Evidence-Based Complementary and Alternative Medicine
Volume 2015 (2015), Article ID 432467, 19 pages
http://dx.doi.org/10.1155/2015/432467

Review Article

Systematic Review of Adverse Effects: A Further Step towards Modernization of Acupuncture in China

Junyi Wu,¹ Yanmei Hu,¹ Yin Zhu,² Ping Yin,¹ Gerhard Litscher,³ and Shifen Xu¹

¹Acupuncture Department, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai 200071, China
²Huadong Hospital Affiliated to Fudan University, Shanghai 200040, China
³Research Unit for Complementary and Integrative Laser Medicine, Research Unit of Biomedical Engineering in Anesthesia and Intensive Care Medicine, and TCM Research Center Graz, Medical University of Graz, 8036 Graz, Austria

Received 8 July 2014; Accepted 30 July 2014

Academic Editor: Lu Wang

Copyright © 2015 Junyi Wu et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract.

As a further step towards the modernization of acupuncture, the objective of this review was to figure out the frequency and severity of adverse complications and events in acupuncture treatment reported from 1980 to 2013 in China. All first-hand case reports of acupuncture-related complications and adverse events that could be identified in the scientific literature were reviewed and classified according to the type of complication and adverse event, circumstance of the event, and long-term patient outcome. The selected case reports were published between 1980 and 2013 in 3 databases. Relevant papers were collected and analyzed by 2 reviewers. Over the 33 years, 182 incidents were identified in 133 relevant papers. Internal organ, tissue, or nerve injury is the main complications of acupuncture especially for pneumothorax and central nervous system injury. Adverse effects also included syncope, infections, hemorrhage, allergy, burn, aphonia, hysteria, cough, thirst, fever, somnolence, and broken needles. Qualifying training of acupuncturists should be systemized and the clinical acupuncture operations should be standardized in order to effectively prevent the occurrence of acupuncture accidents, enhance the influence of acupuncture, and further popularize acupuncture to the rest of the world.

1. Introduction

Complications and adverse effects in medical practice are always of concern to the public and the medical profession. While being widely used in current medical treatment, especially in the area of intertrochanteric hip fractures, the cephalomedullary devices (CMN), however, led to a considerably high complication rate of 41.9% according to Pui et al. [1]. Faunø et al. [2] conducted a study on the medical records of 997 patients who were suffering from stoma closure, which revealed 131 cases of early complications and 187 late ones, accounting for 13.1% and 18.8% of the total subject pool, respectively. Umuroglu et al. [3] identified that the nuss procedure showed an overall complication rate of 18.7% through a retrospective analysis. Fortunately, with the increasing attention from the society on medical care safety and the further standardization of doctor’s qualifications, such medical incidents have been decreasing. As acupuncture and moxibustion (A&M) are increasingly used in world, their widening acceptance necessitates continual safety assessment. This review, a sequel to two previous reviews from our team [4, 5], is an evaluation of the frequency and severity of adverse events (AEs) for acupuncture reported between 1980 and 2013 in China. These two reviews reported the AEs of A&M in the West, reported from 1965 to 1999 and from 2000 to 2011, respectively. In the first review, the main source of infection was found to be hepatitis caused by reused needles. In the second review, the majority of infections were bacterial, caused by skin contact at acupoint sites, without cases of hepatitis. For these two reviews, we just searched English articles, without Chinese reports, so it is unclear which AE happens in China. Since acupuncture is widely used in China, it is necessary to make sure what is happening about AE. In this review, we found internal organ, tissue, or nerve injuries were the main complications of acupuncture in China from 1980 to 2013. Clearly, guidelines must be followed in order to minimize acupuncture-related AEs and to modernize acupuncture and make it safer to apply.

2. Materials and Methods

2.1. Inclusion Criteria

All case reports concerning acupuncture-related complications or AEs in China published from 1980 to 2013 were identified. Only firsthand reports were included to avoid multiple reports of the same event. Thus, reviews, comments, or case-control studies were excluded from this review.

Complications, defined as “an added difficulty: a complex state, a disease, or an accident superimposed upon another without specific relation,” include infections, internal organ or tissue injuries, and other severe consequences. AEs and adverse reactions were defined as “development of an undesired side effect or toxicity” and include less severe consequences, such as contact dermatitis. Side effects, defined as “the action or effect other than that desired,” are included within the discussion of AEs [4, 5].

2.2. Search Strategy

The following databases were searched for case reports published from 1980 to 2013: VIP science and technology periodical database (CQVIP), China National Knowledge Infrastructure (CNKI), and Wanfang Database (WF). Search terms included “acupuncture, electro-acupuncture, acupuncture points, ear acupuncture, needling.” These terms were combined with “safe, safety, adverse event, adverse reaction, side effects, side events, complications, and risk.”

2.3. Data Extraction

A total of 739 papers were found; 133 were relevant (Figure 1). Information pertaining to the author, year of publication, number of patients, patient’s age, sex, original treatment, the punctured site, circumstances of the complication or AE, and long-term patient outcome when available was extracted from each case. These data were then organized according to the type of complication or AE.

Figure 1: Flow chart of the screening process.

3. Results

A total of 133 papers published from 1980 to 2013 were reviewed, and 182 cases of complications or AEs were identified to be associated with pneumothorax (), central nervous system injury (37), peripheral nerve injury (8), organ injury (22), other tissue injury(18), syncope (18), infections (17), hemorrhage (10), complications caused by broken needles (7), and others (15). Pneumothorax and central nervous system injury were the major complications.

3.1. Complications of Acupuncture: Internal Organ, Tissue, or Nerve Injury

A total of 115 cases of internal organ, tissue, or nerve injuries were reported, including pneumothorax (), central nervous system injury (37), peripheral nerve injury (8), organ injury (22), and other tissue injury (18).

3.2. Pneumothorax (Table 1)

Between 1980 and 2013, pneumothorax was the most common complication of acupuncture treatment, as 30 cases in 27 papers were noted to be possibly associated with acupuncture (Table 1). Among the 30 cases presented, 25 recovered through thoracocentesis, thoracic closed drainage, anti-infection treatment, and clinical observation; 2 patients died; and the outcomes of the other 3 cases were not stated or unknown. More than half of them were reported by doctors in emergency rooms or departments of internal medicine, but the practitioner’s training background was not reported. The punctured sites were mostly in the chest, supraclavicular fossa, and the back. The patients’ major complaints were chest stuffy, chest pain, and dyspnea. One pneumothorax patient did not receive timely treatment and died [6]. Another case died because of a tension pneumothorax after acupuncture treatment [7].

