Battlefield acupuncture revisited: Only the thinnest of gruel will do

The zombie has arisen once again to eat the brains of the Air Force.

I'm referring to so-called "battlefield acupuncture," a topic that I wrote about last week for this very blog. I didn't think there'd be a reason to revisit the subject again so soon, but I was wrong for three reasons. First, I remain appalled at how one ideologue, Col. (Dr.) Richard Niemtzow, a radiation oncologist and Air Force physician turned woo-meister-in-chief and number one advocate of acupuncture use in the military, has succeeded in introducing acupuncture into not only formerly hard-nosed and science-based military hospitals like Walter Reed Army Medical Center and Landstuhl Regional Medical Center (the latter of which is, by the way, the first stop outside of the Middle East for our wounded soldiers from Iraq and Afghanistan), but has even started to train U.S. Army Rangers in the technique. Before I had heard the update a couple of weeks ago, I had thought the term "battlefield acupuncture" was a misnomer because it wasn't actually being used on the battlefield, but rather for phantom limb pain and other acute and chronic pain conditions in military hospitals. Unfortunately, this latter development shows just how far Col. Niemtzow wishes to go with this "technique." Second, Col. Niemtzow's acupuncture technique isn't even "real" acupuncture. He calls it "auricular acupuncture," and it involves sticking needles a measly 1 mm into the earlobe. (How he accurately measures 1 mm, who knows?) Worse, he justifies this technique through ignorance of anatomy, claiming that "the ear acts as a 'monitor' of signals passing from body sensors to the brain" and that "those signals can be intercepted and manipulated to stop pain or for other purposes." He even made a comment about 18th century pirates wearing a lot of earrings in order to improve their night vision. I kid you not; it's a hunk o' hunk o' burnin' stupid. Third, and finally, Col. Niemtzow has published another one of his "studies" to support the use of acupuncture in chronic pain syndromes among our combat wounded veterans.

Last time around, I referred to an earlier study by Col. Niemtzow published in Military Medicine in 2006. This study was clearly labeled as a "pilot study." Although it was randomized (good), it was small (tolerable for a pilot study); it was unblinded (bad); and there was no placebo or "sham acupuncture" control group (horrible). There were numerous other serious shortcomings, but those are the main ones. In other words, Col. Niemtzow's 2006 study was almost custom-designed to show a "positive" result that could be entirely explained by the placebo effect, and that's exactly what it did. Indeed, even by that low standard, Col. Niemtzow's results were unimpressive. Although the pain scores in the acupuncture group were reported to have decreased by 23% initially compared to the conventional therapy group, which did not decrease measurably, within 24 hours after treatment there was no difference between the two groups. I've referred to this study as very "thin gruel" upon which to base the creation of a military acupuncture program, much less expanding that program into combat and training military physicians and medics being sent to combat zones in Iraq and Afghanistan to do auricular acupuncture. I still say it's thin gruel,.

So what to my wondering eyes should appear this month? No, it wasn't a miniature sleigh and eight tiny reindeer.. Rather it was this new study by Col. Niemtzow, hot off the presses in the December issue of Medical Acupuncture Before I get to that study, let me refer you back to the an excellent observation about the normal manner by which medical evidence accumulates to support a therapy course of acupuncture research discussed by Steve Novella:

Clinical research tends to follow a certain arc: first smaller and preliminary studies are done to see if there is a potential for a new treatment or approach, then larger and more tightly designed studies are done exploring the relevant research questions, and finally large, double-blind, placebo-controlled consensus trials are completed and the basic question of efficacy is settled.

