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Acupuncture Revisited

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

Ernst et al. systematically reviewed all the systematic reviews of acupuncture published in the last 10 years: 57 systematic reviews met the criteria they set for inclusion in their analysis. They found a mix of negative, positive, and inconclusive results. There were only four conditions for which more than one systematic review reached the same conclusions, and only one of the four was positive (neck pain). They explain how inconsistencies, biases, conflicting conclusions, and recent high quality studies throw doubt on even the most positive reviews.

They also demolished the “acupuncture is harmless” myth by reporting 95 published cases of serious adverse effects including infection, pneumothorax, and 5 deaths. Some but not all of these might have been avoided by better training in anatomy and infection control.

Their analysis does not prove that acupuncture doesn’t work (negatives are hard to prove) but it unquestionably sheds serious doubt on the claim that it does work. Overall the evidence is inconsistent, and the results tend to be negative among those studies judged to be of the highest quality. Where the results are positive, the reported benefits can be explained by the surrounding ritual, the beliefs and expectations of patient and practitioner, and other nonspecific effects of treatment. There is no evidence to support the vitalistic concept of qi or the prescientific mythology of acupuncture points and meridians; it doesn’t seem to matter where you put the needles or whether the skin is pierced. More modern science-based explanations like increased endorphin production are not convincing, since placebo pills can produce the same effects.

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

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

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

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

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

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

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

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

In this issue of Pain Ernst et al. [1], systematically reviewed a decade’s worth of systematic reviews of acupuncture. They found a mix of negative, positive, and inconclusive results. There were only four conditions for which more than one systematic review reached the same conclusions, and only one of the four was positive (neck pain). They explain how inconsistencies, biases, conflicting conclusions, and recent high quality studies throw doubt on even the most positive reviews. Ernst et al.’s analysis cannot prove that acupuncture does not work (negatives are hard to prove) but their study unquestionably sheds serious doubt on the claim that it does work. Overall the evidence is inconsistent, and among those studies judged to be of the highest quality, the results tend to be negative.

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

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

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

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

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

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

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

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

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

Conflict of interest statement

I have no conflicts of interest to report.

References

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

Posted in: Acupuncture

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232 Comments

  1. Ed Whitney April 11, 2011

    From Karl:

    “The problem in such three arm studies is that the usual care groups aren’t blinded like the true and sham acupuncture groups are. It’s highly problematic at best to compare one unblinded group with two blinded groups and draw any particularly useful or definitive conclusions on anything other than the relative strength of the placebo responses.

    To say otherwise seems to require ignoring or undervaluing the value of blinding. ”

    One asks an RCT to control sources of bias that can reasonably be expected to be controlled. Often participants cannot be blinded, but outcome assessors can be; each of the three trials did this. Lack of blinding does leave open some susceptibility to assessment bias, and investigators can be asked to do what they can do to minimize this.

    Even though blinding sometimes cannot be done, I am unable to think of any trial in which randomization cannot be done, and in which concealment of allocation cannot be done. All three trials did this. Selection bias was avoided.

    To repudiate any trial in which blinding is incomplete is to create a novel standard for evaluating the validity of clinical trials. Consider the SPORT trials of surgical vs. nonsurgical treatment of back conditions; the links (free access) are below. The first is the trial of herniated disc treatment; the second is for lumbar spinal stenosis, and the third is for degenerative spondylolisthesis .

    http://jama.ama-assn.org/content/296/20/2441.full.pdf+html
    http://www.nejm.org/doi/pdf/10.1056/NEJMoa0707136
    http://www.nejm.org/doi/pdf/10.1056/NEJMoa070302

    In none of the three trials could the participants be blinded, yet these studies were widely cited and were influential on the thinking of the spine community on the issues that were studied.

    Should they be repudiated because of lack of blinding? This seems unreasonable and unnecessary.

    Basic point: selection bias (randomization and allocation concealment) is always avoidable, and it is a flaw of an RCT not to accomplish it. Lack of participant blinding is not necessarily a fatal flaw.

