# Adverse Events of Acupuncture: A Systematic Review of Case Reports

Authors: Shifen Xu; Lizhen Wang; Emily Cooper; Ming Zhang; Eric Manheimer; Brian Berman; Xueyong Shen; Lixing Lao
Journal: Evidence-Based Complementary and Alternative Medicine
 (2013)

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## Abstract

Acupuncture, moxibustion, and cupping, important in traditional Eastern medicine, are increasingly used in the West. Their widening acceptance demands continual safety assessment. This review, a sequel to one our team published 10 years ago, is an evaluation of the frequency and severity of adverse events (AEs) reported for acupuncture, moxibustion, and cupping between 2000 and 2011. Relevant English-language reports in six databases were identified and assessed by two reviewers. During this 12-year period, 117 reports of 308 AEs from 25 countries and regions were associated with acupuncture (294 cases), moxibustion (4 cases), or cupping (10 cases). Country of occurrence, patient’s sex and age, and outcome were extracted. Infections, mycobacterial, staphylococcal, and others, were the main complication of acupuncture. In the previous review, we found the main source of infection to be hepatitis, caused by reusable needles. In this review, we found the majority of infections to be bacterial, caused by skin contact at acupoint sites; we found no cases of hepatitis. Although the route of infection had changed, infections were still the major complication of acupuncture. Clearly, guidelines such as Clean Needle Technique must be followed in order to minimize acupuncture AEs.


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## Body

## 1. Introduction

Traditional acupuncture, which is defined as needling insertion, moxibustion thermal stimulation, and cupping techniques at acupuncture points [1], has become popular in the United States and the rest of the world in recent decades. Data released by the National Institutes of Health (NIH) in 2008 reported that 3.1 million American adults and 150,000 children used acupuncture in 2007. Adult use of acupuncture increased by approximately a million people in the five years from 2002 to 2007 [2]. This increased use brings attention to the safety and quality of the modality.A number of large surveys on the safety of acupuncture have been conducted, mainly in Europe. Most reported incidents have been fairly minor, and incidence rates were low. For example, in a prospective survey of 34,000 treatments by traditional acupuncturists, MacPherson et al. [3] found no serious adverse events (AEs) and 43 minor ones, a rate of 1.3 per 1000 treatments. In another prospective survey, Melchart et al. [4] found 7.1% minor AEs and 5 serious ones among 97,733 acupuncture patients. The authors of these studies concluded that serious AEs seem to be rare and that acupuncture is generally a safe intervention.More than a decade since our last review [5], we have conducted this systematic follow-up review of case reports published between 2000 and 2011 on AEs and complications associated with acupuncture. Our purpose is to (1) estimate the trend of occurrences of the AEs associated with acupuncture over the past 11 years, (2) identify risk factors in acupuncture practice in order to minimize such events, and (3) recommend safe acupuncture practices based on these reported incidents in order to enhance professional standards of practice.


## 2. Materials and Methods

### 2.1. Search Strategy

We searched six databases in an attempt to locate any and all existing English-language case reports on acupuncture AEs published between 2000 and 2011 in electronic form. PubMed, Medline, the Central Information System of Complementary Medicine (CISCOM), Excerpta Medica (EMBASE), Citations in Nursing and Allied Health Literature (CINAHL), and the Complementary and Alternative Medicine for Pain (CAMPAIN) were searched. Search terms were “acupuncture, acupuncture anesthesia, acupuncture analgesia, electroacupuncture, acupuncture points, auricular acupuncture, moxibustion, needling, and cupping.” These terms were combined with “safe, safety, adverse event, adverse reaction, side effects, complications, and risk.”


### 2.2. Inclusion and Exclusion Criteria

Only original case reports of complications or AEs of acupuncture, moxibustion, and cupping published from 2000 to 2011 were included in this review. Two authors independently screened the titles and abstracts of all papers found from the initial search. Disagreements between the two authors were resolved through discussion.We excluded multiple inclusions and analyses of the same AE as well as irrelevant studies. An irrelevant study was defined as a non-case report, such as a review, commentary, or clinical trial.AEs reporting infection, internal organ or tissue injury, and other severe consequences are categorized as “complications,” defined as an added difficulty; a complex state; a disease or accident superimposed upon another without being specifically related. Peripheral or secondary effects such as syncope, nausea, or immune reactions are classified as “adverse reactions” [5].


### 2.3. Data Extraction

A total of 1613 papers were found; 117 were relevant (Figure1). When provided, we extracted author, year of publication, country of occurrence, number of patients affected, disease originally treated, preexisting conditions that might have contributed to the AE, the needling site, the reported AE and its outcome, the practitioner’s training, and the patient’s status at followup. The majority of the reports did not give the date of the AEs. The data were extracted by two independent coauthors, double checked to ensure matching, and organized by whether the AEs were (1) complications or (2) adverse reactions.Figure 1
Flow chart of the screening process.


## 2.1. Search Strategy

We searched six databases in an attempt to locate any and all existing English-language case reports on acupuncture AEs published between 2000 and 2011 in electronic form. PubMed, Medline, the Central Information System of Complementary Medicine (CISCOM), Excerpta Medica (EMBASE), Citations in Nursing and Allied Health Literature (CINAHL), and the Complementary and Alternative Medicine for Pain (CAMPAIN) were searched. Search terms were “acupuncture, acupuncture anesthesia, acupuncture analgesia, electroacupuncture, acupuncture points, auricular acupuncture, moxibustion, needling, and cupping.” These terms were combined with “safe, safety, adverse event, adverse reaction, side effects, complications, and risk.”


## 2.2. Inclusion and Exclusion Criteria

Only original case reports of complications or AEs of acupuncture, moxibustion, and cupping published from 2000 to 2011 were included in this review. Two authors independently screened the titles and abstracts of all papers found from the initial search. Disagreements between the two authors were resolved through discussion.We excluded multiple inclusions and analyses of the same AE as well as irrelevant studies. An irrelevant study was defined as a non-case report, such as a review, commentary, or clinical trial.AEs reporting infection, internal organ or tissue injury, and other severe consequences are categorized as “complications,” defined as an added difficulty; a complex state; a disease or accident superimposed upon another without being specifically related. Peripheral or secondary effects such as syncope, nausea, or immune reactions are classified as “adverse reactions” [5].


## 2.3. Data Extraction

A total of 1613 papers were found; 117 were relevant (Figure1). When provided, we extracted author, year of publication, country of occurrence, number of patients affected, disease originally treated, preexisting conditions that might have contributed to the AE, the needling site, the reported AE and its outcome, the practitioner’s training, and the patient’s status at followup. The majority of the reports did not give the date of the AEs. The data were extracted by two independent coauthors, double checked to ensure matching, and organized by whether the AEs were (1) complications or (2) adverse reactions.Figure 1
Flow chart of the screening process.


## 3. Results

For the years 2000–2011, a total of 117 reports containing 308 AEs associated with acupuncture (294 cases), moxibustion (4 cases), and cupping (10 cases) were identified from 25 countries and regions (Table1).Table 1
Adverse events associated with acupuncture, moxibustion, and cupping (2000–2011).
Adverse events
Number of cases
Acupuncture
Complications
284
Infections
239
Isolated incidents
48
Outbreaks
191
Internal organ or tissue injury
38
Pneumothorax
13
Central nerve system
9
Peripheral nerves
4
Heart
5
Other injuries
7
Other complications
7
Adverse reactions
10
Moxibustion
4
Cupping
10
Total
308


