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Acupuncture for IVF Revisited – More Tooth Fairy Science?

I read this Reuters Health article on MedlinePlus, and then I read the study the article referred to (The impact of acupuncture on in vitro fertilization) and now my head hurts. The study found that acupuncture was not effective in increasing the pregnancy rate (PR) during in vitro fertilization (IVF). As quoted on MedlinePlus, the lead author, Alice Domar, seems to blame her patients (the presumably poor quality of their embryos) rather than acupuncture for the lack of success, and then she recommends using acupuncture even if it doesn’t work. That was bad enough, but “poor quality embryos” is a hypothesis that was actually tested and rejected in the study itself. Has Domar forgotten?

The headline of the MedlinePlus article says “acupuncture doesn’t boost IVF success for all” – suggesting that it boosts success for some? Then the first sentence says the study suggested that acupuncture doesn’t work, period. But wait…

The lead researcher says acupuncture may not have worked in her study because, unlike past research, her investigation wasn’t limited to women who had good quality embryos available for transfer. “I’m wondering if my sample was just not a good sample, in that most of the patients in my study were probably not the best-prognosis patients,”
Domar and her team say the most likely explanation for the lack of an acupuncture effect in their study was the fact that they included many women who didn’t have good quality embryos available for transfer. While acupuncture may help a woman become pregnant after the transfer of a healthy embryo, the researcher noted in an interview, it can’t repair an embryo with chromosomal defects or other abnormalities.

Hold the boat!! In the Discussion section of the paper itself, Domar et al point out that previous research has included mostly patients with good quality embryos. They ask if perhaps acupuncture only works for good quality embryos? They test that hypothesis by separately analyzing the subjects in this study who had good quality embryos. There was no increase in PR with acupuncture in this sub-group; the results were the same as for the entire sample. (more…)

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When “CAM” is mandatory: A science-based medical student’s dilemma

Early in the history of this blog, I wrote a rather long post expressing my dismay at the infiltration of unscientific “complementary and alternative medicine” (CAM) or “integrative medicine” (IM) modalities into American medical schools. In it, I listed the medical schools that had embraced pseudoscience through having started a CAM/IM program (a list desperately in need of an update). Moreover, we have also complained vociferously here about a clear effort on the part of advocates of faith-based medicine to infiltrate bastions of science-based medicine and to piggyback their agenda onto President Obama’s health care reform initiative in a clear political strategy to slip CAM/IM into any health care reform legislation as a form of “preventative medicine.” It’s all part of a multi-pronged strategy to claim popular and legal legitimacy in the absence of scientific legitimacy. At one point I even despaired because of the apparent success of half physician, half CAM huckster Dr. Andrew Weil at developing a CAM/IM curriculum that would be part of the mandatory training program in several family medicine residencies, while the rest of us watch Senator Tom Harkin try to promote pseudoscience in the halls of the Senate.

However, since one of our newest co-bloggers, medical student Tim Kreider, arrived, I’ve come to appreciate that medical schools and medical school curriculae are ground zero in the battle for science- and evidence-based medicine. Besides the infiltration of non-science-based modalities into the standard curriculum, another technique for making medical students believe that woo is equal to science is the student “campus CAM group” that invites, for example, homeopaths and naturopaths to give talks to medical students, too many of whom are too timid to challenge them on their pseudoscience. However, a reader of a “friend” of mine wrote me an e-mail that truly appalled me. In fact, it appalled not just me, but all of my co-bloggers who read it. It’s from a medical student in an American medical school. It’s not Harvard or a huge famous medical school. However, it is in medical schools like this one where the vast majority of medical students are trained in this country. If the infiltration of CAM/IM into medical schools continues in this way, we’ll have more than just “integrating” woo into the medical school curriculum from day one. We’ll have more tales like this; eventually, no one will find such tales unusual or even unacceptable anymore. The shruggies will no longer even shrug anymore. Such clinics will become simply the way medical students are educated. The following e-mail is de-identified, and I’ve edited it a bit to make as sure as I can that it is not traceable:
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Posted in: Acupuncture, Medical Academia, Medical Ethics

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Acupuncture – Disconnected from Reality

The primary goal of science-based medicine (SBM) is to connect the practice of medicine to the best currently available science. This is similar to evidence-based medicine (EBM), although we quibble about the relative roles of evidence vs prior plausibility. In a recent survey 86% of Americans said they thought that science education was “absolutely essential” or “very important” to the healthcare system. So there seems to be general agreement that science is a good way to determine which treatments are safe and work and which ones are not safe or don’t work.