Table 1: Pneumothorax associated with acupuncture.

Author/year (reference)
Cases
Age/sex
Disease treated
Punctured site
Practitioner
Follow-up

Jiang, 1980 [117]
1
54/F
Gastroptosis
RN15
Not specified
Recovered

Cai and Wang, 1982 [118]
1
41/M
Numbness and pain of shoulders and chest
Shoulder and back
Not specified
Recovered (1 mo)

Zheng and Pang, 1983 [119]
1
21/M
Stiff neck
GB21
Not specified
Recovered after surgery (1 mo)

Gao, 1984 [120]
1
50/F
Chest and back pain
Back
Factory doctor
Recovered (12 d)

Duan and Wang, 1984 [29]
2
26/F
Bronchitis
GB21, BL13, EX-B2
Not specified
Recovered (3 d)

50/F
Bronchitis
GB21, BL13
Not specified
Recovered (7 d)

Chang, 1984 [121]
1
33/M
Back pain
Back
Country doctor
Recovered (19 d)

Yan, 1985 [122]
1
55/F
Chronic bronchitis
RN22
Health center
Recovered (16 d)

Hu, 1986 [123]
1
58/F
Pulmonary heart disease
BL13
Not specified
Recovered (13 d)

Zhang, 1986 [124]
1
52/M
Cervical pain
Left shoulder
Factory doctor
Recovered (20 d)

Yang, 1986 [6]
1
57/F
Chronic asthmatic disease
BL12
Not specified
Dead

Jin, 1987 [125]
1
26/F
Shoulder pain
SI13
Acupuncturist
Recovered (9 d)

Song and Xu, 1987 [126]
1
60/F
Shoulder pain
GB21
Not specified
Not specified

Ruan et al., 1992 [127]
1
35/F
Hysteria
Supraclavicular fossa
Acupuncturist
Recovered (10 d)

Zhang et al., 1992 [38]
3
53/F
Chronic bronchitis and emphysema
BL18
Not specified
Recovered (1 wk)

65/F
Cough
RN22
Recovered (1 mo)

21/M
Spasmodic torticollis
LI17
Recovered (2 wk)

Lu, 1993 [128]
1
60/M
Cough, chest, and back pain
Back
Acupuncturist
Recovered (1 wk)

Xia, 1993 [129]
1
60/M
Back pain caused by hyperplastic spondylitis
BL18, BL23
Acupuncturist
Recovered (10 d)

Li and Chen, 1997 [130]
1
65/F
Shoulder pain
Scapular region
Clinic
Recovered (5 d)

Ma and Zhang, 1997 [131]
1
48/M
Neck and shoulder pain
Shoulder and back
Clinic
Recovered (1 wk)

Wang, 1999 [7]
1
47/F
Shoulder and leg pain
LI17
Not specified
Dead

Song and Wu, 2001 [9]
1
45/F
Scapulohumeral periarthritis
GB21, SI11
Hospital
Recovered (1 wk)

Qin and Ao, 2003 [132]
1
55/M
Intercostal neuralgia
The sixth intercostal space on the anterior axillary line
Factory doctor
Recovered (2 wk)

Zha, 2006 [133]
1
32/M
Chronic hepatitis B
Chest and back
Itinerant doctor
Recovered (14 d)

Gan et al., 2006 [134]
1
30/M
Neck and back pain
Back
Individual clinic
Not specified

Huo et al., 2007 [135]
1
39/M
Chest and back pain
Not specified
Not specified
Recovered after surgery (7 d)

Liu, 2007 [136]
1
50/M
Cervical and back pain
Back
Individual clinic
Not specified

Ma, 2007 [137]
1
35/F
Shoulder pain
Not specified
Individual clinic
Recovered

Zhang and Zhao, 2012 [138]
1
65/F
Cervical spondylopathy
GB21
Acupuncturist
Recovered (10 d)

3.3. Central Nervous System Injury (Table 2)

There were 37 cases of central nervous system injury associated with acupuncture (Table 2). The 37 patients suffered subarachnoid hemorrhage (), subdural hematoma (2), spinal cord injury (2), cerebral hemorrhage reformulation (2), cervical spinal epidural hematoma (1), medulla oblongata hemorrhage (1), cisterna magna hemorrhage (1), and leukemia acute intracerebral hemorrhage (1). The causes were acupuncture of cervical acupoints (), acupoints between the second and third thoracic spinal process [8], acupoints KI01 (Yongquan) [9] and BL37 (Yinmen) [10], waist acupoint [11] (each ), and body acupuncture () [12, 13]. Among the 37 cases, 26 recovered and 11 died.

Table 2: Central nervous system injury associated with acupuncture.

Author/Year (reference)
Cases
Age/Sex
Disease treated
Punctured site
Complication
Onset after acupuncture
Follow-up

Liu, 1980 [139]
1
19/F
Impaired vision
GB20
Subarachnoid hemorrhage
1 h
Recovered (20 d)

Liu, 1981 [14]
     3
16/M
    Schizophrenia
DU16
Subdural hematoma
     Immediately
Dead

30/F
DU14
Cervical and thoracic cord injury

30/M
GB20
Subarachnoid hemorrhage
1 h
Recovered (47 d)

Bao and Gao, 1983 [140]
3
30/F
Eyelid muscle twitch
GB20
Subarachnoid hemorrhage
Immediately
Recovered (14 d)

27/M
Bulbar palsy
DU15
Recovered (20 d)

40/F
Headache
GB20
Recovered (19 d)

Chen and Wu, 1985 [141]
1
30/F
Hysteria
Ex-HN18
Subarachnoid hemorrhage and medulla oblongata hemorrhage
1 d
Dead

Yang et al., 1985 [8]
1
15/M
Chronic tracheitis
Between 2 and 3 thoracic spinous process
Subarachnoid hemorrhage
Immediately
Recovered (1 mo)

Chen and Huang, 1985 [142]
1
57/M
Facial Spasm
Neck
Subarachnoid hemorrhage
Immediately
Recovered (3 wk)

Su et al., 1985 [143]
1
11/F
Deaf-mute
DU15
Subarachnoid hemorrhage
At night
Recovered (1 wk)

