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

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Robert F. Kennedy, Jr., vaccines, the EPA, and the interface with science-based medicine and public policy

This blog is entitled Science-Based Medicine for a reason, and that’s because we here at SBM believe that the best method to result in the most efficacious treatments for the most people is through the application of science to the evaluation of the biology, pathophysiology, and treatment of disease and disorders.

I may (or may not) be departing a bit from the views of my co-bloggers with this belief, but for purposes of this blog I consider “medicine” to go far beyond what we as physicians do when we undertake to treat patients. In fact, in my view, the purview of science-based medicine should not be so limited but should include any area where decisions, actions, or policy have a direct impact on health. Thus, my definition of science-based medicine encompasses environmental policy, because of the profound effect on human health environmental pollution and toxins can have. Unfortunately for those of us who don’t like its messiness, such a view drives me even more directly into politics than previous issues I’ve taken on. Like Dr. Novella, I rarely write about politics, but when it directly impacts science-based medicine. Mostly, such discussions here on SBM have involved the regulation of the medical profession by government, as Dr. Atwood discussed recently (1, 2, 3) in the context of the difficulties medical boards have in preventing quackery to my discussion of how a quack like Dr. Rashid Buttar could continue to practice in North Carolina, despite his despicable preying upon desperate cancer patients and the parents of children with autism, not to mention the frequent criticisms of the National Center for Complementary and Alternative Medicine. Dr. Sampson, on the other hand, was more than willing to examine a much more explicitly political issue, namely the number of Iraq War dead (1, 2), and that provoked a bit of disagreement with our commenters, not to mention me.

Recently, hot on the heels of the election of Barack Obama in the Presidential election last week, an issue relevant to several aspects of where science-based medicine intersects public policy popped up. Steve Novella has already commented on it on his own blog, as have numerous other medical bloggers, science bloggers, and political bloggers but I feel justified in commenting on it here, for the reasons that I’ve just mentioned. The controversy is that antivaccine activist and true believer in the scientifically discredited notion that mercury in the thimerosal preservative in vaccines causes autism, Robert F. Kennedy, Jr., is being seriously considered by Barack Obama either to head the Environmental Protection Agency or even to be Secretary of the Interior. Like our fearless leader Steve, I believe that such a selection would be an unmitigated disaster for science policy in government.
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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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“Urban Zen” and homeopathy at Beth Israel Medical Center, or: Dr. Gorski destroys his chances of ever being invited to join the faculty at BIMC or the Albert Einstein College of Medicine

I guess I never really wanted to work in Manhattan anyway. At least, that’s what I keep telling myself.

I mean, why on earth would I want to? What’s the attraction? Living in the heart of it all, all those shows and all those amazing cultural activities, all those world-class restaurants? Being close to Boston, Philadelphia, and other cool East Coast cities, which are all just a quick Acela train ride away? Who cares about those things, anyway?

Apparently I don’t, because I’m about to destroy my chances of working at what has been considered one of the premiere academic hospitals in New York City, specifically Beth Israel Medical Center, an academic affiliate of the Albert Einstein College of Medicine. It’s possible for me to have been ignored when I first included the Albert Einstein College of Medicine and its affliated Continuum Center for Health & Healing in my roll call of shame as a medical center that has not just added woo to its offerings, but actively embraced it. At the time I originally discovered it, though, its offerings seemed limited to fairly mild woo, the usual stuff like acupuncture, what I like to call “gateway modalities” that centers embrace first because they’re relatively tame and commonplace. All too commonly, though, dabbling in gateway modalities leads to the “hard stuff,” outright quackery with zero scientific basis like homeopathy, reflexology, and craniosacral therapy. Such is the pathway an academic medical center follows when it degenerates from science-based medicine to what Dr. R. W. famously dubbed “quackademic medicine,” usually driven by a few famous true believers, which, alas, is exactly what happened at fearless leader Steve Novella’s institution of Yale, thanks to Dr. David Katz and his “more fluid concept of evidence.”

