Steven Salzberg, a friend of this blog and Director of the Center for Bioinformatics and Computational Biology at the University of Maryland, is on the editorial boards of three of the many journals published by BioMed Central (BMC), an important source of open-access, peer-reviewed biomedical reports. He is disturbed by the presence of two other journals under the BMC umbrella: Chinese Medicine and BMC Complementary and Alternative Medicine. A couple of days ago, on his Forbes science blog, Dr. Salzberg explained why. Here are some excerpts:

The Chinese Medicine journal promotes, according to its own mission statement, studies of “acupuncture, Tui-na, Qi-qong, Tai Chi Quan, energy research,” and other nonsense. Tui na, for example, supposedly “affects the flow of energy by holding and pressing the body at acupressure points.”

Right. What is this doing in a scientific journal?… I support BMC…But their corporate leaders seem to care more about expanding their stable than about maintaining the integrity of science. Chinese Medicine simply does not belong in the company of respectable scientific journals.

Forming a scientific journal whose goal is to validate antiquated, unproven superstitions is simply not science, whatever the editors of Chinese Medicine claim.

BMC should be embarrassed to be publishing journals that promote anti-scientific theories and otherwise muddy the literature. By supporting these journals, they undermine the credibility of many excellent BMC journals. They should cut these journals loose.

Matthew Cockerill, a molecular biologist and self-described skeptic who is Managing Director of BMC, responded. Quoting Tim Minchin’s poem Storm (“You know what they call alternative medicine that’s been proved to work?…Medicine”), he wrote:

Well-known examples of “alternative medicines” that have made the transition to “medicine” include aspirin (explicitly cited in ‘Storm’) and artemisinin, a compound identified in a type of traditional Chinese herbal medicine, derivatives of which are now used to treat malaria.

Clearly for this transition to be possible, there must be a way for effective aspects of Complementary/Alternative Medicine (CAM) to prove themselves and to become “Medicine”. Journals focused on evaluating CAM are not the only approach to doing this (such research might also be published in a regular medical journal), but they are one valid approach…

… Regular medical journals may tend to be dismissive of anything with CAM-associations…

In a second comment (which at the time of this writing is unavailable, but Dr. Salzberg sent me a copy) Dr. Cockerill continued:

Steven,

In your post you suggest that journals relating to complementary/alternative medicine (CAM) including Traditional Chinese Medicine have no place in BioMed Central’s portfolio, and your broader implication is that these fields represent nothing but pseudoscience and are unworthy of (or indeed are incompatible with) scientific investigation.

BioMed Central does not share this view. We accept that this is a challenging and controversial area, and that one of the problems to be addressed is that much CAM research is lacking in scientific rigor. However, to dismiss all aspects of CAM out-of-hand and to exclude research on CAM from scientific discourse would only give ammunition to those who try to characterize the scientific process as being close-minded and based on presumptions which are not open to question.

You refer to BMC Complementary and Alternative Medicine as a “pseudoscience journal” which “promote[s] anti-scientific theories”, but this is really not the case.

Dr. Cockerill argued that standards of peer-review and methodological rigor for that journal are not different from those for the rest of the BMC group. He named Edzard Ernst as a member of the editorial board. More:

Moving to the field of Traditional Chinese Medicine – while it is true that there are some aspects of TCM as traditionally practiced that are likely to hold only anthropological/psychological interest from a scientific point of view, it is also clear that there are many active ingredients in traditional Chinese Herbal Medicine (CHM) which are worthy of further investigation in terms of biological mechanism and clinical effectiveness. This is an area that has attracted significant funding from commercial and public sources – see for example this article from Science magazine in 2003. http://www.sciencemag.org/content/299/5604/188.long

Looking at articles published in the journal Chinese Medicine, the evaluation of active components within herbal remedies accounts for a large fraction of research articles published, and this cannot easily be dismissed as either irrelevant or inherently pseudoscientific.

In an earlier email to Steven Salzberg, Dr. Cockerill had written:

The major problem I have with such a blanket dismissal is that it lumps everything together as being equally valueless, whereas the goal of the scientific process is to winnow the wheat (however rare) from the chaff…

If you look at articles published in Chinese Medicine, you will find little if anything on “Energy fields” (not a fruitful area for scientific investigation, I quite agree, and not something which I believe should be in the scope of the journal), but a great deal on biochemical and functional genomic work in relation to traditional herbal medicine, which is quite a different matter.

Bait and Switch: the Yin and the Yang

Sigh. Where to begin? Let’s start by trying a slight revision of Dr. Cockerill’s own words: The major problem I have with such a blanket acceptance is that it lumps everything together as being equally valuable, whereas the goal of the scientific process is to winnow the wheat (however rare) from the chaff…

That’s more like it. I imagine that Dr. Cockerill will find that statement unfair, in that it fails to acknowledge that there may be reports in the two journals that disconfirm hypotheses that are not fruitful for scientific investigation (if you catch my drift). I concede that, but the point here is a different one: Dr. Salzberg objects to including anti-scientific topics in the journals precisely because doing so gives the appearance that real scientists believe that they must be intriguing enough to warrant space in real biomedical journals.

But they are not: it is clear, after a moment’s reflection, that natural products research is the ONLY worthwhile scientific endeavor within the editorial purview of Chinese Medicine, so why pretend that it justifies the rest? Matthew Cockerill may agree that “energy fields” should not be included; nevertheless they are—which was Dr. Salzberg’s point. Tim Minchin, bless his heart, probably doesn’t realize that his statement about “alternative medicine that’s been proved to work” is itself purely hypothetical: there has yet to be an example of such a medicine. Dr. Cockerill ought to know that, as I will explain a bit later in this piece.

