Volume 1, Special Edition | Current Japanese Acupuncture and Moxibustion 2010

SafetyIssueonAcupuncture
Moxibustion in Japan
HitoshiYamashita1),Hiroshi

andWe have reviewed case report papers in order toTsukayama2)

1) Department of Acupuncture, Morinomiya University of
Medical Sciences, Osaka, Japan
2) Center for Integrative Medicine, Tsukuba University ofTechnology, Tsukuba, Japan

1. Introduction
Evidence-BasedMedicine(EBM)

becamepopularized in the medical field in 1990s whensubstantial randomized control trials (RCT) on
efficacy were actively performed. Against this positivetrend, even in these years, methodology showed theleast development in clinical research on safety ofacupuncture and moxibustion. For example, although
it has been publicized that “the incidence of sideeffects

fromthepracticeofacupunctureandmoxibustion is none”, data of side effects based onwell planned and systematic research have not beenpresented. There are, indeed, various case reports on
infections

thatdeveloped

after

2. Case reports

acupuncture

treatments. There are, however, almost no papers
released that clearly show the evidence of thesecausal relationships.

grasp the incidences in Japan of adverse eventsassociated withacupuncture treatment. Our review

results showed that medical journals carried 120
articlesreportingabout150

adverseevents

associated with acupuncture treatment in Japan
during the period of the latter half of 1980s and 2002
(Table 1) 1,2) (Note: An adverse event is defined as anunfavorable medical event which occurred during or
afterthetreatment

regardlessofcausal

relationships)3). The most reported adverse event waspneumothorax.

In

therecentyears,

however,pneumothorax does not have novelty for a journal
article and the number of the case reports relating tothe adverse event has been reduced. In contrast, thenumber of cases handling liability insurance tocompensate pneumothorax resulted from the acts ofacupuncture and moxibustion in Japan is as highest
as ever in Japan4). As far as infections are concerned,
a diversified range of infections from abscess,bacterial infections to hepatitis B were reported;
althoughformostofthese

adverseevents,

cause-effect relationships have not been clarified..

Generally, arguments of safety of acupuncture
and moxibustion often took place on the basis ofanecdotal evidence, such as case reports on adverse
events and various experiences of individuals. It was
only after the latter half of

the1990s that clinicalresearch other than case reports on safety ofacupuncture and moxibustion, began to appear in
medical journals on a full scale and actively
discussed.

As for “embedding needles” practiced by a few
acupuncture and moxibustion therapists, the Japan
Acupuncture & Moxibustion Association submitted arequest to the then Ministry of Health and Welfare in
1976 to issue its directions to prohibit embedding
needles. However, fragments of needles embedded
before the order of prohibition (some after the order)
caused unique adverse events such as organ injury,
foreign body, localized argyria and others. On theThis report will provide case reports, prospective

other hand, many reports on accidents of needle

surveys and data from RCT on the basis of thebreakage and organ or spinal injury were seen until

strength

the first half of 1990s. In recent years, reports ofofevidence

anddiscussacupuncture and moxibustion in Japan.

94

safetyof

these cases and liability compensation cases have

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

Volume 1, Special Edition | Current Japanese Acupuncture and Moxibustion 2010

decreased1,2,4). It can be considered that the decreasemeasures.

is closely related to the wide use of disposable needles

acupuncture and moxibustion treatments was known,in Japan.

which

Casesofadverse

eventsresultedfrommoxibustion are shown in Table 22,5). Moxibustion is,of course, performed by acupuncture and moxibustion
therapists in Japan. However, there is a significant
number of cases in Japan in which patients use moxa
cones at home according to the instructions byacupuncture and moxibustion therapists or people doThefacilitatedtotal

numbertheofcalculation

recipients
ofofincidence

frequencies of adverse events. As a result, adverse
events were reported・recorded as Table 3 shows6,7). If
the denominator or the total number of recipients ofacupuncture and moxibustion treatments is taken
into account, it can be said that serious adverse
events will rarely occur in the standard acupuncture
practice.

