Evidence-Based Evaluation of Alternative Medicine

Posted on May 3, 2012 by skeptvet

This presentation, originally given as a continuing education talk at Kansas State University, discusses the evaluation of alternative medicine, particularly veterinary alternative practices, from a science-based perspective. It is divided into three parts, and these are available both as the narrated videos below and as Powerpoint slide presentations, which can be viewed with or without the narration.

Part 1. Science Works: How We Go Wrong and How Evidence-Based Medicine Can Set Us Right

The first segment illustrates the limitations of unstructured evaluation, such as personal experience, trial and error, and historical traditions, and introduces the principles and techniques of evidence-based medicine.

Part 1 Powerpoint Presentation

 

Part 2. What is Complementary and Alternative Medicine?

The second part of this series investigates the philosophy and ideology of alternative medicine in preparation for applying the principles and techniques of evidence-based medicine to these practices.

Part 2 Powerpoint Presentation

 

Part 3. Apply a Science-Based Approach to Evaluating Specific Alternative Practices

The final part of the presentation applies a systematic science-based evaluation to several examples of alternative medical approaches, incuding Reiki, Homeopathy, and Probiotics.

Part 3 Powerpoint Presentation

 

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Acupuncture Points: Do They Exist?

Posted on May 1, 2012 by skeptvet

There are many levels at which one can, and should, evaluate a proposed medical treatment. Certainly, high level and high quality clinical trial research is likely to be the deciding factor for many interventions. But another important thing to look at, especially when interpreting mixed results or generally poor quality clinical trials, is the underlying mechanism proposed for a therapy. If it contradicts well-established science or cannot be convincingly demonstrated to be correct, this raises the bar even higher for clinical research evidence.

When it comes to acupuncture, the clinical research evidence is vast and highly variable in terms of quality and results. Overall, the preponderance of the evidence seems to support the conclusion that acupuncture is not superior to placebo treatment and exerts very broad, non-specific physiological effects indistinguishable from other kinds of mild traumatic or irritating stimulation (e.g. 1, 2, 3).

One way to help decide whether extensive further efforts to sort out potential clinical benefits of acupuncture through expensive and laborious clinical trials is to look at the potential justifications for why the practice might or might not be helpful. Obviously, anecdotes and testimonials are the primary reason people believe in the usefulness of acupuncture despite the lack of strong support from clinical research. However, these are only useful in generating hypotheses in medicine, not in proving or disproving them. Every therapy every used has been able to claim anecdotal evidence of an effect, and since it’s clear that many therapies turn out not to actually work when objectively studied, reliance on anecdotal evidence is a big mistake.

There are a couple of ways to approach the theoretical explanation of possible mechanisms for acupuncture. The traditional explanations are purely vitalistic. Mystical life energy (Ch’i) that is undetectable by scientific means, explanations about balancing non-physical, spiritual concepts such as Yin and Yang, metaphorical explanations involving Heat, Cold, Damp, Wind and so on are all part of the theoretical structure many practitioners use to explain and justify so-called Traditional Chinese Medicine, including acupuncture. These explanations are part religion, part folklore, and no scientific examination suggests they have any physical reality or any relevance to health and disease as it is understood in scientific medicine. Employing such explanations makes one’s practice essentially a religious rather than a medical one.

However, other acupuncture advocates claim a solidly scientific explanation for the proposed effects of acupuncture, involving identifiable anatomic structures, such as nerves, biochemical effects involving substances naturally produced in the body, and so on. This is a more promising theoretical approach, but despite some effort, there is not yet a consistent and convincing body of evidence to validate the clinical practice of inserting needles in specific locations (with or without twirling them, burning herbs on them, passing electrical current through them, and all the other varieties of acupuncture seen) in order to effect health. Putting needles in animals undoubtedly has some measurable physiological effects. But whether these are specific, predictable, controllable effects that have a meaningful impact on health is not established.

One question that has been investigated many times is whether the supposed acupuncture points, specific locations on the body where insertion of needles is proposed to have a particular effect, can be consistently identified by acupuncturists or associated with identifiable anatomic structures.  Even among those who believe acupuncture to be clinically useful, there is controversy about whether specific locations for needle insertion are real or necessary (e.g. 3), and of course some acupuncturists argue that acupuncture points do not need to correspond to identifiable anatomic or functional locations since they follow the vitalist model in which the focus of acupuncture is on the Ch’i rather than the body per se.

There are some scientific papers that purport to identify real structures or other measurable characteristics at some traditionally used acupuncture points. Many of these reports come from China, where negative studies about acupuncture (or other alternative therapies) are almost never published, so the potential for bias in this source has to be considered. A review of the literature presented at the 2000 meeting of the American Association of Equine Practitioners by veterinarian David Ramey found no consistent body of scientific evidence to support the notion of specific identifiable functional or anatomic acupuncture points. A recent paper seems to add support to this conclusion.

A.F. Molsberger, J. Manickavasagan, H.H. Abholz, W.B. Maixner, H.G. Endres. Acupuncture points are large fields: The fuzziness of acupuncture point localization by doctors in practice. Eur J Pain. 2012 Apr 10 [Epub ahead of print]

This study took the approach of testing whether properly trained and experienced acupuncturists could consistently identify commonly used acupuncture points on a single patient. Twenty-three common points were selected and identified by the 71 test subjects. The area within which specific points were identified by 95% of the acupuncturists ranged from 2.7cm in diameter to 41.4cm in diameter.  Because of the variability with which experienced acupuncturists identified common acupuncture points, the authors concluded that to stimulate fake points as a placebo control for a clinical trial, it would be best to stimulate the skin at least 6cm away from the spot identified as the real point on the face or hands and at least 12cm away from a proposed real spot anywhere else on the body.

Of course, the authors are acupuncturists and so must find a way to interpret these results that is supportive of acupuncture as a therapy. Their conclusion is that it would be more meaningful to talk about “acupuncture fields” rather than acupuncture “points.” Since the variance in the size of the area within which supposed points were identified was not associated with the experience or training of the doctor, and could not have been associated with individual differences between patients since the same patient was examined by all the doctors, it seems more reasonable to interpret the results as indicating that no specific locations associated with traditional acupuncture points can be reliably identified even by trained acupuncturists. Likely, such points don’t exist as anatomical or functional entities, especially given the lack of convincing and consistent evidence for their existence despite decades of study.

