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Needles in the skin cause changes in the brain, but acupuncture still doesn’t work

ResearchBlogging.orgI don’t recall if I’ve mentioned it on SBM before, but I went to the University of Michigan. In fact, I didn’t go there just for undergraduate studies or medical school, but rather for both, graduating with a B.S. in Chemistry with Honors in 1984 and from medical school in 1988. In my eight years in Ann Arbor, I came to love the place, and I still have an affinity for it, even though it’s been over 20 years since I last walked about the campus as a student, although I have been back from time to time for various functions, most recently to see Brian Deer speak last winter. True, I’m not fanatical about it, as some of my contemporaries and friends who attened U. of M. with me back in the 1980s (and, sadly, the string of losses to Ohio State and the definitively mediocre last season Michigan had last year make it very hard to be a Michigan football fan these days). However, I do have considerable affection for the place. It molded me, trained me in science, taught me medicine, and provided me the basis for everything I do professionally today.

I mention all of this because I’ve become very disappointed with the University of Michigan Medical School of late. The reason is that it’s “distinguished itself” as a leading institution teaching and promoting the mish-mash of sometimes mutually contradictory modalities, the vast majority of which are either based on mysticism or pseudoscience, known commonly as either “complementary and alternative medicine” (CAM) or “integrative medicine” (IM). The University of Michigan Integrative Medicine Program (UMIM) describes itself thusly:

University of Michigan Integrative Medicine, an interdisciplinary program, is committed to the thoughtful and compassionate integration of complementary therapies and conventional medicine through the activities of research, education, clinical services and community partnerships. As a healing-oriented approach to medical care, integrative medicine takes into account the whole person (body, mind, spirit and emotion), including all aspects of lifestyle.

The vision, mission and values of the University of Michigan Integrative Medicine (UMIM) program reflect our belief that patients and our community are best served when all available therapies are considered in concert with an approach that recognizes the intrinsic wholeness of each individual. It also reflects our belief that the best medicine is practiced in collaboration with a wide variety of healthcare professionals and with our patients.

Alas, my alma mater could well be featured in Kim’s old feature, the Weekly Waluation of the Weasel Words of Woo (W5). Indeed, look at the medical student curriculum supported by this program:

Supported by a five-year grant from the National Institutes of Health (NIH), University of Michigan Integrative Medicine (UMIM) piloted its first Complementary and Alternative Medicine (CAM) courses for medical students during the Fall Term of 2000. A unique aspect of the CAM course sequence is that it is longitudinal, extending across the entire four-year U-M Medical School curriculum.

To date, implementation of the curriculum has involved the participation of approximately 600 undergraduate medical students and 200 physicians/practitioners. Instruction has touched upon the following five CAM domains as identified by the National Center for Complementary and Alternative Medicine (NCCAM):

  • Alternative medical systems
  • Mind-body interventions
  • Biologically based therapies
  • Manipulative and body-based methods
  • Energy therapies

Energy therapies? As you can see my alma mater, my beloved U. of M., appears to have wholeheartedly embraced what Dr. Robert Donnell has referred to as “quackademic medicine.” Indeed, it now has a fellowship in IM that is described thusly:

Fellows design elective experiences in integrative medicine using resources found within the university health care system. Topics may include (but are not limited to): Aromatherapy, Health System Management, Herbal Therapies, Holistic Nutrition, Integrative Pharmacy, Manipulative Therapies, Mind-Body Medicine, and Naturopathic Medicine. Fellows also participate in weekly formal learning activities through U-M Integrative Medicine and the Department of Family Medicine.

Financial support is provided to achieve competency in one defined core curricular area.

[...]

Graduates of this program will model best practices in integrative health care by embracing healing-oriented medicine that takes into account the whole person (body, mind and spirit), including all aspects of lifestyle. This philosophy emphasizes therapeutic relationships and recognizes use of all appropriate therapies, both conventional and alternative.

W5 indeed. Notice how no mention is made of science or the scientific basis of any of these therapies. To read the educational objectives is to see just how little science matters in IM.

All of this is yet another in the series of my characteristically self-indulgently logorrheic introductions to an analysis of a study. It turns out that U. of M. is trying to do something resembling science about CAM. The problem is that, like many investigators and universities do, it’s falling for the same problems and fallacies when true believers try to do what Harriet Hall has so delightfully termed “Tooth Fairy science.” I never thought I’d be saying it, but it looks as though my alma mater is doing a bit of the ol’ Tooth Fairy science. Several readers sent me this study, and, since it came from U. of M., I figured it falls upon me, among the SBM bloggers, to take it on. Let us start with how I found out about this study, a credulous article published last week and entitled Acupuncture boosts effects of painkillers, natural or prescription:

High-tech images of the brains of chronic pain sufferers have found that the ancient practice of acupuncture fights pain by making key brain cells more sensitive to the pain-dampening effects of opioid chemicals. The study, published online in the August issue of the journal NeuroImage, comes less than a year after the publication of a controversial study that concluded acupuncture was no more effective than sham treatment at reducing pain.

