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Compare and Contrast

I have been in Infectious Diseases for almost 25 years. I have two major jobs: I see inpatient consults and I chair the Infection Control program. I have been involved in quality improvement, especially as it relates to hospital acquired infections, for my entire career. It has been an interesting quarter century. Year after year we have driven down infection rates and other kinds of mortality and morbidity in hospitalized patients. Everyone recognizes that medicine is difficult and dangerous and its biggest problem is medicine is practiced by humans, who, I would venture to observe, are prone to mistakes and any number of cognitive errors.

It has not been a easy journey. People hate change and there has not always been certainty as to the best options to choose to solve a problem, a problem that continues today. For example, how best to treat a patient with potential methicillin resistant Staphylococcus aureus colonization (MRSA). Should we screen everyone? Screen high risk patients? Surgical patients? Do we decolonize, with the long term consequence of accelerating antibiotic resistance? Do we place everyone with MRSA in isolation, with the known decrease in care that patients in isolation may have? Everything we do has potential downsides and unintended consequences. No good deed ever goes unpunished.

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Posted in: Acupuncture, Chiropractic, Science and Medicine

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Of SBM and EBM Redux. Part II: Is it a Good Idea to test Highly Implausible Health Claims?

Review

This is the second post in a series* prompted by an essay by statistician Stephen Simon, who argued that Evidence-Based Medicine (EBM) is not lacking in the ways that we at Science-Based Medicine have argued. David Gorski responded here, and Prof. Simon responded to Dr. Gorski here. Between that response and the comments following Dr. Gorski’s post it became clear to me that a new round of discussion would be worth the effort.

Part I of this series provided ample evidence for EBM’s “scientific blind spot”: the EBM Levels of Evidence scheme and EBM’s most conspicuous exponents consistently fail to consider all of the evidence relevant to efficacy claims, choosing instead to rely almost exclusively on randomized, controlled trials (RCTs). The several quoted Cochrane abstracts, regarding homeopathy and Laetrile, suggest that in the EBM lexicon, “evidence” and “RCTs” are almost synonymous. Yet basic science or preliminary clinical studies provide evidence sufficient to refute some health claims (e.g., homeopathy and Laetrile), particularly those emanating from the social movement known by the euphemism “CAM.”

It’s remarkable to consider just how unremarkable that last sentence ought to be. EBM’s founders understood the proper role of the rigorous clinical trial: to be the final arbiter of any claim that had already demonstrated promise by all other criteria—basic science, animal studies, legitimate case series, small controlled trials, “expert opinion,” whatever (but not inexpert opinion). EBM’s founders knew that such pieces of evidence, promising though they may be, are insufficient because they “routinely lead to false positive conclusions about efficacy.” They must have assumed, even if they felt no need to articulate it, that claims lacking such promise were not part of the discussion. Nevertheless, the obvious point was somehow lost in the subsequent formalization of EBM methods, and seems to have been entirely forgotten just when it ought to have resurfaced: during the conception of the Center for Evidence-Based Medicine’s Introduction to Evidence-Based Complementary Medicine.

Thus, in 2000, the American Heart Journal (AHJ) could publish an unchallenged editorial arguing that Na2EDTA chelation “therapy” could not be ruled out as efficacious for atherosclerotic cardiovascular disease because it hadn’t yet been subjected to any large RCTs—never mind that there had been several small ones, and abundant additional evidence from basic science, case studies, and legal documents, all demonstrating that the treatment is both useless and dangerous. The well-powered RCT had somehow been transformed, for practical purposes, from the final arbiter of efficacy to the only arbiter. If preliminary evidence was no longer to have practical consequences, why bother with it at all? This was surely an example of what Prof. Simon calls “Poorly Implemented Evidence Based Medicine,” but one that was also implemented by the very EBM experts who ought to have recognized the fallacy.

There will be more evidence for these assertions as we proceed, but the main thrust of Part II is to begin to respond to this statement from Prof. Simon: “There is some societal value in testing therapies that are in wide use, even though there is no scientifically valid reason to believe that those therapies work.”

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Posted in: Chiropractic, Clinical Trials, Energy Medicine, Health Fraud, History, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Politics and Regulation, Science and Medicine

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The DC as PCP?

Subluxation-free Chiropractic?

