Another Homeopathy Lawsuit-This time one that at least makes sense!

Posted on August 17, 2011 by skeptvet

There has certainly been a lot of talk lately about homeopathy and lawsuits. I have discussed the Academy of Veterinary Homeopathy’s attempt to obtain through litigation the legitimacy they can’t achieve by proving their methods work through scientific research. And Science-Based Medicine had an article today about the French company Boiron suing an Italian blogger for pointing out that their product Oscillo is nothing but a sugar pill and cannot possibly be useful for treating flu symptoms. So I admit I was a little bit ambivalent to see the tables turned by a lawsuit in California, accusing Boiron of fraud for implying Oscillo has therapeutic effects. In general, I don’t believe the courts are the best place to adjudicate disputes about the scientific merits of medical therapies. However,  it is true that homeopathy cannot be viewed as anything other than delusion or fraud, and it is satisfying to see someone has the courage to point out that there can be no reasonable justification for profiting from selling homeopathic products.

The complaint is succinct and illustrates starkly how ridiculous it is to market any homeopathic remedy as if it were medicine.

Oscillococcinum (the “Ocillo”) is nothing more than a sugar pill that Defendants falsely advertise has the ability to cure the flu. In reality, Oscillo has no impact on the flu or any symptoms that accompany the flu…

The truth is that the listed active ingredient in Oscillo, Anas Barbariae Hepatis et Cordis Extractum, is neither active in combating the flu nor is it actually an ingredient in Oscillo… Anas Barbariae Hepatis et Cordis Extractum has no known medicinal quality, further, in the extreme dilution claimed by Defendants, it has no impact on the human body whatsoever because it is not present in Oscillo.

Defendants claim that the active ingredient in Oscillo, Anas Barbariae Hepatis et Cordis Extractum, is diluted to 200CK…At this purported dilution, the probability of getting 1 molecule of the active ingredient of Oscillo in a regular dosage is approximately equal to winning the Powerball every week for an[sic] nearly an entire year…

Defendants are fully aware that there is no Anas Barbariae Hepatis et Cordis Extractum present in Oscillo. In an interview with the U.S. News and World Report, Defendants stated, “[of] course its safe. There’s nothing in it.”

…Defendants sell Oscillo for approximately $10 per unit based on the preceding false advertising claims. As a result, Defendants have wrongfully taken milloons of dollars from California consumers.

I am not optimistic that the suit will be successful or meaningfully impact the marketing of water as medicine. But as a matter of principle, and as an opportunity to educate the public, the lawsuit is worthwhile, and I applaud the plaintiff for making his efforts.

Posted in Homeopathy, Law, Regulation, and Politics | 4 Comments

Academy of Veterinary Homeopathy Lawsuit Update

Posted on August 16, 2011 by skeptvet

Back in May, I wrote about a lawsuit involving the Academy of Veterinary Homeopathy (AVH) and the American Association of Veterinary State Boards (AAVSB) committee that certifies continuing education courses veterinarians must take to maintain their state licensure (the RACE committee). In brief, the RACE committee changed their standards for approving continuing education programs to require some minimal standards of scientific legitimacy for veterinary continuing education. The standards requires approved courses,

build upon or refresh the participant in the standards for practice and the foundational, evidence-based material presented in accredited colleges or schools of veterinary medicine or accredited veterinary technician programs…CE programs that advocate unscientific modalities of diagnosis or therapy are not eligible for RACE approval…All scientific information referred to, reported or used in RACE Program Applications in support or justification of an animal-care recommendation must conform to the medically accepted and scientifically supported standards of experimental design, data collection and analysis.

As I’ve discussed in detail before, homeopathy cannot by any but the most absurd contortions of reason be viewed as a scientifically legitimate or validated approach to health care, so it is not surprising that once RACE ceased rubber stamping applications for approval and applied these reasonable standards, homeopathy courses were judged ineligible for continuing education credit. It is also not surprising, of course, that homeopaths and others practicing scientifically questionable veterinary medical methods would object.

What is surprising and disturbing, however, is that the limited media coverage of the AVH lawsuit has been generally biased in favor of the AVH position, and there has been virtually no criticism of the deeply anti-science stance of the AVH, which if successful will essentially end all meaningful regulation of veterinary continuing education. Like much media coverage of creationism, journalists seem to believe that fair coverage requires ignoring the overwhelming consensus among scientists and veterinarians that homeopathy is nonsense and presenting veterinary homeopaths as a legitimate minority community being unjustly discriminated against. The media reports I have seen so far seem to entirely ignore the underlying issue of the scientific evidence against homeopathy or the threat the lawsuit, if successful, poses to the very idea of regulating the standard of veterinary care through the process of state licensure.

The Media Gets It Wrong
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.

Another article on the subject was released today by the Veterinary Information Network (VIN) News Service. This article is more neutral than the VPN piece, but it still creates a false impression of the nature of the debate. It misrepresents the conflict as a balanced difference of opinion within the profession, when in fact it is about a small group of believers in a long-discredited belief system agitating for a special exemption from the scientific standards normally applied to mainstream veterinary medical practices.

The article extensively quotes the AVH veterinarian and attorney who filed the lawsuit, and also less extensively the president of the AAVSB. In general, much attention is given to the idea that homeopathy and other alternative approaches are “discriminated against,” and almost no attention is given the underlying scientific issue and the question of whether education of licensed veterinarians should be rooted in accepted science.  

What’s the Point of Continuing Education for Vets?
I have discussed the legal and historical issues of licensing healthcare providers, including veterinarians, in detail elsewhere. In brief, the state is required to establish standards for the practice of medicine and issue licenses to healthcare providers in order to protect the public health and prevent unsafe and ineffective treatments from being sold as legitimate healthcare. Prior to the development of this practice, quacks and charlatans routinely sold useless or harmful, even deadly “remedies” freely, to the great harm of patients in need of real care. Continuing education requirements are part of this system, and they are intended to ensure that veterinarians stay current on progress in veterinary medicine.

It makes no sense to have such standards if there is no reasonable, scientific criteria for what counts as legitimate continuing education. Should veterinarians be able to maintain their licensure by studying anything they want? Psychic surgery, astrology, voodoo, faith healing, etc? The AVH argues that the standard of scientific evidence is fundamentally unfair. According to the VIN article, the new RACE standards’ emphasis on science, “worked to preclude homeopathic courses that were not based on what RACE committee members considered to be clear, evidence-based science. It narrowed the road to acceptance, critics say, giving more weight to published science and less to the experts in homeopathy. ”

This as much as admits that homeopathy is not accepted as scientifically legitimate by anyone but homeopaths. The logical consequence of this, apparently, is that only experts in homeopathy should be allowed to judge if  homeopathy is scientifically legitimate. And presumably only psychics, astrologers, and voodoo priests should be allowed to judge whether these are legitimate veterinary medical approaches?

This is a form of special pleading which says that there is no real scientific standard of evidence that can prove anything is or is not effective medicine, so followers of every individual approach should simply be free to judge their own practices by their own standards and then the state should simply endorse their judgments. Such an approach effectively eliminates any meaningful standard of quality for veterinary care and takes us back to the medical anarchism of the 19th century.

Taking this sort of approach even further, the American Holistic Veterinary Medicine Association has formed its own standards group, the Registry of Alternative and Integrative Veterinary Medical Education (RAIVE) to circumvent the RACE standards board with one stacked with believers in alternative therapies and more inclined to rubber stamp continuing education in these approaches. This will be meaningless, of course, unless state veterinary boards agree to accept RAIVE in lieu of RACE approval. Of course, since such boards are fundamentally political, rather than scientific, agencies, and they have a solid history of ignoring blatantly even the most egregiously ridiculous and harmful sorts of medical nonsense so long as it is promulgated by a licensed veterinarian, it seems not unlikely that this separate-and-equal approach to deciding what is legitimate medicine will succeed.

Why Does It Matter?
The simple answer to this is that our patients are better off if they receive effective care. And this is more likely to happen if veterinarians are trained in legitimate scientific medicine. We have a special privilege by virtue of the license we are granted by the state to practice veterinary medicine. We can make our living providing healthcare for animals. And this privilege is granted us with the understanding that we will employ safe, effective, scientifically valid treatments. Our clients come to us trusting that our status as licensed veterinarians means we are meaningfully different from unlicensed individuals who might offer veterinary services. The state has essentially certified that we can be trusted to take proper care of our clients’ companion animals using valid methods.