This by itself does not invalidate acupuncture as a clinical practice. However, it has bearing on the study and evaluation of acupuncture. Many studies using supposed “sham” acupuncture points may now be reinterpreted. Acupuncturists will likely interpret these results to mean that the lack of difference between effects in groups where “real” acupuncture points were used and those in which “sham” points were used is actually due to the fact that both groups benefitted from stimulation in the same “acupuncture fields.” Skeptics like myself are more likely to view this as indicating that “sham” acupuncture points are not a legitimate placebo control since specific acupuncture points can’t even be shown to exist, and so trials comparing real and fake points are simply poorly controlled. In any case, it suggests that if the central tenet of most acupuncture treatment, stimulation of the body in specific locations, is invalid because even acupuncturists don’t know where these locations are, then the concept of acupuncture as a meaningful therapy is even less convincing.

Posted in Acupuncture | 3 Comments

More Misleading and Unethical Advertising for Alternative Veterinary Medicine

Posted on April 27, 2012 by skeptvet

I’ve written before about the unethical and misleading negative advertising that so often characterizes the promotion of alternative veterinary medicine. But I ran across another example that set my teeth on edge and illustrated a particular problem I have with this kind of thing.

Dr. Karen Becker, a prominent CAVM vet who writes for one of the most notorious sites promoting quackery through denigrating conventional medicine, Mercola.com, recently blogged about the much-reported decline in veterinary office visits. In this article, she makes a number of assumptions for which there is little or no evidence, and several accusations about the inadequacy of conventional veterinary care.

The accusations essentially amount to saying that conventional medicine ignores preventative care apart from given vaccinations and selling pest-control products, both of which Dr. Becker frequently cites as significant health hazards for our pets.

Perhaps a reason for fewer vet visits is the new canine vaccination guidelines which will hopefully put an end to the dangerous and unnecessary practice of yearly re-vaccinations.

I suspect another reason (aside from today’s tough economic climate), is because many traditionally trained DVMs practice ‘reactive’ veterinary medicine.

This means they don’t have much to offer pets unless and until they’re good and sick…

…preventive medical care in the mainstream veterinary community has evolved to mean not much more than yearly vaccines and chemicals to discourage pests and parasites like fleas, ticks and heartworm.

There is rarely discussion between vets and pet owners about nutrition (because vet students receive almost no education in the subject), exercise and other physical therapies, or the importance of a strong, resilient and balanced immune system.

This also raises the cliché about conventional veterinarians being ignorant in the area of nutrition, which is nonsense. The definition of ignorance most likely meant here, is simply a failure to agree with specific theories about what constitutes a healthy diet, including the unsubstantiated beliefs often promoted about the benefits of raw diets, the dangers of grains, and so on.

This then leads to the suggestion that alternative veterinarians do a better job of preventative care, because they promote “wellness” therapies.

For some reason the methods used to maintain a pet’s vibrant good health – everything from species-appropriate nutrition to maintenance chiropractic care to homeopathic remedies and herbal supplements – fall into the category of ‘alternative medicine.’

Isn’t it strange that natural modalities used not to cure illness (although they do that, too), but to maintain health are thought of as ‘alternative,’ yet chemical drugs and invasive surgery are considered mainstream health care?

Actually, it isn’t strange at all. There is no reliable scientific evidence for the preventative health benefits of maintenance chiropractic care, homeopathic remedies or herbal supplements. These products are touted as “wellness” care based solely on the personal beliefs of the vets who use them and the beliefs of previous generations of vets and animal owners. This is the same level of evidence that has supported such winning strategies as bloodletting, purging, and animal sacrifice as preventative health measures.

What is strange is that someone with medical training can so blithely denigrate preventative and therapeutic methods proven to work and wonder at the failure of mainstream medicine to accept without proof her belief that these alternative therapies are better.

I recommend twice yearly wellness examinations to my Natural Pet clients.

A thorough nose-to-tail professional checkup every six months is the best way for you and your vet to detect and stay on top of any changes in your pet’s health. This is especially true for older pets.

This is undoubtedly great for the bottom line, but again there is no evidence that biannual or annual wellness examinations recommended for all pets is an effective or efficient strategy for preventing disease or extending length and quality of life. In humans, the evidence in fact is building against the value of annual exams for well people. There is no evidence either way in veterinary medicine, so while I myself think it likely that regular examinations could have some benefit, there is no objective reason for a strong recommendation of this kind. And certainly such visits are not a substitute for the “chemical drugs” and vaccinations that have been far more effective than any other measure and reducing disease and preserving health in our companion animals.

…Proactive vets are typically obsessive about clinical pathology…most proactive vets recommend annual vector borne disease testing instead of waiting until lyme disease has set in, causing incurable auto-immune polyarthritis.

This is a completely irrational and baseless recommendation. Screening tests without an appropriate reason for doing them waste money and cause far more harm than they prevent. There is a strong movement in human medicine now to reduce exactly this kind of misguided thinking. So to imply that the care such alternative vets provide is superior to that of conventional veterinarians because the former recommend unproven preventative measures and unnecessary testing is misleading and unethical. Given the complaints so often made by CAM vets about the purported financial motivation behind many mainstream practices, it is quite ironic that this sort of advertising promotes far more aggressive, and likely expensive, use of approaches with no proven value.

 

 

 

 

Posted in General | 47 Comments

Credulous, Superficial Media Coverage of Veterinary Alternative Medicine

Posted on April 26, 2012 by skeptvet

The media loves to run cute human interest pieces on alternative medicine for animals. Reporters are seldom interested in the complexities or nuance of the evidence, but they love the warm, fuzzy, and slightly humorous image of alternative medicine applied to pets. In the name of “balance,” they usually include a quote from a token skeptic, though this is generally buried in an avalanche of quotes from CAM supporters, and often is edited and positioned to seem as unconvincing and unsympathetic as possible.

More and more often, I’m being asked to be that token skeptic. It’s not a very satisfying role, since the chances are slim of seeing a final article that reflects the reality of veterinary CAM as a marginalized practice with little convincing scientific evidence behind it. Still, presumably having even a sanitized token skeptical voice in these pieces is better than having none. Right? Hmm, well I hope so anyway.

Here are a couple of examples.

