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On the pointlessness of acupuncture in the emergency room…or anywhere else

"This patient's qi isn't flowing the way it should. Consult Acupuncture, STAT!!"

“This patient’s qi isn’t flowing the way it should. Consult Acupuncture, STAT!!”

Sometimes there is a strange confluence of events that dictate what I feel that I need to write about when my turn here at SBM rolls around each Monday. Last week, a reader sent me a rather bizarre acupuncture study, and I thought I might write about that. Then I saw Mark Crislip’s (as usual) excellent deconstruction of the frequent claim by acupuncture apologists that acupuncture “works” by releasing endorphins and thought, “Maybe another topic.” But then, over the weekend, the Friends of Science in Medicine sent me a link to their latest article, a review of acupuncture entitled “Is there any place for acupuncture in 21st century medical practice?” Not surprisingly, the FSM (Friends of Science in Medicine, not the Flying Spaghetti Monster) concludes that the answer is no. However, in stark contrast to that conclusions are studies like the one mentioned above, studies so ridiculous that, when I discuss it, you will hardly believe that anyone thought it was a good idea to utilize the money, time, and precious, precious human subjects to answer such a ridiculous question. After that discussion, I’ll come back to the FSM’s statement and discuss the evidence base (or rather, lack thereof) for acupuncture for pretty much anything.
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Posted in: Acupuncture, Clinical Trials

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Acupuncture and Endorphins: Not all that Impressive

Acupuncture needling

Pictured: A great way to get a staph infection, not a great way to get an endorphin rush.  Try jogging.  Or heroin.*

I was reading, and deconstructing, a particularly awful bit of advice for acupuncture by Consumer Reports. It was the same old same old, but it was the source that made it particularly awful. I expect more from Consumer Reports than the uncritical regurgitation of the standard mythical acupuncture narrative. The report included the quote

One possible reason for the benefits of acupuncture: Studies show that it causes us to release feel-good hormones, called endorphins, that suppress pain.

I have never bothered to go back and see what the original literature was to support endorphins as a potential mechanism for a beneficial effect of acupuncture on pain.

That endorphins are released as a result of a noxious stimulus didn’t surprise me; that is what endorphins are for. And endorphins are unlikely to be the mechanism for all the other diseases for which the WHO suggests acupuncture benefits.

To my surprise, my brief search that day came up with very little information on the endorphins and acupuncture.

What I wanted to know was the evidence behind the universal meme that acupuncture releases feel-good hormones. If Consumer Reports says it is so, it must be true, right? So I plugged ‘acupuncture endorphin’ into PubMed and went to work. (more…)

Posted in: Acupuncture, Basic Science, Clinical Trials, Traditional Chinese Medicine

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Forget stem cell tourism: Stem cell clinics in the US are plentiful

Snake Oil Salesman & Wagon
I had planned on writing about something else this week, but late last week another story caught my eye, because it served as a perfect follow-up to what I wrote about last week. To recap, I wrote about a man named Jim Gass, a former chief legal counsel for Sylvania, who had suffered a debilitating stroke in 2009 that left him without the use of his left arm, and weak left leg. He could still walk with a cane, but was understandably desperate to try anything to be able to function more normally in life. Mr. Gass was both driven enough, credulous enough, and wealthy enough to spend $300,000 pursuing stem cell tourism in China, Mexico, and Argentina over the course of four years. The result is that he now has a tumor growing in his spinal column, as reported in The New England Journal of Medicine (NEJM) and The New York Times (NYT). Genetic analysis has demonstrated that the cells in this tumor mass did not come from Jim Gass, and the mass has left him paralyzed from the neck down, except for his right arm, incontinent, and with severe chronic back pain. Worse, although radiation temporarily stopped the tumor from growing, apparently it’s growing again, and no one seems to know how to stop it. Given that the traits that make stem cells so desirable as a regenerative treatment, their plasticity and immortality (ability to divide indefinitely), are shared with cancer, scientists doing legitimate stem cell research have always tried to take precautions to stop just this sort of thing from happening in clinical trials. Clearly, “stem cell tourist” clinics, which intentionally operate in countries where the regulatory environment is—shall we say?—less than rigorous are nowhere near as cautious, as they charge tens of thousands of dollars a pop for stem cell treatments that might or might not actually have real stem cells in them.

