Research on Acupuncture Safety
For the past 50 years, acupuncture has been subjected to intensive scientific evaluation in over 8,000 clinical trials and has demonstrated its effectiveness in the treatment of many diseases occurring in modern Western societies. But in order to be a viable healthcare choice, any treatment must not only be effective but also be safe for patients, demonstrating a good balance of benefit to potential harm. The following article discusses the safety of acupuncture as well as some of the main issues concerning research in the field.
Systematic reviews of clinical trials have demonstrated the effectiveness of acupuncture 1 and have extended our knowledge of the mechanisms of action in the treatment of numerous medical conditions. However, the benefits of any treatment must be weighed against potential harms in order to assess its potential role in health care.
When reporting on adverse events within acupuncture research there are usually two aspects considered: serious adverse events such as pneumothorax or needles piercing organs and minor adverse events such as bruising, fainting or symptoms becoming temporarily worse. Some trials also include a person feeling energized or feeling tired following a treatment as a minor adverse event, although many practitioners and patients may consider this a useful treatment response.
In 2006, an analysis of acupuncture safety was published by British researcher Adrian White.2 The author presented the findings of two prospective trials carried out in the United Kingdom between 1998-2000. 66,229 treatments were reviewed. This treatment analysis found the incidence of Serious Adverse Events to be zero. In the Survey of Adverse Events Following Acupuncture (SAFA) in 2002, 2178 minor adverse events were reported with 31,822 treatments included (7%). In The York Acupuncture Safety Study published in 2001, which included 34,407 treatments, 4,528 (13%) minor adverse were reported. The different rates between these two studies is due at least in part to different criteria for what qualified as an adverse event, which in the York trial included, for instance, patients feeling weak and tired after treatment.
In the same paper, White also provides the findings from other studies describing the safety of acupuncture. The analysis included 13 studies and 4,441,103 treatments. Overall, there were 11 serious adverse events reported. The most common serious adverse event was pneumothorax (7 per 4,441,103 treatments). There were also two incidents of a needle breaking while still inserted however, this involved the use of reusable needles rather than the single use disposal needles that are used in today’s practice.
Out of 4,441,103 acupuncture treatments, the number of reported serious adverse events was only 11. The largest source of safety data comes from the 2006 German PEP-Ac study, involving 454,920 patients and over 4 million treatments administered through the German healthcare system.3 7.9% of patients in this study reported minor adverse effects while only 0.003% (13 patients) experienced severe adverse events. Minor adverse events included needling pain, haematoma, and bleeding, while serious adverse events included pneumothorax, acute hyper- or hypotensive event, a skin infection known as erysipelas, asthma attack, and aggravation of suicidal thoughts.
Further research continues to demonstrate a low rate of adverse events for acupuncture. These studies include a prospective feasibility study published in 2017, acupuncture was deemed a ‘feasible, safe and acceptable’ treatment in a Californian ICU setting with no significant adverse effects reported and a significant decrease in morphine usage found.4
Systematic reviews of trials between 2013 and 2016 concluded that acupuncture performed by trained practitioners using ‘clean needle technique’ is a generally safe procedure. The medical literature also indicates that acupuncture may be used successfully on cancer patients for symptom management due to the low risks associated with its use5 and in pregnancy related care.6
These clinical results make acupuncture one of the safest procedures available in contemporary medicine. When this safety profile is compared to, for instance, serious side effects of non-steroidal anti-inflammatory drugs and opioids and the number of deaths connected with their application, the safety of acupuncture becomes even more apparent. There is only one caveat: acupuncture must be performed by qualified acupuncturists with adequate training.
“The risks associated with acupuncture can be classified as negligible, and acupuncture is a very safe treatment in the hands of competent practitioners.” White, 2006
Acupuncture Safety in Context
♦ Of patients prescribed opioids for pain relief, up to 25% of them go on to develop a life-long addiction 7
♦ In 2015, opioid-involved drug overdoses accounted for 33,091 deaths in the United States (which is more than deaths due to car accidents) 8
♦ A recent study of non-steroidal anti-inflammatory use in 446,763 subjects found that taking any dose of NSAIDs for any duration increased the risk of heart attack9
WHEN IT COMES TO ACUPUNCTURE SAFETY, TRAINING IS KEY
According to the acupuncture safety literature, proper education of acupuncturists is the essential condition ensuring the safety of patients benefiting from this method of treatment. In 2011, the prestigious journal Pain published a review of systematic reviews by Edzard Ernst and colleagues.10 The authors reviewed the literature detailing all and any description of adverse effects that could be attributed to acupuncture. The authors discussed cases reported mainly in developing countries, where acupuncture may be performed by untrained practitioners in conditions lacking normal standards of hygiene. Acupuncture performed in such a manner inevitably increases the risk of transmission of infectious disease or of puncture wounds. What is more important is that these complications are easily avoided, which is why ensuring the professional education of acupuncturists is so vital.
In order to help patients and physicians make informed choices about treatment options, acupuncture’s safety should be evaluated in light of the available data and compared to the safety of available alternatives. The overall evidence, including that from controlled clinical trials, demonstrates that acupuncture applied by qualified practitioners is one of the safest methods of treatment compared to available alternatives.
“Serious complications after acupuncture continue to be reported. Many are not intrinsic to acupuncture, but caused by malpractice of acupuncturists. This might explain why surveys of adequately trained therapists failed to yield such complications . . . The key to making progress would be to train all acupuncturists to a high level of competency.” Ernst et al, 2011
Preventing Rare Adverse Effects
The most common adverse effects of acupuncture, though extremely rare, are pneumothorax, the fracture of a needle in the patient’s body, transmission of infectious disease, haematoma or bleeding at the site of the needle insertion, no effect, deterioration of symptoms and vertigo.
♦ Pneumothorax or possible puncture of other structure (vessel, urinary bladder, pericardium), can be avoided by training in anatomy and physiology as well as proper needle technique
♦ The use of high-quality acupuncture needles made of stainless steel, assuring flexibility which ensures the patients’ safety
♦ Acupuncture needles are single-use only, and they are utilized in accordance with clean needle technique regulations, minimising the possible transmission of infectious diseases
♦ Proper needle insertion and removal techniques prevent haematomas from developing
Dizziness, vertigo, lack of effect or even deterioration of symptoms occurs mainly in the case of wrong diagnosis. In order to avoid this, acupuncturists must have adequate knowledge of diagnosing and treating. The World Health Organization recommends 2,500 hours of formal training as part of an accredited program.
In summary, acupuncture is amongst the safest interventions in modern medicine with the frequency of occurrence of serious adverse events at 11 per 4,441,103 procedures. In order to maintain this profile of safety, acupuncture must be performed by qualified acupuncturists who have demonstrable knowledge of anatomy and physiology and clean needle technique, meeting the standards of training as detailed by the World Health Organization. Practitioners using acupuncture without adequate training increase the risk to their patients of possible adverse effects and practitioners without skills in proper diagnosis may provide ineffective treatment. Despite the reporting of rare adverse clinical events, acupuncture remains one of the safest contemporary treatments available.