### 3.1. Acupuncture Complications: Infections

A total of 239 reported cases were infections associated with acupuncture. These include 48 individual isolated cases reported in 45 papers (Table2) and 191 cases reported in five outbreaks (Table 3). Incidents were reported in 17 countries and regions. Korea reported 162 cases, Canada 33, Hong Kong 7, Australia 8, Japan 5, Taiwan 5, UK 4, USA 6, Spain 1, Ireland 1, France 1, Malaysia 1, Croatia 1, Scotland 1, Venezuela 1, Brazil 1, and Thailand 1. Most of the papers did not report the practitioner’s training, but 4 cases were treated by individuals with no medical training or license [6, 7]. One patient with a knee infection died due to renal failure [8]. All other cases recovered after the infection was treated.Table 2
Infections associated with acupuncture (48 cases).
First author/year(references)
Country
Cases age/sex
Disease treated
Punctured  site
Diagnosis
Practitioner
Followup time
Origuchi 2000 [9]
Japan
67/M
Not stated
Not stated
Infectious aortic aneurysm
Not specified
Recovered   (≥8 d)
Ishibe 2001 [10]
Japan
13/M
LBP #
Not stated
Septic arthritis
Acupuncturist
Recovered    (1 wk)
Woo 2001 [11]
HK
79/F
Knee OA
GB38* (leg)
Mycobacterium chelonae
Not specified
Recovered    (3 wk)
Nambiar 2001 [12]
UK
42/F
LBP #
Not stated
Endocarditis
Not specified
Recovered (?)
Shah 2002 [13]
UK
37/M
Tendonitis
BL57* (leg)
Streptococcus
Not specified
Recovered (?)
Leavy 2002 [14]
USA
33/M
Hip pain
Low limb
Staphylococcus aureus
Not specified
Recovered    (6 wk)
Laing 2002 [15]
Ireland
45/F
Postoperative recovery
Around tibia
Staphylococcus aureus strain sensitive to methicillin (in knee joint)
Practitioner
Recovered    (6 wk)
Uchino 2002 [16]
Japan
47/F
Weight loss
Earlobes
Infected left atrial myxoma (Gram-positive)
Not specified
Recovered (after surgery)
Woo 2003 [17]
HK
73/M
LBP
Back
Staphylococcus
Not specified
Recovered    (5 wk)
Ara 2003 [18]
Spain
58/F
Obesity
Abdomen
Mycobacterium  chelonae
Not specified
Recovered    (3 mo)
Cho 2003 [19]
Korea
56/M
Right flank discomfort
Not stated
Klebsiella pneumoniae
Not specified
Recovered (?)
Kettaneh 2003 [20]
France
70/F
Not stated
Face
Facial erysipelas
Physiotherapist
Recovered    (4 wk)
Wiwanitkit 2003 [6]
Thailand
60/F
muscle pain
Not stated
HIV
Non-MD
Not stated
Ha 2003 [21]
Korea
68/F
LBP
Back
Staphylococcus
Not specified
Recovered    (4 mo)
Lin 2003 [22]
Australia
44/F
Not stated
Thigh
Tissue abscess and osteomyelitis
Not specified
Recovered (?)
Daivajna 2004 [23]
UK
48/F
LBP
Low back
Septic arthritis
Not specified
Recovered    (3 wk)
Studd 2004 [24]
Australia
64/F
Epigastric pain
Abdomen  (embedded needles)
Intra-abdominal abscess
Not specified
Recovered    (3 wk)
Kim 2004 [25]
Canada
50/M
LBP
Lower back
Discitis from staphylococcus
Acupuncturist
Recovered (?)
Saw 2004 [26]
Malaysia
55/F
Knee OA
Knee
Necrotizing fasciitis
Not specified
Recovered (?)
Chen 2004 [27]
Taiwan
44/M
Nuchal and subscapular pain
Cervical paraspinal and medial scapular region
Staphylococcus aureus
Not specified
Recovered    (5 mo)
Vucicevic 2005 [28]
Croatia
53/F
Shoulder stiffness
Shoulder and arm
Staphylococcus pleural empyema
Not specified
Recovered    (6 wk)
Bang 2005 [29]
Korea
64/M
LBP
Lumbar paraspinal muscles
Escherichia coli
Not specified
Paraplegic
Seeley 2006 [30]
USA
31/M
Hip pain
Bip, thigh
Staphylococcus bacteraemia
TCM doctor
Recovered    (4 wk)
Simmons 2006 [8]
Scotland
69/M
Knee pain
SP10* (knee)
Cellulitis, septicemia, and pneumonia
Not stated
Death due to renal failure
Tien 2008 [31]
Taiwan
78/M
Knee RA
Knee
Listeria monocytogenes Septic arthritis
Acupuncturist
Recovered    (3 wk)
Morgan 2008 [32]
USA
16/F
Weight loss
Auricular
Pseudomonas aeruginosa
Acupuncture parlor
Recovered   (21 d)
Lee 2008 [33]
Korea
79/M
LBP
Back
Escherichia coli and MRSA
Not specified
Recovered   (76 d)
Hwang 2008 [34]
Korea
25/F
LBP
Back
Pneumoretroperitoneum
OMD
Recovered    (1 wk)
Jeong 2009 [35]
Korea
24/F
Weight loss
Both arms
Factitial panniculitis
Not specified
Recovered (?)
22/F
Weight loss
Abdomen
Factitial panniculitis
Not specified
Recovered (?)
Hwang 2008 [36]
Korea
25/F
LBP
Not stated
Pneumoretroperitoneum
Licensed OMD
Recovered (7 d)
Wu 2009 [37]
Taiwan
12/M
Neurologic sequelae of encephalitis
Head
Pott’s puffy tumor from pseudomonas
Not specified
Recovered    (8 wk)
Woo 2009 [38]
HK
43/F
Knee pain
Knee
MRSA
Not specified
Recovered    (3 mo)
Ogasawara 2009 [39]
Japan
50/F
LBP
Lower back
Septic arthritis(MRSA)
Not specified
Recovered   (70 d)
Guevara-Patiño 2010 [40]
Venezuela
23/F
Not stated
Not stated
NTM
Not specified
Recovered    (6 mo)
Nakajima 2010 [41]
Japan
60/F
Knee pain
Needles embedded at knee
Enterococcus faecalis knee infection
Not specified
Recovered (1 y)
Winter 2010 [42]
USA
21/F
Obesity
Auricular
Auricular cellulitis
Acupuncturist
Recovered (2 d)
30/M
Obesity
Auricular
Auricular cellulitis
Acupuncturist
Recovered    (1 wk)
Kim 2010 [43]
Korea
53/F
LBP
Lower back
Psoas abscess
Not specified
Recovered    (2 wk)
Cho 2010 [44]
Korea
59/F
Not stated
Abdomen, thigh
Mycobacterium skin infection
Not specified
Recovered    (3 mo)
77/M
Not stated
Back and abdomen
Cutaneous tuberculosis infection
Illegal treatment
Recovered (1 y)
Kim 2010 [7]
Korea
72/F
Not stated
Back, shoulder, and right thigh
Cutaneous tuberculosis infection
Illegal treatment
Recovered    (9 mo)
75/F
Not stated
Back and thigh
Cutaneous tuberculosis infection
Illegal treatment
Recovered    (9 mo)
Macuha 2010 [45]
USA
84/M
Osteoarthritis
Left groin
Necrotizing fasciitis
Not specified
Recovered    (2 mo)
Buckley 2011 [46]
UK
15/M
Eczema
Around the knee
Staphylococcus  aureus endocarditis
Not specified
Recovered (3 mo)
Kuo 2011 [47]
Taiwan
57/M
LBP
Bilateral paraspinal muscles
MRSA
Not specified
Recovered (2 mo)
Castro-Silva 2011 [48]
Brazil
59/M
Ankle pain
Limb
Mycobacterium haemophilum infection
Not  specified
Recovered (4 mo)
Hsieh 2011 [49]
Taiwan
44/F
Calf pain
Calf
Necrotizing fasciitis
TCM doctor
Recovered (21 d)
MRSA:  methicillin-resistantStaphylococcus aureus Infection.
NTM: nontuberculous mycobacterial skin infection.
*Acupuncture points.Table 3
Infectious outbreaks associated with acupuncture (191 cases).
First author/year (references)
Country
Cases
Diagnosis
Practitioner
Followup time
Woo 2002 [50]
HK
4
Alcohol-resistant mycobacteria
Not specified
Recovered
Tang 2006 [51]
Canada
32
Mycobacteriosis
Acupuncturist
Recovered
Song 2006 [52]
Korea
40
Mycobacteriosis
Oriental medical clinic
Recovered
Murray 2008 [53]
Australia
6
MRSA
Acupuncturist
Recovered
Koh 2010 [54]
Korea
109
Mycobacteriosis
Acupuncturist
Recovered


### 3.2. Mycobacterium Infection

Of the 239 cases of infection, 193 (80.75%; 153 from Korea, 32 from Canada, 5 from Hong Kong, 1 from Venezuela, 1 from Brazil, and 1 from Spain) were associated with mycobacterium.In 2006, Song et al. reported an outbreak of 40 cases of infection in an Oriental medicine clinic in Republic of Korea. Although disposable acupuncture needles were used, the patients developed skin lesions at two or more sites on the body; infections were confirmed by laboratory culture, clinical signs, and histopathology. All patients recovered after active treatment with antibiotics. Reportedly, these patients received hot-pack therapy and gel massage after acupuncture treatment. No further cases were found in that clinic after equipment sterilization, and regular towel changes were instituted. The authors of the report concluded that the outbreak of infection was due to improper sterilization of equipment applied to the skin after withdrawal of acupuncture needles [52].In 2006, Tang et al. reported an outbreak of acupuncture-associated bacterial infection in Canada. Between April and December 2002, thirty-two patients developed cutaneous mycobacteriosis after visiting an acupuncture practice in Toronto. Interviews with the patients and acupuncturist revealed that needles were reused and kept in a container of glutaraldehyde disinfectant prior to insertion. The solution was no longer available at the time of the investigation but was probably improperly diluted with tap water [51].In 2009, Koh et al. reported an outbreak of 109 cases of skin and soft tissue infection in an acupuncture clinic in Republic of Korea. Most patients had at least one skin lesion. Investigators determined that disposable acupuncture needles were used and were unlikely to be the source of infection. Infected patients were all treated by a physical therapy called “interferential current therapy” or “low-frequency therapy.” The authors found that the diluted disinfectant used to sanitize the therapeutic equipment had been prepared several months earlier and was contaminated withMycobacterium abscessus, the likely source of the outbreak [54].Woo et al. reported four cases of infection by alcohol-resistant mycobacterium, discovered over a two-year period, in patients with skin lesions who were receiving acupuncture treatment in Hong Kong (Table3). The patients had clinical and/or radiological lesions at acupuncture points. The acupuncturists’ training and whether disposable acupuncture needles were used were not reported. The authors recommended that proper infection control guidelines for acupuncture should be mandatory and strictly implemented [50].