If any and all methods are considered equally acceptable as support for our licensure, and if only believers in a given method are allowed to judge the legitimacy of that method, regardless of how few they are or how lacking the scientific evidence in support of their beliefs, than licensure is meaningless. A pet owner has no way of knowing if the licensed veterinarian they go to is practicing accepted, scientific medicine or a completely bogus method they have invented and judged legitimate all by themselves.

The harm that unscientific approaches to medicine, including homeopathy, can do is real and easy to illustrate (here and here, for example). The issue behind the AVH lawsuit is not fairness or open-mindedness, it is about whether scientific evidence and regulatory standards are to have any meaning or any influence on the quality of veterinary care the public is offered. The AVH is fundamentally seeking an exemption from any such standards and the right of any group to judge their own beliefs and promote them as legitimate under the imprimatur of state government without interference from the judgment of the rest of the profession or state regulators.  

Posted in Homeopathy, Law, Regulation, and Politics | 11 Comments

Probiotic Fortiflora: Not apparently very helpful in preventing diarrhea in shelter animals

Posted on August 9, 2011 by skeptvet

Probiotics, living microorganisms fed to humans and animals to prevent or treat disease, are an interesting area of ongoing research. I have written about this intervention a number of times (1,2) and it seems a promising area of research, though the current evidence for meaningful beneficial effects is quite limited. There is reasonable evidence for some benefit in treating antibiotic-associated diarrhea or acute diarrhea of unknown cause(3). The evidence is not very good for many other claimed benefits, such as strengthening of immune system function, treatment of kidney disease(4,5), management of feline upper respiratory viral infections(6), and so on. And there are serious problems with irresponsible, excessive hype(7) and poor quality control(8) for probiotics.

Overall, I am cautiously optimistic that we will eventually find legitimate therapeutic uses for some probiotics, though I find the existing evidence unconvincing for most claims currently made about them. A new study looking at the use of Fortiflora, a veterinary probiotic product, for control of diarrhea in shelter animals, does not add much support to the proposed value of this probiotic.

Bybee SN, Scorza AV, Lappin MR. Effect of the Probiotic Enterococcus faecium SF68 on Presence of Diarrhea in Cats and Dogs Housed in an Animal Shelter. J Vet Intern Med. 2011 Jul;25(4):856-60.

Cats in this study were housed for variable periods of time in two rooms, one for previously owned cats and another for feral cats. Canine subjects were also housed in two separate areas. Subjects in both rooms for each species were observed for 4 weeks to establish a baseline incidence of diarrhea in the population. Then subjects in one of the rooms for each species were given Fortiflora daily for 4 weeks while the subjects in the other room were given a placebo.  All subjects were taken off the Fortiflora and placebo for one week, and then the treatments were switched, so subjects in the room that had originally received placebo got the Fortiflora and vice versa.

The stool of every animal was scored on a stool consistency chart every day. Abnormal stool samples were evaluated for parasites whenever possible, and an effort was made to evaluate a normal stool from another animal in the same room at the same time to identify what if any role parasites played in the incidence of diarrhea. It is not clear from the paper what if any treatment was given for diarrhea or fecal parasites.

For both dogs and cats, some fecal parasites were detected in some individuals, but the rate of parasitism was no higher in those with diarrhea than in those with normal stools, so the parasites did not seem to influence the incidence of diarrhea significantly in a way that would complicate evaluating the effect of the probiotic. This effect, however, was not especially clear. For the dogs, there was no significant different in the incidence of diarrhea between those getting the Fortiflora and those receiving the placebo regardless of how the data was analyzed. The overall incidence of diarrhea in both groups was lower than expected for reasons that were not identified.

In the cat groups, the overall incidence of diarrhea was no different between the probiotic and placebo groups. However, when the data was broken down to compare the proportion of cats having diarrhea for more than 2 days, this was lower in the probiotic group than in the control group, though the level of significance was not dramatic (P=0.0297 with a cutoff of <0.05).

The authors conclude this finding “suggests the probiotic may have beneficial effects on the gastrointestinal tract.” This is certainly possible, but this particular study provides little support for the idea.

 

 

 

 

 

Posted in Herbs and Supplements | 3 Comments

Denamarin: Does it prevent chemotherapy-induced liver damage?

Posted on August 8, 2011 by skeptvet

Silymarin and s-adensylmethionine (SAM-e) are plant-derived chemicals frequently used as supplements for a wide variety of applications. I’ve written about both before, evaluating the available evidence in humans and in dogs and cats (1,2,3). So far, the evidence concerning the safety and efficacy of these supplements is limited and conflicting. A recent study, however, provides a little bit more low-level support for the use of at least one combination product, known as Denamarin, containing these chemicals.

KA, Hammond GM, Irish AM, Kent MS, Guerrero TA, Rodriguez CO, Griffin DW. Prospective Randomized Clinical Trial Assessing the Efficacy of Denamarin for Prevention of CCNU-Induced Hepatopathy in Tumor-Bearing Dogs. J Vet Intern Med. 2011 Jul;25(4):838-45.

In this study, fifty dogs being treated for various cancers with the chemotherapy agent lomustine (CCNU) were randomly divided into two groups. One group was given Denamarin and the other was not. CCNU is known to frequently cause increases in liver enzymes measured in the blood. Although it is much more rarely the cause of serious liver damage, the elevations in liver enzyme levels often causes concern that can lead to delaying or discontinuing use of the drug. The goal of the study was to see if Denamrin could prevent the increase in liver enzyme levels.

In terms of this narrow criteria, the study showed a positive effect. While only 68% of the dogs on Denamarin showed liver enzyme increased, 86% of those not on the supplement had increased levels of the major enzyme of interest, alanine aminotransferase (ALT). And while these elevations reached the highest levels in 28% of the control dogs, only 7% of the dogs on Denamrin showed such very high increases in ALT.

There are a number of caveats, however, that limit the degree to which these results can support a general recommendation to use Denamarin in dogs given CCNU. The cause of liver enzyme elevations was not determined in most dogs, so it is possible that a progression of the underlying cancer, rather than the CCNU, caused the increases in some of these dogs. And only 1 of the fifty dogs actually showed clinical symptoms associated with liver damage, so it even if Denamarin prevents increased enzyme levels, this may or may not have any actual clinical benefits.

Methodologically, there are some additional caveats that must be considered in judging the significance of this study. There was no placebo group, and owners and investigators were not blinded to the treatment group. While this potential source of bias would not have directly affected ALT measurements, it could potentially have led to differences in how the dogs in the two groups were treated, which might have indirectly affected these levels. This is especially a concern since the study was funded by the manufacturer of Denamarin, and several of the authors have financial links to the company.

Overall, this study provides low-level evidence that Denamarin may have benefits in protecting against CCNU-induced liver damage in dogs with cancer. Independent replication with better controls and more comprehensive assessment of outcome would help to determine if the current results truly represent a clinically meaningful benefit from this supplement or not. However, given the low level of risk associated with this specific product, it is not unreasonable to consider using this supplement for this indication. This does not, of course, translate into support for a generalized use of Denamarin for any and all liver problems.

 

 

Posted in Herbs and Supplements | 12 Comments

Neoplasene: Benefits Unproven and Risks Severe

Posted on July 27, 2011 by skeptvet

Two years ago, I wrote about an herbal product called Neoplasene, an excharotic derived from bloodroot that is marketed for treatment of cancer. I pointed out in that article that apart from a couple of in vitro studies suggesting the active chemical ingredient has some interesting effects on cancer cells, there is little evidence the product is an effective cancer treatment. And there is ample anecdotal and in vitro evidence of harm caused by the product, which kills healthy tissues as well as cancer cells and has been shown in humans to create horrible wounds while leaving hidden cancer that later spreads and kills the patient. No controlled research has been done in dogs and cats, and there is no reliable evidence to support the claims made by the marketers of this product.

Nevertheless, due to the power of anecdotes, and the weakness of government regulation of herbal products, this preparation is still marketed for use, and there are veterinarians who employ it. A recent case report in the Journal of the American Veterinary Medical Association (JAVMA) discusses the lack of evidence supporting the use of bloodroot and illustrates the significant harm these products can do.