    “Also remember, since standard care is not particularly effective for the pain typically being studied here, you’re closer to comparing acupuncture to no treatment rather than seeing how it measures up to an established, effective treatment.”

    “An established, effective treatment” for chronic LBP is the Holy Grail. If there were, the volume of literature devoted to RCTs of various interventions would be reduced, If you find the Grail, the world will beat a path to your door.

    The best surrogate is care from an evidence-based practice guideline, which was Haake’s third comparison group. It included 10 sessions with a physician or physiotherapist who administered PT, exercise, and such. They improved (the usual care group improved in each of the three trials), just not as much as the two comparison groups.

    “The subjects are likely well aware that usual care is generally ineffective ”

    Their awareness of its ineffectiveness should be seen as part of its ineffectiveness, and not as a confounder. That is, their awareness is part of the causal pathway for the ineffectiveness compared to the other two randomized groups.

    “pseudopuncture” FANTASTIC! I will shamelessly plagiarize! “There is good evidence from three randomized trials that pseudopuncture was more effective than conventional care in blah blah blah. ”

    From GLaDOS:

    “Example: You can’t say acupuncture has absolutely no effect. Therefore doctors should offer acupuncture as an option to their patients.’”

    But, as per the above, I am claiming that the a-word has an effect, and that doctors should be willing to offer it as an option to patients who express an interest. You can’t say it has absolutely no effect because patients who got it fared better than patients who did not.

    As mentioned earlier, I think that Dr. Hall is correct to suspect that the effect of BCH intervention on hastening the ability of the patient to resume activities of daily living has to do with their willingness to push through the discomfort. A survey of a convenience sample of physicians specializing in occupational medicine and physical medicine (i.e., a coupla guys I know) suggested that patients who went for acupuncture were more willing to get up and get moving again than before that intervention.

    It was not clear whether she was meaning this as a way of dismissing acupuncture, but since active movement is the cure for nonspecific LBP, this effect of acupuncture should be seen as a direct therapeutic effect, and not as a confounder. It is because they pushed through and moved again that they were able to reach up and get things off of tall shelves, pick things up off the floor, run for the bus, and all the other functions that were in Haake’s outcome.

    This seems reasonable: poking the patients makes them more willing to do stuff in spite of pain, which leads to their recovery. I think this is where the discussion was leading earlier. The willingness is an intermediate in the pathway from the needle to the resolution of symptoms. It is not an extraneous factor; it is the essential factor.

    To say, “well, it only made them better because it increased their willingness to push through the pain” seems like saying “the only reason the antibiotic resolved the pneumonia is because it killed all those bacteria, so that the patient’s immune system could eliminate the disease organisms.”

  2. Harriet Hall April 12, 2011

    @Ed Whitney,

    I was not “dismissing” acupuncture. I was pointing out that part of the placebo response is the expectation and that encouragement leads people to try harder on objective tests. Is this enough to justify knowingly prescribing placebos? The consensus of medical ethicists is that it doesn’t. If I gave the patient a sugar pill and told him it was a narcotic, he might feel better and try harder too, but I would be wrong to lie to him.

  3. nybgrus April 12, 2011

    Almost there Ed…. you are getting closer to realizing what you need to do now. Toss the whole idea in the trash!

    Their awareness of its ineffectiveness should be seen as part of its ineffectiveness, and not as a confounder. That is, their awareness is part of the causal pathway for the ineffectiveness compared to the other two randomized groups.

    So when a patient is educated as the the ineffectiveness of acupuncture then it will also be… ineffective. Which it already is. Except that:

    A survey of a convenience sample of physicians specializing in occupational medicine and physical medicine (i.e., a coupla guys I know) suggested that patients who went for acupuncture were more willing to get up and get moving again than before that intervention.

    Which only happens because the patients in question are under the impression that it is something novel and intriguing that should help them move more – this is what they are sold as working by the acupuncturists. They are claiming acupuncture actually fixes the back pain. Thus, they start to move more, and voila! the back pain becomes cured.