Researchers at the University of Michigan’s Chronic Pain and Fatigue Research Center used a positron emission tomography (PET) scanner to view the brains of 20 women diagnosed with fibromyalgia who reported suffering nerve and muscle pain at least 50% of the time. The PET scans were conducted during each woman’s first acupuncture session and, a month later, her eighth.

In the regions of the brain that process and dampen pain signals — the amygdala, caudate, cingula, thalamus and insula — the PET scans showed an increase in the receptivity — and possibly the number — of brain cells to which opioid substances bind. Study author Richard E. Harris said that suggests that acupuncture appears to make the body more responsive to opioid painkillers.

It turns out that Dr. Harris is not only a molecular biologist but a licensed acupuncturist, which goes to show just how much people can compartmentalize science and belief, walling them off from each other. There are, not unexpectedly, methodological problems with this article that render its conclusions questionable, but in reality it’s more a problem of interpretation. There’s a famous line from The Princess Bride, where the character Inigo Montoya says of a word, “I do not think it means what you think it means.” In the case of this study, I would paraphrase that famous line to say, “I do not think your results mean what you think they mean.” Here’s why.

Harris acknowledges up front that several studies have now shown acupuncture to be no more efficacious than sham acupuncture. Indeed, we have written about such studies right here on SBM that show that acupuncture is no more effective than sham acupuncture. It doesn’t matter if the sham acupuncture is needles inserted in the “wrong” acupuncture points or fake needles that do not penetrate the skin or even toothpicks. The most reasonable scientific conclusion from all of these studies is that acupuncture, as practiced by adherents of traditional Chinese medicine, does not work. At the very best, it’s a nonspecific effect that doesn’t rely on anything resembling a system. More likely, acupuncture is nothing more than an elaborate placebo. None of this, however, stops Harris’ group from trying to show that there is a different between sham acupuncture and real acupuncture at some sort of level, and this study is their attempt to do just that. Here is the background as Harris states it in the introduction to his study, entitled Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on μ-opioid receptors (MORs):

Recent controversy in the field of acupuncture research was generated when several large scale randomized controlled trials in chronic pain patients failed to show superiority of acupuncture over sham acupuncture methods (Brinkhaus et al., 2006; Linde et al., 2005; Melchart et al., 2005; Harris et al., 2005). This has lead opponents of acupuncture therapy to suggest that it is no more effective than a placebo intervention. Since placebo administration also induces activation of opioid receptors, specifically the μ-opioid receptor (MOR) class (Benedetti and Amanzio, 1997; Zubieta et al., 2005; Amanzio and Benedetti, 1999; Levine et al., 1978; Pomeranz and Chiu, 1976), acupuncture may indeed operate in part via placebo mechanisms.

There’s almost certainly no “may” about it, and you can also almost certainly safely scratch “in part,” but that’s just me being a nasty skeptic or, as I like to think, a good scientist. I also find it curious why Harris would refer to investigators who are telling it like it is, so to speak, and pointing out accurately what these studies show “opponents” of acupuncture. It suggests a bit of an adversarial, defensive, “I’ll show you” mindset right from the start.

Be that as it may, the hypothesis to be studied is that long term acupuncture therapy somehow results in increased μ-opioid receptor availability and that this effect would not be seen in a sham acupuncture group. Harris chose fibromyalgia (FM) patients for his study because previous work of his had shown that FM patients have reduced central μ-opioid receptor (MOR) binding potential. In that study patients with greater clinical pain were found to have reduced MOR binding potential, and Dr. Harris wondered if acupuncture could somehow increase that binding potential and thus relieve pain. Thus, this study is the classic example of a researcher taking a technique developed for the study of one question and applying it to another question, and what Harris asks is whether acupuncture and sham acupuncture have different (or any) effects on these receptors. Specifically, the technique used is positron emission tomography (PET) designed to look at the binding of opioids to these receptors using 11C-carfentanil (CFN) positron emission tomography (PET) with the μ-opioid selective radiotracer [11C]carfentanil.

The study involved randomizing 20 women with FM into one of two groups, either sham acupuncture or “real” acupuncture. Subjects were blinded to which group they were in, but investigators were not, and a questionnaire was given to see if patients could guess what group they were in. The results in each group were no more accurate than random chance, suggesting that patient blinding, at least, was good. It was not clear to me, however, from the text whether those who were evaluating the PET scans were also blinded to which experimental group each patient was in. That is such a mind-numbingly obviously necessary part of designing any imaging experiment such as this that I will assume that the physicians reading the scans were in fact blinded to what experimental group each scan came from, but it’s disturbing that this very basic experimental design point wasn’t explicitly stated anywhere. Also, it’s clear that the investigators doing the acupuncture or sham acupuncture were not blinded. There are now retractable sham needles available that do a pretty good job of hiding from even acupuncturists whether a real needle went in or not; I wonder why those weren’t used.

In any case, there were no significant differences between the groups with respect to demographics or initial pain scores, and patients were excluded who: had previous experience with acupuncture; had current use or a history of use of opioid or narcotic analgesics; had a history of substance abuse; had the presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture; had the presence of concurrent autoimmune or inflammatory disease; had concurrent participation in other therapeutic trials; were pregnant and nursing mothers; had severe psychiatric illnesses; or had contraindications to PET. Outcome measures included clinical pain scores using the Short Form of the McGill Pain Questionnaire and measures of μ-opioid binding.

