to a patient during an

three symptoms numbness of the right hand, low backacupuncture treatment by a staff member was due topain and numbness of the right leg and for subject No.

incomplete explanation for the staff members. After3 the four symptoms low back pain, pain of boththat we put up written announcements making it

shoulder joints and shoulder stiffness were evaluatedobvious, that the particular patient is receiving

and the average values for each of the subject shown

acupuncture and thereby solved this problem.

(Figure 5, left side). Looking at subject No. 1 shows a

Next, Figure 4 shows how the subjects were classified

pretreatment value of 67.5, that decreased only little

depending on their general condition. The figureduring the treatment period to 63.3. During the postshows the average values of results obtained during

treatment period, however, it rose to 69.5, which is

the 5-week treatment and post treatment observation

higher than the pretreatment value. For subject No.

periods. Examination of the Face Scale showed, that

2 the pretreatment value was as high as 73.3, but

it improved for subject 1 from the pretreatment value

markedly improved during the treatment period toof 3.0 to 2.3 during the treatment period and 2.2 in

54.6 and almost maintained that level, namely 55.6,

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

15

Volume 8, Number 1 | Spring 2013

during the post treatment period. Subject No. 3

dealing with the concepts of the dialysis staff

showed during the pretreatment period a value ofpertaining to the safety and effectiveness of

60.0 that improved as in subject No. 2 during theacupuncture treatment, the needs of the patients andtreatment period to 50.3. During the post treatment

further the effectiveness of acupuncture treatment.

period it showed a slight tendency towards returning

In this study we attempted to use filiform needles forto the pretreatment level to 54.7.

the treatment of patients undergoing hemodialysis,
for which previously no reports have been publishedin Japan. We kept the number of subjects low andconducted it as a pilot study. We made the best use of
ourprevious

therapeutic

experiences

andconcentrated foremost on the safety. The results
showed

for

this

study

an

incidenceofincidents/accidents of 20% requiring the interventionof a physician, but serious sequelae for the patients
did not occur. Investigation of each incident showedthat internal bleeding even occurred with 0.6 mmpress needles, suggesting that this is unavoidable inhemodialysis patients presenting with a heightened
bleeding tendency15). It is therefore essential to makesure patients understand this risk when obtaining an

Figure 5 Results of the VAS

informed consent. Problems arising from staff coming
The following shows a classification of symptoms used
for the examination of the results. The theclassification of therapeutic targets in all threesubjects showed pain (6 cases), numbness (2 cases),
stiffness (1 case). Examining first the complaints ofpain showed a pretreatment VAS value of 67.5 that
improved during the treatment period to 56.3.
However, during the post treatment observation
period it tended to return to a level of 62.2. Regarding
the numbness the pretreatment value was 62.0 and
improved similar to that of pain to 53.1. This value too
returned slightly during the post treatment
observation period to 55.6, but not as much as in thecase of pain. Finally, the pretreatment value of 62.0
for a feeling of stiffness improved during thetreatment period to 48.0 and was basicallymaintained at 48.5 during the post treatment
observation period.

contact with the patients were solved by putting up
announcement boards. It is important to thoroughly
announce the acupuncture treatment to the staff,
implement all conceivable safety precautions and incase of incidents relevant measures should be
examined one by one and implemented. Finally,
fluctuations in blood pressure induced by changes inposition are not limited to this particular study, but
may occur whenever the patient changes his/her
position. However, since there is a possibility of major
accidents, the practitioner too should be careful toobserve the shunt and any changes in position,
possibly assisting the patient when necessary.
Regarding the treatment effects 2 of the subjects
reported, their physical condition improved ascomparedtothepretreatment

condition.

Interestingly all subjects maintained a stablecondition during the treatment and the post
treatment

4. Discussion
We

performedamultifaceted

study

about

acupuncture treatment for hemodialysis patients

16

observation

period.

This

may

be

interpreted as lasting effects of the acupuncture
treatment, but the physical condition is strongly

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

Volume 8, Number 1 | Spring 2013

influenced by the dialysis method and the living

endpoint for clinical Dialysis patient QOL: An

environment, so that further studies are necessary.

attempt to use SF-36.: The Japanese Journal of

The symptoms of all patients improved during theClinical Dialysis, 13(8), 1107-1113, 1997.

treatment period, but tended to approach the4.