    The problem, Ed, is that we understand what this is working – the placebo effect and expectancy of the patient leading them to actively partake in the actual science based treatment whereas before they were not. And don’t underestimate the heightened effect of people loving some mystical thing that will certainly cure their pain in one easy swoop! They aren’t being told “This will do nothing but let you work through your pain” they are told “This will fix your pain!”

    So now that we have established that the only possible mechanism for TCM acupuncture working is via said placebo effect and that “pseudopuncture” works because it mimics the placebo effect of acupuncture we are left with the question: “What do we do now?”

    We have a “therapy” that is shown to actually improve outcomes. However, we have also understood by removing confounders and bias, tossing in some basic sciences, a little understanding of psychology, and some analogy that the fundamental basis for the improved outcome is placebo effect.

    Since we now know this, is it ethical to advise patients to use it? Or to administer it yourself as a physician? The answer we have decided on as a society and a profession is simple: No. It is patently unethical to administer a placebo to a patient regardless of whether or not we have good reason to assume it will lead to a positive outcome.

    If you are wishing to try and assert that pseudopuncture or BCH acupuncture or whatever has some specific mechanism besides placebo then you need to think up and devise a hypothesis and experiment to test that – beware the sharpshooters. The problem is, there isn’t and no one has.

    Oh yes, almost forgot – you claim that “any poking” has not been established to work. It has. From a science based standpoint whether I poke you with a toothpick 2cm superior to the tibial tuberocity or 2.5cm or 3, or 1cm laterally, or within the same myotome or dermatome, or what have you the results would be the same. If the mechanism is patent, then the only difference you would expect to see is that pain confined to one myotome would not be affected by poking in a different one. Otherwise, scientifically speaking, there isn’t much difference at all.

    So now we now reasonably well that acupuncture and pseudopuncture are essentially no more than placebo and expectancy effects. It is a shame we can’t use them anymore. It reminds me of the joke:

    Preacher: If you don’t believe in god and accept him you will go to hell.
    Eskimo: What if I had never heard of god before?
    Preacher: Then you wouldn’t because you never knew.
    Eskimo: So then why did you tell me?

    Except the difference here is that is how science works. We find out what works and what doesnt and how and then determine the ethical way to approach it. I am honestly confused as to why you keep pressing the notion that there is “something” to the pseudopuncture nonsense that isn’t understood and should be applied.

  4. Karl Withakay April 12, 2011

    Ed Whitney

    “To repudiate any trial in which blinding is incomplete is to create a novel standard for evaluating the validity of clinical trials.”

    I never did any such thing. Of course, in some studies blinding is not always possible, even though it is pretty much always desired. I never disputed that, though you apparently inferred that I did.

    My point was, in case you missed it, why bother blinding the acupuncture and pseudopuncture groups in regard to which of those two groups they are in if there is no blinding between the acupuncture like meta group and the usual care group?

    The lengthy section about accessory blinding, randomization, and, selection bias in your reply was a response to a criticism that nobody made, but you glossed over the point that the study had inherently inconsistent participant blinding. Every participant knew whether they were in an acupuncture like group or the usual care group, but the people in the acupuncture like groups did not know if they were in the acupuncture or pseudopunture group. If you are going to use the usual care group as anything but a baseline for the measure of the strength of the placebo response, then it really should have as close to the same amount of blinding as the other two groups as possible.

  5. Chris April 12, 2011

    Must kill italics!

  6. Chris April 12, 2011

    Rats! It didn’t work.

  7. Ed Whitney April 12, 2011

    Awwww! Just when I was on the verge of declaring victory on this thread!

    Main reason to think it ethical to offer acupuncture as an option is the comparison of the three bar graphs from the three LBP studies, where the height of the bar represents therapeutic response. The three bars are labeled A, B, and C. A and B are higher than C in all three studies. The studies have done everything that can be asked of them to control sources of bias that can be controlled. Bars A and B are the same height, and both of them are higher than C.

    If these bar graphs were presented to an observer without labels as to which interventions they represented, that observer would be expected to say that A and B were more effective than C. If the morbidities of A and B were no greater than C, that observer would say that it is ethical to offer A and B as an option to a patient whose condition had not resolved under intervention C. An observer who said the contrary, that C was ethical but A and B were not, would be defending a position which would require much additional explanation if most ethicists were to be convinced.