As in many other studies of acupuncture versus sham acupuncture, non-insertional sham needles were used for the sham acupuncture procedure. Patients underwent a total of nine acupuncture or sham acupuncture treatments over the course of a month, undergoing PET scans at treatment #1 and tretament #9. At each of the two PET sessions, study participants first underwent a baseline scan for minutes 10-40 after infusion of the radiotracer, then the acupuncture or sham procedure, then another scan at 45-90 minutes. The researchers reported both short term increases in μ-opioid binding in various parts of the brain involved in sensory processing, including the cingulate, amygdala, insula, thalamus, and caudate. Longer term increases in MOR binding were also observed in a subset of the same structures, including the cingulate, caudate, and amygdala. There were no such increases in the sham acupuncture group, and in some regions small reductions of MOR binding were observed. Consistent with the other acupuncture studies that Harris mentioned, there was no difference in pain scores between the sham and “true” acupuncture groups.

Well, at least that much is consistent with previous results.

Here’s one big problem with this study. Needles were retained for the acupuncture group, but there were no needles in the sham acupuncture group because no needles had been inserted. It’s not clear to me from the methods whether the sham needles were left attached to the skin or not. Even if the subject were blindfolded, as these subjects were, I would think that would be very important in order to make the groups as much “alike” as possible. Whatever the true case was, the fact remains that, during the second PET scan period there was a definite difference between the two groups. The “true acupuncture” group had needles sticking into their skin at acupuncture points. The sham acupuncture group did not. Couldn’t that more or less completely explain the short term results? In essence, what Harris studied was differences in neurobiology between subjects who had needles sticking out of their skin and those who did not.

Here’s the second big problem. Take a look at this figure, which is Figure 1B from the paper:

Figure 1B

Notice something? The “true acupuncture” (left side, in red) procedure is not only different from the sham in that the sham doesn’t actually insert any needles. It uses different locations! The text calls them “similar” because they are in the same body part. Not how, for example, sham point #1 is on the head, but not in the same location as Du 20); sham point #2 is on the ear but on the earlobe instead of the pinna; sham point #3 is on the anterior surface of the right arm instead of the posterior surface of the left arm; most of the sham points in the leg are on the thigh, rather than the lower leg, where the “true” acupuncture points are.

Does anyone see a problem with this?

I do. In designing a good placebo control for an acupuncture study (or any other randomized clinical study), you shouldn’t, if you can possibly help it, mix and match changes in the procedure to produce your sham procedure. When you choose a sham acupuncture procedure, either insert the needles as usual in the “wrong” places or use the sham needles that don’t pierce the skin in the “right” places. Or have two groups and compare both. Don’t place sham needles that don’t pierce the skin in the “wrong” places. That’s two differences between the sham procedure and acupuncture and opens the door to a lot of confounders. Again, couldn’t this using a sham procedure that uses the “wrong” points and needles that don’t pierce the skin also partially explain the results of this study? Couldn’t the combination of using different locations and no insertion for the sham confound the results sufficiently as to render the results of this study virtually meaningless. I argue that they potentially can. I can’t prove it, but certainly the methodological shortcomings of this trial make it hard to take as any definitive evidence that there is different neurobiology going on between real acupuncture and sham acupuncture. All it does is to show that maybe there is a neurobiological difference between having needles sticking out of the skin and not having needles sticking out of the skin, which would be of little surprise, although the exact difference could be of interest. What this study does not show is that acupuncture “works.” I suppose it’s possible that sticking needles in the skin may have nonspecific effects that might alleviate pain, but this very study shows that they are no different than placebo. After all, there was no difference in pain relief between subjects receiving sham acupuncture and real acupuncture. Both experienced the same amount of subjective pain relief!

Not that that stops Harris from trying to imply that sham and true acupuncture “work” through different mechanisms:

Another intriguing result from the present study is that although MOR BP values were differentially altered by TA and SA, reduction in clinical pain was similar between groups. In a clinical trial, when an active treatment does not exhibit superior efficacy to a sham or placebo, the active treatment is assumed to be ineffective and only operating via a placebo effect. However this study suggests that this may be an erroneous conclusion. In this instance, our non-insertion sham procedure evoked a similar reduction in pain as our true acupuncture and we speculate that this occurred via a different mechanism. The analgesic effects of SA could have been due to regional reductions in MOR BP, consistent with activation of this class of receptors during placebo effects (Zubieta et al., 2005), whereas TA evoked an increase in receptor binding availability.

Alternatively, the perceived pain relief accorded by sham acupuncture and true acupuncture could be occurring by placebo mechanisms entirely unrelated to the observation of this study, which may have had nothing to do with the clinical placebo effects seen. That’s a rather more simple explanation for these results than all that handwaving (and, yes, it is mostly handwaving) in the paragraph above. I’m rather surprised the reviewers didn’t make Harris revise his manuscript to consider this possibility and discuss it. Harris could be correct. I doubt that he is, but he could be. However, my alternate explanation could also be correct. Moreover, even if he is correct, so what? It might be intellectually interesting and useful for understanding the placebo effect to determine the differences in neurobiology underlying two different placebo treatments, but none of this validates acupuncture as anything more than an elaborate placebo. It’s also a long run for a short slide, so to speak, in that nine sessions in a month of sticking needles into the body seems a lot to undergo for such minimal results based on such tenuous mechanisms.