Childress, MO. Burgess, RC. Holland, CH. Gelb, HR. Consequences of intratumoral injection of a herbal preparation containing bloodroot (Sanguinaria canadensis) extract in two dogs. Journal of the American Veterinary Medical Association 2011;239(3):374-379.

The report discusses two dogs, belonging to the same owner, who had Neoplasene injected into skin tumors. The first, a 2 year old golden retriever, had a benign tumor about 2cm in diameter. Such masses usually cause no problem for dogs, but if they are disturbing to owners or if they become injured or infected, they can be easily removed surgically, which is curative. Unfortunately, the treating veterinarian elected to inject the mass with Neoplasene. Six days later, the tumor had become bruised and much larger. The veterinarian instructed the client to give an oral homeopathic remedy to reduce the swelling of the tumor (which, given the mountain of evidence that homeopathy is nothing more than water and a bit of placebo effect, cannot reasonably viewed as an acceptable standard of care). After the swelling failed to resolve following drainage and bandaging, the pet was taken to the hospital of the veterinary medical school at Purdue University. By this time the benign 2cm diameter mass had become a 6cm area of severely inflammed and necrotic (dead) tissue.

The dog had surgery to remove the mass and a margin of healthy tissue around it, which involved a very extensive surgical procedure. After many weeks involving several additional surgical procedures and physical therapy to treat the loss of mobility caused by the large wound, the patient eventually made a full recovery.

The second patient discussed in the report, owned by the same client and treated by the same original veterinarian as the first dog, also had bloodroot injected into a benign tumor. A smaller amount of Neoplasene was used, and it appears that some of this leaked out after the injection. As a consequence of this, or perhaps of the variability in unregulated herbal products, the tissue reaction was not as severe as in the first patient. When the mass was surgically removed, an area of inflammation and tissue necrosis was observed near but not in the tumor. Luckily, this dog experienced minimal complications.

Clearly, complications can occur with any medication or treatment that has a measurable physiological effect. Anything that has no possibility of any side effects isn’t doing anything! And it is important to remember that anecdotes cannot be used to prove either the safety or the efficacy of a treatment. Anecdotes of benefit provide only enough evidence to justify more rigorous, systematic testing, not proof that a therapy works. In the majority of cases, such anecdotes turn out not to be accurate when more objective testing is done. Cases in which harm may have resulted from a treatment also cannot prove the treatment is unsafe. They do, however, provide reason to be cautious, and they raise the level of supportive evidence of benefit that should be expected prior to employing the treatment. Medicine is always about balancing the urgency of intervening in a patient’s condition with the available information about the risks and benefits of the intervention.

In the case of bloodroot, there is limited preclinical evidence to suggest it might be a useful treatment. It does kill cancer cells, but so does bleach, which is obviously not a good candidate for use as a medicine. The evidence that bloodroot kills cancer cells and spares healthy tissues is weak and contradicted by numerous cases of obvious tissue damage following application of the chemical. And there simply are no clinical studies to indicate a benefit in actual patients, much less a benefit greater than the potential risks. So we are left with anecdotes about bloodroot curing patients, which are of limited value as such anecdotes are often wrong for many reasons, and anecdotes of patients suffering severe, sometimes disfiguring or disabling injury after using it. Severe injury may not always happen, but it is an extreme risk to take when there is no real reason to expect the treatment has any benefit. Both of these patients would have been effectively cured, with much less suffering, injury, and expense for the owner, if they had been treated with conventional surgery rather than bloodroot.

Given the current state of the evidence, it is irresponsible of veterinarians to use bloodroot products on their patients. And in my opinion it is absolutely unethical for companies and individuals to profit from marketing these remedies without investing the resources in proper clinical studies to prove that they can be used safely and that they actually benefit patients. As I have discussed many times, herbal remedies are likely the most promising area of alternative medicine in which we will hopefully find effective medicines. But until they have been rigorously tested, and until they are regulated as stringently as pharmaceuticals, they are a dangerous gamble with our pets’ health and cannot reasonably be viewed as an alternative to established conventional treatments. Just as the pharmaceutical industry must be carefully watched to constrain the bad behavior that the profit motive can generate, so the herbal medicine industry cannot be trusted to provide trustworthy information and safe and effective remedies without much more oversight that it currently receives.

 

 

 

Posted in Herbs and Supplements | 92 Comments

Holistic Anesthesia for Dogs and Cats

Posted on July 20, 2011 by skeptvet

In a bit of advertising on his blog, a prominent alternative veterinary medicine advocate recently discussed the case of a 15 year old dog that reportedly had heart disease and dental disease and had come to see this doctor because the client’s regular veterinarian felt the risk of anesthesia for dentistry outweighed the benefits in this patient. Few details are provided, but our hero claims to have determined that the heart condition did not require medication and could be managed with “natural therapies” (which likely means there was a heart murmur but no true heart disease, since there are no “natural” substitutes for real medication when there is real heart disease). The author then claims that he was able to successfully treat the dental disease with “holistic anesthesia,” which left the patient “acting like a puppy again.”

I am certainly a proponent of proper dental care, and I applaud the author for taking the position of mainstream veterinary medicine that proper dental care requires general anesthesia in our pets. This is a more controversial idea in alternative medicine circles than in the profession as a whole. And I certainly oppose the inappropriate use of potent heart medications, which sounds like it may have occurred in this case.  However, the core message of this article seems to be that conventional doctors are inappropriately frightened by anesthesia in older pets and that such anesthesia can be done more safely if it is “holistic.” Having never heard the term “holistic anesthesia” before, I was curious what it might mean and whether there is any evidence that it is safer than conventional anesthetic practices.

As I have already discussed previously, “holistic” is one of those vacuous marketing terms that means whatever the speaker wants it to mean or nothing at all, like “natural” or “integrative.” I suspected the phrase “holistic anesthesia” simply meant ordinary anesthesia with some herbs, homeopathy, acupuncture, or other unproven or bogus methods added on and then falsely promoted as somehow safer than conventional anesthetic practices. And, that is pretty much what I found, though I was surprised that it is also sometimes used to refer to practices indistinguishable from conventional anesthetic methods.

The author of the heartwarming story about the old poodle advertises his “holistic” approach to anesthesia this way on his web site:

No More Anesthetic Worries
Surgery can be scary, and we know that you may be a bit nervous about anesthesia. That’s why your pet will receive a comprehensive physical examination prior to every surgery. Blood and urine tests will also be done when needed to minimize the risk associated with anesthesia. And to keep your pet’s chances of anesthetic complications to a minimum, we only use isoflurane gas. It’s a bit more expensive, but it’s the safest anesthetic available.

Your pet is also monitored by a veterinary assistant and 3 monitoring machines which monitors: respiratory rate, heart rate, pulse oximetry and body temperature.

No surgery is routine at [We Make Stuff Up] Animal Hospital. You want the best for your pet, and so do we! And for those owners who are a bit nervous about anesthesia, or who wish to minimize anesthetic complications in their pets, we offer holistic anesthesia to allow for a safer procedure and quicker recovery time.

Wow! What a radical departure from conventional anesthetic practices! Who would have thought of doing a physical examination or laboratory tests before anesthesia, using the cutting edge isoflurane gas anesthetic, monitoring the patient under anesthesia, or treating each patient as a unique individual? Oh, wait…How about EVERYBODY!!! Ok, maybe not everybody, since there are undoubtedly some incompetent veterinarians in practice. But these practices are standard in conventional veterinary medicine and have been since I went to vet school over a decade ago. To advertise them as if they were somehow superior, “holistic” practices is deceitful rubbish, purely marketing driven. Is this really all there is to “holistic anesthesia?” Well, there might be a bit more to it.

The rich mine of nonsense that is the American Holistic Veterinary Medical Association (AHVMA) web site provides two articles from the AHVMA “journal” that go into a bit more detail.

Winter, W. Holistic anesthesia and surgery Part 1. Journal of the American Holistic Veterinary Medical Association 1999;18(2):33-36.

Winter, W. Holistic anesthesia and surgery Part 2. Journal of the American Holistic Veterinary Medical Association 1999;18(3):19-23.

The tone of these articles is unremittingly arrogant, self-aggrandizing, and hostile to conventional veterinary medicine, and the information provided is entirely opinion, with no effort to support any assertions with scientific evidence. For example:

When you need it, surgery is good. It is one of the two only good things going for allopaths. When used properly, modern equipment, drugs, and techniques are approaching the sacred, magical healing we see in Shamanism.