    If the interventions under consideration were anything other than acupuncture, I would expect most ethical clinicians to be willing to offer A and B as options. If A and B were analgesics with acceptable side-effect profiles, I expect that most SBM folks would endorse their use.

    To switch opinions after the labels are revealed to deal with acupuncture and pseudopuncture (a tip of the had to Karl), and to say that offering A is now unethical, seems to partake of the post hoc data re-evaluating that would be unacceptable under most circumstances. It will not do to reverse course after finding out that A and B are interventions you have always opposed, but to stay the course if you find that A and B are interventions you have always approved.

    I was not aware of a consensus among ethicists about the use of placebos, but was aware of a consensus against deception. Not exactly equivalent. Finnis et al (Lancet 2010;375:686-95) looked at these three selfsame studies, and suggest saying this to a patient who has not been helped by standard therapy: “I recommend that you try
    acupuncture. Several large studies have shown that traditional acupuncture is not better than fake acupuncture treatment, but that both of these produce substantially greater symptom improvement in patients with chronic low back pain compared with those
    patients who receive no treatment or conventional medical therapy. Although the specific type of needling does not seem to make any difference, it is possible that acupuncture works by a psychological mechanism that promotes self-healing, known as the placebo effect.” They suggest that this disclosure is honest.

    BTW, if it is my patient, I would be heavily influenced by a paper that the selfsame Cherkin published in 2001 (Arch Intern Med 2001;161:1081-1088), comparing traditional Chinese medical acupuncture with therapeutic massage and self-care education. Here, when massage was part of an RCT and there was a massage protocol (in which considerable room was left for variation as to exact massage technique), massage was effective, with long-lasting benefits. Traditional Chinese acupuncture was relatively ineffective. The massage group used the least medication and had the lowest cost of subsequent care. The big difference between this study and the other three (Cherkin, Brinkhaus, and Haake) looks to be in the nature of the comparison group. Rather than comparing acupuncture with a nebulous “usual care” or “standard care,” the comparison is with an intervention that was designed into the trial itself.

    Having trained in massage myself at the Esalen Institute long, long ago, I would push massage before discussing acupuncture. Of course, the participants in this study were not blinded, but I trust that there will be no objections raised on that account in this instance!

  8. Harriet Hall April 12, 2011

    @Ed Whitney,

    You have fixated on those bar graphs. They don’t mean what you think they mean.

    “The studies have done everything that can be asked of them to control sources of bias that can be controlled.”
    No they haven’t. They didn’t control the bias between “treatment with impressive rigamarole” and “conventional boring treatment.”

  9. Karl Withakay April 12, 2011

    @Ed Whitney,

    “I would expect most ethical clinicians to be willing to offer A and B as options.”

    Not if B was designed to be an inert control, and not necessarily if there was no blinding between the A-B meta group and group C. If B was designed to be an inert control, and the results showed it was just as effective as A, the natural conclusion would be that A was also inert.

    One could speculated that B might not be inert as intended, but you’d need a plausible mechanism whereby it might be otherwise, and then you’d need to design a new study to attempt to determine if B really had a clinically significant effect beyond a control.

    If you’re not going to treat the pseudopuncture group as a control, then it’s really an unblinded comparison between a meta-puncture group and a usual care group.

    In that case, we’ve seen plenty of similar studies of acupuncture before, and this one just tells us that regardless of whether or not acupuncture is bogus, the invasive needling and points used don’t really matter.

  10. Ed Whitney April 12, 2011

    @ Harriet:

    No they haven’t. They didn’t control the bias between “treatment with impressive rigamarole” and “conventional boring treatment.”

    Let me check quickly before attributing meaing you may not intend.

    Patient in acupuncture or pseudopuncture group experiences paresthesias during the course of the session, and, because of expectations of benefit, attributes them as evidence of a powerful therapeutic effect of the puncture, feels that recovery is happening, and gets up and does what needs to be done, hastening functional recovery.