self-treatment by using large moxa cones (mass ofSubsequently,weconductedathoroughmoxa) according to the oral tradition without seeing

prospective survey over four months to gain theacupuncture and moxibustion therapists. In manyfrequencies of mild adverse reactions (side effects)

serious cases of malignant tumor or pulmonarythat patients can experience in daily acupuncture

edema, moxa cones were used excessively on patients’practice. The results are shown in Table 48). Fatigue

own judgment. It is highly controversial thatand drowsiness occurred most frequently at theself-treatment that does not have guidance from, or is

initial treatment and bleeding and subcutaneous

not practiced by the therapist of acupuncture andbleeding had higher rates of frequency when applying

moxibustion,current to needles8). Pain when pricking was claimed

shouldbecalled“moxibustiontreatment”

at a high rate of frequency among younger subjects orwomen9). Any of these adverse reactions were

3. Prospective surveys
As introduced above, it will not be appropriate
from the view points of publication bias, retrospective
descriptions, recall bias, and an unknown total
number of treatment sessions, to argue the safety oftransitory and no medical procedures were taken.

Ithas been confirmed in this survey that most of theside effects, which were frequently encountered in theacupuncture treatments, were mild cases.

acupuncture and moxibustion based on case reports.

4. RCTs

With these points in mind, since 1992 we have

There could be many cases of adverse events recorded

required reports on adverse events to be submitted toin the prospective surveys that actually did not have

Tsukuba College of Technology Clinic (present Center

anyfor Integrative Medicine, Tsukuba University oftreatment. In order to assess how many specificTechnology) in order to obtain more reliable data onadverse reactions to penetration of the skin aresafety of acupuncture and moxibustion. In thisincluded in reported adverse events in case reports

prospectiveand prospective surveys, we performed a literature

information

gatheringsystem,acausalassociation

withtheacupuncturesemi-structured report form has been used, enabling

review of

the collection of necessary information for studying

osteoarthritis of the knee (knee OA) by way ofcause-effect relations and recurrence prevention

example10).

published

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

RCTs

onacupuncturefor95Volume 1, Special Edition | Current Japanese Acupuncture and Moxibustion 2010

We searched for papers on RCT of acupuncture forReferences

knee OA, using two data sources: PubMed and1) Yamashita H., Tsukayama H., White A.R., Tanno Y.,

Japana Centra Revuo Medicina (Igaku Chuo Zasshi).

Sugishita C., Ernst E.: Systematic review of adverse

Of the twelve RCT papers located, seven included

eventsinformation on adverse events.

Joint swelling, local

inflammation, hematoma and back pain occurred
more often in the dummy electroacupuncture or
minimal acupuncture group.

following

acupuncture:theJapaneseliterature. Complement Ther Med 2001; 9: 98-104.
2) Yamashita H., Egawa M., Umeda T., Miyamoto T.,
Ishizaki N., Katai S.: Update of adverse events
associated with acupuncture and moxibustion inTherefore, it is likely

Japan (1998-2002) and controversy over infectionthat many non-specific or unconnected “adversecontrol in acupuncture treatment. J Jpn Soc

events of acupuncture”are reported in published caseAcupunct Moxibust 2004; 54: 55-64.
3) Beam Jr T.R., Gilbert D.N., Kunin C.M.: Generalreports and prospective surveys10).

guidelinesfortheclinicalevaluationofanti-infective drug products. Clin Infect Dis 1992;

5. Conclusion
In a series of surveys introduced above, it has
been confirmed that the incidence of serious sideeffects (adverse reactions) is rare in the acupuncture
and moxibustion clinic. On the other hand, since mild15(Suppl 1): S5-S32.
4) Fujiwara Y.: Shinkyu massage ni okeru Iryo Kago
Genba kara no Houkoku. San-No Shoji, Osaka, 2004.
5) Yamashita H., Egawa M., Miyamoto T., Umeda T.,
Tani M., Nabeta R., et al.: Japanese literature survey

side effects are common, it is essential to informon risks and safety of acupuncture and moxibustion

patients about information relating to these side(4) - adverse events in moxibustion treatment -. Jeffects. Moreover, it is fact that serious adverse