### 3.3. Staphylococcus Infection

Nineteen cases from 14 case reports concern staphylococcus infections associated with acupuncture [14, 15, 17, 21, 25, 27, 28, 30, 33, 38, 39, 46, 47, 53]. Of these, nine patients were infected by methicillin-resistant Staphylococcus aureus (MRSA): six from Australia [53], one from Korea [33], one from Taiwan [47], and one from Hong Kong [38].In the Australian case, Murray et al. reported a 2008 outbreak of eight cases of invasive MRSA, six of them associated with acupuncture (Table3). After extensive investigation, the authors concluded that the outbreak most likely resulted from a breakdown in sterile technique during the acupuncture procedure and that the MRSA was probably transmitted from the medical practitioner to the patients. At two time points fifteen months apart, that practitioner had been positively colonized with the MRSA strain that caused the infection [53].


### 3.4. Other Infections

Other infections (31 cases) include septic arthritis [10, 23, 31, 39], necrotizing fasciitis [26, 45, 49], pneumoretroperitoneum [34, 36], facial erysipelas [20], HIV [6], Listeria monocytogenes-caused arthritis [31], and infections by Enterococcus faecalis [41] and Pseudomonas[32, 37]. Although most of the reports did not state possible cause of the infections, reusable needles were used in a few cases.


### 3.5. Acupuncture Complications: Organ and Tissue Injuries

Of 38 cases of organ or tissue injuries, 13 were pneumothoraxes (Table4); 9 were central nerve system injuries (Table 5); 4 were peripheral nerve injuries (Table 6); 5 were heart injuries (Table 7); 7 were other organ and tissue injuries (Table 8). The cases were distributed among ten countries: 10 from South Korea, 6 from the USA, 6 from Taiwan, 5 from Japan, 3 from the UK, 2 from Germany, 2 from Hong Kong, 1 from Austria, 1 from Iran, 1 from Singapore, and 1 from New Zealand. Although most papers did not report the training background of the practitioner, 3 cases were reportedly treated by individuals with no medical training or license [55–57].Table 4
Pneumothoraxes associated with acupuncture (13 cases).
First author/year (reference)
Country
Cases age/sex
Disease treated
Punctured site
Practitioner
Followup
Kao [58]
Taiwan
28/F
Back pain
Thoracic spine bilaterally
Not specified
Recovered (2 d)
Leung 2002 [59]
HK
70/F
Asthma
Thoracic spine bilaterally
Acupuncturist
Not stated
Iwadate 2003 [60]
Japan
72/F
Stiff neck
Thoracic cavity
Acupuncture clinic
Death
Peuker 2004 [61]
Germany
38/F
Breathing problem
Points at chest and upper back (LU1 and BL13)
Medical acupuncturist
Recovered   (1 wk)
Saifeldeen 2004 [62]
UK
31/M
Shoulder pain
Right scapular region
Not specified
Recovered   (1 wk)
Lee 2005 [63]
HK
36/F
Back pain
Upper back
Registered TCM practitioner
Recovered (5 d)
Chauffe 2006 [64]
USA
27/M
Upper back pain
Upper back (T2-8 levels)
Not specified
Recovered (2 d)
Su 2007 [65]
Singapore
52/F
Chronic bronchitis
Upper back (T3)
Not specified
Recovered (2 d)
Von Riedenauer 2007 [66]
USA
25/M
Shoulder pain
Migration of embedded needles
Not specified
Recovered (1 wk)
Juss 2008 [67]
UK
50/F
Neck and back pain
Acupoints at upper back (BL13, BL14, BL15, and BL16)
Physiotherapist
Recovered (2 d)
Richter 2008 [68]
New Zealand
35/F
Back pain
Back region
Physiotherapist
Recovered  (10 d)
Kennedy 2010 [69]
USA
54/F
Musculoskeletal pain
Left side chest
Not specified
Recovered (?)
Inayama 2011 [70]
Japan
37/F
Not stated
Neck and upper back
Acupuncturist
Recovered  (12 d)Table 5
Central nervous system injuries associated with acupuncture (9 cases).
First author/year (reference)
Country
Cases age/sex
Disease treated
Punctured site
Complication
Onset after acupuncture
Practitioner
Followup
Choo 2000 [71]
USA
44/M
Neck pain
GV16 (neck)
Acute intracranial hemorrhage
Immediately
Not specified
Recovered (10 d)
Hama 2004 [72]
Japan
70/M
Not stated
Not stated (broken needle)
Medulla oblongata injury, left facial paresthesia
3 wk
Not specified
Recovered  (1 y)
Eftekhar 2005 [73]
Iran
74/M
LBP
Lumbar region
Epidural hematoma
Shortly
Not specified
Recovered (after surgery)
Chen 2006 [74]
Taiwan
30/M
Back pain
Upper back
Epidural haematoma
1 h
Acupuncturist
Recovered (after surgery)
Ulloth 2007 [75]
USA
52/M
LBP
L1, L2, and L3 Vertebrae (embedded needles)
Cerebrospinal fluid fistula
14 mo
Acupuncturist
Recovered (after surgery)
Liou 2007 [55]
Taiwan
29/M
Stiffness of neck
Epidural space at C2 level (a broken needle)
Spinal Cord Injury
3 y
“Nonmedical practitioner”
Recovered (after surgery)
Tsukazaki 2008 [76]
Japan
32/F
Not stated
GV16 (neck)
Subarachnoid hemorrhage
1 d
Oriental medicine clinic
Not stated
Lee 2011 [77]
Korea
58/F
Quadri- paresis neck pain
Neck
Cervical epidural hematoma
1 h
Family physician
Recovered  (8 wk)
Heo 2011 [56]
Korea
65/M
Not stated
Posterior neck
Intracranial hemorrhage and cerebellar infarction
3 d
Unauthorized acupuncturist
Recovered  (1 mo)Table 6
Peripheral nerve injuries associated with acupuncture (4 cases).
First author/year (reference)
Country
Cases age/sex
Disease treated
Punctured site
Complication
Onset after acupuncture
Practitioner
Followup
Sato 2003 [78]
Japan
62/F
Sciatica
Anterior of the leg
Peroneal nerve palsy
1 d
Not specified
Recovered  (4 mo)
Patrick 2005 [79]
USA
63/F
LBP
Low back
Injury of the L5 nerve root
28 y
Not specified
Recovered(after surgery)
Rosted 2007 [80]
UK
47/M
TMD
ST6, ST7 (face)
Bell’s Palsy
1 d
Not specified
Recovered  (2 wk)
Lee 2008 [81]
Korea
47/M
Abdominal discomfort
PC5 & PC6 (forearm)
Median nerve neuropathy
Shortly
Oriental medicine practitioner
Recovered  (1 y)Table 7
Heart injuries associated with acupuncture (5 cases).
First author/year (reference)
Country
Cases age/sex
Disease treated
Punctured site
Complication
Onset after acupuncture
Practitioner
Followup
Kirchgatterer 2000 [82]
Austria
83/F
Not stated
Sternum
Cardiac tamponade
20 min
Experienced acupuncturist
Recovered  (2 wk)
Park 2004 [83]
Korea
49/F
Shoulder pain
Shoulders and upper back
Cardiac tamponade
2 h
Not specified
Recovered(after surgery)
Kim 2006 [84]
Korea
70/M
Chronic lung disease
Neck, chest, and abdomen (embed needles)
Right ventricular embolism
1 y
Not specified
Not stated
Song 2010 [85]
Korea
69/F
Pain
Shoulders and neck (implanted needles)
Myocardium injury
10 y
Traditional medicine practitioner
Unknown
Kim 2011 [57]
Korea
54/f
Myalgia and dyspepsia
Chest, abdomen
Hemopericardium
30 min
Unauthorized acupuncturist
Recovered  (6 d)Table 8
Other organ or tissue injuries associated with acupuncture (7 cases).
First author/year (reference)
Country
Cases age/sex
Disease treated
Punctured site
Complication
Onset after acupuncture
Practitioner
Followup
Kim 2002 [86]
Korea
54/M
Abdominal pain
Back
Pseudoaneurysm of abdominal aorta
Immediately
OMD
Recovered  (8 d)
Kao 2002 [87]
Taiwan
61/F
Osteoarthritis
Knee
Pseudoaneurysm of the popliteal artery
6 mo
Not specified
Recovered(in 1 y)
Uhm 2005 [88]
Korea
42/F
Dyspepsia
Abdomen
Acute traumatic pancreatitis
5 h
Acupuncture clinic
Recovered  (4 d)
Chang 2005 [89]
Korea
68/F
LBP
Abdomen
Aortoduodenal fistula
2 wk
Not specified
Dead
Cheng 2005 [90]
Taiwan
37/F
Weight loss
Abdomen
Rectus sheath hematoma
4 h
Not specified
Recovered  (1 mo)
Usichenko 2006 [91]
Germany
78/M
Postoperative pain
Ear lobe (embedded needles)
Ear hematomas
4 d
Not specified
Recovered with discoloration
Kuo 2010 [92]
Taiwan
39/F
Knee soreness
Popliteal fossa
Popliteal arteriovenous fistula
Several years
Not specified
Discharged


### 3.6. Pneumothorax (Table4)

Of 13 cases of pneumothorax [58–70] associated with acupuncture, the USA reported 3, the UK 2, Hong Kong 2, Japan 2, Singapore 1, Germany 1, Taiwan 1, and New Zealand 1. Most of these were reported by emergency room physicians. The major patient complaints were dyspnea and chest pain; pneumothorax was confirmed by X-ray. All but one of the 13 patients recovered. A 72-year-old woman died 90 minutes after an acupuncture treatment; autopsy confirmed that the cause was needle penetration of the thoracic cavity [60].