We holistic types get to use surgery too, but there are things we have to take into consideration if we want to claim it as a holistic modality (God, I love using the word “modality”). Sometimes it really is a pain to have a conscience. It is that weight we feel once we are “enlightened.”

Now, the article is twelve years old and written by a now-retired 1975 veterinary school graduate. So one can reasonably argue that it is not representative of what contemporary AHVMA members and other self-proclaimed “holistic” practitioners believe. However, it is the only published discussion of “holistic anesthesia” in the veterinary field, and it shares with the blog article mentioned above both the underlying tone and the absence of any reference to objective scientific evidence. Without some clearer definition of what is meant by “holistic anesthesia,” and without a specific repudiation on the part of the AHVMA and individual members, one might reasonably assume that the principles articulated here are still accepted by proponents of this purported special anesthetic approach.

The first claim Dr. Winter makes about “holistic” surgery and anesthesia is that many of the procedures conventional veterinarians perform are, or should be, unnecessary once the conditions that necessitate them are prevented or successfully treated with alternative methods. Prevention is certainly preferable to treatment of almost any disease, and contrary to the mythology and advertising of alternative medicine, this is an accepted principle in all veterinary medicine. Similarly, he goes on to claim that it is “holistic” to do the safest, least invasive procedure that will yield the desired outcome and that the cost of the procedure and overall condition of the patient should be considered. This is about as radical and unconventional line of thought as the advertising cited above, which is to say it is banal and universally accepted.

Dr. Winter then describes his preoperative routine. Interestingly, he specifically recommends avoiding alternative therapies before anesthetics, though not for the reason you might expect:

Rescue Remedy can be used preop but should be used sparingly as it may interfere with anesthesia. The same is definitely true of using Arnica pre-op. I never give it immediately before surgery. Since anesthetics are “toxic,” many of the good herbs, homeopathics, and flower essences are contraindicated. More anesthetic will be required and the animal will wake up too soon. Use these fine medicines later, after surgery.

Ah, so the “good” natural remedies interfere with the “toxic” anesthetics, so a holistic anesthetic approach should begin with only the same poisons conventional veterinarians employ for anesthesia. Hmm…

He then goes on with some more radical and counterculture notions such as reading the patient’s record and studying the specific procedure before performing it, referring cases beyond one’s expertise to specialists, trying to avoid interrupting surgical procedures, and so on. All revelations to most veterinary surgeons, no doubt. However, Dr. Winter does introduce a few concepts I will admit to not having been taught in vet school:

Surgeries also should be done in the morning to catch the best biorhythms… The holistic surgeon is always aware of moods, the overall feeling of the day, and whether it is a “good surgery day” or a “bad surgery day.” If the feeling of the staff, room or schedule feels off, it is much better to take a break, regroup, and reconsider the pace. In the worst case scenario, stop for the day and reschedule.

Good and true holistic clients will totally understand and even be grateful. I have also learned to read the body language and the words of each client as they bring in their animal for surgery. If you perceive any negativity, especially hostility or an ominous premonition, sit right down with them and talk about alternatives. Don’t cut on an animal if the owner is against you; it is very powerful and should be honored.

I have learned to benefit from cleansing the surgical rooms psychically and spiritually using smudges, candles, herbs, and other processes.

I will admit, it hasn’t occurred to me to cancel surgery if the staff or owner happen to be in a bad mood or to cleanse the surgical room psychically with incense to improve the safety of anesthetic and surgical procedures. Something to think about.

The bulk of the discussion of anesthesia per se emphasizes the use of injectable anesthetics and avoiding gas anesthetics, which he describes as “part of an expensive racket.” He also emphasizes speed above all other considerations in reducing surgical and anesthetic risks. These are opinions, mostly without scientific justification, that say more about the era in which the author was trained than about anything uniquely “holistic,” and I suspect they are not widely held by contemporary alternative practitioners. The same is likely true for the outdated sterile technique advice, the belief that pain should be largely left untreated because it forces the patient to “rest” and thus aids healing, and much of the other “Common Man technology” and techniques Dr. Winter recommends. However, what is common to these articles and the writing of younger advocates of “holistic” medicine is the blithe reliance on individual opinion and experience as a justification for pronouncements about what is or is not safe and effective care, the lack of interest in scientific evidence, and the continual derogation of conventional veterinary medicine.

Of course, in order to make so-called “holistic anesthesia” detectably different from conventional anesthesia, it is necessary to add a variety of unproven therapies to the usual treatment, and Dr. Winter certainly does this. Needless to say, he provides no evidence whatsoever to justify these practices:

I augment the natural raw diet, which we have discussed in other articles or which can be found in Dr. Pitcairn’s book, with extra chopped greens every day and bits of raw liver, 1-5 raw eggs (with shell)/ week helps too. For minerals I use Vitamineral Mix (see Pitcairn) varying from 1/2 teaspoon to several tablespoons daily and especially sea kelp, 1/8-1/2 teaspoon daily. I add Vitamin C, 1000mg/day for a cat and up to three times that amount for a large dog, and Vitamin E, 400 iu/week for a cat amd up to 400 iu/day for a large dog. My personal favorite herb for bone healing is Comfrey and I usually use dried herb added to the food. Herb books list many other bone setting herbs that will work as well. Continue all supplements for several months after healing. This diet and supplement regimen should be used in all trauma cases regardless of type of fixation. I also add specific homeopathics, flower essences, sometimes acupuncture, and sometimes magnets, depending upon the case…

Herbal medicine is at its zenith when it comes to wound dressing. Who has not applied Aloe Vera to a wound? It is satisfying, it soothes, the client loves it (usually), and it works. I have a veterinary book, out of print now, by Richard Holliday, DVM, which shows hundreds of pictures of wounds allowed to heal open, naturally with some debridement and with Aloe Vera. I have used the book and its pictures many times to convince an owner that natural healing will really work.

After all, who needs clinical research when you have pictures to prove something works?

Finally, Dr. Winter provides some marvelous examples of cognitive dissonance and the misunderstood, even persecuted attitude that often characterizes the writing of those promoting approaches widely believed to be nonsense. Like so much else in these articles, of course, this is not uniquely “holistic,” but it does reveal the nature of a perspective completely immune to evidence or any possibility that the author might be mistaken.

In closing, there is a problem with all that I have just said, and it applies equally to all holistic services. That is when things do not work out in a rapid, linear, positive manner with full healing. It will not take long for some owners (or did they all come to me and me alone?) to go to another non-holistic vet who will assure them that had they chosen any other option than the one you did, the animal would have healed perfectly! I call this Double Jeopardy, because you can be a loser either way. If you are afraid to try natural healing, you lose because you can never be brave enough to be holistic, but if you try it, and for whatever reason (almost always due to bad owner post-op care, not you) there is a problem, you will be the scum of the universe. You have to follow your heart here. Holistic medicine is not for the cowardly and the weak…

Other vets are very threatened by this simple healing style, primarily because they have never tried it and they may truly think you are crazy. I know from firsthand experience that they will often report you to State Boards for being incompetent if they get involved with a case you are healing this way, so be careful. Stitching or bandaging some wounds strictly for legal reasons could be considered holistic too. We live in a crazy world.

So if it doesn’t get better, it’s not your fault it’s probably the owner’s. But other veterinarians are likely to blame the bad outcome on your idiosyncratic and unconventional techniques (while, of course, holistic veterinarians would never claim that bad outcomes are the result of conventional medical practices and that they could have been avoided if the owner had followed a superior holistic technique). Other vets only object, of course, because they don’t understand, they haven’t tried your methods themselves, or they are “threatened.” So you have to follow your heart regardless of the apparent outcome of the evidence, though if legally threatened it can be “holistic” to do something incompatible with what you really believe is the best care.

Bottome Line
“Holistic anesthesia” is a meaningless, “feel-good” marketing term. In many cases, it is simply a rebranding of conventional anesthetic and surgical practices. In others, it is the addition of bogus or unproven alternative therapies to conventional care, with the credit for good results always going to the alternative methods and the blame for bad results always attributed to the conventional drugs or procedures. The use of the term, however, is a warning sign of a philosophical approach fundamentally hostile to science and scientific evidence and willing to alternative approaches by means of denigrating conventional medicine regardless of the lack of evidence to support claims of superior safety and efficacy.