This is, of course, a reasonable way to progress. It doesn't make sense to spend millions of dollars on a double-blind, placebo-controlled prospective randomized trial if there isn't good preliminary evidence that the therapy is likely to be efficacious, and that preliminary evidence comes from smaller, less expensive trials. I'll expand upon what Steve wrote a bit. Often the very first evidence of potential efficacy of a new therapy comes from anecdotes. Yes, believe it or not, anecdotes. However, these anecdotes are not like the "testimonials" so beloved of so-called "complementary and alternative medicine" (CAM) practitioners. Oh, no, not at all. Real anecdotes are carefully documented and contain objective measures, complete with laboratory tests not performed by quack-friendly laboratories that find, for instance, that virtually everyone with a vague complaint is suffering from "heavy metal toxicity." (Does that mean if I listen to too much Metallica or Ted Nugent I'll need to be chelated? Maybe so.) By their very nature, however, anecdotes can never be definitive evidence of efficacy for a therapy. They are useful primarily for hypothesis generation. They suggest questions that require further research, but they can't ever be definitive. There's way too much variability in human biology and the natural history of disease. A perfect example is autism and the antivaccine movement that blames vaccines for autism and espouses all manner of quackery to repair "vaccine injury." Autism is not a condition of devleopmental stasis but rather delay. It can have a hugely varying course from child to child, with periods of rapid development followed by periods of stasis or even some regression. Some children--perhaps as high as 19% of them--even improve enough to lose their diagnosis; i.e., they improve to the point where they no longer meet the diagnostic criteria for an autistic spectrum disorder. Consequently, saying that this or that "biomedical intervention" has "worked" based on testimonials without a control group is meaningless.

Steve also correctly pointed out that in acupuncture the progression did initially trend from anecdotes and small pilot studies to more and more rigorous studies. But then the woo-meisters ran into a problem. It was a big problem. A huge problem. At least, it was a problem for those who wanted scientific credibility for acupuncture; i.e., the types who have infested academic medical centers of late. The problem is, as is usually the case for CAM modalities, the bigger and more rigorously designed the study, the smaller the effect observed until in the biggest and best studies no effect distinguishable from that of a placebo is detectable. So it has been with acupuncture. A normal medical scientist, faced with such results, would abandon the therapy. True, he might persist for a while doing more studies our of a human desire not to want to to believe that his favored modality, into which he has placed so much effort and belief, doesn't work. No one likes to face accumulating negative evidence. However, a scientist worthy of the name will eventually realize that evidence trumps belief and face facts. So what do acupuncturists do?

They go in reverse.

That's right. They go from more rigorous to less rigorous studies. That's exactly what Col. Niemtzow has done with his latest article. First, let's compare it to his previous article from 2006. That study was a randomized trial involving 87 patients culled from the emergency room at the Malcolm Grow Medical Center at Andrews Air Force Base. Right there, that means at least Col. Niemtzow was still trying. He even tried (laughably ineffectively) to blind ER personnel to which patient was in which group by putting small pieces of tape over every study participant's ears. Of course, neither the acupuncturist nor the patient were blinded, which renders this effort pretty close to useless, but, again, at least Col. Niemtzow tried. He almost did science. (Of course, "almost" only counts in horseshoes and hand grenades--and thermonuclear weapons.) Dr. Niemtzow might even be forgiven (somewhat) for this lack back in 2006, as the preferred sham acupuncture needle, with a retractable point that gives a realistic appearance of entering the skin, was not as widely available then. On the other hand, the other form of sham acupuncture, namely inserting needles into the "wrong" points, was easily done. In any case, in 2006 Col. Niemtzow was at least trying to be somewhat objective and to follow somewhat proper clinical trial design.

Since then, apparently, he has given up all pretense of trying to do proper science.

Let's take a look at his study. First off, the very fact that it was published in the woo-friendly Medical Acupuncture should be a tip off that this is not likely to be a good study. Actually, saying that Medical Acupunture is not a good journal is like saying that Hitler was not a nice man. (I know, I know, I risk the invocation of Godwin here.) Indeed, I can't help but speculate that Col. Niemtzow very likely tried to submit this manuscript to real medical journals, got rejected, and ended up "settling" for Medical Acupuncture just to get it published. In fact, agreeing with Steve Novella's complaint about acupuncture studies, it's a step backward. Once again, it was carried out at the Malcolm Grow Medical Center at Andrews Air Force Base. This time, however, there was no attempt to randomize patients. None at all. Nor was there any attempt to control for or standardize the acupuncture therapy used. All manner of acupuncture was used, as described in the Methods section:

