Arya Nielsen, PhD
It is true that acupuncture has a relative risk that is low. The reporting of adverse events in clinical trials as well as safety surveys has helped establish a positive safety record in the West (White 2004; MacPherson et al. 2001), China (Birch et al. 2013; He et al. 2012), and Japan (Yamashita et al. 2001); in the treatment of children (Adams et al. 2011; Jindal et al. 2008) as well as for pregnant women (Park et al. 2014). Patients may experience minor side effects such as feeling relaxed, elated, tired, or having point sensation or itching etc. (MacPherson and Thomas 2005) or slight bleeding and hematoma on needle withdrawal (Witt et al. 2009).
There are rare serious complications associated with acupuncture. Reviewers point out that injuries relate directly to insufficient training (White 2004; Yamashita et al. 2001). White (2004) surveyed 12 prospective studies of more than a million treatments reporting ‘the risk of a serious adverse event with acupuncture is estimated to be 0.05 per 10,000 treatments, and 0.55 per 10,000 individual patients. The conclusion was that the risk of serious events occurring in association with acupuncture is very low, and below that of many common medical treatments.
And yet there are deaths that have resulted from acupuncture treatment as well as serious infections, organ punctures, and other complications. Published cases of adverse events clarify that acupuncture carries a risk of harm. Many acupuncture professionals are, in fact, not aware of the published cases of acupuncture harms because they may not read the medical literature in general and because cases of harm are not necessarily reported by or back to the practitioner who caused them. They appear in medical journals often as emergency department cases and acupuncture therapy is represented as risky and irresponsible.
To be clear, accurate reporting of adverse effects, events, reactions, and complications collectively known as ‘harms’ is a challenge in every aspect of medical research (Pitrou et al. 2009). Primary research studies fail to adequately report harms data and systematic reviews compound poor reporting by failing to report on whether harms data was even collected (Zorzela et al. 2014). While adoption of the Consolidated Standards of Reporting Trials (CONSORT) by medical journals may beneficially influence completeness of reporting, general inadequacies of reporting harms in randomized controlled trials (RCTs) remains a problem (Hodkinson et al. 2013; Turner et al. 2012) and confounds efforts to weigh the risk and benefit of an any intervention. An extension to the CONSORT checklist was adopted in 2004 to include specific reporting of harms in all trials (Ioannidis et al. 2004). To their credit, acupuncture researchers further extended the CONSORT statement by adopting the Standards for reporting Interventions in Clinical Trials of Acupuncture (STRICTA) to improve reporting of both intervention and adverse events (MacPherson et al. 2010).
As practitioners, it is possible that we rely on our safety record and the ‘ancient goodness’ of our medicine and think that the cases of harm are rare enough and happen somewhere else. But mitigating even one chance for harm is worth a review. Here is an overview of case reports of harms attributed to acupuncture, categorized with practical recommendations:
The medical literature uses many terms to denote side effects, which can be unwanted (adverse) or even beneficial. The relationship of an adverse effect to an intervention must be considered: is a side effect a direct result of an intervention, and is it expected, common, or rare? Is a reaction the result of negligence or misapplication of an intervention?
Unfortunately, current medical literature fails to distinguish between negligent medical errors associated with acupuncture, rare complications that are unanticipated, and adverse reactions that may be expected as part of normal practice but can be mitigated with attention. That is, these are conflated as adverse events from acupuncture. It is important that our professional community distinguish medical errors from risks of adverse events for acupuncture.
Harms associated with acupuncture can be listed as risks of the following:
- Lesions including organ, vascular, and nerve puncture injury
- Broken and migrating needle
Negligence is involved in almost all cases of infection, organ or vascular puncture, bleeding and broken or migrating needle. Some infections and lesions are rare unexpected complications that might be avoided in the future.