It’s also depressing to see how the press has spun this study. Reports on the study are more or less reporting it exactly as Harris represented his results in the Discussion section of his paper. I have yet to see a news story with anything more than a very token skeptical view. Instead, they all proclaim this study as evidence that acupuncture can somehow crank up the level of opioid receptors to the point where they make opioid drugs work better. Heck, the article I cited said that this study shows that acupuncture can increase the efficacy of opioid analgesics, either natural or prescription! There’s zero evidence presented in this paper that shows that.

This paper represents to me the latest in a line of rationalizations of acupuncture. Acupuncturists start out saying that “acupuncture works” based on nonblinded studies for which placebo effects are not adequately controlled for. Then, when better studies show that true acupuncture is no better than sham acupuncture (or, amusingly, sometimes that the sham acupuncture “works” better), they rationalize it by saying either that the sham was not a good sham or that these studies don’t say anything because sham acupuncture “works” too. Harris takes a different tack in saying that, yes, there’s no difference in perceived pain due to sham acupuncture or true acupuncture not only because they both work but because they both work by different physiological mechanisms. He might have had a (weak) point were it not for his seemingly willful misinterpretation of his results and his changing too many things at the same time in his sham control group. Instead, all he’s shown is that opioid receptors light up more if there are needles in the skin than they do if there are not–hardly a finding that shows that acupuncture “works” and certainly not any sort of finding to validate the entire system of acupuncture, which relies upon the idea of qi flowing through meridians, flows that can be altered to therapeutic effect by sticking needles into those meridians.

“I do not think your results mean what you think they mean,” indeed.

REFERENCE:

Harris, R., Zubieta, J., Scott, D., Napadow, V., Gracely, R., & Clauw, D. (2009). Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on μ-opioid receptors (MORs) NeuroImage, 47 (3), 1077-1085 DOI: 10.1016/j.neuroimage.2009.05.083

ADDENDUM: Christina Stephens at the JREF Swift Blog has written a good analysis of this study.

Posted in: Acupuncture, Clinical Trials, Medical Academia, Science and the Media

Leave a Comment (46) ↓

46 thoughts on “Needles in the skin cause changes in the brain, but acupuncture still doesn’t work

  1. Peter Lipson says:

    That my alma mater is so deeply involved; that it can, with an apparent straight face, use words like “energy therapy”, disappoints me deeply.

  2. David Gorski says:

    Yikes. I forgot that you went to Michigan too.

  3. Joe says:

    That sham acupuncture procedure is inconceivable. (I don’t think that word means what you think it means …) In addition to the problematic design in this case, blinding any physical/manual therapy is especially difficult because it is very hard to control the demeanor of the practitioner. In this case, although the subjects (who are naive about acupuncture) may not perceive any difference overtly, they may have gotten subtle cues that the practitioner was more enthusiastic when providing the “true” process.

    There is a further problem specific to acupuncture. I don’t know if it was mentioned in the article; but many acus try to achieve de qi (“an irradiating feeling deemed to indicate effective needling”). That effect cannot be duplicated with non-penetrating needles. At the same time, an acu trying to elicit de qi must have a different interaction with a subject than one who is not (because they have to ask). I have also read studies using where the sham was needle-penetration at the wrong places, with instructions to not cause de qi.

    As a result, when I see a paper with an apparently good design showing clear superiority for acupuncture, I am still left wondering whether to believe the researchers or my own, lying eyes.

  4. Scott says:

    It would be interesting and useful if this research eventually led to a way to improve the effectiveness of opiates, whether via needling or something else. But somehow I’m afraid that Harris won’t follow up in that direction.

  5. David Gorski says:

    There is a further problem specific to acupuncture. I don’t know if it was mentioned in the article; but many acus try to achieve de qi (”an irradiating feeling deemed to indicate effective needling”).

    Yes. Investigators did try to elicit de qi. Sorry I forgot to mention that.

  6. TimonT says:

    The University of Michigan has been teaching pseudoscience (i.e. psychoanalysis) in the Psychiatry Department for a long time.

    I look forward (speaking sarcastically, of course) to the time when they offer degrees in creationism in the biology dept., flat-earthism in the geology dept., and perpetual-motion in the physics dept.

  7. Harriet Hall says:

    Since there was no difference in pain relief between the groups, the opioid receptor findings are not clinically significant. This is not POEMS – Patient Oriented Evidence that Matters. It suggests a possible clinical application: that patients needing opioids might be able to take lower doses if combined with acupuncture, but that might be true of any placebo adjunct you could name. And it bothers me that all the subjects were women with fibromyalgia, raising the question of whether the findings can be generalized to other populations.