The need for SBM also stems from an understanding of human frailty – there are a host of psychological effects and intellectual pitfalls that tend to lead us to wrong conclusions.  Even the smartest and best-meaning among us can be lead astray by the failure to recognize a subtle error in logic or perception. In fact, coming to a reliable conclusion is hard work, and is always a work in progress.

There are also huge pressures at work that value things other than just the most effective healthcare. Industry, for example, is often motivated by profit. Institutions and health care providers may be motivated by the desire for prestige in addition to profits. Insurance companies are motivated by cost savings. Everyone is motivated by a desire to have the best health possible – we all want treatments that work safely, often more so than the desire to be logical or consistent. And often personal or institutional ideology comes into play – we want health care to validate our belief systems.

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Posted in: Acupuncture, Science and Medicine

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Yes We Can! We Can Abolish the NCCAM! Part II

Pseudoscience and Dishonesty, continued: “Reliable Information”?

In the previous post, we examined misrepresentations by the late National Center for Complementary and Alternative Medicine (NCCAM) Director Stephen Straus and Margaret Chesney, written in 2006 as a rebuttal to a critical article by Donald Marcus and Arthur Grollman in Science magazine. Here, we continue. According to Straus and Chesney:

Before the establishment of NCCAM, there was no central source of CAM information. NCCAM brings evidence-based information on CAM to the public, practitioners, and researchers. NCCAM disseminates research findings and provides reliable information about commonly used CAM practices through numerous channels, including…its award-winning Web site… NCCAM’s communications program deals with a field that is controversial, that has many critics, and that reaches a public that wants reliable information.

Before the establishment of the NCCAM, there was an excellent source of reliable information about “CAM”: Quackwatch. It continues to be the most comprehensive source of such information.

The NCCAM itself does not provide “reliable information about commonly used ‘CAM’ practices.” Rather, it bends over backward—in some instances making categorically false statements—to portray absurd, dangerous, implausible, or disproved practices as safer and more promising than they are.

Examples follow, but first please consider an implicit yet abundant and compelling piece of evidence that has left several of us (1, 2, 3) scratching our heads since the NCCAM began: each year the Center bestows numerous grants for the purpose of teaching “CAM” (not “CAM research”) to health professionals or for “integrating CAM” into various programs, or for establishing “integrative medicine” centers. For examples, look here. Isn’t this putting the cart before the horse? How can this be viewed as anything other than promoting “CAM”? Consider that Straus and Chesney also wrote:

In the early years of NCCAM, there was a sense of urgency to scientifically assess a range of CAM therapies that had been in long use by the public in the absence of proof of safety or efficacy.

In the subsequent 8 years, there has not been a burgeoning list of “CAM therapies” that have been proven safe and effective. The number of treatments that would qualify for that list, or for a comparable list before the creation of the NCCAM is, if you’ll excuse the rudeness of reliable information,…zero. In other words, the NCCAM admits that the treatments that characterize its “CAM integration” projects have not been shown safe and effective.

But back to a few explicit examples of unreliable information.

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Posted in: Acupuncture, Clinical Trials, Science and Medicine

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Battlefield acupuncture revisited: That’s it? That‘s all Col. Niemtzow’s got?

It’s like the zombie that wouldn’t die, isn’t it?

