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The Safety of Pediatric Acupuncture: A Systematic
Review
abstract
CONTEXT: Acupuncture is increasingly used in children; however, the
safety of pediatric acupuncture has yet to be reported from systematic
review.
OBJECTIVE: To identify adverse events (AEs) associated with needle
acupuncture in children.
METHODS: Eighteen databases were searched, from inception to Sep-
tember 2010, irrespective of language. Inclusion criteria were that the
study (1) was original peer-reviewed research, (2) included children
from birth to 17 years, inclusively, (3) involved needle acupuncture,
and (4) included assessment of AEs in a child. Safety data were ex-
tracted from all included studies.
RESULTS: Of 9537 references identified, 450 were assessed for inclu-
sion. Twenty-eight reports were included, and searches of reference
lists identified 9 additional reports (total: 37). A total of 279 AEs were
identified, 146 from randomized controlled trials, 95 from cohort stud-
ies, and 38 from case reports/series. Of the AEs, 25 were serious (12
cases of thumb deformity, 5 infections, and 1 case each of cardiac
rupture, pneumothorax, nerve impairment, subarachnoid hemor-
rhage, intestinal obstruction, hemoptysis, reversible coma, and over-
night hospitalization), 1 was moderate (infection), and 253 were mild.
The mild AEs included pain, bruising, bleeding, and worsening of symp-
toms. We calculated a mild AE incidence per patient of 168 in 1422
patients (11.8% [95% confidence interval: 10.1–13.5]).
CONCLUSIONS: Of the AEs associated with pediatric needle acupunc-
ture, a majority of them were mild in severity. Many of the serious AEs
might have been caused by substandard practice. Our results support
those from adult studies, which have found that acupuncture is safe
when performed by appropriately trained practitioners. Pediatrics
2011;128:e1575–e1587
AUTHORS: Denise Adams, PhD,
a
Florence Cheng, MD,
a
Hsing Jou, MD,
a
Steven Aung, MD, PhD,
b
Yutaka Yasui,
PhD,
c
and Sunita Vohra, MD, MSc
a,c
a
CARE Program, Department of Pediatrics, and Departments of
b
Medicine and
c
Public Health Sciences, University of Alberta,
Edmonton, Alberta, Canada
KEY WORDS
acupuncture, pediatric, safety, systematic review
ABBREVIATIONS
AE—adverse event
RCT—randomized controlled trial
CI—confidence interval
www.pediatrics.org/cgi/doi/10.1542/peds.2011-1091
doi:10.1542/peds.2011-1091
Accepted for publication Aug 12, 2011
Address correspondence to Sunita Vohra, MD, MSc, CARE
Program, Department of Pediatrics, University of Alberta, 8B19
11111 Jasper Ave, Edmonton, Alberta, Canada T5K 0L4. E-mail:
svohra@ualberta.ca
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
Copyright © 2011 by the American Academy of Pediatrics
FINANCIAL DISCLOSURE: The authors have indicated they have
no financial relationships relevant to this article to disclose.
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Acupuncture therapy is believed to
have developed in China over thou-
sands of years and refers to the stim-
ulation of precisely defined, specific
points on meridians (or channels) that
lie along the surface of the body and
within organs. Stimulation of acu-
points can be accomplished through a
variety of methods including applica-
tion of heat, pressure, or laser or in-
sertion of thin needles.1
Acupuncture is a popular treatment
modality in many parts of the world. A
2007 US study estimated that 3 million
adults use acupuncture, up from ⬃2
million people in 2002. Among US chil-
dren, it has been estimated that
150 000 (0.2%) used acupuncture in
2007.2Canadian figures indicate that
12% of the population has ever used
acupuncture and that 2% used acu-
puncture in 2003.3,4 Use among specific
patient populations is frequently much
higher (ie, up to 47.5%).5–8
Studies on the safety of acupuncture
have been conducted; however, none
of them have reported specifically on
the safety of pediatric acupuncture. In
a study published in 2009, the authors
prospectively surveyed 229 230 pa-
tients (mean age: 46 years) for ad-
verse acupuncture effects.9A total of
19 726 patients (8.6%) experienced at
least 1 adverse effect, and 2.2% of pa-
tients required treatment. The most
common adverse effects were bleed-
ing (6.1% of patients) and pain (1.7% of
patients). In a 2005 study of ⬎9400
consecutive adult patients, short-term
reactions to acupuncture, both posi-
tive and negative, were documented.10
Of the 15 745 reactions reported, 68%
were positive and included feeling re-
laxed and energized, whereas 18%
were negative and included pain, dis-
comfort or bleeding, bruising, vasova-
gal reactions, and worsening of condi-
tion; 14% of all reports were of
tiredness or drowsiness. The rate of
occurrence of these 2 latter categories
of adverse events (AEs) was reported
as 53.9 in 100 treatment sessions;
tiredness/drowsiness and pain at in-
sertion accounted for 24.4% and 12%
of them, respectively. Only 13 (0.14%)
patients were unwilling to have acu-
puncture again because of short-term
reactions. The authors of a meta-
analysis in which the safety of acu-
puncture was reviewed concluded that
the risk of serious events associated
with acupuncture was 5 per 1 million
treatment sessions.11 The authors did
not specify if this estimate included
adults and children, but of the 12 stud-
ies in the meta-analysis, 2 included
only adults and 4 included a small pro-
portion of children, whereas for the re-
maining 6 studies, age-related infor-
mation was not available from either
the publications or the authors. In all
cases, details about the patients in
whom the AEs occurred, including age,
were not reported. There is general
consensus that acupuncture is safe if
performed by appropriately trained
practitioners, and no distinction has
been made between adults and chil-
dren in this conclusion.12–24
In a recent review of the literature,
Jindal et al25 presented a summary of pe-
diatric acupuncture safety. Despite the
fact that randomized controlled trials
(RCTs) are known to underestimate rare
harms,26,27 their review was limited to
RCT evidence of 4 different acupoint
stimulation techniques: needle (with and
without electrical stimulation) (5 stud-
ies); laser (3 studies); and acupoint injec-
tion (1 study). The authors identified a
total of 29 predominantly mild AEs that
occurred in either acupuncture treat-
ment arms or control arms and pre-
sented a combined AE-incidence rate of
1.6 in 100 treatments.
