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The Safety of Pediatric Acupuncture: A Systematic Review


Abstract and Figures

Acupuncture is increasingly used in children; however, the safety of pediatric acupuncture has yet to be reported from systematic review. To identify adverse events (AEs) associated with needle acupuncture in children. Eighteen databases were searched, from inception to September 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 extracted from all included studies. Of 9537 references identified, 450 were assessed for inclusion. 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 studies, 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 hemorrhage, intestinal obstruction, hemoptysis, reversible coma, and overnight hospitalization), 1 was moderate (infection), and 253 were mild. The mild AEs included pain, bruising, bleeding, and worsening of symptoms. We calculated a mild AE incidence per patient of 168 in 1422 patients (11.8% [95% confidence interval: 10.1-13.5]). Of the AEs associated with pediatric needle acupuncture, 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.
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The Safety of Pediatric Acupuncture: A Systematic
CONTEXT: Acupuncture is increasingly used in children; however, the
safety of pediatric acupuncture has yet to be reported from systematic
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
AUTHORS: Denise Adams, PhD,
Florence Cheng, MD,
Hsing Jou, MD,
Steven Aung, MD, PhD,
Yutaka Yasui,
and Sunita Vohra, MD, MSc
CARE Program, Department of Pediatrics, and Departments of
Medicine and
Public Health Sciences, University of Alberta,
Edmonton, Alberta, Canada
acupuncture, pediatric, safety, systematic review
AE—adverse event
RCT—randomized controlled trial
CI—confidence interval
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:
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.
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
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
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
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
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
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
4249 duplicates removed;
4838 articles excluded after
titles/abstracts screen
9 RCTs 6 cohort
22 case
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
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
AE No. of Events per
Group (Treatment
or Comparator)
Age, y Gender Practitioner Association to
Serious AEs
Somri et al43 (2001),
Emesis related to
dental anesthesia
Hospitalization for
1/30 acupuncture,
1/30 drug, 2/30
NR NR MD licensed
in TCM
Unlikely Resolved
Case reports
Ou et al30 (1989),
NR Thumb adduction
12 7.5 (mean), 3–11
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),
Mild pain in right
Septic sacroiliitis 1 14 Female NR Possible Resolved after antibiotics
and hospitalization
Ishibe et al33 (2001),
Pain in lumbar
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),
Pott’s puffy tumor 1 12 Female Acupuncturist Possible Resolved after surgery
and antibiotics
Ye36 (1956), China Tuberculosis, heart
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),
Tiredness, rapid
Nerve impairment 1 16 at treatment,
18 at
diagnosis of
Male NR Certain Improvement after
Su et al39 (1985),
Limited speech and
hearing abilities
1 11 Female Acupuncturist Certain Resolved after
Liu et al40 (1992),
Diarrhea Intestinal
1 2 Male NR Possible Resolved after surgery
Ke et al41 (2007),
Encephalopathy Hemoptysis from
aspirated needle
1 15 Male NR Certain Resolved after surgery
Kirton et al42 (2008),
Reversible coma 1 15 Male Acupuncturist Unlikely Resolved after surgery
Moderate AEs
Morgan44 (2008),
United States
Weight loss External ear
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
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
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
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 and
AE No. of Events per
(Treatment or
Age, Range and/or
Mean (SD)
Gender Time to Event Practitioner Association
Shenkman et al45
(1999), United
Emesis from general
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
trained by
Ng et al46 (2004),
Hong Kong
Persistent allergic
T: needle acupuncture;
C: minimal
