Background
Methods
Literature searches
Data selection
Data extraction
Assessment of reporting quality of information related to the patients, adverse events and acupuncture practice
Causality assessment
Results
Search results
Study characteristics
Study ID (author, year) | Patient’s age (gender) | SOC classification | Final diagnosis (case numbers) |
---|---|---|---|
Bahn (1999) [34] | 45 (M) | Nervous system | Cerebrospinal fluid rhinorrhea (1) |
Chun (2014) [19] | 48 (F) | Cardiac | Cardiac tamponade (1) |
Chung (2008) [16] | 66 (M) | Vascular | Limb hematoma (1) |
Chung (2016) [40] | 62 (M) | Eye | Ocular perforation (1) |
Chung (2020) [33] | 55 (M) | Gastrointestinal | Iatrogenic retroperitoneal hematoma (1) |
Ha (2009) [17] | 36 (M) | Gastrointestinal | Retropharyngeal hematoma (1) |
Her (2013) [14] | 62 (M) | Cardiac | Cardiac tamponade (1) |
Hong (2006) [24] | 46 (M) | Vascular | Pseudoaneurysm (1) |
Hwang (2008) [26] | 25 (F) | Gastrointestinal | Pneumoretroperitoneum (1) |
Jeon (2004) [22] | 56 (F) | Nervous system | Cisterna magna infarction (1) |
Kang (2013) [30] | 42 (F) | Eye | Ocular perforation (1) |
Koo (2022) [21] | 64 (F) | Vascular | Vertebro-vertebral arteriovenous fistula (1) |
Kim (2006) [25] | 66 (M) | Nervous system | Spinal cord infarction (1) |
Kim (2009) [27] | 71 (F) | Renal and urinary | Perirenal hematoma (1) |
Kim (2011a) [36] | 78 (M) | Cardiac | Cardiac tamponade (1) |
Kim (2011b) [18] | 55 (M) | Nervous system | Compression neuropathy of superficial peroneal nerve and deep peroneal nerve (1) |
Kim (2011c) [37] | 54 (F) | Cardiac | Hemopericardium (1) |
Lee (2001) [13] | 27 (F) | Respiratory | Pneumothorax (1) |
Lee (2005) [23] | 75 (F) | Gastrointestinal | Cecal hemorrhage (1) |
Lee (2008) [35] | 47 (M) | Nervous system | Median sensory neuropathy (1) |
Lee (2020) [39] | 58 (F) | Eye | Ocular perforation (1) |
Moon (2013a) [29] | 71 (F) | Vascular | Hemorrhage from the inferior epigastric artery (1) |
Moon (2013b) [38] | 55 (M) | Vascular | Ileocecal vein rupture (1) |
Park (2013) [28] | 69 (M) | Nervous system | Acute spinal subdural hematoma (1) |
Park (2019) [31] | 47 (M) | Nervous system | Spinal subdural hematoma (1) |
Sung (2016) [15] | 32 (M) | Respiratory | Pneumothorax (1) |
Woo (2020) [32] | 66 (F) | Nervous system | Cervical spinal cord injury (1) |
Yeo (2021) [20] | 54 (F) | Renal and urinary | Vesicocutaneous fistula (1) |
Reporting quality assessment
The reporting quality of information regarding the patient characteristics and acupuncture-related traumatic adverse events
Patient’s information | AEs information | |||||||
---|---|---|---|---|---|---|---|---|
Study ID (author, year) | Age (gender) | Reason for AT | Patient medical history | Duration from last AT and onset of symptom | Diagnostic test | Clinical outcome (follow up) | Explanation on the association between needling site and lesion | Consideration for other risk factors for AEs |
Bahn (1999) [34] | 45 (M) | WD | WD | WD | WD | WD | WD | ND |
Chun (2014) [19] | 48 (F) | ND | DS | WD | WD | WD | WD | ND |
Chung (2008) [16] | 66 (M) | WD | DS | WD | WD | WD | DS | ND |
Chung (2016) [40] | 62 (M) | WD | DS | WD | WD | WD | DS | ND |
Chung (2020) [33] | 55 (M) | WD | WD | WD | WD | WD | ND | ND |
Ha (2009) [17] | 36 (M) | ND | WD | WD | WD | WD | DS | ND |
Her (2013) [14] | 62 (M) | WD | WD | WD | WD | WD | WD | ND |
Hong (2006) [24] | 46 (M) | ND | WD | ND | WD | WD | ND | ND |
Hwang (2008) [26] | 25 (F) | WD | ND | DS | WD | WD | ND | ND |
Jeon (2004) [22] | 56 (F) | WD | WD | WD | WD | WD | DS | ND |
Kang (2013) [30] | 42 (F) | WD | WD | ND | WD | WD | DS | ND |
Koo (2022) [21] | 64 (F) | WD | DS | WD | WD | WD | DS | ND |
Kim (2006) [25] | 66 (M) | WD | WD | DS | WD | WD | DS | DS |
Kim (2009) [27] | 71 (F) | WD | DS | WD | WD | WD | ND | ND |
Kim (2011a) [36] | 78 (M) | WD | WD | WD | WD | WD | WD | ND |
Kim (2011b) [18] | 55 (M) | WD | WD | WD | WD | WD | DS | ND |