At the time I wrote that article, I emphasized primarily clinics outside of the US, where shady operators locate in order to be able to operate largely unhindered by local governments. You’d think that such a thing couldn’t possibly be going on in the US. You’d be wrong. Last week, Paul Knoepfler, a stem cell scientist who has previously contributed to Science-Based Medicine, teamed up with Leigh Turner to publish a paper in Cell Stem Cell estimating the number of stem cell clinics in the US. The number they came up with astonished me. (more…)

Posted in: Clinical Trials, Medical Ethics, Politics and Regulation, Science and the Media

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A systematic review about nothing

Water
There is dubious content in PubMed that you won’t find unless you look for it, or stumble across it inadvertently. It’s the entire field of alternative medicine which is abstracted and complied along with the actual medical literature. In this world, the impossible is accepted as fact, and journal articles focus on the medical equivalent of counting angels on pinheads. I’ve been trying to avoid blogging about alternative medicine practices like homeopathy lately because the practice itself is a scientific dead end. There is no emerging evidence or interesting research to describe, because there is no science to build on. But research on homeopathy is interesting if one wants to understand how placebo effects can appear to be real. Importantly, research and clinical trials of homeopathy allow us to see the underlying (baseline) challenges, flaws, and biases in evaluating real medicine more clearly. Today I want to review a newly-published systematic review of, adverse effects attributed to homeopathy. The casual reader might not see the multiple problems with this type of research. But once you understand the basis of homeopathy, the conclusion that one can draw is quite different from that of the author’s. And if inert sugar pills can appear to have medicinal effects, and even adverse effects, then we can better adjust for these biases when we’re studying actual medicine. (more…)

Posted in: Clinical Trials, Homeopathy

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What’s the harm? Stem cell tourism edition

What's the harm? Stroke victim Jim Gass went from requiring a cane and leg brace to walk to being confined to a wheelchair, thanks to dubious stem cell treatments. There's the harm.

What’s the harm? Stroke victim Jim Gass went from requiring a cane and leg brace to walk to being confined to a wheelchair, thanks to dubious stem cell treatments. There’s the harm.

It’s been over two weeks now since hockey legend Gordie Howe died at the age of 88. Detroit, as I’ve pointed out elsewhere, is a serious hockey town, as hockey-crazy as any town in Canada (just look at the fancy new hockey arena named after crappy pizza being built downtown only a mile from where I work), and it worshiped Gordie Howe for as long as I can remember growing up here.

The reason I mentioned this is because in late 2014, Howe suffered a series of debilitating strokes that brought him close to death. He survived, but with major neurologic deficits. As a result of Gordie Howe’s fame, representatives of a company known as Stemedica who were also fans of Gordie Howe and whose company is developing stem cell treatments for a variety of illnesses, approached the family and persuaded them to take Gordie Howe to the Novastem Clinic in Tijuana, a clinic that to me appeared to exist mainly as a means for patients not eligible for Stemedica’s clinical trials in the US to receive Stemedica’s stem cells outside of a clinical trial, cash on the barrelhead, no questions asked. In a rather ethically dubious move that could only be viewed as paying for publicity (which it got in abundance), Stemedica administered its stem cells to Gordie Howe for free. If you’re not Gordie Howe, however, it’ll cost you about $32,000.

As is the case for most anecdotes like this, Gordie Howe did improve. That is not surprising, because, as Steve Novella, who is a neurologist and thus takes care of stroke patients as part of his practice, told me at the time, the natural history of stroke is neurologic recovery that eventually plateaus several months after the stroke. This occurs as the inflammation from the initial stroke abates and as much regeneration as the body can muster occurs. Also, as I noted before, Howe had a hemorrhagic stroke, which is more dangerous and likely to kill early but, if the victim survives, he is more likely to experience better functional recovery than in the case of the much more common ischemic stroke, in which a blood clot clogs a blood vessel, resulting in the death of brain tissue supplied by that vessel. In any case, as I described in a three part series of posts (part one, part two, part three), it’s impossible to know whether the stem cell infusion that Howe underwent had anything whatsoever with his partial recovery that allowed him to make a few public appearances in 2015 and 2016.

