acupuncture https://scienceblogs.com/taxonomy/term/797/feed en A new nomenclature for auricular acupuncture: The ultimate in Tooth Fairy science https://scienceblogs.com/insolence/2017/08/25/a-new-nomenclature-for-auricular-acupuncture-the-ultimate-in-tooth-fairy-science <span>A new nomenclature for auricular acupuncture: The ultimate in Tooth Fairy science</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p><a href="http://www.dcscience.net/Colquhoun-Novella-A&amp;A-2013.pdf">Acupuncture is nothing more than a theatrical placebo</a>.</p> <p>I wish I could take credit for the term "theatrical placebo" to describe acupuncture, just as I wish I could take credit for coining the term "quackademic medicine" to describe the unfortunately increasing infiltration of quackery into academic medical centers and medical schools and as I wish I could take credit for the term "<a href="http://skepdic.com/toothfairyscience.html">Tooth Fairy science</a>" to <a href="https://sciencebasedmedicine.org/therapeutic-touch-pseudoscience-the-tooth-fairy-strikes-again/">describe</a> doing scientific studies on a phenomenon that has not been proven to exist, but alas I cannot. I can, however, use the terms as I see fit, even if it might annoy some believers in acupuncture and other alternative medicine modalities that have no definable, demonstrable effect on any disease or medical condition detectable in randomized controlled clinical trials.</p> <!--more--><p>I can take credit, however, for pointing out that the history of "traditional Chinese medicine" was <a href="https://sciencebasedmedicine.org/retconning-traditional-chinese-medicine/">retconned by Chairman Mao Zedong</a>. (I don't think anyone thought to borrow a term from comics and TV to describe the rewriting of history that Mao did to portray TCM as somehow being a single unified ancient and powerful system of medicine, so that he could sell it to his people (and later the world) as a viable alternative to "Western" medicine that should in fact be "integrated" into it. It's a <a href="http://scienceblogs.com/insolence/2017/01/23/first-china-next-the-world-the-chinese-government-gives-a-big-boost-to-traditional-chinese-medicine-just-like-chairman-mao-did/">process that's still going on today</a>. Indeed, as I like to say, Chairman Mao was the father of "integrative medicine," at least with respect to "integrating" TCM into science-based medicine despite the lack of evidence that much, if any, of it worked, except for the <a href="http://scienceblogs.com/insolence/2015/10/12/the-nobel-prize-versus-traditional-chinese-medicine/">occasional lucky guess</a>.</p> <p>However, as ridiculous as acupuncture can be, with its basis in ideas rooted in prescientific vitalism that claim that sticking needles into anatomically nonexistent "meridians" can somehow redirect the flow of "life energy" (qi) to heal, there is a form of acupuncture that is even more ridiculous than that, and it's auricular acupuncture. Basically, the idea behind auricular acupuncture is that there is a homunculus of the human body on the external ear, usually with the head near the earlobe and the feet near the triangular fossa (the upper part of the ear). Basically, in auricular acupuncture, an acupuncturist sticks smaller, shorter needles into the external ear, the location determined according to the homunculus to target the organ or body part that is diseased or in pain. This mapping generally corresponds to similar maps developed for that other form of homunculus-based quackery, reflexology. These are a couple of excellent examples of Tooth Fairy science, in which one studies the amount of money the Tooth Fairy leaves per tooth or the phases of the moon when she is most likely to come but never bothered to show that the Tooth Fairy exists in the first place. In this case, it is the existence of a homunculus mapping different organs to areas on the external ear that has never been demonstrated.</p> <p>Sadly, auricular acupuncture is the preferred form of acupuncture that's been adapted to "<a href="https://sciencebasedmedicine.org/acupuncture-invades-the-military/">battlefield acupuncture</a>" (I <a href="http://scienceblogs.com/insolence/2008/12/22/battlefield-acupuncture-revisited-only-t/">kid you not</a>), where our military (yes, our military) is training medics and other healthcare providers in its ranks to use auricular acupuncture right on the battlefield. Meanwhile, military hospitals and the <a href="http://scienceblogs.com/insolence/2017/01/27/quackery-at-the-va-our-veterans-deserve-real-medicine-not-fake-medicine/">VA medical system</a> are rapidly <a href="http://scienceblogs.com/insolence/2017/03/29/the-quackery-that-is-battlefield-acupuncture-continues-to-metastasize/">adopting the same quackery</a>.</p> <p>Here's an example of such a homunculus (click to embiggen):</p> <p><a href="/files/insolence/files/2017/08/fig1.jpg"><img src="http://scienceblogs.com/insolence/files/2017/08/fig1-271x450.jpg" alt="" width="271" height="450" class="aligncenter size-medium wp-image-11017" /></a></p> <p>Of course, alternative medicine being alternative medicine and quacks being quacks, there is no evidence for the above homunculus, and other maps have appeared, some quite complex, like this one:</p> <p><a href="/files/insolence/files/2017/08/Homu1.jpg"><img src="http://scienceblogs.com/insolence/files/2017/08/Homu1-350x450.jpg" alt="" width="350" height="450" class="aligncenter size-medium wp-image-11018" /></a></p> <p>So naturally, given the rapidly expanding complexity of their quackery, the quacks practicing auricular acupuncture need a new homunculus. They need a new system that can incorporate the rapidly expanding list of areas to map to the ear. Not surprisingly, there are quackademic medical "researchers" who are more than willing to provide just such a system. Behold, published online ahead of print in that repository of quackademic medicine, <em>The Journal of Alternative and Complementary Medicine</em>, a "study" that provides just what cutting edge auricular acupuncture researchers need, a <a href="http://online.liebertpub.com/doi/abs/10.1089/acm.2016.0351">New Universal Nomenclature of Auriculotherapy</a>. (No, I didn't capitalize that. The authors did. Humble, aren't they?) The authors, David Alimi, MD, and Jacques E. Chelly, MD, PhD, MBA, are both based at the University of Pittsburgh, in the Departments of Anesthesia (Alimi and Chelly) and Orthopedics (Chelly). I do find it appropriate that Dr. Chelly has an MBA, because, of course, the business possibilities for auricular acupuncture are endless.</p> <p>So what is the justification for needing a new system of nomenclature for auricular acupuncture? I'll let Alimi and Chelly explain:</p> <blockquote><p> Auricular acupuncture (Auriculotherapy) has gone through the centuries, and, in particular, the last 40 years, going from traditional to modern. By word of mouth, from empirical practice to efficient medicine, it was slowly approved, thanks to neuroimaging progress, and has become, at least, a part of neuroscience.</p> <p>Since the rediscovery of Auriculotherapy by Paul Nogier in 1957 in Lyon (France), and his brilliant vision of a fetus curled up in the ear pavilion, presaging the understanding of his somatotopic bases, modern neuroscientific knowledge has allowed us, as neurophysiologists, to bring understanding of the neurophysiological bases of its action.</p> <p>Since this scientific certification, its development, universal propagation, and academic education have never stopped developing, just like the multiplication of clinical and experimental study publications.</p> <p>After Dr. Paul Nogier's initial cartography of the ear, multiple cartographies have been developed by different authors/countries/schools. Until recently, the construct of these cartographies was anatomically based. Basically, the ear was divided in anatomic zones (helix, Antihelix, Tragus, Lobule, etc.) and each zone was subdivided in areas. This led to the description of each point by a letter referring to the zone and a number referring to an area within the zone.</p> <p>The World Health Organization (WHO) recognized it in 1987 and developed its first International Nomenclature in 1990 (Fig. 1). Its continuous development currently requires an update of its international standardization. </p></blockquote> <p>The WHO? Et tu, WHO? Sadly, it's true. The WHO did come up with a nomenclature for auricular acupuncture, which was <a href="http://apps.who.int/medicinedocs/documents/s7144e/s7144e.pdf">published in 1991</a>. It's a simultaneously depressing and hilarious read, pure pseudoscience, a blot on the WHO forever. Fortunately, I haven't been able to find anything on the WHO website like it that's more recent, other than a couple of papers that have references about auriculotherapy or auricular acupuncture in them.</p> <p>But what about Paul Nogier? Who is he? Or, rather, who was he, given that he died over 20 years ago? Well, helpfully, there is a website that tells all about him and how he "discovered" auricular acupuncture. I got a bad feeling about Nogier from the very first paragraph:</p> <blockquote><p> The XIXth and the XXth centuries were the centuries where the chemistry was omnipotent and where the medical therapy was based upon this chemistry. For every disease, a chemical drug. For every symptom, a molecule. It was very rare in the XXth century that someone explored new physical paths for therapy. Dr. Paul NOGIER, who received a formation as an engineer, looked at the individual with an eye of a physicist. He understood that the biological systems were not only sensitive to active chemical substances but also to physical stimulations. Therefore he systematically tried to find physical therapies to be used in the treatment in order to avoid the secondary effects of the chemical drugs. As soon as he graduated in medicine in Lyon, he focused his interest on homeopathy, as the homeopathic granule liberated from any chemical substance, finds its action through the physical electromagnetic information. Afterwards, he studied manual medicine and later acupuncture. </p></blockquote> <p>Yep. Even though he was a physician, Nogier was a practitioner of The One Quackery To Rule Them All, homeopathy. He was also into other forms of woo, like "energy medicine." Indeed, he <a href="http://www.mylighttherapy.com/nogier-frequencies.html">claimed to have discovered</a> "through painstaking research with the subtle energies of the body" three frequencies that "stimulate the creation of our body tissues." His "finding" with respect to this was described by Dr. Charles McGee, who attended one of Nogier's lectures in 1975:</p> <blockquote><p> He must have been astounded by the orderliness of a pattern he discovered. He found that specific body tissues were in resonance with specific frequencies according to their embryologic origin. … I believe this single finding will one day be recognized as one of the greatest discoveries of medicine, possibly worth a Nobel Prize for Nogier. </p></blockquote> <p>Vibrations. It's always the vibrations with quacks. I know I've said that before. Maybe I should say: <em>Le vibration. C'est toujours le vibration</em>. Oddly enough, poor Dr. Nogier died without ever being awarded a Nobel Prize.</p> <p>Vibrations or not, this next part will sound very familiar to those of you familiar with the history of chiropractic and how D.D. Palmer "discovered" chiropractic:</p> <blockquote><p> In 1951, Paul NOGIER received in his consultation a patient, who explained to him that he was relieved from a sciatica pain by a cauterisation on the ear carried out by a quack in Marseille, Madame BARRIN. Following this observation, Paul NOGIER examined the external ear and tried to understand why this strange cure took place. It will take him more than 30 years to ascertain the mechanisms of the ear properties. </p></blockquote> <p>Yep. A patient with a "miracle cure," although this miracle cure isn't as impressive as what Palmer claimed, the <a href="https://en.wikipedia.org/wiki/Chiropractic#History">cure of someone almost deaf by a "pop" in his spine</a>. Poor auricular acupuncture. It can't even come up with an impressive origin story, either. However, just like every good quack who invented a medical treatment (or, in this case, almost a system of medicine) out of whole cloth, Nogier has been portrayed as laboring many years to figure out that there supposedly exist points in the ear like acupuncture that appear as soon as "pain or functional disorder is provoked" in the body. Supposedly, these points can be detected either by pain sensitivity or with equipment designed to detect electrical impulses in the skin. According to Alimi and Chelly, it is known (obligatory Game of Thrones reference) that the surface of the external ear carries areas of lower resistance that appear in the case of the presence of a functional disorder. It is (also) known that "every point on the ear corresponds to a well defined part of the body" and that a "real cartography is present on the ear."</p> <p>Using that idea as a jumping off point, man, oh, man can the adherents of auricular acupuncture do up some sciencey quackademic medicine studies to justify their woo! In this case, Alimi and Chelly reported on how they used electronic database searches from 1958 to 2012 to find different formulations of Auricular Acupuncture Points (AAPs). They then claim to have studied brain dissections and to have "proved the neurophysiological correlations existing between auricular displays and their brain correspondences." Hilariously, they claim to have found that the middle of the corpus callosum (the structure that connects the two hemispheres of the brain) is the "epicenter of the somatotopic organization of the brain homunculus." Funny, but that's news to neuroscientists, I'm sure! In any case, the authors used this risibly unbelievable analysis to propose a new way to divide up the ear for purposes of auricular acupuncture. It involves a semicircle of an angular value of 180°, which they divided into 20 equal angles (that is, 9°. The called this the “Segmentogram,” which covers the totality of the surface of the auricle. Overall, this system divides the lateral ear in 189 areas and the medial ear in 89 areas. It's easier just to look at the illustrations (click to embiggen):</p> <p><a href="/files/insolence/files/2017/08/figure4.jpeg"><img src="http://scienceblogs.com/insolence/files/2017/08/figure4-450x379.jpeg" alt="" width="450" height="379" class="aligncenter size-medium wp-image-11019" /></a></p> <p><a href="/files/insolence/files/2017/08/figure5.jpeg"><img src="http://scienceblogs.com/insolence/files/2017/08/figure5-443x450.jpeg" alt="" width="443" height="450" class="aligncenter size-medium wp-image-11021" /></a></p> <p>And these areas of the ear supposedly map to organs and body parts (click to embiggen):</p> <p><a href="/files/insolence/files/2017/08/figure7.jpeg"><img src="http://scienceblogs.com/insolence/files/2017/08/figure7-450x342.jpeg" alt="" width="450" height="342" class="aligncenter size-medium wp-image-11022" /></a></p> <p><a href="/files/insolence/files/2017/08/figure9.jpeg"><img src="http://scienceblogs.com/insolence/files/2017/08/figure9-450x389.jpeg" alt="" width="450" height="389" class="aligncenter size-medium wp-image-11020" /></a></p> <p>It's really complicated; so it must be right, right?</p> <p>Wrong.</p> <p>There are no neuroanatomic correlates to suggest that there is any sort of mapping between body parts and organs to specific areas on the external ear. This is the ultimate in Tooth Fairy Science, which is basically doing studies on a phenomenon that has not yet been shown to exist. Sadly, there's a lot more where that came from in quackademic medicine.</p> </div> <span><a title="View user profile." href="/oracknows" lang="" about="/oracknows" typeof="schema:Person" property="schema:name" datatype="">oracknows</a></span> <span>Thu, 08/24/2017 - 21:44</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/education" hreflang="en">Education</a></div> </div> </div> Fri, 25 Aug 2017 01:44:03 +0000 oracknows 22611 at https://scienceblogs.com Emergency acupuncture! (2017 edition) https://scienceblogs.com/insolence/2017/06/20/emergency-acupuncture-2017-edition <span>Emergency acupuncture! (2017 edition)</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>If there's one form of quackery that is among the most "respected," it has to be acupuncture. I've often speculated about why this might be, and the best that I can come up with is that doctors are a bit more open to acupuncture because it involves sticking actual needles into the body. It's very easy to ignore the mystical, vitalistic BS about "redirecting the flow of qi" because doctors can easily handwave and postulate other, more scientific-sounding explanations, such as that it <a href="https://www.sciencebasedmedicine.org/acupuncture-and-endorphins-not-all-that-impressive/">releases endorphins</a> or <a href="http://scienceblogs.com/insolence/2010/06/01/when-what-an-acupuncture-study-shows-is/">adenosine</a>. If that doesn't work, then acupuncturists add electricity and thereby rebrand transcutaneous electrical nerve stimulation (TENS) as "<a href="http://scienceblogs.com/insolence/2015/08/26/acupuncture-bait-and-switch-hot-flash-edition/">electroacupuncture</a>." At the risk of being too anecdotal, a decade or two ago I was more open to acupuncture for this very reason. I never accepted idea that sticking needles into specific points somehow redirected the flow of a mystical, magical "life energy," but I could imagine that somehow sticking needles into the skin might "do something." What, I wasn't sure, but <em>something</em>. Of course, over the years, the more acupuncture studies and literature I read, the more I realized just how little "there" was there and how acupuncture is no more than a <a href="http://www.dcscience.net/2013/05/30/acupuncture-is-a-theatrical-placebo-the-end-of-a-myth/">theatrical placebo</a>.</p> <!--more--><p>One thing that I've always had a hard time understanding about acupuncture advocates is their desire to represent acupuncture as a useful treatment modality for emergency situations. The first time I encountered this sort of thinking was nearly ten years ago, when I first learned of "<a href="http://scienceblogs.com/insolence/2008/03/19/woo-invades-the-military/">battlefield acupuncture</a>." Yes, it is exactly what it sounds like, and unfortunately it's becoming more common in the military. Indeed, it was less than three months ago that I described how <a href="http://scienceblogs.com/insolence/2017/03/29/the-quackery-that-is-battlefield-acupuncture-continues-to-metastasize/">flight surgeons are being trained</a> in the technique, to be used on wounded soldiers in Afghanistan and wherever US troops are in harm's way. Then there's "emergency acupuncture," which is, as it sounds, the use of acupuncture in the emergency room. I've <a href="http://scienceblogs.com/insolence/2016/08/02/emergency-acupuncture/">deconstructed various studies</a> of acupuncture use in the emergency room over the years, and it never ceases to amaze me how any emergency medicine physician could think this was a good idea. Well, here's another one out of Australia by Cohen et al entitled, <a href="https://www.mja.com.au/system/files/2017-06/10.5694mja16.00771_amended.pdf">Acupuncture for analgesia in the emergency department: a multicentre, randomised, equivalence and non-inferiority trial</a>.</p> <p>Before I dig into the study itself, I often like to look at how the study is being reported in the press. The Conversation let the first author of the paper, Marc Cohen, Professor of Health Sciences, RMIT University, to basically pimp his paper's findings under the title <a href="https://theconversation.com/emergency-doctors-are-using-acupuncture-to-treat-pain-now-heres-the-evidence-79430">Emergency doctors are using acupuncture to treat pain, now here’s the evidence</a>. It's basically a recounting of the study itself, touting it as the "largest of its kind in the world," as though size guaranteed scientific rigor. First, he notes:</p> <blockquote><p> Using acupuncture to relieve pain involves placing needles in various parts of the body to stimulate the release of endorphins and other neurochemicals, which can act as the body’s naturally occurring pain relievers.</p> <p>For generations various cultures around the world have used acupuncture to treat multiple conditions, including providing pain relief. And in Australia, it is reimbursed through the Medicare Benefits Schedule when administered by a medical doctor. </p></blockquote> <p>Of course, this is just the usual nonsense acupuncture apologists routinely lay down as a justification for their theatrical placebo. It's basically handwaving and impressive, sciencey-sounding babble. He does, however, provide a succinct explanation of what an "equivalence" or "non-inferiority" study is:</p> <blockquote><p> Our trial was an “equivalence” study, which means we aimed to see if the different treatments were equivalent rather than seeing if they were better than placebo. We did this as it would not be ethical to give a placebo to people coming to an emergency department for pain relief. </p></blockquote> <p>This is, of course, a reasonable enough rationale to run a non-inferiority study. It's the reason most such studies are run, because, for whatever reason (usually ethical), a placebo control arm can't be used. I also note that this is a pragmatic trial as well. The idea is to show that the novel treatment is not inferior to existing standard-of-care treatments. What is usually done is to decide upon a non-inferiority margin, which is basically how much different by whatever scale measured than control an effect has to be before it is considered clinically inferior. It's also reasonable to do a randomized controlled clinical trial using a design appropriate for a non-inferiority trial. Those are the pluses of the trial, such as they are. And, yes, it's a decent-sized trial, although by no means really large. Indeed, that this is being touted as the largest such trial of its kind in the world rather speaks poorly of the state of acupuncture research. In any case, the study involved 1,964 patients who were assessed between January 2010 and December 2011, resulting in the randomization of 528 patients with acute low back pain (270 patients), migraine (92) or ankle sprain (166) were randomised to acupuncture alone (177 patients), acupuncture plus pharmacotherapy (178) or pharmacotherapy alone (173). (1,112 patients did not meet inclusion criteria, and 324 declined to participate.) The study itself was carried out at four different tertiary hospitals in Melbourne, Australia. Finally, the primary outcome measure assessed was pain at one hour (called T1 in the study). Clinically relevant pain relief was defined as achieving a pain score on a 10-point verbal numerical rating scale (VNRS) below 4, and statistically relevant pain relief as a reduction in VNRS score of greater than 2 units.</p> <p>The interventions themselves included:</p> <blockquote><p> <strong>Acupuncture alone.</strong> Acupuncture was provided by either a registered Chinese medicine practitioner or an ED physician with medical acupuncture qualifications. Treatment protocols (online Appendix), determined by a panel of specialist acupuncturists, provided predetermined points for each condition, as well as additional points for individualising treatment.</p> <p><strong>Pharmacotherapy alone.</strong> Pharmacotherapy was administered according to a standardised protocol based on the relevant national guidelines of the National Institute of Clinical Studies and the National Health and Medical Research Council. This protocol included first and second line drugs, as well as rescue medication administered at the discretion of the treating physicians, regardless of group allocation.</p> <p><strong>Combined treatment.</strong> Combined therapy included both acupuncture and pharmacotherapy, with acupuncture administered 15 minutes before or after pharmacotherapy to maintain blinding of the acupuncturist. </p></blockquote> <p>You can see the pragmatic trial design. The acupuncturists could individualize treatment within limits, and pharmacotherapy could also be personalized within the context of Australian national guidelines for the pharmacotherapy of pain. Here I consider it important to mention that I've discussed the use of pragmatic trials in acupuncture more times than I can remember. There is one requirement for a pragmatic trial, and it's a requirement for a <a href="http://www.rds-sc.nihr.ac.uk/planning-a-study/study-design/quantitative-studies/clinical-trials/non-inferiority-trials/">non-inferiority trial as well</a>. That requirement is that the novel modality being tested against standard-of-care must already have been demonstrated to work in randomized clinical trials. As much as acupuncturists like to try to claim that acupuncture has been shown to work for the various health issues for which it is used, in reality when you look closely it's not hard to see that the studies are <a href="http://scienceblogs.com/insolence/2012/09/12/can-we-finally-just-say-that-acupuncture-is-nothing-more-than-an-elaborate-placebo-can-we-2012-edition/">most consistent with acupuncture</a> "working" through placebo effects, not through any specific physiologic effect. As I like to say when discussing acupuncture studies, doing pragmatic studies on acupuncture is putting the cart before the horse. The same is true of non-inferiority studies. Show that acupuncture works in randomized clinical trials first, and then do the pragmatic or non-inferiority trials, if applicable.