An Article Brings Homeopathy to Mind

I have little time to investigate the non-[natural products pharmacology] articles in Chinese Medicine; Dr. Salzberg cited one, which he characterized as “a laughably bad study.” I’ll tell you a bit about another, just published in January:

Misdiagnosis and undiagnosis due to pattern similarity in Chinese medicine: a stochastic simulation study using pattern differentiation algorithm

The article is nearly incoherent. Passages such as this abound:

In Chinese medicine, diagnosis is also important. Practitioners recognise and label nosological conditions based on inspection (Ip, wang), auscultation and olfaction (AO, wen), inquiry (Iq, wen) and palpation (P, qie), also known as the Four Examinations (Sizhen). According to traditional literature, these methods should be applied in order to enhance recovery of the patients. Manifestations (ie signs and symptoms) collected from patients are interpreted using Chinese medicine theories (eg eight principles, five phases, vital substances, six channels, four levels, triple burner and Zangfu), which were developed on the basis of some observations of Nature. Similar to Western medicine, the collected manifestations are interpreted collectively; however, diagnosis is established through a pattern differentiation process whereby a unique, stable manifestation profile is obtained for the identification of a pattern among other diagnostic hypotheses.

The article appears to torture statistics to show that each additional Examination among the Four confers a slightly greater degree of certainty that the examiner will not confuse two different “diagnoses” (in the TCM sense of the term). At least I think that’s the point. But the investigator didn’t determine this by testing actual practitioners, as far as I can tell; he did it using “a stochastic computational simulation based on Monte Carlo method implemented for patient simulation from ZFSP in a dataset.” And a good thing, too, because if there’s anything useful to be gleaned from this paper, it’s found in references 19-24. They show, unsurprisingly, that there isn’t much agreement from one TCM practitioner to the next about either “diagnoses” or treatments.

Hmmm. No surprise when you consider what those diagnoses, i.e., patterns, involve. Here is the pattern of “Deficient Cold of Small Intestine…often discussed as Deficient Spleen Qi,” according to Ted Kaptchuk, an American who seems to have invented the “OMD” degree that won him a professorship at the Harvard Medical School, and who is on the editorial board of Chinese Medicine:

Signs: slight, persistent discomfort in lower abdomen; gurgling noises in abdomen; watery stools.

Tongue: pale material; thin white moss

Pulse: empty

Here is the pattern of “Deficient Cold in Stomach…often called Deficient Spleen Yang”:

Signs: chronic diarrhea; slight persistent pain in epigastrium; discomfort relieved by warmth, eating, and touching; shy; easily influenced by others

Tongue: pale material; most white moss

Pulse: deep or moderate without strength

And so on, for hundreds of patterns. According to Kaptchuk, “pulse examination can be the most important of the Four Examinations and is crucial to pattern discernment in general.” Paul Unschuld, a prolific historian of Chinese medicine, explains how this is done:

The physician has the choice of either feeling the (radial) pulse with three fingers or with one finger. Using three fingers, light pressure with the index finger above the imaginary line level with the styloid process allows him to feel the state of the lung and heart, greater pressure with the middle finger on the imaginary line enables him to feel the state of the spleen, and greater pressure still with the ring finger allows him to feel the liver and kidney. According to a third (and certainly not the last) variant, he can, with one finger, apply a pressure equal to the weight of three beans to feel the lung, a pressure of six beans to feel the heart, a pressure of nine beans to feel the spleen, a pressure of twelve beans to feel the liver, and finally a pressure that brings the fingertip almost to the bone, to feel the kidney.

What does “correct” pattern recognition mean, in the practical sense? Well, it means that the correct therapeutic intervention will occur. Kaptchuk again:

The goal of all treatment methods in Chinese medicine is to rebalance those aspects of the body’s Yin and Yang whose harmonious proportion and movement have become disordered…inappropriate anger such as that characterized by excessive Liver activity must be calmed…insufficient activity, say of the Kidney Yang, must be tonified to avoid lack of sexual energy…If there is not enough Qi in the Lungs, it must be replenished…If the Qi in the Spleen descends, causing chronic diarrhea, it must be lifted; if the Qi of the stomach ascends, it causing nausea, it must be sent down. Stagnant Qi must be moved…Too much Cold in the Kidney must be warmed; extra Fire in the Lungs must be cooled. Whatever is out of balance must be rebalanced. The complementary aspects of Yin and Yang must be harmonious.

Here’s how it’s done:

…the insertion of very fine needles into points along the Meridians can rebalance bodily disharmonies. A related technique [is] moxibustion…The action of the needles or of moxibustion affects the Qi and Blood in the Meridians, thus affecting all the fundamental textures and Organs. The needles can reduce what is excessive, increase what is deficient, warm what is cold, cool what is hot, circulate what is stagnant, move what is congealed, stabilize what is reckless, raise what is falling, and lower what is rising.

OK, enough already. Is it not obvious that this is the classic assortment of metaphors, myths, traditions, and appeals to authority that is common to the medicine of pre-scientific cultures? Were Chinese medicine theories developed on the basis of some observations of Nature? I don’t think so.

The claims regarding pulse examination are quite fanciful, to say the least: that changing the pressure of the examining finger would allow the practitioner to feel the state of the various, named organs is hard to conceive, given what is now known about anatomy and physiology; it’s also clear that pre-modern Chinese physicians would have had no way test this claim. There is a smattering of empirically gathered symptoms and signs that are based on history taking and external examinations, some of which are repeatable and might have eventually become useful, if pre-modern Chinese medicine had pursued anatomy, physiology, and pathology before those fields were developed elsewhere—thus making that aspect of “TCM” moot.

Funny: the “patterns” remind me of another conspicuous pre-scientific “school” of medicine: homeopathy, with its elaborate ‘symptom’-gathering scheme, its voluminous repertories, rubrics, and simillima. And, of course, its lack of agreement from one homeopath to the next regarding the ‘correct’ constellation of ‘symptoms’ and therefore the correct ‘remedy.’