Posted in General, Miscellaneous CAVM | 9 Comments

Placebo Treatment for Asthma: Works for the Mind but not the Lungs

Posted on July 18, 2011 by skeptvet

Note: I originally wrote this for Science-Based Medicine, but Dr. David Gorski has posted a far more detailed review of the study, which I encourage everyone to read, so I am just posting my thoughts on the subject here.

The placebo effect is a controversial, and in my opinion deeply misunderstood, phenomenon. At Science-Based Medicine, there has been plenty of discussion and debate on the subject before, and different authors have slightly different perspectives (for example, Drs. Novella, Gorski,Ramey and pharmacist Scott Gavura). A recent study in the New England Journal of Medicine (NEJM) serves to illustrate nicely my own view of the nature of this phenomenon, so I thought I’d have a go at characterizing it.

The placebo effect is often claimed to be a real improvement in a patient’s disease that is caused by an inert treatment, purportedly through the power of the mind to heal the body when the patient believes they are receiving an effective therapy. This is certainly how alternative medicine advocates characterize it when scientific studies identify their interventions as no more effective than placebos. However, in my opinion this is not an accurate characterization of the placebo effect.

There are many non-specific treatment effects seen in clinical trials, including the placebo, and all create the perception and appearance of improvement in patients given a fake therapy which is actually doing nothing to alter the underlying medical condition causing the patients’ symptoms. Some such effects are artifacts of the research setting, like the Hawthorne Effect. In this phenomenon, people take better care of themselves when they are participating in a research study and being closely monitored, and so they tend to improve regardless of whether the treatment being studies is helping them or not.

Other non-specific treatment effects, like the placebo, are illusions created by the belief and expectations of the patient or investigators. They do not represent an unlocking of deep and powerful forces of mind over body. They simply trick us into feeling or looking better when our condition is really unchanged.  

One can argue, of course, that if a patient perceives inherently subjective symptoms, such as pain or nausea, to be improved, then they must really be improved. There is some truth to this, but the argument can easily lead to exaggerating the benefits of fake treatments which don’t actually affect the patient’s physical health. Homeopathy may make a person experience his or her pain less intensely, but a real medicine will achieve this, usually to a greater extent than a placebo, by actually reducing the pain generated in the body as well as the perception of pain in the mind. Taking advantage of placebo affects that accompany all real medical treatments is fair enough, but substituting alternative therapies that are nothing but placebo for real medicine is not in the best interest of patients.

And this is doubly true for veterinary patients. Lacking beliefs and expectations about their health, my patients cannot experience the placebo effect per se. Some improvement in symptoms may occur as a result of conditioning and the human contact associated with  therapy, but in general animals don’t enjoy the “benefit” of being fooled by their own minds into thinking an inert treatment has made them better. Unfortunately, animal owners and veterinarians are subject to being misled by non-specific treatment effects, and the “placebo-by-proxy” effect is quite potent. It creates an especially dangerous situation in which an animal’s caretakers believe they are helping the patient and the combination of cognitive errors and cognitive dissonance prevents them from appreciating that the animal’s condition is actually not improved.

The new NEJM paper demonstrates both how powerfully our own beliefs and expectations can fool us into feeling better and how careful we must be to distinguish this from actual improvement in our condition. The full article is behind a paywall, but a short summary is available.

Wechsler, ME. Kelley, JM. Ph.D. Boyd, IOE. Dutile,S. Marigowda, G. Kirsch, I. Israel, E. Kaptchuk, TJ. Active albuterol or placebo, sham acupuncture, or no intervention in asthma. N Engl J Med 2011; 365:119-126

Forty-six patients with asthma were randomly assigned to receive no treatment, or to treatment with an inhaled bronchodilator (albuterol, which opens up airways constricted by asthma), a placebo identical to the bronchodilator treatment, and sham acupuncture presented as “real” acupuncture (whatever that is). All patients were rotated through all the treatments and assessed after each, and the patients and investigators were blinded to the treatments insofar as possible. Obviously, patients and researchers could tell the difference between no treatment, an inhaler, and acupuncture. And as is always the case in studies of acupuncture, the acupuncturist undoubtedly knew that they weren’t providing what they would call genuine acupuncture treatment.

The patients were evaluated both in terms of their own perceptions of any improvement in their symptoms as well as an objective measure of their respiratory function. When given no treatment at all, patients reported an improvement in their symptoms of 21%. This likely represents a variety of non-specific treatment effects, such as the natural history of the disease, the aforementioned Hawthorne Effect, and so on. It also illustrates the value of a no-treatment group in clinical trials, when it is ethically possible to have one. This is an element of clinical trial design that sometimes gets inadequate attention in discussions of the pitfalls of medical research, though there is evidence that when such groups are included, the purportedly powerful effects of the placebo phenomenon become less impressive.

There was no difference in the improvement perceived by patients regardless of which of the other treatments they received. Between 45-50% improvement was reported after treatment with the albuterol inhaler, placebo inhaler, and sham acupuncture. So patients experienced nearly twice as much benefit from some treatment as from no treatment, but it made no difference whether the treatment was real or inert. This would seem to suggest that the placebo is a potent therapy and as good as a physiologically active medicine. After all, asthma symptoms are quite recognizable and uncomfortable, so it seems unlikely that such high rates of improvement would be only a function of the patients’ imagination. Perhaps there is something to this mind-body medicine idea, and alternative therapies really can make us better through placebo effects even if they don’t have any other effects?

Well, not so fast. In addition to asking the patients how they felt after each treatment, the investigators also measured their lung function, using an instrument that records, among other data, how much air the patients could force out of their lungs in a given period of time. It turns out that this objective measure showed a 20% improvement with the bronchodilator inhaler, but a significantly lower 7% improvement with the inert therapies or no treatment at all. So while the patients couldn’t tell the difference between real and fake therapies, their lungs certainly could.

This illustrates what I think is the key point to understand about the placebo effect: It can make us feel better without actually affecting our physical health. In any discussion of the placebo effect, we must bear this fact in mind. There is no magical power of mind over body involved. Placebo treatments affect our perceptions of our symptoms, but they do not improve our underlying medical condition.

It is a desirable and appropriate for doctors to make their patients feel better, but it is not enough to do so only in ways that leave the physical health of the patient fundamentally unchanged. We owe it to our patients to apply rigorous scientific methods to investigating our therapies and to developing interventions which actually treat the cause of the symptoms, not just the patients’ perceptions of them.

There is nothing wrong with taking advantage of placebo effects that inevitably accompany therapeutic interactions. But I believe it is unethical to employ therapies which are demonstrated to have only placebo effects, particularly when interventions that actually treat the underlying medical condition are available. And as a veterinarian, I am strongly opposed to using treatments that clearly work in humans only through belief and expectation, since these are very likely to mislead owners into believing the therapy is working without actually benefitting the patient.

This study illustrates both the power of the placebo effect to make us experience marked improvements in seemingly undeniable disease symptoms and also the powerlessness of the placebo effect to improve our physical health. It shows how easy it is for us to be fooled concerning the effectiveness of a medical therapy by our personal experiences as patients and doctors, as well as how easily a clinical study can generate the false impression of a beneficial therapeutic effect if placebo and no-treatment controls and objective outcome measures are not employed. Finally, it provides a point of evidence against the currently popular contention that even though some alternative therapies cannot be shown to have effects greater than placebo, they can be viewed as having real benefits by means of the placebo effect and the power of mind over body. At best, placebo effects can alter our perceptions of our symptoms to reduce our discomfort. But they cannot fundamentally improve our physical health, and there is real danger in believing they can if it leads us to rely on therapies that are only placebos.

Posted in General | 6 Comments

Prolotherapy for Dogs and Cats

Posted on July 14, 2011 by skeptvet

What Is It?
Prolotherapy is a commonly offered alternative treatment for joint, connective tissue, and back pain. The practice consists of injecting substances into painful or dysfunctional joints and connective tissue with the intent of relieving discomfort and restoring function. There is a wide range of substances that are used with a much variation among practitioners of prolotherapy. Examples of these substances include: dextrose or other sugars, Vitamin B12, local anesthetic agents, a wide variety of herbal products, homeopathic remedies, zinc sulfate, the patient’s own blood, and hundreds of others. Often, cocktails of multiple substances are used based on the individual preferences of the practitioner.