</p> <p>So back to this study. There's another aspect to the design of the study that should make you immediately question its results. Before I get to that, I'll tell you the results. Quite predictably the trial showed noninferiority. Basically, acupuncture was not detectably inferior in short turn pain relief in any of the conditions tested. Depressingly, overall, only 16% of patients had clinically relevant pain relief and 36.9% statistically relevant pain relief at T1. That's a rather low number. Then there was no statistically significant differences between the three groups. Now what would you think if I were to tell you that this was only a single-blind study. Neither the patients nor the practitioners were blinded to experimental group. Those who assessed pain scors were blinded, and so were the statisticians who carried out the analysis. Thus, the potential for placebo effects was maximized.</p> <p>There's also another little tidbit buried in the results that no one seems to be reporting on, and that's the use of rescue analgesics. "Rescue" therapy is additional therapy given at the discretion of the treating physician after the primary therapy, usually because there hasn't been sufficient improvement. In the case of this study:</p> <blockquote><p> The acupuncture only group received significantly more rescue medication therapy than the groups that received pharmacotherapy(at T1: p=0.016; after T1: p=0.008; Box 6). Oral opiate medication was offered as first line rescue medication to patients in the acupuncture group and parenteral opiates to the two pharmacotherapy groups. </p></blockquote> <p>Basically, the acupuncture-only group was nearly twice as likely to require rescue opioids as pharmacotherapy alone after T1. To me this suggests that acupuncture doesn't work for the types of pain for which it was being tested. The authors grudgingly concede this possibility too, but can't help but adding some hand waving trying to explain this result:</p> <blockquote><p> While pain reduction at T1 was similar for all three groups, patients in the acupuncture group were almost twice as likely to receive rescue analgesia. This may indicate that acupuncture was ineffective and patients sought alternative analgesia or that they were more likely to accept pharmacotherapy because they felt they had missed out on standard care, whereas patients who had already received oral opiates were reluctant to accept parenteral opiates. Patients treated with acupuncture who received rescue medication were classified as having received pharmacotherapy in the PP analysis, in which the equivalence and non-inferiority of groups were maintained, but we cannot discount the possibility that this may partly reflect the potentially self-limiting nature of the treated conditions. </p></blockquote> <p>So, basically what we have here is a pragmatic non-inferiority study that is only single blinded that purports to find no difference between acupuncture and pharmacotherapy for several different kinds of pain with different etiologies. (Seriously, migraine headaches are very different from ankle sprains and low back pain.) The lack of full double-blinding easily explains the positive result of the trial as very likely due to placebo effects, after all. Moreover, this study finds significantly increased use of rescue treatments for the acupuncture-alone group, which implies that the the subjects in the acupuncture-alone group were not getting adequate pain relief.</p> <p>Of course, none of this tops the authors from concluding:</p> <blockquote><p> There is a clear demand for analgesia in the ED and a multimodal approach is desirable given concerns about the use of opioids and the potential for addiction. Some Australian EDs already offer acupuncture as an alternative when trained staff are available, and the relative efficacy, acceptability and safety of acupuncture support its playing a role in non-pharmacological analgesia in acute care settings. Acupuncture may also improve patient satis- faction by providing analgesia to patients with contraindications for certain drugs, and for those who prefer acupuncture. Pain management in EDs in general must be improved. The potential role of acupuncture should also be further explored, including determining the conditions in which it is most useful and the feasibility of employing it in emergency settings, including acupuncture training for emergency physicians and allied health personnel. </p></blockquote> <p>I'll agree that there's a clear demand for effective analgesia in the emergency room, although for short term use for pain relief opioids are acceptably safe. Increasingly, there has been a narrative among advocates of "integrative medicine" that equates nonpharmacological methods of pain management with woo. What this study does is basically to use the opioid epidemic as an excuse for embracing quackery. Quackademic medicine marches on.</p> </div> <span><a title="View user profile." href="/oracknows" lang="" about="/oracknows" typeof="schema:Person" property="schema:name" datatype="">oracknows</a></span> <span>Tue, 06/20/2017 - 01:53</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/medicine" hreflang="en">Medicine</a></div> </div> </div> Tue, 20 Jun 2017 05:53:53 +0000 oracknows 22571 at https://scienceblogs.com Quackery invades another once science-based journal https://scienceblogs.com/insolence/2017/05/30/quackery-invades-another-once-science-based-journal <span>Quackery invades another once science-based journal</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>Surprisingly, I made it through an entire three day weekend without posting anything to the blog. Believe it or not, this is a good thing. It means that I actually worked on my grant that's due at the end of the week. Still, a blogger's gotta blog; so I can't just shut down until the end of the week. So, hwere we go.</p> <p>I've long lamented the <a href="http://scienceblogs.com/insolence/2017/03/08/hallelujah-the-mainstream-press-finally-notices-quackademic-medicine/">creeping infiltration of quackery into medical academia</a> in which modalities once considered quackery, such as acupuncture, reiki, naturopathy, homeopathy, and various other dubious treatments, have found their way into what should be bastions of science-based medicine (SBM). Over the years, I've noted the proliferation of "integrative medicine" programs and <a href="http://scienceblogs.com/insolence/2011/05/23/dr-andrew-weil-versus-evidence-based-med/">residencies</a> in medical academia, and <a href="https://sciencebasedmedicine.org/integrative-oncology-the-trojan-horse-that-is-quackademic-medicine-infiltrates-asco/">professional conferences</a>, the credulous teaching of "complementary and alternative medicine" (CAM) modalities as part of the normal medical school curriculum. (Georgetown University <a href="http://scienceblogs.com/insolence/2015/07/31/a-portrait-of-quackademia-triumphant-georgetown-university/">even had a program where acupuncture meridians and points were taught during gross anatomy</a>.) Basically, CAM has been a <a href="https://sciencebasedmedicine.org/the-trojan-horse-called-integrative-medicine-arrives-at-another-medical-school/">Trojan horse</a> for quackery in which appeals to more "humanistic" medicine and emphasis on diet and exercise have lured medical schools to bring the <a href="https://sciencebasedmedicine.org/integrative-oncology-trojan-horse-quackademic-medicine-or-both/">giant horse</a> in, after the doors on the bellies of the Trojan horses opened to disgorge quackery such as naturopathy, homeopathy, acupuncture, reiki, and even <a href="http://scienceblogs.com/insolence/2011/03/21/anthroposophic-medicine-at-the-universit/">anthroposophy</a>.</p> <!--more--><p>Besides the enthusiastic embrace of quackery by large, respected academic institutions like the Cleveland Clinic and Memorial Sloan-Kettering Cancer Center, this "integration" of quackery with medicine has manifested itself in medical journals. Once hard-nosed, science-based medical journals have, unfortunately, started publishing what can only be described as credulous endorsements of quackery. Indeed, I've documented many examples of this shameful phenomena over the years, but I'm about to document a whopper of an example now in, of all places, <cite>The BMJ</cite>, which has recently published two "state of the art reviews" on "integrative medicine" that can only be described as fully buying into the false paradigm that quackery needs to be "integrated" with medicine. The first "state of the art review is about the <a href="http://www.bmj.com/content/357/bmj.j1284">management of chronic pain using complementary and integrative medicine</a> by Lucy Chen from the Massachusetts General Hospital Center for Translational Pain Research and Andreas Michalsen from the Institute for Social Medicine, Epidemiology and Health Economics and Immanuel Hospital in Berlin. The second is about <a href="http://www.bmj.com/content/357/bmj.j1805">complementary and integrative medicine in the management of headache</a> by Denise Millstine, Christina Y Chen, and Brent Bauer, all from the Mayo Clinic. Sadly, both <a href="https://sciencebasedmedicine.org/harvard-medical-school-veritas-for-sale-part-vi/">Harvard</a> and the Mayo Clinic have become bastions of quackademic medicine.</p> <h2>The evolving language of "integrative medicine"—or whatever they're calling it this week</h2> <p>One of the most striking things about both of these articles is the term their authors chose to use to describe what was once "CAM" or "integrative medicine": "complementary and integrative medicine" (CIM). It's an odd choice that seems a bit out of sync with what is going on in quackademic medicine these days, as I will describe. But first, let's take a look at what I'm referring to.</p> <p><a href="http://www.bmj.com/content/357/bmj.j1284">Chen and Michalsen describe it thusly</a>:</p> <blockquote><p> The concept of complementary and integrative medicine (CIM) encompasses both Western-style medicine and complementary health approaches as a new combined approach to treat a variety of clinical conditions. CIM may have a unique role in chronic pain management because the multidimensional nature of the pain experience requires a multimodality treatment approach. Recent advances in basic science and clinical research on CIM have substantially increased patients’ awareness about the potential therapeutic use of CIM. </p></blockquote> <p>Note the false dichotomy, in which "Western" (i.e., European) tradition is presented as scientific, reductionistic, and lacking in humanism, compared to "CIM," which is the opposite.</p> <p>I've been noticing a new step in the evolution of language about CAM, and this is another part of it. It first struck me when the National Center for Complementary and Alternative Medicine (NCCAM) <a href="http://scienceblogs.com/insolence/2014/12/18/congress-polishes-the-turd-that-was-nccam/">first proposed renaming itself</a> to the National Center for Research on Complementary and Integrative Health. The actual name NCCAM took, as we all know now, was the National Center for Complementary and Integrative Health (NCCIH). This is just the latest iteration of rebranding quackery to try to make it respectable by calling it something else, and the <cite>BMJ</cite> articles contribute to this rebranding. Let's look a bit at the history.</p> <p>Around a quarter century or so ago, as part of a conscious effort to make quackery respectable, the term alternative medicine morphed into "complementary and alternative medicine" (CAM). The process continued, such that around 15 years or so ago, the term "CAM" then "evolved" into "integrative medicine." Each name change was an intentional use of language that served two purposes. First and foremost, the goal of CAM advocates has been for their pseudoscientific treatments like acupuncture, reiki, "functional medicine," and the like to come to be seen by physicians and the public as legitimate medicine, rather than the rank quackery that many of them are. Second, such terms have facilitated the co-optation of real, science-based treatments (such as those involving dietary manipulation and exercise) as somehow being "alternative" or "integrative." The reason, whether acknowledged or not, for lumping such treatments together with quackery is because "lifestyle" treatments (such as diet and weight loss for early type II diabetes) can be science-based and can work. They thus provide a patina of respectability to all the other nonsense that gets lumped together with them as "complementary" or "integrative."</p> <p>It's telling to note how the terms evolved. I've discussed this in detail on several occasions over the years, but it's worth a brief recap. Way back in the mists of time (say, the 1980s) there was alternative medicine. Alternative medicine was (and, when the term is used, still is) medicine that does not fit into the current scientific paradigm, a term used to describe medical practices that were not supported by evidence, were ineffective and potentially harmful, and were used instead of effective therapies. Instead of giving up therapies without evidence to support them, however, alternative medicine practitioners rebranded them as "complementary and alternative medicine" (CAM). Over a relatively brief period of time, the name change had its intended effect. No longer did many physicians automatically view modalities that were once considered quackery, later considered “alternative,” and now considered “CAM” as quackery, and those who still did were dismissed as close-minded, stubborn, and dogmatic, relics who were trying to stop what was clearly the future of medicine. The term "complementary", however, soon became a problem.</p> <p>Thus, back in the mists of time (say around the late 1990s to early 2000s) was born a new term: "integrative medicine." No longer were CAM practitioners content to have their favorite quackery be “complementary” to real medicine. After all, “complementary” implied a subsidiary position. Medicine was the cake, and their wares were just the icing. That wasn’t good enough. They craved respect. They wanted to be co-equals with physicians and science- and evidence-based medicine. The term “integrative medicine” (IM) served their purpose perfectly. No longer were their treatments merely “complementary” to real medicine. The very intentional implication, was that alternative medicine was now co-equal to science- and evidence-based medicine, an equal partner in the “integrating," and that "integrative medicine" combined the "best of both worlds" (<a href="http://memory-alpha.wikia.com/wiki/Locutus_of_Borg">Cue the Locutus of Borg jokes</a>). Of course, I like to refer to such "integration" of pseudoscience into medical academia as "quackademic" medicine.</p> <p>Then came the NCCIH, which broadened the term to gauzy near-meaninglessness. "Integrative health"? Just what the heck is that? Why get rid of the word "medicine"? Obviously, the intent was to expand the meaning to encompass nearly anything health-related and to further blunt any concerns that pseudoscience is being used instead of SBM (although, contrary to what CAM promoters claim, <a href="https://sciencebasedmedicine.org/myths-integrative-medicine-sells-us-part-1-we-never-advocate-alternative-medicine-without-conventional-medicine/">it is</a>). Indeed, I've started noticing the term "integrative health" popping up more and more, supplanting "integrative medicine."</p> <p>All of this is why I found the choice of the term "CIM" to be so odd. Thus far, every step in the evolution of nomenclature for CAM or "integrative medicine" (or whatever you want to call it) has been to make it more and more indistinguishable from real medicine, to lessen its dependence on real medicine, to sell the pseudoscientific modalities embraced by integrative medicine as being co-equal with real SBM. As part of that messaging and rebranding, CAM has positioned itself as a means of <a href="http://scienceblogs.com/insolence/2016/09/12/nccih-co-opting-nonpharmacologic-treatments-for-pain-as-being-alternative-or-complementary/">"nonpharmacologically managing" pain</a> and a large part of any potential solution to the opioid addiction epidemic, messaging that's been <a href="https://sciencebasedmedicine.org/nccam-versus-integrative-medicine-whats-in-a-word/">going on at least five years</a>, is <a href="http://scienceblogs.com/insolence/2016/04/11/meet-the-new-nccih-five-year-strategic-plan-same-as-the-old-nccam-five-year-strategic-plan/">part of the NCCIH's strategic plan</a>, and has been so successful that <a href="http://scienceblogs.com/insolence/2017/05/22/tell-the-fda-not-to-embrace-quackery-write-to-oppose-its-proposal-on-acupuncture-and-chiropractic-for-chronic-pain/">even the FDA is buying into it</a>. Going from "integrative medicine" to "complementary and integrative medicine" would seem to be a step backward, a step back towards terminology in which SBM is the real medicine and "CIM" is just the icing on the cake.</p> <p>Millstine et al <a href="http://www.bmj.com/content/357/bmj.j1805">explain it this way</a>:</p> <blockquote><p> Conventional treatments, particularly drugs, are often effective in resolving acute headaches and reducing the frequency of chronic or recurrent headaches. However, many patients turn to complementary and alternative medicine (CAM) for greater improvement. CAM has evolved over time but it generally includes treatments that are not typically considered part of conventional medicine. Examples include massage therapy, acupuncture, mind-body medicine, and the use of botanicals and supplements. The distinction between CAM and conventional medicine, however, is not always clear, as is the case with several over the counter supplements now commonly recommended by conventionally trained providers, such as magnesium supplements in migraine.</p> <p>However, partly as a result of research support by organizations such as the National Center for Complementary and Integrative Health (NCCIH), a growing body of literature has shown that many CAM therapies are effective when used in conjunction with conventional care.<sup>3</sup> This has led to the use of the more appropriate term, complementary and integrative medicine (CIM), reflecting the fact that evidence based CAM therapies are increasingly being incorporated into conventional care. The Academic Consortium for Integrative Medicine and Health notes that integrative medicine “reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic and lifestyle approaches, healthcare professionals and disciplines to achieve optimal health and healing.” </p></blockquote> <p>My head hurts after reading that. After all, the term "CAM" was originally coined to assuage the doubts of doctors who feared that alternative medicine was being used <em>instead of</em> conventional SBM. That was the very purpose of the term. One of the references the authors cite is an NCCIH web page entitled "<a href="https://nccih.nih.gov/health/providers/digest/chronic-pain-science">Complementary Health Approaches for Chronic Pain: What the Science Says</a>." Let's just say that it doesn't really provide compelling evidence that "many CAM therapies are effective when used in conjunction with conventional care." Even if it did, the renaming is still…curious. In essence, it does what we have been doing all along here and equates the word "integrative" with "alternative." In essence, it almost admits to the linguistic prestidigitation that turned "complementary and alternative" to "integrative" medicine. One wonders if a lone science-based holdout editor at the <cite>BMJ</cite> forced the authors to use this term as a subtle joke. Whatever the reason for the term CIM, Edzard Ernst agrees with me that "CIM" is a <a href="http://edzardernst.com/2017/05/alternative-medicine-for-chronic-pain-state-of-the-art-review-in-the-bmj/">nonsensical term</a>.</p> <p>But what do the articles say?</p> <h2>One more time: Nonpharmacologic treatments for pain ≠ CAM, CIM, or whatever it's called</h2> <p>The article by Chen and Michalsen on CIM for pain is long. It clocks in at well over 18 pages, although over five of those pages are references, which brings up something that Ernst also mentioned, namely how much the authors strive to give the appearance of scholarship. After all, a lengthy references section equals strong scholarship, right? Wrong. To cite an extreme example, I can point to antivaxers who write articles with dozens of references. Indeed, one of them, Ginger Taylor, likes to list well over 100 references that supposedly support her view that vaccines cause autism. <a href="http://lizditz.typepad.com/i_speak_of_dreams/2017/05/are-there-131-papers-that-support-vaccineautism-causation-papers-91-131.html">They don't</a>, as the articles she cites as supporting a causative role for vaccines in autism do nothing of the sort and the ones that she cites that do support a causal role are uniformly crap. No, I'm not saying that Chen and Michaelsen were that bad. I only chose the example I did as a very extreme example. I mean only to point out that quantity of references do not equal high quality science and to reinforce <a href="http://edzardernst.com/2017/05/alternative-medicine-for-chronic-pain-state-of-the-art-review-in-the-bmj/">Ernst's point</a> that this article left out a whole lot of negative studies, cherry picking "only evidence for the efficacy of the treatments they promote."</p> <p>One thing that struck me about this review is that it was weighted very heavily towards either rheumatoid arthritis or studies of back or neck pain, which is not entirely unreasonable given that back and neck pain are very common. Another thing that struck me about this article right away is that it is how heavily weighted towards acupuncture it appears, with a large table of studies that supposedly establish efficacy of acupuncture for pain. Fortunately, I just <a href="http://scienceblogs.com/insolence/2017/05/22/tell-the-fda-not-to-embrace-quackery-write-to-oppose-its-proposal-on-acupuncture-and-chiropractic-for-chronic-pain/">wrote about acupuncture last week</a> and <a href="http://scienceblogs.com/insolence/2017/05/15/acupuncturists-mistake-insufficient-rigor-for-bias-against-them/">a couple of weeks before that</a>, so I don't have to go into much detail as to why the evidence cited does not support the efficacy of acupuncture for pain. Basically, the larger and better designed the clinical trial, the <a href="http://scienceblogs.com/insolence/2017/05/19/acupuncture-versus-science-acupuncture-apologist-edition/">less likely it is to show an effect of acupuncture above placebo</a>. Acupuncture is <a href="http://www.dcscience.net/Colquhoun-Novella-A&amp;A-2013.pdf">theatrical placebo</a>.</p> <p>None of this stops Chen and Michalsen from enthusiastically embracing it, even buying into the multiple odd ways that acupuncturists combine acupuncture with other "treatments," from potentially science based (electroacupuncture, which is really just transcutaneous electrical nerve stimulation, or TENS, with needles) to bee venom:</p> <blockquote><p> <em>Bee venom acupuncture</em> falls into the category of herbal acupuncture, which combines the effect of bioactive compounds isolated from bee venom with acupuncture stimulation. Several meta-analyses found limited evidence assessing its effectiveness. Pain was lowered significantly more with bee venom acupuncture than saline acupuncture (n=112; weighted mean difference on 100 mm visual analog scale 14.0, 95% confidence interval 9.5 to 18.6, mm; P&lt;0.001). However, the limited number, low quality, and small size of the RCTs make drawing conclusions difficult.<sup>73‑75</sup></p></blockquote> <p>This is basically a very silly and unreliable way of administering a potentially pharmacologically active compound.