To our knowledge, a systematic review
of pediatric acupuncture safety has
not yet been published. The purpose of
this review was to systematically col-
lect and synthesize all published re-
ports of pediatric AEs associated with
needle acupuncture.
METHODS
Data Sources
Comprehensive search strategies
were developed in conjunction with a
clinical librarian and run in 18 data-
bases. The search was originally run
in June 2007 and updated in Septem-
ber 2010 in most databases: Medline
(1950 –2010); PubMed (1950 –2010);
Embase (1988 –2010); AMED (Allied
and Complementary Medicine) (1985–
2010); CINAHL (Cumulative Index to
Nursing and Allied Health Literature)
(1937–2010); Cochrane Database of
Systematic Reviews (1991–2010); Co-
chrane Central Registry of Controlled
Trials (1991–2010); PsycInfo (1806 –
2010); Alternative Health Watch (1990 –
2010); Web of Science (1990 –2010); In-
dex to Chiropractic Literature (1985–
2010); Sport Discus (1975–2010);
Scopus (1900 –2010); MANTIS (Manual,
Alternative and Natural Therapy In-
dex System) (1990 –2007); HealthStar
(1966 –2007); Acubriefs (inception
through 2007); CAMPAIN (Complemen-
tary and Alternative Medicine and
Pain) (inception through 2007); and
OCLC (Online Computer Library Center
Inc) Dissertation Abstracts (1861–
2010). Searching was not limited by
language. Search terms are available
by request to the corresponding au-
thor. Reference lists of review articles
and included studies were searched
for additional studies.
Study Selection
Titles and abstracts of identified stud-
ies were screened independently by 2
reviewers. Full texts of potentially rel-
evant studies were obtained and re-
viewed for inclusion on the basis of
predetermined criteria. Disagreement
was resolved by discussion.
Studies were included if they (1) con-
tained original patient data published
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in a peer-reviewed journal, (2) in-
cluded children from birth to 17 years,
inclusively, (3) involved needle acu-
puncture, and (4) included assess-
ment of AEs in a child. Note that we
searched for reports that mentioned
safety or harm/AEs as assessed and
reported by the authors. Studies were
not excluded for lack of harm/AEs but
for lack of mention of safety/harm/AE
assessment. Studies in which no
harm/AEs had reportedly occurred
were included in the systematic
review.
Inclusion of studies in this review was
not limited by any other variables.
Data Extraction
Data were extracted by 1 reviewer us-
ing standardized forms and verified by
a second reviewer. Disagreement was
resolved by discussion. The following
information was extracted: author(s);
year, country, and language of publica-
tion; study design; number, age, and
gender of participants; reasons for
seeking acupuncture; comorbid condi-
tions and concomitant treatments; de-
tails of acupuncture and control treat-
ments; practitioner qualifications; and
details of AEs. If necessary, the princi-
pal authors were contacted for further
details.
Data Synthesis
AE severity was assessed indepen-
dently by 2 reviewers and was based
on the Common Terminology Criteria
for Adverse Events (CTCAE) scale.28
The categories were mild (minor, no
specific medical intervention), moderate
(minimal, local, or noninvasive interven-
tion), or serious (required hospitaliza-
tion or invasive procedures, resulted
in persistent or significant disability/
incapacity, was life-threatening, or re-
sulted in death). Disagreement be-
tween reviewers was resolved by
discussion, and if necessary, a third
party was consulted.
The degree of association between the
intervention and the AE was indepen-
dently assessed by 2 reviewers using
the causality algorithm used by Health
Canada and the World Health Organiza-
tion Collaborating Centre for Interna-
tional Drug Monitoring; terminology
was modified for use in a device rather
than for a therapeutic product.29 The
categories for assessment were cer-
tain, probable/likely, possible, unlikely,
conditional/unclassified, and inacces-
sible/unclassifiable. Disagreement be-
tween reviewers was resolved by dis-
cussion, and if necessary, a third party
was consulted.
Results were presented as descriptive
summaries. AEs in treatment and con-
trol groups (for 2-arm studies) were
tallied separately to examine differ-
ences in incidence between these 2
groups. Because some acupuncture
control groups used a different form of
needle acupuncture as a control,
all AEs that occurred in needle-
acupuncture groups, treatment or
control, were also tallied. Incidences
are presented on the basis of the num-
ber of patients. Only those AEs that
were adjudicated as possibly, proba-
bly/likely, or certainly caused by acu-
puncture, from prospective studies,
were included in the calculations. Dif-
ferences in AE occurrence between
groups were examined by using
2
tests.