Mittal SK, Ahern L, Flaster E, Maesaka JK,

pretreatment level again during the post treatment

Fishbane S.: Self-assessed physical and mental

observation period. Classified by symptoms allfunction of hemodialysis patients. Nephrol Dial

complaints of pain, numbness and stiffness improved

Transplant, 16(7), 1387-94, 2001.

during the treatment period and tended to return5.

Sakuraba H., Mukai Y., Sawazaki K., Masuda F.:

slightly, but did not return to the pretreatment level.

Questionnaire survey concerning acupuncture

Based on the above described results treatment withtreatment to dialysis facilities in Mie Prefecture.

filiform needles can to a certain degree be evaluated

Journal of the Japan Society of Acupuncture, 60(2),as being effective.

209-215, 2010.

In this study we found that acupuncture treatmentwithfiliform

needlesatthebedside

6.

T.:

3th

HD-CAM

report.

ClinicalEngineering, 15, 1216-1229, 2004.

duringhemodialysis does not cause any serious adverse

Agishi7.

Togo T., Urata S., Sawazaki K., Sakuraba H.,

events and is to a certain degree effective for

Ishida T., Yokoyama K.: Demand for CAM

alleviating pain, numbness and stiffness. Yet,

Practice at Hospitals in Japan: A Population

regarding pain and stiffness 0.6 mm press needles

Surveyreportedly

Complement Alternat Med, 2011;2011:591868.

have

also

causedimprovements13).

Mie

Prefecture,

Evid

Based

Epub 2011 Jun 18.

Compared to press needles filiform needles are
considered to pose a higher risk, so that the balancein8.

Sakuraba

H.,

Sawazaki

K.,

Honda

T.,

between the risk of serious adverse events andMoriyama T.: Possibility for Acupuncture

beneficial effects is important. We therefore think,

Treatment in Maintenance Dialysis Medicalthat it is necessary to collect more cases, compare andTreatment – From a Questionnaire Survey

investigate

completed by Dialysis Medical Treatment

them,

accumulate

incident/accident

information and publish the relevant information

Staff-.

pertaining to effects and safety.

Acupuncture, 56(1), 76-83, 2006.
9.

Journal

of

the

Japan

Societyof

Che-Yi, C., C. Y. Wen, et al. Acupuncture in

References

haemodialysis patients at the Quchi (LI11)

1.

Committee of Renal Data Registry, Japanese

acupoint

Society for Dialysis Therapy, Tokyo, Japan:

Nephrol Dial Transplant. 20(9): 1912-15, 2005.

Overview of Regular Dialysis Treatment in

10. Kim, K. H., T. H. Kim, et al. Acupuncture for2.

refractory

dysfunctioninuraemicapruritus.

Japan (As of 31 December 2010), Therapeutic

erectile

Apheresis and Dialysis, 16(6), 483–521, 2012.

haemodialysis patient: a case report. Acupunct

Sakuraba H., Takeuchi H., Takeuchi M., Syoji

Med. 29(1): 58-60, 2011.

non-diabetic

M., Moriyama T.: Questionnaire survey of

11. Kim, K. H., T. H. Kim, et al. Acupuncture forcomplaints and acupuncture treatment insymptomatic relief of gastroparesis in a diabetic

maintenancehaemodialysis patient. Acupunct Med. 28(2):hemodialysis

patients,

Therapeutic Apheresis and Dialysis (Japanese),
Takai I., Shinzato T., Maeda K., Fukuhara S.:
Measuring

101-103, 2010.
12. SEIRIN Co.ltd.: Product Information. SEIRIN

40(6), 513-516, 2007.
3.

forHealth-Related

QOL;

A

Co.ltd. Homepage, http://www.seirin.tv/.

new

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

17

Volume 8, Number 1 | Spring 2013

13. Okuno T., Yasuno T., Sakai T., Akamatsu M.,
Agishi T.: Clinical study including 32 patients
about the effects of press needles used for
acupuncture

treatmentofpatientsonmaintenance hemodialysis; Modern Acupunctureand Moxibustion; 3(1): 19-27, 2003.
14. Sakuraba H., Sawazaki K., Takeuchi H.,
Takeuchi M., Masuda F., Moriyama T.: The
study about introduction and effect of theacupuncture

which

aimed

at

the

maintenanceandimprovementinahemodialysis

patient

-A

of

the

practice

QOL

acupuncture for an itching - The Japan Kidney
Foundation, 30(2), 167-174, 2007.
15. Kasuya D., Yamamoto K., Etou F.: Two cases ofacupuncture treatment for lumbar spinal canalstenosisduetohemodialysis-related