Yu, 1986 [144]
7
42/M
Psychosis
DU15
Subarachnoid hemorrhage
Several hours
Recovered (1 mo)

4.5/M
Cerebral agenesis with aphasia
DU15
Immediately
Recovered (20 d)

29/M
Weakness of limbs
DU15, DU16
Minutes after treatment
Recovered (1 mo)

22/M
Acid swells of the neck
Back neck
Immediately
Recovered (40 d)

55/F
Aural vertigo
Back neck
Recovered (20 d)

24/F
Stuffy head
GB20
Recovered (1 mo)

22/M
Facial paralysis
Ex-HN21
Recovered

Chen, 1987 [145]
1
37/F
Neck pain
DU15
Subarachnoid hemorrhage
1 min
Recovered (1 mo)

Jiang and Chen, 1987 [146]
1
77/F
Stiff neck
GB20
The cerebellopontine and subarachnoid hemorrhage
After treatment
Dead

Zhou, 1988 [147]
1
15/M
Cold
GB20
Subarachnoid hemorrhage
During the treatment
Dead

Mi et al., 1989 [148]
1
28/F
Neurosis
DU15
Subarachnoid hemorrhage
2 d
Recovered (27 d)

Wu and Xu, 1990 [149]
1
57/M
Stroke
Ashi points near C3
Subarachnoid hemorrhage
1 h
Dead (10 d)

Liu, 1992 [150]
1
28/M
Insomnia
GB20
Acute subdural hematoma
3 hours
Recovered after surgery

Mi, 1993 [12]
1
73/M
Cerebral hemorrhage
LI11, LI4, GB30, ST36, GB39, GB14, ST2
Cerebral hemorrhage reformulation
10 min
Dead

Jiang et al., 1996 [151]
2
45/M
Cervical spondylopathy
GB20
  Subarachnoid hemorrhage
Immediately
Recovered (30 d)

54/M
Neck
Recovered (1 mo)

Liu et al., 1996 [152]
1
35/M
Ankylosing Spondylitis
DU16
Medulla oblongata hemorrhage
5 hours
Dead

Bian et al., 1997 [153]
1
29/F
Headache caused by pesticide poisoning
GB20
Subarachnoid hemorrhage
3 min
Recovered (1 mo)

Wang, 1999 [10]
1
54/M
Low back pain
BL37
Acute subarachnoid hemorrhage
Immediately
Recovered

Wang, 1999 [154]
1
39/F
Neurosis
GB20
Cervical cord injury
Immediately
Dead

Song and Wu, 2001 [9]
1
58/M
Hypertensive cerebral hemorrhage
KI01
Cerebral hemorrhage reformulation
Immediately
Dead

Li et al., 2003 [155]
1
55/M
Neck and back pain
Neck and back
Cervical spinal epidural hematoma
Immediately
Recovered

Niu and Zhang, 2006 [156]
1
42/M
Headache
Neck
Cisterna magna hemorrhage
Not specified
Recovered after surgery

Li et al., 2008 [157]
1
36/F
Migraine
DU16
Subarachnoid hemorrhage
At night
Recovered (3 wk)

Chen, 2009 [11]
1
43/F
Lumbago pain
Waist
Subarachnoid hemorrhage
Immediately
Recovered (1 mo)

Li et al., 2011 [13]
1
45/F
Toothache
RN16, RN10, RN9, RN4
Leukemia acute intracerebral hemorrhage
Immediately
Dead (2 d)

Because of insufficient compliance and protected observation, accidents occurred in 3 schizophrenia patients, of whom 2 died and 1 recovered [14]. Two cerebral hemorrhage patients after receiving body acupuncture died from recurrence, and the authors speculated the reason might be that acupuncture had irritated the parasympathetic nerve, causing vascular contraction and increasing blood pressure and thus cerebral hemorrhage recurred before the original cerebrovascular fracture could be fully restored [9, 12]. Two patients suffered from dizziness and vomiting during treatment, but the acupuncturists did not pay high attention; the symptoms did not improve significantly after treatment, but the acupuncturists did not realize the severity and even allowed the patients to go home. One patient was treated the next day after onset and was diagnosed as subarachnoid hemorrhage; he recovered and left hospital [11]. The other patient died the next day [13].

3.4. Peripheral Nerve Injury (Table 3)

There were 8 cases of acupuncture-induced peripheral nerve injury (Table 3). They include aggravated facial paralysis [15], mistakenly hitting the vagus [16], phrenic nerve injury [17], optic atrophy [18], oculomotorius injury [19], right trigeminal nerve injury [20], sciatic nerve injury [10], and peroneus nerve injury [21], respectively. The patient with optic atrophy lost sight [18], the patient with right trigeminal anchor injury improved after 3 days [20], the patient with sciatic nerve injury did not recover [10], and the other 5 patients recovered.

Table 3: Peripheral nerve injury.

Author/Year (reference) 
Cases
Age/Sex
Disease treated
Punctured site
Complication
Practitioner
Follow-up

Tang and Fang, 1986 [15]
1
Not specified
Facial paralysis
Not specified
Aggravated facial paralysis
Not specified
Recovered

Nie and Zhou, 1990 [16]
1
26/M
Left eye pain
SJ17
Cardiac arrest
Acupuncturist
Recovered (1 min)

Yan, 1994 [17]
1
57/M
Cervical dislocation
Bitong point
Phrenic nerve injury
Acupuncturist
Recovered (1 wk)

Yang and Wang, 1996 [18]
1
62/M
Lateral rectus paralysis
Ex-HN07
Optic atrophy
Acupuncturist
Blind

Xu and Liu, 1997 [19]
1
48/M
Tinnitus and hearing loss
ST1, ST2, BL2, LI20, SJ21, SI19
Oculomotorius injury
Not specified
Recovered (17 d)

Huang and Wei, 1997 [20]
1
53/F
Trigeminal nerve pain
Around the mandible
Trigeminal nerve injury
Acupuncturist in the stomatological hospital
Improved (3 mo)

Wang, 1999 [10]
1
54/F
Lumbago
GB30
Sciatic nerve injury
Private practitioner
Unrecovered

Ruan et al., 2009 [21]
1
67/F
Lumbago
GB34
Peroneus nerve injury
Not specified
Recovered (3 wk)

3.5. Organ Injury (Table 4)

Twenty-two cases were reported to have organ injury associated with acupuncture treatment (Table 4). There was cardiovascular injury () [14, 22–27], thoracic duct injury (1) [28], peritonitis induced by abdominal system (9) [29–33], gastric perforation (3) [34–36], intestinal obstruction (1) [37], and multiple organ injury (1) [38]. Of them, 14 recovered, 7 died, and 1 did not recover. Most of them were caused by too deep puncture and incorrect acupoint location.