acupuncture at
same sites
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
47 male, 25
Acupuncturist Certain
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
At start of
Acupuncturist Possible
Reindl et al48 (2006),
Emesis from
T: needle acupuncture;
C: no treatment
Needle pain 1/11 T; 0/11 C 10–16 y 4 male, 7
During treatment Acupuncturist Certain
Gottschling et al49
(2008), Germany
Emesis from
T: needle acupuncture;
C: no treatment
Needle pain 4/23 T; 0/23 C 13.6 y (2.9) 10 male, 13
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
During treatment Acupuncturist Certain
Wong and Sun51
(2010), Hong
Autism spectrum
T: needle acupuncture;
C: acupressure at
same sites
Initial crying with fear and
possible minor pain
25/25 T; NR/25 C
Treatment: 6.2 y (1.9);
control: 6.0 y (2.0)
7.3:1 male/
At start of
Acupuncturist Possible
Wong et al52 (2010),
Hong Kong
Autism spectrum
T: needle acupuncture;
C: minimal
acupuncture at
different sites
Hemorrhage (local) or
crying or irritability
30/30 T; NR/25 C
Treatment: mean 9.2 y
(4.1); control: 9.6 y
47 male, 8
During treatment Acupuncturist Possible
Cohort studies
Chen et al53 (1990),
Various T: needle acupuncture;
Fainting 2/NR
11–19 y NR During treatment NR Probable
Yamashita et al54
(2001), Japan
Various T: needle acupuncture;
Hemorrhage (local)
6/8 10–19 y NR After removal Acupuncturist Certain
Pain on insertion
6/8 During treatment Certain
Petechiae or ecchymosis
6/8 NR Probable
Wong et al55 (2001),
Hong Kong
Persistent drooling T: needle acupuncture;
Initial crying with fear and
possible minor pain
3/10 patients 7.3 y (4.8) 5 male, 5
NR Acupuncturist Possible
Endres et al56
(2004), Germany
Headache or chronic
lower back pain
or arthrosis
T: needle acupuncture;
Hematoma 44/1109 patients 2–17 y NR NR MD trained in
Vasovagal reaction
13/1109 NR Possible
1/1109 NR Possible
Aggravation of condition 5/1109 NR Possible
Sensation during
1/1109 During treatment Probable
PEDIATRICS Volume 128, Number 6, December 2011 e1581
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TABLE 2 Continued
Authors and Location Indication for
Treatment and
AE No. of Events per
(Treatment or
Age, Range and/or
Mean (SD)
Gender Time to Event Practitioner Association
Wong et al57 (2006),
Hong Kong
Visual disorder T: needle acupuncture;
Initial crying with fear and
possible minor pain
4/12 patients 7.9 y 5 male, 7
NR Acupuncturist Possible
Chen et al58 (2008),
United Kingdom
Autism spectrum
T: needle acupuncture;
Hemorrhage 2/2 patients
2/2 patients
11 y Female NR
Acupuncturist Possible
Case reports/series
Buchta59 (1972),
United States
Pneumonia T: needle acupuncture;
Petechiae, multiple 1 2 y Female Treatment
occurred 2 d
observation of
Acupuncturist Possible
Cheng60 (1988),
Hip pain T: needle acupuncture;
Rash 1 11 y Female 27 h after
NR Possible
Liu and Wang61
(1993), China
Paralytic strabismus T: needle acupuncture;
Hemorrhage (local) 6/20
18 y NR NR NR Certain
Campbell62 (1999),
United Kingdom
Migraine T: needle acupuncture;
Prolonged migraine 1 16 y Male NR MD trained in
Rusy et al63 (2002),
United States
Feeding intolerance T: needle acupuncture;
Crying, vomiting 1 14 mo Male During treatment NR Possible
Wong and Wong64
(2008), Hong
Bell’s palsy T: needle acupuncture;
Pain at site 1 15 y Female During treatment TCM
Sidhanee et al65
(2008), United
Pain related to spina
T: needle acupuncture;
Worsened symptoms 1 15 y Female After 3 wk of
NR Possible
Watson66 (2009),
United Kingdom
Cerebral palsy T: needle acupuncture;
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.
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.
When contacted, the authors stated that there were 8 pediatric patients in this study, up to 6 of whom had 1 of these 3 AEs (personal communication).
Including collapse, dizziness, and nausea/vomiting.
Tingling/prickling/burning dysesthesias, paresthesia, and hyperesthesia not related to de qi sensation.
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.
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:
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
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 (%)
Control Arm, No.
of AEs/No. of
Patients (%)
Total No. of AEs/No.
of Patients (%)
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
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.
