200 BCE. Some place it much earlier. Acupuncture is a practice based on a belief system from Chinese philosophy. The central idea involves the concept of "qi' (or sometimes referred to as 'chi'). Qi is on of the three dimensions of human existence (Jing, Qi and Shen, or 'elegant movement', 'energy flow', and 'presence of mind'). The Six Taoist Arts symbolize the opposing forces of Yin and Yang at these three dimensions.
Qi is a complex idea. In common use, it refers to a form of vital life energy, a force that flows through living bodies through channels called 'meridians'. It is thought that the flow of qi can become imbalanced, which results in poor health, pain, infertility and disease. These imbalances are believed to be restored by stimulating acupuncture points located along the meridians.
Chines tradition holds that the body has 365 parts corresponding to the days of the year. Qi flows through the body through 12 meridians, which are said to have corresponded to 12 rivers in ancient China, 12 parts of the day and commonly related to 12 organs of the body.
It is important to emphasize that this is a belief system. It is not, nor has it ever been, science. Belief systems and cultural traditions exist outside of the realm of science. They are not empiric. Belief systems provide believers with comfort by unifying them into groups that share the belief. Belief systems give people a sense of belonging to something bigger and better than themselves.
rituals that members practice together and hold sacred, thereby deepening the feeling of belonging to the larger something. Rituals are soothing, reaffirming and provide psychological comfort to believers. Humans are a social species that evolved through group living, whereby individuals depended on having a place in the group. Rituals enforce the bond between group members. As illness is a major problem for any social group, healing rituals are common among human cultures. In prescientific cultures, healing rituals arise from the belief systems of those cultures.
The notion of acupuncture as a healing ritual within a cultural belief system is not what concerns us here. People have a right to believe what they want and that right should be respected. But again, belief systems are not science. Indeed, people who find comfort in their belief system often lament those who confuse it with a field of scientific study. One writer in The Chinese Times laments about "those who acknowledge acupuncture’s clinical value while disavowing its traditional rational. This new breed of supporter is beginning to do more to undermine long-held notions about Chinese medicine than all the sceptics who doubted its effectiveness combined!"
As Dr. Novella has pointed out, concepts like qi and meridians do not correspond with any scientifically known aspect of human physiology. If we approach the concepts of qi, meridians, Yin and Yang, we find acupuncture's pretest probability (at least by way of these traditional concepts) to have a pretest probability that approaches zero. They are not science.
"Taoist" Elizabeth Reninger acknowledges that meridians are not anatomic structures:
"Like a network of rivers nourishing a landscape, the meridians are the channels through which qi flows, to nourish and energize the human body. These channels exist within the subtle body – you won’t find them on the operating table! Collectively, they form the matrix within which the physical body functions."
We are concerned with the modern marketing of acupuncture as if it were science.
NCCAM defines acupuncture as, "A family of procedures that originate in Traditional Chinese Medicine. Acupuncture is the stimulation of specific points on the body by a variety of techniques including the insertion of thin metal needles through the skin. It is intended to remove blockages in the flow of qi and restore and maintain health."
Acupuncture as it is often marketed today, bears only superficial resemblance to the ancient Chinese practices, although many departments of 'Integrative Medicine" pay lip-service to them. Some actively promote the ideas of blocked qi and meridians, others propose scientific sounding mechanisms to explain acupuncture's 'effects'. Modern practitioners must resolve the cognitive dissonance that arises when confronted with the myriad of studies that fail to show significant effects in randomized controlled trials. They do so either by denying the studies outright, rationalizing them, or touting only the one's that suggest minor effects, such as the studies on nausea, and extrapolating these morsels of evidence to support acupuncture as a legitimate treatment for a wide range of medical conditions.
To argue for a mechanism for Acupuncture is to assume that Acupuncture works in the first place. However, this has not been established, and as we shall see, is not supported by the evidence. The stasis point of conjecture cannot be assumed here. Recall the fallacy of the false premise and Dr. Hall's "Tooth Fairy Science".