The physician first treated all patients with auricular acupuncture. Each treatment was adjusted based on whether the pain was focal, regional, or systemic. If auricular acupuncture was determined to be less than fully successful, the physician then selected another appropriate modality: dry needling, French Energetics, 18 microcurrent, electroacupuncture (CraigPens), electro-auriculotherapy, or piezo-electric stimulation. Administration of either auricular, traditional, or electroacupuncture was adjusted based on assessment of the patient's response to treatment. The physician made adjustments until the subject experienced complete or near complete pain relief (0-1 on the NRS), at which point that treatment ended. The physician sometimes elected to use several modalities in 1 therapy session.

This is a mess. Basically, it's a huge uncontrolled gmish of methods with no rhyme or reason. Of course, one also can't help but wonder on what scientific basis acupuncturists chose different treatments based on whether the pain was focal, regional, or systemic. Worse, it's a single arm uncontrolled observational study, which is one step above an anecdote--barely. Because the article is behind a password-protected wall and is also not in PubMed yet, I feel justified in reproducing the abstract in full:

Background: Acupuncture may play a significant role in the management of acute and chronic pain. A United States Air Force (USAF) acupuncture clinic managed pain for active duty members, dependents, and retirees. The majority of these patients had unsuccessful control of their pain when employing conventional medications and therapies.

Objective: To study the benefits of acupuncture to control acute and chronic pain in active duty military members, dependents, and retirees who were not successfully palliated with conventional Western care. Design, Setting, and Subjects: Measurements of pain were made on adult male (n=58) and female (n=60) patients ranging in age from 21 to 85 at Malcolm Grow Medical Center (MGMC), Andrews Air Force Base, Maryland, USA, from October 2003 to September 2005.

Intervention: Various acupuncture modalities were employed on patients with pain: acupuncture, electroacupuncture, auriculotherapy, and electroauriculotherapy. The choice of the acupuncture modality and the actual points used were based on the decision of the treating physicians, who were also trained medical acupuncturists.

Main Outcome Measures: We delineated anatomic areas of most frequent pain, pain scales before, during, and after therapy, pre- and post-treatment quality of life, and post-treatment patient satisfaction.

Results: Patients had significant improvement in pain control and a highly significant improvement in their scores on standardized Quality of Life scores at the end of the 4-week study.

Conclusions: Acupuncture appears to be helpful as adjunctive therapy for controlling acute and chronic pain in patients for whom standard care is not wholly effective. Possibly as a result of this intervention, patients demonstrated a highly significant improvement in both the mental (P < .01) and physical (P < .001) subscales of the SF-8 quality of life measure, 4 weeks following the first acupuncture treatment.

To boil it down, basically Col. Niemtzow took 118 patients, subjected them to a grab bag of different acupuncture modalities, including one (electroacupuncture) that's not really acupuncture at all but a real modality used by pain management specialists in a different form based on actual neuroanatomy, not the fantasy anatomy of "meridians" favored by acupuncturists. Worse, as I mentioned before, he did not even bother to break down the numbers of patients who received each modality. Here's why that's important. How many received "electroacupuncture," which could function like transcutaneous electrical nerve stimulation, TENS for short? Worse still, he did not even attempt to control for the usage of other pain medications. Patients could start and stop pain medications as they wished and take anything they wished. Col. Nietmtzow acknowledges this problem, but waves it away:

One limitation of the study was that the usage of pain medication was not controlled or effectively tracked. Subjects could start and stop taking various pain medications at their own discretion and thus, their medication use may have confounded the results. In addition, patients often did not accurately recall medication names, dosages, or usage. This limitation should be considered in the context of the fact that the acupuncture clinic only treated patients referred by their primary care physician. In most cases, these referrals were made because the standard care (often involving pain medication) was not effective. Hence, for many of these subjects, medication was ineffective or unsatisfactory. If so, the reduction in pain scores can more credibly be attributed to the acupuncture treatments, rather than to concurrent use of pain medication.