spondyloarthropathy. Kampo Med, 54(4), 773779, 2003.
16. Sakaguchi

S.,

YamazakiT.,

IkefujiH.,

Kawakami C., Nakayoshi T., Endo H., Umeda T.,
Wakayama I., Ujita T.: The clinical effects ofacupuncture

treatmentonintermittent

claudication in a diabetic hemodialysis patient.
Therapeutic Apheresis and Dialysis(Japanese),
39(7), 1257-63, 2006.
17. Kim, K. H., M. S. Lee, et al. Acupuncture fortreating uremic pruritus in patients with endstage renal disease: a systematic review. J Pain
Symptom Manage. 40(1), 117-125, 2010.

18

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

Volume 8, Number 1 | Spring 2013

Clinical Report 2 (Kampo Medicine)

Initially, the patient refused to take the prescription.

Cornelia de Lange Syndrome with Recurrent Pneumonia
Hideaki Yamaguchi
Tosei General Hospital
Case: 6-year-old girl with Cornelia de Lange
Syndrome and recurrent pneumonia

Lange Syndnrome, and received six operations since
her neonatal period. They included diaphragmatic
repairsurgery,colectomy,such as by baking a cake mixed with the decoction or
adding it to the sauce when making simmeredvegetables. As a result, the patient was able to takeabout two-thirds of the daily dose every day.
She was admitted to the hospital once after two-and-The patient was clinically diagnosed with Cornelia deherniaHowever, her mother thought of ways of taking it,

colostomy,

esophagocardioplasty, and pyloroplasty. She began todevelop recurrent respiratory tract infections at theage of 1. At the age of 4, the frequency of her being
hospitalized increased, and it eventually got to thepoint where she was admitted to the hospital eighttimes in a year, for a total of 100 days.
The patient showed no susceptibility to infection,and general examinations and immunological tests
showed no abnormality. The recurrent pneumonia
was thought to occur mainly from diaphragmaticparalysis on the left side. Kampo therapy wasconsidered, as no effective control could be found inWestern medicine.

a-half months, but has not required hospitalization
thereafter, and her symptoms markedly improved.
The prescription was administered for a year andfive months while making adjustments, and thesymptoms have stabilized even after terminating theprescription.
Observation:

Kampo

therapy

based

on

the

reinforcing and reducing method is effective againstrecurrent infections. However, decoction is no lesseffective in flexibly addressing severe cases such as
this particular case.
Reference: Cornelia de Lange Syndrome is acongenital disease that is characterized by delayed
physical and intellectual development. Patients with
Cornelia de Lange Syndrome have a distinct
appearance, including a small head, thick eyebrowsthat meet in the middle, a small pointed nose, asmall chin, excessive body hair, and small hands andPresent status: Weight 11kg. No speech.
Treatment: Assuming a dual deficiency in the lungand spleen, qi and yin deficiency, and congestion oflung heat, the following prescription (decoction) wasfeet. Cornelia de Lange Syndrome also accompanies
various malformations of the organs and epilepsy.
Certain genetic mutations are seen in roughly half ofall patients.

administered (daily dose; brewed and taken in 2 to 3
separate doses per day).

Astragali Radix 8g
Ephedrae Herba 1g
Ophiopogonis Radix 5g
Armeniacae Semen 3g
Bupleuri Radix 3g
Platycodi Radix 2g
Ziziphi Fructus 3g
Glycyrrhizae Radix 1g
Gypsum Fibrosum 4g (short-term usage)

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

19

Volume 8, Number 1 | Spring 2013

Conference Report
The 3rd JSAM International Symposium on Evidencebased Acupuncture – Evidence of the Effectiveness of
Acupuncture for Headache -Hitoshi Yamashita

Graduate School of Health Sciences,
Morinomiya University of Medical Sciences,
Osaka, JapanOn June 7 and 8, 2012, the 3rd JSAM

headaches and the characteristics of headache
patients. Next, Prof. Byung-Cheul Shin (School of
KoreanMedicine,

Pusan

National

University)

lectured on acupuncture and moxibustion therapy
for headaches in South Korea, followed by Ms. Mari
Suzuki (Saitama Medical University), who gave areport on acupuncture and moxibustion case series
studies in university hospitals in Japan.