The long-simmering internecine wars among various factions of chiropractic recently reached a full boil when the Council on Chiropractic Education (CCE) had the audacity to eliminate the word “subluxation” from its draft 2012 “Standards for Doctor of Chiropractic Programs.” The CCE is the official U.S. Department of Education-approved accreditation agency for chiropractic colleges. It intends to adopt the revised Standards in January 2011and asked for comment from those affected.

“Totally unacceptable,” is the response of James Edwards, DC, in a recent article in Dynamic Chiropractic entitled “What Is the CCE Trying to Pull?

Perhaps taking up the spirit of this election season, Edwards defines the problem in terms of conservative vs. liberal ideologies: “After beating back and defeating the ridiculous ‘subluxation only, no diagnosis’ position of the extreme right-wing minority of the profession, we are now faced with the equally unacceptable ‘ivory tower’ position of the extreme left-wing minority of the profession.” Later in the article he refers to the proponents as the “left-wing fringe.”
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Posted in: Chiropractic, Legal

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Vaccine Wars: the NCCAM Drops the Ball

If you go to the website of the National Center for Complementary and Alternative Medicine (NCCAM), you’ll find that one of its self-identified roles is to “provide information about CAM.” NCCAM Director Josephine Briggs is proud to assert that the website fulfills this expectation. As many readers will recall, three of your bloggers visited the NCCAM last April, after having received an invitation from Dr. Briggs. We differed from her in our opinion of the website: one of our suggestions was that the NCCAM could do a better job providing American citizens with useful and accurate information about “CAM.”

We cited, among several examples, the website offering little response to the dangerous problem of widespread misinformation about childhood immunizations. As Dr. Novella subsequently reported, it seemed that we’d scored a point on that one:

…Dr. Briggs did agree that anti-vaccine sentiments are common in the world of CAM and that the NCCAM can do more to combat this. Information countering anti-vaccine propaganda would be a welcome addition to the NCCAM site.

In anticipation of SBM’s Vaccine Awareness Week, I decided to find out whether such a welcome addition has come to fruition. The short answer: nope.

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Posted in: Chiropractic, Health Fraud, Homeopathy, Legal, Medical Ethics, Naturopathy, Politics and Regulation, Public Health, Science and the Media

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Uff Da! The Mayo Clinic Shills for Snake Oil

A couple of weeks ago, in a review of the Mayo Clinic Book of Home Remedies, Harriet Hall expressed relief that she hadn’t found any “questionable recommendations for complementary & alternative medicine (CAM) treatments” in that book:

Since “quackademic” medicine is infiltrating our best institutions and organizations, I wasn’t sure I could trust even the prestigious Mayo Clinic.

The Home Remedies book may be free of woo, but Dr. Hall was right to wonder if she could trust the Mayo Clinic. About a year ago I was asked to comment on an article in the American Journal of Hematology (AJH), in which investigators from the Mayo Clinic reported that among a cohort of lymphoma patients who were “CAM” users,

There was a general lack of knowledge about forms of CAM, and about potential risks associated with specific types of CAM…

This suggests the need to improve access to evidence-based information regarding CAM to all patients with lymphoma.

No surprise, that, but I couldn’t help calling attention to the paradox of one hand of the Mayo Clinic having issued that report even as the other was contributing to such ignorance:

The Mayo Clinic Book of Alternative Medicine details dozens of natural therapies that have worked safely for many patients in treating 20 top health issues. You may be surprised that Mayo Clinic now urges you and your doctor to consider yoga, garlic, acupuncture, dietary supplements and other natural therapies. Yet the record is clear. Many of these alternative therapies can help you achieve reduced arthritis pain, healthier coronary arteries, improved diabetes management, better memory function and more.

Mayo Clinic cover

Nor could such a paradox be explained by the right hand not having known what the left was doing: Brent Bauer, MD, the Director of the Mayo Clinic Complementary and Integrative Medicine Program, is both the medical editor of the Book of Alternative Medicine (MCBAM) and a co-author of the article in the AJH.

As chance would have it, I had picked up a copy of the latest (2011) edition of the MCBAM only a couple of days before Dr. Hall’s post. Does it live up to its promises? Do its “straight answers from the world’s leading medical experts” respond to “the need to improve access to evidence-based information regarding CAM?” Let’s find out. In some cases I’ll state the implied questions and provide the straight answers.