This piece from New York Magazine, preciously titled Dogupuncture, includes 4 positive quotes, 1 negative quote, and a graphic right up front purporting to show the rising popularity of acupuncture among vets. Out of all that I have written about acupuncture, the quote chosen was the conclusion from a systematic review which concluded there was insufficient evidence to reach a conclusion!

I have added a comment to give at least a bit of a response to some of the inaccurate implications of the pices, but that will likely only draw more angry responses from “satisfied customers” of veterinary acupuncture, rather than start a substantive discussion of the evidence.

The claim of ancient veterinary acupuncture is false: http://skeptvet.com/Blog/2010/07/the-history-of-ve… And it’s irrelevant anyway since bloodletting and slavery have been around as long or longer, and that doesn’t make them good ideas.

Even though animals don’t have beliefs about their care, there are absolutely placebo effects in veterinary care. The simplest is the Placebo by Proxy, in which the owner or vet thinks the pet is better because they want or expect it to be, and after all they are the ones who decide if the pet looks like it feels better. There is also Regression to the Mean, the Hawthorne Effect, Classical Conditions, Non-Specific Effects of Human Contact and many other factors that make bogus therapies look like they work.

Even in humans, acupuncture has not been shown to be more effective than fake acupuncture, and the evidence is even weaker in animals. (http://skeptvet.com/Blog/category/acupuncture/)

The bottom line is that belief in acupuncture, the popularity of acupuncture, and the length of time people having beein using acupuncture are all meaningless in terms of deciding whether or not it is useful. And despite decades or trying and a huge number of studies, scientific evidence still hasn’t shown it to be any better than placebo in controlled trials.  So the strength of the evidence for acupuncture is no better than that for faith healing, psychics, bloodletting, and lots of other healthcare practices that lots of people have believed in for a long time.

Unfortunately (for our pets), these things last because we so easily fool ourselves, and unreliable personal experiences are far more compelling emotionally than scientific data.

I’ve written previously about a Veterinary Practice News article on the Academy of Veterinary Homeopathy lawsuit against the American Association of Veterinary State Boards. It too is an example of a clearly one-sided piece with a token skeptic selectively cited in order to portray the skeptic position as weakly as possible.

The Veterinary Practice News reported on this lawsuit in early August. In a roughly 2000 word article, the author extensively quoted five supporters of homeopathy and of the lawsuit. She also quoted an official at the AAVSB who was not free to comment on pending litigation. And finally, she interviewed me for the article as the sole critic of the AVH position.

I was quoted as saying that homeopathy was not a science-based intervention, which is accurate. I was also quoted as saying that, “Alternative medicine providers are often better at treating psychological aspects of a medical incident an owner is dealing with, and there’s no doubt they are caring and compassionate…”This is partially correct in that I did acknowledge that alternative practitioners are undoubtedly as caring and compassionate as other veterinarians, but it misrepresents the point I was making that the reason methods like homeopathy are popular with a small percentage of the pet-owning public is not because they actually work but because of the psychological effects, essentially a placebo-by-proxy, that the interaction with the practitioner has on the owner.

Lastly, I was quoted as saying that, “these therapies are not taught in veterinary schools.” This is followed by a “gotcha” list of veterinary schools that offer elective courses in “integrative medicine” or have “holistic medicine” student organizations. This is clearly intended to undermine the credibility of my comments. However, this is again a manipulative misrepresentation of my position.

Homeopathy is clearly not part of the core veterinary curriculum, nor is it generally accepted as a valid approach to medicine at U.S. veterinary colleges. The AVH does not dispute this in their complaint. And of the four veterinary schools (out of 28 in the U.S.) mentioned in the article as having “elective courses in CAVM or integrative veterinary medicine,” I could not find any that actually do have a course in homeopathy, though CSU does offer an elective called “Critical Overview of Complementary and Alternative Medicine” taught by Narda Robinson, who is a vocal critic of homeopathy. It is possible, of course, that a couple of schools do have credulous individuals on faculty who teach that homeopathy is scientifically legitimate, but if so these represent a rare minority opinion which is discounted by the overwhelming majority of veterinary scientists. The article was a barely disguised propaganda piece for the AVH position with only a superficial nod towards the idea of journalistic neutrality.

There are a few other similar pieces I’ve been involved with that haven’t come out yet, but only one that I expect may be of higher quality than the usual sort like these.

Perhaps it’s the intrinsic character of the subject matter. Alternative medicine presents a simplistic and comforting face, and science is naturally complicated, ambiguous, and seemingly hypercritical. Or perhaps it’s the declining number of well-trained reporters specializing in science-journalism. After all, most veterinary stories appear in the Lifestyle section of magazines and newspapers, where the standards are lower than in the science, health, or news sections. In any case, as long as even a token skeptical voice is included, perhaps this will at least offer some comfort to those who value the messy truth over a good story.

Posted in General | 8 Comments

Veterinary Orthopedic Manipulation (VOM)-A Familiar Tale of Quackery

Posted on April 23, 2012 by skeptvet

The hallmark of classic medical quackery is the lone genius proclaiming the discovery of a radical new approach to healing that is simple, perfectly effective, and perfectly safe. This magical new therapy, described in impressive scientific terminology invented from scratch for the purpose, would revolutionize medicine if not for the sinister individuals and institutions of conventional medicine suppressing the good news about it. Fortunately, published research demonstrating the safety and efficacy of such innovations isn’t necessary anyway, because the proof is in all the happy stories the inventor can tell about his own successes.

While I’ve posted several lists of warning signs of quackery (1, 2, 3), and discussed a number of individuals and companies whose marketing activities exemplify some of the specific signs on these lists (such as Eric Weisman, Gloria Dodd, Nzymes.com, and others), seldom have I seen such a paragon of quack medical self-promotion as Dr. William Inman’s Veterinary Orthopedic Manipulation and Laser Therapy Roadshow.

I became aware of this operation through a direct mail solicitation to attend a training workshop in Dr. Inman’s special style of cold laser therapy. I’ve written about cold laser before, and the bottom line is that while there is some plausibility to the idea that low-frequency lasers might have beneficial effects, based in preclinical research, the clinical trial evidence is mixed and inconclusive in humans and non-existent in veterinary medicine. So no firm conclusion about the efficacy of this treatment is justified by anything more than speculation and anecdote. Despite Dr. Inman’s revolutionary new “Chaos Conversion Therapy” (a term he apparently invented, since I can find no other use of it) that has apparently made lasers even more effective for allergies, endocrine disease, and cancer, I was not tempted to attend. I was also not tempted to write a post about it, until I checked out his website.