The theoretical rationale for the practice is that the substances injected into damaged joints or connective tissue will cause inflammation and chemical or cellular activity that will lead to repair of the affected tissues. (1,2) The logic of this theory is questionable. For one thing, inflammation is a normal physiologic response to tissue injury, and is already present in damaged tissues and joints. However, the evidence is clear that excessive or prolonged inflammation interferes with healing. Arthritis, a disorder prolotherapy is supposed to treat, is by definition chronic inflammation of joints, and this inflammation is known to cause much of the pain and tissue damage associated with arthritis. In general, excessive or chronic inflammation does more harm than good, and many conventional and alternative medical therapies are intended to reduce the deleterious effects of inflammation, so deliberately causing it to induce healing seems a dubious approach.

There are theoretical arguments involving the stimulation of cells involved in healing, such as fibroblasts, or the release of growth factors and other substances that are associated with tissue repair, which might plausibly explain how prolotherapy could be beneficial. However, the in vitro research to date suggests the effects of prolotherapy agents on tissues are broad and non-specific, and such effects are as likely to be harmful as beneficial. The underlying theory is questionable but not impossible. However, without a clearly demonstrated physiological mechanism and consistent animal model and clinical research evidence, it is not enough to justify the use of this therapy or the claims often made for it.

Does It Work?
There have been a number of studies and reviews investigating the use of prolotherapy in humans, and more are ongoing. Overall, the evidence has been mixed and of generally low quality. A Cochrane Review of prolotherapy for lower back pain examined five studies involving 366 people.(3) The review concluded,

There is conflicting evidence regarding the efficacy of prolotherapy injections for patients with chronic low-back pain. When used alone, prolotherapy is not an effective treatment for chronic low-back pain. When combined with spinal manipulation, exercise, and other co-interventions, prolotherapy may improve chronic low-back pain and disability. Conclusions are confounded by clinical heterogeneity amongst studies and by the presence of co-interventions.

The insurance companies Aetna and Cigna and the Veterans Administration have published extensive reviews of the scientific literature on prolotherapy.(4,5,6) The reviews conclude:

Aetna:

Aetna considers prolotherapy (also known as proliferant therapy or proliferation therapy) experimental and investigational for any indications because there is inadequate evidence of its effectiveness.


Cigna:

Medical studies in the literature evaluating this technology present few randomized, double-blind clinical trials that had adequate sample size and controls and that used objective outcome measures. Additionally, studies have not successfully supported the use of prolotherapy as an effective treatment for joint or ligament instability. Furthermore, several systematic reviews, a Cochrane review, and technology assessments have reported prolotherapy injections have not been proven to be as effective as or more effective than placebo injections. Additional randomized studies are needed to evaluate the efficacy of prolotherapy for joint or ligament instability. The evidence in the peer-reviewed, published scientific literature is insufficient to support the use of prolotherapy for any therapeutic indication.

 

Veterans Administration

Although proponents have advocated the use of prolotherapy for a range of indications, relatively few clinical uses have been studied systematically or published in the peer-reviewed literature. Results of the most recent systematic reviews are inconclusive for demonstrating the effectiveness of prolotherapy for treatment of musculoskeletal pain, and new evidence from case series would not alter these conclusions. The majority of published experimental studies have included conservative therapy with prolotherapy for relief of chronic low back pain, and to a lesser extent, osteoarthritis of the knee with varying results. Sample sizes have been insufficient on which to base national policy decisions.

These reviews are particularly useful as sources of references to studies examining prolotherapy. Reviewing the studies cited in these summaries, it is clear that the majority of positive results stem from trials without proper controls: randomization of subjects, placebo or no treatment control groups, proper blinding, etc. And because the agents used and other aspects of the treatments are inconsistent between studies, it is difficult to compare studies or to generalize from one study to a different prolotherapy treatment approach, and it is impossible to combine small studies in meta-analyses that might have greater power to determine if the treatment is truly effective.

It  is often the case that smaller and less rigorously designed studies tend to have positive conclusions. As the quality and quantity of research improves, many of these results turn out not to be trustworthy. Prolotherapy in humans is currently supported by a limited quantity of low-quality research. Until stronger evidence accumulates, if it does, the practice should be viewed as an experimental therapy of unknown benefits and reserved for circumstances in which conservative management and established conventional therapies are unsuccessful.

As is also often the case, there are absolutely no rigorous, controlled clinical studies of prolotherapy in dogs and cats. The use of this approach in pets is based entirely on anecdotal evidence, which is highly unreliable, and on extrapolation from human medicine, in which the practice has little supportive evidence and is not widely accepted as a legitimate therapy. Prolotherapy might be justifiable as an experimental intervention in cases in which better studied therapies with more established physiological rationales have failed or cannot be used, but it should not be marketed with strong claims of “proven” benefits, and it should not be used in lieu of conventional treatment.

 Is it Safe?
Any injection into a joint must be done with careful attention to technique to avoid introducing infection or damaging tissues, and sedation may be necessary for such treatments, so these are risks associated with but not unique to prolotherapy treatment of joints. In humans, there have been limited efforts to assess the risks of prolotherapy. One survey of practitioners of this treatment has been reported.(7)

Dagenias et al. (2006) studied the effects and adverse events related to prolotherapy for back and neck pain. The authors conducted a practitioner postal survey evaluating prolotherapy for back and neck pain in the United States and Canada. Surveys were mailed to members of the American Academy of Orthopaedic Medicine (AAOM) and the American College of Osteopathic Pain Management and Sclerotherapy (ACOPMS), both closely affiliated with prolotherapy conference, in addition to nonmembers attending the 2004 AAOM annual conference. A 50% response rate was obtained. The authors published that the side effect with the highest estimated median prevalence was temporary post-injection pain (70%), stiffness (25%), bruising (5%), and temporary numbness (1%). The most commonly reported adverse events (total of 472) were spinal headache (n=164), pneumothorax (n=123), temporary systemic reactions (n=73) and nerve damage (n=54). A total of 69 adverse events required hospitalization, and five resulted in permanent injury, secondary to nerve damage. Almost 98% of the respondents held MD or DO degrees, and 83% were board certified in related disciplines. The authors concluded that to better assess the true risk of adverse events related to prolotherapy, further well-designed clinical trials that are designed to over-come bias inherent to practitioner surveys are needed.

Overall, prolotherapy likely presents a low to moderate risk depending on the agents used and the skill and experience of the practitioner.

Bottom Line
Prolotherapy is a purported treatment for connective tissue and joint pain and disability. It involves injecting substances which induce inflammation and other chemical and cellular reactions into affected tissues. These reactions are theorized to relieve pain and improve function. The logic of this theory is questionable, and no clear mechanism for beneficial effects from prolotherapy has been described, but it is possible that the theory could be valid.

The clinical research on prolotherapy in humans is generally of low quality and results have been mixed. There is great variation in the techniques used by different investigators, so it is difficult to compare or generalize between studies.

There is virtually no controlled research investigating prolotherapy in companion animals, and all claims made for safety and efficacy in these species are based solely on anecdotal evidence.

The use of proltherapy in pets should be viewed as experimental with unknown risks and benefits. Such treatments should be reserved for patients that have significant symptoms that have failed to respond or cannot be treated by conventional means.

References
1. Banks, A.R. A rationale for prolotherapy. Journal of Orthopaedic Medicine. 1991;13(3). Accessed at http://www.prolotherapy.com/articles/banks.htm July 13, 2011.

2. Robinson, NG. Prolotherapy for pain. 2007. Accessed    at http://csuvets.colostate.edu/pain/Articlespdf/Prolotherapy%20for%20Pain.pdf July 13, 2011.

3. Dagenais S, Yelland MJ, Del Mar C, Schoene ML. Prolotherapy injections for chronic low-back pain. Cochrane Database of Systematic Reviews 2007, Issue 2.

4. Aetna. Clinical Policy Bulletin: Prolotherapy. Last revised May 24, 2011. Accessed at http://www.aetna.com/cpb/medical/data/200_299/0207.html July 13, 2011.

5. Cigna HealthCare Coverage Position: Prolotherapy. Last revised December 15, 2006. Accessed at http://stage.cigna.com/health/provider/medical/procedural/coverage_positions/medical/mm_0006_coveragepositioncriteria_prolotherapy.pdf July 13, 2011.