RESULTS
Searches resulted in a total of 9537
references, of which 4249 were dupli-
cates. After screening titles and ab-
stracts of the remaining 5288 refer-
ences, 4838 were excluded because of
a lack of relevance to topic, lack of pri-
mary data, or lack of mention of safety
or AEs; the full texts of the 450 poten-
tially relevant articles were obtained.
Of these articles, 29 representing 28
studies met all inclusion criteria (the
results of 1 study were published as 2
different articles). Nine additional in-
cluded studies were found through re-
view of reference lists. Of the total of 38
included publications, 30 were pub-
lished in English, 5 were published in
Chinese, and 1 each was published in
French, German, and Japanese.
Articles were excluded for the follow-
ing reasons: full publication data were
not available (5); there was duplicate
publication of material (5); there were
no primary patient data (48); the sub-
jects were not human (3); no children
were included (172); the study did not
involve needle acupuncture (60); and
information about AEs was not re-
ported (128).
Of the 37 included studies, 9 were RCTs,
6 were cohort studies, and 22 were
case reports or case series. Four stud-
ies included adults and children,
whereas 33 included only pediatric
participants. Of these 4 studies, pediat-
ric data were presented separately or
further information on patient ages
and AEs was obtained from study au-
thors. The flow of articles through the
review is shown in Fig 1.
A total of 279 AEs were identified by the
authors of the included studies: 146
from the RCTs, 95 from the cohort stud-
ies, and 38 from the case reports/se-
ries. Of these AEs, 253 were adjudi-
cated in our review process as mild, 1
as moderate, and 25 as serious. Two
serious AEs were rated as unlikely to
have been caused by the acupuncture
(details to follow). For the remaining
AEs, causality was assessed as possi-
ble (167), probably/likely (53), or cer-
tain (57).
Serious AEs
Twenty-five pediatric AEs were rated
as serious: 12 cases of thumb defor-
mity, 5 cases of infection, and 1 case
each of cardiac rupture, pneumotho-
rax, nerve impairment, subarachnoid
hemorrhage, intestinal obstruction,
hemoptysis, reversible coma, and
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overnight hospitalization. Six serious
AEs occurred with treatment by acu-
puncturists, 1 with a physician certi-
fied in acupuncture, and 18 with
unspecified practitioners. Case infor-
mation and association to acupunc-
ture ratings are detailed in Table 1.
The 12 cases of thumb deformity, which
occurred in 4 boys and 8 girls aged 3 to
11 years, were reported from a clinic in
China between 1983 and 1989. Nine of the
children had a history of acupuncture at
the Hegu point, accompanied with use of
Western medicines, whereas 3 patients
had acupuncture alone; however, the
reasons for and the details of the acu-
puncture treatments were not reported.
The deformities usually presented ⬃1
year after acupuncture treatment; the
longest time before presentation was 5
years. Nine patients had fibrosis of the
thumb adduction muscle, and the 3 re-
maining patients had fibrotic changes.
All 12 patients underwent corrective
surgery.30
In the first case of infection, a 17-year-
old boy in France who was being
treated for tendonitis was diagnosed
with HIV infection. The first symptom
(fever) developed during the week af-
ter the end of acupuncture treatment,
and test results were suggestive of
early HIV infection. Because other risk
factors for HIV were excluded, the au-
thor of the primary article linked the
infection to the preceding acupunc-
ture treatment.31
In the second case, a 14-year-old girl in
Taiwan who was being treated for mild
gluteal pain developed septic sacroili-
itis within 1 day of acupuncture treat-
ment. Her condition resolved within 10
days, after hospitalization and treat-
ment with intravenous antibiotics and
analgesics.32
In the third case, a 13-year-old boy in
Japan who was being treated for lum-
bar pain developed fever and pain 1
day after acupuncture treatment and
was diagnosed with septic arthritis of
a lumbar facet joint. After hospitaliza-
tion and treatment with antibiotics, his
symptoms resolved within 1 week.33
In the fourth case, a 15-year-old boy in
the United States was treated for tho-
racic spinal pain with chiropracty and
acupuncture. After the development of
fever several weeks later, radiographs
identified a paravertebral soft tissue
mass diagnosed as pyogenic spondyli-
tis. Biopsy results indicated bacterial
infection that was resolved through an
extended course of antibiotics.34
In the fifth case, a 12-year-old girl in
Taiwan was admitted to the hospital
with a Pott’s puffy tumor (subperios-
teal abscess and osteomyelitis of the
frontal bone). She had previously re-
ceived acupuncture for her neurologic
condition. Emergency surgery was
performed to drain the abscess, and
culture confirmed bacterial infection
at the site. The patient was discharged
in stable condition.35
In the case of cardiac rupture, a 9-year-
old boy in China received acupuncture
to the chest and abdomen. He was be-
ing treated for preexisting conditions
including malnutrition, pulmonary tu-
berculosis, and heart disease, for
which other care had failed. During the
sixth treatment the boy experienced
severe chest pain and died shortly af-
ter. The autopsy revealed that the pa-
tient had a severely enlarged heart.