In any case, last week, I realized that I’ve been completely neglecting the aforementioned roll call of shame. Perusing it, I now realize that it’s been over five months since I did a significant update to it. You just know that, given the rate of infiltration of unscientific medical practices into medical academia as seemingly respectable treatment modalities that there must be at least several new additions to this roll of shame. Alas, even today, having been shamed myself by the realization of my failure to keep the list updated, I’m not going to do the full update and revamping that the Roll Call of Quackademic Medicine cries out for. However, that doesn’t mean I can’t do a piecemeal addition here and there. That doesn’t mean I can’t point out new additions as they pop up, even if it takes me a while to find the time to give the list the facelift it cries out for. It doesn’t mean I can’t call out hospitals like Beth Israel when they fall into woo, especially when they dive into quackademic medicine in a big way for cancer patients.
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Posted in: Cancer, Homeopathy, Medical Academia, Science and the Media

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Another take on those “50 Facts About Homeopathy”

You may recall that a week ago fellow SBM blogger Mark Crislip did a truly amusing takedown of an article by a homeopath purporting to provide us with 50 Facts About Homeopathy that supposedly validate the efficacy of this most amazing form of quackery. Not surprisingly, others wanted to get in on the fun, given how outrageously ridiculous and riddled with numerous logical fallacies the homeopath’s article was. Indeed, that’s why prominent Australian skeptic Peter Bowditch, whose website The Millenium Project is always an entertaining read (except that, at only once every one or two weeks, its updates are too infrequent) couldn’t resist getting in on the action with his answer to A Homeopathic Challenge.

Unfortunately, by the time he hit “Fact” #25 Peter was laughing so hard that, try as he might, he just couldn’t continue with his deconstruction. He does, however, promise to finish up the list in a future installment.

Posted in: Homeopathy, Humor

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Placebos in the news again

ResearchBlogging.orgTowards the end of last week, I was contemplating what I would be writing about for Monday. No topic had quite floated my boat, but I hated to dip into the archive of topics I’ve written about before to update a post. After all, I like to be topical whenever possible. Then what to my wondering eyes should appear (yes, I know Christmas is still two months away) but a study in the British Medical Journal by a group lead by Jon C. Tiburt at the Department of Bioethics at the National Institutes of Health in collaboration with investigators at the Osler Institute at Harvard University and the McClean Center for Clinical Medical Ethics at the University of Chicago entitled Prescribing “placebo treatments”: results of national survey of US internists and rheumatologists.

Serendipity? Who cares? The study addresses a very important aspect of science-based medicine.
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Posted in: Herbs & Supplements, Science and Medicine, Science and the Media

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Another new blogger, or SBM is going to the dogs (well, horses, actually)

We at Science-Based Medicine are pleased to announce the recruitment of yet another blogger to add to the discussion of the scientific basis of medicine. We’re especially pleased because he will help us address questions that we were not particularly well-equipped to address before his joining us. So, please welcome to the SBM fold David Ramey, DVM, who will be discussing science- and evidence-based veterinary medicine.

David Ramey, DVM, is a 1983 graduate of Colorado State University. After completing an internship in equine medicine and surgery at Iowa State University, he entered private equine practice in southern California. Dr. Ramey is an author of numerous books on equine health care, and a prominent voice for the application of evidence-based standards to veterinary medicine. He was a member of the task for on “Therapeutic Options” of the American Association of Equine Practitioners, as well as a member of the task force that wrote the current guidelines for the use of “Complementary and Alternative” veterinary medicine for the American Veterinary Association. He has published numerous articles and books pertaining to “alternative” approaches to veterinary medicine, including the 2004 Complementary and Alternative Veterinary Medicine Considered, co-authored with world renowned veterinary ethicist Dr. Bernard Rollin.

We get a fair number of questions about the use of “alternative” medical practices such as homeopathy and acupuncture on animals, particularly from people who ask us how they can appear to work on animals when animals supposedly don’t exhibit placebo effects. Dr. Ramey will be of great value in discussing such issues. Unfortunately, he will only be able to contribute posts around once a month or so. Fortunately, his first post will appear tomorrow. Don’t miss it.