    Patient in conventional care group experiences identical paresthesias during PT or other aspect of usual care, and, because of belief that conventional care sucks, interprets same paresthesias as exacerbations of problem, feels that recovery is not happening, and curtails activity, delaying functional recovery.

    Is this in the balll park?

  11. pmoran April 12, 2011

    In that case, we’ve seen plenty of similar studies of acupuncture before, and this one just tells us that regardless of whether or not acupuncture is bogus, the invasive needling and points used don’t really matter.

    This the usual interpretation, but we can’t quite say that. The patients still have to believe that they are being needled. Perhaps there is anticipatory release of endorphins and other neurotransmitters.

    The same could apply to the needling of more sensitive areas.

  12. Harriet Hall April 12, 2011

    What I meant was that it is not fair to compare usual treatment to two procedures that both have a much greater likelihood of eliciting a placebo response. The usual treatment will always come off looking worse.

    Your paresthesia scenario is a possibility, but it is more likely that the patient will not develop any specific symptoms from the treatments. He will simply expect to feel better where his expectations have been influenced by nonspecific factors.

  13. Jan Willem Nienhuys April 12, 2011

    If that doesn’t kill them, I don’t know what will.

  14. nybgrus April 12, 2011

    You are indeed fixated Ed. However you are incorrect.

    If these bar graphs were presented to an observer without labels as to which interventions they represented, that observer would be expected to say that A and B were more effective than C. If the morbidities of A and B were no greater than C, that observer would say that it is ethical to offer A and B as an option to a patient whose condition had not resolved under intervention C. An observer who said the contrary, that C was ethical but A and B were not, would be defending a position which would require much additional explanation if most ethicists were to be convinced.

    The casual lay observer might say these things yes. And yes, a medical ethicist would need more information to make a determination. However, the lay observer is not versed in medical ethics and we do have the additional information that lets us decide such a recommendation is unethical. It is unethical to use a placebo because a placebo requires the use of deception. If we honestly do not know that it is placebo and the deception is unintentional we can be forgiven for our transgression. But once we know the crux of the treatment to be elaborate placebo effect intellectual honesty demands we follow the established guidelines of medical ethics. Period. Full stop.

    Your attempt to word something in such a way as to make it somehow ethical to offer a placebo fails.

    “I recommend that you try acupuncture. Several large studies have shown that traditional acupuncture is not better than fake acupuncture treatment, but that both of these produce substantially greater symptom improvement in patients with chronic low back pain compared with those patients who receive no treatment or conventional medical therapy. Although the specific type of needling does not seem to make any difference, it is possible that acupuncture works by a psychological mechanism that promotes self-healing, known as the placebo effect.”

    If your patient fully understands and appreciates what you are saying to them, then acupuncture, by definition, will not work. If they do not fully understand and it works, then you have mislead your patient. The fact that you, as a physician, is recommending the treatment means that most patients will view that as your implicit approval based on the notion that it works – beyond placebo. As a physician, your duty is to fully inform your patients. That means making it clear to them that it is a placebo. So, either your patients are informed and the placebo of the treatment fails, or you have failed in correctly informing your patient. Intellectual honesty would demand that you recognize this and actually work to ensure proper understanding. Since we know that the proper understanding would lead to it not working…. why recommnd it at all? Perhaps now you will finally understand why it is unethical to promote acupuncture.

    And furthermore, you have mentioned this a few times and I haven’t touched on it since it is a minor point, but if you think that all acupuncture practiced in the states is held to such high standards of application and infection control you are sorely mistaken. It is in the US that you still get infection, pneumothorax, and broken off bits of needle. I have personally seen xrays of people with dozens of small broken off bits of needle in various parts of their bodies. Granted this is much better than in developing countries, but the fact of the matter is it exists in the states.