Apart from having apparently devised a whole new theory to dramatically improve the effectiveness of the questionable practice of cold laser therapy, Dr. Inman has made great strides (and a good deal of money) reinventing the even more questionable chiropractic theory of subluxations and devising an entirely way to waste your time and money banging on your pet to cure every imaginable ill caused by this imaginary abnormality.

According to his web site:

Veterinary Orthopedic Manipulation (VOM) is a healing technology that locates areas of the animal’s nervous system that has fallen out of communication, and re-establishes neuronal communication and thus induces healing. VOM is singularly the most simple, effective and safe healing modality in veterinary care to date.

Wow, sounds cool! So what can it fix? Well, apparently almost any musculoskeletal, gastrointestinal, glandular, or behavioral problems, ear infections, allergies, and just about anything else.

And how does it work? This is the fun part. Some proponents describe it as simply a variation of veterinary chiropractic, in which the imaginary vertebral subluxation complex interferes with either nerve conduction or the mysterious spiritual force known as innate intelligence, thus causing disease in almost any body system. This disease is supposedly treated by “adjusting” the spine to fix the undetectable subluxation and restore the body’s natural state of health. Apart from some evidence that chiropractic is about as useful for back pain as other kinds of physical therapy, over a century of research has failed to document the subluxation or any other benefits to this therapy.

This lack of evidence hasn’t much hampered the work of chiropractors in human or veterinary medicine. However, selling just another variant of chiropractic apparently isn’t good enough for Dr. Inman. He even went so far as to found his own organization, the International Association of Veterinary Chiropractitioners, and  according to his web site:

Is Veterinary Orthopedic Manipulation (VOM) chiropractic care?

No! VOM exists in between veterinary medicine and chiropractic care. It has similarities to some of the chiropractic modalities and functions by restoring function by reducing “subluxations” as is done in chiropractic care. It uses a hand-held device that is used in a popular human chiropractic technique called “Activator Methods” but it is not to be confused with that technique. The differences between VOM and Chiropractic care are significant and distinct.

VOM exists in a gray area between both professions (Veterinary and Chiropractic) and benefits from the positive aspects of both, a hybrid, and thus more effective than either by themselves.

Ah, so it is neither chiropractic nor veterinary medicine, and naturally this means it’s better than either one. (?!) In an article on the subject Dr. Inman published in the Journal of the American Holistic Veterinary Medical Association, he expands on his notion of the subluxation.

The location of the subluxation phenomenon is not the nerve or the bone, but it is the neuronal interference that exists at the interneuron of the dorsal horn of the facilitated spinal segment. 

It cannot be seen on x-ray, cannot be imaged by ultrasound or MRI, but can be readily demonstrated with the application of a simple diagnostic protocol using a hand-held device….

Subluxation is only a switch that can potentially be turned back on. This is simply done by providing adequate force to the interneuron through the mechano-receptor inputs into the dorsal horn. (Please see diagram). Note: this is mechano-receptor force, not motion, thus the process is inherently safe and amazingly effective.

…Thus 100% of all subluxations can easily and objectively be located and evaluated using the VOM Diagnostic Technology and neurological subluxation signs.

…The VOM Diagnostic Technology is amazingly accurate. Diagnostic reading patterns are demonstrable weeks to years before radiographic and other diagnostic technique will verify.

Now any medical approach which fixes a problem that cannot be detected except by the special methods of that approach and that does so with perfect accuracy, absolute safety, and “amazing” effectiveness is by definition either a miracle or bullshit. It would seem likely that if this one was in the miracle category, it would have succeeded in replacing the rest of veterinary medicine in the 30-odd years since Dr. Inman claims to have begun developing the technique in 1982. Certainly, many revolutionary new medical practices have gone from ridicule to dominance in that amount of time. But Dr. Inman has some thoughts on both the fact that VOM sounds too good to be true and why it hasn’t achieved the recognition it deserves.

How can VOM be that easy?

Why not? Who says that a healing modality has to be complicated, difficult and expensive? Who says it should take hundreds of hours to learn and perfect? A technology that goes to the root of the problem, a simple technology that relies on the animal’s innate ability to heal itself, one that re-establishes communication with the pet’s ability to heal itself, will be easy, powerful and effective. 

Why haven’t I heard of the VOM Technology before?

Because it works! That may not make sense at first, but consider this: if the VOM Technology does what it appears to do, it makes a lot of techniques, surgeries and medications obsolete. The professionals that provide those techniques, surgeries and medications will be placed in academic and financial jeopardy. These are the people that control publications in the field and control licensure and applications. AKA politics.

Ah, of course, the Dan Brown Gambit, in which a vast conspiracy suppresses the miraculous truth out of fear and greed. Sure.

So what sort of evidence is offered for the quite grandiose claims made for VOM? As usual, pseudoscientific ramblings based on bogus theories and piles of anecdotes, which (as Dr. Mark Crislip has pointed out in a different context) don’t become evidence by force of numbers any more than piles of cow dung become gold when enough is collected. VOM is apparently a one-man vision with no need for input from science or any formal clinical research.

VOM was developed in a vacuum, meaning it was developed with a trial and error approach in a clinical setting without input from other sources. Dr. William Inman has been the sole source of the VOM Technology.

Over the past 18 years and represented by over 45,000 clinical cases (on file and available on computer) the patterns for over 250 disease conditions have been recognized and tested for reliability.

Wow! One doctor, 45,000 clinical cases, and not a single published clinical trial. Why is that again? Oh yeah, the obstinate oppression of the medical establishment. Uh huh.

Well, at least VOM is an efficient form of quackery and easy to learn. As Dr. Inman points out,

Unlike AVCA certification and instruction that takes 150 hours and five modules to complete, a veterinary Chiropractitioner (VCP) can adequately apply VOM after a “VOM Small Animal Module One” seminar attended in their home town in a weekend.

Apparently, Dr. Inman no longer practices so he can devote himself to teaching:

In 1996 he began teaching the VOM, VMR, Somato-Visceral, and Myofascial Release fulltime in lieu of clinical practice. Currently he is not licensed in any jurisdiction and limits his efforts to teaching only. He does not consult on specific cases as that infers clinical practice.