Let's look at some of the hand-waving explanations given by otherwise respected institutions for Acupuncture's "Tooth Fairy".
"There are many theories as to how acupuncture actually works. When acupuncture points are stimulated, it causes a dull ache or other sensations in the muscle. One theory holds that the stimulated muscle and sensory neurons send a message to the central nervous system (the brain and spinal cord), causing the release of endorphins (naturally produced pain killers) and other neurotransmitters (body chemicals that modify nerve impulses), which help block the message of pain from being delivered to the brain and have other regulatory effects as well."
"The anatomical points (acupuncture points) are thought to have certain electrical properties, which affect chemical neurotransmitters in the body."
Brigham and Women's Hospital (Harvard)
"It is based on the concept that the body has specific channels (meridians) through which energy (chi) flows. While this energy, or chi, is flowing smoothly, there will be no specific pain or disease, but if the chi is either deficient or excess in quantity, or is not flowing freely, there will be disease. When acupuncture needles are placed in specific points on the skin, energy is redirected to bring about a healing response."
"The scientific explanation of how acupuncture works is through the nervous system. The channels are thought to represent the nerves that course from the spinal cord and spread throughout the body. When the nerves are stimulated by an acupuncture needle, signals are sent to the brain and chemicals, called neurotransmitters, are released. These chemicals trigger the body’s self-healing mechanisms."
Statements such as these from institutions that should be promoting science and critical thinking cast doubt on the scientific literacy of their administrators and doctors. As we discussed, qi and meridians have a near zero plausibility. However, putting needles in the skin is an active practice. It is no really like homeopathy in this regard in that homeopathic remedies have absolutely no ingredients. So, the practice of needling the skin to treat disease may be higher than zero. RCTs may be somewhat appropriate, but the results would have to be unequivocal in quality studies. Without such evidence, acupuncture remains a pseudoscience.
Let's be clear. Acupuncture is really a heading for several practices, some of which are NOT what most people think of when they consider the idea. Most think of acupuncture as putting needles in the skin at specific points to achieve specific effects. 'Electroacupuncture' involves passing electric current into the needles. This is similar to TENS (transcutaneous electrical nerve stimulation). Acupressure is the practice of pressing the acupuncture points with the fingers (like massage?). 'Acupuncture point injection' is the practice of actually injecting drugs or other substances into acupuncture points. 'Moxibustion' involves burning incense in a cone that is placed on or near acupuncture points. It is not intellectually fair to call all of these practices acupuncture. Literature that supports 'electroacupuncture' should not be touted as support for 'acupuncture'.
Occam's razor tells us to reject such a result in favor of the null hypothesis. Let's look at the body of literature.
Publication bias was found in to be a tremendous problem in studies from Asia. The 1998 review of clinical trials from 1966 to 1995 states, "Research conducted in certain countries was uniformly favorable to acupuncture; all trials originating in China, Japan, Hong Kong, and Taiwan were positive, as were 10 out of 11 of those published in Russia/USSR." In fact, the study looked at clinical trials from China and Russia for treatments besides acupuncture. They found that these countries never publish negative studies! "No trial published in China or Russia/USSR found a test treatment to be ineffective."
We are faced with a dilemma when evaluating studies published in China, Japan and Russia. All of the acupuncture studies are positive. This is in complete dissonance with studies conducted elsewhere. Unfortunately, this leads us to take any and all studies from these countries with a grain of salt. In fact, if all of them are positive, then many would conclude that none of them should be included in the scientific analysis of acupuncture.
The 1997 NIH Consensus statement explains, "While there have been many studies of its potential usefulness, many of these studies provide equivocal results because of design, sample size, and other factors. The issue is further complicated by inherent difficulties in the use of appropriate controls, such as placebos and sham acupuncture groups."
An review of the literature in 2006, Edzard Ernst looked at the RCTs using sham needles. He states, "The majority of studies using such devices fails to show effects beyond a placebo response." Let's look for ourselves at the systematic reviews that are available for specific ailments.
- For addiction treatment (for smoking, alcohol and heroin) the 1990 BJGP meta-analysis concluded, "Claims that acupuncture is efficacious as a therapy for these addictions are thus not supported by results from sound clinical research."