    And how do you then divorce the practice of acupuncture from TCM and use it via placebo? The whole point of your claim rests on the disclosure and lack of understanding, but lets assume for a minute that bit works. The people actually doing the acupuncture must believe it works beyond placebo as well. Otherwise, what do you have but a giant moneymaking scheme that does nothing? Can you imagine the scandal associated with that? You say look at the graphs and what would you recommend. I say imagine the headline “Doctors push placebo and create entire industry to support a treatment which actually does nothing but line their pockets” And if you don’t do that, you either have to rely on TCM acupuncture providers and/or suspend intellectual honesty in your recommendation.

    This is higher order thinking that is required of us as physicians and goes well beyond graphs A, B, and C. You need to unfixate yourself from that and actually integrate all of these things to come up with a cogent, ethical, and intellectually honest recommendation. Sticking your head in the sand and saying “la la la la” (as the TCM acupuncturists do) or fixating on a few tidbits of data saying “But look this MIGHT work! There may be SOMETHING to this!” (as you do) is simply not a viable way of approaching these topics.

  15. GLaDOS April 12, 2011

    …because of expectations of benefit, attributes them as evidence of a powerful therapeutic effect of the puncture

    No, the puncture isn’t the important thing. If it were, skeptics could enjoy some pain relief from being poked.

    What is it then? The disrobing? The comfy massage table? The time spent relaxed while a nice professional paid attention?

    No.

    If you are very good and cause no serious trouble while I am away, later on this evening I may share with you an important insight. But you must brace yourself for transformation.

  16. Ed Whitney April 12, 2011

    Groups A, B, and C have positive expectations of acupuncture. A and B get acupuncture and pseudopuncture while group C gets usual care. The comparison of groups A and B is unbiased. The comparison of A with C and of B with C is biased because the groups are unbalanced with respect to one very important predictor of the measured outcome: their expectations of their allocated treatment.

    The randomization (assuming all that computer-generated allocation sequence, etc) results in a design that balances the groups with respect to their expectations of acupuncture. The study can get 9 out of 10 possible Cochrane Brownie points, and be assessed as a high-quality study, but still have an important bias that can influence the interpretation of the outcome.

    The groups are balanced on one logical level (interest in acupuncture) but unbalanced on another logical level (interest in their allocated treatment). The latter imbalance creates a biased comparison of outcomes across the bar graphs. The measured differences between A vs. C and B vs. C arise from differences in expectation and not differences in specific efficacy of the interventions.

    Sure this isn’t what you are driving at?

  17. nybgrus April 12, 2011

    You seem to be completely avoiding what I am driving at Ed

  18. Ed Whitney April 12, 2011

    @ nybgrus:
    Sorry, I forgot to say “@ Harriet.”
    I am trying to see if I am in the same ball park with her.

  19. Ed Whitney April 12, 2011

    @ Harriet:
    Maybe more succinctly: Validity means that a measurement actually measures what it purports to. A measurement of response to an expectation is an invalid measure of a response to an intervention. The comparisons of A and B with C measure the former and not the latter.

    Any closer?

  20. pmoran April 12, 2011

    “This is higher order thinking that is required of us as physicians and goes well beyond graphs A, B, and C.

    Now, let’s not be too smug about our supposed intellectual superiority.

    There is much for us to be sheepish about if for any reason at all we are actively trying to deny patients potential benefits, especially if in clinical settings where science-based medicine lacks adequate answers.

    I, too, think that Ed is going beyond present plausibilities if he believes that acupuncture may yet be shown to have any special physiological activity.

    But nagging questions remain after consideration of all the relevant evidence.

    The neutral observer, for example, may still want to know “why not give acupuncture the benefit of a little doubt?. There are many different ways in which it might benefit individual patients. I mean, what is medicine for?”

    Also: “are ethicists being asked the right questions?” Do they understand what the science actually shows, i.e. substantial effect sizes from so-called placebos over standard medical care, even equivalent outcomes but with fewer side effects than with some drugs e.g. in the prophylaxis of migraine?

    Are they fully aware of common contextual matters, including that these methods are mostly used for symptom relief when science-based medicine has no adequate answers?

    These questions will only go away if you can show that the combination of placebo and non-specific influences that acupuncture and other regimes incorporate are of no value at all to users.

    How do you think the evidence weighs up on that?