### 3.7. Central Nervous System Injury (Table5)

There were nine cases of central nervous system injury, including five spinal cord injuries [55, 73–75, 77] and four of brain injury [56, 71, 72, 76].Two of the spinal injuries were caused by migrating broken needles [55, 75]; the others were probably the result of needling too deeply. All patients recovered after treatment.The brain injuries were an acute intracranial hemorrhage [71], an injury to the medulla oblongata [72], a subarachnoid hemorrhage [76], and an intracranial hemorrhage with cerebellar infarction [56]. Three were due to needle insertion; the medulla injury was caused by a broken needle. Three patients recovered after treatment; outcome was not given for the fourth (Table 5).


### 3.8. Peripheral Nerve Injury (Table6)

Four reported cases of peripheral nerve injury were associated with acupuncture treatment [78–81], one each in Japan, Korea, the USA, and the UK. The injured nerves were the peroneal nerve via acupuncture point GB34 the median nerve via PC5 and PC6, the facial nerve via ST7 and ST8, and the L5 nerve root via a broken needle in the lumbar region. All patients recovered.


### 3.9. Heart Injury (Table7)

Five cases of heart injury include two of cardiac tamponade [82, 83], one of the hemopericardium [57], one ventricular embolism [84], and one myocardial injury [85]. Of these, two were due to the migration of embedded needles [83, 84] and two were due to needle insertion [57, 82]. Two were caused by an acupuncturist or TCM practitioner, and one by an “unauthorized acupuncturist” [57]. The status of two practitioners was unreported. Three patients recovered; outcome was not reported in the other two cases.


### 3.10. Other Organ and Tissue Injuries (Table8)

Seven cases of other organ and tissue injuries were found: a pseudoaneurysm of the abdominal aorta [86], a pseudoaneurysm of the popliteal artery [87], acute traumatic pancreatitis [88], an aortoduodenal fistula causing direct communication between the aorta and the GI tract [89], a rectus sheath hematoma [90], ear hematomas [91], and a popliteal arteriovenous fistula [92]. The patient with acute traumatic pancreatitis had been treated with 13 cm needles placed at three sites on the anterior abdominal wall. Abdominal computed tomography revealed small multiple gold acupuncture needles on the anterior abdominal wall and back muscles. The patient's condition quickly improved with fasting and intravenous fluids [88]. One patient died [89].


### 3.11. Other Complications of Acupuncture

Seven other complications associated with acupuncture were reported (Table9): bilateral hand edema [93], epithelioid granuloma at needling sites [94], pseudolymphoma [95], localized argyria [96], pustules [97], pancytopenia [98], and scars at needling sites [99]. The localized argyria and pancytopenia were caused by needles embedded 20 and 17 years earlier, respectively [96, 98], in a type of Japanese acupuncture reported in our previous review [5]. The epithelioid granulomas were caused by silicone coating on the needles [94]. The scars were due to a hot needle technique in which the needles were heated in fire before insertion [99].Table 9
Other complications associated with acupuncture (7 cases).
First author/year(reference)
Country
Case age/sex
Disease treated
Puncture site
Complication
Followup time
Remarks
McCartney 2000 [93]
UK
52/M
LPB
LI4 (Hand)
Bilateral hand edema
Recovered(in 8 wk)
No lab evidence of inflammation
Yanagihara 2000 [94]
Japan
55/F
Shoulder pain and lumbago
Back, hip, neck, legs and arms
Epithelioid granuloma at needling sites
Improved
Caused by silicone coating on needles
Kim 2002 [95]
Korea
37/F
Abdominal discomfort
Not state
Pseudolymphoma
Improved
CD-30 positive
Takeishi 2002 [96]
Japan
66/F
Arthralgia
Extremities
Localized argyria
Not stated
Embedded silver needles 20 y earlier
Murray 2002 [97]
UK
35/M
Tennis elbow
Arm
Pustules
Not stated
Pt has Behcet disease
Vassiou 2003 [98]
Greece
67/F
LBP
Chest & abdomen
Pancytopenia
Not stated
Embedded needles 17 y earlier
Pigatto 2004 [99]
Italy
36/F
Hyperthyroidism
St10 (neck)
Scars at needling site
No improvement
“Hot needle” used


### 3.12. Adverse Reactions Associated with Acupuncture

Ten cases of adverse reactions from acupuncture were found (Table10): three of syncope from two reports [100, 101]; two of galactorrhoea (spontaneous milk flow) [102, 103]; one of bilateral nystagmus [104]; one of pyoderma gangrenosum due to immune reaction, in which the tissue became necrotic and deep ulcers formed [105]; one of hepatotoxicity [106]; one of eruptive lichen planus [107]; one of spontaneous needle migration [108]. These unusual cases are uncommonly seen in regular acupuncture practice. The case report authors postulated that these AEs were likely caused by a rare physiological reaction to the acupuncture needle. For example, the case report of spontaneous needle movement involved the acupuncture needles having “spontaneously moved deeper as far as the hilt, travelling an extra depth of 5-10 mm,” which was observed repeatedly on the same patient. Although there was no resulting complicating in this case, the authors cautioned that this could have caused serious complications if the needles had been placed near a vital organ [108].Table 10
Adverse reactions associated with acupuncture (10 cases).
First author/year (reference)
Country
Case age/sex
Disease treated
Puncture sites
Adverse reactions
Remarks
Castro-Durán 2000 [105]
Spain
48/F
Arthralgia
Not stated
Pyoderma gangrenosum
Immune response
Jenner 2002 [102]
UK
41/F
Cancer pain
Points at upper back
Galactorrhoea
Breast cancer
Cole 2002 [100]
USA
25/M
Healthy volunteer for a clinical study
ST36 (bilateral)
Convulsive syncope
Pt was sitting
Campbell 2005 [103]
UK
32/F
Foot pain
Local points at foot
Galactorrhoea (left side)
Pt had no lactation prior to the tx
Kung 2005 [101]
Taiwan
72/M
Arm pain
LI11, TB5 (arm)
Syncope
Pt was sitting
63/F
Ankle pain
GB34, B40 (leg & ankle)
Syncope
Pt was sitting
Bradbury 2006 [104]
UK
50/F
Shoulder pain
Points around shoulder
Nystagmus
Semirecumbent position
Smyth 2007 [108]
Scotland
55/M
Back pain
Back
Spontaneous needle movement
No complication
Hong 2008 [106]
China
52/F
Leg weakness
ST36 (leg)
Hepatotoxicity
Pt was in menopause
Fleming 2011 [107]
UK
41/F
Back pain
Lower back
Eruptive lichen planus
Immune responseThe syncope cases occurred immediately or several minutes after a first acupuncture treatment; the patients were sitting or semirecumbent during treatment [100, 101].


### 3.13. Complications Associated with Moxibustion

Four AEs associated with moxibustion were found (Table11): bruising [109], burns and cellulitis [110], spinal epidural abscess [111], and large superficial basal cell carcinoma [112]. Of these, two were self-administered [111, 112]. An “untrained individual” performed the third [110]; there was no information on the fourth [109].Table 11
Adverse events associated with moxibustion (4 cases).
First author/year(reference)
Country
Case age/sex
Disease treated
Moxibustion site
Adverse events
Practitioner
Remarks
Fisman2002 [109]
Canada
38/M
Not stated
Abdomen
Ecchymoses
Not specified
Pt had a hx of liver disease
Chau 2006 [110]
USA
53/F
Headache
Leg and feet
Cellulitis
Untrained individual
Recovered
Lee 2008 [111]
Korea
78/F
Pain
Fingers
Infection caused spinal epidural abscess
Self
Pt had diabetes
Yun 2009 [112]
Korea
58/M
Abdominal pain
Abdomen
Basal cell carcinoma
Self
Pt. self-treated for 10 y


### 3.14. AEs Associated with Cupping

Ten AEs associated with cupping were found (Table12): four from Turkey, three from Korea, two from Taiwan, and one from the UK. Most were minor: keloid scarring [113], burns [114, 115], and bullae [116, 117]. Several were serious: acquired hemophilia A [118], stroke 14 hours after cupping on the back and neck [119], factitious panniculitis [120], reversible cardiac hypertrophy [121], and iron deficiency anemia [122]. These last two cases involved cupping with bleeding [121, 122]. In six cases, there was no information on practitioner training; in the other four, treatment was self-administered.Table 12
Adverse events associated with cupping (10 cases).
First author/year (reference)
Country
Case age/sex
Disease treated
Cupping site
Adverse events
Practitioner
Remarks
Birol 2005 [113]
Turkey
36/F
Cough
Back
Keloid scar
Not specified
Recovered (several days)
Kose 2006 [114]
Turkey
30/M
Back pain
Back
10% burns at shoulder and back
Self
Recovered (11 d)
Tuncez 2006 [116]
Turkey
57/F
LBP
Low Back
Suction bullae
Not stated
Diabetic; cupping lasted 40 min
Weng 2008 [118]
Taiwan
58/F
Not stated
Thigh
Acquired hemophilia A
Not stated
Improved (1 wk)
Sohn 2008 [121]
Korea
66/F
Pain
Not specified
Reversible cardiac hypertrophy
Self
Bloodletting with cupping >10 y, recovered (3 mo)
Lee 2008 [122]
Korea
39/M
Musculoskeletal  pain
Back
Iron deficiency anemia
Not stated
Bloodletting with cupping Pt. fully recovered
Lin 2009 [117]
Taiwan
55/M
Not stated
Back
Bullae
Not stated
Recovered (several wk)
Blunt 2010 [119]
UK
55/M
Not stated
Back and neck
Hemorrhagicstroke (14 h later)
Not stated
May be due to stimulation of baroreceptor, neck area
Kulahci 2011 [115]
Turkey
32/M
Back pain
Back
Burns on back and shoulder
Mother
Recovered
Moon 2011 [120]
Korea
56/F
Neck and shoulder
Factitious panniculitis
Self
Recovered (3 mo)