Jpn Soc Acupunct Moxibust 2000; 50: 713-718.

events exist, such as pneumothorax and spinal injury,

6) Yamashita H., Tsukayama H., Tanno Y., Nishijo K.:

althoughlimited,likelyduetotherapists’negligence. Thus, as well as education and training26),
it is also important to develop error-prevention

Adverse events related to acupuncture. JAMA 1998;
280: 1563-1564.
7) Yamashita H., Tsukayama H., Tanno Y., Nishijo K.:
Adverse events in acupuncture and moxibustion

system, like incident reporting, to prevent avoidable

treatment: a six-year survey at a national clinic inadverse events30).

Japan. J Altern Complement Med 1999; 5: 229-236.
8) Yamashita H., Tsukayama H., Hori N., Kimura T.,

TheJapanSocietyandTanno Y.: Incidence of adverse reactions associatedMoxibustion (JSAM), a largest academic body ofwith acupuncture. J Altern Complement Med 2000;

acupuncture

6: 345-350.

andofAcupuncturemoxibustioninJapanhasestablished the Committee for Safe Acupuncture tostudy safety of these treatments and promote
education. We consider that a professional body like9) Yamashita H., Tsukayama H., Sugishita C.: Local
adverse reactions commonly seen in Japanese-style
medical acupuncture practice. Clin Acupunct Orient
Med 2001; 2: 132-137.

JSAM should assume roles of undertaking analyses of10) Yamashita H., Masuyama S., Otsuki K., Tsukayama

reported individual adverse events, verifying theirH.: Safety of acupuncture for osteoarthritis of thecausal relationships, giving feedback of the results toknee – a review of randomised controlled trials,

members, and shaping the safety education before

focusing on specific reactions to acupuncture.

and after graduation.

Acupunct Med 2006; 24(Suppl): S49-52.

96

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

Volume 1, Special Edition | Current Japanese Acupuncture and Moxibustion 2010

Table 1

Published case reports of adverse events

associated with acupuncture in Japan1,2)Type

Diagnosis or symptom

Comments(Number of cases in parentheses)

Organ injuries
Pneumothorax

Organ injuries
or foreign bodies(26),

arterial

injury(3),cardiactamponade (3), renal injury (2) and pseudoaneurysm (1).

Many of the cases wereForeign bodies

causedbyaccidental

breakageor(3), needle
embeddingretroperitoneum (2), paravertebral muscle (2), ventricle prohibited
Needlefragment(s)intheurinarytract(1), lung and diaphragm (1), liver (1), maxilla (1), cervicalneedles.

interspinous ligament (1), hip joint (1), abdominal aortic
aneurysm (1) and nucha (1).

Bacterial infections
Abscess

Infection(6),septicaemia(6),spinalinfection(4),

erysipelas (3), streptococcal toxic shock-like syndrome (2: Causal relationship withandone fatal), pyothorax or pyohemothorax (2: one fatal), acupuncture
skull tuberculosis (1), infected atrial myxoma (1) and infection
established.
local redness (1).

isnot

Viral infections
Acute hepatitis B (12).

Central nervous system
Spinal cord injury (18), subarachnoid hemorrhage (5),Neurologicalproblems

subdural hematoma (1), epidural hematoma (1), and Many of the cases werecaused by embedding
medullary lesion (1),.

Peripheral nerves

needles.

Peripheral nerve injury (3).

Pigmentation
Dermatologicalproblems

Localized argyria (15) and cutaneous chromatosis (1).

Localized

Otherscausedargyria

bywasembedding

Contact dermatitis (4), lichen planus (2), nodular lesion silver needles.
(2), growth of tumor (1), and skin sarcoid (1).
Subcutaneous bleeding (2), syncope (1) and asthmatic

Other problems

death (which might have been associated with emotional
stress of the first-time acupuncture treatment) (1: fatal).

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)97