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
No. of AEs Reported/
No. of Subjects (%
[95% CI])
Needle, without electrical
29/348 (8.3 [5.4–11.2])
Needle, with electrical
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])
PEDIATRICS Volume 128, Number 6, December 2011 e1583
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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
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
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
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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DOI: 10.1542/peds.2011-1091
; originally published online November 21, 2011; 2011;128;e1575Pediatrics Vohra
Denise Adams, Florence Cheng, Hsing Jou, Steven Aung, Yutaka Yasui and Sunita
The Safety of Pediatric Acupuncture: A Systematic Review
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The Safety of Pediatric Acupuncture: A Systematic Review
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... In children, acupuncture has been shown to be effective and safe with a limited number of adverse events. These include minor events like transient bleeding and numbness to more severe events like infection and pneumothorax [2,3]. Multiple studies and systematic reviews have found that acupuncture has broad and promising benefits for various types of pain conditions, including acute and chronic pain, migraine headaches, sickle-cell disease, and procedural pain [4][5][6]. ...
Full-text available
Previous studies have shown the benefit and safety of pediatric acupuncture, but it is often rejected by patients and their caregivers due to the perception of needling pain associated with acupuncture. A retrospective cohort study of 230 unique patients (1380 sessions) aged 8 to 21 underwent Kiiko Matsumoto Style acupuncture in an outpatient pain clinic. Patients completed a post-acupuncture survey, including the Faces Pain Scale-Revised and Likert-like scales about overall satisfaction, relaxation, and anxiolysis. Univariate analyses were conducted on all outcomes of interest. The mean needling pain score was 1.3 out of 10 with 57.7% of patients reporting no needling pain during their first acupuncture session. The mean score for overall satisfaction was 8.4 out of 10, relaxation was 8.2 out of 10, and anxiety reduction was 7.7 out of 10. The overall satisfaction, relaxation, and anxiolytic effect of acupuncture was increased in patients with more sessions (p = 0.003, 0.022, 0.004, respectively). There was no change in needling pain scores in patients with an increased number of acupuncture sessions (p = 0.776). Patients experience minimal needling pain during acupuncture needling and are highly satisfied with acupuncture. Those with more treatment sessions report feeling increased satisfaction and relaxation.
... Nevertheless, in the literature other adverse effects in the pediatric population are reported: mild effects including crying, pain, bruising, transient hemorrhage at the puncture site, numbness at the puncture site, aggravation of preexisting symptoms, and vasovagal reactions such as dizziness or nausea/vomiting; moderate effects including severe bacterial infections at the site of needle insertion; and serious adverse effects including infections, pneumothorax, and nerve impairments [98]. ...
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Background: Acupuncture is a spreading and promising intervention, which has proven to be very useful in the treatment and prevention of chronic pain, in particular chronic headaches, in adults; the literature about the treatment of pediatric chronic headaches is scarce. In addition, few guidelines advise its use in children. The aim of this review is to collect all relevant studies with available data about the use, effect, and tolerability of acupuncture as a treatment for pediatric primary headaches. Methods: This is a narrative review based on eight studies selected from 135 papers including pediatric cases treated with acupuncture for headache. Results: Despite the differences in tools, procedures, and application sites, acupuncture demonstrated a positive effect on both the frequency and intensity of headaches and was well tolerated. There are no studies considering the long-term efficacy of acupuncture. Conclusion: Further additional studies are needed on acupuncture in children and adolescents, with larger series and standardized procedures, in order to better assess efficacy, tolerability, and long-term prognosis and to define guidelines for the use of this promising and safe treatment. It is particularly relevant to identify safe and well-tolerated treatment options in pediatric patients affected by recurrent and debilitating headaches.
... 21 A systematic review found most adverse events in pediatric acupuncture were categorized as mild, such as pain and bruising. 22 In 2020, a prospective, randomized controlled trial was done on auricular acupuncture (Battlefield acupuncture protocol, BFA) for adult patients who underwent tonsillectomy at a tertiary care Naval Hospital. Ninety-nine patients completed the study and received either BFA or control (ear bandages). ...
The use of acupuncture among US adults was estimated at nearly 40% in 2012. A study from the United Kingdom in 2010 found 60% of otolaryngologic patients had used a form of complementary or integrative medicine, with greater than a third in the last year alone. Acupuncture, a therapeutic modality of traditional Chinese medicine, has been used for millennia in Asian countries. Within otolaryngology, acupuncture has been used for a variety of conditions encompassing otology, laryngology, rhinology, and pediatrics. Herein, we review the current literature on the applications of acupuncture for a range of ENT disorders.