## 3.1. Acupuncture Complications: Infections

A total of 239 reported cases were infections associated with acupuncture. These include 48 individual isolated cases reported in 45 papers (Table2) and 191 cases reported in five outbreaks (Table 3). Incidents were reported in 17 countries and regions. Korea reported 162 cases, Canada 33, Hong Kong 7, Australia 8, Japan 5, Taiwan 5, UK 4, USA 6, Spain 1, Ireland 1, France 1, Malaysia 1, Croatia 1, Scotland 1, Venezuela 1, Brazil 1, and Thailand 1. Most of the papers did not report the practitioner’s training, but 4 cases were treated by individuals with no medical training or license [6, 7]. One patient with a knee infection died due to renal failure [8]. All other cases recovered after the infection was treated.Table 2
Infections associated with acupuncture (48 cases).
First author/year(references)
Country
Cases age/sex
Disease treated
Punctured  site
Diagnosis
Practitioner
Followup time
Origuchi 2000 [9]
Japan
67/M
Not stated
Not stated
Infectious aortic aneurysm
Not specified
Recovered   (≥8 d)
Ishibe 2001 [10]
Japan
13/M
LBP #
Not stated
Septic arthritis
Acupuncturist
Recovered    (1 wk)
Woo 2001 [11]
HK
79/F
Knee OA
GB38* (leg)
Mycobacterium chelonae
Not specified
Recovered    (3 wk)
Nambiar 2001 [12]
UK
42/F
LBP #
Not stated
Endocarditis
Not specified
Recovered (?)
Shah 2002 [13]
UK
37/M
Tendonitis
BL57* (leg)
Streptococcus
Not specified
Recovered (?)
Leavy 2002 [14]
USA
33/M
Hip pain
Low limb
Staphylococcus aureus
Not specified
Recovered    (6 wk)
Laing 2002 [15]
Ireland
45/F
Postoperative recovery
Around tibia
Staphylococcus aureus strain sensitive to methicillin (in knee joint)
Practitioner
Recovered    (6 wk)
Uchino 2002 [16]
Japan
47/F
Weight loss
Earlobes
Infected left atrial myxoma (Gram-positive)
Not specified
Recovered (after surgery)
Woo 2003 [17]
HK
73/M
LBP
Back
Staphylococcus
Not specified
Recovered    (5 wk)
Ara 2003 [18]
Spain
58/F
Obesity
Abdomen
Mycobacterium  chelonae
Not specified
Recovered    (3 mo)
Cho 2003 [19]
Korea
56/M
Right flank discomfort
Not stated
Klebsiella pneumoniae
Not specified
Recovered (?)
Kettaneh 2003 [20]
France
70/F
Not stated
Face
Facial erysipelas
Physiotherapist
Recovered    (4 wk)
Wiwanitkit 2003 [6]
Thailand
60/F
muscle pain
Not stated
HIV
Non-MD
Not stated
Ha 2003 [21]
Korea
68/F
LBP
Back
Staphylococcus
Not specified
Recovered    (4 mo)
Lin 2003 [22]
Australia
44/F
Not stated
Thigh
Tissue abscess and osteomyelitis
Not specified
Recovered (?)
Daivajna 2004 [23]
UK
48/F
LBP
Low back
Septic arthritis
Not specified
Recovered    (3 wk)
Studd 2004 [24]
Australia
64/F
Epigastric pain
Abdomen  (embedded needles)
Intra-abdominal abscess
Not specified
Recovered    (3 wk)
Kim 2004 [25]
Canada
50/M
LBP
Lower back
Discitis from staphylococcus
Acupuncturist
Recovered (?)
Saw 2004 [26]
Malaysia
55/F
Knee OA
Knee
Necrotizing fasciitis
Not specified
Recovered (?)
Chen 2004 [27]
Taiwan
44/M
Nuchal and subscapular pain
Cervical paraspinal and medial scapular region
Staphylococcus aureus
Not specified
Recovered    (5 mo)
Vucicevic 2005 [28]
Croatia
53/F
Shoulder stiffness
Shoulder and arm
Staphylococcus pleural empyema
Not specified
Recovered    (6 wk)
Bang 2005 [29]
Korea
64/M
LBP
Lumbar paraspinal muscles
Escherichia coli
Not specified
Paraplegic
Seeley 2006 [30]
USA
31/M
Hip pain
Bip, thigh
Staphylococcus bacteraemia
TCM doctor
Recovered    (4 wk)
Simmons 2006 [8]
Scotland
69/M
Knee pain
SP10* (knee)
Cellulitis, septicemia, and pneumonia
Not stated
Death due to renal failure
Tien 2008 [31]
Taiwan
78/M
Knee RA
Knee
Listeria monocytogenes Septic arthritis
Acupuncturist
Recovered    (3 wk)
Morgan 2008 [32]
USA
16/F
Weight loss
Auricular
Pseudomonas aeruginosa
Acupuncture parlor
Recovered   (21 d)
Lee 2008 [33]
Korea
79/M
LBP
Back
Escherichia coli and MRSA
Not specified
Recovered   (76 d)
Hwang 2008 [34]
Korea
25/F
LBP
Back
Pneumoretroperitoneum
OMD
Recovered    (1 wk)
Jeong 2009 [35]
Korea
24/F
Weight loss
Both arms
Factitial panniculitis
Not specified
Recovered (?)
22/F
Weight loss
Abdomen
Factitial panniculitis
Not specified
Recovered (?)
Hwang 2008 [36]
Korea
25/F
LBP
Not stated
Pneumoretroperitoneum
Licensed OMD
Recovered (7 d)
Wu 2009 [37]
Taiwan
12/M
Neurologic sequelae of encephalitis
Head
Pott’s puffy tumor from pseudomonas
Not specified
Recovered    (8 wk)
Woo 2009 [38]
HK
43/F
Knee pain
Knee
MRSA
Not specified
Recovered    (3 mo)
Ogasawara 2009 [39]
Japan
50/F
LBP
Lower back
Septic arthritis(MRSA)
Not specified
Recovered   (70 d)
Guevara-Patiño 2010 [40]
Venezuela
23/F
Not stated
Not stated
NTM
Not specified
Recovered    (6 mo)
Nakajima 2010 [41]
Japan
60/F
Knee pain
Needles embedded at knee
Enterococcus faecalis knee infection
Not specified
Recovered (1 y)
Winter 2010 [42]
USA
21/F
Obesity
Auricular
Auricular cellulitis
Acupuncturist
Recovered (2 d)
30/M
Obesity
Auricular
Auricular cellulitis
Acupuncturist
Recovered    (1 wk)
Kim 2010 [43]
Korea
53/F
LBP
Lower back
Psoas abscess
Not specified
Recovered    (2 wk)
Cho 2010 [44]
Korea
59/F
Not stated
Abdomen, thigh
Mycobacterium skin infection
Not specified
Recovered    (3 mo)
77/M
Not stated
Back and abdomen
Cutaneous tuberculosis infection
Illegal treatment
Recovered (1 y)
Kim 2010 [7]
Korea
72/F
Not stated
Back, shoulder, and right thigh
Cutaneous tuberculosis infection
Illegal treatment
Recovered    (9 mo)
75/F
Not stated
Back and thigh
Cutaneous tuberculosis infection
Illegal treatment
Recovered    (9 mo)
Macuha 2010 [45]
USA
84/M
Osteoarthritis
Left groin
Necrotizing fasciitis
Not specified
Recovered    (2 mo)
Buckley 2011 [46]
UK
15/M
Eczema
Around the knee
Staphylococcus  aureus endocarditis
Not specified
Recovered (3 mo)
Kuo 2011 [47]
Taiwan
57/M
LBP
Bilateral paraspinal muscles
MRSA
Not specified
Recovered (2 mo)
Castro-Silva 2011 [48]
Brazil
59/M
Ankle pain
Limb
Mycobacterium haemophilum infection
Not  specified
Recovered (4 mo)
Hsieh 2011 [49]
Taiwan
44/F
Calf pain
Calf
Necrotizing fasciitis
TCM doctor
Recovered (21 d)
MRSA:  methicillin-resistantStaphylococcus aureus Infection.
NTM: nontuberculous mycobacterial skin infection.
*Acupuncture points.Table 3
Infectious outbreaks associated with acupuncture (191 cases).
First author/year (references)
Country
Cases
Diagnosis
Practitioner
Followup time
Woo 2002 [50]
HK
4
Alcohol-resistant mycobacteria
Not specified
Recovered
Tang 2006 [51]
Canada
32
Mycobacteriosis
Acupuncturist
Recovered
Song 2006 [52]
Korea
40
Mycobacteriosis
Oriental medical clinic
Recovered
Murray 2008 [53]
Australia
6
MRSA
Acupuncturist
Recovered
Koh 2010 [54]
Korea
109
Mycobacteriosis
Acupuncturist
Recovered


