Essay on Evidence based evaluation of Acupuncture for CMS
Conflicts of interest: None
First, I must provide a disclaimer as not being a world expert on acupuncture. My name is Mark W Asplund MD FACS RVT RPVI. I am a general and vascular surgeon newly retired. I have spent most of my life studying anatomy, physiology, and pathophysiology and practicing evidence-based medicine and surgery. I am also an avowed skeptic of all non-science-based treatments now described as alternative medicine. As almost all “seasoned” physicians like myself, I have seen damages done on unsuspecting and gullible public such as laetrile for cancer, seen chelators deny limb saving surgery, cases of metastatic prostate cancer misdiagnosed and treated with holistic medicine, and a neck sprain in a 21 year old lead to brainstem stroke and death from chiropractic neck manipulation. I have witnessed these alternatives become more mainstream as if they are based on any science. Now our tax dollars may pay for these dangerous and unproven therapies. Therefore, I have taken to the challenge to write to CMS regarding legitimizing acupuncture for low back pain by considering reimbursing acupuncture and discussing who should perform it. I thought, how could this be? This started as what I thought would be an hour adventure to answer this to my satisfaction. Is there evidence for efficacy of acupuncture in treating lower back pain, what is the science behind it, what are the risks, how would this be regulated, and who would perform this. I am now two days into it, the many thousands of conflicting articles and reviews are at best can be confusing and voluminous.
As part of my disclaimer I have relied on previously written excellent reviews referenced below and have paraphrased their thoughts. (12)
Acupuncture appears to be the shining star of alternative medicine. As I mentioned there are literally thousands of articles and opinions regarding evidence of efficacy for a multiplicity of conditions.
In trying understanding acupuncture and its claims, it clearly cannot work by the mechanism hypothesized by its practitioners. (1) There seems to be some mystique to ancient Chinese medicine and acupuncture as if the ancients somehow knew something modern medicine has yet to discover. This is preposterous. Ancient Chinese medicine is as unenlightened as all folk medicine. (2) There is no physiologic life force, Qi, to tap into (like in the force in Star Wars) nor anatomic basis for meridians that somehow needling will alter the Qi to treat the myriad of processes purported to be improved by acupuncture. Anyone claiming such a mechanism of action is immediately discredited and should not be given authority to perform any medical care. Therefore, one cannot endorse the Accreditation Commission for Acupuncture and Oriental Medicine as a regulating body. (3) We must therefore start out very skeptical of acupuncture since its theory is no more plausible than “The Force” that helps Luke Skywalker.
Does however acupuncture work, possibly by some other mechanism? What do the studies show? Are there non-biased studies? What other problems arise in studying acupuncture evidence based? The sine qua non of evidenced based medicine is prospective randomized doubly blinded studies showing statistically significant advantages over controls. It is very difficult to blind sticking needles in a patient’s body, both to the patient and investigator. Investigator bias tends to be very common. The NIH gives a somewhat lukewarm endorsement for acupuncture (4), and our government sponsorship of studies of efficacy of acupuncture. (5,6 Interesting these sites have now been removed). I was taken a bit aback by this. Why would the NIH have any endorsement of acupuncture and sponsor studies based on centuries old nonscientific theories? Especially such biased studies. One such NIH grant is for 375,000$ to a company called Stromatec to study their Needle Torque Test and its “capabilities of detecting connective tissue abnormalities … by inserting acupuncture needles into connective tissue and using “Automated Needle Torque Sensors to deliver a precise biomechanical stimulus to the needle probe by rotation. The tissue response is quantified by torque.” The Automated Needle Torque Sensors are made by Stromatec. The research was done at the National Center of Complimentary and Alternative Medicine and was sponsored by the NIH for the purpose to “bolster the evidence needed to justify reimbursements for alternative medicine”. This study seems typical of bias and junk really. One cannot be sure what they were studying. A main researcher is on the board of Stromatec. These same biased researchers on the Stromatec board also wrote a positive review in the NEJM advocating acupuncture.(5, 13).