Objective: Pain following total knee arthroplasty (TKA) is common. Various modalities of treating orthopedic postoperative pain (POP) exist; however, the optimal management of POP remains unclear. The purpose of this study was to examine acupuncture's effect on postoperative analgesic consumption and cortisol levels in patients undergoing TKA. Materials and Methods: In this randomized controlled trial, 80 patients scheduled for elective TKA surgery were recruited and randomly assigned to 2 groups: (1) an intervention group, receiving acupuncture treatment on days 1 and 2 in addition to standard POP management (n = 40) and a control group, who received standard POP management only (n = 40). Results: There was no statistical difference between the groups in analgesic consumption on days 1 and 3 postoperatively. On day 5 postoperatively, lower analgesic consumption was seen in the intervention group, compared to the control group. However, this difference was not statistically significant (1.4 versus 2.3, respectively; P = 0.215). There was no statistical difference between the groups in cortisol levels on day 1 postoperatively. In contrast, on day 2 postoperatively, cortisol level was significantly lower in the intervention group, compared to the control group (296 nmol/L versus 400 nmol/L, respectively; P < 0.05). Conclusions: The findings suggest that acupuncture may have some effect on patients' analgesic consumption short-term after TKA. Further studies with larger samples are required for establishing these results.
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Johar Baru is one of the most densely populated residential areas in Southeast Asia. The high level of density faced by Johar Baru raises other problems such as juvenile delinquency, low quality of human resources, economic inequality, unemployment, crowded and slum environments, and health problems. Johar Baru has another name known as the “Kampung Tawuran” or “Brawl Village” becauseof the fighting problem is difficult to eradicate. The condition of low education and weak skills makes the young group of people in the Johar Baru area vulnerable and stigmatized. It also cannot be separated from the socio-economic context of the people who have slum and dense living conditions. The anticipatory steps that have been taken have not been able to reduce the existing brawl. So that preventive measures are needed that not only focus on the brawl itself, but also on restoring the degradation of people who are easily provoked. Urban Acupuncture is used as an approach in this design with the help of mapping and daily methods to restore the degradation caused by the proneness of brawls in Johar Baru. With a deconstructivism architecture approach, this project aims to be an architectural solution that can act as a forum for brawl mitigation efforts in Johar Baru through spatial design and preventive programs; replace the negative daily life of society with positive and productive activities. Keywords: acupuncture; brawl; preventive Abstrak Kecamatan Johar Baru termasuk sebagai salah satu wilayah pemukiman terpadat se-Asia Tenggara. Tingginya tingkat kepadatan yang dihadapi Kecamatan Johar Baru menimbulkan permasalahan lain yakni seperti kenakalan remaja, kualitas SDM yang rendah, kesenjangan ekonomi, pengangguran, lingkungan padat dan kumuh, serta permasalahan kesehatan. Johar Baru memiliki sebutan lain yang dikenal sebagai kampung tawuran karena masalah tawuran yang sulit untuk diberantas. Kondisi rendahnya pendidikan dan lemahnya keterampilan membuat kelompok warga usia muda di kawasan Johar Baru menjadi rentan dan terstigma. Hal tersebut juga tidak bisa lepas dari konteks sosial ekonomi masyarakat yang memiliki kondisi kehidupan yang kumuh dan padat. Langkah antisipatif yang sudah diupayakan tidak dapat mengurangi tawuran yang ada. Sehingga dibutuhkan tindakan preventif yang bukan hanya memusatkan perhatian pada tawuran itu sendiri, namun juga pada pemulihan degradasi masyarakat yang mudah terprovokasi. Akupunktur Perkotaan digunakan sebagai pendekatan dalam perancangan ini dengan bantuan pemetaan dan metode keseharian untuk memulihkan degradasi yang timbul akibat rawannya tawuran di Johar Baru. Dengan pendekatan arsitektur dekonstruktivisme, proyek ini bertujuan untuk menjadi solusi arsitektur yang bisa berperan sebagai wadah kegiatan upaya mitigasi tawuran di Johar Baru melalui perancangan spasial dan program preventif; menggantikan keseharian negatif masyarakat dengan kegiatan-kegiatan yang positif dan produktif.