## 3.2. Mycobacterium Infection

Of the 239 cases of infection, 193 (80.75%; 153 from Korea, 32 from Canada, 5 from Hong Kong, 1 from Venezuela, 1 from Brazil, and 1 from Spain) were associated with mycobacterium.In 2006, Song et al. reported an outbreak of 40 cases of infection in an Oriental medicine clinic in Republic of Korea. Although disposable acupuncture needles were used, the patients developed skin lesions at two or more sites on the body; infections were confirmed by laboratory culture, clinical signs, and histopathology. All patients recovered after active treatment with antibiotics. Reportedly, these patients received hot-pack therapy and gel massage after acupuncture treatment. No further cases were found in that clinic after equipment sterilization, and regular towel changes were instituted. The authors of the report concluded that the outbreak of infection was due to improper sterilization of equipment applied to the skin after withdrawal of acupuncture needles [52].In 2006, Tang et al. reported an outbreak of acupuncture-associated bacterial infection in Canada. Between April and December 2002, thirty-two patients developed cutaneous mycobacteriosis after visiting an acupuncture practice in Toronto. Interviews with the patients and acupuncturist revealed that needles were reused and kept in a container of glutaraldehyde disinfectant prior to insertion. The solution was no longer available at the time of the investigation but was probably improperly diluted with tap water [51].In 2009, Koh et al. reported an outbreak of 109 cases of skin and soft tissue infection in an acupuncture clinic in Republic of Korea. Most patients had at least one skin lesion. Investigators determined that disposable acupuncture needles were used and were unlikely to be the source of infection. Infected patients were all treated by a physical therapy called “interferential current therapy” or “low-frequency therapy.” The authors found that the diluted disinfectant used to sanitize the therapeutic equipment had been prepared several months earlier and was contaminated withMycobacterium abscessus, the likely source of the outbreak [54].Woo et al. reported four cases of infection by alcohol-resistant mycobacterium, discovered over a two-year period, in patients with skin lesions who were receiving acupuncture treatment in Hong Kong (Table3). The patients had clinical and/or radiological lesions at acupuncture points. The acupuncturists’ training and whether disposable acupuncture needles were used were not reported. The authors recommended that proper infection control guidelines for acupuncture should be mandatory and strictly implemented [50].


## 3.3. Staphylococcus Infection

Nineteen cases from 14 case reports concern staphylococcus infections associated with acupuncture [14, 15, 17, 21, 25, 27, 28, 30, 33, 38, 39, 46, 47, 53]. Of these, nine patients were infected by methicillin-resistant Staphylococcus aureus (MRSA): six from Australia [53], one from Korea [33], one from Taiwan [47], and one from Hong Kong [38].In the Australian case, Murray et al. reported a 2008 outbreak of eight cases of invasive MRSA, six of them associated with acupuncture (Table3). After extensive investigation, the authors concluded that the outbreak most likely resulted from a breakdown in sterile technique during the acupuncture procedure and that the MRSA was probably transmitted from the medical practitioner to the patients. At two time points fifteen months apart, that practitioner had been positively colonized with the MRSA strain that caused the infection [53].


## 3.4. Other Infections

Other infections (31 cases) include septic arthritis [10, 23, 31, 39], necrotizing fasciitis [26, 45, 49], pneumoretroperitoneum [34, 36], facial erysipelas [20], HIV [6], Listeria monocytogenes-caused arthritis [31], and infections by Enterococcus faecalis [41] and Pseudomonas[32, 37]. Although most of the reports did not state possible cause of the infections, reusable needles were used in a few cases.


## 3.5. Acupuncture Complications: Organ and Tissue Injuries

Of 38 cases of organ or tissue injuries, 13 were pneumothoraxes (Table4); 9 were central nerve system injuries (Table 5); 4 were peripheral nerve injuries (Table 6); 5 were heart injuries (Table 7); 7 were other organ and tissue injuries (Table 8). The cases were distributed among ten countries: 10 from South Korea, 6 from the USA, 6 from Taiwan, 5 from Japan, 3 from the UK, 2 from Germany, 2 from Hong Kong, 1 from Austria, 1 from Iran, 1 from Singapore, and 1 from New Zealand. Although most papers did not report the training background of the practitioner, 3 cases were reportedly treated by individuals with no medical training or license [55–57].Table 4
Pneumothoraxes associated with acupuncture (13 cases).
First author/year (reference)
Country
Cases age/sex
Disease treated
Punctured site
Practitioner
Followup
Kao [58]
Taiwan
28/F
Back pain
Thoracic spine bilaterally
Not specified
Recovered (2 d)
Leung 2002 [59]
HK
70/F
Asthma
Thoracic spine bilaterally
Acupuncturist
Not stated
Iwadate 2003 [60]
Japan
72/F
Stiff neck
Thoracic cavity
Acupuncture clinic
Death
Peuker 2004 [61]
Germany
38/F
Breathing problem
Points at chest and upper back (LU1 and BL13)
Medical acupuncturist
Recovered   (1 wk)
Saifeldeen 2004 [62]
UK
31/M
Shoulder pain
Right scapular region
Not specified
Recovered   (1 wk)
Lee 2005 [63]
HK
36/F
Back pain
Upper back
Registered TCM practitioner
Recovered (5 d)
Chauffe 2006 [64]
USA
27/M
Upper back pain
Upper back (T2-8 levels)
Not specified
Recovered (2 d)
Su 2007 [65]
Singapore
52/F
Chronic bronchitis
Upper back (T3)
Not specified
Recovered (2 d)
Von Riedenauer 2007 [66]
USA
25/M
Shoulder pain
Migration of embedded needles
Not specified
Recovered (1 wk)
Juss 2008 [67]
UK
50/F
Neck and back pain
Acupoints at upper back (BL13, BL14, BL15, and BL16)
Physiotherapist
Recovered (2 d)
Richter 2008 [68]
New Zealand
35/F
Back pain
Back region
Physiotherapist
Recovered  (10 d)
Kennedy 2010 [69]
USA
54/F
Musculoskeletal pain
Left side chest
Not specified
Recovered (?)
Inayama 2011 [70]
Japan
37/F
Not stated
Neck and upper back
Acupuncturist
Recovered  (12 d)Table 5
Central nervous system injuries associated with acupuncture (9 cases).
First author/year (reference)
Country
Cases age/sex
Disease treated
Punctured site
Complication
Onset after acupuncture
Practitioner
Followup
Choo 2000 [71]
USA
44/M
Neck pain
GV16 (neck)
Acute intracranial hemorrhage
Immediately
Not specified
Recovered (10 d)
Hama 2004 [72]
Japan
70/M
Not stated
Not stated (broken needle)
Medulla oblongata injury, left facial paresthesia
3 wk
Not specified
Recovered  (1 y)
Eftekhar 2005 [73]
Iran
74/M
LBP
Lumbar region
Epidural hematoma
Shortly
Not specified
Recovered (after surgery)
Chen 2006 [74]
Taiwan
30/M
Back pain
Upper back
Epidural haematoma
1 h
Acupuncturist
Recovered (after surgery)
Ulloth 2007 [75]
USA
52/M
LBP
L1, L2, and L3 Vertebrae (embedded needles)
Cerebrospinal fluid fistula
14 mo
Acupuncturist
Recovered (after surgery)
Liou 2007 [55]
Taiwan
29/M
Stiffness of neck
Epidural space at C2 level (a broken needle)
Spinal Cord Injury
3 y
“Nonmedical practitioner”
Recovered (after surgery)
Tsukazaki 2008 [76]
Japan
32/F
Not stated
GV16 (neck)
Subarachnoid hemorrhage
1 d
Oriental medicine clinic
Not stated
Lee 2011 [77]
Korea
58/F
Quadri- paresis neck pain
Neck
Cervical epidural hematoma
1 h
Family physician
Recovered  (8 wk)
Heo 2011 [56]
Korea
65/M
Not stated
Posterior neck
Intracranial hemorrhage and cerebellar infarction
3 d
Unauthorized acupuncturist
Recovered  (1 mo)Table 6
Peripheral nerve injuries associated with acupuncture (4 cases).
First author/year (reference)
Country
Cases age/sex
Disease treated
Punctured site
Complication
Onset after acupuncture
Practitioner
Followup
Sato 2003 [78]
Japan
62/F
Sciatica
Anterior of the leg
Peroneal nerve palsy
1 d
Not specified
Recovered  (4 mo)
Patrick 2005 [79]
USA
63/F
LBP
Low back
Injury of the L5 nerve root
28 y
Not specified
Recovered(after surgery)
Rosted 2007 [80]
UK
47/M
TMD
ST6, ST7 (face)
Bell’s Palsy
1 d
Not specified
Recovered  (2 wk)
Lee 2008 [81]
Korea
47/M
Abdominal discomfort
PC5 & PC6 (forearm)
Median nerve neuropathy
Shortly
Oriental medicine practitioner
Recovered  (1 y)Table 7
Heart injuries associated with acupuncture (5 cases).
First author/year (reference)
Country
Cases age/sex
Disease treated
Punctured site
Complication
Onset after acupuncture
Practitioner
Followup
Kirchgatterer 2000 [82]
Austria
83/F
Not stated
Sternum
Cardiac tamponade
20 min
Experienced acupuncturist
Recovered  (2 wk)
Park 2004 [83]
Korea
49/F
Shoulder pain
Shoulders and upper back
Cardiac tamponade
2 h
Not specified
Recovered(after surgery)
Kim 2006 [84]
Korea
70/M
Chronic lung disease
Neck, chest, and abdomen (embed needles)
Right ventricular embolism
1 y
Not specified
Not stated
Song 2010 [85]
Korea
69/F
Pain
Shoulders and neck (implanted needles)
Myocardium injury
10 y
Traditional medicine practitioner
Unknown
Kim 2011 [57]
Korea
54/f
Myalgia and dyspepsia
Chest, abdomen
Hemopericardium
30 min
Unauthorized acupuncturist
Recovered  (6 d)Table 8
Other organ or tissue injuries associated with acupuncture (7 cases).
First author/year (reference)
Country
Cases age/sex
Disease treated
Punctured site
Complication
Onset after acupuncture
Practitioner
Followup
Kim 2002 [86]
Korea
54/M
Abdominal pain
Back
Pseudoaneurysm of abdominal aorta
Immediately
OMD
Recovered  (8 d)
Kao 2002 [87]
Taiwan
61/F
Osteoarthritis
Knee
Pseudoaneurysm of the popliteal artery
6 mo
Not specified
Recovered(in 1 y)
Uhm 2005 [88]
Korea
42/F
Dyspepsia
Abdomen
Acute traumatic pancreatitis
5 h
Acupuncture clinic
Recovered  (4 d)
Chang 2005 [89]
Korea
68/F
LBP
Abdomen
Aortoduodenal fistula
2 wk
Not specified
Dead
Cheng 2005 [90]
Taiwan
37/F
Weight loss
Abdomen
Rectus sheath hematoma
4 h
Not specified
Recovered  (1 mo)
Usichenko 2006 [91]
Germany
78/M
Postoperative pain
Ear lobe (embedded needles)
Ear hematomas
4 d
Not specified
Recovered with discoloration
Kuo 2010 [92]
Taiwan
39/F
Knee soreness
Popliteal fossa
Popliteal arteriovenous fistula
Several years
Not specified
Discharged