Table 4: Organ injury associated with acupuncture.

Author/year (reference)
Cases
Age/sex
Disease treated
Punctured site
Complication
Follow-up

Liu, 1981 [14]
1
19/F
Schizophrenia
RN15
Cardiac tamponade
Dead

Zhu, 1990 [22]
1
64/M
Chest stiffness and rib pain
LR14
Aortoclasia
Dead

Shi, 1993 [23]
1
42/F
Witchcraft
Limbs, chest, abdomen, back
Aortoclasia
Dead

Xie and Lin, 2003 [24]
1
35/F
Intercostal neuralgia
Right breast
Cardiac trauma
Dead

Luo et al., 2006 [25]
1
40/M
Chronic esophagitis
RN15
Cardiac tamponade
Recovered

Zhang and Dong, 2006 [26]
1
37/M
Chest tightness, asthma
Chest and back
Cardiac tamponade
Dead

Zhu et al., 2008 [27]
1
44/F
Diabetes
Chest
Cardiac tamponade
Dead

Yang, 1991 [28]
1
21/M
Bad cold
BL13
Chylothorax
Recovered (2 wk)

Zheng and Zhao, 1983 [30]
1
31/F
Stomachache
ST25, LR14, RN12
Gallbladder perforation and   biliary peritonitis
Recovered after surgery

1
59/M
Cervical spondylopathy
RN12, RN13, ST25

Deng, 1985 [31]
1
45/F
Acute attack of chronic cholecystitis
ST21
Gallbladder perforation
Not specified

Bai, 1991 [32]
1
32/F
Paralytic ileus
Upper abdomen
Gallbladder perforation and biliary peritonitis
Recovered after surgery

Duan and Wang, 1984 [29]
1
42/M
Intestinal spasm
RN8, RN12, ST25
Intestinal perforation and suppurative peritonitis
Recovered after surgery (14 d)

Zhang, 1997 [33]
4
51/M
Paroxysmal abdominal pain
Abdomen
 Localized peritonitis
Recovered  after surgery

47/F
Right lower abdominal pain

53/F
Abdominal pain, diarrhea

37/F
Periumbilical pain

Xiao, 1985 [34]
1
20/M
Abdominal discomfort
RN12
Gastric perforation
Recovered after surgery (11 d)

Huang, 1999 [35]
1
54/M
Gastric ulcer
ST36
Gastric ulcer with perforation
Recovered after surgery (10 d)

Tang et al., 2006 [36]
1
61/M
RA
ST34, ST40, SP6, SP10, GB33, GB34
Gastric stress ulcer and hemorrhagic shock
Recovered (2 mo)

Liu et al., 1992 [37]
1
2/M
Diarrhea
RN12, ST25, DU1
Complete intestinal obstruction
Recovered after surgery

Zhang et al., 1992 [38]
1
45/F
Chronic bronchitis, coronary disease
GB21, BL13, BL23
Multiple organ injury
Dead

One patient received treatment following gastric abscess induced by gastric ulcer. He was treated by electroacupuncture (EA) at ST36 (Zusanli) and the acupoint was located without violation, but the state of illness was not relieved and gastric perforation occurred. The doctor was puzzled and put forward this case for discussion [35]. One patient with a history of stomach bleeding received treatment following knee pains induced by rheumatoid arthritis and took anti-inflammatory analgesic drugs for a long time. The lower limb acupoint was selected, but the excessive EA irritation during treatment caused an irritable gastric ulcer and then hemorrhagic shock and the patient recovered after timely rescue [36].

3.6. Other Tissue Injuries (Table 5)

In addition to injuries of the organs in thorax and abdomen, 18 cases of other tissue injuries were reported (Table 5), including cervical common carotid aneurysm [39], shock [38, 40], asphyxia [41], dyspnea [42], eye injury [18, 43, 44], and the locomotor system injury [10, 44–50]. Among the 18 cases, 12 recovered, 2 improved, 2 did not recover, 1 died, and the outcome of 1 was not stated.

Table 5: Other tissue injury.

Author/year (reference)
Cases
Age/sex
Disease treated
Punctured site
Complication
Practitioner
Follow-up

Chen, 1980 [39]
1
33/F
Sore throat
Neck
Cervical common carotid aneurysm
Not specified
Recovered after surgery (3 mo)

Wang, 1987 [40]
1
42/F
Thyroid cancer (anaesthesia for thyroidectomy)
SJ17
Sinus caroticus syndrome, shock
Not specified
Recovered

Zhang et al., 1992 [38]
1
39/M
Asthma
BL13
Pleural shock
Not specified
Recovered (2 d)

Zhu, 1986 [41]
1
56/M
Chest distress
RN22
Asphyxia
Acupuncturist
Dead

Gao, 1989 [42]
1
73/M
Cough
LI18
Dyspnea
Not specified
Recovered (3 d)

Liu et al., 1988 [43]
1
53/M
Blepharospasm
The lateral upper eyelid
Retinal detachment
Health worker
Recovered after surgery

Yang and Wang, 1996 [18]
1
63/F
Left eye ptosis
Periocular
Traumatic cataract
Acupuncturist
Blind

Wang, 1982 [44]
  2
20/M
Traumatic mydriasis
EX-HN5
The orbicularis oculi muscle tremor
Not specified
Recovered (3 d)

35/F
Right migraine
Speech and swallowing difficulties
Recovered (2 h)

Li and Zhou, 1980 [45]
1
40/M
Schizophrenia
EX-HN5
Femoral neck fracture
Acupuncturist
Not specified

Liang and Song, 1984 [46]
1
23/M
Cramp
BL57
Flexor hallucis muscle and digitorum longus muscle scar contracture
Health worker
Recovered after surgery

Chen, 1992 [47]
1
17/F
Shortsightedness
GB20, EX-HN17
Nape spasm
Acupuncturist
Recovered (6 d)

Wang, 1994 [48]
1
65/F
Stroke
LI4, SJ5, LI15
Subluxation of wrist
Intern
Recovered (1 wk)

Shi and Chen, 1994 [49]
1
52/M
Facioplegia
LI11
Elbow pain
Acupuncturist
Recovered (2wk)

1
61/F
Scapulohumeral periarthritis
Not specified
Shoulder pain
Recovered (20 d)

Wang, 1999 [10]
1
53/M
Cough, epistaxis
LU6
Amyotrophy
Private practitioner
Unrecovered

Luo and Huang, 2006 [50]
2
42/M
Amyotrophic lateral sclerosis
Upper limb
Fasciculation
 Not specified
Improved

63/M
Upper limb
Improved

One patient suffered from retinal detachment, and eyesight was corrected to 0.2 after treatment [43]. One patient lost eyesight because of traumatic cataract [18]. One patient experienced femoral neck fracture after strong stimulation to myospasm [45]. One patient suffered from subluxation in right wrist joint due to excessive EA intensity [48].