Pharmacognosy is neither “CAM” nor “Chinese Medicine”

Dr. Cockerill’s other points are a mixture of reason and misunderstanding. Legitimate natural products research is not “CAM,” and should neither be billed as such (or as some other misnomer such as “Chinese Medicine”) nor should it be purported to justify “CAM,” which, if anything, hinders such research. Aspirin is not an example of an “alternative medicine that made the transition to medicine” any more than quinine or atropine or digoxin are such examples. Nor is artemisinin. Everyone with a modicum of education knows that many useful drugs have been, and will continue to be, derived from natural sources, exactly as biology would predict. This is completely unsurprising. The term “alternative medicine,” along with its various synonyms, refers to a recent political and quasi-religious movement, not to a longstanding branch of drug development that is scientific and that has not required the help of pseudoscientific zealots to pursue its investigations.

If Chinese Medicine were limited to pharmacognosy and had a more appropriate title—Asian Pharmacognosy, for example, referring to the geographic origin of the products studied, not to some pre-scientific medical ‘system’—I’d have little problem with it, assuming that the natural products reports are as rigorous as Cockerill claims them to be.

“Chinese Medicine” is a misnomer in several ways. First, the medicine overwhelmingly used in China today is modern, scientific medicine. Second, pre-scientific Chinese Medicine was not one or even a few schools of medicine but many disparate schools, occurring at various times over millennia and in various places over a huge geographical region. Some schools were completely unrelated or even contradictory. There was much influence from abroad, including India and Greece. Third, the term “Traditional Chinese Medicine” was coined only about 55 years ago in the PRC, mainly for pitching to (gullible) Westerners. It heralded something that, paradoxically, had never before been true in China: a forced standardization, such as to make ‘Chinese Medicine’ appear to be something that it was not: a conceptual whole.

Last Thoughts

I’m running out of gas, but another straw man used by the “CAM” movement, repeated by Matthew Cockerill, is that “Regular medical journals may tend to be dismissive of anything with CAM-associations.” There was a time in the 1990s when editors of the major journals had to answer this charge on a regular basis, and each time it went something like this:

Dr. Siegel’s charge that medical journals will not publish studies of alternative medicine comes out of thin air. Journals compete avidly to publish important new clinical research, if it is rigorously done. As we indicated in our editorial, the problem with the studies funded by the Office of Alternative Medicine in 1993 was not their size, as suggested by Dr. Cherkin and Ms. Street, but their quality.

In fact, major medical journals have, to their own embarrassment and to the detriment of uninformed readers, bent over backward to accommodate substandard “CAM” treatises.

“CAM” advocacy journals, moreover, have become far more evident in the past few years, thanks in part to political pressure applied by anti-intellectual demagogues such as Dan Burton—even as the only journal committed to an appropriate, skeptical view of “CAM” was excluded from listing by the US National Library of Medicine after similar political pressure.

Perhaps someone else will look at some of the articles in BMC Complementary and Alternative Medicine. I have neither the time nor the inclination, but I would like to reiterate a point that Steven Salzberg and we have all made at one time or another: even the subsequent publication of a reasonable scientific report doesn’t justify creating a journal for the purpose of “helping aspects of CAM prove themselves.” If there’s scientific promise for some new way to solve a problem, and if a legitimate study is done, there are plenty of opportunities to report it in the medical literature.

Could a vitamin with proven benefits in one group cause harm to another? That’s the growing concern with folic acid, the vitamin that dramatically reduces the risk of neural tube birth defects such a spina bifida. Studies designed to explore the possible benefits of folic acid for heart disease, stroke and cancer are giving out some worrying signs: At best, folic acid is ineffective, and at worst it may be increasing the risks of some cancers. So what does this say about routine supplementation for the typical healthy individual, and its overall risk and benefit?

Folate (vitamin B9) is an essential nutrient found green, leafy vegetables, broccoli, peas, corn, oranges, grains, cereals, and meats. Folate has important roles in the synthesis of DNA, and consequently cell division. Significant folate deficiency can lead to macrocytic anemia. Folic acid, a synthetic form of folate, is used in multivitamins supplements because it is better absorbed.

Folic acid’s benefits in pregnancy are well documented. Supplementation before conception, and in the first few weeks of pregnancy, significantly and substantially lower the risk of several different birth defects, including neural tube defects (NTDs). The neural tube is the embryonic precursor to the brain and spinal column. NTDs include very serious defects like spinal bifida and anencephaly, birth without part of the brain.

The stakes are high, and because the neural tube forms so early in pregnancy (day 26 to 28), deficiencies must be corrected before a woman knows she is pregnant. This has led to public health strategies that mandate supplementation in food products: In both the United States and Canada, folic acid has been added to white flour since the late 1990’s, where it finds its way into baked goods like bread. Following food fortification, neural tube defects have subsequently dropped.

In addition to food fortification, women that could become pregnant are generally advised to take a multivitamin containing at least 0.4mg of folic acid daily. Women at high risk of NTDs may be advised to take higher doses. But as higher doses of folic acid can mask the symptoms of Vitamin B12 deficiency, higher doses warrant medical advice and supervision.

Even with fortification, it’s clear there are still opportunities to improve folic acid consumption in pregnancy. A Canadian population study showed that 20% of women of childbearing age failed to have appropriate folic acid levels in their blood. And while virtually no-one was dangerously deficient, over 40% had levels that would be considered high.

Beyond pregnancy

Observational trials have correlated a diet rich in fruits and vegetables with a lower risk of diseases like colorectal cancer. Based on this epidemiologic evidence, several randomized controlled trials were initiated investigating the effect of the B vitamins (including folic acid) on cancer risk. Folic acid held particular promise because of its proven effects preventing neural tube birth defects.

But the effects were not as expected.

The Warning Signals

That folic acid may interfere with cancer has been known since the 1940’s. The chemotherapy drug methotrexate is an antifolate agent that blocks the metabolism of folic acid, developed after it was noted that a diet deficient in folic acid helped patients with leukemia.