Needle holes were found in the dia-
phragm, pericardium, and right ven-
tricular wall, which led the examiner to
conclude that death occurred as a re-
sult of puncture of the heart and sub-
sequent rupture.36
The case of pneumothorax involved a
15-year-old girl in France who became
symptomatic during acupuncture
treatment for an acute asthma attack
and was immediately hospitalized. The
patient recovered, and 3 months later,
signs of lung scarring were observed
at the needling location.37
In the case of nerve impairment, a
16-year-old boy in Japan with a his-
tory of fatigue, tachycardia, and con-
stipation was treated in such a way
that ⬎70 needles were found embed-
ded throughout his body during later
9537 references identified
through searches
450 references remain
29 articles (28 studies) included
9 additional
studies identified
through reference
searches
4249 duplicates removed;
4838 articles excluded after
titles/abstracts screen
9 RCTs 6 cohort
studies
22 case
reports/series
421 excluded because of lack of:
Availability of full article (5)
Duplicate publications (5)
Primary report (48)
Human subjects (3)
Pediatric subjects (172)
Needle acupuncture (60)
Reported AEs (128)
38 articles (37 studies) included
FIGURE 1
Flow of studies through the review.
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TABLE 1 Serious/Moderate AEs in Studies of Needle Acupuncture
Authors and Location Indication for
Treatment
AE No. of Events per
Group (Treatment
or Comparator)
Age, y Gender Practitioner Association to
Treatment
Outcome
Serious AEs
RCTs
Somri et al43 (2001),
Israel
Emesis related to
dental anesthesia
Hospitalization for
emesis
(overnight)
1/30 acupuncture,
1/30 drug, 2/30
placebo
NR NR MD licensed
in TCM
Unlikely Resolved
Case reports
Ou et al30 (1989),
China
NR Thumb adduction
deformity
12 7.5 (mean), 3–11
(range)
4 male, 8 female NR Possible Resolved after surgery
Vittecoq et al31
(1989), France
Tendonitis HIV infection 1 17 Male NR Possible Ongoing
Lau et al32 (1998),
Taiwan
Mild pain in right
buttock
Septic sacroiliitis 1 14 Female NR Possible Resolved after antibiotics
and hospitalization
Ishibe et al33 (2001),
Japan
Pain in lumbar
spine
Septic arthritis of
lumbar facet joint
1 13 Male Acupuncturist Possible Resolved after antibiotics
and hospitalization
Petrie et al34 (2009),
United States
Thoracic spinal pain Pyogenic spondylitis 1 15 Male NR Possible Resolved after antibiotics
Wu et al35 (2009),
Taiwan
Neurologic
condition
Pott’s puffy tumor 1 12 Female Acupuncturist Possible Resolved after surgery
and antibiotics
Ye36 (1956), China Tuberculosis, heart
disease
Cardiac rupture 1 9 Male Acupuncturist Certain Death
Carette et al37
(1984), France
Asthma Pneumothorax 1 15 Female Acupuncturist Possible Resolved
Saski et al38 (1984),
Japan
Tiredness, rapid
heartbeat,
constipation
Nerve impairment 1 16 at treatment,
18 at
diagnosis of
AE
Male NR Certain Improvement after
surgery
Su et al39 (1985),
China
Limited speech and
hearing abilities
Subarachnoid
hemorrhage
1 11 Female Acupuncturist Certain Resolved after
hospitalization
Liu et al40 (1992),
China
Diarrhea Intestinal
obstruction
1 2 Male NR Possible Resolved after surgery
Ke et al41 (2007),
Taiwan
Encephalopathy Hemoptysis from
aspirated needle
1 15 Male NR Certain Resolved after surgery
Kirton et al42 (2008),
Canada
Musculoskeletal
pain
Reversible coma 1 15 Male Acupuncturist Unlikely Resolved after surgery
Moderate AEs
Morgan44 (2008),
United States
Weight loss External ear
infection
1 16 Female NR Certain Resolved after drainage
and antibiotics
MD indicates medical doctor; TCM, traditional Chinese medicine; NR, not reported.
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investigations; 1 needle was located in
the spinal canal between the first and
second cervical vertebrae. Symptoms
of nerve impairment began soon after
acupuncture treatment and pro-
gressed over 2 years to numbness in
both legs and 1 arm. Surgery to re-
move the cervical needle resulted in
good recovery from muscle weakness
but sensation remained impaired.38
The case of subarachnoid hemorrhage
involved an 11-year old girl in China
who experienced headache and vomit-
ing after acupuncture for limited hear-
ing and speech abilities. She was hos-
pitalized for 1 week with a diagnosis of
traumatic subarachnoid hemorrhage.
Acupuncture treatment included in-
sertion of a needle to ⬃2 inches
slightly above the thyroid cartilage.
The authors concluded that the treat-
ment possibly led to damage of the
meningeal or cephalic blood vessels.
No other causative factors could be
identified for her symptoms. Examina-
tion 2 months later was normal.39
In the case of intestinal obstruction, a
2-year-old boy with diarrhea was
treated with acupuncture at a clinic in
China. After treatment the boy exhib-
ited periodic crying, refusal to eat,
vomiting, constipation, stopped pro-
duction of gas and bowel movement,
and general worsening of symptoms.