3.7. Syncope (Table 6)

A total of 18 cases of acupuncture-associated syncope were reported (Table 6). Syncope occurred during the treatment in 9 cases, several minutes after the treatment in 5 cases, and several hours later in 4 patients. Two patients fainted after taking liquors [51, 52]. The positions were sitting (), lying (5), and not specified (8). Most patients recovered with rest and drinking sugar water, while 2 patients recovered after injection of metoclopramide via ST36 [53]. Two cases suffered from sudden cardiac arrest and were cured after first aid [54, 55]. One patient recovered after massaging an ear acupoint [56].

Table 6: Syncope associated with acupuncture.

Author/year (reference)
Cases
Age/sex
Disease treated
Punctured sites
Position
Start time
Causes
Practitioner
Follow-up

Yang, 1986 [6]
1
32/M
Facioplegia
GB14, ST 6, ST4, SJ 17, LI20, LI4
Sitting
5 min after inserting needle
Limosis
Acupuncturist
Recovered

Shao, 1989 [51]
1
53/M
Myotenositis of long head of biceps brachii
LI15, LI11, ashi
Not specified
After inserting needle
After drinking
Acupuncturist
Recovered (20 m)

Shi and Chen, 1994 [49]
1
57/F
Stomachache
LI3, ST 36, PC6
Not specified
Finish needling
Limosis
Acupuncturist
Recovered (30 min)

Guo, 1995 [158]
    2
65/F
Scapulohumeral periarthritis
Ex-UE01, GB21, LI14, LI11, SJ5, LI4
Clinostatism
Finish needling
Weakness
Acupuncturist
Recovered

24/F
Waist sprain
BL40, ashi point and acupoint of bladder meridian
Finish needling
Nervous
Acupuncturist
Recovered (10 min)

Wu et al., 2001 [56]
1
24/F
Insomnia
PC6, ST 36, HT7
Not specified
At night
Not specified
Acupuncturist
Recovered (2 d)

Liu, 2001 [52]
3
45/F
Lumbago pain
BL23, BL40, DU3, GB30, KI7
Not specified
Finish needling
After drinking
Acupuncturist
Recovered

34/F
Shoulder pain
LI11, LI14, LI15, SJ5, SJ14
Sitting
After inserting needle
Tiredness
Acupuncturist

56/F
Right thumb pain
LI4, LI5, LI11, ashi point
Not specified
On the way home
Limosis
Acupuncturist

Ma, 2005 [54]
1
28/M
Prosopalgia
EX-HN5, LI4, ST6, SJ5
Sitting
5 min after inserting needle
Not specified
Acupuncturist
Recovered (30 s)

Long et al., 2006 [55]
3
72/M
Stroke
LI11, SJ5, ST36, SP6, EX-UE17, EX-LE11
Clinostatism
10 min after inserting needle
Nervous
Acupuncturist
Recovered (2 min)

41/F
Cervical spondylopathy
BL10, GB20
Sitting
1 min after inserting needle
Not specified
Acupuncturist
Recovered (30 min)

42/F
Lumbago pain
ST36
Clinostatism
After inserting needle
Heavy stimulus
Acupuncturist
Recovered (2 min)

Liu, 2007 [159]
1
42/F
Scapulohumeral periarthritis
Ex-UE01, LI14, Ashi point, SJ3
Sitting
10 min after inserting needle
Not specified
Acupuncturist
Recovered (30 min)

Chen, 2009
[11]
1
42/M
Acute lumbar sprain
EX-B5, BL40
Not specified
Finish needling
Not specified
Acupuncturist
Recovered (10 min)

Liao and Guo, 2009 [160]
1
57/F
Gouty arthritis
GB20
Clinostatism
After inserting needle
Limosis
Acupuncturist
Recovered (10 min)

Li et al., 2009 [53]
2
48/M
Cervical spondylopathy radiculaire
GB21, LI11, SJ5, Ex-B5
Not specified
6 h after treatment
Not specified
Acupuncturist
Recovered after stop treatment

68/F
Facial paralysis
GB14, ST2, ST4, ST6, SJ17, LI4, Ex-HN16
12 h after treatment
Not specified
Acupuncturist
Recovered after stop treatment

3.8. Infection (Table 7)

A total of 17 cases were infections associated with acupuncture (Table 7). Among them, 10 recovered, 3 died, 2 improved after 3 days, 1 was disabled, and 1 was not stated. The infection was caused by tetanus bacillus () [10, 57–61], hydatid (1) [62], Escherichia coli (1) [63], and Mycobacterium tuberculosis (3) [64]. One patient was infected after deep 3-degree burning [65] while others were not stated.

Table 7: Infection associated with acupuncture.