Complementary therapies are commonly sought for treatment of pediatric headache by primary care physicians, specialists, and parents alike. Herein, we describe the use of nutraceuticals, manual therapies, and acupuncture for headache treatment. We specifically address safety and efficacy evidence when available for children and teens.
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ACKNOWLEDGMENTS The Alberta Heritage Foundation,for Medical Research is most grateful to the following persons,for provision,of information and comments,on the draft report. The views expressed,in the final report are those of the Foundation. Dr. Brian Berman, MD, Complementary Medicine Program, Baltimore, MD Dr. Stephen Birch, Stichting (Foundation) for the Study for Traditional East Asian Medicine (STEAM), Amsterdam Netherlands
Background and objective: Within a large research and reimbursement program by German social health insurance the effectiveness and safety of acupuncture for the treatment of patients suffering from chronic pain was investigated. We provide here the results regarding safety aspects from a large observational study. Methods: Safety aspects were investigated in three ways: Physicians were asked to make a global assessment of safety and to report adverse effects for all 503,397 treatment cycles documented between July 2001 and June 2003. Serious adverse effects had to be reported directly to the research center and were collected up to December 2004. In addition, a sample of 6,140 patients was asked about the side effects they had experienced. Results: Physicians documented at least one adverse effect in 7.8% of all patients, the most frequent being needling pain in 3.9%. Serious adverse events were reported in 17 cases, the most frequent event being pneumothorax (5 cases). 9.3% of patients reported side effects, a quarter of these were considered as truly bothersome. The most frequent side effects reported by patients were pain, fatigue and circulatory disturbances. Conclusions: Serious adverse effects of acupuncture are very rare; however, minor side effects occur frequently. Overall, acupuncture provided by trained physicians is a comparably safe therapy.
A 15-year-old boy with severe encephalopathy and vegetative status was found coughing fresh blood from a tracheostomy 1 day after the tracheostomy tube had been changed. A chest X ray revealed a fractured wire retained over the peripheral right lower thorax region. Computed tomography revealed the retained metal wire with an abscess formed over the right lower lobe of the lung. Flexible bronchoscopy was performed but no foreign body or intrabronchial lesions were detected, although fresh blood from the bronchus of the right lower lobe was found. An exploratory thoracotomy was performed with lobectomy of the right lower lobe of the lung and an acupuncture needle was found within the bronchus. Hemoptysis subsided and the infection resolved gradually after the surgical removal of the needle.
The effect of standardised, Western acupuncture on hay fever symptoms was investigated in a randomised, controlled, single-blind trial in comparison with “sham” acupuncture. Three general practices, in Oxfordshire (rural), Lincolnshire (semi-rural), and Peterborough (urban), recruited 102 patients aged 16 or over with long-standing, moderate or severe hay fever symptoms that had required continuous therapy for at least one month of the year for three or more consecutive years. The patients were asked to keep a diary to record: the amount of medication used daily; a daily symptom score (using a ten-point scale), from which was derived a weekly remission of symptoms score; and their assessment of the effect of acupuncture on the hay fever symptoms. Symptom scores and use of medication were similar in the two groups. In the four-week period following each patient's first treatment, remission of symptoms was reported by 39.0% in the active treatment group and 45.2% in the sham group; mean weekly symptom scores were 18.4 and 17.6 respectively; and mean units of medication used were 4.1 and 5.0 respectively. Sixteen out of 43 patients in the active treatment group and 14 out of 43 in the sham group felt that the acupuncture had had an excellent or very good effect on their hay fever. The treatments were simple, safe, reproducible and perceived as equally effective. Whether this represented an acupuncture effect, a placebo effect, or natural variation in a fluctuating condition, is not clear.