- For 'fibromyalgia', a 2006 Rheumatology systematic review reports, "The notion that acupuncture is an effective symptomatic treatment for fibromyalgia is not supported by the results from rigorous clinical trials. On the basis of this evidence, acupuncture cannot be recommended for fibromyalgia."
- For rheumatoid arthritis, a 2008 Rheumatology systematic review states, "RCTs failed to show specific effects of acupuncture for pain control in patients with RA. More rigorous research seems to be warranted."
- For Parkinson's disease, a 2008 Movement Disorders systematic review states, "the evidence for the effectiveness of acupuncture for treating PD is not convincing. The number and quality of trials as well as their total sample size are too low to draw any firm conclusion. Further rigorous trials are warranted."
- For 'irritable bowel syndrome', a 2008 Cochrane review reported, "When randomized controlled trials of acupuncture for irritable bowel syndrome were evaluated, some trials showed no clear evidence in support of acupuncture as an effective treatment for IBS, although other poor quality trials showed beneficial effects of acupuncture. There is no evidence to support the use of acupuncture for the treatment of irritable bowel syndrome. Acupuncture for irritable bowel syndrome needs further investigation."
- For arm pain due to overuse syndrome (a real problem for working class patients), a 2008 Journal of Clinical Pain RCT found a slightly better response to sham acupuncture over the real thing! "Sham acupuncture reduced arm pain more than true acupuncture during treatment, but the difference did not persist after 1 month. Mild side effects from true acupuncture may have blunted any positive treatment effects. Overall, this study did not find evidence to support the effectiveness of true acupuncture in treatment of persistent arm pain due to repetitive use."
- For chronic asthma, a 2009 Cochrane review states, "There is insufficient evidence to make recommendations about the value of acupuncture as a treatment for asthma based on current evidence."
- For high blood pressure, a 2009 American Journal of Hypertension systematic review and meta-analysis found most of the studies to be of poor quality and lacking. The conclusion states, "Considering the limitation of the four positive noninferiority studies and the results of the meta-analysis of the three sham-controlled studies, the notion that acupuncture may lower high BP is inconclusive. More rigorous trials are warranted."
- For insomnia, a 2009 Cochrane review states, "Currently there is a lack of high quality clinical evidence supporting the treatment of people with insomnia using acupuncture. More rigorous studies are needed to assess the efficacy and safety of various forms of acupuncture for treating people with insomnia."
- For depression, a 2010 Cochrane review states, "Thirty trials, and 2812 participants were included in the review and meta-analysis, however there was insufficient evidence that acupuncture can assist with the management of depression."
An acupuncture study was published in September 2013 PLoS that compared 3 groups of patients with depression. Most in all 3 groups were on medication. One group got medication only, the second got counselling and medication, the third was given acupuncture treatments plus medication. The counselling and the acupuncture groups showed similar improvements over the medication alone group after 3 months and then 12 months. Is this surprising?
What does this actually show? It would seem that groups that had frequent interactions with caregivers do better than those with minimal to no interaction. This is not surprising. Acupuncture sessions are intimate and involve interaction between the patient and another individual. The acupuncturist likely talked to the patient while performing the ritual. These meetings happened repeatedly over the course of the study. Additionally, they did not use a sham acupuncture group. Why not? Well done sham studies show no difference between real acupuncture and fake acupuncture in pain studies. Would sham acupuncture appear to work as well as counselling too? What about comparing counselling to massage therapy? At least no needles are involved with massage.
The study’s lead author states, "Although these findings are encouraging, our study does not identify which aspects of acupuncture and counselling are likely to be most beneficial to patients, nor does it provide information about the effectiveness of acupuncture or counselling, compared with usual care, for patients with mild depression.”
The big problem here is that it fuels the belief in vitalistic energy fields, meridians and magical thinking. This unintended consequence already has the acupuncture blogosphere touting the wonders of this magical ritual.