Author/year (reference)
Cases
Age/sex
Disease treated
Punctured site
Diagnosis
Practitioner
Follow-up

Zhang, 1980 [161]
1
5/F
Heat, cough
Ex-UE19
Infection
Not specified
Middle finger disability

Xie and Zong, 1983 [62]
1
38/F
Right upper abdominal mass and discomfort
Ashi points
Abdominal metastatic hepatic hydatid
Local hospital
Recovered after surgery

Gao and Qi, 1989 [65]
1
54/M
Right leg pain
Local points
Third-degree burns with infection
Clinic
Not specified

Xu, 1990 [162]
1
19/M
Migraine
EX-HN5, GB14, DU20
Head abscess, intracranial infection
Health worker in the army
Recovered

Xia, 1993 [129]
1
37/F
Facioplegia
ST5
Right cheek hematoma with infection
Not specified
Recovered (1 wk)

Chen and Gao, 1995 [63]
1
30/M
Insomnia
Head
Encephalopyosis
Not specified
Recovered after surgery

Zhou, 1999 [64]
3
From 22 to 28/M (1); F (2)
Lumbar muscle strain
Loin
Tuberculous abscess on the body surface
Not specified
Recovered (3–6 mo)

Song and Wu, 2001 [9]
1
38/M
Rheumatic arthritis
EX-LE4, EX-LE5, GB34, SP9
Pyogenic arthritis
Individual clinic in the country
Recovered (2 wk)

Ding et al., 2008 [112]
1
60/F
Scapulohumeral periarthritis
ST38
Diabetes foot
Not specified
Remission after 3 days

Yang et al., 1990 [57]
1
2/F
Malnutritional stagnation
Ex-UE19
Tetanus
Illegal treatment
Dead

Liu, 1991 [58]
1
52/F
Headache
Ex-HN05, DU20, GB20, LI4
Tetanus
Village acupuncturist
Recovered (2 wk)

Liu, 1992 [59]
1
52/F
Leg pain
Not specified
Tetanus
Private practitioner
Recovered (1 mo)

Sun and Hu, 1997 [60]
1
23/M
Facioplegia
Not specified
Tetanus
Health-center
Remission after 3 days

Wang, 1999 [10]
1
60/M
Headache and fever
GB20, GB21, SJ5
Tetanus
Not specified
Dead

Chen et al., 2008 [61]
1
62/F
RA
Knee
Tetanus
Illegal treatment
Dead

In one patient, the right epigastric mass due to acupunctured liver hydatid caused extensive metastasis in hydatid abdominal cavity; the patient recovered after operation [62]. One diabetic patient without controlling blood glucose suffered from diabetic feet because of infection and recovered after hypoglycemic and anti-infection treatments.

3.9. Hemorrhage (Table 8)

Among 10 cases of acupuncture-induced local hemorrhage (Table 8), 8 patients recovered, 1 improved, but 1 died. The positions of hemorrhage included eyes () [6, 66], extraperitoneal (1) [67], thyroid (1) [68], hypoglossus (2) [69, 70], suffocated death from hematoma compressed trachea (1) [71], hand (1) [72], 1 case of buttock hematoma due to acquired hemophilia B which improved after treatment [73], and lower limb (1) [74].

Table 8: Hemorrhage.

Author/year (reference)
Cases
Age/sex
Disease treated
Punctured site
Complication
Practitioner
Follow-up

Yang, 1986 [6]
1
28/F
Chronic conjunctivitis
BL1
Eye hematoma
Acupuncturist
Recovered (14 f)

Li, 1989 [67]
1
62/F
Teratoma of ovary
Hypogastrium
Extraperitoneal hematoma
Roving doctor
Recovered after surgery

Cai, 1991 [68]
1
47/M
Neck mass
Neck
Thyroid intracapsular hemorrhage with apnea
Not specified
Recovered after surgery (10 d)

Han, 1994 [69]
1
56/M
Stroke
RN23
Sublingual hematoma
Not specified
Recovered (1 wk)

Zeng and Liu, 1996 [71]
1
50/M
Cough
ST9
Hematoma compression tracheal cause apnea
Unauthorized
acupuncturist
Dead

Wang, 1996 [70]
1
72/M
Cerebral infarction
Ex-HN20
Sublingual hematoma
Not specified
Recovered (2 d)

Gan, 2000 [66]
1
46/F
Cold headache
Ex-HN05
Orbital hemorrhage
Not specified
Recovered (1 mo)

Jiang, 2001 [72]
1
68/M
Hypertension, stroke
LI4
Hand hematoma
Acupuncturist
Recovered (7 d)

Duan, 2007 [73]
1
65/F
Neck, waist, and leg pain
Hip
Buttock hematoma
Not specified
Improved

H. Liu and X. H. Liu, 2007 [74]
1
61/M
Cerebral thrombosis
SP6
Lower extremity hematoma
Acupuncturist
Recovered (1 d)

3.10. Complications Caused by Broken Needles (Table 9)

Seven cases of accidents due to broken or bent needles were identified (Table 9). Five recovered after the surgery [75–79], and 2 cases of bent needles were slowly pushed out by acupuncturists [6, 80].

Table 9: Complications caused by broken needles.

Author/year (reference)
Cases
Age/sex
Disease treated
Punctured site
Complication
Practitioner
Follow-up

Yang, 1986 [6]
1
45/M
Flaccid paralysis
ST36, LI11
Bent needle
Acupuncturist
Recovered

Lu and Teng, 1994 [75]
1
39/M
Scapulohumeral periarthritis
Supraclavicular fossa
Hemopneumothorax caused by broken needle
Country doctor
Recovered after surgery

Wang, 2000 [80]
1
54/M
The left upper limb dysfunction
Upperlimb
Sticking of needle
Not specified
Recovered

Geng, 2005 [76]
1
58/M
Chronic bronchitis and emphysema
LU1
Damage of arteria coronaria and cardiac tamponade caused by embedded needle
Self
Recovered after surgery

Quan, 2008 [77]
1
43/F
Gastric disease
Xiphoid
Palpitation and paroxysmal pricking pain caused by broken needle
Not specified
Recovered after surgery

Liu and Yu, 2010 [78]
1
45/F
Multiple injuries by traffic
RN23
Pulmonary bulla caused by embedded needle
Not specified
Recovered after surgery

Cheng, 2010 [79]
1
55/M
Lumbago
Lower limb
Broken needle
Not specified
Recovered after surgery

3.11. Other Complications Associated with Acupuncture (Table 10)

A total of 15 other complications associated with acupuncture were reported (Table 10): aphonia [81], hoarseness [82], allergy to electroacupuncture [83] and metal [84], epilepsy [85, 86], fever [87], cough [88], thirst [88], infusion reaction [89], hyperventilation syndrome [90], and aggravation of fatigue [91]. Of them, 14 cases recovered completely and 1 improved.

Table 10: Other complications associated with acupuncture.