What then is the peer reviewed evidence for or against acupuncture. In reviewing the data, it is remarkable how the better the controls, the better the blinding, the studies show a null result there is no effect beyond placebo. Studies with poor controls done by biased advocates of acupuncture tend to show positive results, such as many studies out of China. However, the largest and most recent meta-analysis’ of well controlled studies have all been negative (as most previous have been). Out of the British Journal of Medicine Madsen concluded “a small analgesic effect of acupuncture was found, which seems to lack clinical relevance and cannot clearly distinguished from bias. Whether needling at acupuncture points, or at any site, reduces pain independently of psychological impact of treatment ritual in unclear.(7). Ernst in PAIN in 2011 magazine concluded in his “Review of Reviews” that “the apparent analgesic effect of acupuncture seems to be below a clinically relevant pain improvement.” (8). They added “serious adverse effects continued to me noted”, including infection, pneumothorax and 5 deaths. These are both extensive reviews. An excellent commentary was also provided to the Ernst article by Harriet Hall, quoted here. “Ernst et al. systematically reviewed all the systematic reviews of acupuncture published in the last 10 years: 57 systematic reviews met the criteria they set for inclusion in their analysis. They found a mix of negative, positive, and inconclusive results. There were only four conditions for which more than one systematic review reached the same conclusions, and only one of the four was positive (neck pain). They explain how inconsistencies, biases, conflicting conclusions, and recent high quality studies throw doubt on even the most positive reviews.
They also demolished the “acupuncture is harmless” myth by reporting 95 published cases of serious adverse effects including infection, pneumothorax, and 5 deaths. Some but not all of these might have been avoided by better training in anatomy and infection control.
Their analysis does not prove that acupuncture doesn’t work (negatives are hard to prove) but it unquestionably sheds serious doubt on the claim that it does work. Overall the evidence is inconsistent, and the results tend to be negative among those studies judged to be of the highest quality. Where the results are positive, the reported benefits can be explained by the surrounding ritual, the beliefs and expectations of patient and practitioner, and other nonspecific effects of treatment. There is no evidence to support the vitalistic concept of qi or the prescientific mythology of acupuncture points and meridians; it doesn’t seem to matter where you put the needles or whether the skin is pierced. More modern science-based explanations like increased endorphin production are not convincing, since placebo pills can produce the same effects.” (9)
A most interesting observation was found in an ingenious way to double blind the sham acupuncture for low back pain. The results show no difference between real acupuncture and sham needling made to believe its is real. What is even more fascinating both these arms outperformed physical therapy, epidural, anti-inflammatories. This speaks to several other obstacles in assessing acupuncture namely how ineffective our current treatments are, and the power of placebo.(10)
In conclusion acupuncture needs to be placed along with all other alternative medicines, an oxymoron if there ever was one. Medicine should be evidenced based otherwise it is simply folk treatments and is not proven medicine. Acupuncture is in the latter category. It should be noted the British health service has looked at this very issue and has given it the thumbs down.(11).
As to who should perform acupuncture, since there is no real evidence to support it’s use it should only be performed in clinical trials by licensed medical professions. The ACOAM would most certainly not qualify as a credentialing and training body.
And finally on what basis is the NIH sponsoring trials by biased researchers into nonscientific “alternative medicine”?
1.Rosa L, Rosa E, Sarner L, Barrett S. A close look at therapeutic touch. JAMA. 1998 Apr 1;279(13):1005–10.
2.Ramey D, Buell PD. A true history of acupuncture. Focus on Alternative and Complementary Therapies. 2004;9(4):269––273.
3. http://acaom.org/ ACAOM Website.
4. https://nccih.nih.gov/health/acupuncture Interestingly since I researched the NIH website three days ago thes sites have all been taken down.
5. NIH sponsorship of Stromatec and Bloomberg report of the company https://www.sbir.gov/sbc/stromatec-inc
6. Chicago Tribune [Internet]. Tsouderos T. CAM: Taxpayer money spent on studies with questionable scientific value; 2011 Dec 16 [cited 12 Feb 19].
7. Madsen MV, Gotzsche PC, Hrobjartsson A. Acupuncture treatment . for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ. 2009;338:a3115.
8. Ernst E, Lee MS, Choi TY. Acupuncture: Does it alleviate pain and are there serious risks? A review of reviews. Pain. 2011 Apr;152(4):755–64. PubMed #21440191.
9. Commentary from Hall H. Acupuncture’s claims punctured: Not proven effective for pain, not harmless. PAIN 2011 Apr; 152(4): 711-712
10. Schultz IZ, Crook J, Meloche GR, Berkowitz J, et al. Psychosocial factors predictive of occupational low back disability: towards development of a return-to-work model. Pain. 2004 Jan:77–85.
11. NICE.org.uk [Internet]. National Institute for Health and Care Excellence. Low back pain and sciatica in over 16s: assessment and management; 2016 Nov [cited 16 Dec 21].
12. https://www.painscience.com/articles/acupuncture-for-pain.php This website was Done by Paul Ingraham Vancouver, Canada.
13. Berman, B; Longevin, H NEJM 2010:363:454-461.