Of course, this might have something to do with his history of legal troubles:

The license of Dr. William Inman, Seattle veterinarian, has been suspended for a minimum of five years and he has been fined $10,000 by the state Department of Health’s Veterinary Board of Governors…The board found Inman displayed “incompetence, negligence or malpractice”….The action is believed by longtime veterinarians to be the harshest ever taken in this state.

Dr. Inman has maintained that the Board identified his technique as safe and effective even while disciplining him for other reasons. However, news reports claim, “The board in its report, however, made “no conclusion” whether the technique was improper conduct.”

And the record of his appeal of the veterinary medical board case indicates:

The Board found twelve violations, four of which are not at issue on appeal: the failure to keep adequate records; unprofessional conduct in failing to perform a proper work-up on a cat named Mickey; surgery that did not conform to the appropriate standard of care; and misrepresentation to Mickey’s owners that veterinary orthopedic manipulations were effective when Dr. Inman should have known they were not.

The appeals court affirmed the veterinary medical board’s findings and after a review of the procedures found the judgment and punishment appropriate. These findings include gross misconduct including deliberately encouraging staff to falsely identify parasites patients did not actually have and giving medications and vaccinations in clearly inappropriate circumstances. Apparently, unable to practice conventional medicine appropriately, Dr. Inman chose to invent his own alternative approach to healthcare and sell that instead.

Of course, Dr. Inman and his supporters will undoubtedly dismiss my criticism and his legal troubles as mere vindictive attacks by those threated personally and financially by his revolutionary invention. And undoubtedly many anecdotes will be presented from satisfied pet owners and veterinarians convinced that VOM works wonders and that Dr. Inman is unjustly accused.

But the pattern seen in this case is strikingly similar to that seen in the other examples of snake oil salespeople I have discussed here. Lone misunderstood genius offers revolutionary therapy supported by theories inconsistent with established science and anecdotes. This therapy makes money and converts but is either not tested in any formal scientific way or fails such testing. Lone genius is undeterred and continues practicing. Said genius then persecuted by the establishment and accused of gross misconduct or incompetence unrelated to revolutionary invention and switches from clinical practice to full-time promoter of said revolutionary practice. Supporters claim genius is misunderstood martyr and critic are frightened, greedy, or just plain mean.

One has to wonder whether this pattern can be said to indicate the seemingly obvious: Each of these people is either deluded or deliberately deceiving the public, and the reason their therapies are not accepted with adulation by the mainstream is because there is not good reason to think they work. Isn’t this more likely than the alternative the each and every one of them has discovered something original and miraculous that should be accepted widely without any proof beyond their say so and the testimonials of their clients?

Posted in Chiropractic, General, Law, Regulation, and Politics | 18 Comments

What’s in Chinese Medicine? New DNA Study Finds Some Unpleasant Answers.

Posted on April 15, 2012 by skeptvet

The lack of effective regulation covering herbal remedies and dietary supplements is well-known. The General Accounting Office has warned Congress about the widespread deceptive and illegal marketing of such remedies. And there are numerous studies which illustrate the potential dangers of unregulated and inadequately tested herbal products. Apart from the issues that such remedies are often put together on the basis of unscientific mythological understandings of health and disease, or that they are marketed on the basis of the naturalistic fallacy, the notion that such remedies can be viewed as “natural” and so are automatically safe, and that they are seldom rigorously evaluated through adequate pre-clinical and clinical trial testing, one big problem with herbal and other Chinese Medicine products is that practitioners and patients often don’t even know what they contain.

For example, I’ve written previously about Yunnan Paiyao, which is supposed to control bleeding, both topically and systemically. Many preparations of this product don’t even list an active ingredient. I cannot imagine most people being willing to take a medicine when the manufacturer refused to disclose the ingredients, but the same sensible caution doesn’t always seem to be applied to herbal products.

Of course, many Traditional Chinese Medicine products do list their ingredients, but given the problems with label accuracy for other unregulated alternative remedies, such as probiotics, some skepticism about the accuracy of these labels seems warranted. An objective method for determining what such remedies actually contain would be a good start in evaluating their quality control and the potential for harm from undisclosed ingredients.

Some studies have looked at chemical components, including undisclosed pharmaceuticals and heavy metals. A recent pilot study has taken a different approach, trying to identify the plant and animal ingredients through identification of DNA found in the products.

Coghlan ML. Deep sequencing of plant and animal DNA within traditional Chinese medicines reveals legality issues and health safety concerns. PLOS Genetics. 2012;8(4):e1002675.

The authors looked at 28 samples of TCM products seized by the Australian customs service and were able to identify plant and animal components of 15 products. One of the methodological problems with this approach is that databases of DNA sequences, particularly for plants, are not yet sufficiently extensive to allow precise species-level identification of many plants. However, these databases are growing rapidly, and the precision of this technique is likely to be excellent as the reference resources improve.

Examples of the usual sorts of concerns did surface in the study. Plants with known toxic properties were identified in 4/15 samples, including Ephedra, and Asarum, a potential source of aristolochic acid, which is a TCM ingredient known to cause kidney failure and   urinary tract cancer. The authors did not evaluate the samples to determine if these toxins were actually present, though they indicated that combining such standard chemical analysis with their DNA sequencing approach would be the optimal way to evaluate such products.

The study also identified DNA from known endangered species of both plants and animals, including bears and Saiga antelope. TCM remedies made from parts of endangered species are a significant environmental problem which is particularly infuriating since there is no reasonable evidence to suggest the inclusion of these ingredients has any actual health benefit. Sympathetic magic and other mythological foundations for such practices are not legitimate reasons to contribute to the threats to endangered animal and plant species.

Finally, the study identified significant mislabeling. 78% of the samples contained DNA for species of animals not listed on the label. Sheep, goats, water buffalo, and cows were found, among other species, and these likely represent adulteration with cheaper, easier to acquire ingredients replacing traditional ingredients such as those from bear and Saiga antelope. While this may reduce the risk to such endangered species, one can hardly approve of substituting animal products with no demonstrated health effects for other animal products with no evidence of health benefits and then not even honestly labeling the products.