Author/year (reference)
Cases
Age/sex
Disease treated
Acupoint
Complication
Practitioner
Follow-up

Wang and Lan, 1980 [81]
 2
46/F
Intercostal neuralgia
PC6
Aphonia
Not specified
Recovered    (3 d)

36/F
Obstinate hiccup

Zhou et al., 2005
[82]
1
43/F
Neck pain
Ex-B05
Hoarseness
Acupuncturist
Recovered (10 min)

Peng, 1982 [83]
1
54/not specified
Scapulohumeral periarthritis
Ex-UE01, GB21, LI11, SJ5
Allergy to electroacupuncture
Acupuncturist
Recovered (10 min)

Gao and Zheng, 2008 [84]
 2
72/M
Nerve root cervical spondylopathy
EX-B2
Allergy to metal
Not specified
Recovered (1 wk)

49/F
Cervical type cervical spondylopathy
EX-B2
Recovered (5 d)

Wang, 2004 [85]
1
35/M
Soft tissue injury
Ashi point
Epilepsy
Acupuncturist
Recovered

Dai, 2012 [86]
 2
45/M
Epilepsy
Not specified
Epilepsy
Acupuncturist
Recovered (2 min)

53/M
Cervical spondylosis
Recovered (1 min)

Li, 2000 [87]
1
52/M
Cerebral concussion
DU20, GB20, GB30, GB39, LI4, LI11, ST36
Fever
Acupuncturist
Recovered

Shang, 2006 [88]
 2
65/F
Facial neuritis
GB14, BL2, ST2, SI18, RN24, LI4, ST36, LR3
Cough
Acupuncturist
Recovered (2 min)

46/F
Obesity
ST25, ST36, SP15, RN6, LI11, SJ6, SP9, ST40
Thirsty
Acupuncturist
Recovered

Quan and Jiang, 2008 [89]
1
45/F
RA
Local points
Infusion reaction
Acupuncturist
Recovered (2 h)

Fang, 2010 [90]
1
35/F
Cervical pain
GB20, EX-B2
Hyperventilation syndrome
Acupuncturist
Recovered (15 min)

Wang, 2010 [91]
1
46/F
Nasopharyngeal carcinoma radiation sequela with fatigue
LI11, LI4, ST36, SP6, KI3; LU7, SI6, SJ3
Aggravation of fatigue
Acupuncturist
Improved

One patient was not allergic after several acupuncture treatments, but systemic allergy occurred after EA treatment [65]. Among three patients with acupuncture-induced epilepsy, only one had a history of epilepsy [85, 86].

4. Discussion

The studies about safety of acupuncture are gradually increasing. One study protocol of a randomized controlled trial is efficacy and safety of acupuncture for chronic dizziness [92]. This trial’s aim is to get result that acupuncture has good efficacy and without adverse effect for chronic dizziness. We hope it is success.

Some studies that researched acupuncture as an alternative means for pediatric diseases found that it is safe, feasible, and acceptable [93–99]. One study explored acupuncture as an effective therapy of pain relief for children and adolescents after tonsillectomy [100]. Severe throat pain can result from tonsillectomy and last up to 10 days in children. Codeine elixir has long been used for pain relief but has recently been banned by the Food and Drug Administration due to a recently recognized risk of death. This study suggested that acupuncture decreases perceived pain in children and adolescents after tonsillectomy. These data, combined with the cost effectiveness, safety, and ease of administering acupuncture, suggest that further studies exploring the effectiveness of acupuncture in juveniles after tonsillectomy are merited.

One research evaluated the feasibility of delivering acupuncture in an emergency department (ED) to patients presenting with pain and/or nausea [101]. The acupuncture group comprised 200 patients who received usual medical care and acupuncture; the usual care group comprised 200 patients with retrospective data closely matched from ED electronic health records. The results confirmed that acupuncture in the ED appears safe and acceptable for patients with pain and/or nausea. Further high-quality, sufficiently powered randomized studies evaluating the cost-effectiveness and efficacy of the add-on effect of acupuncture are recommended.

Some reports confirmed that acupuncture for pregnant women is safe and effective [102–109]. For example, one reported a complete recovery from Bell’s palsy (BP) of a 27-year-old woman, 27-week pregnant, after 2 weeks of acupuncture treatment. Prior to treatment, her House-Brackmann facial nerve grading system (HBS) was II, Nottingham facial nerve grading system was 50.88%, and the Facial Disability Indexes (FDI) were 90. After 2 weeks, her symptoms had disappeared, her face was restored to normal, HBS was I, Nottingham was 96.46%, and FDIP was 100. These results suggest that acupuncture may be a safe, alternative treatment for BP in pregnancy [110]. Another study described patients’ experience of acupuncture treatment in low back and pelvic pain during pregnancy. Women received acupuncture treatment from gestational week 20 or week 26, for a period of 6 weeks divided into eight sessions of 30 minutes each. The results of Pain-O-Meter and visual analogue scale (POM-VAS), Short-Form McGill Questionnaire (SF-MPQ), and Short-form-36 health survey (SF-36) showed a relief of pain. Telephone interviews confirmed that expectations of treatment were fulfilled. The authors suggested that it may be advantageous to begin acupuncture therapy later in pregnancy to maximize pain relief [111].

However, complications and adverse effects in medical practice always concern the public and the medical profession. Acupuncture has been used for several thousand years in China. Although it has been deemed a safe and reliable therapy, the rare adverse effects and complications should arouse concerns. During the 33 years from 1980 to 2013, about 182 cases of acupuncture-associated complications and adverse effects were reported in China, including 25 fatal cases. The frequency of acupuncture associated complications reported in China appears to be steady over time (see Figure 2).

Figure 2: Distribution of cases of acupuncture-associated complications reported from 1980 to 2013.

As indicated in Table 1, the most frequent complication of acupuncture treatment is internal organ, tissue, or nerve injury. Of the 115 reported cases involving internal organ, tissue, or nerve injury, 30 (26.08%) were pneumothorax, 37 concerned the central nervous system (32.17%), others included injury in peripheral nerve, organ, and other tissues. Based on our research, one major cause of direct thrusted injuries to organ, tissue, or nerve is the lack of knowledge about anatomy and other systems. In 1980s, the acupuncturists or individuals in many country grassroot regions performed acupuncture because of low cost and convenience, but the deficient knowledge on anatomy led to many cases of pneumothorax and subarachnoid hemorrhage, as well as injuries to abdomen organs, heart, and peripheral nerves. With the increasing requirement for acupuncturists, these accidents decreased from the 1990s. Particularly, the frequency of pneumothorax and central nervous system injury appears to be on the decline since the 2000s (see Figure 3). This may be because the government has demanded that the acupuncturists should have licenses and formal education background if they practice in clinic in recent years. They should also undergo short time training every year. All these make the acupuncture technique become more and more standardized so that the accidents of pneumothorax and central nervous system injury are reduced. However, there is a possibility that we lack the accident reporting system so that the incidences were underreported.