Infection from negligent acupuncture has been associated with transmission of the following diseases:
- Hepatitis (in the U.S., Vietnam, Korea and China)
(Stryker 1986; Nguyen et al. 2010, Seong et al.2013; Birch et al. 2013)
- Tuberculosis (Kim et al. 2010)
- Mycobacterium (Woo et al. 2002; Kim et al. 2011)
- Methicillin-resistant Staphylococcus aureus (MRSA) infection
An MRSA infection related to acupuncture negligence caused a severe case of septic arthritis in Hong Kong (Woo et al. 2009) and necrotizing aortitis with infected pseudoaneurysm in Korea (Lee et al. 2008). A medical practitioner in Perth, Western Australia who was colonized with MRSA was responsible for transmission to eight patients using acupuncture and joint injections (Murray at al. 2008).
A woman being treated for low back pain developed bilateral psoas abscesses (MRSA) and polyarticular septic arthritis two days following an acupuncture treatment (Japan) (Ogasawara et al. 2009).
Finally, a 15 year-old boy in the U.K. was treated with acupuncture for eczema. Two days after his fifth treatment he suffered bilateral knee swelling, fever, and subsequent endocarditis from Staphylococcus aureus (Buckley 2011). He was admitted to a hospital for weeks and was left with permanent cardiac damage. Four months prior to the initiation of acupuncture, nasal and skin swabs isolated Staphylococcus aureus. The acupuncturist was likely not aware of this finding and inserted needles at the sites of his eczema lesions on his knees and then firmly massaged the knees following acupuncture, carrying Staph deep into the tissues. This patient’s abnormal skin barrier function, leading to colonization with S. aureus, was a predisposing risk factor. Here, acupuncture caused a complication that is rare and unexpected, and yet might have been avoided.
Negligent acupuncture has also caused cases of auricular perichondritis but these were reported in the 1970’s, 80’s and 1990 and were likely associated with imbedded needles (Buckley 2011). Necrotizing fasciitis has been a reported adverse risk of acupuncture (Saw et al. 2009). A diabetic patient who received acupuncture for osteoarthritis of the knee later developed serious necrotizing fasciitis that required surgery.
What must be taken from these reports?
- Re: Hepatitis
Acupuncture transmission of hepatitis is rare with strict adherence to single use pre-sterilized needles. Medical practitioners must follow strict sterile and clean field protocols, as if every person is a potential carrier (including themselves).
- Re: MRSA and other infections
Even single use sterile needles can lead to infection. All medical practitioners who have had a MRSA infection should be tested to see if they are carriers or are colonized with MRSA and treated if need be. Because eczema and other forms of dermatitis represent compromised skin barrier function, acupuncture should be avoided at inflamed sites. A careful patient history should include questions about MRSA infection or history of colonization.
- Practitioners should be aware of the immune status of their patients and the increased risks involved in treating patients with diabetes, or who are on immune suppressants, which are increasingly used to treat auto-immune disorders.
- Acupuncture needles should not penetrate deep into the thoracic or abdominal cavity or into a joint capsule. Deep needling is not necessary for a therapeutic effect and greatly increases risk of injury and/or infection.
Harms: Traumatic Lesions
Traumatic lesions include punctures of any of the following:
- Thoracic viscera (cardiac tamponade, endocarditis, pneumothorax)
- Abdominal or retroperitoneal viscera
- Peripheral nerves
- Central nervous system
- Blood vessels
While qualified acupuncture programs that lead to licensure have greatly reduced the incidence of traumatic lesions, “It is important to recognize that even one avoidable adverse event is one too many….It should be emphasized that medical practitioners are not exempt from the need to study anatomy relevant to acupuncture, since they are unlikely to have needed this information in conventional medical practice” (Peuker et al. 2001). Rather than review each case, several take-away points are critical in terms of depth of needling and special circumstances.
- 5-8% of the population has a sternal foramen congenital abnormality from incomplete fusion of the sternal plates (Peuker et al.) at the location of CV 17. Palpation cannot detect the abnormality where the inner chest wall may be as little as 15mm deep. Acupuncture needling of this area should be superficial and tangential to prevent harm.