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Posted in: Acupuncture, Book & movie reviews, Chiropractic, Energy Medicine, Health Fraud, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Science and Medicine, Science and the Media

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Chiropractic Vertebral Subluxations: Science vs. Pseudoscience

A 1997 publication by the Foundation for Chiropractic Education and Research, supporting the vertebral subluxation theory, noted that “…we [chiropractors] have successfully distanced the concept of a chiropractic subluxation from that of an orthopedic subluxation.”1 When discussing “subluxations” or misaligned vertebrae, however, chiropractors often fail to point out the difference between an orthopedic subluxation and a chiropractic subluxation. Reference to subluxations in medical literature is often presented as support for the practice of chiropractic as a method of adjusting vertebral subluxations to “restore and maintain health.”

In the eyes of the public, the chiropractic vertebral subluxation theory has confused the definition of the word “subluxation,” a common medical term. Unlike the mysterious, undetectable and asymptomatic chiropractic “vertebral subluxation complex” alleged to be a cause of disease, a real vertebral subluxation, that is, an orthopedic subluxation, can be a cause of mechanical and neuromusculoskeletal symptoms but has never been associated with organic disease.

Subluxations: Real and Imaginary

An orthopedic subluxation, recognized and named as such since the days of Hippocrates, is a painful partial dislocation. Simple misalignment of a vertebra, also referred to as a “subluxation,” is commonly caused by disc degeneration, curvatures, spondylolysis, and structural abnormalities. Such a subluxation may or may not be mechanically symptomatic and can be seen on a plain x-ray image. In the absence of pathology such as disc herniation or osteophyte formation, these common vertebral subluxations or misalignments rarely affect spinal nerves and have never been associated with organic disease. Spinal nerves supply musculoskeletal structures. The body’s organs are supplied primarily by autonomic nerve ganglia and plexuses located outside the spinal column and by cranial and sacral nerves that pass through solid bony openings, providing overlapping nerve supply independent of any one spinal nerve that passes between two vertebrae.

An orthopedic subluxation, a true vertebral misalignment, or a mechanical joint dysfunction that affects mobility in the spine is not the same as a “chiropractic subluxation” that is alleged to cause disease by interfering with nerve supply to organs. Such a subluxation has never been proven to exist. There is no plausible theory and no credible evidence to support the contention that “nerve interference” originating in a single spinal segment can cause an organic disease.
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Kaiser Rejects Neck Manipulation

Despite quackademia, anti-vaccine propaganda, and other discouraging trends, the news is not all bad. A major HMO has taken a decisive action in support of science-based medicine. 

Kaiser Permanente Mid Atlantic States and Mid-Atlantic Permanente Group recently announced the elimination of neck manipulation from their chiropractic coverage. The revised policy states,

Given the paucity of data related to beneficial effects of chiropractic manipulation of the cervical spine and the real potential for catastrophic adverse events, it was decided to exclude chiropractic manipulation of the cervical spine from coverage. 

Their decision was applauded by some  but was predictably attacked by chiropractors. (more…)

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Germ theory denialism: A major strain in “alt-med” thought

The longer I’m in this whole science-based medicine thing, not to mention the whole skepticism thing, the more I realize that no form of science is immune to woo. To move away from medicine just for a moment, even though I lament just how many people do not accept evolution, for example, I can somewhat understand it. Although the basics of the science and evidence support the theory of evolution as the central organizing principle of all biology, much of the evidence is not readily apparent to those who don’t make it a calling to study biology, evolution, and speciation. It’s not like, for example, gravity, which everyone experiences and of which everyone has a “gut level” understanding. So, not unexpectedly, when the theory of evolution conflicts with a person’s religious beliefs, for most people it’s very easy to discount the massive quantities of evidence that undergird the theory of evolution. It’s not so easy to discount the evidence for gravity.