Unfortunately, the offer by Dr. Maynard Howe (CEO) and Dave McGuigan (VP) of Stemedica Cell Technologies to treat Gordie Howe at Novastem worked brilliantly. Gordie Howe quickly became the poster child for dubious stem cell therapies. Local and national news aired credulous, feel-good human interest stories about his seemingly miraculous recovery, while Keith Olbermann practically served as a pitch man for Stemedica and didn’t take kindly at all to any criticism of his—shall we say?—enthusiastic coverage. The predominant angle taken in stories about Gordie Howe was he had undergone Stemedica’s stem cell therapy and, as result, enjoyed a “miraculous recovery” from his stroke. The vast majority of news coverage also tended to present the magic of stem cell therapies credulously, as all benefit and no risk, as a qualitative analysis published last year clearly showed, finding that the “efficacy of stem cell treatments is often assumed in news coverage and readers’ comments” and that media coverage “that presents uncritical perspectives on unproven stem cell therapies may create patient expectations, may have an affect [sic] on policy discussions, and help to feed the marketing of unproven therapies.”

No kidding.

Why, you might ask, am I reminding you of Gordie Howe’s use of stem cells to treat his strokes? Simple, it became part of a marketing blitz, credulously swallowed whole by Keith Olbermann and many reporters, for unproven stem cell therapies, which have been portrayed as very promising (which is likely true, although that promise hasn’t yet been proven or realized) and harmless, which is definitely not true, as evidenced by the story of Jim Gass, as published last week in The New England Journal of Medicine, The New York Times, The Boston Globe, and a variety of other media. Before I discuss Mr. Gass in more detail, however, let’s recap a bit about stem cells. (more…)

Posted in: Clinical Trials, Ethics, Health Fraud, Science and the Media

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Whither the randomized controlled clinical trial?

Whither the randomized controlled clinical trial?

One of the most frequent complaints about evidence-based medicine (EBM), in contrast to science-based medicine (SBM), is its elevation of the randomized clinical trial as the be-all and end-all for clinical evidence for an intervention for a particular disease or condition. Unknown but enormous quantities of “digital ink” have been spilled explaining this distinction right here on this blog, beginning with our founder’s very first post, continuing with Kimball Atwood’s series of posts explaining the shortcomings of EBM’s reliance on clinical trials über alles using homeopathy as his example, to my referring to this aspect of EBM as “methodolatry,” defined as profane worship of the randomized controlled clinical trial (RCT) as the only valid method of clinical investigation. The problem, of course, with methodolatry, is that it completely ignores prior plausibility, and when that prior plausibility is as close to zero as you can imagine (e.g., for clinical trials of homeopathy), then the only positive results that you see in such trials can reasonably be concluded to be due to noise, shortcomings in trial design, and bias. Unfortunately, a failure to realize this has led to many pointless clinical trials and contributed to the rise of a whole new “specialty” known as integrative medicine, dedicated to “integrating” quackery and pseudoscience into science-based medicine.

So we know that practitioners of “complementary and alternative medicine” (CAM), now referred to more frequently as integrative medicine, don’t like RCTs. They love pragmatic trials, because such trials are usually unblinded, often not randomized, and generally face a lower bar of evidence. That pragmatic trials are intended to test the “real world” use of medical and surgical interventions that have already been shown to be safe and effective in RCTs and that the vast majority of CAM nostrums have not met that standard appears not to concern them in the least. However, CAM practitioners are not the only ones critical of RCTs, as I learned when, via Steve Novella, I came across an article in The New England Journal of Medicine entitled “Assessing the Gold Standard — Lessons from the History of RCTs” by Bothwell et al. Given that the article is two weeks old, I wonder how I missed it. Be that as it may, although Bothwell et al make some good points, I tend to agree with Steve that the overall gist of the article is overly critical, to the point of, as Steve put it, portraying the RCT as broken rather than flawed and advocating revolution rather than reform.
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Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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False balance about Stanislaw Burzynski and his disproven cancer therapy, courtesy of STAT News

Stanislaw Burzynski: 40 years of failure to prove that his antineoplastons are effective against cancer.