Evidence-based

Session 2 was themed on acupuncture for

Acupuncture was held at Yokkaichi Municipal

headaches. Prof. Benno Brinkhaus (Institute forCultureSocialInternational
Hall

Symposium
in

Mie

on

Prefecture,

under

the

Medicine,

Epidemiology

andHealthsponsorship of The Japan Society of Acupuncture

Economics, Charité University Medical Center)and Moxibustion (President: Shuji Goto). JSAM has

introduced the results of large-scale RCTs on

previously held its first international symposium in2006 themed on osteoarthritis of the knee, and thesecond symposium in 2009 themed on low back pain,
to promote understanding of the concept of evidence-

acupuncture for headache that was conducted inGermany, and gave his interpretation of the overall
evidence. Dr. Myeong Soo Lee (Korea Institute ofbased medicine (EBM) among its members, and to

Oriental Medicine) gave an outline of systematic

reinvigorate studies that present clinical evidence ofreviews of RCT papers on acupuncture for headache,acupuncture and moxibustion in Japan based on an

and noted the problems in the quality of RCTs onawareness of the status of overseas studies. Thisacupuncture. Mr. Tomokazu Kikuchi (Saitama

third symposium was themed on headaches, and also

Medical University) mainly reported on the results

included a program for discussing sham acupuncture,
which

is

causingacontroversy

about

the

appropriateness of its control groups.
Pre-symposium lectures first introduced thefeatures of Japanese acupuncture to participantsfrom Japan and overseas. Based on surveys, six
speakers gave lectures on the present state ofacupuncture practice in Japan, the characteristics ofacupuncture patients, the history and present stateof pediatric acupuncture and meridian therapy, andan overview of Japanese acupuncture in Europe.
Session 1 began after the opening ceremony. Dr.
Sakai

Fumihiko(Saitama

NeuropsychiatricInstitute) and Prof. Hisaka Igarashi (Kanagawa
Dental College of Medicine Yokohama Clinic),
leading authorities on headache research in Japangave a presentation on the latest classification of20of a basic research on acupuncture for primaryheadache conducted by the research team to which
he belongs.
In Session 3 held on the following day, Prof. Shoko
Masuyama (Morinomiya University of Medical
Sciences) gave an overview of clinical trials ofacupuncture in Japan, and underlined some issues
on quality of the studies. Prof. Brinkhaus discussed
researchmethodology

inclinical

trial

on

acupuncture, and emphasized that the selection of
trial design and control group depends on the
primary research question. Mr. Yasuhisa Kaneko(Tokyo College of Medico-Pharmaco Technology)
introduced the thumbtack needle effect in the sports
field, followed by Prof. Kenji Kawakita (Meiji
University of Integrative Medicine), who explained
the mechanisms of physiological activities produced

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

Volume 8, Number 1 | Spring 2013by various sham interventions used in recent clinicalThe symposium underlined the importance of

trials of acupuncture, and logically emphasized thatorganizing

even shallow stimulations on the skin can have aworkshops and other similar opportunities in Japan

clinical effect. Lastly, Dr. Stephen Birch (Foundationin order to foment greater understanding offor the Study of Traditional East Asian Medicine,Japanese acupuncture and moxibustion.

Amsterdam)

pointed

to

the

fact

that

more

international

symposiums,

shamacupuncture in RCTs are frequently misinterpreted
by reviewers and readers, although it is not a placebo
treatment, and expressed his concern that wrong
study designs are being selected for the relevant
research question.
In Japan, acupuncture and moxibustion havebeen utilized to treat diseases and maintain healthsince olden days as a matter of course, precisely
because they existed as traditional medicine. For
this reason, the idea of examining the evidence that
acupuncture and moxibustion are effective had
never emerged until recently. As a result, clinicalstudies that are conducted in Japan from thestandpoint of EBM have lagged behind foreigncountries. This symposium is thought to haveprovided a renewed awareness of this issue and
other

such

issuesamong

acupunctureandmoxibustion researchers and school teachers inJapan. It was particularly a large achievement that
acupuncture and moxibustion researchers andclinicians acquired a common understanding of the
need

to

disseminatecharacteristics

ofinformation

Japanese

about

the

acupunctureandmoxibustion and papers that introduce Japanese
acupuncture and moxibustion to the outside world,
as well as the need to more accurately evaluate theclinical effects and physiological activity of shamneedling that is used in the Western countries as aplacebo control group and the comprehensive clinicaleffects of acupuncture that includes not only specificeffects but also skin stimulation effects.

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

21

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