The patient was admitted to hospital
with abdominal tenderness. Conserva-
tive treatment was unsuccessful; ex-
ploratory surgery revealed an egg-
sized hematoma that was obstructing
the intestine. The affected section of
intestine was removed, and the patient
recovered.40
The case of hemoptysis involved a 15-
year-old boy in China who was bedrid-
den and in a vegetative state as a re-
sult of complications of epilepsy. He
was treated with acupuncture in the
chin region for his encephalopathy;
soon after that, his condition wors-
ened and he was diagnosed with per-
sistent hemoptysis. After radiograph
identification of a wire in his lower
right thorax, surgery was conducted
and a 7-cm acupuncture needle was
removed. The patient was treated with
antibiotics and recovered. It is be-
lieved that a needle was aspirated into
his tracheostomy during acupuncture
treatment.41
In the case of reversible coma, a 15-
year-old boy in Canada received acu-
puncture treatment for musculoskele-
tal pain. During treatment, after laying
on his right side for 30 minutes, the
patient could not be roused and was
taken to the emergency department.
He was determined to be in a coma, from
which he spontaneously awoke after ⬃1
hour. After a similar incident at home 12
days later, further testing suggested
that he had posterior cerebral hypoper-
fusion. Surgery was conducted to im-
prove the perfusion, and the patient re-
covered and remained symptom-free
during follow-up. The reversible coma
was judged unlikely to be related to the
acupuncture but, rather, related to his
posture during treatment.42
The case of overnight hospitalization
occurred during an RCT of acupunc-
ture versus ondansetron versus saline
for emesis related to dental anesthe-
sia in Israel. The child (age and gender
were not reported) was admitted for
excessive vomiting after dental treat-
ment under general anesthesia. The AE
was rated as unlikely to be associated
with acupuncture, because 3 other
study participants were hospitalized
for the same reason: 1 had received
ondansetron control and 2 had re-
ceived intravenous saline.43
Moderate AEs
The single moderate AE was a case of
infection in a 16-year-old girl who de-
veloped severe bacterial infections at
the site of ear stapling in both ears.
She was being treated for weight loss
with surgical staples, which were left
in place, at an acupuncture parlor. In-
fection was noted 2 weeks later after
complaint of ear pain and was treated
with drainage and multiple courses of
antibiotics44 (Table 1).
Mild AEs
The mild AEs included crying, pain,
bruising, transient hemorrhage at the
puncture site, numbness at the punc-
ture site, aggravation of preexisting
symptoms/condition, and vasovagal
reactions such as dizziness or nausea/
vomiting (Table 2). Most (158) mild AEs
occurred under treatment by acu-
puncturists, 83 by physicians certified
in acupuncture, 1 by a physician whose
acupuncture credentials were not
reported, and 11 by unspecified
practitioners.
A total of 145 mild AEs occurred within
RCTs, 7 in comparison to standard
care and the rest in comparison to
sham acupuncture, which consisted of
pressure, minimal penetration at ac-
tive points, or insertion at sham points.
AE Incidence
A summary of AEs, based on study de-
sign, is listed in Table 3. Three of the 8
RCTs collected AE data from both the
acupuncture treatment and acupunc-
ture control arms,45,46,52 whereas the
other 5 collected AE data from the acu-
puncture treatment arms (compared
with either acupressure or conven-
tional care in the control arms).47–51
Four cohort studies also contributed
usable acupuncture AE data.55–58 The 2
other cohort study reports did not pro-
vide reliable numerator and denomi-
nator values and were not included in
the AE totals.53,67
Combining the AE data from both arms
of all RCTs and the 4 cohort studies
resulted in a total of 170 AEs of 1487
patients (11.4% [95% confidence inter-
val (CI): 9.8 –13.1]), and restricting
data to only treatment and control
arms that provided needle acupunc-
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TABLE 2 Mild AEs in Studies of Needle Acupuncture
Authors and Location Indication for
Treatment
Treatment and
Comparator
AE No. of Events per
Group
(Treatment or
Comparator)
Age, Range and/or
Mean (SD)
Gender Time to Event Practitioner Association
to
Treatment
RCTs
Shenkman et al45
(1999), United
States
Emesis from general
anesthesia
T: needle acupuncture;
C: acupuncture at
sham point
Redness at site
Irritation at site
9/47 T; 8/53 C
1/47 T; 0/53 C
2–12 y; 6.1 (2.4) 50 male, 50
female
NR
NR
Anesthesiologist
trained by
licensed
acupuncturist
Certain
Certain
Ng et al46 (2004),
Hong Kong
Persistent allergic
rhinitis
T: needle acupuncture;
C: minimal
acupuncture at
same sites
Numbness
Headache
Light-headedness
3/32 T; 2/31 C
1/32 T; 2/31 C
1/32 T; 0/31 C
Treatment: 11.7 y
(3.2); control: 11.0 y
(3.8)
47 male, 25
female
NR
NR
NR
Acupuncturist Certain
Possible
Possible
Sun et al47 (2004),
Hong Kong
Cerebral palsy T: needle acupuncture;
C: acupressure at
same sites
Initial crying with fear and
possible minor pain
4/22 T; 2/11 C Treatment: 3.52–16.80
y, 8.62 y (3.5);
