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Clinical trials of integrative medicine: testing whether magic works?

 

I just thought that I’d take the editor’s (and, speaking for Steve, the founder’s) prerogative to promote our own efforts. Regular readers of SBM are familiar with our message with respect to randomized clinical trials of highly implausible “complementary and alternative medicine” treatments, such as homeopathy or reiki. Well, believe it or not, Steve and I managed to get a commentary published in a very good journal in which we present the SBM viewpoint with respect to these trials. Even better, at least for now, you can read it too, because it doesn’t appear to be behind a paywall. (I’m at home as I write this, and I can read the whole thing on my wifi, no VPN needed.)

The article is entitled “Clinical trials of integrative medicine: testing whether magic works?” There’s also been a fair amount of news coverage on the article, and I’ve been frantically doing interviews over the last couple of days, including:

There are likely to be at least a couple more, given the interviews I’ve done; that is, unless editors reject the ideas.

In any case, Steve and I are interested in your comments. Trends in Molecular Medicine is good in that it published our article and it’s a pretty high impact review journal, but it doesn’t have a section for comments. So consider this your section for comments on our article.

Posted in: Basic Science, Clinical Trials, Homeopathy

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A tale of quackademic medicine at the University of Arizona Cancer Center

Quackademic medicine.

I love that term, because it succinctly describes the infiltration of pseudoscientific medicine into medical academia. As I’ve said many times, I wish I had been the one to coin the phrase, but I wasn’t. To the best of my ability to determine, I first picked it up from Dr. R. W. Donnell back in 2008 and haven’t been able to find an earlier use of the term. As much as I try to give credit where credit is due, I have, however, appropriated the term “quackademic medicine” (not to mention its variants, like “quackademia”), used it, and tried my best to popularize it among supporters of science-based medicine. Indeed, one of my earliest posts on this blog was about how quackery has infiltrated the hallowed halls of medical academia, complete with links to medical schools that have “integrative medicine” programs and even medical schools that promoted the purely magic-based medical modalities known as reiki and homeopathy. It’s been a recurrent topic on this blog ever since, leading to a number posts on the unethical clinical trials of treatments with zero or minimal pre-trial plausibility, the degradation of the scientific basis of medicine, and the acceptance of magical thinking as a means of treating patients in all too many medical centers.

One strong candidate for quackademic ground zero, if there can be such a thing for the phenomenon like quackademic medicine, which is creeping up like so much kudzu in the cracks of the edifice of science-based medicine (SBM), is the University of Arizona. U. of A. is, of course, the home of one of the originators of the concept of quackademic medicine and one of its most famous and tireless promoters, Dr. Andrew Weil. Dr. Weil, as you might recall, has even been the driving force for creating a highly dubious “board certification” in integrative medicine. Sadly, apparently this new board certification has been so popular among physicians wanting to “integrate” a little quackery into their practices, that its first examination has been delayed from May to November 2014, so that the American Board of Physician Specialties can figure out how to accommodate the unexpectedly large number of applicants.

So what happens when a patient arrives at U. of A. for treatment? I found out last week when I received an e-mail, which led to a fairly long e-mail exchange, with a man whose son was diagnosed with leukemia and is being treated at the University of Arizona Cancer Center (UACC). Although this man gave me permission to use his name, I am going to decline to do so because there is a child involved, although anyone involved in his case at U. of A. will likely quickly be able to identify who the man is. It turns out that he is a professor at U. of A. in a humanities department (which is why I’ll refer to him henceforth as the Professor), and, even though he is not a scientist, he clearly knows how to think (which would not be surprising if you knew what department he was in). In his e-mail, he told me how appalled he was at the sorts of treatments being offered to his son:
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Posted in: Acupuncture, Cancer, Chiropractic, Energy Medicine, Medical Academia, Religion

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Does thinking make it so? CAM placebo fantasy versus scientific reality

Last week, I discussed a rather execrable study. Actually, the study itself wasn’t so execrable, at least not in its design, which was a fairly straightforward three-arm randomized clinical trial. Rather it was the interpretation of the study’s results that was execrable. In brief, the authors tested an “energy healing” modality known as “energy chelation” versus a placebo (sham “energy chelation”) and found, as is so often the case in studies of “complementary and alternative medicine” (CAM) or “integrative medicine” (IM) that both modalities did better than no treatment on the primary outcomes but that the “real” treatment (if one can call energy chelation “real treatment”) produced outcomes that were statistically indistinguishable from the “sham” treatment. Not surprisingly, the next move on the part of the researchers was to do a bunch of comparisons, and, as is so often the case (particularly when one fails to correct statistically for multiple comparisons), they found a couple of secondary endpoints with barely statistically significant differences and trumpeted them as meaning that their “energy chelation therapy” has “significant promise for reducing fatigue.” They then argued that the study was also ” designed to examine nonspecific and placebo elements that may drive responses.”