</p> <p>Another section of the review covers "mind-body" therapies. I always find this category problematic, because, as is the case with much "CIM," it lumps together techniques that could be science-based, such as exercise, with other modalities that are probably not. Inevitably, the "body" part of mind-body modalities always emphasizes "exotic" forms of exercise, such as tai chi, quigong or yoga, over more mundane forms, such as walking or gentle aerobic exercise. For instance, early mobilization is recommended in the treatment of back pain now, and these forms of exercise are just more "sexy" ways of achieving that. In any event, the best that Chen and Michalsen could conclude is that yoga and tai chi might be beneficial, while the evidence for qigong was more conflicting.</p> <p>Chen and Michalsen are also very much taken with supplements, herbal medicines, and dietary manipulations. For instance, they recommend the Mediterranean diet, citing a small randomized controlled trial and a larger nonrandomized controlled trial as evidence of its efficacy, both of which were thin-gruel indeed, scientifically speaking. Unfortunately, they also included a dubious dietary intervention, elimination diets:</p> <blockquote><p> Among a broad variety of food and nutrients that are associated with increases in disease activity, meat, milk and dairy products, wheat gluten, citrus fruit, alcohol, and coffee are ranking high.<sup>172 173</sup> Doctors may encourage patients to find individual associations and try individual elimination after confirmation by re-challenging. Clinical research in elimination diets is difficult and complex to perform. So far, only one RCT with 53 patients has examined the concept of an elimination diet with a complex study design, including an initial washout period and specific responder analyses.<sup>188</sup> Foods least likely to cause intolerance were reintroduced first in a stepwise manner, and any foods inducing symptoms of rheumatoid arthritis were removed from the diet. There was a significant reduction in pain with the diet in both groups during the dietary elimination phase, but differences between groups were not reported. </p></blockquote> <p>Elimination diets are a favorite of naturopaths who like to think that all disease is traceable to diet or various food "allergies." It's at best dubious and at worst quackery. (Let's just put it this way; <a href="http://www.macleans.ca/society/health/its-all-good-actually-gwyneth-paltrows-new-cookbook-borders-on-quack-science/">Gwyneth Paltrow is a fan</a>.) Elimination diets are <a href="http://www.cmaj.ca/content/184/6/666">rarely based on properly conducted allergy testing</a>. Indeed, the testing used to determine what foods to "eliminate" is <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3443017/">not scientifically supported</a>.</p> <p>If you want an idea of how credulous Chen and Michalsen are, look no further than this passage:</p> <blockquote><p> This treatment was evaluated in a cohort study and a further prospective non-randomized comparative study. The comparative study included 86 patients with back pain and compared a complex anthroposophical therapy with the standard approach, finding comparable improvements in both groups after six and 12 months for pain, function, and quality of life.<sup>214</sup> A longer term cohort study that assessed effects of anthroposophical medicine in 75 patients with chronic back pain found sustained benefits after two years.<sup>215</sup> Future randomized trials are warranted. </p></blockquote> <p>Anthroposophic medicine is mystical hooey created by Rudolf Steiner. It's a medical "system" (if you can call it that) that is at the bottom of a lot of <a href="http://www.quackwatch.com/11Ind/steiner.html">quackery</a> and <a href="https://web.archive.org/web/20080624075259/http://www.blacktriangle.org/blog/?p=879">antivaccine beliefs</a>. It also encompasses <a href="http://scienceblogs.com/insolence/2007/02/23/your-friday-dose-of-woo-old-macdonald-ha/">biodynamic farming</a>, which involves actions like stuffing cow manure into the horn of a cow and burying it in the autumn, leaving it to decompose during the winter, and taking crushed powdered quartz and stuffing it into a horn of a cow to bury in the spring until autumn, supposedly to control fungal diseases. <a href="http://scienceblogs.com/insolence/2007/05/18/your-friday-dose-of-woo-old-macdonald-ha-2/">You get the idea</a>. No wonder I was so depressed when anthroposophic medicine <a href="http://scienceblogs.com/insolence/2011/03/21/anthroposophic-medicine-at-the-universit/">showed up at my old alma mater</a>.</p> <p>Any review that takes anthroposophic medicine seriously is not a serious review.</p> <h2>All this woo is giving me a headache</h2> <p>The <a href="http://www.bmj.com/content/357/bmj.j1805">second review, by Millstine et al</a>. suffers from many of the same issues as Chen and Michalsen's review. For instance, it is very much as acupuncture-heavy and credulous. It even goes into auricular acupuncture, explaining it thusly:</p> <blockquote><p> Hand, ear, and scalp acupuncture can be more accessible than traditional acupuncture in various clinical settings. The ear holds a microsystem of the body, where stimulation of specific points on the external surface of the ear may provide therapeutic relief of symptoms that are connected to the body system (fig 2).<sup>28</sup> Ear acupuncture, for example, can be performed quickly with the patient sitting upright and fully clothed. An RCT of 94 women with migraine without aura compared ear acupuncture in a therapeutic area with treatment in an area deemed unlikely to be beneficial. VAS was significantly reduced 10 minutes after needle insertion time and the effect lasted for two hours (P&lt;0.001).<sup>29</sup> Another RCT compared ear acupuncture with traditional acupuncture in 35 patients with migraine without aura. The severity of pain (using the migraine index) was reduced after eight weeks of weekly treatments; it was significantly improved from baseline and both groups were comparable after treatment and three months later (residual pain 54.83% and 63.43% for somatic and ear acupuncture, respectively). After six months residual pain was 16.80% and 48.83% for somatic and ear acupuncture, respectively (P=0.038). These results were confirmed by the visual analog scale test and by the evaluation of pain threshold.<sup>30</sup></p></blockquote> <p>My brain tuned out after I read the part about the ear holding "a microsystem of the body" and how "stimulation of specific points on the external surface of the ear may provide therapeutic relief of symptoms that are connected to the body system." Actually, my brain didn't tune out enough not to notice that <a href="https://www.ncbi.nlm.nih.gov/pubmed/23409612">the trial cited</a> appears to have had no sham control group and compared regular acupuncture to auricular acupuncture. I don't have online access to the journal in which the article was published, but it also appears not to have been double-blinded. Placebo effects are therefore highly suspected as the reason for the results. (Yes, this appears to have been a comparative effectiveness trial.) Back to the silliness of ear acupuncture. Remember, auricular acupuncture basically assumes a <a href="http://www.acuwatch.org/reports/auriculotherapy.shtml">homunculus on the ear</a> whose parts map to organs and other body parts. It is just as scientific as reflexology, and reflexology is utter pseudoscience. Millstine et al. leave out the homunculus, but they do include an illustration of an ear that shows parts of the ear mapping to the same parts that the traditionally drawn homunculus does. Despite its <a href="http://scienceblogs.com/insolence/2008/12/22/battlefield-acupuncture-revisited-only-t/">utter pseudoscience</a>, unfortunately there are military advocates who are successfully integrating auricular acupuncture into the treatment of wounded soldiers and <a href="http://scienceblogs.com/insolence/2017/01/27/quackery-at-the-va-our-veterans-deserve-real-medicine-not-fake-medicine/">veterans</a> in <a href="http://scienceblogs.com/insolence/2016/07/25/the-va-and-dr-tracy-gaudet-integrating-quackery-into-the-care-of-veterans/">general</a> as "<a href="https://sciencebasedmedicine.org/acupuncture-invades-the-military/">battlefield acupuncture</a>." It's been a wildly <a href="http://scienceblogs.com/insolence/2017/03/29/the-quackery-that-is-battlefield-acupuncture-continues-to-metastasize/">successful effort</a>, unfortunately.</p> <p>The rest of the review reads very much like that of Chen and Michalsen, listing "mind-body" interventions, botanicals, diet, and the like, with very little compelling evidence presented for efficacy and no mention at all of the extreme implausibility of so many of the treatments. In doing so, Millstine et al. propagate the idea that there's something about diet and exercise that is somehow "integrative" or "complementary" when dietary interventions and exercise, when used in a manner supported by sound science and evidence, are just medicine.</p> <p>None of this stops Millstine et al. from concluding:</p> <blockquote><p> The use of CIM therapies has the potential to empower patients and help them take an active role in their care.<sup>90 91</sup> Many CIM modalities, including mind-body therapies, are both self selected and self administered after an education period. This, coupled with patients’ increased desire to incorporate integrative medicine, should prompt healthcare providers to consider and discuss its inclusion in the overall management strategy. </p></blockquote> <p>Wait a minute. The evidence base for CIM strategies for migraine is low quality, but providers should recommend it because they "empower" patients and help them take an active role in their care? What a false dichotomy! Empowering patients and getting them to take a more active role in their own care do not require prescribing unscientific treatments with no compelling evidence for their efficacy. In other words, accepting quackery does not equal "patient-centered" care or "empowering" patients. These desirable outcomes can and should be achieved while recommending science-based medicine.</p> <h2>Count <cite>The BMJ</cite> among the fallen</h2> <p>With the increasing infiltration of quackery into medicine in the form of CAM, or "integrative medicine," or "CIM," or whatever you want to call it, we are seeing more and more journals succumb to the temptation to publish nonsense like these two review articles that appeared in <cite>The BMJ</cite>. In this case, it's particularly puzzling, given how <cite>The BMJ</cite> has a history of publishing articles decrying <a href="http://www.bmj.com/content/343/bmj.d4606">the overhyping of acupuncture</a> and warning about <a href="http://www.bmj.com/content/340/bmj.c1268">acupuncture-transmitted infections</a> and <a href="http://www.bmj.com/content/345/bmj.e6060">potentially serious adverse events</a>. It's also published articles with titles like "<a href="http://www.bmj.com/content/343/bmj.d4446">The scam of integrative medicine</a>", "<a href="http://www.bmj.com/content/341/bmj.c6979">Integrative medicine and the point of credulity</a>", and "<a href="http://www.bmj.com/content/355/bmj.i5439">Doctors warn of dangers of complementary medicine for children</a>." It has also published credulous articles as well, but seldom, as far as I can tell, as "systematic reviews" as obviously biased as these two are.</p> <p>Prof. Ernst is justifiably unhappy. As he says, <cite>The BMJ</cite> used to be a good journal. What is happening? Sadly, I think I know. The tide of pseudoscience that has been rising over the last quarter century has simply engulfed <cite>The BMJ</cite> too. At least in this case there has been some pushback, but I fear it will be short lived. In the meantime, I eagerly await <cite>The BMJ</cite>'s next systematic review on the use of CIM to treat patients with a vague sense of unease or a touch of the nerves or even just more money than sense. I'm sure it will be equally positive as the reviews by Chen and Michalsen and Millstine et al.</p> <iframe width="560" height="315" src="https://www.youtube.com/embed/cLoMGb5CaXE" frameborder="0" allowfullscreen=""></iframe></div> <span><a title="View user profile." href="/oracknows" lang="" about="/oracknows" typeof="schema:Person" property="schema:name" datatype="">oracknows</a></span> <span>Mon, 05/29/2017 - 21:02</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/education" hreflang="en">Education</a></div> </div> </div> Tue, 30 May 2017 01:02:36 +0000 oracknows 22561 at https://scienceblogs.com Tell the FDA not to embrace quackery: Write to oppose its proposal on acupuncture and chiropractic for chronic pain https://scienceblogs.com/insolence/2017/05/22/tell-the-fda-not-to-embrace-quackery-write-to-oppose-its-proposal-on-acupuncture-and-chiropractic-for-chronic-pain <span>Tell the FDA not to embrace quackery: Write to oppose its proposal on acupuncture and chiropractic for chronic pain</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>Last week, I <a href="http://scienceblogs.com/insolence/2017/05/15/acupuncturists-mistake-insufficient-rigor-for-bias-against-them/">wrote about acupuncture</a>, specifically how acupuncturists are unhappy that the UK National Institute for Health and Care Excellence (NICE), which provides guidelines for recommended treatments for diseases and conditions, does not recommend acupuncture for the treatment of knee osteoarthritis but does recommend arthroscopic washouts and debridement, for which the evidence is weak. My retort was simple: If this is true, the answer is not for NICE to start recommending quackery like acupuncture, but rather for it to stop recommending conventional medical and surgical treatments with very little evidence for efficacy. Unfortunately, I recently learned that on my side of the pond our FDA appears poised to go in the opposite direction, as an article in STAT News, <a href="https://www.statnews.com/2017/05/10/pain-acupuncture-chiropractic-fda/">FDA proposes that doctors learn about acupuncture for pain management</a>:</p> <blockquote><p> Chiropractors and acupuncturists who have lobbied for a bigger role in treating pain have won a preliminary endorsement from federal health officials.</p> <p>The Food and Drug Administration released proposed changes Wednesday to its blueprint on educating health care providers about treating pain. The guidelines now recommend that doctors get information about chiropractic care and acupuncture as therapies that might help patients avoid prescription opioids.</p> <p>“[Health care providers] should be knowledgeable about the range of available therapies, when they may be helpful, and when they should be used as part of a multidisciplinary approach to pain management,” the agency wrote in the proposal.</p> <p>The suggested changes come as chiropractors and other alternative medicine providers have stepped up lobbying Congress and state legislatures to elevate their role in treating chronic pain. They’ve scored several big victories in recent years. </p></blockquote> <p>The draft document is entitled <a href="https://www.fda.gov/downloads/Drugs/NewsEvents/UCM557071.pdf">FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain (May 2017)</a>, and it is the culmination of an effort on the part of alternative medicine practitioners to use the opioid epidemic as a rationale to promote their pseudoscience as "nonpharmacologic treatments" for pain. I'll give Megan Thielking credit for a sharp eye, as the relevant passage in the FDA document doesn't dwell on acupuncture or chiropractic, but only mentions each once. Once is enough, however. First, the stage is set early on, as the FDA discusses pain management and the various strategies that might be used to control chronic pain:</p> <blockquote><p> Possible constituents of the treatment plan – The HCP [health care provider] should be knowledgeable about which therapies can be used to manage pain and how these should be implemented.</p> <ul><li>Nonpharmacologic therapies – includes psychological, physical rehabilitative, surgical approaches; and complementary therapies</li> <li>Pharmacologic therapies – non-opioid, opioid, and adjuvant medications</li> </ul></blockquote> <p>Which leads to this:</p> <blockquote><p> A number of nonpharmacologic therapies are available that can play an important role in managing pain, particularly musculoskeletal pain and chronic pain.</p> <ul><li>Psychological approaches – e.g., cognitive behavioral therapy</li> <li>Physical rehabilitative approaches – e.g., physical therapy, occupational therapy</li> <li>Surgical approaches</li> <li>Complementary therapies – e.g., acupuncture, chiropracty</li> </ul><p>HCPs should be knowledgeable about the range of available therapies, when they may be helpful, and when they should be used as part of a multidisciplinary approach to pain management. </p></blockquote> <p>Notice how the FDA lists "complementary therapies," like acupuncture and chiropractic, as, in essence, co-equals with conventional medical nonpharmacologic therapies for treating pain. This is profoundly misleading, given that acupuncture is <a href="http://journals.lww.com/anesthesia-analgesia/Pages/articleviewer.aspx?year=2013&amp;issue=06000&amp;article=00025&amp;type=Fulltext&amp;WT.mc_id=HPxADx20100319xMP">nothing more than a theatrical placebo</a>. As I like to put it, it doesn't matter where you place the needles or even if you place the needles. The effect is the same, and consistent with placebo effects.</p> <p>How did we get to this point?</p> <h2>"Integrative" medicine and rebranding</h2> <p>It's no secret that the US is in the midsts of an opioid addiction epidemic. Opioid overuse and abuse are major problems, and government at all levels has started to take notice. A recent article in <a href="http://www.economist.com/news/united-states/21721960-deaths-drugs-say-more-about-markets-about-white-despair-inside-opioid">The Economist</a> provides some perspective on the scope of the problem:</p> <blockquote><p> THEY have America in a deadly grip. In 2015, the most recent year for which full statistics are available, 33,091 Americans died from opioid overdoses, according to the Centres for Disease Control—almost three times the number who perished in 2002. Nearly as many Americans were killed by opioids in 2015 as were killed by guns (36,132) or in car crashes (35,092). In the state of Maryland, which releases more timely figures, drug-overdose deaths were 62% higher in the first nine months of 2016 than a year earlier.</p> <p>The opioid epidemic is quite unlike past drug plagues. Deaths are highest in the Midwest and north-east, among middle-aged men, and among whites. Some of the worst-affected counties are rural. In 2013 a 40-year-old woman walked into a chemist’s shop in the tiny settlement of Pineville, West Virginia, pulled out a gun, and demanded pills. Don Cook, a captain in the local sheriff’s department, says he continues to nab many people for illegally trading prescription painkillers. </p></blockquote> <p>I first noted proponents of "integrative medicine" (or, as I like to refer to it, the "integration" of quackery into real medicine) using the opioid epidemic as a rationale to promote their preferred brand unscientific medicine about a year ago, when the National Center for Complementary and Integrative Health (NCCIH) <a href="http://scienceblogs.com/insolence/2016/04/11/meet-the-new-nccih-five-year-strategic-plan-same-as-the-old-nccam-five-year-strategic-plan/">released its strategic plan for 2016-2021</a>. In that plan, the "nonpharmacologic management of pain" and difficult-to-control symptoms leapt front and center to become a major scientific priority, explicitly invoking the opioid crisis as the external problem that its leaders believed that "integrative medicine" could make some headway with.</p> <p>More recently, the NCCIH made its intent even more explicit when it held a Twitter chat on <a href="http://scienceblogs.com/insolence/2016/09/12/nccih-co-opting-nonpharmacologic-treatments-for-pain-as-being-alternative-or-complementary/">Pain and Complementary Health Approaches</a> under the hashtag <a href="https://twitter.com/hashtag/talkpain">#TalkPain</a>, after having released a review article on complementary approaches for five painful conditions. The review was widely touted as demonstrating the following "positive" results for pain:</p> <ul><li>Acupuncture and yoga for back pain</li> <li>Acupuncture and tai chi for osteoarthritis of the knee</li> <li>Massage therapy for neck pain—with adequate doses and for short-term benefit</li> <li>Relaxation techniques for severe headaches and migraine.</li> </ul><p>As I <a href="http://scienceblogs.com/insolence/2016/09/12/nccih-co-opting-nonpharmacologic-treatments-for-pain-as-being-alternative-or-complementary/">pointed out at the time</a>, the methodology used to construct the review was quite weak, and even the positive conclusions listed above were quite suspect. Yet in the press coverage, never (or almost never) was heard a discouraging word regarding these treatments. The NCCIH spin on its own questionable review was pretty much parroted without skepticism, other than in a few skeptic blogs.</p> <p>It just goes to show that the new preferred framing of "integrative medicine" (or "complementary and alternative medicine," i.e., CAM) is working. That framing flows from a common device that has been used by CAM advocates since the 1990s at least. It's a devilishly simple and plausible-sounding frame, too. In this frame, potentially science-based interventions based on lifestyle changes, such as dietary interventions and exercise, have been co-opted as being somehow "complementary" or "integrative," even though there is nothing “alternative” about them. I realize I use this example fairly frequently, but that's becasue it's a good one, especially if there are any newbies to SBM reading. Think about it this way: What is the first science- and evidence-based intervention for type II diabetes? It’s to alter diet, lose weight, and to start to exercise, with the hope of losing enough weight to reverse the disease, or at least to prevent the need to begin pharmacological management with metformin. There's another example I like to use from my own personal life, too: Hypertension. I remember when I was first diagnosed with hypertension several years ago, partially likely thanks to the curse of genetics but also influenced by my sedentary lifestyle. My doctor insisted on at least three visits to see if I could bring my blood pressure down without drugs through dietary changes and exercise, even though I myself thought my blood pressure was probably too high for that. I couldn’t; so I ended up on an antihypertensive. I realize this is just one anecdote, but it does suggest that a lot of primary care doctors don’t go straight to the prescription pad, contrary to the stereotype promoted by CAM advocates.</p> <p>What's happening with the opioid crisis as a pretext for promoting the embrace of quackery is different from the "rebranding" I described above, but it's also related. In CAM, the "rebranding" of science-based treatments based on lifestyle, diet, and exercise is not enough. Rather, it serves to give cover to the quackery that is also labeled CAM or "integrative medicine," such as acupuncture, naturopathy, and so many other pseudoscientific or prescientific modalities. If CAM and "integrative medicine" only "integrated" these forms of quackery into medicine, it would be much harder to gain traction. However, if CAM practitioners can somehow convince patients and their fellow physicians that there's something somehow "complementary" about diet, exercise, and healthy lifestyle modification and claim them as CAM, then they add plausibility to at least some of their treatments.</p> <p>So we come to the rebranding of various CAM modalities as "nonpharmacological." Basically, after co-opting sensible and potentially science-based lifestyle interventions as being “complementary” or “integrative,” CAM advocates divide interventions into two categories, “pharmacological” and “non-pharmacological.” Naturally, CAM claims all the non-pharmacological interventions for its own, furthering the stereotype that science- and evidence-based medicine is about nothing more than drug therapy, while they are about the "whole" patient.</p> <h2>Quacks see an opening in the opioid crisis to seek legitimization</h2> <p>In her article on the FDA, Thielking doesn't go into much depth about how aggressively CAM practitioners have used the opioid crisis as a convenient pretext to persuade desperate legislators that they offer a solution (or at least a major part of the solution). However, back in April she <a href="https://www.statnews.com/2017/04/04/opioid-chronic-pain-naturopaths-chiropractors/">did a story on just that</a> basically confirming what I've been saying all along about integrative medicine advocates using the opioid epidemic to brand their specialty as legitimate "nonpharmacologic treatments" for pain. Chief among them are naturopaths (nearly all of whom offer some forms of traditional Chinese medicine, like acupuncture) and, of course, chiropractors:</p> <blockquote><p> Seizing on the opioid epidemic as a chance to expand their reach, naturopaths and chiropractors are aggressively lobbying Congress and state governments to elevate the role of alternative therapies in treating chronic pain. They’ve scored several victories in recent months, and hope the Trump administration will give them a further boost.