Kim (2011c) [37] | 54 (F) | WD | ND | WD | WD | WD | DS | ND |
Lee (2001) [13] | 27 (F) | WD | WD | WD | WD | WD | WD | ND |
Lee (2005) [23] | 75 (F) | WD | WD | DS | WD | WD | DS | ND |
Lee (2008) [35] | 47 (M) | WD | ND | DS | WD | WD | WD | ND |
Lee (2020) [39] | 58 (F) | WD | WD | WD | WD | WD | WD | DS |
Moon (2013a) [29] | 71 (F) | WD | WD | WD | WD | WD | DS | ND |
Moon (2013b) [38] | 55 (M) | ND | WD | DS | WD | WD | DS | ND |
Park (2013) [28] | 69 (M) | DS | DS | WD | WD | WD | DS | ND |
Park (2019) [31] | 47 (M) | WD | WD | WD | WD | WD | DS | ND |
Sung (2016) [15] | 32 (M) | WD | WD | DS | WD | WD | WD | ND |
Woo (2020) [32] | 66 (F) | ND | ND | WD | WD | WD | DS | ND |
Yeo (2021) [20] | 54 (F) | ND | WD | DS | WD | WD | DS | ND |
The reporting quality of information regarding the acupuncture practice
Details of acupuncture practice | |||||||||
---|---|---|---|---|---|---|---|---|---|
Study ID (author, year) | Practitioner’s type | Needle type (diameter, length) | Names of points or locations | Depth of insertion | Direction of insertion | Needle stimulation method | Posture during treatment | Needle retention time | |
Bahn (1999) [34] | WD | WD | WD | ND | ND | ND | ND | ND | |
Chun (2014) [19] | WD | ND | WD | ND | ND | ND | ND | ND | |
Chung (2008) [16] | ND | ND | DS | ND | ND | ND | ND | ND | |
Chung (2016) [40] | ND | ND | DS | ND | ND | ND | ND | ND | |
Chung (2020) [33] | WD | DS | ND | ND | ND | ND | ND | ND | |
Ha (2009) [17] | WD | DS | DS | ND | ND | ND | DS | ND | |
Her (2013) [14] | ND | WD | WD | ND | ND | ND | ND | ND | |
Hong (2006) [24] | ND | ND | ND | ND | ND | ND | ND | ND | |
Hwang (2008) [26] | WD | ND | ND | ND | ND | ND | ND | ND | |
Jeon (2004) [22] | ND | ND | DS | ND | ND | ND | ND | ND | |
Kang (2013) [30] | WD | ND | DS | ND | ND | ND | ND | ND | |
Koo (2022) [21] | ND | ND | DS | ND | ND | ND | ND | ND | |
Kim (2006) [25] | WD | ND | DS | ND | ND | ND | ND | ND | |
Kim (2009) [27] | WD | ND | ND | ND | ND | ND | ND | ND | |
Kim (2011a) [36] | WD | ND | WD | ND | ND | ND | ND | ND | |
Kim (2011b) [18] | WD | ND | DS | ND | ND | ND | ND | ND | |
Kim (2011c) [37] | WD | ND | DS | ND | ND | ND | ND | ND | |
Lee (2001) [13] | WD | WD | WD | WD | DS | WD | ND | ND | |
Lee (2005) [23] | WD | ND | DS | ND | ND | ND | ND | ND | |
Lee (2008) [35] | WD | ND | WD | ND | ND | ND | ND | ND | |
Lee (2020) [39] | WD | ND | WD | ND | WD | ND | ND | ND | |
Moon (2013a) [29] | DS | ND | DS | ND | ND | ND | ND | ND | |
Moon (2013b) [38] | ND | DS | DS | ND | ND | ND | ND | ND | |
Park (2013) [28] | WD | ND | DS | ND | ND | ND | ND | ND | |
Park (2019) [31] | DS | DS | DS | ND | ND | ND | ND | ND | |
Sung (2016) [15] | WD | WD | WD | WD | WD | WD | WD | ND | |
Woo (2020) [32] | ND | ND | DS | ND | ND | ND | WD | ND | |
Yeo (2021) [20] | ND | ND | DS | ND | ND | ND | ND | ND |
Causality assessment
Causality assessment according to the modified WHO-UMC criteria
Study ID (author, year) | Authors’ conclusion on the causal relationship between acupuncture and adverse events (Quotation from studies) | Causality assessment* |
---|---|---|
Bahn (1999) [34] | “We experienced an interesting case of traumatic CSF rhinorrhea associated with acupuncture.” | Probable/likely |
Chun (2014) [19] | “The diagnosis of cardiac tamponade induced by an acupuncture needle should be considered when unexplained shock after an acupuncture procedure at the chest wall is found.” | Unlikely |
Chung (2008) [16] | “We present the case of a 66-year-old male with a long-standing history of type 2 diabetes who presented with a painful left lower extremity after needle acupuncture and was diagnosed with acute compartment syndrome.” | Unlikely |
Chung (2016) [40] | “We observed a case of ocular perforation and endophthalmitis following ocular acupuncture treatment. This case illustrates the dangers of intraocular acupuncture therapy.” | Possible |
