Science-Based Medicine

On SBM we have documented the many and various ways that science is abused in the pursuit of health (or making money from those who are pursuing health). One such method is to take a new, but reasonable, scientific hypothesis and run with it, long past the current state of the evidence. We see this with the many bogus stem cell therapy clinics that are popping up in parts of the world with lax regulation.

This type of medical pseudoscience is particularly challenging to deal with, because there is a scientific paper trail that seems to support many of the claims of proponents. The claims themselves may have significant plausibility, and parts of the claims may in fact be true. Efforts to educate the public about such treatments are frustrated by the mainstream media’s lazy tendency to discuss every study as if it were the definitive last word on a topic, and to site individual experts as if they represent the consensus of scientific opinion.

Recent claims made for low dose naltrexone (LDN) fit nicely into this model – a medical intervention with interesting research, but in a preliminary phase that does not justify clinical use. And yet proponents talk about it as if it is a medical revolution.

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Acupuncture has been a frequent topic on this blog because, of all the “complementary and alternative medicine” (CAM) modalities out there, it’s arguably the one that most people accept as potentially having some validity. The rationale behind acupuncture is, as we have explained many times before, little different than the rationale behind any “energy healing” method (like reiki, for example) in that it claims to redirect the flow of “life energy” (the ever-invoked qi). The only difference is that acupuncturists claim to bring this therapeutic qi rearrangement about by sticking thin needles into the pathways in the body through which this qi is fantasized to flow. These pathways, called meridians, are just as much a fantasy as qi itself or the “universal source” that reiki masters claim to be able to channel through themselves and into believers. Contributing to the popularity of acupuncture is its mythology as having been routinely practiced for over two thousand years, a myth that was the creation of Chairman Mao, who elevated what was a marginal practice at the time to a modality that the state supported and promoted (1,2,3,4).

In addition, because acupuncture involves sticking actual metal objects into the skin rather than simply laying on hands or making magical gestures over the patient, it retains some credibility, even among doctors. It doesn’t matter that, reviewing the totality of the research, one finds that it doesn’t matter where you stick the needles or even if you stick the needles in the skin. The results are the same and indistinguishable from placebo. The inescapable conclusion is that acupuncture is placebo medicine with needles. Personally, I’d prefer my placebo medicine without needles, but that’s just me.

Yet, the studies keep rolling in, trying desperately to demonstrate that acupuncture works or assuming that acupuncture works . Two more popped up within the last couple of weeks, and one of them, if you read the press releases, sounds really convincing. As is frequently the case, for this latter study, there is less to it than meets the eye. I’ll start, however, with a study that is a followup to a study I blogged about a couple of years ago that I characterized as another overhyped acupuncture study misinterpreted. This one, thankfully, is not nearly as hyped as the study from two years ago—or as the second study I will discussed, but it is very instructive how the original misinterpreted story is leading to a classic CAM “bait and switch” applied to acupuncture.
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I usually rely on the Secret.  Every two weeks or so the Universe offers up some bit of wacky whimsey and I have a topic for an SBM blog entry.  This week the Universe has failed me. Nothing has crossed my LCD so I have no studies to evaluate and I have been unusually busy at work preventing my browsing the Interwebs for material.  But try telling that to the Managing Editor.   I write half to amuse myself, half to learn about the topic, and half to clarify in my own mind the topics at hand (1).  So this week  is content free idle thoughts for my own benefit.

I have been reading 13 Things That Don’t Make Sense by Michael Brooks. The book concerns topics in science that are unexplained by the current understanding  of the laws of the universe or contradict the dominant paradigm. Well, almost.  His final topic is homeopathy, and it is the one topic whose conclusions, while qualified, belong on Failblog.  The first chapter concerns dark matter and dark energy and how what we can see makes up only a small fraction of the content of the universe.   Continue Reading »

If there’s one thing about quacks, it’s that they are profoundly hostile to science. Actually, they have a seriously mixed up view of science in that they hate it because it doesn’t support what they believe. Yet at the same time they very much crave the imprimatur that science provides. When science tells them they are wrong, they therefore often try to attack the scientific method itself or claim that they are the true scientists. We see this behavior not just in quackery but any time scientific findings collide with entrenched belief systems, for example, medicine, evolution, anthropogenic global warming, and many others. So it was not surprising that a rant I saw a few weeks ago by a well-known supporter of pseudoscience who blogs under the pseudonym of Vox Day caught my interest. Basically, he saw a news report about an article in Nature condemning the quality of current preclinical research. From it, he draws exactly the wrong conclusions about what this article means for medical science:

Fascinating. That’s an 88.6 percent unreliability rate for landmark, gold-standard science. Imagine how bad it is in the stuff that is only peer-reviewed and isn’t even theoretically replicable, like evolutionary biology. Keep that figure in mind the next time some secularist is claiming that we should structure society around scientific technocracy; they are arguing for the foundation of society upon something that has a reliability rate of 11 percent.