In many ways, medicine is similar to evolution, but the situation is possibly even worse. The reason is that much of the evidence in medicine is conflicting and not readily apparent to the average person. There’s more than that, though, in that there are a number of confounding factors that make it very easy to come to the wrong conclusion in medicine, particularly when looking at single cases. Placebo effects and regression to the mean, for example, can make it appear to individual patients that, for example, water (i.e., what the quackery that is homeopathy is) or placebo interventions (i.e., acupuncture) cures or improves various medical conditions. Add to that confirmation bias, the normal human cognitive quirk whereby all of us — and I do mean all of us — tend to remember information that reinforces our preexisting beliefs and to forget information that would tend to refute those beliefs — and, at the level of a single person or even practitioner, it’s very, very easy to be misled in medicine into thinking that quackery works. On the other hand, at the single patient/practitioner level, one can also see evidence of the efficacy of modern medicine; for example, when a person catches pneumonia, is treated with antibiotics, and recovers quickly. Regardless of whether they’re being used to demonstrate quackery or scientific medicine, because personal experience and the evidence that people observe at the level of the people they know can be very deceptive in medicine, science-based medicine, with its basic science underpinnings and clinical trial evidence, is necessary to try to tease out what actually works and what doesn’t.

Medicine does, however, have its version of a theory of evolution, at least in terms of how well-supported and integrated into the very fabric of medicine it is. That theory is the germ theory of disease, which, just as evolution is the organizing principle of biology, functions as the organizing principle of infectious disease in medicine. When I first became interested in skepticism and medical pseudoscience and quackery, I couldn’t envision how anyone could deny the germ theory of disease. It just didn’t compute to me, given how copious the evidence in favor of this particular theory is. It turns out that I was wrong about that, too.

On Friday there was a video released that provides a very clear, succinct explanation of germ theory denialism:

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Posted in: Chiropractic, Naturopathy, Nutrition, Vaccines

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Not to worry! Chiropractic Board says stroke not a risk of cervical manipulation.

Back in January, the Connecticut Board of Chiropractic Examiners held a four-day hearing to decide whether chiropractors must, as a part of the informed consent process, (1)warn patients about the risk of cervical artery dissection and stroke following neck manipulation and (2) give patients a discharge summary listing the symptoms of stroke.1 On June 10th, the Board of issued a written opinion that stroke or cervical artery dissection is not a risk of cervical spine manipulation, so no warning is necessary. Presumably, although it is not specifically mentioned in the decision, no discharge summary is required because, if there is no risk of a stroke after neck manipulation, what would be the point?

Background

Janet Levy and Britt Harwe are two Connecticut women who suffered strokes resulting from neck manipulation by chiropractors. That’s not just their lay opinion, it’s the opinion of their respective treating physicians, right there in the medical records.

Each decided that some good should come of their unfortunate situations, so each formed a non-profit and began warning patients of the risk of stroke following manipulation. Victims of Chiropractic Abuse, Levy’s organization, put giant ads on the sides of busses in Bridgeport, CT., much to the chagrin of the folks at the University of Bridgeport. Within the hallowed halls of the University (Go Purple Knights!) is a College of Chiropractic, a College of Naturopathic Medicine, and the Acupuncture Institute. The chiropractors demanded that the ads be taken down, which got exactly nowhere.

Some chiropractors also began harassing Levy and Harwe, calling them Nazis and KKK members, for example, and threatening their personal safety and that of their families.(What is it with the pseudoscience crowd and calling people Nazis? Perhaps, having used up their entire supply of imagination creating their nostrums, they are reduced to these tired tropes.) The FBI recommended Levy and Harwe have one of the harassers arrested, which they did, and that calmed things down for a while. (more…)

Posted in: Chiropractic, Politics and Regulation

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Professional Integrity for Sale? “Sure,” Says Medscape!

Some chiropractors also practice homeopathy. According to Frank King, D.C., many more should be doing just that:

Homeopathy is an energetic form of natural medicine that corrects nerve interferences, absent nerve reflexes, and pathological nerve response patterns that the chiropractic adjustment alone does not correct. The appropriate homeopathic remedies will eliminate aberrant nerve reflexes and pathological nerve responses which cause recurrent subluxation complexes.

Not only does homeopathy correct nerve interferences, it empowers the doctor of chiropractic to reach the entire nervous system. What this means is that we can now better affect the whole person, and all of the maladies that affect us. Homeopathy’s energetic approach reaches deep within the nervous system, correcting nerve interferences where the hands of chiropractic alone cannot reach. Homeopathy is the missing link that enables the chiropractor to truly affect the whole nervous system!

But that’s not all:

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Posted in: Chiropractic, Health Fraud, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Politics and Regulation, Science and Medicine

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