Summary PointsWhy do we need Systematic Reviews of Observational Studies?Confounding and BiasRare insight? The Protective Effect of Beta—Carotene that wasn'tExploring Sources of HeterogeneityConclusion Acknowledgements
Objectives: To explore further the incidence of local adverse reactions to acupuncture in individual patients.Design: Reanalysis of our prospective survey.Setting: Tsukuba College of Technology Clinic in Japan.Outcome measures: Incidence of adverse reactions which were commonly seen in Japanese-style standard acupuncture practice.Results: Minor bleeding was less than 15% (of insertions) in 96% of the patients (pt), and 20% or more in 1.5% of pt. Pain on insertion was less than 15% in 98% of pt, and more than 30% in 0.5% of pt. Subcutaneous bleeding was less than 10% in 97% of pt, and more than 30% in 0.3% of pt. Patients under 20 and female patients tended to express pain on insertion more frequently. Minor bleeding on the head region and the lateral forearm, pain on insertion to the back of the hand and the lower back, and subcutaneous bleeding on the front upper arm and the abdomen were more than twice as frequent as the average incidence.Conclusion: A few patients had remarkable tendencies for bleeding or hyperalgesia. Each school which has its own model of practice should survey the type and incidence of adverse reactions.
Acupuncture has been used therapeutically in China for thousands of years and is growing in prominence in Europe and the United States. In a recent review of complementary and alternative medicine use in the US population, an estimated 2.1 million people or 1.1% of the population sought acupuncture care during the past 12 months. Four percent of the US population used acupuncture at any time in their lives. We reviewed 31 different published journal articles, including 23 randomized controlled clinical trials and 8 meta-analysis/systematic reviews. We found evidence of some efficacy and low risk associated with acupuncture in pediatrics. From all the conditions we reviewed, the most extensive research has looked into acupuncture's role in managing postoperative and chemotherapy-induced nausea/vomiting. Postoperatively, there is far more evidence of acupuncture's efficacy for pediatrics than for children treated with chemotherapy. Acupuncture seems to be most effective in preventing postoperative induced nausea in children. For adults, research shows that acupuncture can inhibit chemotherapy-related acute vomiting, but conclusions about its effects in pediatrics cannot be made on the basis of the available published clinical trials data to date. Besides nausea and vomiting, research conducted in pain has yielded the most convincing results on acupuncture efficacy. Musculoskeletal and cancer-related pain commonly affects children and adults, but unfortunately, mostly adult studies have been conducted thus far. Because the manifestations of pain can be different in children than in adults, data cannot be extrapolated from adult research. Systematic reviews have shown that existing data often lack adequate control groups and sample sizes. Vas et al, Alimi et al, and Mehling et al demonstrated some relief for adults treated with acupuncture but we could not find any well-conducted randomized controlled studies that looked at pediatrics and acupuncture exclusively. Pain is often unresolved from drug therapy, thus there is a need for more studies in this setting. For seasonal allergic rhinitis, we reviewed studies conducted by Ng et al and Xue et al in children and adults, respectively. Both populations showed some relief of symptoms through acupuncture, but questions remain about treatment logistics. Additionally, there are limited indications that acupuncture may help cure children afflicted with nocturnal enuresis. Systematic reviews show that current published trials have suffered from low trial quality, including small sample sizes. Other areas of pediatric afflictions we reviewed that suffer from lack of research include asthma, other neurologic conditions, gastrointestinal disorders, and addiction. Acupuncture has become a dominant complementary and alternative modality in clinical practice today, but its associated risk has been questioned. The National Institutes of Health Consensus Statement states "one of the advantages of acupuncture is that the incidence of adverse effects is substantially lower than that of many drugs or other accepted procedures for the same conditions." A review of serious adverse events by White et al found the risk of a major complication occurring to have an incidence between 1:10,000 and 1:100,000, which is considered "very low." Another study found that the risk of a serious adverse event occurring from acupuncture therapy is the same as taking penicillin. The safety of acupuncture is a serious concern, particularly in pediatrics. Because acupuncture's mechanism is not known, the use of needles in children becomes questionable. For example, acupoints on the vertex of infants should not be needled when the fontanel is not closed. It is also advisable to apply few needles or delay treatment to the children who have overeaten, are overfatigued, or are very weak. Through our review of pediatric adverse events, we found a 1.55 risk of adverse events occurring in 100 treatments of acupuncture that coincides with the low risk detailed in the studies mentioned previously. The actual risk to an individual patient is hard to determine because certain patients, such as an immunosuppressed patient, can be predisposed to an increased risk, acupuncturist's qualifications differ, and practices vary in certain parts of the world. Nevertheless, it seems acupuncture is a safe complementary/alternative medicine modality for pediatric patients on the basis of the data we reviewed.