Studies of folic acid supplementation are raising flags about the potential risks of therapy, possibly as a result of excessive consumption. One of the most startling was a study that looked at folic acid supplementation in patients with colorectal adenomas, which are cancer precursors. Participants were randomized to folic acid 1mg or placebo for up to six years. While it was hypothesized that folic acid would provide a protective effect, the results were disappointing. Not only did folic acid have no effect on adenoma incidence (even in those with low folate status),  there was a significant increase in the risk of non-colorectal cancers (10.5% vs. 6.3%), due mainly to an excess of prostate cancers.

Futher worrying evidence emerged in 2009, when a Norwegian study of heart failure patients was published. Researchers randomized almost 7000 patients to folic acid and vitamin B12 versus other vitamins or placebo. The vitamins significantly raised the risks of both cancer and all-cause mortality, driven mainly by more cases of lung cancer. On balance, looking at heart disease, folic acid supplementation don’t seem to have any persuasive effects, either. In combination with other B-vitamins to lower homocysteine levels it hasn’t been shown to have meaningful effects on cardiovascular disease prevention, either.

The same worrying cancer signal has appeared with breast cancer in postmenopausal women, even while dietary folate seems to be beneficial. And in studies looking at prostate cancer, when folic acid is combined with other vitamins, the data are unclear.

So could fortification be causing harm? While correlations have been drawn between food fortification and population studies of colorectal cancer, causality hasn’t been established. Screening rates or other factors could be contributing. Still, the idea is troubling, even though the harms (if real) are slight compared to the demonstrable and significant benefits fortification has played  in reducing NTDs.

Conclusion

In women of childbearing age, folic acid supplementation has a demonstrable and meaningful benefit, reducing the incidence of NTDs. Its use in this population is evidence-based and demonstrably effective. And for treatments for conditions like end-stage kidney disease, folic acid may be of benefit. But when we look at the use of folic acid for primary prevention, the data are less clear. In children, men, and women beyond their childbearing years, supplementation in the absence of deficiency has no demonstrated health benefits, and there are worrying signals that it may raise cancer risks, possibly by “feeding” existing cancers.

Is fortification of our food supply harming and hurting? The benefits on NTD incidence have been demonstrated, while the harms haven’t been proven yet. Still, folic acid’s evolving story may become a cautionary tale about the consequences of fortification and supplementation with the hope of improved health outcomes. If we’re not in our childbearing years, we may be better off relying only on food sources for folate. So pass the spinach, and hold the multivitamins with folic acid.

The scientific approach to understanding the world includes the process of carefully separating out variables and effects. Experiments, in fact, are designed specifically to control for variables. This can be especially challenging in medicine, since the body is a complex and variable system and there are always numerous factors at play. We often characterize the many variables that can influence the outcome in a clinical study as “placebo effects” or “non-specific effect” – things other than a specific response to the treatment in question.

A common error to make when interpreting clinical studies is to confuse non-specific effects – those that result from the therapeutic interaction or the process of observation – with a specific effect from the treatment being studied. While this is broadly understood within the scientific medical community, it seems that within certain fields proponents are going out of their way to sell non-specific effects as if they were specific effects of the favored treatment.

This is perhaps most true for acupuncture. As has been discussed numerous times on SBM, the consensus of the best clinical studies on acupuncture show that there is no specific effect of sticking needles into acupuncture points. Choosing random points works just as well, as does poking the skin with toothpicks rather than penetrating the skin with a needle to elicit the alleged “de qi”.

The most parsimonious interpretation of the evidence is that the needles (i.e. acupuncture itself) are superfluous – any perceived benefit comes from the therapeutic interaction. This has been directly studied, and the evidence suggests that the way to maximize the subjective effects from the ritual of acupuncture is to enhance the interaction with the practitioner, and has nothing to do with the acupuncture itself. Acupuncture is a clear example of selling a specific procedure based entirely on non-specific effects from the therapeutic interaction – a good bedside manner and some hopeful encouragement.

This phenomenon is by no means limited to acupuncture. Perhaps another example is Eye Movement Desensitization and Reprocessing (EMDR), a practice that is increasingly popular among psychiatrists.

The concept of EMDR – how it is supposed to work – sounds pseudoscientific to this neurologist. According to the EMDR Institute:

During treatment various procedures and protocols are used to address the entire clinical picture. One of the procedural elements is “dual stimulation” using either bilateral eye movements, tones or taps. During the reprocessing phases the client attends momentarily to past memories, present triggers, or anticipated future experiences while simultaneously focusing on a set of external stimulus. During that time, clients generally experience the emergence of insight, changes in memories, or new associations.

The external stimulus – whether moving the eyes or tapping on the client or playing certain tones – is supposed to help the brain reprocess memories and information, and is alleged to be useful for a wide range of psychiatric symptoms. The proposed mechanism sounds highly dubious. While the brain certainly has plasticity, the ability to change its wiring through use, it is hard to imagine how such a simple procedure could have a significant effect on this plasticity. There are many who suspect that the eye movement component to EMDR therapy may be the equivalent to the needle component of acupuncture.

In psychotherapy there are many sources of non-specific effects that would need to be carefully controlled for before the effects of any specific component can be determined. The interaction with the therapist, the time taken to focus on ones problems and symptoms, and the introduction of a novel element into the therapeutic relationship are all recognized factors. In addition, EMDR (not surprisingly) has evolved into a multifaceted treatment approach, that includes many standard elements of therapy. This always reminds me of the commercials who proudly advertise that their products are “part of this nutritious breakfast.” Yes, but are they an important part – or is the breakfast nutritious without it?

A 2002 review of EMDR in general concluded:

Current component analyses of EMDR have failed to effectively evaluate the relative weighting of its procedures.

And a more recent 2006 review of EMDR compared to cognitive-behavioral therapy for post traumatic stress disorder (PTSD) concluded:

Our results suggest that in the treatment of PTSD, both therapy methods tend to be equally efficacious. We suggest that future research should not restrict its focus to the efficacy, effectiveness and efficiency of these therapy methods but should also attempt to establish which trauma patients are more likely to benefit from one method or the other. What remains unclear is the contribution of the eye movement component in EMDR to treatment outcome.