Posted in: Announcements

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Dr. Jay Gordon and me: Random encounters with an apologist for the antivaccine movement

27452983Although he doesn’t detest me nearly as much as antivaccine honcho and founder of Generation Rescue J. B. Handley does, Santa Monica celebrity pediatrician Dr. Jay Gordon doesn’t like me very much at all.

Actually, I’m not sure whether that’s entirely true or not, but Dr. Gordon sure doesn’t like it when I criticize him for his antivaccine rhetoric. He affects an oh-so-wounded posture and self-righteously assures me that he is not “anti-vaccine” and that it is “beneath me” to use such rhetoric against him. Whether such rhetoric is “beneath me” or not, however, I’ve never quite understood why Dr. Gordon gets so upset at when I describe him as “anti-vaccine.” After all, his words are frequently apologetics for the anti-vaccine movement, and his actions frequently give it aid and comfort. After all, he is Jenny McCarthy‘s son Evan’s pediatrician, and as a result of that connection he has been giving speeches to antivaccine rallies, such as the “Green Our Vaccines” rally in Washington, D.C. in June. (He is the man in the sunglasses behind Jim Carrey in the picture at the top of this post by me.) After all, he has been palling around with luminaries of the antivaccine movement, such as Jenny McCarthy and her boyfriend Jim Carrey, the aforementioned J. B. Handley, Robert F. Kennedy, Jr., Boyd Haley, and numerous others at events like the “Green Our Vaccines” rally.

But, above all, over the last three or four years, Dr. Gordon has become the go-to pediatrician that the media seemingly always wants to interview when a vaccine “skeptic” with an MD after his name is required to provide the “balance” that journalists worship above all else, even when that “balance” gives undue credence to pseudoscientific nonsense. He clearly relishes that role, too, most infamously on his appearance with Jenny McCarthy on Larry King Live!, in which McCarthy shouted down pro-vaccine physicians and yelled “Bullshit!” (as if she who yells the loudest and is the most foul-mouthed wins the debate) and as evidenced by his appearances on certain antivaccination mailing lists, from which messages are occasionally forwarded to me.

What else am I supposed to think, except that Dr. Jay is at the very least an apologist for the antivaccine fringe, if not a card-carrying member himself?

Unfortunately, Dr. Gordon strikes me as being mostly a nice guy. I say “unfortunately” because it would be much easier to be as harsh on him as his promotion of antivaccine pseudoscience deserves if he were not. He also clearly believes that he is right based on the evidence. Based on science and clinical evidence, he most definitely is not. Recently, I had decided more or less to lay off him for a while, so as to avoid the wounded cries that invariably accompany valid charges that he is an apologist for the antivaccine fringe. Also, I felt kind of bad beating up on him so regularly and thought that perhaps a respite was in order. Then I found out that Dr. Gordon wrote the foreword to Jenny McCarthy’s new antivaccine and pro-autism quackery book, Mother Warriors: A Nation of Parents Healing Autism Against All Odds. Then, one of my readers actually took the time to transcribe Dr. Gordon’s foreword and e-mail it to me.

I read it, and I was appalled.
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Posted in: Neuroscience/Mental Health, Public Health, Science and the Media, Vaccines

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Fun with homeopaths and meta-analyses of homeopathy trials

ResearchBlogging.orgHomeopathy amuses me.