I’m referring to so-called “battlefield acupuncture,” a topic that I wrote about last week for this very blog. With a week separating my usual posts, I normally don’t write about the same topic two times right in a row, but I’m making an exception for this topic. There are three reasons. First, I remain appalled at how one ideologue, Col. (Dr.) Richard Niemtzow, a radiation oncologist and Air Force physician turned number one advocate of acupuncture use in the military, has succeeded in introducing acupuncture into not only military hospitals like Walter Reed Army Medical Center and Landstuhl Regional Medical Center (which is, by the way, the first stop outside of the Middle East for our wounded soldiers from Iraq and Afghanistan), but has even started to train U.S. Army Rangers in the technique. While before I thought the term “battlefield acupuncture” was a misnomer because it wasn’t actually being used on the battlefield, but rather for phantom limb pain and other chronic pain conditions, this latter development shows just how far Col. Niemtzow wishes to go with this “technique.” Second, Col. Niemtzow’s acupuncture technique isn’t even “real” acupuncture. He calls it “auricular acupuncture,” and it involves sticking needles a mere 1 mm into the earlobe. Worse, he justifies this technique through ignorance of anatomy, claiming that “the ear acts as a ‘monitor’ of signals passing from body sensors to the brain” and that “those signals can be intercepted and manipulated to stop pain or for other purposes.” He even made a comment about 18th century pirates wearing a lot of earrings in order to improve their night vision. I kid you not. Third, and finally, Col. Niemtzow has published another one of his “studies” to support the use of acupuncture in chronic pain syndromes among our combat wounded veterans.

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

So what about this new study by Col. Niemtzow, hot off the presses in the latest issue of Medical Acupuncture?
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Posted in: Acupuncture, Medical Academia, Science and the Media

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“Battlefield acupuncture”?

THE SCENE: Iraq, Afghanistan, or anywhere where U.S. troops are risking life and limb.

THE TIME: The not-too-distant-future. Maybe even 2009.

Joe is on patrol.

It’s the middle of summer in the desert town. The air hangs heavy, hot, dry and dusty, like a blast furnace firing steel. The heat penetrates Joe’s 80 lb pack in much the same way the heat from boiling water penetrates the shell of an unfortunate lobster. Joe’s heart races. His squad is on edge; their eyes dart furiously to and fro, looking for the deadly threat that might lurk in the shadows. Every shadow is a potential source of death, every alley a refuge from which the enemy can attack and kill him or his buddies, every rooftop a fortress from which the enemy can rain death upon the squad. The area is known to be thick with terrorists and insurgents. Joe pictured them waiting unseen from every nook and cranny for the opportunity to attack. The skin on Joe’s back is all prickly. He distinctly feels as though he has a huge bullseye pointed on his back. He feels a bead of sweat dripping down his forehead and onto his eyelid, all slimy and salty. Joe desperately wants to wipe it away, but that would necessitate removing one of his hands from his weapon. The split second it would take for him to put it back might mean the difference between life and death for him or one of his buddies.

A loud roar fills Joe’s ears, and suddenly he feels as though he has no weight. The scene unfolds in slow motion, just like in the movies. Dazed, Joe hears a tumult as though from a great distance, but can see nothing. Yelling and gunfire all around, he becomes conscious enough to realize that he’s lying flat on his back. He feels searing pain in his legs and a hot liquid oozing around them. It occurs to Joe that it must be his own blood or even perhaps his own urine, but he’s just too dazed to care.

“Medic!” Joe hears someone scream. He feels someone pull his helmet from his head and realizes that the sound of gunfire and yelling is receding. His unit must be driving away the ambushers. Good! He thinks. Give those assholes hell, guys! He opens his eyes, and realizes that his buddy’s got his back, and turns to see another man, a medic, drop to his knees at his side. His uniform is stained a disturbing red. Joe feels the medic wrapping something around his thigh. It’s a tourniquet, and Joe cries out in pain as he feels it constricting around his upper thigh.

“Bleeding’s better!” Joe hears the medic say to his buddy. “I’ll take it from here.” Joe’s buddy runs off to join the rest of his unit, and the medic moves his face close to Joe’s. He feels himself being moved from side to side and then his legs being moved. More pain. Joe cries out.

The medic leans in to talk to Joe, “I think we’ve got the bleeding under control for now. I put a tourniquet on your leg. Let’s get you out of here. The docs’ll patch you up in no time.” Joe is vaguely aware of another corpsmen with a stretcher nearby. The medic leans in again, “Are you in pain, soldier?”

“What do you think? My leg hurts like a sonofabitch! I could really use something for the pain,” Joe hears himself yelling, again as if from a distance. Pain is shooting through his leg, setting every nerve on fire, and the tourniquet is biting into raw muscle through the edge of a wound that comes all the way up to his groin. The flayed edges of his skin shoot fire to his brain, and he can feel his broken bones grinding against each other every time he moves in spite of the splint.