- For allergic rhinitis, a 2013 study in the Annals of Internal Medicine claimed that acupuncture may help the symptoms. The results were of questionable significance and were short-lived. The study did not adequately control for biases and was deconstructed here and also on Medscape: "the CIs surrounding the estimates of improvement included values that were less than predefined thresholds for clinically important differences, so the clinical significance of the findings is uncertain," the authors write.
- For COPD, a 2013 study in Archives of Medicine by Suzuki et al. looked at the effect of acupuncture on COPD (chronic obstructive pulmonary disease). It was a small study in which patients with COPD were randomized to "real" or "placebo" acupuncture. The patients were blinded and the placebo group were given treatments with needles that appeared to penetrate the skin, but really retracted into the handle. The results were positive across a number of parameters. However, the providers were not blinded. They knew when they were trying to deceive the patients. This lack of blinding allows for significantly erroneous results. The study cannot be taken seriously unless a larger, double-blinded study is done. (See the Skeptical Medicine page, "Why Won't You Skeptics Accept My Study?").
So, these reviews find no quality evidence to support acupuncture for the above conditions. One begins to get the idea that finding evidence for any practical application of acupuncture is like finding a needle in a haystack. Maybe, there is no needle in that haystack. Of course, when prior probability is not considered, EBM declares the results to be inconclusive and, in most of the above reviews, calls for more studies.
There are two conditions for which acupuncture is touted as being supported by RCTs. These are short term relief of chronic back pain, and post-operative & chemotherapy induced nausea & vomiting. Let's look at the research for nausea & vomiting first.
A 2006 Autonomic Neuroscience review looked at the available RCTs for acupuncture's effects on induced nausea and vomiting. The report states, "There is good clinical evidence from more than 40 randomized controlled trials that acupuncture has some effect in preventing or attenuating nausea and vomiting." This study is quoted frequently by various Integrative Medicine departments at respected academic medical centers. It is even discussed on the American Cancer Society's website.
Let's look at the 3 categories of nausea and vomiting discussed in this review (sounds like fun, eh?).
The first category is post-operative nausea and vomiting. The 2006 review states, "For postoperative nausea and vomiting, results from 26 trials showed acupuncture-point stimulation was effective for both nausea and vomiting." This sounds pretty good.
However, a few months earlier, a 2006 Journal of Clinical Epidemiology did a systematic review of the acupuncture literature for post-operative nausea and vomiting. This review looked at the problem of publication bias in the world of acupuncture and found that about 33% of studies regarding post-op nausea (with negative results) were unpublished. This is a perfect example of the 'file drawer problem' in which negative studies tend to be discarded as they are not sensational enough to sell journals. The report states, "If around 33% of studies have been unpublished, the RR of nausea (0.92, 95% CI: 0.80 to 1.06, P=.25) is no longer significant. For vomiting, however, there is no strong evidence of publication bias. The number of unpublished studies required to substantially overturn the above significant result is implausibly large."
So, when publication bias was accounted for, acupuncture's effect on post-op nausea vanished. It did not find the same for vomiting. So, perhaps there is a morsel of positive evidence for post-op vomiting but not nausea.
Next, the 2006 review reported on chemotherapy nausea and vomiting. It states, "For chemotherapy-induced nausea and vomiting, results of 11 trials differed according to modality with acupressure appearing effective for first-day nausea, electroacupuncture appearing effective for first-day vomiting, and noninvasive electrostimulation appearing no more effective than placebo for any outcome."
The odd part here is that none of the benefits reported here come from acupuncture as it is commonly thought of. Fist-day nausea is improved with 'acupressure', which is admittedly a different procedure involving the physical touch of a caring human being. Again, this is not acupuncture. 'Electroacupuncture' may have had an effect on first-day vomiting. Applying an electrical current to needles under the skin may or may not have significant effect on post-op vomiting. While intriguing, it also is not acupuncture. To advertise it as such is disingenuous.