  8. It’s interesting that they didn’t include needling with sham points. The results of that would have very likely show what other studies have shown: the location of where the needles are inserted is totally irrelevant, and without question, the underlying principles and traditional understandings of acupuncture are bunk. It seems some believers in acupuncture have abandoned the grandiose claims of healing ability and have retreated to the claim that randomly sticking people with needles can have a small effect of pain relief that is apparently indistinguishable from a placebo response. Even if true, it would hardly be a compelling reason to recommend acupuncture.

    Non-rhetorical question: If your treatment had an effect strength/size equal to the placebo response (assuming you could somehow determine when the effect was due to your treatment), wouldn’t you expect your treatment group to show more effect than your control group since the results in that group should consist of the “real” effect in addition to the placebo effect? Are we supposed to assume that “real” effects are DISPLACING the placebo effect and occur where and only where a placebo response exists?

    Even if the conclusions were correct, so what? For acupuncture to have any practical use, it needs to have a lasting effect that extends beyond the removal of the needles.

    Not that I’m recommending doing more studies of acupuncture, but have there been any well done studies of acupuncture for management of pain that IS able to be managed effectively with either OTC or prescription medication? Studying pain that is not otherwise well managed is a search for relatively small effect that is, at best, difficult to distinguish from a placebo response, and seems to be an admission of the concept that the acupuncture is not effective enough to displace effective pain management, where it already exists.

  9. Neuroskeptic says:

    “Consistent with the other acupuncture studies that Harris mentioned, there was no difference in pain scores between the sham and “true” acupuncture groups.”

    Ah, so this is one of those studies that finds that Treatment A is no better than Treatment B, and then tries to explain the difference!

    Also, if acupuncture really does work by opioid mechanisms, doesn’t that mean we can forget acupuncture and just give everyone codeine? It would be a lot cheaper, and more fun.

  10. JMG says:

    I agree, the way the sham part of the study was set up invalidates the whole protocol. The study basically shows physically poking a human illicits a physical measurable response, not poking it doesn’t do it. It also shows that the measured response has nothing to do with the effectiveness of acupuncture for pain relief.
    This is like measuring the difference of right hand or left hand driving on tire wear, and wondering why it doesn’t make a difference on fuel consumption.

  11. durvit says:

    In other news in the UK: GPs urged to commission acupuncture to ease back pain.

    GPs should develop acupuncture schemes through practice-based commissioning (PBC) to help implement NICE back pain recommendations, the British Acupuncture Council has said.
    NICE guidance issued in June recommended a course of up to 10 sessions of acupuncture should be offered as a treatment option to patients with low back pain.

  12. stephend50 says:

    As faculty in internal medicine — IM — at UM I my heart jumped when I read your article; then I realized you meant integrative medicine not internal medicine, whew! Yes integrative stuff is in the department of Family Medicine. I have only sent one patient there. She had DM2 and absolutely no intention of being compliant with standard of care. She had an A1c > 12 and refused to believe or accept that she had to take medications. I thought that at the very least there would by an MD taking part in her care and maybe she could be guided / nudged towards at least taking metformin as long as she was with people who shared her belief system. But yes, major woo going on over at the Briarwood FP clinic.

  13. seemstome says:

    Medical research studies are never perfect. While this study does not justify a claim that acupuncture works, it does suggest that possibility. You really have to consider that patient reports are not the same thing as placebo effect — in other words, patients who think they received a treatment might report decreased pain even though they did not experience any decrease. Because this study used brain imaging, it gets around that potential source of confusion. So this research is interesting, if only for that reason.

    We still don’t know if acupuncture works, but brain imaging may eventually help to settle the question. I think this study should be followed up. If, as you say, all it showed was that needles in the skin have an effect on the brain, then in order to find out, they should include a non-acupuncture control group with needles in the skin.

    The study that showed the same effect for acupuncture and placebo only used patient reports as the outcome measure, as far as I know. Why do you trust that, knowing that patients may, to some extent, be reporting what they think the researchers want to hear? Objective measurements are much better, so this research is a step in the right direction.

  14. Scott says:

    While this study does not justify a claim that acupuncture works, it does suggest that possibility.

    Actually, it’s quite the opposite. It provides good evidence (add it to the massive pile) that acupuncture specifically does not work beyond placebo.

    Put another way, if this study ISN’T firmly against acupuncture being clinically effective, then no possible result is. Which means that regardless of your experimental results you reach the same conclusion, which means what you’re doing is completely divorced from science.

  15. seemstome says:

    “It provides good evidence (add it to the massive pile) that acupuncture specifically does not work beyond placebo.”

    You missed what I said. This study agrees with the one that shows no difference in patient reports for acupuncture vs sham. However, patient reports are not the same thing as placebo — a patient might report an improvement they did not experience. Not because they’re lying, but because it’s hard to tell, so their reports are slightly biased to the positive side. It looks like a placebo effect, but it isn’t.

    In this study, an objective measurement is used in addition to patient reports, and that’s what makes it interesting and meaningful. As Gorski said, maybe the effect was caused only by needles in the skin, not by acupuncture. But it’s possible to find out — just repeat the study with a needles-in-skin control group.

    And that is what should be done. Rather than dismissing the research as meaningless just because it isn’t perfect. If you reject all imperfect medical research, there would be almost nothing left.