“I’ve got something better that’ll help,” the medic screams over the din.

Better? Joe thinks. I’m in agony here. I need something! Anything!

The medic pulls a small box out of his pack. Joe sees that it’s a small case. He opens it. Its contents look something like this:

acupuncturekit

Joe is puzzled. Where’s the morphine? He wonders. “What are those needles?” Joe asks. “What are you doing? I’ve never seen syringes that look like that before!”

“Acupuncture,” replies the medic. “I’ll take care of you.”

“What are you going to do with them?” Joe replies.

“Stick them into your earlobe. It’ll take the pain away really fast.”

“Are you shittin’ me?” Joe screeches, trying to get up to grab the medic by the front of his uniform. “My leg’s a bloody mess, I’m in agony, and you’re tellin’ me you’re gonna stick little needles in my ear and make it all better? Like that‘s going to do anything! I need real pain medicine! Give me morphine! NOW!
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Posted in: Acupuncture, Medical Ethics, Politics and Regulation

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On the dangers of using valid placebo controls in clinical trials of acupuncture

ResearchBlogging.orgI don’t recall if I’ve ever mentioned this before on this blog, but there was a time when I was less skeptical of acupuncture than I am now. It’s true. Don’t get me wrong, though. I never for a minute considered that the whole rigamarole about “unblocking” or “redirecting” the flow of that mystical life force known as qi had anything to do with whether or not acupuncture did or did not have efficacy treating disease or other conditions. That was clearly a holdover from the pre-scientific medicine times in which most beliefs about the causes of disease involved either the wrath of the gods or vitalism, the latter of which is, when you come right down to it, the philosophical basis upon which many “complementary and alternative” (CAM) modalities are based, especially the so-called “energy healing” modalities, such as reiki, therapeutic touch, and, of course, acupuncture.

However, because unlike so many other “energy healing” methods, acupuncture involved an actual physical action upon the body, namely the insertion of thin needles into the skin to specified depths, it did not seem to me entirely unreasonable that there might be some sort of physiological effect that might produce a therapeutic result. At least, that’s what I used to think until I actually started paying attention to the scientific literature on acupuncture. That’s when I started to realize that “there’s no ‘there’ there,” if you know what I mean. Horribly designed studies with either no controls or utterly inadequate controls tend to be the norm in the acupuncture “literature” (if you can call it that). Moreover, acupuncture was touted as having value for conditions and procedures for which there is no plausible (or even mildly plausible) physiological mechanism by which it could be reasonably postulated to have an effect. Arthritis, allergies, headache, back pain, gastroesophageal reflux disease (GERD), Parkinson’s disease, post-operative nausea, hot flashes in breast cancer patients caused by the anti-estrogen drugs they have to take, infertility, it doesn’t matter. Seemingly acupuncture can do it all; it’s the Swiss Army knife of CAM therapies. Moreover, the “explanations” given to explain “how acupuncture works” seemed increasingly less plausible to me. Most of these explanations involve counterirritation or the release of opioids, and I’ve had an increasingly hard time believing that, even if these mechanisms are at play, they could have anything other than nonspecific effects, with no mechanism to explain how acupuncture could possibly do all things attributed to it. One rule of medical skepticism is that you should be very skeptical of modalities that are touted to be useful for a wide variety of medical conditions that have very different pathophysiology. Indeed, a funny thing happens when rigorous placebo controls are introduced, and that’s sometimes the placebo control does better than the “true” acupuncture; i.e., the evidence for acupuncture, taken in its totality, is completely compatible with placebo effect.

As Harriet Hall put it in her excellent analysis of a study purporting to show that acupuncture is useful for GERD:

This study falls into the category of what I call Tooth Fairy science. You could measure how much money the Tooth Fairy leaves under the pillow, whether she leaves more cash for the first or last tooth, whether the payoff is greater if you leave the tooth in a plastic baggie versus wrapped in Kleenex. You can get all kinds of good data that is reproducible and statistically significant. Yes, you have learned something. But you haven’t learned what you think you’ve learned, because you haven’t bothered to establish whether the Tooth Fairy really exists.