6. Adams E. Bibliography: Prolotherapy for musculoskeletal pain. Boston, MA: Veterans Administration Technology Assessment Program (VATAP); April 2008.

7. Dagenais S, Ogunseitan O, Haldeman S, Wooley JR, Newcomb RL. Side effects and adverse events related to intraligamentous injection of sclerosing solutions (prolotherapy) for back and neck pain: A survey of practitioners. Arch Phys Med Rehabil. 2006 Jul;87(7):909-13.

Posted in General | 13 Comments

Pressure Wraps for Anxiety in Dogs

Posted on July 10, 2011 by skeptvet

Here is another excellent, informative post from contributing author and dog trainer Kyzyl.

Pressure Wraps for Anxiety and Fearful Behavior

Fear is a set of evolutionarily important behaviors for animals.  Fear often keeps animals alive in a dangerous world by teaching them to avoid things that could bring about their untimely end.  However, when fearfulness runs out of control or is coupled with common, innocuous events, it can become a serious behavior problem for pets and their owners.  Whether it is associated with specific triggers, such as car rides, thunderstorms, and veterinary visits, or generalized, excessive anxiety and fearfulness can intensify to the point where normal functioning becomes impossible, and pets can act out in extreme ways including aggressively, urinating and defecating on themselves, or shutting down completely when forced into situations that trigger fear. 

If your dog has moderate or severe problems with fear, there are a limited number of treatments to help alleviate anxiety including behavior modification and drug therapy. Behavior modification, when done effectively, is very successful at alleviating considerable amounts of stress due to specific stimuli.  Behavior modification plans for fearful dogs often consist of two techniques: counter conditioning and systematic desensitization. These techniques change behavior by changing the underlying emotional state of the dog, therefore relieving the stress and anxiety of the fear-based behavior (8). In severe cases, vets might also prescribe a sedative to help with specific situations like grooming or veterinary visits or general anxiety or an anti-anxiety medication to reduce fear enough to improve the patient’s quality of life and allow behavior modification a chance to work.

However, behavior modification techniques are often very difficult for owners to execute correctly.  Behavior modification tools require training skill and time, neither or which average owners can often provide.  And many owners are also very reluctant to medicate their pets for behavior problems. 

As a result, many owners and trainers have turned to alternative therapies that promise great results for treating phobic behavior, one of which is pressure wraps.  Commercial pressure wraps (the Anxiety Wrap® and the ThundershirtTM) use elastic fabric and velcro to create a tight-fitting garment that is worn during anxiety-causing events.  When fitted properly, the garment creates distributed pressure over the chest, sides, and back that supposedly has a calming effect.

How do they work?  According to the ThundershirtTM website, several reasons were listed as evidence for why the product’s gentle pressure worked to calm anxious behavior (10).  These include a reference to people with autism using pressure to relieve anxiety, swaddling as a method of calming upset babies, acupressure, and TTouch practitioners using pressure to address anxiety. These are not high-quality sources of evidence, but interesting ideas to consider none the less. 

While there is little research on touch and pressure therapies in dogs, the effects of these therapies have been studied in humans and other mammals.  Touch is critical for normal development of infant rats and humans and profoundly affects our social interactions (1,2,9).   We know that touch, especially deep touch such as a hug, releases endorphins that promote relief from pain and a sense of well-being and self-reported improvement of symptoms of compulsive disorders and depression in humans(1,2).  

Massage has long been used to successfully address issues with musculoskeletal pain,   but when used to treat anxiety in people results have been both positive and negative leading to an inconclusive answer on whether or not it is useful treatment for anxiety (1,3,4,5). 

Knowing that generally pressure and touch have effects on people, and by extension pets, makes evaluating claims of specific systems that employ it very difficult.  Firstly, since general touching provides many of the benefits claimed through the system, it may be that the specific motions, actions, or places suggested by different systems of touching are not as important as the act of touching itself.  Without controlling for these general effects, one can never be sure if positive results are due to the general effects or more specific effects of the system’s protocol. 

Other modalities supporting pressure for anxiety relief, such as acupressure and Tellington TTouch®, have very little supporting evidence.  Acupressure, a variation on acupuncture where acu-points are pressed to influence the flow of qi, has been addressed several times on this blog (12).  In the great majority of cases, it has no specific effect beyond placebo or sham treatments.  Tellington TTouch® combines specific touches with exercises in order to, as its website claims, “activate the function of cells and awaken cellular intelligence” (16).  (Though anxiety and fear may be a big problem for a dog, I doubt it has much to do with how ‘intelligent’ its cells are.)  Despite the complicated protocols and mystical thinking called for by both, no evidence these modalities work beyond the general effects of touching.

The effects of touch seem to be best studied in systems with human contact, touch by a human, and there is no reason to think that touching by inanimate objects would have the same effects.  A supporting example referenced on the ThundershirtTM website illustrates this: swaddling babies.  Is it the tight wrapping that calms the child, or the warm touch of its mother?  These claims should be evaluated separately to determine the effectiveness of a pressure wrap.

What is the specific evidence for pressure wraps?  People with autism report anecdotally feeling at ease when experiencing pressure from inanimate objects. Dr. Temple Grandin, who is referenced on the ThundershirtTM website (10), developed a hugging machine to help her through anxiety related to autism..  This machine allowed the user to control the duration and intensity of pressure applied to his or her body.  In preliminary, uncontrolled trials, both autistic and neurotypical people suffering from anxiety self-reported improvement (6).  Despite initial research being promising, this hypothesis has garnered little support in the scientific literature over the past decade.

However, there are major differences between the hug machine and pressure wraps which are meant to reproduce its calming effects. Pressure wraps apply a constant pressure not under user control.  Also, pressure wraps likely do not produce the same type of deep pressure as the machine.  A pressure wrap, similar to those for dogs, was developed for autistic children seeking to replicate the effects of the machine have not had success in relieving anxiety in stressful situations (ref). 

Several professionals report success in the ‘testimonial’ section of the products’ websites (10), reporting dramatic and immediate improvement of anxious and fearful behavior in dogs wearing these wraps.  They both make fantastic claims that their wraps can correct problems ranging from behaviors associated with phobias to pulling on leash during walks, with very little cited research or concrete numbers to back up these claims.

While these anecdotal reports from professionals certainly justify interest in conducting trials, they do not necessarily support the confident claims made on the product websites.  The problem with anecdotes is that they often only tell the story we want to hear, they don’t describe the truth of a situation.  Humans have very selective memories, often remembering only the details that support a line of thought (conformation bias: 14,15), so that details or cases that don’t support the thought are forgotten or neglected.  Furthermore, companies have great financial motivation to only share extremely successful cases and ignore all the wraps they sold that didn’t work as advertised.  Customers reports in which the wraps didn’t work don’t often make it to the ‘testimonial‘ page, but plenty have shown up in product review pages for third party sites such as Amazon.com, in which 30-40% of reviewers said that the Thundershirt had little or no effect on their dog’s anxiety(11).

Strong evidence for the effectiveness of pressure wraps would come from trials looking at the effect of pressure wraps compared to controls for each of the behavior problems listed. I was unable to find any controlled trials that test for efficacy of pressure wraps for any dog behavior problems, much less the long list of problems each product’s website claimed to solve.  (If you should know of any trials, please let me know.)  Other than one clinical trial still enrolling at Tufts University’s Veterinary School (13), I have found no evidence that either company has attempted to at all test the claims they make for their pressure wraps for dog behavior problems.

So maybe pressure wraps work, and maybe they don’t. If they don’t hurt, why not try them out? The biggest concerning of using a pressure wrap is one of the more dangerous aspects of using alternative therapies: giving up on conventional treatments that do work.  On its website, the ThundershirtTM insists that no training is needed for these wraps to work, simply strap it on and all the behavior problems lessen or go away.  By not engaging in behavior modification, particularly systematic desensitization, the emotional state causing fearful or anxious behavior will never be addressed.  And for this training to work, often times medication must be used to lessen anxiety to a manageable level.  Much like putting a bandaid on an infected sore, simply using the pressure wrap may only serve to mask visible symptoms without curing the underlying infection.  With no real treatment, a pet could continue to quietly suffer from fear or anxiety.