  21. Ed Whitney April 12, 2011

    From pmoran:

    “I, too, think that Ed is going beyond present plausibilities if he believes that acupuncture may yet be shown to have any special physiological activity.”

    I gotta work on my English Composition more! I am not expressing a belief that acupuncture has a physiological activity which is relevant to low back pain.

    I am not invested that much in acupuncture per se. I am greatly invested in sources of bias that remain in RCTs when they have crossed all the i’s and dotted all the t’s that go into making the Cochrane Risk of Bias Tables and the CONSORT 2010 reporting guidelines.

    It was a while back that I alluded to the persistent bias with the acupuncture trials share: namely, that the patients who enter them are a special population, specifically, people who have an interest in acupuncture and are enticed to enter the trials in order to have access to it at the end if they are not originally randomized to it.

    Usually we think of recruitment biases as affecting external validity. In the past few posts, I am looking at how they can threaten internal validity. Today A, B, and C stand for true acupuncture, sham acupuncture, and conventional therapy. Tomorrow, they may stand for something different.

    Randomization may distribute expectations of a specific treatment uniformly across groups, but expectations of the allocated treatment differently. Percutaneous vertebroplasty could be studied in a three-arm trial with a true group, a sham group, and a group with usual care. The group labels A, B, and C would look the same as in acupuncture, but the analytical issues would be the same. If both vertebroplasty groups did better than usual care, we would be facing the same kinds of bias; the group which got the real thing and the group that got the placebo would be about equal, and both would be superior to usual care. If the patients all entered the trial with positive attitudes about the trial intervention, group comparisons could be biased even if the trialists did everything right. The less favorable measured outcomes in the usual care group could be measures of disappointed expectation and not of anything to do with an intervention on the vertebral body.

    Vertebroplasty is a very hot potato issue right now. Acupuncture is chicken feed in comparison. More clinical trials are coming out in the future. The content will change, but the questions of process will persist. Many of the arguments will follow a similar form. It is the form, and not the content of the debates, that is of greatest interest to me.

    “…not be too smug about our supposed intellectual superiority? ”

    Good suggestion, pmoran. Tough to do, but always worth remembering.

    Also, if ethics enter the discussion, your point about context markers sounds interesting. Maybe on another thread you can tell us more.

  22. GLaDOS April 13, 2011

    There is much for us to be sheepish about if for any reason at all we are actively trying to deny patients potential benefits, especially if in clinical settings where science-based medicine lacks adequate answers.

    I have a glass of cranberry juice. I have a glass of milk. TWO THINGS for my patient, if kept separate. If integrated –as you recommend– my patient gets only ONE THING, and it does not taste very good.

    You can’t mix pseudoscience with science in medicine. You just can’t. All you get for your effort are dull witted doctors skilled at equivocation, at best. Oh, and dead rhinos.

  23. Harriet Hall April 13, 2011

    @Ed Whitney,

    “Any closer?”

    I have said what I meant, and I think my meaning is clear by now. I don’t see any point in your seeking some more ideal wording of your own to express what you think I meant.

  24. Alison Cummins April 13, 2011

    I’ve asked about massage as a control for acupuncture before, but it turns out that it’s been compared to acupuncture and is better?

    So why are we even talking about acupuncture/pseudo puncture at all?

  25. Ed Whitney April 13, 2011

    @ Harriet:
    I read your remarks about comparing high-placebo interventions with conventional treatment and agree with it.
    This influences my interpretation of Haake and the other studies.

    Haake 2007 had some regrettable omissions that would have shed light on these issues:

    Patients were excluded if they had previous acupuncture for low back pain, but not if they had had it for other indications more than one year previously

    The number of patients with previous acupuncture was not reported

    The response rates of patients with and without previous acupuncture were not compared

    Because some (including Dr. Ernst) think that its placebo effects may arise from a “novelty” effect (acupuncture-naïve patients more likely to respond), an opportunity to test this idea was lost

    Expectations of acupuncture were reported in Table 2, and were high in all groups (7.7 on a scale from 0 to 10), but expectations of conventional treatment were not reported

    The idea that conventional treatment came off worse because of much lower expectations is highly plausible, but not certain in the absence of data

  26. daedalus2u April 13, 2011

    Allison, I suspect that massage therapy is stigmatized in the US because sometimes massage treatments are euphemisms for prostitution and because people tend to like massage therapy even if they don’t “need it”.