## 3.6. Pneumothorax (Table4)

Of 13 cases of pneumothorax [58–70] associated with acupuncture, the USA reported 3, the UK 2, Hong Kong 2, Japan 2, Singapore 1, Germany 1, Taiwan 1, and New Zealand 1. Most of these were reported by emergency room physicians. The major patient complaints were dyspnea and chest pain; pneumothorax was confirmed by X-ray. All but one of the 13 patients recovered. A 72-year-old woman died 90 minutes after an acupuncture treatment; autopsy confirmed that the cause was needle penetration of the thoracic cavity [60].


## 3.7. Central Nervous System Injury (Table5)

There were nine cases of central nervous system injury, including five spinal cord injuries [55, 73–75, 77] and four of brain injury [56, 71, 72, 76].Two of the spinal injuries were caused by migrating broken needles [55, 75]; the others were probably the result of needling too deeply. All patients recovered after treatment.The brain injuries were an acute intracranial hemorrhage [71], an injury to the medulla oblongata [72], a subarachnoid hemorrhage [76], and an intracranial hemorrhage with cerebellar infarction [56]. Three were due to needle insertion; the medulla injury was caused by a broken needle. Three patients recovered after treatment; outcome was not given for the fourth (Table 5).


## 3.8. Peripheral Nerve Injury (Table6)

Four reported cases of peripheral nerve injury were associated with acupuncture treatment [78–81], one each in Japan, Korea, the USA, and the UK. The injured nerves were the peroneal nerve via acupuncture point GB34 the median nerve via PC5 and PC6, the facial nerve via ST7 and ST8, and the L5 nerve root via a broken needle in the lumbar region. All patients recovered.


## 3.9. Heart Injury (Table7)

Five cases of heart injury include two of cardiac tamponade [82, 83], one of the hemopericardium [57], one ventricular embolism [84], and one myocardial injury [85]. Of these, two were due to the migration of embedded needles [83, 84] and two were due to needle insertion [57, 82]. Two were caused by an acupuncturist or TCM practitioner, and one by an “unauthorized acupuncturist” [57]. The status of two practitioners was unreported. Three patients recovered; outcome was not reported in the other two cases.


## 3.10. Other Organ and Tissue Injuries (Table8)

Seven cases of other organ and tissue injuries were found: a pseudoaneurysm of the abdominal aorta [86], a pseudoaneurysm of the popliteal artery [87], acute traumatic pancreatitis [88], an aortoduodenal fistula causing direct communication between the aorta and the GI tract [89], a rectus sheath hematoma [90], ear hematomas [91], and a popliteal arteriovenous fistula [92]. The patient with acute traumatic pancreatitis had been treated with 13 cm needles placed at three sites on the anterior abdominal wall. Abdominal computed tomography revealed small multiple gold acupuncture needles on the anterior abdominal wall and back muscles. The patient's condition quickly improved with fasting and intravenous fluids [88]. One patient died [89].


## 3.11. Other Complications of Acupuncture

Seven other complications associated with acupuncture were reported (Table9): bilateral hand edema [93], epithelioid granuloma at needling sites [94], pseudolymphoma [95], localized argyria [96], pustules [97], pancytopenia [98], and scars at needling sites [99]. The localized argyria and pancytopenia were caused by needles embedded 20 and 17 years earlier, respectively [96, 98], in a type of Japanese acupuncture reported in our previous review [5]. The epithelioid granulomas were caused by silicone coating on the needles [94]. The scars were due to a hot needle technique in which the needles were heated in fire before insertion [99].Table 9
Other complications associated with acupuncture (7 cases).
First author/year(reference)
Country
Case age/sex
Disease treated
Puncture site
Complication
Followup time
Remarks
McCartney 2000 [93]
UK
52/M
LPB
LI4 (Hand)
Bilateral hand edema
Recovered(in 8 wk)
No lab evidence of inflammation
Yanagihara 2000 [94]
Japan
55/F
Shoulder pain and lumbago
Back, hip, neck, legs and arms
Epithelioid granuloma at needling sites
Improved
Caused by silicone coating on needles
Kim 2002 [95]
Korea
37/F
Abdominal discomfort
Not state
Pseudolymphoma
Improved
CD-30 positive
Takeishi 2002 [96]
Japan
66/F
Arthralgia
Extremities
Localized argyria
Not stated
Embedded silver needles 20 y earlier
Murray 2002 [97]
UK
35/M
Tennis elbow
Arm
Pustules
Not stated
Pt has Behcet disease
Vassiou 2003 [98]
Greece
67/F
LBP
Chest & abdomen
Pancytopenia
Not stated
Embedded needles 17 y earlier
Pigatto 2004 [99]
Italy
36/F
Hyperthyroidism
St10 (neck)
Scars at needling site
No improvement
“Hot needle” used


## 3.12. Adverse Reactions Associated with Acupuncture

Ten cases of adverse reactions from acupuncture were found (Table10): three of syncope from two reports [100, 101]; two of galactorrhoea (spontaneous milk flow) [102, 103]; one of bilateral nystagmus [104]; one of pyoderma gangrenosum due to immune reaction, in which the tissue became necrotic and deep ulcers formed [105]; one of hepatotoxicity [106]; one of eruptive lichen planus [107]; one of spontaneous needle migration [108]. These unusual cases are uncommonly seen in regular acupuncture practice. The case report authors postulated that these AEs were likely caused by a rare physiological reaction to the acupuncture needle. For example, the case report of spontaneous needle movement involved the acupuncture needles having “spontaneously moved deeper as far as the hilt, travelling an extra depth of 5-10 mm,” which was observed repeatedly on the same patient. Although there was no resulting complicating in this case, the authors cautioned that this could have caused serious complications if the needles had been placed near a vital organ [108].Table 10
Adverse reactions associated with acupuncture (10 cases).
First author/year (reference)
Country
Case age/sex
Disease treated
Puncture sites
Adverse reactions
Remarks
Castro-Durán 2000 [105]
Spain
48/F
Arthralgia
Not stated
Pyoderma gangrenosum
Immune response
Jenner 2002 [102]
UK
41/F
Cancer pain
Points at upper back
Galactorrhoea
Breast cancer
Cole 2002 [100]
USA
25/M
Healthy volunteer for a clinical study
ST36 (bilateral)
Convulsive syncope
Pt was sitting
Campbell 2005 [103]
UK
32/F
Foot pain
Local points at foot
Galactorrhoea (left side)
Pt had no lactation prior to the tx
Kung 2005 [101]
Taiwan
72/M
Arm pain
LI11, TB5 (arm)
Syncope
Pt was sitting
63/F
Ankle pain
GB34, B40 (leg & ankle)
Syncope
Pt was sitting
Bradbury 2006 [104]
UK
50/F
Shoulder pain
Points around shoulder
Nystagmus
Semirecumbent position
Smyth 2007 [108]
Scotland
55/M
Back pain
Back
Spontaneous needle movement
No complication
Hong 2008 [106]
China
52/F
Leg weakness
ST36 (leg)
Hepatotoxicity
Pt was in menopause
Fleming 2011 [107]
UK
41/F
Back pain
Lower back
Eruptive lichen planus
Immune responseThe syncope cases occurred immediately or several minutes after a first acupuncture treatment; the patients were sitting or semirecumbent during treatment [100, 101].