Chung (2020) [33] | “In conclusion, we report a case of reversible duodenal obstruction due to a large retroperitoneal hematoma after acupuncture therapy.” | Unassessable/Unclassifiable |
Ha (2009) [17] | “We report here on a case of a retropharyngeal hematoma following acupuncture therapy and we review the relevant literature.” | Unlikely |
Her (2013) [14] | “We report a case of 62-year-old man with cardiac tamponade due to coronary artery injury after acupuncture into the substernum.” | Certain |
Hong (2006) [24] | “We had experienced … pseudoaneurysms that occurred after acupuncture … and the patients were treated successfully with interventional and surgical procedures.” | Unassessable/Unclassifiable |
Hwang (2008) [26] | “This report describes a case of pneumoretroperitoneum that developed after acupuncture.” | Unassessable/Unclassifiable |
Jeon (2004) [22] | “It is probable that the acupuncture needle had been inserted deep enough to enter the cisterna magna and provoked a small hemorrhage in the cistern.” | Unassessable/Unclassifiable |
Kang (2013) [30] | “We report the case of ocular perforation and retinal tear with normal retinal function and persistent visual field impairment due to retinal nerve fiber severance, caused by acupuncture treatment, which has not yet been reported in Korea.” | Unassessable/Unclassifiable |
Koo (2022) [21] | “We herein report a case of a traumatic vertebro-vertebral arteriovenous fistula that occurred following the application of oriental acupuncture in the posterior neck region.” | Unlikely |
Kim (2006) [25] | “This report describes a case of spinal cord infarction after acupuncture.” | Unassessable/Unclassifiable |
Kim (2009) [27] | “Recently, we experienced … perirenal hematoma in patients without blood coagulation abnormalities (one case induced by acupuncture in oriental medicine clinic…).” | Unassessable/Unclassifiable |
Kim (2011a) [36] | “In the following case, cardiac tamponade was caused by epigastric acupuncture.” | Probable/likely |
Kim (2011b) [18] | “The purpose of this report is to describe what we believe to be the first case of delayed superficial and deep peroneal nerve compressive neuropathy caused by fibrotic mass formed by neglected broken acupuncture needle.” | Unlikely |
Kim (2011c) [37] | “We report a case of hemopericardium that occurred shortly after acupuncture … “ | Possible |
Lee (2001) [13] | “In order to make known that acupuncture can cause pneumothorax in reality and to prevent more acupuncture-related adverse effect cases in future, this report was made.” | Certain |
Lee (2005) [23] | “We report the case of 75-year-old woman with an intramural hematoma who took cumadin after acupuncture …” | Unassessable/Unclassifiable |
Lee (2008) [35] | “This case highlights the possibility of a focal peripheral nerve lesion resulting from acupuncture, possibly caused by herbal medicine coating the needle.” | Possible |
Lee (2020) [39] | “Authors present a case of a patient with vitreous hemorrhage and ocular perforations caused by periocular acupuncture therapy in both eye, …” | Probable/likely |
Moon (2013a) [29] | “We report a rare case of haemorrhage from the inferior epigastric artery, which was injured after acupuncture.” | Unassessable/Unclassifiable |
Moon (2013b) [38] | “We report here on a case of an iliocecal vein rupture following acupuncture therapy and we review the relevant literature.” | Possible |
Park (2013) [28] | “In this report, we present an atypical case of SDH with unilateral weakness after acupuncture …” | Unassessable/Unclassifiable |
Park (2019) [31] | “This patient has functional dysfunction due to SSDH after the acupuncture, which shows that even severe complications may occur after acupuncture.” | Unassessable/Unclassifiable |
Sung (2016) [15] | “For acupuncture treatment to the interscapular area, the depth and manual technique should be carefully performed.” | Certain |
Woo (2020) [32] | “The authors report a case of cervical neurological damage that occurred after an acupuncture procedure.” | Unassessable/Unclassifiable |