Though this particular study looked at a very limited selection of remedies and only identified a relatively small set of ingredients, it demonstrates both that such methods can be useful in identifying the true constituents of TCM products and also that these products can contain ingredients that are toxic, that come from endangered species, or that aren’t listed on the labels. Such problems aren’t likely to improve without meaningful regulations requiring thorough and accurate labeling, independent monitoring of compliance with label regulations, and ideally requirements for reasonable evidence of safety and efficacy before the products can be marketed at all. Unfortunately, none of these sensible requirements seem likely to be put in place any time soon.

 

Posted in Herbs and Supplements | 4 Comments

Choosing Wisely: Physicians Take a Stand Against unecessary Tests and Treatments

Posted on April 9, 2012 by skeptvet

The subject of unnecessary diagnostic testing is a contentious one that I’ve addressed here before (Overdiagnosis, Screening Tests). In human medicine, the government provides evidence-based guidelines for preventative healthcare interventions, including screening tests, through the U.S. Preventative Services Task Force (USPSTF). While being mostly ignored, this agency occasionally draws great controversy when challenging the classic American myths that More is Better and Statistics Don’t Matter. For example, after concluding that the evidence didn’t support routine screening mammography for as many women as had previously been told to have it done, the USPTF revised the screening guidelines. This generated a media conflagration on the scale of the Culture Wars, and led to a bunch of lawyers and politicians with remedial science knowledge passing legislation directing the government to ignore the evidence. Fortunately, other recommendations for less widespread screening for prostate cancer and cervical cancer have been greeted with less hysteria.

Still, the idea that unnecessary screening tests hurt more people than they help is a tough sell to those who don’t understand the complexities of reliability, validity, predictive value, and other factors involved in evaluating the risks and benefits of disease screening. Anecdotes about individuals who had a potentially serious disease detected by screening and believe that the subsequent treatment saved their lives are very compelling. They seem to get more coverage and have more impact than stories about people harmed by unnecessary treatment after detection of lesions that likely would never have caused them any problem. Nevertheless, unnecessary diagnostic tests not only cost a lot of money, reducing the resources available for providing necessary healthcare, but they also do harm many individual patients who are forced to go through unneeded secondary testing or treatment for diseases that either don’t exist or would never have made them ill.

A new organization of physicians has been formed to try and educate both clients and doctors about this problem and to make sound, evidence-based recommendations about diagnostic testing. Choosing Wisely has gotten a fair bit of media coverage lately for promoting lists of specific procedures that are often done unnecessarily, and for suggesting that these only be done when certain criteria are met. The lists also address some therapies which may be unnecessary, including the ever-popular excessive and inappropriate use of antibiotics.

These lists have generally avoided particularly controversial subjects, and so far haven’t been greeted with the panic that some of the USPSTF recommendations have. Hopefully, the effort will have some impact on physician behavior and consumer expectations. And once the organization and its approach is familiar and gains some credibility, perhaps they will be able to take on more controversial subjects, such as the lack of evidence to support annual physical examinations in adults without symptoms of illness (or even CAM therapies and tests not supported by evidence?).

 

 

Posted in General | 13 Comments

New Review Finds Little Evidence that Nutraceuticals Help Animals with Arthritis

Posted on March 27, 2012 by skeptvet

I have written extensively about various supplements and herbal treatments for arthritis. For the most part the evidence seems weak for all of these products, though there are a couple of suggestive studies that might lead to demonstrably effective treatments someday. I have also talked about the need for application of rigorous, explicit evidence-based medicine techniques (EBM) in veterinary medicine. A recent paper in the Journal of Veterinary Internal Medicine does an excellent job of illustrating EBM methods, and its subject is the use of nutraceutical for treatment of osteoarthritis in animals.

J.-M. Vandeweerd, C. Coisnon, P. Clegg, C. Cambier, A. Pierson, F. Hontoir, C. Saegerman, P. Gustin, S. Buczinski. Systematic Review of Efficacy of Nutraceuticals to Alleviate Clinical Signs of Osteoarthritis. Journal of Veterinary Internal Medicine. 2012. Epub ahead of Print.

The authors adapted the CONSORT statement and recommendations from the Centre for Evidence-Based Medicine at Oxford to design an explicit and detailed scoring sheet for research trials involving nutraceuticals for osteoarthritis. This sort of transparency, and establishing criteria for grading evidence in advance, are important aspects to an evidence-based review, which help to minimize the potential impact of personal bias on the results.

The authors then conducted a thorough literature search for articles in English and French that concerned the use of common nutraceuticals in arthritis treatment. A total of 67 articles were found, of which 22 met the inclusion criteria of the review (controlled clinical trials evaluating clinical signs of pain or locomotion). The literature search terms are presented in the report in a way that makes replicating the search straightforward.

An exhaustive evaluation of these 22 studies was then conducted, with a grading of the quality of evidence for the following nutraceuticals:

Glucosamine
Chondroitin Sulfate (various forms)
Undenatured Type II Collagen
Avocado and Soybean
Gelatine Hydrolysate
Omega-3 Fatty Acids (aka fish oil)
Hydroxycitric Acid
Green-Lipped Mussel Powder
Special Milk Protein Concentrate
Indian and Javanese Turmeric
Various combinations of these ingredients and such as manganese, vitamins, amino acids, chromium, and more

The conclusions were quite straightforward:

The strength of evidence was low for all nutraceuticals except for omega-3 fatty acid in dogs…The evidence of efficacy of nutraceuticals is poor, with the exception of diets supplemented with omega-3 fatty acids in dogs.

The authors also touched on many of the limitations of the available literature, not only the small numbers of studies and subjects, but the lack of replication, the tendency for all the research on a single subject to come from one researcher or research group, the lack of motivation for studies given the lack of effective regulation of dietary supplements and many others.

This is an excellent example of the application of EBM methods to veterinary questions. While the available evidence is often limited in quantity and quality, we need to critically appraise what there is in order to make the best clinical decisions. I think the methodology used in this paper is a model for how such reviews can be conducted and how they can be useful to general practitioners.

My only quibble was with the conclusion the authors reached concerning fish oils. I have previously reviewed three of the four studies they evaluated (here and here), and while I agree that they are generally good quality studies, I think the results are less convincing than the authors claim or than this review suggests. It can be difficult to balance an objective, checklist-based evaluation of the evidence, which reduces the influence of reviewer bias, with the need for a judicious assessment of the details of the evidence, and I think the authors of this review generally do a good job. But I think they reach the wrong conclusion with regard to the fish oil question.