</p> <p>Their most powerful argument: We don’t prescribe addictive pain pills.</p> <p>Shunning pharmaceuticals, they treat pain with everything from acupuncture to massage to castor oil ointments. They offer herbal supplements and homeopathic pills. </p></blockquote> <p>Yes, it's true that naturopaths, acupuncturists, and chiropractors don't prescribe addictive pain pills. They do, however, frequently prescribe boatloads of supplements and use treatments with little basis in evidence. With the new administration, coupled with a bipartisan consensus that <em>something</em> needs to be done to combat opioid addiction, CAM practitioners see an opening that they hope to drive a Mack truck full of acupuncture needles and chiropractic tables through:</p> <blockquote><p> Hoping to make even more inroads, both naturopaths and chiropractors are lobbying Congress to push the Veterans Affairs health system to hire alternative providers. Chiropractors are also pushing for a role in the National Health Service Corps, which puts providers to work in community health centers, often in rural areas.</p> <p>And this month, naturopaths will descend on Washington, D.C., for a meeting all about chronic pain. “Naturopathic doctors are poised to be the leaders in combating the opioid epidemic,” the promotional materials claim.</p> <p>The pain workshops will be followed by a three-day conference to set a lobbying agenda and teach naturopaths organizing techniques.</p> <p>The American Association of Naturopathic Physicians clearly sees an opening to make gains: The arrival of the Trump administration and a new, Republican-controlled Congress “opens up new opportunities for AANP to push for insurance non-discrimination, to have [naturopaths] included in the VA, and to emphasize that naturopathic care is a much-needed alternative to opioids for the treatment of chronic pain,” the AANP website declares. </p></blockquote> <p>Unfortunately, the Veterans Administration (VA) medical system has been heavily infiltrated by advocates of subjecting our veterans, to whom we owe so much, to quackery. Naturopaths have been lobbying to be hired as practitioners at the VA for at least two years. Indeed, in 2015, the American Veterans (AMVETS) teamed up with the American Association of Naturopathic Physicians (AANP, which unfortunately shares an abbreviation with the American Association of Nurse Practitioners and must be distinguished from such a respectable organization) to lobby Congress to pass a bill that would pay for "<a href="http://www.amvets.org/aanp-amvets-team-up-to-promote-non-pharmacological-approaches-to-treating-veterans-with-chronic-pain/">natural, non-pharmacological approaches to treating veterans suffering from chronic pain</a>." The argument was basically a classic quack talking point: Opiate pain relievers, as effective as they are, have a downside, including dependence, addiction, and overdosing. Because of these problems, a common problem with opioids is that physicians are often overly cautious prescribing opioids, resulting in undertreatment of chronic pain. What “non-pharmacologic” treatments of chronic pain would help? The AMVETS press release didn't say.</p> <p>I've written before about "battlefield acupuncture," a form of ear acupuncture that has actually been foisted upon our injured soldiers. As I like to say, as goes the military, so goes the VA. Indeed, the VA, led by Dr. Tracy Gaudet, director of the VHA’s Office of Patient Centered Care and Cultural Transformation, is a <a href="http://scienceblogs.com/insolence/2016/07/25/the-va-and-dr-tracy-gaudet-integrating-quackery-into-the-care-of-veterans/">big fan of CAM</a>, including naturopathy, acupuncture, and chiropractic. Indeed, Dr. Gaudet spoke at the AANP legislative initiative mentioned in Thielking's story, <a href="http://www.naturopathic.org/content.asp?contentid=669">characterizing naturopathy</a> as “a huge answer for the country, for practice, for patients” that is available “at a pivotal transformational moment” in health care and referring to them as “pioneers” who have been practicing integrative medicine “all along.” One notes that, before being hired by the VHA, Dr. Gaudet was a very <a href="https://www.holisticprimarycare.net/topics/topics-h-n/news-policy-a-economics/1339-holistic-medicine-is-militarys-new-marching-order.html">high profile promoter of “integrative medicine,”</a> having served as the director of Duke Integrative Medicine, a “pioneer” institution in quackademic medicine, as well as, before that, the founding director of the University of Arizona Program in Integrative Medicine with Dr. Andrew Weil.</p> <p>Basically, the bottom line is that, as in the NCCIH and medical academia, advocates of unscientific and vitalistic treatments like acupuncture, chiropractic, and naturopathy are in ascendance. The might not always win, but they <a href="https://sciencebasedmedicine.org/legislative-alchemy-2016-update-acupuncturists-win-naturopaths-and-chiropractors-dont/">always come back again and again and again</a> until they do.</p> <p>But what about the FDA?</p> <h2>Will the FDA give its blessing to chiropractic and acupuncture for pain?</h2> <p>The law mandates that new drugs and devices must be shown through rigorous clinical evidence to be safe and effective for the indication for which they are intended. Over the last few years, there has been a push by free market fundamentalists, who have co-opted the narrative by falsely claiming that the caution and slow bureaucratic pace of FDA approval is keeping the free market from unleashing a flood of cures to the people. Indeed, a couple of truly scary men, one of whom believes that the FDA should <a href="http://scienceblogs.com/insolence/2016/12/09/fixing-the-fda-by-appointing-a-commissioner-who-doesnt-believe-in-the-fdas-mission/">require evidence only of safety, not efficacy</a>, before approval (because, you know, the free market will sort efficacy out), the other of whom thinks that online rating systems (as in a <a href="http://scienceblogs.com/insolence/2017/01/16/next-up-on-the-trump-fda-crazy-train-a-man-who-thinks-that-a-yelp-like-system-will-do-better-than-the-fda-at-maintaining-drug-safety/">Yelp or Über for drugs</a>) can replace rigorous science for drug approval. So bad were these two Peter Thiel associates that it was actually a relief that we <a href="http://scienceblogs.com/insolence/2017/04/17/federal-biomedical-science-policy-under-donald-trump-nearly-100-days-in/">got the pharma shill</a>, Scott Gottlieb, as FDA director. Gottlieb will likely champion "streamlining" and deregulation, but not beyond the pale of what we would see in any Republican administration.</p> <p>The FDA doesn't move that rapidly when it comes to draft policies; so most likely this recently released draft has been under development since before the election. Be that as it may, the FDA has a bit of a strange relationship with CAM modalities, such as acupuncture. For instance, the FDA does regulate acupuncture needles as <a href="https://web.archive.org/web/20071219041730/http://www.fda.gov/fdac/departs/596_upd.html">Class II medical devices</a>, which means that the needles are regarded as safe and effective when used appropriately by a licensed practitioner. Manufacturers must include on the label the statement "for single use only" and provide information about device material sterility and compatibility with the body, and the needles must also bear a prescription label restricting use to qualified practitioners as determined by individual states.</p> <p>If you want to get an idea of how...complicated...the FDA's relationship with CAM products is, it's worth perusing <a href="https://www.fda.gov/RegulatoryInformation/Guidances/ucm144657.htm">Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration: Guidance for Industry</a>. The document quite reasonably points out that botanical products and probiotics might, depending upon what they are and what they are used for, be subject to FDA regulation. However, when the FDA starts discussing "energy medicine," things get weird. First, the FDA distinguishes between veritable energy fields (which can be measured and use either mechanical vibrations or electromagnetic forces, including visible light, magnetism, monochromatic radiation, and other light rays) from putative energy fields (have defied measurement to date by reproducible methods and include things like the "human energy field" in therapeutic touch). Then it says:</p> <blockquote><p> In a sense, "conventional" medicine already uses various forms of "energy" medicine. For example, a magnetic resonance imaging (MRI) device uses electromagnetic waves to create images of internal body organs and tissues. As another example, an ultrasound machine uses sound waves to create images of body organs, tissues, and fetuses. Given their intended uses, we regulate these products as medical devices under the Act.</p> <p>CAM products that use veritable energy fields in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease in man or animals or to affect the structure or any function of the body of man or animals may be medical devices under the Act.10 Additionally, if the product is electronic and emits radiation, it may be subject to additional requirements to ensure that there is no unnecessary exposure of people to radiation.</p> <p>CAM products that use putative energy fields in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or animals may be medical devices under the Act. For example, we regulate acupuncture needles as "class II" medical devices. </p></blockquote> <p>Talk about asking how many angels can dance on the head of a pin!</p> <p>Manipulative therapies, such as chiropractic, are more straightforward:</p> <blockquote><p> To the extent that manipulative and body-based practices involve practitioners physically manipulating a patient's body, without using tools or machines, we do not believe that such practices are subject to regulation under the Act or the PHS Act. If, however, the manipulative and body-based practices involve the use of equipment (such as massage devices) or the application of a product (such as a lotion, cream, or oil) to the skin or other parts of the body, those products may be subject to regulation under the Act, depending on the nature of the product and its intended use. </p></blockquote> <p>So basically, the FDA has tried to thread the needle, stating that the equipment used to do acupuncture and chiropractic can be regulated but saying nothing about the efficacy of acupuncture or chiropractic themselves. That's part of the reason why this new FDA draft policy is disturbing. It goes from an approach that is (mostly) nonjudgmental about the treatments themselves and concentrates only on regulating the equipment, which is definitely suboptimal, to one that is even worse, recommending that physicians know about acupuncture and chiropractic for pain and consider them as valid treatments on par with the real medical treatments.</p> <p>One can't help but wonder how the FDA interpreted existing evidence to come to this conclusion. As <a href="http://theness.com/neurologicablog/index.php/open-letter-to-fda-on-acupuncture/">Steve Novella notes</a>, whenever acupuncture is compared with sham acupuncture, there is no detectable difference and usually both sham and "real" acupuncture produce modest improvement in pain completely consistent with placebo effects. Yes, there is a large meta-analysis that found otherwise for knee osteoarthritis, but <a href="http://scienceblogs.com/insolence/2012/09/12/can-we-finally-just-say-that-acupuncture-is-nothing-more-than-an-elaborate-placebo-can-we-2012-edition/">we've discussed it before</a>. Its flaws render its results highly questionable, particularly given that the actual magnitude of the clinical benefit reported was less than the “minimally clinically important difference” (MCID). In any case, the vast preponderance of evidence is consistent with acupuncture having no specific effect for any condition and for all its claimed "effects" being due to placebo.</p> <p>The evidence for chiropractic is a little more complex, but, boiled down to its essence, not that much. I like to refer to chiropractors as undertrained physical therapists with delusions of grandeur. What I mean by that is that chiropractors claim to be able to treat a lot of diseases and conditions not related to the spine or musculoskeletal system through spinal manipulation, such as allergies, hence the delusions of grandeur. Whatever benefit might derive from chiropractic is likely limited to the effect of spinal manipulation on back pain, which <a href="https://sciencebasedmedicine.org/spinal-manipulation-and-the-jama-meta-analysis-an-analysis-of-fuel/">could well be nonexistent</a>.</p> <p>So, basically, in this draft FDA education blueprint for healthcare providers on managing chronic pain, the FDA is about to put its imprimatur on chiropractic, which makes no sense given that physical therapy does everything that chiropractic does, minus the woo and plus modalities other than spinal manipulation. It goes beyond no sense to do the same for acupuncture, an ancient, prescientific treatment that originated as bloodletting and was retconned by Chairman Mao Zedong into having always been practiced in its present form, a treatment that is nothing more than a theatrical placebo. To add the proverbial insult to injury, the FDA lists these forms of quackery alongside evidence-based treatments, as though they were on close to equal footing.</p> <h2>It's not too late to stop this</h2> <p>Fortunately, the FDA being a federal government regulatory agency and all, this revised draft guideline is not final, and there is a <a href="https://www.statnews.com/2017/05/10/pain-acupuncture-chiropractic-fda/">period for public comment</a>:</p> <blockquote><p> The FDA’s draft blueprint isn’t final — and drug makers, doctors, and alternative medicine providers will all have a chance to weigh in. The FDA will take <a href="https://www.federalregister.gov/documents/2017/05/10/2017-09442/draft-revisions-to-the-food-and-drug-administration-blueprint-for-prescriber-education-for">public comments through July 10</a>.</p> <p>The blueprint released this week is part of a strategy the FDA rolled out in 2011 to address a crisis of prescription drug abuse. The FDA required opioid manufacturers to provide education for health providers who prescribe their pain medications — but didn’t mention chiropractic care or acupuncture in <a href="https://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM515636.pdf">its initial blueprint</a> for what that education ought to look like. </p></blockquote> <p>Interesting. I wonder how that one line recommending acupuncture and chiropractic found its way into the <a href="https://www.fda.gov/downloads/Drugs/NewsEvents/UCM557071.pdf">revised draft guidelines</a>.</p> <p>However it happened, you know what to do. The FDA needs to hear from supporters of science-based medicine. The opioid epidemic is a serious problem, and it needs science-based medical solutions, not the liberal application of fairy dust, if we are to dramatically reduce the toll taken by opioid addiction.</p> </div> <span><a title="View user profile." href="/oracknows" lang="" about="/oracknows" typeof="schema:Person" property="schema:name" datatype="">oracknows</a></span> <span>Sun, 05/21/2017 - 22:11</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/medicine" hreflang="en">Medicine</a></div> </div> </div> Mon, 22 May 2017 02:11:50 +0000 oracknows 22557 at https://scienceblogs.com Acupuncture versus science, linguistic edition https://scienceblogs.com/insolence/2017/05/19/acupuncture-versus-science-acupuncture-apologist-edition <span>Acupuncture versus science, linguistic edition</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>Acupiuncture is a system of treatment rooted in the prescientific vitalism of traditional Chinese medicine (TCM). It doesn't work. For anything. As Steve Novella and David Colquhoun put it, acupuncture is basically a <a href="http://www.dcscience.net/Colquhoun-Novella-A&amp;A-2013.pdf">theatrical placebo</a>, which is why rigorous studies consistently fail to find a treatment effect due to acupuncture that is detectably greater than placebo. Not that that's stopped acupuncturists and acupuncture advocates from trying desperately to show that acupuncture "works," even if it means <a href="http://scienceblogs.com/insolence/2017/05/15/acupuncturists-mistake-insufficient-rigor-for-bias-against-them/">hooking up acupuncture needles to electrode</a>s and turning it into transcutaneous nerve stimulation (TENS). Never mind that two thousand years ago even the Chinese didn't understand electricity.</p> <p>That's why I was rather amused to come across an article in the <em>Journal of Integrative Medicine</em> by Ted Priebe et al entitled <a href="http://www.jcimjournal.com/articles/publishArticles/pdf/S2095-4964%20(17)60338-8.pdf">Can a science-based definition of acupuncture improve clinical outcomes?</a> It's tempting just to say no and leave it at that, but there's too much amusement to be had by examining parts of the article and the contortions of logic the authors undergo to try to justify the use of acupuncture. Indeed, in the introduction, it's almost as though Priebe et al admit that acupuncture is based on prescientific superstition, as they declare their purpose to "to unwind this entanglement and conduct acupuncture research according to biomedical principles." Good luck with that. They also suggest that "avoiding prescientific arguments is one approach towards explaining acupuncture mechanism of action, efficacy and effectiveness." Good luck with that, too.</p> <!--more--><p>First, Priebe et al liken acupuncture to the construction of knives, which is a perhaps a bit more apropos than they realize, given how acupuncture also "evolved" from primitive bloodletting of the kind favored by "traditional European medicine" (as I like to refer to it) in the Middle Ages:</p> <blockquote><p> Acupuncture, like knives, has evolved over millennia. They have ancient origins, modern utility, varied history, and even today, spiritual value. The manufacture of knives has evolved further than has the application of acupuncture. Acupuncture needs to migrate from a mind- body-spirit medicine described by Hui et al.[1] to a healing art based on science. Knife construction has moved past a “hand me down” craft to a precise, replicable, and standardized industry where quality is measured scientifically. Although knife making and acupuncture still value the traditional master-apprentice teaching practices, it is time for acupuncture, like knife manufacture, to advance towards scientific methodology for assessing practice outcomes and effectiveness. </p></blockquote> <p>One might also point out that knives, unlike acupuncture, can be shown unambiguously to be useful tools to accomplish specific tasks. Acupuncture, not so much. Of course, the big question I have is basically: How do you take a modality that posits the existence of anatomic structures that do not exist (meridians) and "energies" (qi) that have never been detected and make it scientific? Science requires parameters that are reliably detectable, measurable, and reproducible. Indeed, a Nobel Prize likely awaits the first acupuncturist or "integrative medicine" specialist who can definitively demonstrate the existence of qi and meridians and definitively demonstrate that inserting thin needles into these meridians somehow "unblocks" the flow of qi.</p> <p>Of course, acupuncturists are starting to figure that out, but, instead of resulting in the rejection of acupuncture as the pseudoscience that it is, instead acupuncturists now tend to sweep all that inconvenient mystical mumbo-jumbo about qi and meridians under the rug:</p> <blockquote><p> Kendall [3] scientifically described the mechanisms of action of acupuncture as based upon early Chinese descriptions of “blood circulation, organization of the cardiovascular system, somatovisceral relationships (communication between the external body and the internal organs), immune system function and the organization of the musculoskeletal system.” The American College of Occupational and Environmental Medicine Guidelines recognized the effectiveness of needling without providing evidence of “meridians” or defining vital energy ow (qi).[4] </p></blockquote> <p>Let's talk a bit about these early Chinese descriptions, shall we? TCM involves various modalities like pulse and tongue diagnosis. In the former, it is claimed that detailed diagnoses can be made just by feeling the pulse. Of course, the pulse is valuable in science-based medicine, but mainly as an indicator of cardiovascular status. In TCM, there are at least <a href="https://www.sacredlotus.com/go/diagnosis-chinese-medicine/get/4-pillars-pulse-images-tcm-diagnosis">29 different pulse types</a> ranging from floating to slippery to forceful. Try to figure out how to recognize the Ge Mai (Leathery, Drumskin, Tympanic, Hard) pulse, for instance:</p> <blockquote><p> Bowstring and large (wide) with an empty center; feels like the head of a drum. Felt with light pressure. Floating, large, and hard and resistant to pressure. </p></blockquote> <p>Supposedly Ge Mai is associated with "Hemorrhage, Spermatorrhea, Abortion, Excessive Menstrual Flow, Xu Cold" and means, "The Qi becomes detached and floats to the exterior, the healthy Qi is failing to store sperm and blood." There's lots more where that came from, with the vague, mystical diagnoses failing to correspond with any physiological condition. Physiologically, these pulse diagnoses are meaningless. It's diagnosis disconnected from reality.</p> <p>Don't even get me started on tongue diagnosis. Skeptics rightfully make fun of reflexology, which posits a homunculus on the soles of the feet and the palms of the hands, where various areas of the soles and palms "map" to various organs or body parts. Well, where do you think reflexologists got the idea? Probably from TCM tongue diagnosis, which basically <a href="https://www.sacredlotus.com/go/diagnosis-chinese-medicine/get/tongue-diagnosis-chinese-medicine">maps different areas of the tongue to different organs</a> and claims that by looking at the tongue one can diagnose illness in various organs. While it's true that looking at the tongue is a useful part of physical diagnosis in science-based medicine, the way it's used in TCM is, like pulse diagnosis, meaningless.</p> <p>Now here's the funny thing. Priebe et al appear to realize that the philosophical underpinnings of TCM are mystical prescientific superstition. That's probably why they want so desperately to get away from them, noting with unintentional drollness that "fealty to traditional themes may add complexity, raising the bar and occluding the picture" and listing four areas (placebo, comparative effectiveness, Deqi and linguistics) where "fealty to traditional themes needlessly confounds acupuncture research." Perhaps most telling is how Priebe et al invoke Ted Kaptchuk and his arguments:</p> <blockquote><p> He argued that placebo research must move beyond the view wherein placebo signifies a failure, instead investigating it as a straightforward clinical outcome; “We need more research involving clinical interventions designed to elicit placebo effects in participants without deception ... we need to know precisely when, how and in what dose ... these interventions can provide therapeutic benefit.”[14] Kaptchuk applied the “dose × frequency × duration” model to a meta-analysis of complementary and alternative medicine (CAM) therapies limited to supplements and herbs used for treating irritable bowel syndrome.[15] The study is of interest here because it pooled CAM interventions excluding acupuncture and discussion of traditional, non-scienti c considerations. </p></blockquote> <p>Kaptchuk's arguments flow from the observation that, as alternative medicine therapies have been more intensively studied using more rigorous methodology, inevitably their effects are found to be indistinguishable from placebo effects. So Kaptchuk embraces placebo effects and has spent decades trying to demonstrate that they are useful and can be evoked without deception (<a href="http://scienceblogs.com/insolence/2016/10/18/rehashing-the-myth-of-placebo-without-deception/">they can't</a>). <a href="http://scienceblogs.com/insolence/2016/12/20/does-thinking-make-it-so-the-placebo-myth-rears-its-ugly-head-again/">His arguments</a> are similar to those of other alternative medicine advocates like <a href="http://scienceblogs.com/insolence/2012/08/20/deepak-chopra-placebo-effects-and-the-secret/">Deepak Chopra</a> that their woo works by "harnessing the power of placebo." Unfortunately, <a href="http://scienceblogs.com/insolence/2012/01/17/does-thinking-make-it-so/">thinking does not make it so</a>.