Well, actually it both amuses me and appalls me. The amusement comes from just how utterly ridiculous the concepts behind homeopathy are. Think about it. It is nothing but pure magical thinking. Indeed, at the very core of homeopathy is a concept that can only be considered to be magic. In homeopathy, the main principles are that “like heals like” and that dilution increases potency. Thus, in homeopathy, to cure an illness, you pick something that causes symptoms similar to those of that illness and then dilute it from 20C to 30C, where each “C” represents a 1:100 dilution. Given that such levels of dilution exceed Avagaddro’s number by many orders of magnitude, even if any sort of active medicine was used, there is no active ingredient left after a series of homeopathic dilutions. Indeed, this was known as far back as the mid-1800’s. Of course, this doesn’t stop homeopaths, who argue that water somehow retains the “essence” of whatever homeopathic remedy it has been in contact with, and that’s how homeopathy “works.” Add to that the mystical need to “succuss” (vigorously shake) the homeopathic remedy at each dilution (I’ve been told by homeopaths, with all seriousness, that if each dilution isn’t properly succussed then the homeopathic remedy will not attain its potency), and it’s magic all the way down, just as creationism has been described as “turtles all the way down.” Even more amusing are the contortions of science and logic that are used by otherwise intelligent people to make arguments for homeopathy. For example, just read some of Lionel Milgrom‘s inappropriate invocations of quantum theory at the macroscopic level for some of the most amazing woo you’ve ever seen, or Rustum Roy‘s claims for the “memory of water.” Indeed, if you want to find out just how scientifically bankrupt everything about homepathy is, my co-blogger Dr. Kimball Atwood started his tenure on Science-Based Medicine with a five part series on homeopathy.

At the same time, homeopathy appalls me. There are many reasons for this, not the least of which is how anyone claiming to have a rational or scientific viewpoint can fall so far as to twist science brutally to justify magic. Worse, homepaths and physicians sucked into belief into the sorcery that his homeopathy are driven by their belief to carry out unethical clinical trials in Third World countries, even on children. Meanwhile, time, resources, and precious cash are wasted chasing after pixie dust by our own government through the National Center for Complementary and Alternative Medicine (NCCAM). So while I laugh at the antics of homeopaths going on and on about the “memory of water” or quantum gyroscopic models” in order to justify homeopathy as anything more than an elaborate placebo, I’m crying a little inside as I watch.

The Lancet, meta-analysis, and homeopathy

If there’s one thing that homepaths hate–I mean really, really, really hate–it’s a meta-analysis of high quality homeopathy trials published by Professor Matthias Egger in the Department of Social and Preventative Medicine at the University of Berne in Switzerland, entitled Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy.
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Posted in: Clinical Trials, Homeopathy

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Announcing two more new bloggers

Last week, we at Science-Based Medicine announced the arrival of a new blogger, Dr. Val Jones. She’s already made her mark here by in the course of her description of how she awakened to the problem of unscientific so-called “alternative” medicine infiltrating its way into medicine coining a new term that may well become more widely used than anyone could suspect.

I’m now happy to announce two more additions to the SBM team. Both are experienced bloggers. Both are excellent bloggers. Both are just as alarmed as the rest of us about how antiscience has insinuated its way into biomedical academia. Moreover, each will bring his own useful new viewpoint here to shake things up.

The first, Dr. Peter Lipson, is an internist in private practice. Consequently, he brings the perspective of how a health care professional “in the trenches,” so to speak, must deal with issues of science-based versus non-science-based medicine. His description follows:
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Posted in: Announcements

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Vitamin C strikes (out) again

I didn’t think I’d be revisiting this topic again so soon. After all, I wrote one of my characteristic magnum opuses (opi?) less than two months ago, when I asked whether a recent animal study had vindicated Linus Pauling’s belief that high dose vitamin C is a highly effective cancer treatment. After that tsunami of verbiage that can only be exceeded by my fellow blogger Dr. Atwood when he’s on a roll doing a multipart deconstruction of some woo or other, I thought it would be best to give it a rest for a while. I guess less than two months will have to be enough.

The reason struck me as I was perusing the very latest issue of Cancer Research, hot off the presses October 1. As I did so, it didn’t take me long to come across an article from the Memorial-Sloan Kettering Cancer Center and the Herbert Irving Comprehensive Cancer Center at Columbia entitled Vitamin C Antagonizes the Cytotoxic Effects of Antineoplastic Drugs, whose first author is Dr. Mark Heaney.

Once more into the fray!
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Posted in: Basic Science, Cancer, Herbs & Supplements, Nutrition

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