Yeo (2021) [20] | “To the best of our knowledge, this is the first case to report the occurrence of bladder injury with VCF following acupuncture. “ | Unlikely |
Appropriateness of acupuncture treatment
Study ID (author, year) | Appropriateness of acupuncture treatment* | |
---|---|---|
Bahn (1999) [34] | Inappropriate | |
Chun (2014) [19] | Unclear | |
Chung (2008) [16] | Unclear | |
Chung (2016) [40] | Unclear | |
Chung (2020) [33] | Unclear | |
Ha (2009) [17] | Unclear | |
Her (2013) [14] | Inappropriate | |
Hong (2006) [24] | Unclear | |
Hwang (2008) [26] | Unclear | |
Jeon (2004) [22] | Unclear | |
Kang (2013) [30] | Inappropriate | |
Koo (2022) [21] | Unclear | |
Kim (2006) [25] | Unclear | |
Kim (2009) [27] | Unclear | |
Kim (2011) [36] | Unclear | |
Kim (2011) [18] | Unclear | |
Kim (2011) [37] | Unclear | |
Lee (2001) [13] | Unclear | |
Lee (2005) [23] | Unclear | |
Lee (2008) [35] | Unclear | |
Lee (2020) [39] | Inappropriate | |
Moon (2013a) [29] | Unclear | |
Moon (2013b) [38] | Inappropriate | |
Park (2013) [28] | Unclear | |
Park (2019) [31] | Unclear | |
Sung (2016) [15] | Inappropriate | |
Woo (2020) [32] | Unclear | |
Yeo (2021) [20] | Unclear |
Discussion
Required | Desirable | |
---|---|---|
Characteristic of patients | ||
Demographic data | Age, sex, social history (alcohol, smoking, job, etc.) | Height, Weight, or Body Mass Index (BMI) |
Medical information | Underlying diseases with duration | Dosage of medication and other treatments (anticoagulation, radiotherapy, etc.) |
Consideration for individual risk factors for AEs | Consideration on possibility of spontaneous occurrence and other traumatic history | Individual vulnerability (sternal foramen, weight loss, cardiomegaly, chronic obstructive pulmonary disease, vascular malformation, etc.) |
Description regarding adverse events | ||
Time relation between last acupuncture treatment and onset of symptom | Duration between last acupuncture treatment and onset of AE symptom | Specific timeline of last acupuncture treatment, onset of AE symptom, and diagnosis of AE |
Radiologic or pathologic findings | Radiologic or pathologic findings | Radiological evidence indicating distance between needling site and trauma lesion |
Clinical outcomes | Clinical diagnosis and medical management | Clinical outcome with follow-up (after a few weeks or years, whether there is recurrence or not) |
Explanation of the association between needling site and lesion | Anatomical location | Points using WHO standard acupuncture point locations |
Causality | Causality assessment using WHO-UMC criteria | Appraisal of the appropriateness of acupuncture |
Description of acupuncture practice | ||
Type of practitioner | Certification of practitioner with affiliation (local, hospital, unauthorized office) | Clinical training and experience period |
Acupuncture type | Needle length | Needle diameter |
Acupuncture points | Anatomical location | Name of acupuncture points with numbers of needles |
Acupuncture stimulation | Depth and direction of insertion | Stimulation method (rotation, lift-thrust, respiration) |
Posture of patient | Posture during treatment | Posture shift during treatment |
Treatment regimen | Number of sessions | Concurrent treatment (chuna manual therapy, spinal manipulation, electroacupuncture, pharmaco-acupuncture, etc.) |
Others | ||
Title | Include acupuncture type (manual acupuncture, electroacupuncture, auricular acupuncture, etc.) and AEs | Include type of adverse events such as trauma or injury |
Author | Consult Korean Medicine doctor for the procedure of acupuncture treatment | Include qualified Korean Medicine doctor as authors |
Discussion | Discussion of previous reports of adverse events, disease specific characteristics, and other patient related risk factors | Based on appraisal of causality assessment and appropriateness of acupuncture in neutral attitude |