Actually, the modest 2 to 2.5 point reduction in pain scores (based on a scale of 10) and the modest improvement in quality of life scores could be more credibly attributed to the placebo effect. Indeed, in patients for whom other treatments appear not to have worked, it's more likely that this "treatment effect" was in actuality no greater than what would be expected due to placebo. Indeed, this study is completely consistent with acupuncture as practiced at MGMC being nothing more than a placebo. Again, without a proper prospective randomized clinical trial with a placebo acupuncture control, Col. Niemtzow cannot validly conclude that acupuncture (or "auricular acupuncture") is anything more than an elaborate placebo. There's another aspect to this tale, too, and that is the question of whether doing such studies in a military setting, in which the patients are soldiers trained to follow orders working in a hierarchical culture where it is expected that orders from higher-ranking soldiers will be followed, either enhances the placebo effect or makes soldiers less willing to report no relief to a superior officer. After all, if you're a PFC and a colonel comes in and tells you that acupuncture's going to make your pain all better, it's not at all implausible that it might enhance the placebo effect and it's even more plausible that the PFC might be reluctant to admit it if there was no pain relief. I will have to look into the literature to see if there is any research that might answer these questions for me.

Of course, it's clear to me that Col. Niemtzow is a True Believer. His titles of woo include

• Chief Medical Consultant for Alternative Medicine for the Air Force Surgeon General
• Editor-in-Chief of Medical Acupunture
• Executive Editor of the Journal of Alternative and Complementary Medicine (this is the same journal that published homeopathy "research" by people like Lionel Milgrom.
• Chairman of the American Association of Medical Acupuncture Research Committee
• President of the Medical Acupuncture Research Foundation

But the pièce de résistance that proves beyond a shadow of a doubt that Col. Niemtzow is a total and complete woo-meister comes in the form of a series of a editorials written for Medical Acupuncture. One such editorial was entitled Acupuncture: Spirits And Healers:

Partly influencing my belief that healers could not be real was my Western medical school education. The human body was just one large chemical factory with trillions of chemical reactions that were taking place in tempo to the laws of thermodynamics, and keeping us alive. I contemplated that a medical cure for our most dreadful diseases was a process that required restoring the biochemical machinery that went astray.

I was not taught about the spirit in medical school. I only learned of its existence from my parents and religion. "Spirit" seemed something very vague, and a time I heard it mentioned was when my grandparents died; there was talk of a spirit that was still present, but I never saw or heard anything. During the majority of my life, I never encountered a spirit or a healer. Nor did it seem to make much difference.

Yes, it's all there, the usual crap that woo-meisters love to lay on scientific medicine, including the characterization of "Western medical education" as reductionist and lacking spirit. But Col. Niemtzow goes even further than that:

I find it fascinating that our ancestors knew of acupuncture points that dealt with a spirit pathway, spirit court, spirit hall, spirit ruins, spirit storehouse, spirit support, spirit gate, spirit tower, spirit path, spirit court, etc.1(425-426) I am unsure what these spiritual sanctuaries do or how to incorporate them into my practice, but the fact that they exist is in itself very exciting.

What about healers? Is there a relationship with the spirit? Are we as physicians actually promoting healing, and are we really the intermediary of the healing event? I do believe there is a strong relationship between healing and spirit. Both are "alive," and both are driving forces that occupy biochemical events all the way down into quantum mechanics. It surfaces in a smile, or in the sparkle of an eye, or a tone of voice that says "all is well." It is reflective in the intense will to live that many of our patients show.

I have found that the healer does indeed exist, and it is nearby and in all of us who practice the healing arts. We are the intermediary that causes healing to take place. We bring about the process. Spirit and healer are the centers of the circle; both defy Newtonian physics, and both beckon to us when our intent is true and deliberate. Healing and spirit are like the Yin and Yang. One cannot exist without the other.