Now, I’ve noted previously that atheists often attempt to compare ideal science with real theology and noted that in a fair comparison, ideal theology trumps ideal science. But as we gather more evidence about the true reliability of science, it is becoming increasingly obvious that real theology also trumps real science. The selling point of science is supposed to be its replicability… so what is the value of science that cannot be repeated?

No, a problem with science as it is carried out by scientists in the real world doesn’t mean that religion is true or that a crank like Vox is somehow the “real” intellectual defender of science. Later, Vox doubles down on his misunderstanding by trying to argue that the problem in this article means that science is not, in fact, “self-correcting.” This is, of course, nonsense in that the very article Vox is touting is an example of science trying to correct itself. Be that at it may, none of this is surprising, given that Vox has demonstrated considerable crank magnetism, being antivaccine, anti-evolution, an anthropogenic global warming denialist, and just in general anti-science, but he’s not alone. Quackery supporters of all stripes are jumping on the bandwagon to imply that this study somehow “proves” that the scientific basis of medicine is invalid. A writer at Mike Adams’ wretched hive of scum and quackery, NaturalNews.com, crows:

Begley says he cannot publish the names of the studies whose findings are false. But since it is now apparent that the vast majority of them are invalid, it only follows that the vast majority of modern approaches to cancer treatment are also invalid.

But does this study show this? I must admit that it was a topic of conversation at the recent AACR meeting, given that the article was published shortly before the meeting. It’s also been a topic of e-mail conversations and debates at my very own institution. But do the findings reported in this article mean that the scientific basis of cancer treatment is so off-base that quackery of the sort championed by Mike Adams is a viable alternative or that science-based medicine is irrevocably broken?

Not so fast there, pardner…
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Glucosamine and chondroitin, used separately or together, are among the more popular diet supplements. They are used widely for osteoarthritis, especially of the knee, and have been better studied than most other diet supplements. But do they really work?

The journal of my medical specialty, American Family Physician, recently published an article about the use of dietary supplements in osteoarthritis. They gave a “B” evidence rating to both glucosamine and chondroitin. This means there is inconsistent or limited-quality patient-oriented evidence. They recommended the use of glucosamine sulfate, saying, “Overall, the evidence supports the use of glucosamine sulfate for modestly reducing osteoarthritis symptoms and possibly slowing disease progression.” They did not exactly recommend chondroitin, although they said it “may provide modest benefit for some patients.”

I remain skeptical. And so does R. Barker Bausell, who devoted several pages of his book Snake Oil Science to an analysis of the research on glucosamine and chondroitin. Continue Reading »

This is actually the second entry in this series;† the first was Part V of the Homeopathy and Evidence-Based Medicine series, which began the discussion of why Evidence-Based Medicine (EBM) is not up to the task of evaluating highly implausible claims. That discussion made the point that EBM favors equivocal clinical trial data over basic science, even if the latter is both firmly established and refutes the clinical claim. It suggested that this failure in calculus is not an indictment of EBM’s originators, but rather was an understandable lapse on their part: it never occurred to them, even as recently as 1990, that EBM would soon be asked to judge contests pitting low powered, bias-prone clinical investigations and reviews against facts of nature elucidated by voluminous and rigorous experimentation. Thus although EBM correctly recognizes that basic science is an insufficient basis for determining the safety and effectiveness of a new medical treatment, it overlooks its necessary place in that exercise.

This entry develops the argument in a more formal way. In so doing it advocates a solution to the problem that has been offered by several others, but so far without real success: the adoption of Bayesian inference for evaluating clinical trial data.
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I have steadily endeavored to keep my mind free so as to give up any hypothesis, however much beloved (and I cannot resist forming one on every subject), as soon as the facts are shown to be opposed to it.
— Charles R. Darwin

I’m getting old: 50, almost 51, and that’s over 350 in dog years. As a result of my advancing age there are things I do not get: tattoo’s, hip hop, visible undergarments, and those rectangular, square plastic glasses that seem so popular and look hideous on everyone. It gets harder to change.