control: 4.47–14.09
y, 10.68 y (3.1)
16 male, 17
female
At start of
treatment
Acupuncturist Possible
Reindl et al48 (2006),
Germany
Emesis from
chemotherapy
T: needle acupuncture;
C: no treatment
Needle pain 1/11 T; 0/11 C 10–16 y 4 male, 7
female
During treatment Acupuncturist Certain
Gottschling et al49
(2008), Germany
Emesis from
chemotherapy
T: needle acupuncture;
C: no treatment
Needle pain 4/23 T; 0/23 C 13.6 y (2.9) 10 male, 13
female
During treatment Acupuncturist Certain
Leung et al50 (2009),
Hong Kong
Nocturnal enuresis T: needle acupuncture;
C: alarm
Hemorrhage (local) 2/15 T; 0/20 C 4–10 y; 9.2 y 23 male, 12
female
During treatment Acupuncturist Certain
Wong and Sun51
(2010), Hong
Kong
Autism spectrum
disorder
T: needle acupuncture;
C: acupressure at
same sites
Initial crying with fear and
possible minor pain
25/25 T; NR/25 C
e
Treatment: 6.2 y (1.9);
control: 6.0 y (2.0)
7.3:1 male/
female
At start of
treatment
Acupuncturist Possible
Wong et al52 (2010),
Hong Kong
Autism spectrum
disorder
T: needle acupuncture;
C: minimal
acupuncture at
different sites
Hemorrhage (local) or
crying or irritability
30/30 T; NR/25 C
f
Treatment: mean 9.2 y
(4.1); control: 9.6 y
(4.2)
47 male, 8
female
During treatment Acupuncturist Possible
Cohort studies
Chen et al53 (1990),
Taiwan
Various T: needle acupuncture;
C: NA
Fainting 2/NR
a
11–19 y NR During treatment NR Probable
Yamashita et al54
(2001), Japan
Various T: needle acupuncture;
C: NA
Hemorrhage (local)
b
ⱕ6/8 10–19 y NR After removal Acupuncturist Certain
Pain on insertion
b
ⱕ6/8 During treatment Certain
Petechiae or ecchymosis
b
ⱕ6/8 NR Probable
Wong et al55 (2001),
Hong Kong
Persistent drooling T: needle acupuncture;
C: NA
Initial crying with fear and
possible minor pain
3/10 patients 7.3 y (4.8) 5 male, 5
female
NR Acupuncturist Possible
Endres et al56
(2004), Germany
Headache or chronic
lower back pain
or arthrosis
T: needle acupuncture;
C: NA
Hematoma 44/1109 patients 2–17 y NR NR MD trained in
acupuncture
Probable
Vasovagal reaction
c
13/1109 NR Possible
Drowsiness/sleep
disturbance
1/1109 NR Possible
Aggravation of condition 5/1109 NR Possible
Sensation during
treatment
d
1/1109 During treatment Probable
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TABLE 2 Continued
Authors and Location Indication for
Treatment
Treatment and
Comparator
AE No. of Events per
Group
(Treatment or
Comparator)
Age, Range and/or
Mean (SD)
Gender Time to Event Practitioner Association
to
Treatment
Wong et al57 (2006),
Hong Kong
Visual disorder T: needle acupuncture;
C: NA
Initial crying with fear and
possible minor pain
4/12 patients 7.9 y 5 male, 7
female
NR Acupuncturist Possible
Chen et al58 (2008),
United Kingdom
Autism spectrum
disorder
T: needle acupuncture;
C: NA
Hemorrhage 2/2 patients
2/2 patients
11 y Female NR
NR
Acupuncturist Possible
Certain
Case reports/series
Buchta59 (1972),
United States
Pneumonia T: needle acupuncture;
C: NA
Petechiae, multiple 1 2 y Female Treatment
occurred 2 d
before
observation of
AE
Acupuncturist Possible
Cheng60 (1988),
China
Hip pain T: needle acupuncture;
C: NA
Rash 1 11 y Female 27 h after
treatment
NR Possible
Liu and Wang61
(1993), China
Paralytic strabismus T: needle acupuncture;
C: NA
Hemorrhage (local) ⬃6/⬃20
f
⬍18 y NR NR NR Certain
Campbell62 (1999),
United Kingdom
Migraine T: needle acupuncture;
C: NA
Prolonged migraine 1 16 y Male NR MD trained in
acupuncture
Possible
Rusy et al63 (2002),
United States
Feeding intolerance T: needle acupuncture;
C: NA
Crying, vomiting 1 14 mo Male During treatment NR Possible
Wong and Wong64
(2008), Hong
Kong
Bell’s palsy T: needle acupuncture;
C: NA
Pain at site 1 15 y Female During treatment TCM
practitioner
Certain
Sidhanee et al65
(2008), United
Kingdom
Pain related to spina
bifida
T: needle acupuncture;
C: NA
Worsened symptoms 1 15 y Female After 3 wk of
treatment
NR Possible
Watson66 (2009),
United Kingdom
Cerebral palsy T: needle acupuncture;
C: NA
Hemorrhage (local) 1 10 y Male During treatment MD Certain
T indicates treatment; C, comparator; NR, not reported; NA, not applicable; MD, medical doctor; TCM, traditional Chinese medicine.
a
This cohort study identified patients who fainted during treatment; of the 52 patients identified, 2 were children. The total number of patients treated was not reported; further information was not available from the authors.
b
When contacted, the authors stated that there were 8 pediatric patients in this study, up to 6 of whom had ⱖ1 of these 3 AEs (personal communication).
c
Including collapse, dizziness, and nausea/vomiting.
d
Tingling/prickling/burning dysesthesias, paresthesia, and hyperesthesia not related to de qi sensation.
e
Values were reported as “some” in manuscript. When contacted, the authors stated that all participants in the treatment groups experienced the indicated event at least once; values for control participants were not available.
f
When contacted, the authors stated that there were ⬃20 pediatric patients, of which ⬃6 had the AE.
e1582 ADAMS et al by guest on November 6, 2015Downloaded from
ture resulted in a total of 168 AEs of
1422 patients (11.8% [95% CI:
10.1–13.5]).