</p> <p>So what do Priebe et al propose, given that rigorous randomized trials of acupuncture fail to show its efficacy beyond that of placebo? I think you know the answer to that one:</p> <blockquote><p> Despite Kaptchuk’s best arguments, placebo effectiveness is viewed as damaging to clinical outcomes research. By contrast, comparative effectiveness research occupies one of the highest rungs on the research ladder. In our view, the most renowned studies of comparative effectiveness in acupuncture research, i.e., the “German studies” did not measure up to Kaptchuk’s standard of when, how and what dose.[16] Comparative effectiveness research in clinical applications should demonstrate cost savings and improved outcomes when comparing techniques or procedures. The model must be specific, as acupuncturists and researchers will attest.[17] Standardization is necessary when comparing outcome measures, targeted points, diagnoses, and experimental/ control models. </p></blockquote> <p>Yes, this is basically the same justification used for preferring "pragmatic" studies on acupuncture, and it has the same flaw. Yes, comparative effectiveness research is important. Indeed, you can view comparative effectiveness research as a form of pragmatic studies. The problem once again is that the premise of such studies is that the treatments whose effectiveness are being compared actually have strong evidence of efficacy from randomized clinical trials. In other words, we already know that they "work." Acupuncture fails that basic test. However, because comparative effectiveness studies generally don't have placebo control arms, pragmatic studies and comparative effectiveness research will produce a false impression that acupuncture actually works, at least for subjective outcomes.</p> <p>Finally, here's the part that made me laugh the loudest, in which Priebe et al argue for changing linguistics:</p> <blockquote><p> Chinese “words” frequently have more than one meaning.[21] The symbol for “qi” can mean air or gas as well as “energy or life force”. For acupuncture traditionalists the word “qi” implies a dynamic functional view of all body systems.[30,31] The word “energy” is central to the cultural description of acupuncture and cannot be separated from Chinese medicine.[32,33] According to this view acupuncture works by releasing blocked energy circulating through invisible meridians. Use of these and similar terms when describing needling therapy is central to the claims, beliefs and practices among a cohort of TCM and acupuncture practitioners unconcerned these ideas have not been demonstrated scientifically. Schnorrenberger[30] has argued acupuncture finally needs an anatomical nomenclature for daily practice and scientific research. Yang et al.[34] has attempted to resolve the mysterious balance of yin and yang with the biophysical, i.e., positive and negative charge or matter and anti-matter.</p> <p><em>These are not prejudices if one takes it as sun and moon, positive and negative charge, or matter and antimatter. However, we must focus on the science alone as there were quite a bit of superstitions, mystics, voodoo, and philosophical musing in the ancient world that should have no place in our scientific thoughts.</em>[34] </p></blockquote> <p>Well, I can certainly agree with that last paragraph, but that's the problem. Acupuncture cannot be separated from its origins in prescientific vitalisms. That "quite a bit of superstitions, mystics, voodoo, and philosophical musing in the ancient world that should have no place in our scientific thoughts" is the very basis of acupuncture. There is no anatomy that corresponds to meridians, nor is there physiology that generates or depends upon qi. That's why there will always be this:</p> <blockquote><p> Pritzker describes a “tension” between “biomedical” and “anti-biomedical” camps that has proved “contentious” for more than a decade. In our view, this tension extends into the research domain. </p></blockquote> <p>Those acupuncturists who have a "biomedical" view are perhaps even more deluded than the "anti-biomedical" camp. After all, they seem to think that there is a biomedical basis to acupuncture and will <a href="http://scienceblogs.com/insolence/2010/06/01/when-what-an-acupuncture-study-shows-is/">contort all sorts of research findings to justify their belief in acupuncture</a>. Priebe et al seem to fall into this category, as they conclude:</p> <blockquote><p> Despite decades of scientific arguments that support a biomedical model, steadfast insistence on the use of traditional terms remains a standard in the conduct of acupuncture research. The use of prescientific language in place of medical language commonly used in mainstream healthcare is harmful to the profession, practitioners and the public. It is our view that this insistence frequently dissolves into a defensive posture that places the patient at risk. This same view compromises and hamstrings practical outcomes in acupuncture research. </p></blockquote> <p>"Practical outcomes." You keep using that term. I do not think it means what you think it means. Notice how Priebe tortures language (and himself) in order to continue to use acupuncture even though he has just admitted that it's rife with mysticism, superstition, and "voodooo" that has no place in modern medicine. How can a system that is based in such nonsense ever be scientific? It can't. Therein lies the conundrum. Priebe et al view themselves as science-based and, because they believe in acupuncture, assume that there must be a way to justify it scientifically as well. There isn't, but that doesn't mean that acupuncturists like Priebe et al won't keep torturing science and language to keep trying.</p> </div> <span><a title="View user profile." href="/oracknows" lang="" about="/oracknows" typeof="schema:Person" property="schema:name" datatype="">oracknows</a></span> <span>Fri, 05/19/2017 - 01:00</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/medicine" hreflang="en">Medicine</a></div> </div> </div> Fri, 19 May 2017 05:00:47 +0000 oracknows 22556 at https://scienceblogs.com Acupuncturists mistake insufficient rigor for bias against them https://scienceblogs.com/insolence/2017/05/15/acupuncturists-mistake-insufficient-rigor-for-bias-against-them <span>Acupuncturists mistake insufficient rigor for bias against them</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>Of all the modalities of alternative medicine currently in use, arguably acupuncture is the one that has achieved the most mainstream acceptance in medicine. I've often asked why it has become so common in academic medical centers and elsewhere, despite the evidence being overwhelmingly in favor of the conclusion that it is <a href="http://www.dcscience.net/Colquhoun-Novella-A&amp;A-2013.pdf">nothing more than a theatrical placebo</a>. It doesn't matter that acupuncture is part of a prescientific system of medicine now known as traditional Chinese medicine (TCM), whose concepts are rooted in vitalism. It doesn't matter that what has passed for acupuncture since the 1940s and 1950s bears little resemblance to what was practiced hundreds or thousands of years ago and <a href="https://sciencebasedmedicine.org/the-reality-of-ancient-wisdom-acupuncture-and-tcm-werent-so-great/">even 100 years</a> ago <a href="https://sciencebasedmedicine.org/acupuncture-and-modern-bloodletting/">more resembled</a> the <a href="https://www.sciencebasedmedicine.org/astrology-with-needles/">bloodletting</a> that was common in ancient European medicine more than the use of thin needles along "meridians" to "redirect the flow" of the life energy qi to alleged healing effect. It doesn't even matter that acupuncture, along with the rest of TCM, was basically <a href="http://scienceblogs.com/insolence/2013/10/25/chairman-mao-inventor-of-traditional-chinese-medicine/">foisted upon the world</a> when Chairman Mao Zedong, unable to provide real medicine for his people after World War II, decided to make up the difference with folk healers even though he himself <a href="http://www.slate.com/articles/health_and_science/medical_examiner/2013/10/traditional_chinese_medicine_origins_mao_invented_it_but_didn_t_believe.html">basically didn't believe in TCM</a> and chose "Western" medicine instead. At that point, the history of TCM and acupuncture were <a href="https://sciencebasedmedicine.org/retconning-traditional-chinese-medicine/">effectively "retconned" into the form we know them today</a>. In the case of acupuncture in particular, the retconned version, which posits acupuncture as being thousands of years old and having been practiced in basically the same form over all that time, has little resemblance to the original, which <a href="https://sciencebasedmedicine.org/puncturing-the-acupuncture-myth/">wasn't documented until the 17th century</a>. Basically, TCM is <a href="https://sciencebasedmedicine.org/what-is-traditional-chinese-medicine/">more philosophy than medicine</a>. None of this has stopped China from continuing to support and <a href="http://scienceblogs.com/insolence/2017/01/23/first-china-next-the-world-the-chinese-government-gives-a-big-boost-to-traditional-chinese-medicine-just-like-chairman-mao-did/">do its best to export TCM to the world</a>, even in 2017. Meanwhile media <a href="http://scienceblogs.com/insolence/2015/09/01/a-commercial-for-acupuncture-masquerading-as-news/">falsely portray acupuncture as having been proven</a> effective for a number of conditions.</p> <!--more--><p>I've <a href="http://scienceblogs.com/insolence/?s=acupuncture">discussed acupuncture many, many times</a> on this blog, sometimes finding some <a href="http://scienceblogs.com/insolence/2017/03/29/the-quackery-that-is-battlefield-acupuncture-continues-to-metastasize/">truly spectacular examples of silliness</a>, because it's an excellent alternative medicine modality to use to discuss placebo effects, shortcomings of clinical trials, and how alternative medicine is sold to the public—even <a href="https://sciencebasedmedicine.org/retconning-traditional-chinese-medicine/">revisionist history</a>. In particular, it's interesting to note how very many forms of acupuncture have developed, and how they are used, and how many conditions that acupuncture can supposedly treat, which encompass basically everything. It's also a great jumping off point to discuss appropriate placebo controls, something that many acupuncture studies conveniently leave out, and how, the larger and more rigorous a study is, the smaller the effect observed is, until the largest, most rigorous studies show no difference between "sham" acupuncture and "real" acupuncture, and how meta-analyses sold as showing the therapeutic efficacy of acupuncture in actuality <a href="http://scienceblogs.com/insolence/2012/09/12/can-we-finally-just-say-that-acupuncture-is-nothing-more-than-an-elaborate-placebo-can-we-2012-edition/">show no such thing</a>. Basically, it doesn't matter where you stick the needles or <a href="https://sciencebasedmedicine.org/acupuncture-does-not-work-for-back-pain/">even if you stick the needles in</a>; the effect is the same. And I haven't even pointed out how studies of acupuncture from China are <a href="http://skeptvet.com/Blog/2014/05/evidence-update-chinese-studies-of-acupuncture-are-always-positive-perfect-medicine-or-hidden-bias/">virtually always positive</a>.</p> <p>Not surprisingly, acupuncturists and believers in acupuncture always think that their favorite modality is being treated unfairly. Not surprisingly, many of them publish in the Journal of Alternative and Complementary Medicine (JACM). Unfortunately, at least one of them writes for <em>Popular Science</em>.</p> <h2>In which medicine is accused of a "double standard" with respect to acupuncture</h2> <p>What made me think about these issues was a recent article by Kendra Pierre-Louis in <em>Popular Science</em> entitled <a href="http://www.popsci.com/does-acupuncture-work">Why it’s so hard to figure out if acupuncture actually works: Should you stick a needle in it?</a> Notice the statement in the title. Yes, I agree that it's hard to figure out whether acupuncture works. Past tense would be better, though, as figuring out whether acupuncture works is something that has already been done over the last three decades. It doesn't.</p> <p>Pierre-Louis, however, doesn't seem to think so:</p> <blockquote><p> Does medicine have a bias against acupuncture?</p> <p>That's the verdict of a paper (and an accompanying commentary) published earlier this week in The Journal of Alternative and Complementary Medicine. While there’s still no medical consensus on acupuncture, and most reputable medical organizations do not support its use for arthritic knee pain, the authors' critique lends interesting insight into the process by which medical procedures are accepted—and which are excluded.</p> <p>How does alternative medicine get to be plain-old medicine? </p></blockquote> <p>In fairness, that last question is a very good question that plays off a common adage in skepticism and science-based medicine: What do you call alternative medicine that has been scientifically proven to work? Answer: Medicine. But what does "scientifically proven to work" mean? If Pierre-Louis had focused on that question, using acupuncture as an example, even if I ended up disagreeing with her conclusion, the article would have been much more worthwhile. Unfortunately, Pierre-Louis is not about exploring that question; she's about proving that acupuncture actually works and the UK's National Institute for Health and Care Excellence (NICE), which provides guidelines for recommended treatments for diseases and conditions, has a bug up its butt about acupuncture:</p> <blockquote><p> Led by Stephen Birch of Kristiania University College in Norway, the researchers behind the new study allege that the United Kingdom’s National Institute for Health and Care Excellence (NICE), which details recommended treatments for given ailments, holds acupuncture to a higher standard than it does traditional medical modalities.</p> <p>If all of the treatments that NICE recommend for knee arthritis—including weight loss and nonsteroidal anti-inflammatory (NSAID) drugs like ibuprofen—had to meet the minimum required standards that NICE sets for acupuncture, “opiates would become the first line of drug prescription,” wrote Birch et al. </p></blockquote> <p>I'd hardly call Birch's article a "study." It's more of an opinion piece with some data backing it up kvetching about how NICE came up with its guidelines for the treatment of osteoarthritis of the knee. Before coming back to the rest of Pierre-Louis' piece, let's take a look at Birch's article, whose title gives away the game, <a href="http://online.liebertpub.com/doi/pdf/10.1089/acm.2016.0385">The U.K. NICE 2014 Guidelines for Osteoarthritis of the Knee: Lessons Learned in a Narrative Review Addressing Inadvertent Limitations and Bias</a>.</p> <h2>Bias. You keep using that word. I do not think it means what you think it means.</h2> <p>Birch's complaint is stated most succinctly in the abstract:</p> <blockquote><p> Several systematic reviews suggest that acupuncture is effective for knee osteoarthritis (OA), and furthermore a safe and cost-effective treatment for this condition. A recent clinical practice guideline (CPG) from the National Institute for Health and Care Excellence (NICE), in the United Kingdom, recommended against the use of acupuncture on the grounds that the effect size (ES) in comparison with sham acupuncture is too small. </p></blockquote> <p>I read this, and couldn't help but think, "You say that as though it were a <em>bad</em> thing." And, yes, Birch does think it's a bad thing:</p> <blockquote><p> The 2014 NICE guideline on OA (CG177) was not a complete revision of the 2008 guidelines, it was more limited. Although originally intended to be more extensive including a broader review of drugs such as NSAIDs, it was decided to review those at a later date. Not only did the update focus on only a few of the interventions, it also applied different criteria for evaluating and accepting in- terventions. In effect, as will be described, the process se- lected for evaluating acupuncture required the treatment to meet higher standards than many other included treatments. A key problem in this NICE update is the introduction of a focus on the development of recommendations based on the consideration of which interventions make ‘‘minimal important differences’’ (MIDs) to patients as a replacement for usual CPG comparisons of evidence. The MID was set as an effect size (ES) of 0.5 or greater. The analysis of the evidence for acupuncture in this review emphasized results from sham studies with a de-emphasis on evidence from pragmatic comparator studies. Despite the fact that the assessment of MIDs should include analysis of benefit and harm, this review did not include an analysis of safety data on acupuncture. This coupled with the lack of usual CPG head-to-head comparison of interventions excluded data relevant to the use of acupuncture as an intervention for knee OA in comparison with other standard recommended care options, namely that it is much safer than many other accepted interventions for knee OA pain. This shift in methodological approaches might have inadvertently biased against acupuncture. </p></blockquote> <p>Notice the main complaint about the NICE guidelines: That they're too rigorous. The dead giveaway in the paragraph above is this sentence: <em>The analysis of the evidence for acupuncture in this review emphasized results from sham studies with a de-emphasis on evidence from pragmatic comparator studies.</em> I've discussed before how much acupuncture advocates love pragmatic studies. Pragmatic studies are designed to demonstrate the "real world" effectiveness of a treatment. Often they are not randomized and don't have a placebo or sham control. Clinical trials are very regimented, with clearly defined protocols, rigorous inclusion and exclusion criteria for subjects, endpoints, and reporting. When a treatment that's been shown to be efficacious in randomized clinical trials gets out into the real world, the inclusion criteria inevitably expand and the exclusion criteria contract. When that happens, patients who wouldn't have been eligible for the clinical trials used to demonstrate the efficacy of the treatment receive the treatment, and the possibility of the treatment not working in these patients or causing adverse reactions becomes a real concern. The idea of a pragmatic trial is to study how well a treatment that <em>has already been demonstrated to be effective and safe</em> works in the real world. Here's the thing. Pragmatic trials are not meant to be the first to demonstrate efficacy. They are meant to see if a treatment proven in randomized clinical trials still works as well when released "into the wild," so to speak.</p> <p>Unfortunately, acupuncture advocates flip the order and put the cart before the horse, emphasizing pragmatic trials. The reason is obvious. Pragmatic trials, because they often don't have a placebo control arm or a sham treatment arm, by their very nature, will produce positive results. That's acceptable for pragmatic trials used properly, because they aren't meant to be the first demonstration of efficacy of a trial. That's exactly what Birch et al are doing here, and the reason they focused on osteoarthritis of the knee is because they can point to a meta-analysis that acupuncturists love to cite as evidence that acupuncture "works." It was <a href="http://scienceblogs.com/insolence/2012/09/12/can-we-finally-just-say-that-acupuncture-is-nothing-more-than-an-elaborate-placebo-can-we-2012-edition/">discussed</a> <a href="https://sciencebasedmedicine.org/an-acupuncture-meta-analysis/">many</a> <a href="https://sciencebasedmedicine.org/i-never-meta-analysis-i-really-like/">times</a> by skeptics when it was first published, and its author, Andrew Vickers, was <a href="http://scienceblogs.com/insolence/2013/03/08/author-of-the-acupuncture-metaanalysis-lambastes-sceptics/">most unhappy about the criticism</a>.</p> <p>See what I mean in the <a href="http://online.liebertpub.com/doi/pdf/10.1089/acm.2017.0029">accompanying commentary by Hugh MacPherson</a>:</p> <blockquote><p> Second, a new methodological approach was used in 2014. Different thresholds were used for the recommenda- tions in 2008 from those made as part of the 2014 update. The new guidance introduced the concept of the minimum clinically important difference (MCID), and required those interventions such as acupuncture that were within the scope of the update to show an MCID of an effect size of 0.5, a difference that is commonly considered ‘‘moderate.’’ When acupuncture is compared with usual care, there is an effect size of approximately 0.5, as has been shown in an individual patient data meta-analysis of acupuncture for osteoarthritis. </p></blockquote> <p><a href="https://sciencebasedmedicine.org/can-we-finally-just-say-that-acupuncture-is-nothing-more-than-an-elaborate-placebo/">As I pointed out</a>, the Vickers meta-analysis did not show an MCID for acupuncture compared to sham acupuncture. That's why MacPherson harps on an MCID between acupuncture and no treatment/usual treatment, a measure that maximizes placebo effects.</p> <h2>Does acupuncture do anything besides leaving little holes in the skin?</h2> <p>I'll have more to say about Birch et al, but this seemed like a good point to jump back to Pierre-Louis' article, because she asks the very pertinent question: Does acupuncture do anything? She seems quite taken by the fact that earlier this year the American College of Physicians listed acupuncture as a minimal invasive treatment of low back pain. But did it? Yes, it sort of did, but it was hardly a ringing endorsement. The actual studies used to justify the recommendations. For example, <a href="https://www.ncbi.nlm.nih.gov/pubmed/22770838">this study</a> showed that there was no difference between “true” acupuncture and sham acupuncture (which is what pretty much all well-designed acupuncture studies show). In other words, it showed that acupuncture is a placebo intervention. This study tested a sort of “scalp acupuncture” that I’ve never heard of before. Another study was from China, and, as has been discussed before, pretty much all acupuncture studies out of China are positive.</p> <p>What about chronic low back pain? Take a look:</p> <blockquote><p> Low-quality evidence showed that acupuncture was associated with moderate improvement in pain relief immediately after treatment and up to 12 weeks later compared with sham acupuncture, but there was no improvement in function (125–130). Moderate-quality evidence showed that acupuncture was associated with moderately lower pain intensity and improved function compared with no acupuncture at the end of treatment (125). Low-quality evidence showed a small improvement in pain relief and function compared with medications (NSAIDs, muscle relaxants, or analgesics) (125). </p></blockquote> <p>I laughed. At least, I laughed when I looked over the list of references. The authors actually included the GERAC study in its list, which basically showed that <a href="http://scienceblogs.com/insolence/2007/09/26/yawnanother-acupuncture-study/">acupuncture does not work</a>, given that sham acupuncture was indistinguishable from acupuncture. Another study was a “bait and switch” in that it studied “<a href="https://www.ncbi.nlm.nih.gov/pubmed/15105215">electroacupuncture</a>,” which is in reality TENS. We’re talking thin gruel indeed.</p> <p>However, that's not enough. Pierre-Louis has to pick out another study that really impressed her.</p> <h2>Carpal tunnel and acupuncture a-go-go</h2> <p>The study that impressed Pierre-Louis so much is one that has special resonance for me, because I once suffered from the condition for which acupuncture was tested. I'm referring to carpal tunnel syndrome. Yes, around 16 years ago, I developed a really bad case of carpal tunnel syndrome in my left hand. Given that I'm a surgeon, you can appreciate the anxiety and fear that my symptoms and diagnosis caused me. I saw my career as potentially being over. The pain and numbness were manageable for a while, but I saw the progressive nature of my carpal tunnel syndrome threatening my ability to operate. I even endured a nerve conduction study, which is basically torture with electricity. In the end, I was basically begging the hand surgeon to operate on me because I couldn't take it any more. Eventually, he did, and I recovered promptly. My career was saved. I still get a twinge every now and then, but haven't had any major carpal tunnel symptoms since.