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)

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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

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