- In general, a depth of 10-20 mm parasternally or at the midclavicular line can reach the lungs, less if the tissue is compressed with palpation. Moreover, the anatomy of patients with chronic respiratory problems like COPD morphs over time. Because the musculature thins and the lungs come closer to the surface of the body, care must be taken and needling should be shallow and tangential. A de qi and therapeutic effect can be achieved by making contact with the superficial fascia that is at the surface of the muscle.
- Deep needling of the thoracic and abdominal region should be strictly forbidden. There are other case reports of organ puncture of the liver, kidney, bladder and intestines. There is no established therapeutic effect from deep needling, while there is established and considerable risk.
- Deep needling of the inner Bladder channel was implicated in lesions of the spinal cord and spinal nerve roots. Deep needling at GV 16 at the neck resulted in an intracranial hemorrhage. Again, acupuncture needling deep into the cervical or spinal structures is not necessary to achieve a therapeutic effect. Penetration should only be to the depth of the superficial fascia for a de qi response.
Curious Adverse Effects
More recent cases of curious adverse events are worth mentioning. More and more patients are on anticoagulant therapy, which increases their risk for serious bleeding especially if there is a deep vascular nick or puncture.
A case in the literature attributes a large hematoma to deep acupuncture needling at the hip and thigh of a patient who had a stable INR (2.4) (International Ratio) on anticoagulants but who was also 82 years old (Kens et al. 2012). The authors failed to acknowledge her age and also increased her risk for vascular injury since the tissue and vascula tend toward thinning in elderly patients. She was hospitalized with low hemoglobin. Her warfarin was withdrawn and not reinstated. She made a full recovery, but still this injury could have been avoided by appropriate needle depth and withdrawal compression. Practitioners should be aware not only of patients taking anticoagulants but the changing nature of the aging body.
Argyria (discoloration of skin from deposit of insoluble silver) from acupuncture is rare but has been reported in Japan over 20 years ago. However, recent cases of localized argyria from acupuncture have been reported (Alés-Fernández et al. 2010) where the argyria likely resulted from a small particle of silver that dislodged from the needle. Sites can resemble metastatic melanoma that prompts a biopsy to rule it out.
Yanagihara et al. (2000) report on a patient who developed epitheloid granulomas at the entry points from the silicone coated acupuncture needles. Silicone was detected in the tissue, which indicated that at least with some coated needles, silicone is actually deposited in the body. Acupuncturists may want to consider using needles that are not coated.
The final curious case involves a child with eczema who had a condition of very high serum IgE (Hon et al. 2013). Her condition represented an uncommon form of immune suppression. Her eczema was treated with acupuncture and cupping, which resulted in serious infection. The only way the acupuncturist could have known is if they had access to the patient’s detailed history and labs. However, one might be cued again to the risk involved in treating chronic skin conditions where the skin barrier is compromised and there is elevated risk of Staph colonization.
As acupuncture therapies gain popularity with increased access to populations of patients with complicated and serious illnesses, practitioners do well to be aware of reported and potential harms so they may balance that knowledge with potential benefits. Our medicine is ancient, and it is good. Still, our first priority is to do no harm.
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Arya Nielsen, PhD has a research Doctorate in Philosophies of Medicine with a specialization in Integrative Clinical Science and Health Care. She is U.S. board certified in acupuncture and Chinese herbal medicine, and is a past chair of the New York State Board for Acupuncture. She teaches in the U.S. and Europe and is considered the Western authority on the traditional East Asian technique of Gua sha. Dr. Nielsen has been in practice for 37 years and has a faculty appointment at Mount Sinai Beth Israel in New York and sees patients at their Department of Integrative Medicine. She developed and directs the Acupuncture Fellowship for Inpatient Care. She is author of the Gua Sha,: A Traditional Technique for Modern Practice (Churchill Livingston/Elsevier). She has also developed the Gua sha Certification Course. Dr. Nielsen can be contacted by email: [email protected] through www.guasha.com