  16. Scott says:

    The relevant measure of a pain treatment is pain relief. Yes, this is inherently subjective, but it’s the entire point. Saying it didn’t help pain, but had some other effect with no known significance, is very explicitly saying that it didn’t help. The other effect (which didn’t actually relieve pain) might have some interest, but it most emphatically does NOT even “suggest” that the treatment is useful.

    However, patient reports are not the same thing as placebo — a patient might report an improvement they did not experience. Not because they’re lying, but because it’s hard to tell, so their reports are slightly biased to the positive side. It looks like a placebo effect, but it isn’t.

    Ah, so the patients who got needled benefited from it in precisely the right amount to counterbalance them being less biased for no discernible reason.

    Doesn’t fly. Doesn’t even start to think about someday perhaps pondering the possibility of taking a slight hop.

    In this study, an objective measurement is used in addition to patient reports, and that’s what makes it interesting and meaningful.

    No, actually it doesn’t. They could have looked at what color socks the patients chose to wear the next day. That would be equally objective, but just as equally irrelevant.

  17. seemstome says:

    No, what they measured was obviously relevant to the experience of pain. If this were a study of a mainstream pain treatment, I’m sure you would not be so anxious to reject it as meaningless.

  18. seemstome says:

    This statement was in the abstract:

    “Long-term increases in MOR BP following TA were also associated with greater reductions in clinical pain.”

    although Gorski said:

    [there was no difference in pain scores between the sham and “true” acupuncture groups.]

    So without access to the article, we don’t really know.

  19. mposey82 says:

    seemstome,

    The statement is deceptive. If you don’t have access I can post a copy to drop.io . On page 5 of the paper under the paragraph “Changes in clinical pain” the authors write:

    “Both TA and SA resulted in clinically meaningful reductions in pain (SF MPQ TotalScore mean diff(SD); TA: −4.00(6.72); SA: −2.90(8.33)), however there were no statistically significant differences in pain reduction between TA and SA (pN0.50).”

    So sham and traditional acupuncture both reduced pain – but neither did better than the other. That is acupuncture did not work better than placebo. The statement you quote is ambiguous. The authors neglected to indicated greater than what. The kindest interpretation is that hey mean that increasing MOR BP results in reduction of pain (which I didn’t see a table measuring).

  20. Scott says:

    No, what they measured was obviously relevant to the experience of pain. If this were a study of a mainstream pain treatment, I’m sure you would not be so anxious to reject it as meaningless.

    Gee, something obviously relevant to the experience of pain which produces no perceptible effect on the experience of pain. Wow! And yes, I most certainly would react the same way if it were a drug which produced these results; I’d conclude that they did not justify using said drug and that without countervailing results it should not be permitted on the market. (Of course, drugs are subject to much greater scrutiny since Congress has decided it’s OK for acupuncturists to defraud the public.)

    This statement was in the abstract:
    “Long-term increases in MOR BP following TA were also associated with greater reductions in clinical pain.”

    Not in the least inconsistent with Dr. Gorski’s comments. What this statement says is that, among the TA subjects, there was a correlation between long-term increases in MOR BP and reduction in pain. There is no comparison here between the two groups, hence no evidence for the proposition that the needles did anything useful.

  21. “No, what they measured was obviously relevant to the experience of pain.”

    Actually, they demonstrated that what they measured wasn’t relevant to the experience of pain, as the experience of pain was no different in the two groups.

    Prior to the study, it was plausible that what they were going to measure was relevant to the experience of pain, but with differences in the measured results and no differences in pain experience, they failed to support that concept.

  22. Darjeeling says:

    seemstome said:
    This statement was in the abstract:

    “Long-term increases in MOR BP following TA were also associated with greater reductions in clinical pain.”

    although Gorski said:

    [there was no difference in pain scores between the sham and “true” acupuncture groups.]

    So without access to the article, we don’t really know.

    I pulled the article, and yes — we do know. The authors describe mu-opioid binding changes in seven brain regions with acupuncture and correlated those changes with improvements in clinical pain. However, the authors DID NOT REPORT a comparable analysis of the effects of sham treatment. Gee, I wonder why?

    The data the authors cite (Table 3: Regions displaying negative correlation between MOR binding changes and changes in clinical pain following acupuncture; and Figure 4: Long-term increases in MOR binding following acupuncture are associated with reductions in clinical pain) shows that “seven regions were identified as showing a negative correlation between changes in clinical pain and changes in MOR BP” with traditional acupuncture.

    Well enough, but they do not show comparable data from the sham group — so we do not know if the same brain regions were affected by sham treatment or whether similar correlations with clinical pain occurred. Remember, there were no differences in clinical pain scores. However, the authors DO state that “No regions were identified in the TA group as showing significant positive correlations between changes in MOR BP and changes in pain (see Supplementary Fig. 1c for glass brain results). However the dorsolateral prefrontal cortex, which showed decreases in MOR BP in the SA group (see Fig. 3) had a significant positive correlation with pain reduction following sham treatment (r = 0.69; p = 0.027). Individuals with greater reductions in MOR BP within this region, had greater reductions in clinical pain.”

    Selective data reporting… I’m not surprised.