Figure 3: Distribution of cases of pneumothorax and central nervous system injury from 1980 to 2013.

We put forward suggestions for the medical system in order to avoid more accidental injury on organ, such as enhancing training on anatomy for acupuncturists; setting up more continuation courses on the safety of acupuncture practice for acupuncturists; establishing a reporting system on the incidents of acupuncture adverse effect; and safety courses and certificates should be required in order to obtain the license of acupuncture in China.

The acupuncturists (1) should avoid important organs and tissues during selection of acupoints and reposition if the patient changes body position; (2) do not distract attention during treatment and do not move the patient after acupuncture so as to avoid accidents; for unconscious patients unable to cooperate, shallow needling or not retaining needle is preferred, and the process of treatment should be strictly monitored; (3) inquire detailed medical history and carefully determine the needling depth for patients with emphysema or hemorrhagic disease. Moreover, traditional medicine holds that acupuncture should be performed to bring about the desired sensations of “sour, numb, heavy, and swelling.” Many acupuncturists and patients think that a stronger sensation of needling will bring about better therapeutic effects, but excessively violent operation will also cause accidents. The 2 cases of irritable stomach bleeding due to excessive irritation [35, 36] and the 1 case of femoral neck fracture due to myospasm [45] are typical examples and should alert clinicians. In case of suspected acupuncture-induced injury, the doctor should prolong the time of observation and warn for prompt treatment.

Syncope is also a common acupuncture-induced accident. The hungry, thirsty, drunken, or nervous patients should be asked to eat, drink, or rest for half an hour before treatment and calm down. They should be observed for a moment during and after treatment to avoid syncope. Once syncope occurs, needles should be pulled out immediately, sugar water should be provided, and the patient should lie down with head low; if the symptom becomes severe, take appropriate treatment. Two patients had severe adverse reaction like shock, with the clinical manifestation, including loss of consciousness, respiratory arrest, and carotid pulselessness. After doing CPR, both of them recovered [54, 55]. Reviewing medical history, one was found to have the similar experience several years ago [55]. Therefore, acupuncturists are required to inquire patients’ medical history carefully and learn to deal with emergencies.

Acupuncture infection usually occurs in rural grassroot health centers with low awareness of hygiene, but accidents will be largely controlled along with the use of disposable needles and the popularization of health knowledge. Moreover, tetanus is still an adverse event that should be strictly prevented, and once it occurs, it will cause a high mortality rate. Along with the increasing incidence of diabetes, for patients with poorly controlled blood glucose [112], careful operation is required to avoid infection due to disunion of acupuncture-caused wounds.

The acupuncture-induced bleeding and hematoma are unavoidable; thus to reduce their incidence rates, acupuncturists should (1) get familiar with the anatomy of acupoints and avoid blood vessels during needle manipulation; (2) avoid manipulation methods such as lifting and thrusting when acupuncturing intraorbital acupoints; (3) appropriately extend the time of compression for patients with hypertension, arteriosclerosis, or inclination to hemorrhage and for women during the menstrual period. The acupuncture-induced hematoma is usually cold compressed within 24 hours and hot compressed after 24 hours. H. Liu and X. H. Liu [74] suggested pressing the local hematoma site heavily for a long time, which could immediately disperse the swelling, without leaving bruises. This method is recommended for other acupuncturists.

With a long history in China, acupuncture has been widely accepted and applied in people’s daily life due to its exceptional therapeutic effects and low side effects. As early as 1980, WHO unveiled 43 kinds of diseases that can be treated with acupuncture. The number had increased to 107 in 2002 [113], from which we can see that acupuncture has been recognized by an increasing number of people and more research in this field is being undertaken. In countries where acupuncture is widely used, it is inevitable to encounter the occurrence of some side reactions in acupuncture therapies. However, the accident rate in acupuncture is relatively low. Although existing reports in China show no statistical data about acupuncture accidents, some studies conducted in large subject pools in Germany reveal some relevant information. It has been reported that Endres et al. [114] conducted a study about accidents in acupuncture therapies on 190,924 patients. The study showed an occurrence of 14,449 acupuncture accidents, which accounted for 7.57% of the total subject pool. According to statistics conducted by Witt et al. [115] on 229,230 clinical acupuncture cases, there were 19,726 accidents, which occupied 8.6% of the total subject pool. Chinese literatures show that most of the acupuncture accidents are caused by acupuncturist’s lack of corresponding techniques and nonstandard operations. Since 2005, the Chinese National Administration of Quality Supervision, Inspection and Quarantine and the Chinese National Standardization Management Committee have issued a total of 18 acupuncture technical operation specifications in two batches, including terms and definitions, operating procedures and requirements, operating methods, attentions, and contraindications. Among them, operating procedures and requirements specifically include the selection of needles, acupuncture points and acupuncture positions, environmental requirements, the disinfection of needles, selected acupuncture points and acupuncturist’s hands, specific operation techniques, and after-treatments of wounds [116]. The acupuncture technical operation specification series covers a wide area and contains comprehensive and specific contents, but it still shows some deficiency in the popularization and implementation of acupuncture.

In conclusion, we recommend that the qualifying training of acupuncturists should be systemized and the clinical acupuncture operations be standardized in order to effectively prevent the occurrence of acupuncture accidents, enhance the influence of acupuncture, and further popularize acupuncture to the rest of the world. All this would mean a huge step towards modernization of acupuncture.

Conflict of Interests

The authors declare that there is no conflict of interests regarding the publication of this paper.

Acknowledgments

This work was supported partially by Grant no. 81102636 from the National Natural Science Foundation (NSFC) in China. In Austria, the work was supported by the Federal Ministries of Science, Research and Economy and of Health (project title “Evidence-Based High-Tech Acupuncture and Integrative Laser Medicine for Prevention and Early Intervention of Chronic Diseases”). The authors would like to thank Ms Ingrid Gaischek, M.S. (Medical University of Graz) for her valuable help concerning this paper.

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