Below is a detailed evaluation of the findings of each study, which I think illustrates why the few positive data reported provide only weak evidence of a benefit for fish oils in treatment of arthritis.  

A.    Dose-titration effects of fish oil in osteoarthritis dogs.  

1.     Semi-objective measure (veterinarian clinical assessment)

Of five measures assessed at four time points, all measures improved for all groups. Without a no-treatment arm, it is impossible to know how much of this apparent improvement is an artifact of study participation.

Only two measures improved significantly more for highest dose diet compared with the lowest dose diet (with no differences between the medium and lowest dose diets). These improvements were small and of dubious clinical significance: from 1.68 to 1.40 (~17% improvement) and from 2.00 to 1.64 (~18% improvement) on a scale where 1-no signs, 2-mild signs, 3-moderate signs, 4-severe signs). 

2.     Subjective measure (veterinarian estimate of overall change based on exam and owner input)

Veterinarians were asked, based on their own assessment and owner input, how much over the 90 days of the study they thought the diets had slowed or accelerated the dogs’ arthritis, or if they had no effect. All diets were believed to have slowed the progression of the disease, with the highest dose diet scoring 2.32 and the lowest dose diet 1.99 on a scale of 1-significantly slowed, 2-slightly slowed, 3-no effect.

Veterinarians were then asked, based on their own assessment and owner input, how much over the 90 days of the study they thought the dogs’ arthritis had changed. All dogs were believed to have improved, with those on the highest dose diet scoring 2.55 and those on the lowest dose diet scoring 3.15 on a scale of 1-extreme improvement, 2-moderate improvement, 3-slight improvement, 4-no effect. 

  1. A multicenter study of the effects of dietary supplementation with fish oil omega-3 fatty acids on carprofen dosage in dogs with osteoarthritis.

Reduction of the carprofen dose was the stated goal of the study, and the dose decreased for both groups. The control diet group dose decreased over 12 weeks by an average of 0.59mg/kg/day (from 4.14 to 3.58mg/kg/day, ~14%). The test diet group dose decreased by an average 1.13mg/kg/day (from 4.39m to 3.26 mg/kg/day, ~26%). The final dose differed between the two groups by 0.32mg/kg/day.

C.    Multicenter veterinary practice assessment of the effects of omega-3 fatty acids on osteoarthritis in dogs 

1.     Semi-objective measure (veterinarian clinical evaluation)

Out of five clinical measures over three time periods, there were no significant differences between control and test diet groups.

2.     Subjective measure (owner survey)

Out of thirteen measures over three time periods, there were two measures that differed significantly between groups at the first evaluation and one other measure that differed significantly at the second and third time period. No express statistical controls for making multiple comparisons were described despite p-values being reported for fifty-four different comparisons.  

D.    Evaluation of the effects of dietary supplementation with fish oil omega-3 fatty acids on weight bearing in dogs with osteoarthritis. 

1.     Objective Measure (force plate analysis)

Two measurements for each group were compared at two points in time and then a comparison was made of the percentage change in these measurements for both groups over the intervening period. Of the total of eight comparisons, one was significantly different between groups. 

2.     Semi-objective measure (veterinarian clinical evaluation)

Of five measures compared between groups at two points in time and in terms of change over time, the test group improved more than the control group in terms of two measures. This was the same measure of effect as used in Study 10, in which no such difference was seen. 

3.     Subjective measure (owner survey)

Of thirteen measures evaluated at two points in time, there were no significant differences between groups. This was the same measure of effect used in Study 10, in which three of the measures did differ at some of the time points.

References
1.     Fritsch D, Allen TA, Dodd CE, et al. Dose-titration effects of fish oil in osteoarthritis dogs. J Vet Intern Med 2010;24:1020–1026.

 2.     Fritsch DA, Allen TA, Dodd CE, et al. A multicenter study of the effects of dietary supplementation with fish oil omega-3 fatty acids on carprofen dosage in dogs with osteoarthritis. J Am Vet Med Assoc 2010;236:535–539.

3.     Roush JK, Dodd CE, Fritsch DA, et al. Multicenter veterinary practice assessment of the effects of omega-3 fatty acids on osteoarthritis in dogs. J Am Vet Med Assoc 2010;236:59–66. 

4.     Roush JK, Cross AR, Renberg WC, et al. Evaluation of the effects of dietary supplementation with fish oil omega-3 fatty acids on weight bearing in dogs with osteoarthritis. J Am Vet Med Assoc 2010;236:67–73.

 

Posted in Herbs and Supplements, Science-Based Veterinary Medicine | 6 Comments

Crananidin: Cranberry Extract for Urinary Tract Infections in Dogs and Cats?

Posted on March 16, 2012 by skeptvet

The question of whether cranberries, in some form, have value in treating or preventing urinary tract infections (UTIs) is a pretty old one. Mark Crislip at Science-Based Medicine has written a nice summary of the topic, and he has found over 100 references dating back to 1962. Like most herbal remedies, it has traditionally been thought helpful for a wide variety of unrelated disorders, but it is now pretty firmly established in most people’s minds as useful for UTIs.

Unfortunately, as usual the subject is more complicated than is generally realized. The theoretical justification for using cranberry to treat UTIs used to be that it acidified urine and made it less hospitable for bacteria, however that is no longer believed to be true. The current theory is that chemicals called proanthocyanidins interfere with the attachment of bacteria to the bladder wall, making it easier for the body to eliminate these bacteria and harder for infections to get started.

This is certainly a plausible mechanism established  by in vitro studies. The trouble is that the proanthocyanidins inhibit attachment only for E.coli with little hairs called fimbriae on them. There are many other bacteria that can cause UTIs, and there isn’t yet any evidence that proanthocyanidins affect these. And in humans fewer than 20% of E.coli in bladder infections have fimbriae, so theoretically, these chemicals should be only be useful in preventing recurrent infection in a small minority of cases. (Interestingly, the vast majority of E.coli from kidney infections are fimbriated, so cranberry could possibly be more useful in these cases). There is also the problem that no one has actually proven that oral cranberry leads to proanthocyanidins getting into the urine, or being biologically active when they get there.