  23. weing says:

    Why shouldn’t needles in skin not have an effect on the brain on imaging studies? Aren’t the subjects alive?

  24. Actually, they demonstrated that what they measured wasn’t relevant to the experience of pain, as the experience of pain was no different in the two groups.

    Actually, what they measured might have been relevant to the experience of pain caused by the acupuncture needles themselves! This is what ‘de qi’ really is, as previously discussed here.

  25. seemstome says:

    If they did the imaging while the subjects had needles inserted, then the imaging results could have been because of the needles, as Gorski said. But we don’t know if that was the case. Acupuncture needles are very fine and do not cause pain, but that still should have been controlled for. However, they probably did the imaging after the treatment, after the needles were removed. We really do not know. It is wrong to assume they made that mistake. Especially since in the news article (linked from this post) the authors say the pain from needles could cause the imaging result. So they knew, and they probably did not screw the whole thing up in that way.

    I’ve had acupuncture (it didn’t work for me) and I know the needles don’t cause any pain. So it seems doubtful painless needles would cause a change in the brain. But, as I said, we don’t know, without actually asking the authors.

  26. @Kimball
    “Actually, what they measured might have been relevant to the experience of pain caused by the acupuncture needles themselves! This is what ‘de qi’ really is, as previously discussed here.”

    I should have been more specific that what they measured didn’t appear to be relevant to the experience of the pain being studied.

    I agree that it may have been very relevant to the pain being experienced (either consciously or unconsciously) from the needling itself.

    @seemstome
    “I’ve had acupuncture (it didn’t work for me) and I know the needles don’t cause any pain.”

    So your anecdote of n=1 is conclusive proof that acupuncture is pain free?

  27. Diane Jacobs says:

    So it seems doubtful painless needles would cause a change in the brain. But, as I said, we don’t know, without actually asking the authors.

    The brain is constantly processing streams of incoming sensory information. Whatever it presents to you and you recognize as “painful,” is only a result of the non-conscious parts of the brain (e.g., the anterior cingulate, the right insula, etc., or their processing patterns/intercommunication) having “decided” that the sensory stream is “dangerous” for whatever reason, and wanting your attention to remove the signal they read as being a threat – to themselves/their organism.

    A therapy does not need to “hurt” to be effective/achieve elicitation of a placebo response. However, if your belief is that it does have to hurt to be effective, then that belief may itselfbe sufficient to interfere with any reorganization/neuroplasticizing the brain might try to do with the sensory stream, i.e., interfere with construction of a good placebo response.

    That’s my current understanding, at least, based on pain/neuro science.

    Diane Jacobs

  28. @ Karl

    I knew you were referring to the pain being studied; didn’t mean to sound flippant, just ironic. :-)

    @ seemstome

    I’ve had acupuncture twice and I know the needles DO cause pain–the pain that I felt was coincident with the practitioner declaring that ‘de qi’ had been achieved (as I wrote in the piece linked above, it seemed pretty clear to me that ‘de qi’ was muscle spasm). James Reston also reported pain from acupuncture:

    That sent ripples of pain racing through my limbs and, at least, had the effect of diverting my attention from the distress in my stomach.

    seemstome, perhaps acupuncture didn’t work for you because there warn’t no ‘de qi.’ Just kidding; I did have de qi but it didn’t work for me, either. ;-)

  29. David Gorski says:

    However, they probably did the imaging after the treatment, after the needles were removed. We really do not know.

    No, we do know. From the article:

    After needle insertion and manipulation, scans from 45 to 90 min during PET1were used as the short-term treatment measurement (i.e. treatment1). During minutes 45 to 90, needles were retained in the TA group, whereas no needles were present in the SA group since SA did not involve skin penetration. For analysis of long-term changes in MOR binding, changes between PET1 and PET2 baseline scans, baseline1 and baseline2 respectively, were examined.

    TA = true acupuncture; SA = sham acupuncture.

  30. Steve S says:

    Very interesting! Since my comment on another section in a previous blog at this site, my department chair had a faculty meeting about the acupuncturist that came to my facility. My colleague now feels that I didn’t respect her after pointing out the deficiencies and half truths that the integrative acupuncturist presented to my residents. She also pointed out the problem of traditional medicine with the revelation on kyphoplasty as being no better than placebo. Then she used the same old tired criticisms of medicine v CAM; money, harm to patients etc. I defended the idea that since we are in a teaching institution I have a greater responsibility to the residents and medical students that come through in making sure they know the truths of acupuncture, even in the face of risking friendship. Since this meeting last week her nurse will not talk to me. And I don’t know if I got in trouble with my boss for this. My integrative colleague has gotten a grant to start integrative medicine here. She has also just recently pointed out the above study as one reason in support of acupuncture. I may be paranoid, but I am beginning to suspect there is a organized move to get this stuff into teaching at traditional medical schools and residencies, particularyly my speciality of family medicine. And the politcal pressure is on.

  31. Jurjen S. says:

    From Dr. Gorski’s piece:

    There are now retractable sham needles available that do a pretty good job of hiding from even acupuncturists whether a real needle went in or not; [...]