Stanislaw Burzynski: 40 years of failure to prove that his antineoplastons are effective against cancer.

One common theme that has been revisited time and time again on this blog since its very founding is the problem of how science and medicine are reported. For example, back when I first started blogging, years before I joined Science-Based Medicine in 2008, one thing that used to drive me absolutely nuts was the tendency of the press to include in any story about vaccines an antivaccine activist to “tell the other side” or to “balance” the story. So in a story on vaccines, on one side you would have Paul Offit, a bona fide, legitimate vaccine expert, and on the other side you would have J.B. Handley, Jenny McCarthy, Andrew Wakefield, or a lesser light of the antivaccine movement. This same trope included stories about autistic children in which a reporter does a human interest story about a family struggling with raising an autistic child in which he lets the parents spout antivaccine misinformation, providing only a brief token quote by a scientist for “balance.” Thus, whether they intended it or not, the reporter would let the emotional impact of the story serve as persuasion to believe the parents’ antivaccine views. So, even though there was not (and hasn’t been at least since 2001 or probably much earlier) anything resembling legitimate scientific controversy over the question of whether vaccines cause or contribute to autism, the press aided the antivaccine movement in keeping alive the appearance of a controversy. It was, as I like to call these things, a manufactroversy, a controversy manufactured by the antivaccine movement to give the appearance of an actual scientific controversy. It’s a time-dishonored journalistic failing that is still a major problem with reporting on, for example, anthropogenic global climate change and genetically modified organisms (GMOs).

Sometimes, however, the press is teachable. A few years ago, after already having blogged about vaccines and autism for several years, I started noticing fewer stories with false “balance” and more stories that simply treated the antivaccine movement like the fringe movement it was, either not bothering to mention it or, if it had to mention it, basically letting scientists explain why it’s bad science and dangerous to public health. These days, false balance and stories that are antivaccine propaganda are relatively rare, aside from stories by fringe journalists like Sharyl Attkisson and Ben Swann. That’s a good thing. Unfortunately, I wish I could say that I really believe it was due to the efforts of skeptics and science advocates more than it was due to the discrediting of a major antivaccine figure, Andrew Wakefield, but even six years after Wakefield lost his medical license and saw his infamous 1998 Lancet paper linking the MMR vaccine to bowel disease in autistic children (the one that ignited the MMR scare in the UK) retracted, I’m not entirely sure. Be that as it may, there still remain blind spots in the press. (more…)

Posted in: Cancer, Clinical Trials, Science and the Media

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Tai Chi versus physical therapy for osteoarthritis of the knee: How CAM “rebranding” works

Tai Chi versus physical therapy for osteoarthritis of the knee: How CAM “rebranding” works

“Complementary and alternative medicine” (CAM), now more frequently referred to as “integrative medicine” by its proponents, consists of a hodge-podge of largely unrelated treatments that range from seemingly reasonable (e.g., diet and exercise) to pure quackery (e.g., acupuncture, reiki and other “energy medicine”) that CAM proponents are trying furiously to “integrate” as coequals into science-based medicine. They do this because they have fallen under the sway of an ideology that posits a false dichotomy: To practice true “holistic” and “preventative” medicine, physicians and other health care professionals must embrace the pre-scientific, pseudoscientific, or anti-scientific ideas about medicine that underlie much of the “alternative medicine” being “integrated.”

Unfortunately, they’ve been largely successful over the last 25 years or so. From my perspective, the strategy that has been the most effective in mainstreaming quack practices as part of “integrative medicine” has been what I like to call the “rebranding” of practices that could and should be part of standard, science-based medicine. I’m referring, of course, to nutrition and dietary interventions, as well as lifestyle interventions, specifically exercise. To the extent that standard medicine might have undervalued such interventions over the past few decades, we practitioners of science-based medicine might be said, to some extent at least, to have brought this on ourselves. On the other hand, it is not as though doctors haven’t been advising our patients to quit smoking and moderate their drinking and to lose weight through altering their diet and exercising more for many decades. We do this because we know it works. For instance, when some naturopathic quack touts “curing” type II diabetes with a vegan diet plus exercise, we know that can work because we know that losing weight can normalize blood sugar values in many cases of type II diabetes. Heck, the Endocrine Society itself even says so, declaring “lifestyle optimization” as “essential for all patients with diabetes” and recommending that all patients with type II diabetes “strive to attain and maintain an optimal weight through a primarily plant-based diet high in polyunsaturated and monounsaturated fatty acids, with limited intake of saturated fatty acids and avoidance of trans fats,” that they lose weight through physical activity, and get enough rest. A vegan diet just takes that dietary advice to an unnecessary extreme, and any supplements recommended are almost always unnecessary.
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Posted in: Clinical Trials, Traditional Chinese Medicine