The last line is most significant – what contribution, if any, does the actual EMDR have? The research has not clearly established that the eye movements are having a specific neurological or psychological effect. Perhaps it’s just all the other components of the therapy that is having the perceived effect. And yet EMDR has been widely accepted as a treatment modality. This acceptance seems premature.

It also seems that this is another failure of the evidence-based medicine (EBM) approach – EMDR  is being hailed as an evidence-based practice. There are indeed studies that show that EMDR therapy works. But a science-based approach would consider more deeply the question of plausibility and mechanism, and from this question whether or not EMDR has indeed been established as having specific efficacy.

Conclusion

EMDR, like acupuncture, is likely nothing more than a ritual that elicits non-specific therapeutic effects.  While there are some who may consider this a justification for both modalities, there is significant risk to this approach. First, the non-specific effects are often used to justify alleged specific mechanisms of action which are likely not true. This sends scientific thought and research off on a wild-goose chase, looking for effects that do not exist. Science is a cumulative process built on consilience – scientific knowledge must all hang together. These false leads are a wrench in the mechanics of science.

Second, the false specificity of these treatments is a massive clinical distraction. Time and effort are wasted clinically in studying, perfecting, and using these methods, rather than focusing on the components of the interaction that actually work.

And in the end these magical elements do not add efficacy. For example, as the review above indicates, EMDR is no more effective than standard cognitive-behavioral therapy.

Rather than getting distracted by alluring rituals and elaborate pseudoscientific explanations for how they work, we should focus on maximizing the non-specific elements of the therapeutic interaction, and adding that to physiological or psychological interventions that have specific efficacy.

Believers in acupuncture claim it is supported by plenty of published scientific evidence. Critics disagree. Thousands of acupuncture studies have been done over the last several decades, with conflicting results. Even systematic reviews have disagreed with each other. The time had come to re-visit the entire body of acupuncture research and try to make sense out of it all. The indefatigable CAM researcher Edzard Ernst stepped up to the plate. He and his colleagues in Korea and Exeter did an exhaustive study that was published in the April 2011 issue of the medical journal Pain:   “Acupuncture: Does it alleviate pain and are there serious risks? A review of reviews.” It is accompanied by an editorial commentary written by yours truly: “Acupuncture’s claims punctured: Not proven effective for pain, not harmless.” (The editorial is reproduced in full below.)

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.

I was delighted when the editor of Pain asked me to write a commentary to accompany the article. It gave me a soapbox in a major medical journal to say all the things I thought needed to be said about acupuncture.

My commentary was edited, but it was a very different experience from the kind of editing I experienced with O,The Oprah Magazine. It was a pleasant collaborative process aimed only at improving the clarity of the writing and strengthening the impact of what I wanted to say.

The journal thought our articles were important enough to warrant a press release. Both Ernst’s article and my commentary immediately got some attention in the media: Science Daily, Medical News Today, e! Science News, and the American Council on Science and Health all reported on them.

Believers in acupuncture will not be pleased. I expect a hostile response and am wondering if Ernst and I should invest in needle-proof vests.

Here is the entire text of my commentary. Thank you to the publishers of Pain, the IASP and Elsevier, for their permission to reproduce it here.

Acupuncture’s claims punctured: Not proven
effective for pain, not harmless

Commentary from Hall H. Acupuncture’s claims punctured: Not proven effective for pain, not harmless. PAIN 2011 Apr; 152(4): 711-712

© 2011 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved. This article has been reproduced on ScienceBasedMedicine.org with permission of the International Association for the Study of Pain® (IASP®). The commentary may not be reproduced for any other purpose without permission. Permission to alter the article is not permitted. Permission to translate the article is not granted.

In this issue of Pain Ernst et al. [1], systematically reviewed a decade’s worth of systematic reviews of acupuncture. 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. Ernst et al.’s analysis cannot prove that acupuncture does not work (negatives are hard to prove) but their study unquestionably sheds serious doubt on the claim that it does work. Overall the evidence is inconsistent, and among those studies judged to be of the highest quality, the results tend to be negative.

Acupuncture is based on pre-scientific concepts of a vitalistic entity (qi) and of meridians and acupuncture points unknown to anatomists. More scientific explanations have been offered as to how it might work, including a counterirritant effect or the gate control theory of pain. There is evidence that acupuncture can stimulate endogenous endorphin production, but there is evidence that placebo pills can do that as well. Importantly, when a treatment is truly effective, studies tend to produce more convincing results as time passes and the weight of evidence accumulates. When a treatment is extensively studied for decades and the evidence continues to be inconsistent, it becomes more and more likely that the treatment is not truly effective. This appears to be the case for acupuncture. In fact, taken as a whole, the published (and scientifically rigorous) evidence leads to the conclusion that acupuncture is no more effective than placebo.

Acupuncture research is inherently riddled with pitfalls. What constitutes an adequate control? People can usually tell whether or not you are sticking needles in them. Various controls have been devised, such as comparing ‘‘true’’ acupuncture points to ‘‘false’’ ones. The best control so far is an ingenious retractable needle similar to a stage dagger, where the needle just touches the skin and retracts into a sheath. Unfortunately, there is no way to blind the practitioner, so double blind studies are impossible.

The practice of acupuncture is also not sufficiently standardized, which makes it difficult, if not impossible to pin down reliably for objective study: there are various schools of acupuncture with different acupoints, and studies of acupuncture have included ‘‘electroacupuncture’’ (with or without needles), ear acupuncture, cupping, moxibustion, and other loosely related procedures. In their book, The Biology of Acupuncture, Ulett and Han [3] showed that transcutaneous electrical stimulation at a single arbitrary point on the wrist was just as effective as piercing the skin at traditional acupuncture points.