    Just as an aside, I am saddened by the fact that time, effort and resources have been expended in the development and manufacture of a device that serves a purpose that ought to be so utterly superfluous, to wit, demonstrating that acupuncture is bunk.

  32. David Gorski says:

    I may be paranoid, but I am beginning to suspect there is a organized move to get this stuff into teaching at traditional medical schools and residencies, particularyly my speciality of family medicine. And the politcal pressure is on.

    You’re not paranoid. There is an organized effort to get this stuff into the curriculum at traditional medical schools. Haven’t you been reading this blog? :-)

    I’m saddened by your story. Saddened, but not surprised. This is very typical. Just ask Val Jones.

  33. DevoutCatalyst says:

    “My colleague now feels that I didn’t respect her after pointing out the deficiencies and half truths that the integrative acupuncturist presented to my residents.”

    There’s no greater respect than telling the truth, tactfully of course. The negative findings for acupuncture should be liberating for acupuncturists — it’s the subsequent squirming and mis-representation of these findings that connote dis-respect. What a sorry thing to live a life and not come to grips with reality, even if the initial impact may be somewhat painful.

    Learning when I am wrong, and just how often, is the greatest gift I’ve ever received.

  34. seemstome says:

    “For analysis of long-term changes in MOR binding, changes between PET1 and PET2 baseline scans, baseline1 and baseline2 respectively, were examined.”

    What about the long-term changes?

  35. Blake Stacey says:

    Outcome measures included clinical pain scores using the Short Form of the McGill Pain Questionnaire and measures of μ-opioid binding.

    This study raises questions. I’m not saying it’s illegitimate, no. . . but why won’t they show us the Long Form questionnaire?

  36. A brief aside to address TimonT’s comment:

    The University of Michigan has been teaching pseudoscience (i.e. psychoanalysis) in the Psychiatry Department for a long time.

    Psychoanalysis has changed a lot since the days of Freud. There are many modern psychologists who use psychoanalytic techniques based on the scientific evidence. While not my favorite method of psychological therapy, and an area of debate, I think it is incorrect to categorize all psychoanalysis as pseudoscience.

  37. The Blind Watchmaker says:

    “Harris acknowledges up front that several studies have now shown acupuncture to be no more efficacious than sham acupuncture.”

    So sham acupunture must work too!

    I’d be interested to see a study measuring the subjective effects and the biochemical effects of someone’s mom holding their hand and saying, “It’s alright. Everything is going to be fine. When we get home, I’m going to make you your favorite soup. I love you, honey.”

  38. Thanks for the blog on acupuncture placebo methods. I was just presenting this idea to someone. Regarding the locations, acupuncture versus sham: I agree that a decent method would be to use the gold pins in each arm, and in proximate locations. Optimal would be to explain the task to some acupuncture experts, and obtain their consensus regarding the minimum distance a fake point would need to be from a genuine point, i.e., in millimeters. Then, develop a set of such non-effective points in an array as similar to the “constellation” as the recognized acupuncture constellation or array. Get the acupuncture gurus to approve this as a valid placebo set.

    Additionally, get a set of neurologists who are familiar with the types and densities of nerves in the skin. It is apparent that we have differnt types of nerves in differnt areas of skin, and the density of sensory nerves varies. A good phlebotomist can inject a needle where there are few pain nerves so that you fell as little pain as posssible. Lips and fingertips are densely populated with sensory nerves, including pain nerves.

    An acupuncture needle at a site with a very different sensory nerve density and profile (some pressure, some pain, some motion, etc.), though proximate, would not deliver the same non-CAM physiological response — including the natural-opiate response to pain mentioned.

    While the geography of the body is peppered with supposed acupuncture spots, it should be feasible to generate constellations of points that would be acceptable as a placebo set to skeptical scientists, acupuncture advocates, and sensory nerve physiologists.

    This is what would be worth funding. Not the rest of the quixotic studies being conducted and reported.

  39. seemstome says:

    A much simpler idea would have been to do the brain imaging after the acupuncture treatments, instead of during. I can’t imagine why they didn’t think of that. Or do the imaging before, during and after, for both sham and real conditions. They must have known they were confounding their experiment by having needles in the experimental group and no needles in the control group, knowing very well that needles could effect the brain scans.

    How do people manage to spend all that time and money on research without thinking about what they are doing?

    Is there any way a non-MD can get the whole article? I would love to know what they were thinking. Or not thinking.

  40. rationalranger says:

    This reminds me that I recently read the Mayo Clinic Book of Alternative Medicine. It is a nauseating promotion of woo, loaded with weasle wording, poor reasoning and false statements. What a pity that even this venerable clinic has jumped on the bandwagon of irrationalism that panders rather than tells the truth. I would like to see someone on this site write a thorough review.

  41. mjranum says:

    It is a nauseating promotion of woo, loaded with weasle wording, poor reasoning and false statements.

    At what point is shrugging and saying “not my problem” in the presence of quack medicine a violation of the hippocratic oath? I’m not a doctor (clearly) so I don’t know how seriously it’s taken anymore – but it seems to me that medicine has a big ethical problem, given that a lot of practitioners are taking money for treatments that have been proven to be ineffective. At the very least that’s “stealing” from the patient and insurance companies, isn’t it?

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