</p> <p>So Pierre-Louis invokes a recent study that I meant to blog about when it first appeared, but for some reason never did:</p> <blockquote><p> A more intriguing example is a March study that appeared in the journal <em>Brain</em>, which found that acupuncture improved the outcomes for carpal tunnel syndrome by literally remapping the brain. Researchers came to that conclusion after exposing subjects diagnosed with carpal tunnel syndrome—broken into three groups—to acupuncture treatments.</p> <p>Patients in the first group received an acupuncture treatment as prescribed by traditional Chinese Medicine—that is, needles were inserted at the site of the pain. The researchers exposed the second group to something known as distal needle acupuncture, in which acupuncture needles aren’t inserted where it hurts, but rather at other sites that practitioners say are connected to the painful regions by “channels of energy.” Yes, we know this sounds like snake oil—and the study authors aren’t alleging that the so-called channels exist. But if you want to know if something—a drug, a workout regimen, or in this case an acupuncture technique—has any effect, you have to test it.</p> <p>Finally, a third group received what’s known as sham acupuncture, which is essentially the sugar pill of acupuncture. In this case, sham acupuncture involved non-penetrating placebo needles designed to convince participants that they had undergone a real acupuncture treatment. Each participant received 16 treatments of their designated form of acupuncture over the course of eight weeks.</p> <p>At the end of the study, all groups equally reported that their symptoms had improved. That's proof that acupuncture is a sham, right? Not exactly. </p></blockquote> <p><a href="https://www.ncbi.nlm.nih.gov/pubmed/28334999">This is the study</a>. Each group of patients with mild to moderate carpal tunnel syndrome received 16 sessions of acupuncture over eight weeks, with before-and-after carpal tunnel symptom questionnaires, median nerve conduction studies, and, of course, functional MRI (fMRI). In any event, the reason why all three groups improved in the short term should be obvious. All are placebo. This result is exactly what I would have predicted. Of course, the other thing that is obvious is that this is a typical "bait and switch" acupuncture study. It's not acupuncture at all. It's electroacupuncture, which is in reality a form of transcutaneous nerve stimulation (TENS). Let's just put it this way: There was no electricity hundreds or thousands of years ago. Hooking up electrodes to acupuncture needles is a 20th century "innovation" that serves no apparent reason other than to "sex up" acupuncture. It also makes no anatomic sense. The distal acupuncture, for instance, was administered to acupuncture points in the lower leg; there is no anatomic reason to believe that this should have any effect on nerves in the distal arm. Remember, carpal tunnel syndrome is due to a very specific anatomic issue, entrapment of the median nerve as it goes through the carpal tunnel, defined by bones and ligaments in the wrist. That's why the surgical treatment, cutting the transverse carpal ligament, works; it frees the entrapped nerve.</p> <p>Now here's where this study has some interesting results. They are not results that have anything to do with acupuncture, as this is in reality the application of electrical current at acupuncture points. But they are somewhat interesting. First, there was a modest (and not strongly statistically significant) improvement in median nerve conduction in both the distal and local acupuncture groups compared to the sham. This result makes little sense from an anatomic standpoint, although it's not entirely implausible that running a weak electrical current along the lower arm might potentially affect nerve conduction studies in the same arm. In fMRI studies, the investigators reported brain remapping associated with symptom improvement only in those receiving the local acupuncture, a result that's somewhat plausible. Of course, again, none of these results has anything to do with acupuncture, the existence of meridians, or TCM, even as they are sold as slam dunk evidence that "acupuncture" remaps the brain.</p> <p>This study also has some significant flaws. For instance, although it was blinded, it appears not to have been truly double-blinded. Patients were blinded to allocation, as were the study physicians who evaluated patients for inclusion. Experimenters, the people who did the nerve conduction studies and evaluated the fMRIs, were blinded as well. You know who weren't blinded? The acupuncturists. I'll give the investigators credit for inserting all the needles in the distal and local acupuncture groups to hide from the patient the allocation. However, the acupuncturists knew which experimental group each patient was in at the first treatment session. So that's a huge problem right there, especially since adequacy of blinding was only evaluated after the first treatment and the patients were unblinded after the fMRI. There's also another huge defect in that the sham acupuncture specifically does not pass current through the needles. A much better control would have been to use random acupuncture points and actually run the same current through the needles. My guess is that this group, had it been included, would have shown the same results as the distal and local acupuncture groups.</p> <p>So basically, what this study shows is mildly interesting, but is not evidence that acupuncture relieves symptoms and function in patients with mild to moderate carpal tunnel. The most generous interpretation is that passing current through the forearm 16 times over eight weeks might improve nerve conduction somewhat. That's about it. Unfortunately, in a <a href="http://news.harvard.edu/gazette/story/2017/03/study-reveals-differences-in-the-effects-of-real-and-sham-acupuncture/">statement</a> issued by Massachusetts General Hospital (which ran the study) and Harvard, the study principal investigator Nataly Napadow that basically sells this as showing that "true acupuncture" works by a different mechanism than the "placebo" of sham acupuncture:</p> <blockquote><p> Even after years of clinical research, controversy continues as to whether acupuncture works primarily by the placebo effect, especially given the slight differences between the efficacy of real and sham acupuncture. The findings of the Brain study help to address this question. Sham acupuncture may produce a stronger placebo effect than a pill because it sends inputs to the brain via skin receptors and is coupled with a specific ritual. But the symptom improvement produced by sham treatment for conditions like CTS also might derive from entirely different mechanisms than those elicited by real acupuncture, the mechanisms of which may more specifically target CTS pathophysiology. </p></blockquote> <p>No, no, no. Maybe running electricity through the leg or arm causes an effect, but acupuncture doesn't. After all, what was the main difference between both "true" acupuncture groups and the sham acupuncture group? It was the application of electrical current!</p> <p>Studies like this and how they are sold infuriate me and are not evidence that acupuncture "works." In this case, though, the press pretty much credulously ate up the given narrative, and I couldn't find a single skeptical take on the study anywhere.</p> <h2>When is a placebo not a placebo?</h2> <p>Pierre-Louis, unfortunately, <a href="http://www.popsci.com/does-acupuncture-work">completely buys into Napadow's narrative</a>:</p> <blockquote><p> Recall that if you were to throw out the objective measure’s—the fMRI and nerve conductivity tests—Napadow’s study looks like a dud, because patients expressed equal levels of pain reduction whether they experienced real acupuncture or sham acupuncture.</p> <p>The whole point of a placebo is that it's inert. It doesn't actually have an effect on the body, making it an excellent control. But physical interventions aren't quite the same as sugar pills: even in sham acupuncture, there is some pressure or sensation being inflicted on the patient's body. In fact, some cases of "sham" acupuncture even involve the insertion a needle, though Napadow's study did not.</p> <p>“There's a controversy as to what sham acupuncture is,” said Napadow, “you still have a tactile sensation and a somatosensory input as a result of sham acupuncture.” </p></blockquote> <p>No, there really isn't a controversy over what sham acupuncture is. At least, there shouldn't be. The idea behind placebo is to isolate the aspect of the treatment that has a specific physiologic effect, which sham acupuncture does in studies of acupuncture studies. Napadow failed to do that in his carpal tunnel syndrome study. The way his study was designed, whether you believe the results or not, all it could do was to isolate the electricity, not the "true" acupuncture, as the part of the treatment modality that causes a physiologic effect. His study shows nothing about acupuncture. Again, repeat after me: It doesn't matter where you stick the needles. It doesn't even matter <em>if</em> you stick the needles in.</p> <p>In his commentary, MacPherson argues that acupuncture for knee osteoarthritis was given a bum rap by NICE, that NICE applied a double standard. She points out that the evidence for surgical interventions for this condition, such as arthroscopic debridement and lavage, is not very strong and that these interventions don't reach the threshold for effect size required by NICE, even though NICE still recommends these procedures, asking. Like so many alternative medicine apologists, he frames it in terms of the opioid epidemic:</p> <blockquote><p> As news of these questionable recommendations spreads, many people will be misled, such that acupuncture services may be commissioned less often, conventional medical practitioners may refer their patients less, and patients might find access to acupuncture more difficult. Moreover, misleading guidance related to chronic pain may inadvertently drive up the utilization of opioids, which is already emerging as an epidemic in the United States. </p></blockquote> <p>Birch et al go even further, using the <a href="http://online.liebertpub.com/doi/pdf/10.1089/acm.2016.0385">NICE recommendations as an excuse to advocate pragmatic trials</a>:</p> <blockquote><p> If NICE were to apply the same criteria to OA [osteoarthritis] treatments, only opioids would be left and with their adverse events profile that may not be acceptable to some patients suffering from OA of the knee. Furthermore, in agreement with other authors, it is time to stop performing sham acupuncture as a control treatment in acupuncture studies. </p></blockquote> <p>Just a reminder: No sham acupuncture control = pragmatic study.</p> <p>So basically, Birch et al and MacPherson are basically arguing that the new NICE criteria are too strict and exclude acupuncture without excluding conventional surgical treatments that don't reach the designated effect size and are not superior to sham surgery. They use these observations to argue that acupuncture should be included in NICE recommendations for osteoarthritis, too.</p> <p>Pierre-Louis then asks the right question, but implies the wrong answer:</p> <blockquote><p> The researchers ask a simple question: if most of the recommended treatments fail to meet this threshold, why is acupuncture excluded while arguably more invasive procedures are included? But as patients, we should perhaps be asking a different question. Why are we being recommended procedures that don’t work? </p></blockquote> <p>An excellent question, actually. Unfortunately, the answer given by Birch et al and MacPherson—for NICE to start recommending acupuncture for osteoarthritis—is the wrong answer. The correct answer is that, if surgical interventions for osteoarthritis truly don't reach the new NICE threshold for MID, then the answer is not to include acupuncture in NICE recommendations for osteoarthritis, but rather to stop including those surgical interventions. That's not how alternative medicine practitioners and apologists see the world, though. When conventional therapies don't reach a given standard of evidence for efficacy and safety, instead of advocating that those treatments be abandoned, as those of us who advocate for science-based medicine do, they use that as a reason for accepting their quackery as valid treatments too. If it requires weakening the standards of evidence to let their quackery stand "integrated" with science-based medicine, so much the better.</p> </div> <span><a title="View user profile." href="/oracknows" lang="" about="/oracknows" typeof="schema:Person" property="schema:name" datatype="">oracknows</a></span> <span>Sun, 05/14/2017 - 21:49</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/medicine" hreflang="en">Medicine</a></div> </div> </div> Mon, 15 May 2017 01:49:21 +0000 oracknows 22552 at https://scienceblogs.com Old wine poured into a newer skin: The Society for Integrative Oncology updates its clinical guidelines for breast cancer https://scienceblogs.com/insolence/2017/05/02/old-wine-poured-into-a-newer-skin-the-society-for-integrative-oncology-updates-its-clinical-guidelines-for-breast-cancer <span>Old wine poured into a newer skin: The Society for Integrative Oncology updates its clinical guidelines for breast cancer</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>"Integrative medicine" is a term for a form of medicine in which pseudoscience and quackery are "integrated" with real medicine. Unfortunately, as Mark Crislip puts it, when you mix cow pie with apple pie, it doesn't make the cow pie better; it makes the apple pie worse. Unfortunately these days, there's a lot of cow pie being mixed with apple pie. Worse, it's gotten to the point where integrative medicine is subspecializing. For instance, there is now a specialty known as "integrative oncology," which particularly burns me. Indeed, supportive care oncology has been very susceptible to the woo embraced by integrative oncology, to the point where <a href="http://scienceblogs.com/insolence/2016/06/01/the-quackery-that-is-naturopathic-oncology/">naturopaths</a> are <a href="http://scienceblogs.com/insolence/2016/12/27/how-cute-naturopathic-oncologists-are-pretending-that-theirs-is-a-real-medical-specialty/">involved</a>, and when naturopaths are involved quackery such as <a href="http://scienceblogs.com/insolence/2011/01/28/you-cant-have-naturopathy-without-homeop/">homeopathy is involved</a>.</p> <!--more--><p>Two years ago, the Society for Integrative Oncology, the main society promoting the integration of pseudoscience into science-based oncology, <a href="http://scienceblogs.com/insolence/2014/12/01/old-wine-in-a-new-skin-the-society-for-integrative-oncology-issues-guidelines-for-breast-cancer/">published a monograph</a> in the <em>Journal of the National Cancer Institute</em> (JNCI) with guidelines for what it referred to as the <a href="http://scienceblogs.com/insolence/2014/12/08/old-wine-in-a-new-skin-the-society-for-integrative-oncology-promotes-integrating-pseudoscience-into-oncology/">evidence-based supportive care of breast cancer patients</a>. I referred to it at the time as "old wine in a new skin." Well, leave it to the SIO not to be able to leave bad enough alone, as it's come up with what I like to refer to as <em>SIO Clinical Guidelines 2: Electric Boogaloo</em>. It comes in the form of an article by Heather Greenlee et al published in CA: A Cancer Journal for <a href="http://onlinelibrary.wiley.com/doi/10.3322/caac.21397/full">Clinicians and entitled Clinical practice guidelines on the evidence-based use of integrative therapies during and after breast cancer treatment</a>.</p> <p>Its author list includes MDs, some of them respected, like Debu Tripathy, but it also contains quacks like an acupuncturist named Misha Cohen. It also contains three naturopaths, starting with the first author, <a href="https://www.mailman.columbia.edu/people/our-faculty/hg2120">Heather Greenlee</a>. Dugald Seely is on the author list again, as well. We've met Seely before on multiple occasions. Indeed, he's quite the flush little naturopathic quack, complete with <a href="http://scienceblogs.com/insolence/2014/10/22/an-anonymous-canadian-foundation-grants-4-million-to-study-integrative-oncology/">millions of dollars</a> donated by an <a href="http://scienceblogs.com/insolence/2015/04/02/an-anonymous-canadian-foundation-grants-4-million-to-study-naturopathic-oncology/">anonymous donor</a> to fund "integrative oncology" research at the Ottawa Integrative Cancer Center (OICC). Then there's <a href="https://medicine.umich.edu/dept/family-medicine/suzanna-m-zick-nd-mph">Suzanna Zick</a>, who's even worse than a naturopath. She's a <a href="http://scienceblogs.com/insolence/2016/07/13/quackademic-medicine-and-acupressure-at-my-alma-mater/">naturopath at my alma mater, the University of Michigan Medical School</a>. It always depresses me to contemplate that U. of M. actually has a naturopath working for it, but, then, it also has an <a href="http://scienceblogs.com/insolence/2011/03/21/anthroposophic-medicine-at-the-universit/">anthroposophic medicine program</a>. So I guess it's not a stretch any more for there to be naturopaths there.</p> <p>Let's get back to the clinical guidelines and systematic review, such as they are. To show just how debased medicine has become in accepting woo as "evidence-based," you can even answer questions about the article and earn CME for learning. One thing I can't figure out is why this group felt the need to update the guidelines a mere two years later, and this explanation doesn't help:</p> <blockquote><p> In November 2014, the Society for Integrative Oncology (SIO) published clinical practice guidelines to inform both clinicians and patients on the use of integrative therapies during breast cancer treatment and to treat breast cancer treatment-related symptoms.[9] The SIO adapted methods established by the US Preventive Services Task Force[10] to develop graded recommendations on the use of specific integrative therapies for defined clinical indications based on the strength of available evidence concerning associated benefits and harms. The 2014 clinical practice guidelines were derived from a systematic review of randomized clinical trials published between 1990 and 2013 and organized by specific clinical conditions (eg, anxiety/stress, fatigue). This review provides an updated set of clinical practice guidelines based on a current, systematic literature review of randomized controlled trials (RCTs) published through December 2015 along with detailed definitions of integrative therapies and clinical outcomes of interest, a detailed summary of the literature upon which the clinical practice guidelines are based, and suggestions for how appropriate therapies may be integrated into clinical practice. </p></blockquote> <p>So my first reaction was: Really? You needed to publish again just to add two years' worth of new trials to the guidelines? Do the new trials add much to the recommendations from the previous iteration of these guidelines? Do they change the recommendations in any substantive way? What do Greenlee et al mean by "recommendations," anyway. It's not what you would normally think:</p> <blockquote><p> Of note, it is important to define the use of the term recommendation in these clinical practice guidelines. In many settings, a clinical guideline recommendation suggests that it should be used as the standard of care and is favorable or equal compared with all other options based on best clinical evidence for benefit/risk ratio. Here, in the setting of integrative oncology, we use the term recommendation to conclude that the therapy should be considered as a viable but not singular option for the management of a specific symptom or side effect. Few studies have conducted a head-to-head comparison of a given integrative therapy against a conventional treatment, and most integrative therapies are used in conjunction with standard therapy and have been studied in this manner. Moreover, combination-based approaches and the interactions of the numerous permutations of integrative and conventional treatments have not been formally investigated, such that recommendations must account for this limitation of our knowledge. Despite these limitations to evaluating the use of integrative therapies in the oncology setting, there is a body of well conducted trials of specific therapies for specific conditions that provides sufficient evidence to warrant recommendations on the therapies as viable options for treating specific conditions. </p></blockquote> <p>Ah, "integrative medicine," where even "recommendation" doesn't mean what it does in real medicine. In clinical guidelines in real medicine, "recommendation" means just that: a recommendation to use the treatment in question, graded, of course, according to the strength of the evidence. Yet here in the world of integrative medicine, "recommendation" means something...squishier. One can't help but make the analogy that integrative medicine's evidence standard is squishier than that of real medicine. Oh, and the answer to that question of whether the new studies add much of anything to the 2014 clinical guidelines is, as I suspected, no, at least as far as I can tell. As was the case with the previous review, interventions are graded thusly:</p> <blockquote><p> Grades were based on strength of evidence, determined by the number of trials, quality of trials, magnitude of effect, statistical significance, sample size, consistency of results across studies, and whether the outcomes were primary or secondary. The highest grades (A and B) indicate that a specific therapy is recommended for a particular clinical indication. Grade A indicates there is high certainty that the net benefit is substantial, while grade B indicates there is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial. Grade C indicates that the evidence is equivocal or that there is at least moderate certainty that the net benefit is small. The lowest grades (D, H, and I) indicate no demonstrated effect, suggest harm, or indicate that the current evidence is inconclusive, respectively. </p></blockquote> <p>Interestingly, this review does add something in that it defines each intervention more explicitly than the previous guidelines. Not surprisingly, the definition of acupuncture parrots the same sort of revisionist history that acupuncture advocates frequently repeat when justifying the practice. It is, in essence, an appeal to antiquity that paints acupuncture thusly:</p> <blockquote><p> Acupuncture involves the stimulation of specific points, (ie, acupoints) by penetrating the skin with thin, solid, metallic needles.[154, 155] A variation of acupuncture includes electroacupuncture, in which a small electric current is passed along acupuncture needles to provide a stronger stimulus than acupuncture alone, with distinct effects suggested by functional magnetic resonance imaging.[156, 157] Acupuncture has been practiced in Asia for thousands of years as a component of traditional medicine systems (eg, traditional forms of Chinese, Japanese, and Korean medicine) and is thought to stimulate the flow of a form of energy called qi (chee) throughout the body. Traditional Chinese acupuncture, which is commonly used in North America, requires needle manipulation to produce a de qi sensation (a soreness, fullness, heaviness, or local area distension[157, 158]), along with a period of rest with the needles in place.[159] It is posited that this removes energetic blockages, thus reestablishing homeostasis. The mechanisms for acupuncture's effects are not well understood but are thought to function in part through modulation of specific neuronal/cortical pathways.