Lest you think that this bit about spirit "defying Newtonian physics" (I'm surprised Col. Niemtzow managed to restrain himself from invoking quantum theory as "non-Newtonian physics" and an explanation for how "spirit" works) is a fluke, check out the followup editorial entitled Acupuncture and Wizards:

In Volume 13/Number 3 of Medical Acupuncture, my editorial addressed the role of Spirits and Healers and how they related to my own beliefs and practice of acupuncture. I stated then that healers could not be real and spirits were not part of the Western medical educational experience. In time, I realized that in the practice of acupuncture, the concept of "spirit" played a vital role in patients' clinical outcome, and that Qi is the driving force behind the "spirit." Now I ask, what about wizards?

He answers:

Acupuncture is not "magic," but a definite science that may even eclipse Newtonian physics. Some of us recognize this. Yet on the other hand, as we begin to talk about energies and spirits that are so important in our art, this notion may conjure up the slightest sense of magic. We become "wizards" when we place our needles into the symbolic points of our belief, and direct the flow of energy through the channels known to our ancestors.

After all, it is our patient's desire to become cured. Are we wizards or healers or a little of both? Modern medical science may not have room for this kind of thinking. After all, as I alluded in my previous editorial, we are like a chemical factory. Many of us can see even deeper than the molecular structures of the atoms that make up the chemicals in our bodies and thus, as acupuncture became ingrained in our souls, we acquired some of the wizard and healer qualities.

Acupuncture may "eclipse Newtonian physics"? Argggh! Of course, lots of things these days have eclipsed Newtonian physics, including the theory of relativity and quantum theory. One wonders about Col. Niemtzow's fixation on Newtonian physics. Don't get me wrong; Newtonian physics is still highly useful given that we spend our existence in frames of reference travelling very much less than the speed of light. Because the ratio of any velocity we might be expected to achieve is always very much less than the speed of light, relativistic effects can usually be approximated as zero, and Newtonian physics provides a perfectly effective tool to use for the necessary calculations for satellites, sending people to the moon, predicting the course of missiles, and even sending probes into the farthest reaches of the solar system and beyond. Unfortunately, the clear implication of Col. Niemtzow's nonsense is that the woo about "spirit" and qi necessary for acupuncture will supplant older physics.

Be that as it may, I would submit to you that this sort of language has no place in a medical scientific journal. Of course, Medical Acupuncture is not a medical scientific journal, and is related to a medical scientific journal solely by coincidence. I would also submit to you that a physician who not only bases his belief in an implausbile medical modality that is based, in essence, on pre-scientific magical thinking invoking "spirit" and being "wizards."

I've said it before, and it seems appropriate to conclude by emphasizing it again. Our soldiers, many grievously wounded in combat, deserve only the best science-based therapy available. We as a nation sent them into battle, and we as a nation are obligated to do our best to make them as whole as we can. Doing so does not involve treating them with magic. They also deserve compassion and as much of the "human touch" as our military medical can provide for them. They do not deserve magical thinking based on pre-scientific superstition and magical thinking that came about because at the time healers simply did not know enough about how the human body functions and, more importantly, how that functioning can go wrong, to be able to do much about most diseases and conditions. Worse, because acupuncture is supposedly "Eastern" and "ancient" (although how "Eastern" or "ancient" is very much a topic for dispute), its invocation of qi and the lack of evidence for meridians are given a pass. If I were to propose treating our injured soldiers with bloodletting and toxic metals (both common methods in the 1700s and early 1800s) based on the concept that it would put the "imbalance of the four humors" back into balance, the Pentagon and the military medical establishment would toss me out on my ear as a dangerous quack--and rightly so. But introduce a method that claims "ancient Chinese wisdom" based on somehow magically redirecting the flow of a mysterious "life energy" by sticking small needles into parts of the body that correspond to no known anatomic structures through which "qi" flows, and suddenly the Air Force is funding a program to train medics and physicians treating our wounded soldiers how to do this method based on the same amount of convincing scientific evidence that qi exists as for the four humors (none) and in the face of no strong clinical evidence that it's any better than a placebo.

What's wrong with this picture? And is that all Col. Niemtzow's got?