Dec 22 2008
It’s like the zombie that wouldn’t die, isn’t it?
I’m referring to so-called “battlefield acupuncture,” a topic that I wrote about last week for this very blog. With a week separating my usual posts, I normally don’t write about the same topic two times right in a row, but I’m making an exception for this topic. There are three reasons. First, I remain appalled at how one ideologue, Col. (Dr.) Richard Niemtzow, a radiation oncologist and Air Force physician turned number one advocate of acupuncture use in the military, has succeeded in introducing acupuncture into not only military hospitals like Walter Reed Army Medical Center and Landstuhl Regional Medical Center (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. While before I 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 chronic pain conditions, 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 mere 1 mm into the earlobe. 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. 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 multiple other serious shortcomings, but those are the main ones. In other words, Col. Niemtzow’s 2006 study was 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 standard, its 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 “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 about this new study by Col. Niemtzow, hot off the presses in the latest issue of Medical Acupuncture?
Before I get to that study, let me refer you back to the words of our fearless leader Steve Novella when it comes to the normal manner in which medical evidence accumulates to support a therapy:
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 manner in which to progress. It doesn’t make sense to spend the millions of dollars a double-blind, placebo-controlled prospective randomized trial can cost 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, anecdotes. However, these anecdotes are not like the “testimonials” so beloved of so-called “complementary and alternative medicine” (CAM) practitioners. Oh, no. real anecdotes are carefully documented and contain objective measures, complete with laboratory tests not performed by quack-friendly laboratories where all too often it is found, for instance, that virtually everyone with a vague complaint is suffering from “heavy metal toxicity.” By their very nature, however, anecdotes are not definitive evidence of anything. They are only hypothesis generating, suggesting questions that require further research. They can’t be definitive. There’s way too much variability in human biology and the natural history of disease. A perfect example is autism, which is not a condition of devleopmental stasis but rather delay. Moreover, 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 noted that in acupuncture, the progression did initially trend from anecdotes and small pilot studies to more and more rigorous studies. 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, as we’ve documented on SBM. A normal medical scientist, faced with such results, would abandon the therapy. Oh, he or she might persist for a while doing more studies, not wanting to believe the accumulating negative evidence, but sooner or later science will persuade a scientist. What do acupuncturists do?
They go in reverse.
That’s right. They start doing 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, as I mentioned, 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 (utterly 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 pointless, but, again, at least Col. Niemtzow tried. He might even be forgiven 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.
Not so in 2008, unfortunately.
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, and it’s not. Indeed, I can’t help but think that Col. Niemtzow probably tried to submit this manuscript to other journals and ended up “settling” for Medical Acupuncture. 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. 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.
Of course, one 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. Because the article is behind a password-protected wall and is also not in PubMed yet, I’ll reproduce 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, he did not even bother to break down the numbers of patients who received each modality. 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, and 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 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
More disturbingly, his lectures have included topics like:
- Niemtzow RC. Lecture: The Role of Acupuncture in Breast Cancer: Medicine or Magic? Department of Defense, Breast Conference. San Diego, California. Sept 1998.
- Niemtzow RC. Lecture: The Role of Acupuncture in Breast Cancer: Medicine or Magic? Breast Cancer Survival Day, Naval Medical Center. San Diego, California, Sep 1998.
- Niemtzow RC. Guest Speaker: Acupuncture and Cancer. Breast Cancer Clinic, Naval Medical Center. San Diego, California, Oct 1998.
But his piece de resistance comes in an editorial written for Medical Acupuncture 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?
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.
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, grievously wounded in combat, deserve only the best science-based therapy available. They also deserve compassion and as much of hte “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, as Harriet explained so well), 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?
Sadly, it is.
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