In more than one recent study, researchers have chosen not to use a sham acupuncture control group. Their reasoning? Since sham acupuncture has been shown to work as well as real acupuncture, then sham acupuncture must be an effective treatment too! Imagine applying this reasoning to a drug trial: if the drug and placebo got the same results, would you decide that the drug worked and that the placebo was just as therapeutic as the drug?

It does not make any difference where you put the needles or whether you use needles at all. Touching the skin with toothpicks works just as well. The crucial factor seems to be whether patients believe they are getting true acupuncture. It is becoming increasingly clear that the surrounding ritual, the beliefs of patient and practitioner, and the nonspecific effects of treatment are likely responsible for any reported benefits.

Is there really any need for more studies? Ernst et al. point out that the positive studies conclude that acupuncture relieves pain in some conditions but not in other very similar conditions. What would you think if a new pain pill was shown to relieve musculoskeletal pain in the arms but not in the legs? The most parsimonious explanation is that the positive studies are false positives. In his seminal article on why most published research findings are false, Ioannidis points out that when a popular but ineffective treatment is studied, false positive results are common for multiple reasons, including bias and low prior probability [2]. More studies are not the answer. No matter how many studies showed negative results, they would not persuade true believers to give up their beliefs. There will always be ‘‘one more study’’ to try, but there should be a common-sense point at which researchers can agree to stop and divert research time and funds to areas more likely to produce useful results.

Of course, advocates of acupuncture have argued that it is worthwhile even if it only produces a placebo response; and that it is harmless, so it does not hurt to try it. Ernst et al. however, have shown that acupuncture is not harmless. While many of the reported adverse effects could be avoided by proper training in sterile precautions and anatomy, they correctly point out that even one avoidable adverse event is too many. With any treatment, we have to consider the risk/benefit ratio. If there is no benefit, any risk is too much. And there are other harms that they did not mention: time and money wasted, effective treatment delayed, unscientific thinking encouraged.

Placebos are unethical: our patients trust us not to prescribe them. With the current state of the evidence, I do not think we should be recommending acupuncture to our patients. On the other hand, if patients ask about it and want to try it, we should not try to stop them. We have a responsibility to educate them, but not to make decisions for them. We can tell them that although some patients believe it has helped them, the evidence does not show that it works any better than placebo, and there is a small risk of infection and other complications. With this information, they can then make their own informed decision.

In summary, Ernst et al. have shown that the evidence for efficacy of acupuncture for the treatment of pain is questionable, to say the least, and of particular concern is that its use can be dangerous. If the 57 systematic reviews they surveyed had been for a prescription drug and a similar list of serious adverse effects had been reported for that drug, we would hesitate to prescribe that drug. Is there any reason not to hold acupuncture to the same standards?

Conflict of interest statement

I have no conflicts of interest to report.

References

1. Ernst E, Lee MS, Choi TY. Acupuncture: Does it alleviate pain and are there serious risks? A review of reviews. Pain 2011;152:755–64.
2. Ioannidis JP. Why most published research findings are false: author’s reply to Goodman and Greenland. PLoS Med 2007;4:e215.
3. Ulett GA, Han SP. The biology of acupuncture. St. Louis, USA: Warren H. Green Inc.; 2002. 160p.

EDITOR’S NOTE Today is a big grant deadline for me; at 5 PM EDT, the grant is due. As a consequence of working on my grant application into the wee hours of the morning last night, I didn’t have a chance to write my usual bit of logorrhea of the sort that I’ve laid down each and practically every Monday for the last three-plus years. Fortunately, retired chiropractor turned skeptic of chiropractic Sam Homola was ready to fill in admirably just for this week. Although I might throw up a post later this week, worst case scenario, I’ll be back here, same time, same day, same Bat Channel. In the meantime, take it away, Sam!

As a chiropractor, I am often asked why the image of chiropractic is so bad. “Why is chiropractic so often ignored by the media and ridiculed by physicians?” Journalists and health professionals tend to judge chiropractic by the worst of what they see, and what they see is often bad. This March 15, 2011, post from a chiropractic group asking for money to provide chiropractic services for earthquake and tsunami victims in Japan is a good example of why chiropractic has a bad image:

Please consider donating whatever you can to the SOTO-I/PAAC [Sacro Occipital Teaching Organization International-Pacific Asian Association of Chiropractic] Japan Relief Fund. 100% of your donation will go directly to helping the needy Japanese people through SOT Chiropractic treatments and services.

Please consider this avenue of donation rather than the Red Cross etc. While they are worthy organizations, we have ZERO overhead to administration and the funds will provide CHIROPRACTIC services to the needy. Please recommend this avenue of aid to your patients and friends also. Any and everything will help!

Practitioners of Sacro Occipital Technic (SOT) and SOT Craniopathy claim to restore innate healing capacity by removing neurological interference and improving the flow of cerebrospinal fluid (“craniosacral respiration”). Vertebral subluxations affecting certain organs are found by palpating tendon insertions at the base of the skull. Craniosacral respiration is improved by adjusting the bones of the skull and the sacroiliac joint.

There are dozens of such nonsensical chiropractic treatment methods foisted on the public through “press releases” and junk-science journals. NUCCA (upper cervical technique), which identifies slight misalignment of the atlas as a major cause of human ailments, is a commonly-promoted technique based on chiropractic vertebral subluxation theory.

This press release further illustrates the reason for chiropractic’s bad image:

A revolutionary neuro relief technique is being used by chiropractors across the United States and Canada to treat a wide-array of Symptoms and Chronic Disorders they were never before able to handle. This technique, when applied correctly performs absolute miracles for patients who have been suffering for an extensive period in their lives. Thus patients are happier and chiropractors are increasing their visibility and incomes!

Online PR News – 12-March-2011

An article titled “Second Opinion: Of Chiropractors & Christians,” published in a Baptist news magazine, describes an “inherently unbelievable” chiropractic message:

My back hurt, so I went to a chiropractor. He is helping my back pain. That’s a good thing.

But that is not what this article is about.

My chiropractor is an evangelist for his particular brand of chiropractic. Literally, he and his staff are religious about it. They preach the word. They offer written materials. They make promises of a greater life. I am unmoved. I just want him to make my back feel better.