Which brings us to the “power” of placebo.

As I was contemplating what I wanted to discuss this week, I thought about the study that Drs. Coyne, Johansen, and I objected to, but then I also thought about Dr. Crislip’s post last week and post I did about a month ago in which I noticed how lately CAM apologists seem to be—shall we say?—retooling their message in the wake of negative trial after negative trial of their implausible treatments. Gone (mostly) are claims of powerful specific effects and efficacy from treatments such as various “energy healing” modalities, acupuncture, homeopathy, and the like themselves, to be replaced by claims that physicians should embrace CAM because it’s “harnessing the power of placebo” to produce “powerful mind-body healing.” It’s a powerful message that has sucked in people who normally would be considered skeptics, such as Michael Specter, who, as I described, apparently bought into the message sufficiently that when Ted Kaptchuk was making the media round right before the holidays he happily published a fairly credulous interview with him entitled, The Power of Nothing: Could Studying the Placebo Effect Change the Way We Think About Medicine? (My answer: Very likely no.) Even Ira Flatow of Science Friday fell hard for Kaptchuk’s message, declaring at the beginning of the interview that Kaptchuk’s irritable bowel syndrome study is evidence that “placebos work even when patients are in on the secret.” (It’s not.)

That skeptics and scientists find the idea that the mind has the power to heal the body, often referred to as “self-healing” or “mind-body healing,” so seductive should probably not be surprising. After all, who wouldn’t want to be able to cure themselves simply by willing it to be so? It’s a concept that, like so many concepts in CAM, goes far back into ancient times and stretches forward to today in ideas like The Secret, which goes quite a bit beyond the whole idea of “mind-body healing” or healing yourself because you wish it to be so, and declares that you can have virtually anything you want simply by thinking the right thoughts. In fact, to me it appears that the “powerful placebo” is being drafted in the service of supporting what are, at their core, mystical beliefs far more than science. I’d like to elaborate on that idea a bit more than I did last time I discussed this isssue, where I concluded by writing:

In the end, all too much of the rebranding of CAM as placebo and the selling of placebos as some sort of powerful “mind-body healing” strikes me as being much like The Secret, in which wishing makes it so.

Let’s take a look at just how far this goes.
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Posted in: Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Religion

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Reiki

Reiki (pronounced raykey) is a form of “energy healing,” essentially the Asian version of faith healing or laying on of hands. Practitioners believe they are transferring life energy to the patient, increasing their well-being. The practice is popular among nurses, and in fact is practiced by nurses at my own institution (Yale).

From reiki.org, we get this description:

Reiki is a Japanese technique for stress reduction and relaxation that also promotes healing. It is administered by “laying on hands” and is based on the idea that an unseen “life force energy” flows through us and is what causes us to be alive. If one’s “life force energy” is low, then we are more likely to get sick or feel stress, and if it is high, we are more capable of being happy and healthy.

Reiki is therefore a form of vitalism – the pre-scientific belief that some spiritual energy animates the living, and is what separates living things from non-living things. The notion of vitalism was always an intellectual place-holder, responsible for whatever aspects of biology were not currently understood. But as science progressed, eventually we figured out all of the basic functions of life and there was simply nothing left for the vital force to do. It therefore faded from scientific thinking. We can add to that the fact that no one has been able to provide positive evidence for the existence of a vital force – it remains entirely unknown to science.

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Posted in: Energy Medicine

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Of SBM and EBM Redux. Part IV: More Cochrane and a little Bayes

NB: This is a partial posting; I was up all night ‘on-call’ and too tired to continue. I’ll post the rest of the essay later…

Review

This is the fourth and final part of a series-within-a-series* inspired by statistician Steve Simon. Professor Simon had challenged the view, held by several bloggers here at SBM, that Evidence-Based Medicine (EBM) has been mostly inadequate to the task of reaching definitive conclusions about highly implausible medical claims. In Part I, I reiterated a fundamental problem with EBM, reflected in its Levels of Evidence scheme, that although it correctly recognizes basic science and other pre-clinical evidence as insufficient bases for introducing novel treatments into practice, it fails to acknowledge that they are necessary bases. I explained the difference between “plausibility” and “knowing the mechanism.”