[160] </p></blockquote> <p>It's always a sad day when a respectable medical publication publishes papers that invoke vitalism in the form of the flow of "life energy" and suggests that this flow can be manipulated. Then there's the revisionist history. Think about it. The claim is that acupuncture has been practiced "thousands of years," most commonly for at least a couple of thousands of years. Yet two thousand years ago the technology to produce thin needles of the sort used by acupuncturists didn't exist. In fact, it's unclear when acupuncture in something resembling its current form evolved, but it appeared to have evolved from bloodletting. Harriet Hall once <a href="https://sciencebasedmedicine.org/the-reality-of-ancient-wisdom-acupuncture-and-tcm-werent-so-great/">related the story of Dugald Christie</a>, a Scottish surgeon who served as a missionary doctor in northeastern China from 1883 to 1913, and his experiences observing traditional Chinese medicine (TCM), including acupuncture. Let's just say that acupuncture practiced 100 years ago was rather brutal. In fact, acupuncture began as nothing more than a <a href="https://sciencebasedmedicine.org/acupuncture-and-modern-bloodletting/">Chinese version of bloodletting</a>, very much like "Western" bloodletting and has been called "<a href="https://sciencebasedmedicine.org/astrology-with-needles/">astrology with needles</a>." In reality, acupuncture and TCM achieved their current form under Chairman Mao Zedong, who promoted their use when he couldn't supply enough doctors for his people and exported to the world, something <a href="http://scienceblogs.com/insolence/2017/01/23/first-china-next-the-world-the-chinese-government-gives-a-big-boost-to-traditional-chinese-medicine-just-like-chairman-mao-did/">China is still doing</a>. It's a <a href="https://sciencebasedmedicine.org/retconning-traditional-chinese-medicine/">history that's been retconned</a>, and Greenlee et al repeat that retconned revisionist history. <a href="https://sciencebasedmedicine.org/infinite-variety/">No wonder there are so many forms of acupuncture</a>.</p> <p>Basically, there's not much new in these guidelines. Relatively uncontroversial modalities like meditation, music therapy, stress management, and yoga are given the highest recommendations. However, acupuncture and its bastard offspring electroacupuncture (which really has no basis in TCM, given that there was no electricity hundreds or thousands of years ago to hook needles up to) consistently get B or C recommendations for several indications, despite acupuncture being nothing more than a <a href="http://www.dcscience.net/Colquhoun-Novella-A&amp;A-2013.pdf">theatrical placebo</a> that <a href="http://skeptvet.com/Blog/wp-content/uploads/2015/02/McGeeney-2015-AcupunctureisAllPlacebo.pdf">hasn't convincingly been shown to work</a> for any clinical indication. <a href="http://scienceblogs.com/insolence/2016/07/13/quackademic-medicine-and-acupressure-at-my-alma-mater/">That includes acupressure</a>.</p> <p>As is the case with most systematic reviews of integrative medicine, there are some head scratchers. For instance there's this level C recommendation, meanding that they can be considered</p> <blockquote><p> Acupuncture,[49-51, 91, 92] healing touch,[93, 94] and stress management[36-38, 95, 96] can be considered for improving mood disturbance and depressive symptoms. </p></blockquote> <p>And:</p> <blockquote><p> Acupuncture,[119-124] healing touch,[93] hypnosis,[125, 126] and music therapy[31, 34] can be considered for the management of pain. </p></blockquote> <p>Healing touch is the rankest quackery. It's energy medicine that postulates that practitioners can manipulate human life energy fields. It's such a silly form of quackery that <a href="https://www.psychologytoday.com/blog/homo-consumericus/201109/eleven-year-old-debunks-therapeutic-touch-the-case-emily-rosa">even a 12-year-old girl could disprove it</a>.</p> <p>Basically, these guidelines were even more unnecessary and pointless than the first set of guidelines published in 2014. It's not as though clinical studies have advanced knowledge enough to justify a new set of guidelines, and these guidelines suffer from the same issue that integrative medicine itself suffers from, mixing cow pie with apple pie as though they were equivalent. I called the previous guidelines old wine in a new skin. Greenlee et al have just poured that old wine out of the new skin into a newer skin, seemingly expecting it to make the vinegary wine better.</p> </div> <span><a title="View user profile." href="/oracknows" lang="" about="/oracknows" typeof="schema:Person" property="schema:name" datatype="">oracknows</a></span> <span>Mon, 05/01/2017 - 21:58</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/technology" hreflang="en">Technology</a></div> </div> </div> Tue, 02 May 2017 01:58:19 +0000 oracknows 22544 at https://scienceblogs.com "Dr. Seuss monsters": The quackery that is "battlefield acupuncture" continues to metastasize https://scienceblogs.com/insolence/2017/03/29/the-quackery-that-is-battlefield-acupuncture-continues-to-metastasize <span>&quot;Dr. Seuss monsters&quot;: The quackery that is &quot;battlefield acupuncture&quot; continues to metastasize</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>After <a href="http://scienceblogs.com/insolence/2017/03/28/adventures-in-bad-veterinary-medicine-reported-by-the-local-media-2017-edition/">yesterday's post on a local news station's credulous promotion of quack acupuncture</a> (but I repeat myself) for pets, I thought I'd stay on the topic of acupuncture for one more day. The reason is that a reader sent me a link to an article in Stars and Stripes that really irritated me, <a href="https://www.stripes.com/news/acupuncture-becomes-popular-as-battlefield-pain-treatment-1.460445#.WNsywFKZPYL">Acupuncture becomes popular as battlefield pain treatment</a>. Longtime readers might remember that I've been writing about the utter ridiculousness and lack of science behind "battlefield acupuncture" and how it makes no sense to be sticking recently wounded soldiers with needles under battlefield conditions. Out of curiosity, before I proceeded to discuss this article and what's going on with battlefield acupuncture in 2017, I decided to try to find my first ever post on battlefield acupuncture. It depressed me a lot to discover that the first time I came across this abuse of our brave men and women in uniform was <a href="http://scienceblogs.com/insolence/2008/03/19/woo-invades-the-military/">way back in 2008</a>, when I began with a brief vignette imagining what battlefield acupuncture might look like.</p> <!--more--><p>So here it is, nine years later, and nothing has changed. If anything, the infiltration of the quackery of battlefield acupuncture has infiltrated the military <a href="https://www.stripes.com/news/acupuncture-becomes-popular-as-battlefield-pain-treatment-1.460445#.WNsywFKZPYL">even more now than then</a>. You might wonder where the reference to "Dr. Seuss monsters" came from. Don't worry. You won't finish this article without knowing, and it's truly mind-numbingly dumb, as one would expect from acupuncturists. In the meantime, let's see how this <em>Stars and Stripes</em> report starts out:</p> <blockquote><p> About 50 flight surgeons from 21 countries wrapped up a day of training at an international medical conference here this week with matching gold-plated studs set in their ears.</p> <p>Their ears sparkled in the name of medicine: This was a hands-on workshop on battlefield acupuncture, an alternative therapy that’s vying to become a standard practice of care at Defense Department and Veteran Affairs medical centers for acute and chronic pain.</p> <p>Battlefield acupuncture, a form of auricular or ear acupuncture so named because the tiny needles can be administered quickly in combat without removing so much as a helmet, has been around for more than 15 years.</p> <p>But use of the technique, once practiced by fewer than a 100 military doctors across the services, is rapidly expanding through a vigorous training program supported by DOD and the VA. </p></blockquote> <p>This is stated as though it were a good thing. It's not.</p> <p>Let's take a step back to when I first discovered the woo that is "battlefield acupuncture." The man most responsible for its promotion was Col. (Dr.) Richard Niemtzow, who is a radiation oncologist by training but, for purposes of this post, one of the foremost proponents of battlefield acupuncture. It should also be noted that "battlefield acupuncture" is somewhat different than regular acupuncture in that it is almost always primarily auricular acupuncture. Basically, the ears are the focus, and auricular acupuncture needles are considerably smaller than standard acupuncture needles. They're also sometimes left in place in the ear for up to several days, basically until they fall out. The idea behind this, presumably, was to come up with an acupuncture method that was easy and could be done under difficult conditions. Unfortunately, there isn't any actual science behind it. When you look at the studies presented in support of the practice, you'll inevitably discover that it's the <a href="http://scienceblogs.com/insolence/2008/12/22/battlefield-acupuncture-revisited-only-t/">thinnest of gruel</a>, no matter <a href="http://scienceblogs.com/insolence/2013/04/29/an-amusing-very-special-issue-of-medical-acupuncture/">how much advocates try</a>.</p> <p>None of this prevented the infiltration of "battlefield acupuncture" into both the military and the <a href="http://scienceblogs.com/insolence/2016/07/25/the-va-and-dr-tracy-gaudet-integrating-quackery-into-the-care-of-veterans/">VA medical system</a>. None of this stopped the military from <a href="http://scienceblogs.com/insolence/2008/12/15/woo-in-the-military-acupuncture/">deploying acupuncture-trained physicians to Iraq</a> back when the war was still in full swing, with Army Rangers, of all forces, learning it and experimenting with it. None of this has stopped Col. (Dr.) Niemtzow from offering webinars, books, and courses in "battlefield acupuncture" or auricular acupuncture, which he now calls "<a href="http://www.n5ev.com/courses.html">rapid acupuncture</a>," advertising them with statements like:</p> <blockquote><p> The medical mission is to provide the latest innovative acupuncture therapy techniques to patients who have not responded well to traditional Western medicine. Only those acupuncture techniques that have a very high success rate, usually successful during the initial treatments and are cost effective will be employed. </p></blockquote> <p>Nowhere is any compelling evidence presented that these techniques "have a very high success rate." There doesn't need to be. It's faith. “Auricular acupuncture” is based on a physiological principle that makes every bit as much sense as reflexology, and I mean that in the worst way possible. Basically, the idea is that parts of the ear "map" to parts of the body, like a homunculus. I was saying this nine years ago. <a href="https://www.stripes.com/news/acupuncture-becomes-popular-as-battlefield-pain-treatment-1.460445#.WNsywFKZPYL">Unfortunately, since then</a>:</p> <blockquote><p> About 2,800 providers have been trained as part of the initiative, said Thomas Piazza, the director of the Air Force Acupuncture Program at Joint Base Andrews, Md.</p> <p>In the Air Force, where the therapy was pioneered by physician and retired Air Force Col. Richard Niemtzow in 2001, close to 60 percent of its bases “are trained up” in battlefield acupuncture, Piazza said. “We’re looking to get battlefield acupuncture as part of standard of care versus a separate thing where we say ‘you can have an alternative medicine.’”</p> <p>He added: “Sometimes people just want a Motrin and that’s fine, great, we’ve got that, too. But some people just don’t want to take medicines; they just want something else for a change.” </p></blockquote> <p>I did indeed cringe when I read that last quote, and you should too. Basically, it's a false equivalence in which a <a href="http://www.dcscience.net/2013/05/30/acupuncture-is-a-theatrical-placebo-the-end-of-a-myth/">theatrical placebo</a> (acupuncture) is represented as being just as effective as proven pharmacologic management and therefore, above all, an equally reasonable choice. That's what this is all about, normalizing quackery and, as "integrative medicine" proponents do, "integrating" quackery with real medicine, and now there are 2,800 military providers who have been trained in "integrating" just this form of quackery. It's a momentum that could well be unstoppable, because once you have thousands of people invested in a technique that technique tends to be offered, used, and, of course, standardized:</p> <blockquote><p> Piazza was at Ramstein last week to teach battlefield acupuncture to U.S. and NATO flight surgeons attending an annual international medical conference. One of the appeals of battlefield acupuncture is simplicity. The training is boiled down into a few hours of academic and clinical instruction. In one afternoon, the flight surgeons at Piazza’s workshop could find the five points on each ear — with names like cingulate gyrus and shen men — corresponding to where the needles go, in a particular order.</p> <p>The training is standardized to ensure it’s done right, Piazza said. “Most of the people we’re teaching to aren’t acupuncturists,” he said. “We say follow this recipe, follow these steps.” </p></blockquote> <p>The cingulate gyrus? What the hell? That's a <a href="http://www.neuroscientificallychallenged.com/blog//know-your-brain-cingulate-cortex">part of the brain</a>, part of the limbic system thought to be involved with controlling emotional responses to internal and external stimuli (among other things). Is Piazza saying that part of the ear maps to the cingulate gyrus in the brain? Then, is he saying that sticking needles into that part of the ear somehow affects the actual cingulate cortex in the brain to block negative responses to painful stimuli? It's hard to interpret his claim otherwise.</p> <p>Perhaps the funniest part of the article, which was undoubtedly not intended to be funny, was this:</p> <blockquote><p> Though side effects and risk of infection are minimal, Piazza told the flight surgeons that one of the hurdles they might face is convincing patients to try a treatment involving needles. “Who likes needles? Most of your patients don’t like needles.</p> <p>“You’re going to learn this is much less painful than getting your ears pierced,” he said.</p> <p>“It’s a little uncomfortable but it’s not like being shot,” said Col. Anthony Mitchell, an aerospace medicine resident at Wright-Patterson who was using the training as a refresher. </p></blockquote> <p>Yes. That's a ringing endorsement! Use battlefield/auricular acupuncture because it doesn't hurt as much as being shot. Well, even though I've never been shot (thankfully) and hope never to have that experience, I can't argue against the contention that having needles stuck in your ear doesn't hurt as much as being shot. What I can argue with is the implication that that this makes it OK to use a treatment that is quackery. Of course, in the article, Piazza throws out anecdotes and his personal clinical experience in which he stated that he used auricular acupuncture in Afghanistan in 2013 on wounded soldiers being transported to medical facilities as "an adjunct, to see if they didn’t need as much medicine." What he didn't say is whether that adjunct really did result in the wounded soldiers needing less medication.</p> <p>Of course, this <em>Stars and Stripes</em> includes the usual trope used since time immemorial in articles discussing quackery of presenting the token skeptic view (in this case, that of Harriet Hall), followed by the quack retort:</p> <blockquote><p> Piazza said the therapy is backed by more than half a dozen randomized control trials and a number of case reports.</p> <p>In one study, conducted by Air Force doctors at Nellis Air Force Base, Nev., and published in 2015, battlefield acupuncture was compared to standard pain treatment in 54 DOD patients with an acute sore throat. Acupuncture was associated with reduced sore throat pain for 24 hours and decreased use of pain medication for up to 48 hours. There was no apparent effect on hours missed from work.</p> <p>Piazza said a group of doctors reported a 64 percent decrease in the rate of medical groundings for deployed pilots who received battlefield acupuncture instead of pain killers for lower back pain.</p> <p>“We’re not looking to replace medicine,” Piazza said, but the procedure has been shown to reduce the use of narcotics. </p></blockquote> <p>Regarding the second claim, I could find no publications in the peer-reviewed medical literature to examine supporting it. Regarding the second claim, I looked up the <a href="https://www.ncbi.nlm.nih.gov/pubmed/26546644">actual study</a>. (It's what I do.) Let's just say that the study is...underwhelming. Yes, it was a randomized controlled trial looking at 54 patients with acute sore throat. However, it was unblinded, a feature that renders any acupuncture trial pretty much worthless scientifically because it doesn't account for placebo effects. Indeed, it's a pragmatic trial. That means that the intent is to determine effectiveness under "real world" conditions; hence, no sham/placebo controls. In real medicine, pragmatic trials are used to assess the real world effectiveness of treatments already shown to be efficacious in randomized controlled clinical trials. However, given that auricular acupuncture has not been shown to be effective in such trials, doing pragmatic trials studying it is putting the cart before the horse.</p> <p>Not that ever stopped acupuncturists from doing such trials before. After all, it's the way they generate "positive" trials. After all, doing rigorous randomized controlled trials with good shame acupuncture controls generally find that acupuncture is indistinguishable from sham acupuncture.</p> <p>Earlier in this post, I said that the funniest thing I read in the article was the reference to the "cingulate gyrus" on the ear. I was wrong. The "cingulate gyrus" didn't invoke Dr. Seuss in a truly nonsensical way. Air Force Lt. Col. Patricia Macsparran did:</p> <blockquote><p> Air Force Lt. Col. Patricia Macsparran, the aerospace medicine consultant to the Air Force Surgeon General, incorporates acupuncture into her practice daily.</p> <p>She’s a licensed acupuncturist with more than 300 hours of training.</p> <p>She explains the science behind it with a reference to Dr. Seuss. When the body perceives pain, it sends a lot of fluid with anti-inflammatory products to fix it, she said. Under a microscope, those products “look a lot like Dr. Seuss monsters,” she said, and the body has a hard time clearing them out. “Acupuncture is sort of like a traffic cop,” she said. “If you know where to place those needles to push ionic flow to get things moving, you basically release that traffic jam so the body can heal itself.”</p> <p>Battlefield acupuncture “is just scratching the surface,” she said. “Every organ in the body, including the brain, is represented on the ear. It’s a microsystem.” </p></blockquote> <p>Theodor Seuss Geisel is doing backflips in his grave. Or maybe not. After all, it's not the reference to Dr. Seuss monsters that's so dumb. I suppose certain immune cells could be described that way under the microscope. However, the rest is, without a doubt, the most ridiculous "explanation" for how acupuncture "works" I've ever heard, and, believe me, I've heard more contortions of science, hand waving, and pseudoscience than I can remember, but I've never seen an acupuncturist likening inflammatory products looking like "Dr. Seuss monsters" or likening sticking acupuncture needles into the skin as being like a "traffic cop" who "releases "ionic flow" to get things moving" so that the body can "heal itself. The entire passage above is what I like to refer to as "woo babble." It's like the technobabble that Star Trek fans (particularly Next Generation fans) are so familiar with, in which science-y-sounding terms are strung together as "explanations" to various phenomenon or used as a plot device to get our heroes out of trouble, only with woo instead. Oh, and Dr. Seuss.</p> <p>Unfortunately, "battlefield acupuncture" is one small, albeit particularly egregious example of the "integration" of quackery into medicine, in this case military medicine. There is actually an active effort to normalize such quackery in medicine, but it seems to be particularly bad in military medicine, <a href="http://scienceblogs.com/insolence/2016/07/25/the-va-and-dr-tracy-gaudet-integrating-quackery-into-the-care-of-veterans/">including the VA</a>. It's being promoted by not just the military and the VA but <a href="https://nccih.nih.gov/news/press/spring2017?nav=rss">by the National Center for Complementary and Integrative Health</a> (NCCIH).</p> <p>I've said it before more times than I can remember. Our men and women in uniform are putting their lives on the line in the defense of us all. They deserve the very best science-based medicine that we can offer. Unfortunately, there seems to be more enthusiasm for offering them quackery like "battlefield acupuncture" than actually improving the science-based medical offerings that benefit them. It's a scandal that no one's talking about.</p> </div> <span><a title="View user profile." href="/oracknows" lang="" about="/oracknows" typeof="schema:Person" property="schema:name" datatype="">oracknows</a></span> <span>Tue, 03/28/2017 - 21:00</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/medicine" hreflang="en">Medicine</a></div> </div> </div> Wed, 29 Mar 2017 01:00:58 +0000 oracknows 22521 at https://scienceblogs.com Adventures in bad veterinary medicine reported by the local media (2017 edition) https://scienceblogs.com/insolence/2017/03/28/adventures-in-bad-veterinary-medicine-reported-by-the-local-media-2017-edition <span>Adventures in bad veterinary medicine reported by the local media (2017 edition)</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p><a href="http://journals.lww.com/anesthesia-analgesia/Pages/articleviewer.aspx?year=2013&amp;issue=06000&amp;article=00025&amp;type=Fulltext">Acupuncture is a theatrical placebo</a>, nothing more. It has no "curative powers," and, when studied objectively in good double-blind, randomized controlled clinical trials with proper sham acupuncture controls, there is consistently found to be no difference between sham and "true" (or, as they like to call it, "verum") acupuncture. (Indeed, I <a href="http://scienceblogs.com/insolence/?s=acupuncture">have written about this many times</a>.) The only exceptions to this rule tend to be <a href="https://sciencebasedmedicine.org/chinese-systematic-reviews-of-acupuncture/">studies that come out of China</a>. Basically pretty much <a href="http://edzardernst.com/2014/05/and-this-is-why-we-might-as-well-forget-about-chinese-acupuncture-trials/"><em>all</em> acupuncture studies that come out of China are positive</a> because they <a href="https://health.spectator.co.uk/fakery-massive-scale-means-just-cant-trust-studies-china/">appear to be conducted with the intent</a> to confirm the prior assumption that the treatment is effective. Yet, there continue to be true believers who think that acupuncture is basically a panacea for anything that ails you. Worse, of all the quackery that is being "integrated" into medicine by "pioneers" in "integrative medicine," acupuncture is one of the most ubiquitous, if not the most ubiquitous of them all. Pretty much every quackademic program in integrative medicine offers acupuncture, even though even the largest meta-analyses presented in favor of its efficacy, when examined critically, <a href="http://scienceblogs.com/insolence/2012/09/12/can-we-finally-just-say-that-acupuncture-is-nothing-more-than-an-elaborate-placebo-can-we-2012-edition/">do nothing of the sort</a>, although they do leave advocates of quackademic acupuncture <a href="http://scienceblogs.com/insolence/2013/03/08/author-of-the-acupuncture-metaanalysis-lambastes-sceptics/">sputtering at the criticism</a>.</p> <!--more--><p>Yet acupuncturists and the various "integrative health" specialists who have embraced acupuncture persist. I was reminded of this by a story I saw over the weekend. It involved acupuncture for pets that was recently <a href="http://www.clickondetroit.com/news/local-4-news-at-11/acupuncture-for-your-pets-some-owners-swear-by-it">glorified (yet again) by a local news station</a> that seems to have a thing for pet acupuncture and other oddities. It's the sort of story that is meant to interest, even amaze, readers by showing something that seems unbelievable on the surface, all wrapped up in a human (or, in this case, pet and human) interest story in which representatives of man's best friends are portrayed as being relieved of suffering that no other veterinarian is able to relieve. Everyone is happy at the end, and acupuncture is normalized as not quackery; that is, if you believe the narrative.