I have been able to stick MD after my name for almost a quarter century now (175 dog years for those keeping track), and it does give a sense of perspective to the ebb and flow of medical therapies. Medicine for the last hundred years has been all about change. Dogma from last century is nonsense this century, all due to that damn science. It gets so tiresome having to learn something new.

Last month’s New England Journal of Medicine was another in a seemingly endless series of plus ça change, plus c’est la même chose moments.⁴ They published the results of the CORTICUS study, a trial that looked at the use of corticosteroids in septic shock. For background, septic shock occurs when a severe infection shuts down most important organs and the patient cannot maintain their blood pressure. Mortality is high and, depending on the patient, the infection and the infecting organism, mortality ranges from 30 to 110%. People can die several times during their admission and be temporarily brought back, at least from the sloppy definitions of the near death experience proponents (shameless plug for Quackcast 23). Sepsis is a Bad Disease. Patients in septic shock often have lower levels of cortisol in their blood than they should. So maybe giving replacement cortisol, in the form of hydrocortisone or prednisone, would decrease the death rates.

The results of the CORTICUS (I so want to be involved in a study that has an obscene acronym) suggests steroids are not effective. When compared to placebo, physiologic hydrocortisone (i.e. giving enough hydrocortisone to replace the deficit) was no better at preventing mortality. It didn’t work. Or didn’t it. Or did it? Which one?

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There it was on Friday greeting me on the ABC News website: “Study: Acupuncture May Boost Pregnancy” in bold blue letters, with the title of the webpage being “Needles Help You Become Pregnant.” The story began:

It sounds far-fetched sticking needles in women to help them become pregnant but a scientific review suggests that acupuncture might improve the odds of conceiving if done right before or after embryos are placed in the womb.

The surprising finding is far from proven, and there are only theories for how and why acupuncture might work. However, some fertility specialists say they are hopeful that this relatively inexpensive and simple treatment might ultimately prove to be a useful add-on to traditional methods.

By the end of the day, the story was all over the media, including radio, TV, news websites, the blogosphere, and various other outlets, all trumpeting the message that a scientific study says that acupuncture can help infertile couples conceive. Nary a skeptical word seemed to be found. Knowing very well just how far parents will go to conceive, I was curious: Did this study actually say what the media says it said? What was so new and radical about this study that it rated a press release and a lot of promotion? Do we here at SBM (particularly Steve) need to rethink our extreme skepticism about acupuncture, given the poor quality evidence and lack of even a glimmer of a convincing physiologic mechanism to explain its supposed activities?
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News bulletin on BBC NEWS International version, 8 Feruary 2008:“Acupuncture ‘boosts IVF chances.’ Acupuncture may increase the success rates of fertility treatment, according to a study. “

(Manheimer E, Zhang G, Udoff L, Haramati A, Langenberg P, Berman BM, Bouter LM. Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilisation: systematic review and meta-analysis. BMJ. 2008 Feb 7)

First off, how plausible is the claim? The press release states that acupuncture had been used in China fior thousands of years for infertility. Has it? No medical historian writing I have seen made such an interpretation of ancient texts. Maybe I missed something…possible. But acupuncture was not used for specific disorders or purposes, but was used as a sort of panacea to cause balance of either the Yin and Yang or of the relationship of the individual with the 5 elements and the cosmos and the earth. There is nothing specific in claims of acupuncture in traditional Chinese Medicine history. Who gave the news people that misleading lead-in?

Second, what is the plausibility that acupuncture could possibly affect a laboratory procedure on tissue removed from the subject, regardless of timing? Negligible to none. There is no consistent and credible information that acupuncture is effective for anything, except as a conditiong agent for perception of symptoms.

So, does acupuncture increase the success of IVF?

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A few years back, my co-blogger Wally Sampson wrote a now infamous editorial entitled Why the National Center for Complementary and Alternative Medicine (NCCAM) Should Be Defunded. When I first read it, I must admit, I found it to be a bit harsh and–dare I say?–even close-minded. After all, plausibility aside, I believed at the time that the only way to demonstrate once and for all in a way that everyone would have to accept that many of these “alternative” therapies were no more effective than a placebo would be to do high-quality randomized clinical trials to test whether they worked, and NCCAM seemed to be the perfect funding agency to see that this occurred. Yes, this attitude in retrospect was quite naïve, as I have since learned the hard lesson over several years that no amount of studies will convince advocates of complimentary and alternative medicine (CAM) that their favored therapy doesn’t work, be it chelation therapy for autism or cardiovascular disease, homeopathy, reiki, or various other “energy” therapies that invoke manipulation of qi as a means of “healing,” such as acupuncture, but that is what I believed at the time.
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