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Chiropractors, Blind Pigs, and Acorns

Sometimes you need to help the blind pig.

Sometimes you need to help the blind pig.

When people are at the end of their life they like to pass on their life lessons. One thing I have never had a patient say is “Doc, I sure wish I had spent more time at work.”

I try and keep that in mind, but then there are those work commitments that are hard to avoid. I need to have a talk with Drs. Gorski and Novella. No one should have write a blog entry any week their team is in the play-offs. The Blazers were not meant to win more than 25 games, much less be the 5th seed in the West with a chance to make the conference finals. I know. Trailblazers fans are not always grounded in reality. But we are up on the Clippers 3–2 and heading home to close out the series tonight. For the record I wrote the preceding sentence during the game 5 tip-off. I really should not have to do any work this week. Basketball is simply more important.

Take this case report. Anywhere else.

Case reports are a tradition in medicine. Usually they are unique or unusual cases, diseases you are likely to see but once in a career, if that. There are all sorts of medical curiosities that need to be reported. I have a blog over at Medscape devoted to Infectious Disease case reports.

Some case reports, however, inspire eye rolls and sniggers. Why are these even reported? (more…)

Posted in: Chiropractic, Clinical Trials, Humor

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Acupuncture does not work for menopause: A tale of two acupuncture studies

Women looking for relief from hot flashes will be disappointed if they think acupuncture will help them.

Women looking for relief from hot flashes will be disappointed if they think acupuncture will help them.

Arguably, one of the most popular forms of so-called “complementary and alternative medicine” (CAM) being “integrated” with real medicine by those who label their specialty “integrative medicine” is acupuncture. It’s particularly popular in academic medical centers as a subject of what I like to refer to as “quackademic medicine“; that is, the study of pseudoscience and quackery as though it were real medicine. Consider this. It’s very difficult to find academic medical centers that will proclaim that they offer, for example, The One Quackery To Rule Them All (homeopathy). True, a lot of integrative medicine programs at academic medical centers do offer homeopathy. They just don’t do it directly or mention it on their websites. Instead, they offer naturopathy, and, as I’ve discussed several times, homeopathy is an integral—nay, required—part of naturopathy. (After graduation from naturopathy school, freshly minted naturopaths are even tested on homeopathy when they take the NPLEX, the naturopathic licensing examination.) Personally, I find this unwillingness of academic medical centers that offer naturopathy to admit to offering homeopathy somewhat promising, as it tells me that even at quackademic medical centers there are still CAM modalities too quacky for them to want to be openly associated with. That optimism rapidly fades when I contemplate what a hodge-podge of quackery naturopathy is and how many academic integrative medicine programs offer it.

If you believe acupuncturists, acupuncture can be used to treat almost anything. Anyone with a reasonable grasp of critical thinking should recognize that a claim that an intervention, whatever it is, can treat many unrelated disorders is a huge red flag that that intervention is almost certainly not science-based and is probably quackery. So it is with acupuncture; yet, that hasn’t stopped the doyens of integrative medicine at the most respected medical schools from being seduced by the mysticism of acupuncture and studying it. I can’t entirely blame them. I must admit, there was a time when even I thought that there might be something to acupuncture. After all, unlike so many other CAM interventions, acupuncture involved doing something physical, inserting actual needles into the body. However, as I critically examined more and more acupuncture studies, I eventually came to agree with David Colquhoun and Steve Novella that acupuncture is nothing more than a “theatrical placebo.”
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Posted in: Acupuncture, Cancer, Clinical Trials, Traditional Chinese Medicine

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