The 2011 Cochrane review looked at these findings and the results are not impressive. "Electroacupuncture reduced first-day vomiting, but manual acupuncture did not. Acupressure reduced first-day nausea, but was not effective on later days. Acupressure showed no benefit for vomiting. Electrical stimulation on the skin showed no benefit. All trials also gave anti-vomiting drugs, but the drugs used in the electroacupuncture trials were not the most modern drugs, so it is not known if electroacupuncture adds anything to modern drugs. Trials of electroacupuncture with modern drugs are needed."
** There is no significant evidence that acupuncture is beneficial for post-operative or chemotherapy induced nausea and vomiting. There just isn't.
Now, what about back pain? It is a common claim among departments of Integrative Medicine that acupuncture helps with back pain.
2005 Annals of Internal Medicine meta-analysis looked at the issue. It reported on 33 RCTs of acupuncture for low back pain. The studies varied in methodology. The study stated, "Acupuncture effectively relieves chronic low back pain. No evidence suggests that acupuncture is more effective than other active therapies." More specifically, for chronic back pain, it stated, "For the primary outcome of short-term relief of chronic pain, the meta-analyses showed that acupuncture is significantly more effective than sham treatment ...and no additional treatment." Also, "For patients with acute low back pain, data are sparse and inconclusive. Data are also insufficient for drawing conclusions about acupuncture's short-term effectiveness compared with most other therapies."
So, for short term management of chronic (but not acute) low back pain, acupuncture might make a difference. Again, the pretest probability for an active intervention such as acupuncture is not zero, so perhaps it should be studied further.
Two major RCTs were then done with good methodology, null (negative) results and bizarre conclusions by the authors. Remember, the purpose of setting up control groups ahead of time is to isolate any real effect of the treatment from all of the other variables. If the treatment effect is not better than the predetermined control, then we are dealing with the placebo effect. In science, this means that it does not work. We need to keep this in mind.
The 2006 Archives of Internal Medicine RCT looked at the role of acupuncture on chronic low back pain. Patients were randomized to 3 groups. The first received real acupuncture at designated acupuncture points on the meridians. The second received superficial needling at random, non-acupuncture points, and the third group was given nothing. The results showed that the 'nothing' group fared the worst. The other two groups did the same. There were no significant difference in back pain between the acupuncture group and the control group in the short run or in the long run. Skeptical doctors would conclude that the acupuncture was no better than the null effect. However, the authors concluded that not only did the acupuncture work, but so did the fake acupuncture!
The authors' conclusion is contrary to what one would expect given the nature of the study design. At best we can say that acupuncture points and meridians do not matter (and that they likely do not exist). At worst, we can say that acupuncture does not work for chronic back pain.
Similarly, a 2009 Archives of Internal Medicine RCT, chronic back pain patients were randomized to get real acupuncture, superficial needling at random points, or a third group which received the superficial twirling of a toothpick without breaking the skin. All patients were adequately blinded. The results were similar to the 2006 study. The groups who thought they were getting acupuncture all fared the same as the group that actually got the acupuncture. Even twirling toothpicks at random locations seemed to produce the same results. Clearly, acupuncture for chronic back pain dose not do better than the placebo methods. Therefore, we should conclude that it doesn't work.
However, as with the 2006 Archives RCT, the authors strangely felt that it was inconclusive. "Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture's purported mechanisms of action. It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects." It is as though the authors tried to spin the conclusion to make it seem that acupuncture may still have some hope at being a scientifically valid treatment for chronic low back pain.
In September, 2012, news agencies were abuzz with reporting on a meta-analysis published in the Archives of Medicine entitled Acupuncture for Chronic Pain, Individual Patient Data Meta-analysis. In this analysis, the authors compared various studies that looked at patients with a wide array of chronic pain. They selected studies that used traditional acupuncture compared to sham acupuncture and also compared to "usual care" (no "real" or "sham" acupuncture). The study was funded by NCCAM and the Samueli Institute, two organizations with a highly vested interest in alternative medicine. They found that pain was reported as significantly improved in patients receiving acupuncture compared to "usual care". The effects were as high as a 50% reduction on a 100 point pain scale. However, when compared to sham acupuncture, the effect was only a 5 point reduction. From this data, the authors conclude:
"Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture." (underline added)
That is a very generous conclusion. A 5 point difference between "real" and "sham" acupuncture may reach a degree of clinical significance on paper, but the clinical difference is unimpressive. Another major problem, as David Gorski pointed out, is that none of the studies were double-blinded. Therefore, none of the studies meet criteria for good scientific methodology. The patients were blinded, but the examiners were not. The 5 point difference in pain between the 2 groups may be easily accounted for by this fact (see the Clever Hans Effect).