Excluded Studies
A number of the excluded studies are
worthy of further mention to promote
transparency in our decision-making.
We excluded 1 report of the insertion
of multiple metal objects by a practitio-
ner described as an African “specialist
witchdoctor”; these objects were de-
tected when the patient was hospital-
ized for acute rheumatic fever.68 Be-
cause we were uncertain if this
treatment qualified as acupuncture,
we chose to exclude it.
We also identified 11 other studies that
included both children and adults,
where, despite repeated requests to
the authors, it remained unclear if any
of the reported AEs occurred in chil-
dren. Therefore, those studies were
not included.14,69–77
DISCUSSION
To our knowledge, this is the first sys-
tematic review to specifically examine
the safety of needle acupuncture in chil-
dren. The majority of identified harms
were mild and were from prospectively
planned studies; few serious harms
were identified. A large proportion of AEs
identified from the RCTs were from 2
studies. In the first study, all 25 partici-
pants who received tongue acupuncture
experienced initial crying with fear and
possible minor pain.51 In the second
study, all 30 participants who received
traditional Chinese medicine acupunc-
ture experienced local hemorrhage, cry-
ing, or irritability.52
The report by Jindal et al25 presented
an overall AE incidence of 29 of 651 pa-
tients (4.5% [95% CI: 2.9 – 6.0]) for pa-
tients who received either real or
sham acupoint stimulation. The re-
sults from breaking down the inci-
dence according to type of acupunc-
ture are listed in Table 4.
All of the AEs occurred in conjunction
with needle acupuncture. The lack of
AEs with laser acupuncture and acu-
point injection might be because, in
part, of inherent differences between
the 3 procedures. If we consider the
RCTs of needle acupuncture alone, to
compare the results of Jindal et al with
those of our systematic review, their
determination of AEs from patients
who received acupuncture treatment
(8.3%) was significantly lower than
ours (29.5% of patients) (P⬍.001).
The methods used by Jindal et al dif-
fered from ours in 3 key ways: (1) the
authors restricted their included stud-
ies to RCTs; (2) they searched for
efficacy studies and subsequently
screened for mention of safety; and (3)
they included studies that did not re-
port harms (both those that made no
mention of harms and those that
stated that no harm occurred; in our
systematic review we differentiated
between the two, because we did not
see them as equivalent).
Problems in the Field
To be able to compare harms with
other medical interventions, we chose
to use a modified version of the Na-
tional Cancer Institute Common Termi-
nology Criteria for Adverse Events
scale. A number of methods for classi-
fying or categorizing harm exist; how-
TABLE 3 AEs Grouped According to Study Design
Authors Treatment Arm, No.
of AEs/No. of
Patients (%)
a
Control Arm, No.
of AEs/No. of
Patients (%)
a
Total No. of AEs/No.
of Patients (%)
a
RCTs
Needle acupuncture in both arms
Shenkman et al45 (1999) 10/47 (21.2) 8/53 (15.1) 18/100 (18.0)
Ng et al46 (2004) 5/32 (15.6) 4/31 (12.9) 9/63 (14.3)
Wong et al52 (2010) 30/30 (100.0) NR/25 (—) 30/30 (100.0)
Total 45/109 (41.3) 12/84 (14.2) 57/193 (29.5)
Needle acupuncture compared to
acupressure
Sun et al47 (2004) 4/22 (18.2) 2/11 (18.2) 6/33 (18.2)
Wong and Sun51 (2010) 25/25 (100.0) NR/25 (—) 25/25 (100.0)
Total 29/47 (61.7) 2/11 (18.2) 31/58 (53.4)
Needle acupuncture compared to other
conventional treatment
Reindl et al48 (2006) 1/11 (9.1) 0/11 (0.0) 1/22 (4.5)
Gottschling et al49 (2008) 4/23 (17.4) 0/23 (0.0) 4/46 (8.7)
Leung et al50 (2009) 2/15 (13.3) 0/20 (0.0) 2/35 (5.7)
Total 7/49 (14.3) 0/54 (0.0) 7/103 (6.8)
RCTs total 81/205 (39.5) 14/149 (9.4) 95/354 (26.8)
Single-arm cohort studies
Wong et al55 (2001) 3/10 (33.3) NA 3/10 (33.3)
Endres et al56 (2004) 64/1109 (5.8) NA 64/1109 (5.8)
Wong et al57 (2006) 4/12 (33.3) NA 4/12 (33.3)
Chen et al58 (2008) 4/2 (200.0) NA 4/2 (200.0)
Cohort total 75/1133 (6.6) NA 75/1133 (6.6)
Total 156/1338 (11.7) 14/149 (9.4) 170/1487 (11.4)
NR indicates not reported; —, could not be calculated; NA, not applicable.
a
AEs were reported at least once per patient.