I showed, with several examples, that in the EBM lexicon the word “evidence” refers almost exclusively to the results of clinical trials: thus, when faced with equivocal or no clinical trials of some highly implausible claim, EBM practitioners typically declare that there is “not enough evidence” to either accept or reject the claim, and call for more trials—although in many cases there is abundant evidence, other than clinical trials, that conclusively refutes the claim. I rejected Prof. Simon’s assertion that we at SBM want to “give (EBM) a new label,” making the point that we only want it to live up to its current label by considering all the evidence. I doubted Prof. Simon’s contention that “people within EBM (are) working both formally and informally to replace the rigid hierarchy with something that places each research study in context.”

In Part II I responded to the widely held assertion, also held by Prof. Simon, that there is “societal value in testing (highly implausible) therapies that are in wide use.” I made it clear that I don’t oppose simple tests of basic claims, such as the Emily Rosa experiment, but I noted that EBM reviewers, including those employed by the Cochrane Collaboration, typically ignore such tests. I wrote that I oppose large efficacy trials and public funding of such trials. I argued that the popularity gambit has resulted in human subjects being exposed to dangerous and unethical trials, and I quoted language from ethics treatises specifically contradicting the assertion that popularity justifies such trials. Finally, I showed that the alleged popularity of most “CAM” methods—as irrelevant as it may be to the question of human studies ethics—has been greatly exaggerated.

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Posted in: Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Medical Academia, Medical Ethics, Science and Medicine

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Mainstream Media’s Sub-Par Health Coverage, Part 2

I recently wrote about an experience that I had with a reporter (Erica Mitrano) who interviewed me about energy healing at Calvert Memorial Hospital in southern Maryland. Erica was very friendly and inquisitive, and we had a nice conversation about the lack of scientific evidence supporting any energy healing modality. I thought it would be fun to post what we had discussed at SBM, and then wait to see what trickled down into the finished piece.

When the final article appeared I was very disappointed. Not only was I not quoted, but there was no skeptical counter-point at all. The story read like an unquestioning endorsement of junk science, and I wondered if it was worth it to continue speaking to journalists to offer expert advice. It seemed to me that this experience was emblematic of all that’s wrong with health reporting these days. (Just ask Gary Schwitzer – who has recently given up on reviewing TV health stories in mainstream media since they are generally so inaccurate.) (more…)

Posted in: Energy Medicine, Science and the Media

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Energy Healing In Maryland

I had an interesting conversation with a reporter today. She called me to get a “medical/skeptical” counterpoint for an article she is preparing on energy healing. Although I don’t know if she’ll faithfully represent what I had to say, we had an entertaining exchange and so I decided to capture the essence of it here. I’m curious to see which parts of our conversation remain in her final article, due out on February 19th. (Stay tuned for that).

Apparently a local hospital in Maryland is now offering nurse-guided therapeutic touch and Reiki healing for inpatients. She decided to interview the practitioners involved, and turned to me for comment. I did not have the benefit of preparing in advance or having references handy – so I gave it my best shot. I’d be interested to know how you might have responded differently.

1. Is there any scientific evidence that energy healing works? (more…)

Posted in: Energy Medicine, Science and the Media

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Mixed Messages on Campus

The past two months have been my first time working in the hospital, as a third-year medical student in my Internal Medicine clerkship. It’s been exciting not only to see how medicine works but to be a part of the action! It really is striking to see the dramatic increases in proficiency and confidence with each stage of the training. From junior student to acting intern to intern to resident to chief resident and eventually to attending, each year brings both more responsibility and more competence. Importantly, physicians-in-training also get very efficient in seeking out and communicating information. Just like SBM editors read widely and blog prolifically whereas I struggle to put together one post a month, experienced clinicians have responsibility for dozens of patients at a time whereas I feebly tag along with one or two each day. Watching my elders on the medical team, I feel excited about how much smarter and more effective I will become as I progress through my training.

Anyway, I want to share an interesting sight in my hospital last month. There were three 3-foot posters on tripods prominently displayed in the hospital lobby, in the cafeteria, and in other public places. The first one read: (more…)

Posted in: Science and Medicine

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