The Guardian reported on this study and included the comments of Dr. Edzard Ernst:
Edzard Ernst, emeritus professor of complementary medicine at the University of Exeter, said the study "impressively and clearly" showed that the effects of acupuncture were mostly due to placebo. "The differences between the results obtained with real and sham acupuncture are small and not clinically relevant. Crucially, they are probably due to residual bias in these studies. Several investigations have shown that the verbal or non-verbal communication between the patient and the therapist is more important than the actual needling. If such factors would be accounted for, the effect of acupuncture on chronic pain might disappear completely."
In 2013, a meta-analysis in the American Journal of Chinese Medicine looked at the trials of acupuncture for back pain. The authors were as charitable as they could be to try to rescue acupuncture, but really could not distinguish it from the placebo effect:
"Compared with no treatment, acupuncture achieved better outcomes in terms of pain relief, disability recovery and better quality of life, but these effects were not observed when compared to sham acupuncture. Acupuncture achieved better outcomes when compared with other treatments. No publication bias was detected. Acupuncture is an effective treatment for chronic low back pain, but this effect is likely to be produced by the nonspecific effects of manipulation."
And as we have seen above, if we consider only the studies with the best controls and the best blinding, the effect does disappear completely. Meta-analyses of doubtful claims can only contaminate good data with bad. Garbage in, garbage out.
Looking at all of these results with proper scientific methodology can only lead to one conclusion:
** Acupuncture does not work for chronic pain beyond the placebo effect. Nor does it have evidence of efficacy for post-op nausea, chemotherapy induced nausea and vomiting, fibromyalgia, rheumatoid arthritis, Parkinson's, irritable bowel syndrome, asthma, overuse syndrome, hypertension, insomnia, depression or any other condition for which proper RCTs and reviews have been done.
Acupuncture has been found to be relatively safe in experienced hands. It is still an invasive procedure involving putting foreign bodies into the skin. Direct harm has been done by way of direct side-effects (puncturing the lung for example), but these complications are rare. Moral harm can be done by promoting placebo treatments, which, as we discussed in The Placebo Effect section, constitutes lying to patients. We decided that this is never morally correct.
As with all of the pseudoscience systems we discuss, the real harm comes about when patients and providers decide to forgo proven medical treatments for serious conditions in favor of the pseudoscience. Fortunately, most of the Integrative Medicine departments of major academic centers have stressed that patients still should follow their doctor's advice. However, there are many examples of supporters of pseudoscience on the internet and in the public eye have not. This list serves as an important lesson.
As stated above, acupuncture's origin is that of a healing ritual within a belief system. As such, it is not science any more that the rituals of other belief systems. For those in the belief system, it is not science. When acupuncture is transplanted from the belief system into the arena of scientific medicine, it becomes pseudoscience.
As with homeopathy, studies have shown very clearly that it is not the actual implantation of needles that makes people feel better, despite the unwarranted scientific sounding rationalizations offered. People feel better because of the attention, the care, the relaxing atmosphere, the trust in the provider, the exotic nature of the 'treatment', the personal validation, the belief in the treatment and all of the other details that come with the package.
Given this understanding, it seems reasonable that we could harness some or most of this benefit for our patients without telling them that implausible, placebo-equivalent treatments are really beneficial.
Practitioners thrive on the personal anecdotes of happy patients. Thus, they practice 'experience based medicine' rather than 'evidence based medicine' (and certainly not 'science based medicine'). For them, no amount of scientific evidence can change their mind. They have taken the blue pill and cannot see the Matrix for what it really is.
John Byrne, MD
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