As Dr. Crislip points out, though, the theoretical mechanisms are not so important if the remedy doesn’t actually work in clinical trials. So does it? Well, there is still no consensus, since some trials show and effect and others don’t. The best that can be said as of now is that cranberry probably isn’t useful for treating UTIS and it may or may not be useful for preventing them.

Despite this uncertainty, the popular belief that cranberry products are useful for urinary tract infections in humans makes it inevitable that such products will be marketed to pet owners for UTIs in dogs and cats. As in humans, many UTIs are caused by bacteria other than E.coli, and I am not aware of any research on the proportion of fimbriated E.coli in canine and feline UTIs, so the theoretical rationale for this remedy is even weaker than in humans. But a quick Google search shows plenty of veterinary versions on the market anyway, often with pretty confident claims.

I recently came across some marketing materials for one of these, Crananidin from Nutramax. They are careful to avoid any treatment or prevention claims, since that would violate the Dietary Supplement Health and Education Act (DSHEA). However, they try pretty hard to suggest a benefit and even superiority over their competitors despite the absence of any clinical trial evidence.

The Nutramax literature has a nifty little graph of bioactivity in the dog purporting to show that “by 7 days the average bioactivity is over 78% at inhibiting E.coli.” They cite two articles to support this statement. One is an NMR study of the molecular structure of proanthocyanidin, and the only bioactivity data is from mixing fimbriated E.coli with human red blood cells and some cell-surface-receptor coated plastic beads in vitro (interestingly, this study was funded by Ocean Spray). There is no testing or discussion of clinical effects, and no data concerning dog urine. There really seems no way to interpret this citation other than being deliberately misleading.

The other reference is “Data on file, Nutramax Laboratories,” so I presume it is an unpublished in-house experiment. Unpublished data from a company selling a product that “proves” the product works, and is better than the competition, ought to be viewed somewhat skeptically, needless to say.

The marketing literature also has a little chart showing their product “passing” a test of bioactivity and all the competing products failing it. The references for this are the same, and since the published article has nothing to do with this issue, apparently the only evidence for this claim is unpublished in-house data from Nutramax. I’m not aware of any published clinical trials investigating this or any other cranberry product for use in UTIs in dogs or cats.

There also isn’t any evidence concerning the safety of cranberry products in dogs and cats. In humans, one concern is that cranberry juice has a lot of salicylic acid, so people with aspirin allergies or on anti-coagulant medications aren’t supposed to take a lot of it. But those are pretty rare issues in veterinary medicine. And some studies have shown it increases oxalate in the urine by up to 43%, so I wouldn’t recommend it for patients with a history of oxalate urinary tract stones (even though, again, this data is for people, and there are no studies I can find in dogs or cats).

Bottom Line
There is weak theoretical justification for using cranberry products for UTIs, though none of the supporting preclinical evidence involves dogs or cats. There is conflicting clinical trial evidence in humans, and no clinical studies in dogs and cats. There are weak theoretical safety concerns. And, of course, there is abundant marketing making bold statements unsupported by the little evidence that exists. You pays your money and you takes your chances. Fortunately (for Nutramax, if not for our pets), anecdotes claiming a benefit are easy to find, so there should be little trouble selling the products even without convincing evidence of safety or efficacy.

 

 

Posted in Herbs and Supplements | 8 Comments

Protandim: An Update from Science-Based Medicine

Posted on March 13, 2012 by skeptvet

Last year I wrote a review of a dubious herbal combination product called Protandim. At that time, my bottom line conclusion was:

Bottom Line
The underlying theory used to promote this product, that anti-inflammatory and anti-oxidant effects are always safe and beneficial, is highly doubtful. There is only weak in vitro and animal model research to indicate that the ingredients in Protandim, or the combination product, have potentially useful effects on cells or biochemical markers. There is absolutely no clinical trial evidence to indicate Protandim has any of the claimed benefits in humans or animals. While the absence of evidence is not proof the product is unsafe or ineffective, it is absolutely a reason to be skeptical of wild claims of miraculous benefits. At best, using this product is simply rolling the dice and hoping for the best. That seldom works out for gamblers in Vegas, and it is not an appropriate approach to healthcare except in the most dire of circumstances.

Dr. Harriett Hall at the Science-Based Medicine Blog has recently provided an update on this product and a recent clinical study investigating it. The study was bizarre and it is amazing any ethics committee would approve it. It is also not prominently featured on the Protanidim web site, no doubt because no effect was seen. Here are a couple of highlights from Dr. Hall’s summary:

To recap their chain of reasoning: alcoholics might develop lung disease, that lung disease might be correlated with abnormal epithelial permeability, protein levels measured by bronchoalveolar lavage (BAL) might be a valid measure of permeability, permeability might be affected by underlying oxidative stress, and Protandim might reduce oxidative stress by stimulating the body to produce its own antioxidants. Do they perhaps think that lots of “mights” add up to a “mighty” argument?

The second listed author, Joe McCord, has a vested interest: he is an officer of the LifeVantage company, the manufacturer of Protandim. They explain that Protandim is “a nutraceutical with a lengthy history of use in homeopathic, Ayurvedic, and traditional Chinese medicine.” An interesting statement, since Protandim was invented only a few years ago by a person with no medical background and it was patented in 2007. Doubly interesting since it belies the common myth that natural medicines are not profitable because they can’t be patented.

They assessed alveolar epithelial permeability by measuring the total protein in bronchoalveolar washings. Total protein levels did not change in either experimental group. They also found no change in oxidative stress indices, epithelial growth factor, fibroblast growth factor, interleukin-1?, interleukin-10, liver function tests, or other blood chemistry tests. The one finding that was statistically significant was a significant decrease in plasma thiobarbituric acid reactive substances (TBARS), a marker of lipid peroxidation — but that was only in the placebo group!

In short, Protandim was significantly (p<0.01) worse than placebo. No wonder they’re not bragging about this study!

Big Pharma gets a lot of criticism, but aren’t Big Supplement and Big Multi-Level Marketing every bit as guilty of self-interest, distortions, and profit motives? At least Big Pharma can’t make its big bucks without first demonstrating effectiveness and safety to the FDA with clinical trials.

Does Protandim provide any real benefit to its customers? I don’t know, and they can’t hope to know unless they do proper clinical studies.

 

Posted in Herbs and Supplements | 51 Comments