I have a better understanding now of how nonbelievers may react to Christian witness. My reactions to the “message” I get at my chiropractor’s office could also be the reactions of someone you know to church, Christianity or the gospel message of Christ:

• These folks are extremely nice, and I appreciate that, but that does not mean I am going to believe what they believe or what they tell me to believe.
• They sincerely believe what they say. I do not doubt that. Their sincerity does not persuade me to change my mind.
• They walk the walk. They cleanse their toxins, go to burst training, take supplements and get regular adjustments. As far as I can tell, they are not hypocrites. But I am not moved.
• They go out of their way to educate me. They offer written information. They invite me to seminars, dinners and meetings. I do not have the excuse that “I don’t understand.”
• These folks care about me. I believe that.

So, why am I not fully sold? Why won’t I buy into the full program instead of just “settling” with having them make my back feel better?

• Their message is inherently unbelievable.
• Their message runs counter to what I know and to what I read and hear everywhere else.
• Their message is too demanding of my time, energies and commitments.

Sound familiar? Those are reasons why people routinely reject our Christian witness…

Published: March 11, 2011 (The Baptist Standard)

Sorting out a Few Good Apples

As illustrated by the above clips, it’s not hard to understand why chiropractic has such a bad image. If the chiropractic profession does not take steps to eliminate the nonsense in chiropractic, it may be difficult for ethical, science-based chiropractors to separate themselves from questionable treatment methods that have been traditionally supported by chiropractic subluxation theory. The practice-centered approach of chiropractors who disseminate misinformation, whether they are true believers or not, hurts the public as well as the profession. It is unlikely that unethical chiropractors will voluntarily give-up a faith-based or money-based approach they are using to make a living. Ethical chiropractors, many of whom are well-meaning but misinformed, struggle while pitch masters thrive. Guardians of public health feel compelled to issue warnings about chiropractic. Science-based chiropractors, as individuals, are forced to distance themselves from misguided colleagues and from purveyors of bogus methods based on the tenets of chiropractic. My heart goes out to those well-meaning chiropractors whose education left them totally dependent upon belief-based self-employment. Few of them have the faculties or the means needed to take a different path.

While it would be painful for chiropractors to point out and renounce obviously worthless diagnostic and treatment methods used by some of their colleagues, it might be prudent for chiropractic associations to do so to establish credibility in the eyes of the public. No other health profession has such a negative image. Good chiropractors are mixed in with bad chiropractors, like a crate of partially spoiled fruit that still contains a few good apples but is often discarded.

The chiropractic profession has to face the reality that chiropractic as a method of treating human ailments by adjusting vertebral subluxations is not acceptable in the scientific community and is unrelated to the generic spinal manipulation now being used by physical therapists and science-based chiropractors. A look at chiropractic journals, advertisements, and office procedures, however, reveals that a large number of chiropractors still cling to Palmer’s subluxation theory, some combining science with pseudoscience. I suspect that chiropractic has survived primarily because its use of manipulation in the treatment of back pain has provided a service not readily available in medical care, that is, symptomatic relief for mechanical-type neck and back pain or a good back-cracking back rub for providing pleasure and relieving tension. I believe the chiropractic profession today would be better off if it renounced the subluxation theory that gave it birth and concentrated on caring for back pain. So far, there is no indication that this will happen any time soon. Until the chiropractic profession does discard the vertebral subluxation theory, it will be difficult for the profession to condemn a multitude of popular, wacky chiropractic techniques based on a theory that defines the profession.

Entrenched Subluxation Theory

When the Council on Chiropractic Education (CCE) proposed new accreditation standards for chiropractic colleges, subject to take effect in January of 2012, all reference to “subluxation” was omitted. (“The CCE does not define or support any specific philosophy regarding the principles and practice of chiropractic, nor do the CCE Standards support or accommodate any specific or political position. The Standards do not establish the scope of chiropractic practice. They specify core educational requirements but do not otherwise limit the educational process, program curricular content, or topics of study.”) The American Chiropractic Association (ACA), the largest association in America representing the chiropractic profession, responded, in part, with this comment regarding the subluxation:

The document removes all references to the term “subluxation” – a core element of the practice of chiropractic that has been integral since the profession’s beginnings over 100 years ago. While the term “subluxation” and its role in the practice of chiropractic is sometimes misunderstood or not fully appreciated by all parties involved in medical related research and the delivery of health care, the term is one which is explicitly recognized in federal law (Section 1861(r) of the Social Security Act) and has been widely recognized by the courts, state legislative bodies and licensing authorities. The elimination of any reference to this term in the proposed standards will be viewed by many within the profession as a counter-productive action that will, in the long-term, likely weaken the profession’s collaborative strength and historic identity. We would propose placing “subluxation theory” back into Section 2, H. Educational Program for the Doctor of Chiropractic Degree and Vertebral Subluxation Complex into Section 3 Initial assessment and diagnosis as a required component.

As a chiropractor and a critic of chiropractic, I often found common ground with other health-care professionals by noting the value of generic spinal manipulation while providing guidelines to separate science-based chiropractors from subluxation-based chiropractors. Failure to point out obvious chiropractic nonsense may simply allow a believing public to assume that all chiropractors are the same, most of whom do not deserve to feed off the positive image projected by a few ethical, science-based chiropractors. Subluxation-based chiropractors peddle dubious services without opposition from their colleagues or from their associations, alienating chiropractic from the scientific community.

When I published my book Bonesetting, Chiropractic and Cultism in 1963, I renounced the vertebral subluxation theory and recommended that chiropractic be developed as a back specialty. It has always been my hope that chiropractic would become a form of physical medicine, a sub-specialty of medicine offering physical treatment methods for mechanical-type neck and back problems. If chiropractic aspires to become an independent, primary non-surgical specialty capable of accepting full responsibility for treating neck and back pain and related problems, it would have to have access to certain prescription medications and all available rehabilitative and physical treatment methods as well as access to hospital facilities, requiring changes in state laws and chiropractic college curriculum. As a back-pain specialty or sub-specialty, the chiropractic profession could be sustained by referrals from other health-care professionals.