</p> <p>Be that as it may, it was actually a bit abnormal that I saw this story on the local news, because normally I don't watch the local news on Sunday night. Instead, I usually watch <a href="http://www.hbo.com/last-week-tonight-with-john-oliver">Last Week Tonight with John Oliver</a> instead. However, for whatever reason, Oliver's show was not on at its usual 11 PM Sunday time slot this week; so instead I watched the same local news show that I usually do on weeknights (if I haven't fallen asleep by 11 PM), the WDIV local news. Whenever I see woo on the local news, it always seems to be WDIV, which has featured <a href="http://scienceblogs.com/insolence/2015/09/01/a-commercial-for-acupuncture-masquerading-as-news/">credulous pieces on acupuncture</a> before, including at least one <a href="http://scienceblogs.com/insolence/2013/06/21/adventures-in-bad-veterinary-medicine-reported-by-the-local-media/">two previous story</a> touting acupuncture for pets. This is the same station that actually did a <a href="http://scienceblogs.com/insolence/2008/02/22/your-friday-dose-of-woo-orbs-invade-the/">story about orbs</a> nine years ago. Yes, I kid you not. Orbs. Of course, that could just be confirmation bias or selective sampling because my wife and I watch WDIV more often than the other local newscasts because we generally like the anchors and reporters more than on the other stations, although the occasional story like this one definitely tries my patince. This time up, the story is <a href="http://www.clickondetroit.com/news/local-4-news-at-11/acupuncture-for-your-pets-some-owners-swear-by-it">Acupuncture for your pets? Some owners swear by it</a>:</p> <iframe src="https://cdnapisec.kaltura.com/p/2031091/sp/203109100/embedIframeJs/uiconf_id/36217991/partner_id/2031091?iframeembed=true&amp;playerId=media-preview_0_1_zxlucybm&amp;entry_id=1_zxlucybm&amp;flashvars[streamerType]=auto" width="640" height="395" allowfullscreen="" webkitallowfullscreen="" mozallowfullscreen="" frameborder="0"></iframe><p> It might as well be a commercial for <a href="http://arborpointe.com/about-us/">Dr. Mike Petty</a>, a local veterinarian who is a "pet acupuncture specialist." His clinic offers quite a cornucopia of alternative medicine treatments for pets, including:</p> <ul><li>Medical Acupuncture</li> <li>Myofascial Trigger Point Therapy</li> <li>Rehabilitation Therapy/Physiotherapy</li> <li>Surgery</li> <li>Stem Cell Therapy</li> <li>PEMF Therapy</li> <li>Pharmaceutical Therapy</li> <li>Laser Therapy</li> <li>Manual Therapy</li> </ul><p>Stem cell therapy? WTF? For chronic pain? The only modalities on that list that could be science-based appear to be rehabilitation therapy/physiotherapy, surgery, pharmacological therapy, and maybe manual therapy (that is, unless it's chiropractic for pets). Of course, Dr. Petty comes across as very caring in this video and the one above:</p> <iframe width="560" height="315" src="https://www.youtube.com/embed/zXRud9-rLog" frameborder="0" allowfullscreen=""></iframe><p> I bet he probably is caring in real life (although, clearly, he's no <a href="http://www.animalplanet.com/tv-shows/dr-jeff-rocky-mountain-vet/">Dr. Jeff</a>), and his caring doesn't excuse his embrace of dubious therapies. In the WDIV clip, we are treated to, as with the previous report, testimonials interspersed with clips of Petty waxing enthusiastic about the various woo he offers. I will admit, however, that his description of why acupuncture "works" is different than any I've heard before. About a third of the way through the report, he claims that sticking needles in certain places distal to where nerves have been injured "reminds the nerves they're there, and that they have a job to do, and you can slowly start waking them up." Later, he claims that putting needles in and twisting them causes "microtrauma" (which is true) but then goes on to claim that that "microtrauma" brings the anti-inflammatories into the area. I must say, that's different from what I learned about neurological function in undergraduate and medical school.</p> <p>In any event, if you don't think that pets can experience placebo effects, you haven't been paying attention. Human contact <a href="http://sciencebasedmedicine.org/is-there-a-placebo-effect-for-animals/">has effects on animals</a> and the expectancy effects underlying placebo effects can work on animals through their human owners who expect the treatment to work and, not coincidentally, often pay a lot more attention to their pet when acupuncture is being done, with petting and treats and all those things that most dogs, for example, love. As veterinarian <a href="http://sciencebasedmedicine.org/is-there-a-placebo-effect-for-animals/">David Ramey once put it</a>:</p> <blockquote><p> The reported intensity of subjective symptoms such as pain, fatigue, and depressed mood in an animal may vary over time for all sorts of reasons, not all of which have to do with actual changes in symptom severity. Further complicating such analyses are treatment effects that might exist on the part of both the animal owner, as well as the veterinarian with a personal investment in an “alternative” approach.</p> <p>Client expectations can be very powerful motivators. Having participated in a therapeutic transaction, clients generally expect to see some results. Optimistic owners may be more likely to diligently pursue treatments. Even failing obvious results, normal reciprocal responses often result in clients reporting improvement, at least initially, even when no improvement has occurred. At the very least, veterinarians can help clients understand what problems are occurring in the animal – such comfort and reassurance may make a problem easier for the client to deal with. That’s a good thing, mostly, unless the veterinarian steers the client into areas that are unsupported by evidence. </p></blockquote> <p>So, yes, placebo effects can occur in animals, although mainly through the influence of their owners.</p> <p>Petty also claims that "90+%" of dogs respond to acupuncture. Personally, my response to this would be that, if this is true Petty really should publish his results in the peer-reviewed veterinary literature, because I smell confirmation bias here. Of course, one of the two dogs featured in the story is portrayed as having had a "miraculous" recovery. The other dog, for whom "expensive surgery" had been recommended, was also portrayed (at least by his owner) as having had great improvement. The story is then capped off with co-anchors Steve Garagiola and Priya Mann expressing awe and wonder at how fantastic Dr. Petty is. Garagiola was particularly effusive in his praise, but also inadvertently revealed a bit more about what goes on as he mentions how the dogs sit in a quiet room and get a little dish of ice cream when they get their treatments, with what Garagiola characterizes as "amazing results." He even said that Petty had "worked some miracles." I don't know about you, but whenever I hear language like that, my skeptical antennae start twitching wildly.</p> <p>As I watched the story, it all sounded very familiar to me. I could swear I had seen Petty before somewhere. So I searched the old blog archives and quickly found that Dr. Petty had been <a href="http://scienceblogs.com/insolence/2013/06/21/adventures-in-bad-veterinary-medicine-reported-by-the-local-media/">featured before in 2013 on this very same newscast</a>, in which he was shown supposedly producing even more miraculous results with acupuncture for a dog with a severe closed head injury. Guess who did the story? Yes, it Steve Garagiola again. In fact, this story in 2017 is practically a carbon copy of the story in 2013, featuring two anecdotes about two dogs who supposedly experienced "miraculous" recoveries thanks to acupuncture interspersed with Dr. Petty explaining how acupuncture "works." That time around, nearly four years ago, Dr. Petty blathered about how acupuncture isn't magic and the needles aren't magic, emphasizing that the needle doesn't heal anything, but rather is "telling the body how to heal itself." I wondered at the time exactly how the needle pulls off this amazing feat and noted at the time that, contrary to what Dr. Petty claimed, magic is exactly what he was claiming for acupuncture. There's nothing less magical in the 2017 edition, although the magic is gussied up in less blatantly mystical terms. There was an interesting reversal, though. In 2013, Garagiola emphasized that "this is science, not magic." In 2017, he all but gave that up, repeatedly referring to acupuncture results in the two dogs featured in his report as "miracles."</p> <p>What I <a href="http://scienceblogs.com/insolence/2013/06/21/adventures-in-bad-veterinary-medicine-reported-by-the-local-media/">said about that piece in 2013</a> applies equally well to this piece. It might as well have been a commercial for Dr. Petty and his clinic. One has to wonder what the connection is between Dr. Petty and Steve Garagiola and/or WDIV is, for him to be featured in what are essentially commercials disguised as news features. My guess is that Garagiola is a believer. Maybe he or a friend of his took his dog to Dr. Petty and was impressed. Whatever the reason, I just hope that I'm not seeing another one of these stories in another three or four years.</p> </div> <span><a title="View user profile." href="/oracknows" lang="" about="/oracknows" typeof="schema:Person" property="schema:name" datatype="">oracknows</a></span> <span>Mon, 03/27/2017 - 21:00</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/medicine" hreflang="en">Medicine</a></div> </div> </div> Tue, 28 Mar 2017 01:00:46 +0000 oracknows 22520 at https://scienceblogs.com The American College of Physicians integrates quackery with medicine in its recommendations for managing back pain https://scienceblogs.com/insolence/2017/02/14/the-american-college-of-physicians-integrates-quackery-with-medicine-in-its-recommendations-for-managing-back-pain <span>The American College of Physicians integrates quackery with medicine in its recommendations for managing back pain</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>One of the overarching themes of this blog, if not the overarching theme, is to expose and combat the infiltration of quackery into medicine. What I'm referring to, of course, is the phenomenon that's risen over the last 25 years or so in which various pseudoscientific alternative medicine therapies (but I repeat myself) have found increasing acceptance, thanks largely to a major lack of critical thinking skills among both patients and, worse, the physicians who have embraced modalities such as acupuncture, naturopathy, chiropractic, and the like. In fairness, it's not just a lack of critical thinking skills, but rather a defect in the very concept of evidence-based medicine, which fetishizes clinical trial evidence <em>über alles</em> and ignores incredibly compelling evidence from the basic sciences that various prescientific modalities, such as much of traditional Chinese medicine, or quackery based in vitalism, such as homeopathy, cannot possibly work. In the case of homeopathy, for instance, many of the remedies are diluted far beyond the point where there is likely to be even a single molecule left.</p> <p>Such treatments first wormed their way into medicine under the guise of "complementary and alternative medicine" (CAM), which was later renamed "i<a href="http://scienceblogs.com/insolence/2014/05/23/dr-josephine-briggs-needs-your-help-nccam-needs-a-new-name/">ntegrative medicine</a>," mainly because its advocates didn't <a href="https://sciencebasedmedicine.org/integrative-medicine-a-brand-not-a-specialty/">like the subsidiary position</a> relative to real medicine implied by the term "complementary." Unfortunately, a whole cottage industry within medical academia has developed to study such incredibly implausible treatments, all with the idea of validating them, a phenomenon I like to refer to as quackademic medicine.</p> <!--more--><p>Given this background, you knew I'd be very unhappy to see this news story last night on NBC Nightly News, <a href="http://www.nbcnews.com/nightly-news/video/overcoming-back-pain-new-doctor-recommendations-876429379688">Overcoming Back Pain: New Doctor Recommendations</a>:</p> <iframe src="http://www.nbcnews.com/widget/video-embed/876429379688" width="560" height="315" frameborder="0" allowfullscreen=""></iframe><p> Basically, the American College of Physicians has issued new guidelines for the treatment of low back pain, as <a href="https://www.eurekalert.org/pub_releases/2017-02/acop-aco020717.php">announced yesterday in this press release</a>:</p> <blockquote><p> The American College of Physicians (ACP) recommends in an evidence-based clinical practice guideline published today in Annals of Internal Medicine that physicians and patients should treat acute or subacute low back pain with non-drug therapies such as superficial heat, massage, acupuncture, or spinal manipulation. If drug therapy is desired, physicians and patients should select nonsteroidal anti-inflammatory drugs (NSAIDs) or skeletal muscle relaxants. </p></blockquote> <p>And:</p> <blockquote><p> For patients with chronic low back pain, ACP recommends that physicians and patients initially select non-drug therapy with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction, tai chi, yoga, motor control exercise (MCE), progressive relaxation, electromyography biofeedback, low level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation. </p></blockquote> <p>Acupuncture? And the ACP started out so well. Yes, it is advisable to start out treating acute and subacute low back pain with nonpharmacological therapies. That's nothing new. What is new—and unwelcome—is the ACP's inclusion of acupuncture as one of its suggested first line "non-drug" therapies.</p> <p>Now go back and watch the news report above, if you haven't already. It's only a minute and a half; so go ahead. Notice how it starts out with a yoga class, where, the correspondent Kristen Dhalgren intones, most of the people in the class are there to overcome "often crippling" back pain, and the caption says, "Back pain relief without drugs or surgery." We meet a woman who used to get cortisone injections but is now doing well with yoga, after which the recommendations. Now, as I've said before, there's nothing special about yoga or Tai Chi when it comes to back pain or anything else. Stripped of its underpinnings in Eastern mysticism, yoga is nothing more than a system of exercise that emphasizes mobility, and the same is true of Tai Chi.</p> <p>The segment on acupuncture is even worse, though. It's so credulous, so downright atrocious, that it might as well have been a commercial for the acupuncturist, <a href="http://www.mountsinai.org/profiles/houman-danesh">Dr. Houman Danesh</a>, a physical medicine and rehabilitation physician, as well as a pain specialist, at Mt. Sinai Medical Center, who is shown administering acupuncture to a patient and then later saying that there is a "lot of benefit to it" and that acupuncture is "based in science." (No, it's not. The evidence is overwhelming that acupuncture is <a href="http://www.dcscience.net/Colquhoun-Novella-A&amp;A-2013.pdf">nothing more than a theatrical placebo</a>. It <a href="http://scienceblogs.com/insolence/2012/09/12/can-we-finally-just-say-that-acupuncture-is-nothing-more-than-an-elaborate-placebo-can-we-2012-edition/">doesn't work</a>.) Not surprisingly, this patient is very happy and satisfied with acupuncture. He's asked where he would be if not for alternative medicine and responds that he probably would have been considering surgery. His assessment? "Amazing!"</p> <p>That's what's so infuriating about the ACP recommendations. Several of them are perfectly reasonable. Then there's the quackery, and it's all "integrated," just as "integrative medicine" preaches.</p> <p>I always like to go straight to the source when discussing guidelines like this. So I had to go immediately to the source, the actual guidlines themselves, <a href="http://annals.org/aim/article/2603228/noninvasive-treatments-acute-subacute-chronic-low-back-pain-clinical-practice">published in the <em>Annals of Internal Medicine</em></a>. Interestingly, the way the recommendations are discussed in the actual guidelines is belied by the news reports. Take a look at the first two recommendations:</p> <blockquote><p> <strong>Recommendation 1:</strong> Given that most patients with acute or subacute low back pain improve over time regardless of treatment, clinicians and patients should select nonpharmacologic treatment with superficial heat (moderate-quality evidence), massage, acupuncture, or spinal manipulation (low-quality evidence). If pharmacologic treatment is desired, clinicians and patients should select nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants (moderate-quality evidence). (Grade: strong recommendation)</p> <p><strong>Recommendation 2:</strong> For patients with chronic low back pain, clinicians and patients should initially select nonpharmacologic treatment with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction (moderate-quality evidence), tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation (low-quality evidence). (Grade: strong recommendation) </p></blockquote> <p>The main two recommendations are hard to argue with. For example, most patients with acute and subacute back pain do get better, regardless of treatment (or lack thereof). Almost anything that is done will appear to result in improvement. Of course, that's the very same reason why pretty much any quackery used to treat acute back pain seems to "work." The patient gets better because it is the natural history of the condition to get better, not because it is necessarily effective. That's also the reason why it is difficult to do randomized clinical trials for acute low back pain, because the placebo group will get better. The question is whether whatever intervention is being used results in faster improvement, at least in most patients. Similarly, given the often intractable, long term nature of chronic back pain, it is certainly preferably to avoid drugs at first if possible.</p> <p>The devil, of course, is always in the details. Look at the levels of evidence for each of the individual interventions. When examining levels of evidence, it is, of course, always a good idea to see exactly what sort of scale is being used to assess the evidence. In this case, here is the standard:</p> <p><a href="/files/insolence/files/2017/02/M162367tt1_Table_The_American_College_of_Physicians_Guideline_Grading_System.jpeg"><img src="http://scienceblogs.com/insolence/files/2017/02/M162367tt1_Table_The_American_College_of_Physicians_Guideline_Grading_System-450x294.jpeg" alt="ACP grading" width="450" height="294" class="aligncenter size-medium wp-image-10698" /></a></p> <p>Diving into the details, I immediately noticed one thing. Although the strength of the overall recommendation for Recommendations 1 and 2 is "strong," when you dive into the weeds you quickly will see that, in general, the quality of evidence for for individual interventions is disappointingly low. That doesn't just include the acupuncture, but a lot of the other interventions for back pain as well. However, for acupuncture, you'd never get the feeling that the evidence for acupuncture and yoga is so poor. For example, notice how the only intervention for acute back pain with even moderate quality evidence is heat. Massage, acupuncture, and spinal manipulation all have low quality evidence for benefit. On the other hand, notice the almost ringing endorsement for nonsteroidal antiinflammatory drugs (NSAIDs) and skeletal muscle relaxants (SMRs), comparatively speaking, where the recommendation states that the evidence is of moderate quality if pharmacological intervention is desired.</p> <p>Looking at this, I had to wonder. For acute back pain, given that it will get better over time anyway, what's wrong with using a short course of NSAIDs and/or SMRs to manage the acute pain while waiting for recovery? I understand why one would want to avoid opioids, if at all possible. I understand why, for chronic pain, one might wish to avoid drugs for as long as possible. After all, long term use of NSAIDs is not without potentially serious complications, but short term use is generally pretty safe.</p> <p>I also couldn't help but note the actual studies used to justify the recommendations. For example, <a href="https://www.ncbi.nlm.nih.gov/pubmed/22770838">this study</a> showed that there was no difference between "true" acupuncture and sham acupuncture (which is what pretty much all well-designed acupuncture studies show). In other words, it showed that acupuncture is a placebo intervention. <a href="https://www.ncbi.nlm.nih.gov/pubmed/22770838">This study</a> tested a sort of "scalp acupuncture" that I've never heard of before. Another study was from China, and, as has been discussed before, pretty much all acupuncture studies out of China are positive.</p> <p>What about chronic low back pain? Take a look:</p> <blockquote><p> Low-quality evidence showed that acupuncture was associated with moderate improvement in pain relief immediately after treatment and up to 12 weeks later compared with sham acupuncture, but there was no improvement in function (125–130). Moderate-quality evidence showed that acupuncture was associated with moderately lower pain intensity and improved function compared with no acupuncture at the end of treatment (125). Low-quality evidence showed a small improvement in pain relief and function compared with medications (NSAIDs, muscle relaxants, or analgesics) (125). </p></blockquote> <p>I laughed. At least, I laughed when I looked over the list of references. The authors actually included the GERAC study in its list, which basically showed that <a href="http://scienceblogs.com/insolence/2007/09/26/yawnanother-acupuncture-study/">acupuncture does not work</a>, given that sham acupuncture was indistinguishable from acupuncture. Another study was a "bait and switch" in that it studied "<a href="https://www.ncbi.nlm.nih.gov/pubmed/15105215">electroacupuncture</a>," which is in reality TENS. We're talking thin gruel indeed.</p> <p>Of course, I have no problem with massage or exercise for low back pain, be it acute or chronic. So I really don't have a problem with recommending massage, Tai Chi, or yoga for back pain. I really don't. What I do have a problem with is representing such interventions as somehow being "alternative" or "integrative." Tai Chi and yoga are, at their hearts, little different than motor control exercise (MCS), which is a form of exercise that aims to restore coordinated and efficient use of the muscles that control and support the spine. Patients are initially guided by a therapist to practice normal use of the muscles during simple tasks. Then, as the patient's skill increases the exercises are progressed to more complex and functional tasks involving the muscles of the trunk and limbs. There is low to moderate quality evidence, according to the <a href="https://www.ncbi.nlm.nih.gov/pubmed/26742533">Cochrane Collaborative</a>, that MCS has a clinically important effect compared with a minimal intervention for chronic low back pain. There is, of course, no evidence that MCS is superior to other forms of exercise—pretty much a lot like Tai Chi and yoga.</p> <p>Seeing Dr. Danesh in that NBC News report piqued my curiosity. I couldn't help but look at M<a href="http://www.wehealny.org/services/bi_im/ICS.html">t. Sinai's integrative medicine offerings</a>. Of course, there's <a href="http://www.wehealny.org/services/bi_im/ICS.html#as">acupuncture</a>. (Isn't there always?) There's <a href="http://www.wehealny.org/services/bi_im/ICS.html#zen">yoga</a>. And, of course, there's "<a href="http://www.wehealny.org/services/bi_im/ICS.html#etp">energy medicine</a>," which is the ultimate form of quackery. There's even something that Mt. Sinai calls the <a href="http://www.wehealny.org/services/bi_im/ICS.html#sp">Holistic Preparation for Surgery Program</a>:</p> <blockquote><p> This program helps patients prepare for surgery using the following techniques:</p> <ul><li>Centering and Grounding</li> <li>Aromatherapy</li> <li>Guided Imagery</li> <li>Biofeedback</li> <li>Energy Healing (Therapeutic Touch, Reiki)</li> </ul><p>The program has been so successful in helping patients feel more comfortable and reduce medication use following surgery that Ms. Ortiz educated and trained nurses throughout surgical units at the hospital to teach patients breath control techniques and clinical imagery for pain management. </p></blockquote> <p>Argh! More "energy healing"!</p> <p>That little detour aside, the ACP recommendations for back pain management are the epitome of what is "integrative medicine." They integrate quackery with real medicine. Depressingly, when that happens, people don't notice the part about how weak the evidence is for therapies like acupuncture. They only hear how great it is. The ACP really should have (and could have) done better. It's just a measure of how far quackery has insinuated itself into medicine that the ACP chose not to do so.</p> </div> <span><a title="View user profile." href="/oracknows" lang="" about="/oracknows" typeof="schema:Person" property="schema:name" datatype="">oracknows</a></span> <span>Mon, 02/13/2017 - 21:53</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/medicine" hreflang="en">Medicine</a></div> </div> </div> Tue, 14 Feb 2017 02:53:52 +0000 oracknows 22492 at https://scienceblogs.com