TABLE 4 Acupuncture AE Rates Reported by
Jindal et al25 for Study Arms in Which
Participants Received Acupoint
Stimulation (Real or Sham)
Type of Acupoint
Stimulation
No. of AEs Reported/
No. of Subjects (%
[95% CI])
Needle, without electrical
stimulation
29/348 (8.3 [5.4–11.2])
Needle, with electrical
stimulation
0/80 patients (0.0)
Laser 0/180 patients (0.0)
Injection 0/43 patients (0.0)
Total 29/651 (4.5 [2.9–6.0])
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ever, a standardized, broadly accepted
method for categorizing the harms
that might be associated with acu-
puncture is not yet in place despite
earlier identification of such a need.78
Research Implications
The overall incidence of AEs in these 2
sets of pediatric-specific results are
much lower (8.3% and 11.4%) than that
reported for similar events in adults
(up to 29.5%).10 This might be because,
in part, of the much larger number of
adult patients studied, as well as study
design, in that the adult data were col-
lected during a large-scale prospec-
tive practice survey. In an editorial
published a decade ago, MacPherson78
strongly encouraged the conduct of
prospective practice surveys as a way
of gathering the strongest safety evi-
dence and overcoming limitations of
both retrospective surveys and litera-
ture reviews. Large-scale prospective
practice-based surveys have since
been carried out in multiple countries
on several different styles of acupunc-
ture, which led to convincing and reas-
suring safety information in adults.
Repetition of this work in children
would go far in closing this gap in pe-
diatric safety knowledge and likely re-
sult in a more convincing estimate of
risk of pediatric AEs.
Clinical Implications
Five of the serious AEs we identified
might have involved technical error
rather than inherent risk from the pro-
cedure. The cases of infection might
have occurred as a result of inade-
quate sterilization, either of the site or
needles, and the cases of cardiac rup-
ture and pneumothorax as a result of
improper technique or poor knowl-
edge of anatomy. The case of cardiac
rupture is particularly disturbing be-
cause of the numerous errors that
were made, by modern standards, in-
cluding the insertion of needles
through clothing. Current acupunc-
ture regulations79 precisely detail pro-
tocols intended to maximize the safety
of acupuncture practice, including
procedures for sterilization and nee-
dling in the area of organs, but it is
unknown what regulations were in
place at the times and places of these
AEs. The case of nerve impairment
might have been a result of a practice
that was common in Japanese acu-
puncture and included deliberately
breaking needles and permanently
embedding them in the body.
Informed consent to any health care
intervention demands accurate knowl-
edge of potential risk and potential
benefit. In conventional medicine,
harms are not uncommon80–82 but are
often accepted in light of the serious-
ness of the illness and the potential
effectiveness of the therapy. In pediat-
ric acupuncture, evidence of effective-
ness is still being developed for most
conditions. The acceptability of offer-
ing acupuncture as a treatment option
then depends on its safety, cost, and
tolerability. In our study we found the
likelihood of serious harm to be very
low in trained hands, and the more
common mild AEs (nature and rate)
are in line with what is known about
subcutaneous needle penetration.83
Limitations
This study was limited by the restric-
tion of searches to conventional
English-language databases because
of logistic considerations. Searches of
non-English databases might have
yielded further information. In some
countries, international access to local
literature might be difficult, because ar-
ticles might not be indexed in conven-
tional databases and because access to
local journals might be restricted. For ex-
ample, in their review of the Japanese
acupuncture safety literature, Ya-
mashita et al determined that of the 89
articles they found, 70 were not listed in
PubMed.84 In some cases, as in Japan,
authors are collecting and publishing
this local information in more readily
available forms.54 Others are collecting
and synthesizing data from large num-
bers of their own studies.50
CONCLUSIONS
We identified common minor AEs and
rare serious harms in pediatric acu-
puncture. Evaluation of the current pe-
diatric literature identified few serious
AEs; however, the small number of par-
ticipants in the included studies ham-
pers our ability to draw conclusions
regarding the overall safety of pediat-
ric acupuncture and to generalize to
other populations. On the basis of the
available data, we determined the inci-
dence of mild AEs that occurred in
needle-acupuncture study arms to be
168 of 1422 patients (11.8% [95% CI:
10.1–13.5]). Estimates of overall risk of
AEs in adult acupuncture, including se-
rious AEs, have been possible because
of the conduct of large prospective
studies. The current pediatric acu-
puncture safety literature is limited to
case reports and small studies or the in-
clusion of small numbers of children in
predominantly adult studies. To produce
convincing risk estimates for pediatric
acupuncture, prospective large-scale
pediatric studies and standardized re-
porting criteria are needed. With the
popularity of pediatric acupuncture, es-
pecially in patient populations, reliable
information about its safety is urgently
needed.
ACKNOWLEDGMENTS
This work was supported by Alberta
Innovates-Health Solutions (formerly
AHFMR) and the Canadian Institutes of
Health Research. Dr Vohra receives
salary support from Alberta Innovates-
Health Solutions as a health scholar.
We thank Courtney Spelliscy, Sheena
Sikora, and Kerri Gladwin for assis-
tance with screening of the articles
and Derek Wang for Chinese article
screening and translation.
e1584 ADAMS et al by guest on November 6, 2015Downloaded from
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