Back Specialists?

In 2005, the World Federation of Chiropractic defined chiropractors as “…spinal health care experts in the health care system…with emphasis on the relationship between the spine and the nervous system…” This ambiguous definition fails to place proper limitations on the practice of chiropractic, leaving the door open for subluxation-based chiropractors who use spinal adjustments to treat general health problems. Such chiropractors, with only a hammer in their tool box, cannot qualify as a legitimate “back specialist” or “spine specialist.”

According to the Agency for Healthcare Policy and Research, low-back trouble is the second most common reason for office visits to primary care physicians and the most common reason for office visits to orthopedic surgeons, neurosurgeons, and occupational medicine physicians. Back problems are the most common cause of disability among persons under the age of 45 (Acute Low Back Problems in Adults, 1994). Despite the fact that back pain is one of this nation’s most common ailments, the niche for a back-pain specialty remains unfilled. With changes, chiropractic could have filled this niche (specializing like optometry or chiropody), but instead chose to be defined as a form of alternative medicine with a limited treatment method and an unlimited scope of practice .

Most people think of a chiropractor as a “back doctor.” And most people who go to a chiropractor go for treatment of a neck or back problem. It is certainly ironic that many chiropractors consider it demeaning to be called a “back specialist,” preferring to “treat human ailments without use of drugs and surgery.” Unfortunately, most state laws define chiropractic in this way, resulting in scientific and societal suspicion that hinders change and keeps utilization of chiropractic low.

Today, 48 years after publication of my Bonesetting book, I am still of the opinion that the chiropractic profession is not properly defined and limited. Chiropractic associations continue to tolerate implausible theories that provide an umbrella for inappropriate use of spinal manipulation and a variety of proprietary treatment methods applied to the gamut of human ailments. Many subluxation-based chiropractors seek support in the camp of alternative medicine where they are more readily accepted and where quackery is rampant. They are not representative of chiropractors who follow the guidelines of science in limiting their scope of practice. The uncontested proclamations of chiropractors who make vague and all-inclusive claims continue to drag the profession down, as indicated by figures showing that the percentage of the population seeing chiropractors annually decreased from 9.9% in 1997 to 7.4% in 2002 (Altern Ther Health Med. 2005;11:42-49), despite increasing popularity of alternative medicine.

Scientific presentations will not eliminate a belief system such as homeopathy or subluxation-based chiropractic, nor will the actions of a few science-based chiropractors. It seems likely that there will always be subluxation-based chiropractors. Until the majority of chiropractors make a clean break from what has traditionally been known as chiropractic (adjusting the spine to restore and maintain health), changes for the better in the profession as a whole will be problematic. Chiropractic associations will tend to represent the views of the majority, even if these views are scientifically indefensible. And the definition of chiropractic will continue to be based upon consensus rather than upon science.

Since physical therapy as a sub-specialty of medicine is now incorporating use of science-based manipulation in an armamentarium designed for treatment of neck and back pain and other musculoskeletal problems, it might be too late for the chiropractic profession to establish itself as a preferred back-pain specialty or sub-specialty. Forty-six states now allow direct access to the services of a physical therapist without physician referral. According to the American Physical Therapy Association, physical therapy, by the year 2020, will be provided by physical therapists who are doctors of physical therapy and who may be board-certified specialists.

The Majority Rules

Chiropractors who use manipulation appropriately may be in the minority, making it necessary for them to seek refuge and camaraderie in small groups of like-minded chiropractors who voluntarily follow the guidelines of science in offering patient-centered care. It would certainly be nice if these chiropractors could be separated from the herd with a special degree in a separate camp until they become a majority and the national associations are forced to follow suit.

Until then, I hope that good chiropractors will offer their patients (and the public) tips on how to recognize questionable claims so that good judgment can be exercised in selecting a chiropractor. It may be necessary for chiropractors themselves to openly criticize esoteric techniques used to locate and correct the mysterious, asymptomatic, and undetectable chiropractic vertebral subluxations alleged to be a cause of disease. Scientifically indefensible theories and treatment methods must be labeled as such to discourage use by the public as well as by chiropractors. As the undesirable aspects of chiropractic (e.g., “killer subluxations”) become less acceptable in the eyes of the public, fewer chiropractors will tout such nonsense. When science-based chiropractors are in the majority, if that ever happens, chiropractic associations might then define chiropractic properly and make appropriate changes in state laws.

Finding a Good Chiropractor

Here are the guidelines I offer patients who might want chiropractic treatment for back pain:

• While a good chiropractor can do a good job treating back pain, not all chiropractors are the same; some follow the guidelines of science, some do not.
• Look for a chiropractor who limits his/her practice to care of musculoskeletal problems and who uses hands-on generic spinal manipulation in combination with physical therapy modalities. Such a chiropractor can often be found working in a multi-disciplinary back-pain clinic.
• Avoid chiropractors who propose to locate and adjust “vertebral subluxations” as a treatment for disease or to “restore and maintain health.”
• Avoid chiropractors who ask for payment in advance for a long course of treatment. As a general rule, treatment should be discontinued if symptoms worsen after one week or have not improved after two weeks.
• Avoid chiropractors who routinely x-ray new patients or who do full-spine x-rays on every patient. Remember that simple back strain will usually resolve on its own in a few weeks and does not require an x-ray exam.
• Do not accept the services of a chiropractor who refuses to share his/her records with your family physician or a medical specialist. An orthopedist who has exchanged office notes with chiropractors can often offer guidance in selecting a chiropractor.
• Persons who want manipulative therapy for a back problem but are reluctant to see a chiropractor should ask for a referral to a physiatrist, a physical therapist, or an orthopedic manual therapist who has been trained in the use of spinal manipulation.