One area that acupuncturists keep needling away at is infertility. Somehow, in the CAM community it’s become conventional wisdom that acupuncture can somehow increase the chance of success for couples undergoing in vitro fertilization (IVF). Indeed, early this year I wrote about a meta-analysis that concluded that acupuncture did actually increase the success rate of IVF and why it did not show what its authors thought it showed. Tooth fairy science, indeed.

Now comes yet another study being publicized in the media that examines once again the question of whether sticking needles into women before they undergo IVF can increase their chances of conceiving. I could not help but be extremely amused by the title given to the ScienceDaily story about it: Placebo Acupuncture Is Associated With Higher Pregnancy Rate After IVF Than Real Acupuncture. You have to love a headline like that, and opening paragraphs like this:
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“It’s just a theory”

I am afraid that the experiments you quote, M. Pasteur, will turn against you. The world into which you wish to take us is really too fantastic.

La Presse, 1860

It’s just a theory. Not evolution. Germ theory. Just a theory, one of many that account for the etiology of diseases.

I should mention my bias up front. I am, as some of you are aware, an Infectious Disease doctor. My job is simple: me find germ, me kill germ, me go home. I think there are three causes of disease: wear and tear, genetic, and germs. Perhaps a bit of an exaggeration, but not much. My professional life for the last 22 years has been spent preventing, diagnosing, and treating the multitudinous germs that a continually trying to kill or injure us. It is a fundamentally futile job, as in the end I will be consumed by the organisms I have spend a lifetime trying to kill.

I would have though that the germ theory of disease was a concept that was so grounded in history, science and reality that there would be little opposition to the idea that germs (a broad term for viruses, bacteremia, fungi, parasite etc) cause infections and some other diseases.

Wrong. There are people who deny the validity of germ theory. Add there are people who deny gravity. And evolution.

Opponents of germ theory come in two flavors:

  1. Germ theory deniers.
  2. Those who propose alternative mechanisms of disease.

There is great overlap between the two categories, and the division serves more as a literary device for the sake of exposition than a true description of reality.
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Posted in: Acupuncture, Chiropractic, Homeopathy, Science and Medicine, Vaccines

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Is There a Placebo Effect for Animals?

One of the occasional arguments used in support of “alternative” approaches to human medicine is the observation that since “alternative” medicine is used (with anecdotal success) in animals, and animals don’t know anything about the treatment that they’re getting, then they must work a priori.  Of course, the fallacy of such an observation is pretty obvious to anyone with a logical/skeptical frame of mind, because it assumes that the therapies do work (even though there’s little evidence of that).

Clearly, however, some people perceive that the therapies work, including veterinarians – there are veterinary acupuncturists, chiropractors, homeopaths, etc., etc.  Since there’s very little scientific support for the idea that the therapies actually have any clinically significant effect on biological processes, including the processes that result in disease, questions arise as to whether there are other effects of “alternative” treatments on animals. Specifically, people may wonder whether or not animals can benefit from placebo effects.
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Puncturing the Acupuncture Myth

Note: This is slightly revised from an article I originally wrote as a “SkepDoc” column for Skeptic magazine. It was pre-released online in eSkeptic and it has already generated a lot of comments, including “a truly amazing piece of peurile pseudo-intellectualism,” “an ad hominem attack on one form of alternative medicine so beset by poor thinking that one must come to the conclusion this woman might just be paid to write such propaganda,” and “twaddle wrapped in swaddling rhetoric.” (I treasure comments like those as evidence that my critics are so bankrupt of real arguments that they have to dip into the insult pouch for ammunition.)  I thought it would be interesting to post it here on the blog and see how much controversy it would stir up among my co-bloggers and readers.  Please keep in mind that it was written for a popular audience and excuse the lack of scholarly citations. You may recognize some of the studies I refer to from previous blog entries.

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“Alternative” medicine is by definition medicine that has not been scientifically proven and has not been accepted into mainstream scientific medicine. The question I keep hearing is, “But what about acupuncture? It’s been proven to work, it’s supported by lots of good research, more and more doctors are using it, and insurance companies even pay for it.”

It’s time the acupuncture myth was punctured – preferably with an acupuncture needle. Almost everything you’ve heard about acupuncture is wrong. (more…)

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