    I suspect that in the US, the puritanical idea that anything that people like but don’t “need” can’t be “good medicine”. Especially if that thing that people like can be conflated with prostitution.

    Acupuncture has avoided being conflated with prostitution, and people don’t “like” acupuncture the way they like massage (and prostitution) and even though acupuncture doesn’t have the same positive effects that massage therapy does, there is a possibility that health insurance will pay for it.

  27. Calli Arcale April 13, 2011

    There appears to be a rogue italics element in here. I shall close it:

    Hopefully that worked, and further comments will not be italicized. ;-)

  28. Calli Arcale April 13, 2011

    Drat — well, I tried.

    Daedalus — I’m not sure massage is all that stigmatized. It’s more that it’s not primarily seen as medicine. It’s associated with spas and exotic vacations and rich people relaxing after a workout. It is also used as a cover for prostitution, yes, but most people think of massage as a luxury, as a way to treat oneself — like going out to a fine restaurant, or having your nails done, or buying a box of extra-special truffles and then scarfing the lot. It’s hard to equate it with real medicine when it’s primarily associated with luxury cosmetics, vacations, and, yes, romance and sex.

    Sidenote: there was a bust in my hometown recently, where the masseuses were openly offering happy endings to the male clients. They apparently didn’t realize that a hand job for pay counts as prostitution here, and consequently were fairly open about what they were doing. The vice officers who arrested them said it was the easiest case they ever investigated — no need to be coy to get them to offer the extra service. Another service in a nearby city was a little more difficult, as the madam was more savvy to what is and is not legal. The investigation only started because of noise complaints from neighboring businesses; she tried to spin the moans as the results of “deep tissue massage” and was very good at figuring out who was a cop. Eventually they got evidence, though, and put an end to it.

  29. Ed Whitney April 13, 2011

    @ Alison:

    You are correct; massage was better than acupuncture in one well-done study referenced by me earlier.

    The Cherkin 2001 article randomized patients to massage, acupuncture, and self-care. They measured symptoms and functional problems as their main outcomes. After follow-up at 4 week, 10 weeks, and 1 year, the massage group had lower symptom and disability scores than self-care, which in turn had lower scores than acupuncture.

    In contrast to the other acupuncture studies we have been talking about, this did not use a sham acupuncture group. Consequently, there was much more variation in how acupuncture was done than in those randomized trials where it was done by a standardized protocol. That is, it included stuff like infrared heat, cupping, and electrostimulation of the needles. Doesn’t seem to have helped the patients much in this instance, since acupuncture came off inferior to the other two groups.

    The massage group mostly got Swedish and deep tissue massage. Most massage therapists included “body awareness” techniques, which can make the clients aware of how they hold themselves, how they move, and how they can recognize early warning signals of injury. The massage practitioner had a choice of how to proceed, but the protocol specifically prohibited the use of so-called energy techniques like Reiki, and also prohibited stimulating meridian therapies like acupressure and Shiatsu.

    The self-care got a book and videotape with instructions on controlling and preventing pain and improving quality of life.

    Having a personal bias in favor of massage, especially combined with body awareness techniques, I had a favorable view of the study. When it comes to body awareness, for my money, Feldenkrais is the way to go.

    The social acceptance of massage is another issue. It was once illegal in Modesto, California, to have a professional massage practitioner come to people’s homes; that law was only repealed in 1990. Massage is pretty mainstream stuff now, and has been for decades.

  30. Karl Withakay April 17, 2011

    I didn’t realize that linking to this post would automatically generate a pingback/trackback that. Feel free to delete them as undesired clutter.

  31. nybgrus April 17, 2011

    I was wondering what the heck those were. I have noticed them on a few posts over time here and was utterly confused. I am not so savvy to these things as I’d like to be.