## 3.13. Complications Associated with Moxibustion

Four AEs associated with moxibustion were found (Table11): bruising [109], burns and cellulitis [110], spinal epidural abscess [111], and large superficial basal cell carcinoma [112]. Of these, two were self-administered [111, 112]. An “untrained individual” performed the third [110]; there was no information on the fourth [109].Table 11
Adverse events associated with moxibustion (4 cases).
First author/year(reference)
Country
Case age/sex
Disease treated
Moxibustion site
Adverse events
Practitioner
Remarks
Fisman2002 [109]
Canada
38/M
Not stated
Abdomen
Ecchymoses
Not specified
Pt had a hx of liver disease
Chau 2006 [110]
USA
53/F
Headache
Leg and feet
Cellulitis
Untrained individual
Recovered
Lee 2008 [111]
Korea
78/F
Pain
Fingers
Infection caused spinal epidural abscess
Self
Pt had diabetes
Yun 2009 [112]
Korea
58/M
Abdominal pain
Abdomen
Basal cell carcinoma
Self
Pt. self-treated for 10 y


## 3.14. AEs Associated with Cupping

Ten AEs associated with cupping were found (Table12): four from Turkey, three from Korea, two from Taiwan, and one from the UK. Most were minor: keloid scarring [113], burns [114, 115], and bullae [116, 117]. Several were serious: acquired hemophilia A [118], stroke 14 hours after cupping on the back and neck [119], factitious panniculitis [120], reversible cardiac hypertrophy [121], and iron deficiency anemia [122]. These last two cases involved cupping with bleeding [121, 122]. In six cases, there was no information on practitioner training; in the other four, treatment was self-administered.Table 12
Adverse events associated with cupping (10 cases).
First author/year (reference)
Country
Case age/sex
Disease treated
Cupping site
Adverse events
Practitioner
Remarks
Birol 2005 [113]
Turkey
36/F
Cough
Back
Keloid scar
Not specified
Recovered (several days)
Kose 2006 [114]
Turkey
30/M
Back pain
Back
10% burns at shoulder and back
Self
Recovered (11 d)
Tuncez 2006 [116]
Turkey
57/F
LBP
Low Back
Suction bullae
Not stated
Diabetic; cupping lasted 40 min
Weng 2008 [118]
Taiwan
58/F
Not stated
Thigh
Acquired hemophilia A
Not stated
Improved (1 wk)
Sohn 2008 [121]
Korea
66/F
Pain
Not specified
Reversible cardiac hypertrophy
Self
Bloodletting with cupping >10 y, recovered (3 mo)
Lee 2008 [122]
Korea
39/M
Musculoskeletal  pain
Back
Iron deficiency anemia
Not stated
Bloodletting with cupping Pt. fully recovered
Lin 2009 [117]
Taiwan
55/M
Not stated
Back
Bullae
Not stated
Recovered (several wk)
Blunt 2010 [119]
UK
55/M
Not stated
Back and neck
Hemorrhagicstroke (14 h later)
Not stated
May be due to stimulation of baroreceptor, neck area
Kulahci 2011 [115]
Turkey
32/M
Back pain
Back
Burns on back and shoulder
Mother
Recovered
Moon 2011 [120]
Korea
56/F
Neck and shoulder
Factitious panniculitis
Self
Recovered (3 mo)


## 4. Discussion

Our primary objective in reviewing case reports of AEs associated with acupuncture has been to identify individual cases and outbreaks of AEs and to analyze their possible causes, in order to minimize future acupuncture AEs and enhance safe practice within the profession. How do the objectives and results of this review fit in the context of other available literatures on the safety of acupuncture? Incidence rates for major AEs of acupuncture are best estimated from large prospective surveys of practitioners. Four recent surveys of acupuncture safety among regulated, qualified practitioners, two conducted in Germany [4, 123] and two in the United Kingdom [3, 124], confirm that serious adverse events after acupuncture are uncommon. Indeed, of these surveys, covering more than 3 million acupuncture treatments all together, there were no deaths or permanent disabilities, and all those with AEs fully recovered [125]. Thus, it can be concluded that acupuncture has a very low rate of AEs, when conducted among licensed, qualified practitioners in the West. Recent systematic reviews of RCTs of acupuncture [126–128], in which the acupuncture procedure is also conducted under well-controlled conditions,also found no serious AEs associated with acupuncture [128], although one of these systematic reviews of RCTs separately examined case reports of AEs associated with acupuncture and had findings comparable to ours. However, any medical intervention has the potential to cause damage, particularly when administered by an untrained or unqualified practitioner, or in an unregulated setting. Our objective was thus to identify signals that might suggest the potential for AEs of acupuncture, when administered in specific settings, or when using specific acupuncture styles, and also to compare the patterns of AEs in the past 12 years with the patterns identified in the 35-year period covered by our first review. Comparing the new data with that of the previous review shows the emergence of some important new patterns, which may be relevant for future regulation and policy making.Although the majority of the AEs are still infections, the routes of infection have changed. Our present findings include 239 AEs from infection; 191 occurred in five outbreaks of bacterial infection caused by skin contact with unsterilized equipment and dirty towels, in unhygienic clinical settings. In our previous findings, hepatitis cross-infections from patient to patient due to reused needles (94 cases reported in four outbreaks) were the most frequent source of infection. Since the introduction of disposable needles, hepatitis infections have rarely been reported, which is an important achievement that has resulted from the greater regulation of acupuncture practice, particularly the requirement for disposable needle use. However, in recent years, bacterial infections, including MRSA and mycobacterium, have become pervasive in healthcare settings in general [129]. Such infections, a pressing concern for all medical practitioners, including acupuncturists, result from poor hygiene. Hygienic clinical settings, sterilized equipment, and clean supplies are critical for preventing future such infections.Pneumothorax is still the most common organ and tissue injury. There were also cases of spinal cord injuries due to short, small needles embedded laterally along the spine in the Japanese practice known asokibari. The putative mechanism responsible for this AE is that the imbedded needles used in the Japanese okibari acupuncture technique could spontaneously migrate within the tissue, with some of them migrating to the spinal cord to cause spinal cord injury [130]. However, this AE has significantly decreased since our previous review, in which 11 cases due to this practice were found. In the present review, we found organ injuries mainly to be associated with faulty needle insertion. Heart injuries can be fatal, although no death was reported in the five cases we found. Acupuncture training programs must enhance student knowledge of anatomy at each acupuncture point. Supervised clinical internships must provide rigorous training in needle direction, depth of insertion with attention to the size of the patient, and methods of manipulation.Three cases reported deaths attributed to acupuncture [8, 60, 89]. Two were due to organ injuries [60, 89], and one was due to infection [8]. Of the organ injury deaths, one case from Japan [60] reported that a 72-year-old woman died after bilateral tension pneumothorax following acupuncture. The finding of the autopsy also suggested the patient that may have been injured by the insertion of the needles into the lungs during the previous acupuncture treatments. The second organ injury death, from Korea, reported that a 68-year-old woman died of massive hematemesis resulting from aortoduodenal fistula. The autopsy showed an injury to the abdominal aorta, caused by a deep insertion with a 15 cm long acupuncture needle into the abdomen [89]. The third case was reported from Scotland in which a 69-year-old man died from an infection after acupuncture treatment at the thigh [8]. The patient was later found to have a preexisting pancytopenia (i.e., low white blood cell count), resulting in an increased susceptibility to infection. The case report author, who is also the practitioner, admitted that the patient’s skin at the acupuncture point was not cleaned prior to the needle insertion and later found local muscle infection which led to septicaemia. The patient died a few weeks later from a multiorgan failure. These three unfortunate death cases suggest that biomedical knowledge such as anatomy and microbiology is needed in order avoid organ injury and infection. Skin cleansing should also be required, particularly for those patients with immune compromised condition.There were only a handful of cases reported by practitioners who performed the acupuncture [8, 100, 101, 103, 104, 108] including a death report [8]. The rest of the cases were reported by investigators who were not the acupuncturists who performed the treatment. Most cases of AEs did not report the qualification of the practitioner. We would suggest that future report on AEs of acupuncture should include the information on the training qualification of the practitioners and the procedure used for the treatment, such as whether or not clean needle techniques were used.Acupuncture safety practice guidance or guidelines such as Clean Needle Technique (CNT) appear to have played a critical role in minimizing the number of AEs associated with acupuncture practice [129]. In the United States, CNT was first addressed by the National Certification Commission for Acupuncture and Oriental Medicine in 1984. This course is designed to train professional acupuncturists on safe practice procedures. Course content includes training on microbiology, infection control, skills of adequately setting up a sterile practice area (e.g., adequate use of disinfectant and sterile equipment), adequate needle insertion, and adequate handling of AEs associated with acupuncture [130]. CNT courses are now offered by the US Council of Colleges of Acupuncture and Oriental Medicine and required by the acupuncture licensing boards of each state; as a result, reported acupuncture AE incidents have significantly decreased in the United States. In our previous review, about half of the 202 cases of AE that we identified were from the USA. However, as our present review shows, AE cases reported from the USA are now rare. Of the 308 cases we found, only 13 were from the United States, and out of 239 cases of infection, only 5 are from the United States. It should be noted that there were very few case reports of AEs from China included in this review, although acupuncture is widely practiced in China. We are aware that cases of AEs associated with acupuncture performed in China are likely to be reported in Chinese language case reports, which are not reflected in the present review due to language limitation. We are currently preparing a separate review on AEs reported in China.In conclusion, although serious AEs associated with acupuncture are rare, acupuncture practice is not risk-free. Adequate regulation can even further minimize any risk. We recommend that not only adequate training in biomedical knowledge, such as anatomy and microbiology, but also safe and clean practice guidelines are necessary requirements and should continue to be enforced in countries such as the United States where they exist, and that countries without such guidelines should consider developing them in order to minimize acupuncture AEs.



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