In conclusion, I find no high-quality evidence that pressure wraps, such as the Anxiety Wrap® or ThundershirtTM, help or correct behavior problems including those associated with anxiety or fearfulness.  Their principle idea, that distributed pressure calms the nervous system and relieves behavior problems in dogs, remains an intriguing, yet unsupported, hypothesis.  While pressure wraps are most likely safe to use, they should not be considered a replacement for more conventional treatments such as behavior modification and drug therapy.

 

1.  Fields, T.M. 1998.  Touch Therapy Effects on Development.  International Journal of Behavioral Development 1998 22: 779-797.

2.  Haans, A. and IJsselsteijn, W. 2006. Mediated social touch: a review of current research and future directions. Virtual Reality 9(2-3): 149–159.

3.  Heidt, P. 1981. Effect of therapeutic touch on anxiet level of hospitalized patients. Nusing Research 30(1): 32-37.

4.  Ferrell-Torry, A.T. and Glick, O. J. 1993. The use of therapeutic massage as a nursing intervention to modify anxiety and the perception of cancer pain. Cancer Nursing 16(2): 93-101.

5.  Randolph, G.L. 1984. Therapeutic and physical touch: physiological response to stressful stimuli. Nursing Research 33(1): 33-37.

6.  Grandin, T. 1992. Calming effects of deep touch pressure in patients with autistic disorder, college students, and animals. Journal of Child and Adolescent Psychopharmacology 2(1): 63-72.

7.  LaChappelle, R. 2009. Use of a Pressure Vest to Reduce the Physiological Arousal of People with Profound Intellectual and Physical Disabilities During Routine Nail Care. Thesis. Dept of Occupational Therapy, East Carolina Univ.

8.  Butler, R., Sargisson, R.J., Elliffe, D. 2011. The efficacy of systematic desensitization for treating the separation-related problem behaviour of domestic dogs. Applied Animal Behaviour Science 129: 136–145.

9.  Field, T. 2010. Touch for socioemotional and physical well-being: A review. Developmental Review 30: 367–383.

10.              Thundershirt website: http://www.thundershirt.com/

11.              Amazon product page for Thundershirt by Ovris: http://www.amazon.com/Thundershirt-Dog-Anxiety-Treatment-Large/dp/B0028QK6EY

12.              Acupuncture category on Skeptvet Blog: http://skeptvet.com/Blog/category/acupuncture/

13. Clinical Trials: The use of the Thundershirt to alleviate anxiety in hospitalized canine patients. Cummings School of Veterinary Medicine, Tufts Univ. http://cgi.vet.tufts.edu/clinical_trials/projects/the_use_of_the_thundershirt_to_alleviate_anxiety_in_hospitalized_canine_patients Accessed: 8 July 2011.

14. Conformation Bias, Wikipedia: http://en.wikipedia.org/wiki/Confirmation_bias Accessed: 8 July 2011.

15. SkeptVet. Why We’re Often Wrong. http://www.skeptvet.com/index.php?p=1_13_Why-We-re-Often-Wrong Accessed: 8 July 2011.

16. Tellington TTouch®: What is TTouch®?http://www.ttouch.com/whyTTouch.shtml Accessed: 8 July 2011.

 

 

 

 

 

 

Posted in Guest Posts | 34 Comments

Vitamin K3 (menadione) in Pet Food: Is It Safe?

Posted on July 8, 2011 by skeptvet

One of the most popular fallacies that arises in discussions of pet health is the appeal to nature or naturalistic fallacy. Simply put, this is the notion that what is labeled “natural” is inherently safe, beneficial, or otherwise good, and what is labeled “artificial” is inherently unsafe, harmful, or bad. This argument fails on many levels. For one thing, the distinction between natural and artificial is often quite arbitrary and based on ideology rather than any rational criteria. How could any food crop, which consists of huge, bizarrely
mutated plants that could never survive without cultivation, be natural? For
that matter, how could most breeds of dog be considered natural when they have
been so dramatically altered in form and function by thousands of years of controlled breeding? Is wearing clothes, washing our hands with soap, cooking our food, or really any of the basic health and safety practices we follow routinely natural if we are the only species who employs them?

The appeal to nature fallacy also fails on the simple basis of being demonstrably untrue. Arguably natural things like Salmonella, hookworm, bubonic plague, and uranium are clearly dangerous. And clearly artificial things like vaccines, antibiotics, and modern sewage and water treatment systems are the only reason the majority of human beings gets to live past childhood these days. So whenever the only basis for declaring something
good or bad for your pets appears to be the idea that it is natural or artificial, it is wise to be very skeptical of such claims and look for more reliable evidence.

A perennial example easily found on the Internet is Vitamin K3 (menadione) in pet foods. Vitamin K is an essential nutrient needed in very low levels by dogs and cats. It is required for producing the substances that allow blood to clot and prevent us from bleeding to death from every little scratch. Most rat poisons consist of chemicals that interfere with Vitamin K, and these common and very dangerous poisons frequently lead to dogs coming into the veterinarian’s office with severe, uncontrollable bleeding. Fortunately, in
most cases these patients can be saved, and the cornerstone of their treatment
is Vitamin K replacement.

Most of the Vitamin K dogs and cats need is manufactured by bacteria in the gastrointestinal system and absorbed from there, so dietary requirements are miniscule. The one known exception is that cats fed diets with a high proportion of fish oil in them have developed Vitamin K deficiency and bleeding problems. Since fish as a protein source and fish oil as a supplement are becoming more widespread, it is possible that this problem could be seen more frequently. In general, however, the amount of dietary Vitamin K required by dogs and cats is still very, very small.

Plant and animal sources of Vitamin K include two types, Vitamin K1 and Vitamin K2. Vitamin K3, or menadione, is a synthetic form of Vitamin K. By itself, it has little biological activity, but it can be converted to a more active form by bacteria in the gut and other pathways. It is useful as a Vitamin K supplement in pet foods because it is more stable and tolerates heating better than the other forms of Vitamin K. Advocates of
“natural” medicine and nutrition often claim, however, that unlike these other forms, Vitamin K3 is toxic to dogs and cats. So what is the basis for this?

Of course, the first foundation “natural” medicine advocates use for claiming menadione is harmful and should be replaced with Vitamins K1 or K2 is the appeal to nature fallacy. As I’ve already pointed out, this is a meaningless claim which tells us nothing about the safety of any food or supplement. So what about other, more meaningful forms of evidence?

Well, to begin with, no case of toxic effects from menadione in commercial dog or cat food has ever been substantiated. Millions of pets have been consuming this vitamin for
decades, so if the supplement were to have any significant potential risk, one
would expect many documented cases of harm. This is, at least, the basis
“natural” medicine advocates use to claim that the herbal products and dietary supplements they recommend are safe. Unfortunately, without any systematic effort to monitor for such events the best we can say is that there does not appear to be a large or common risk, though we cannot rule out the possibility of some negative effects in some individuals solely on the basis that such cases have not been reported.

There is some laboratory research and pre-clinical animal studies that look at the safety of menadione. These have found that toxic effects can be seen on isolated cells, rats, and other animal models in the laboratory, but at levels tremendously higher than could ever be achieved by eating foods supplemented with Vitamin K3. This points out another common fallacy employed by so-called “holistic” medicine practitioners, the
notion that chemical compounds are inherently either toxic or safe. The reality
is that toxic effects are a function of the dose or amount of a substance one
is exposed to, the route of exposure, the individual’s susceptibility, and many other factors. Water and oxygen are toxic at high enough doses and under the right circumstances. And deadly natural poisons such as curare and other animal toxins can have beneficial medical uses if handled and dosed appropriately. So it is meaningless to simply label something as
“toxic” and ignore the devil in the details.

It turns out that doses of menadione needed to cause health problems are more than 1000 times greater than could be gotten through food supplementation, and the studies showing toxic effects usually involve injecting the vitamin into animals at high doses, not providing it in food in miniscule amounts. It is true that Vitamin K3 supplements for human use have been banned by the Food and Drug Administration (FDA), however this is because
of the potential for very large exposures when humans irrationally choose to take extreme quantities of dietary supplements. The FDA does permit the use of menadione in animal feeds because the consumers, our pets, are unlikely to make similar mistakes. When the toxic dose is more than can be found in an entire bag of food, the risk of accidental exposure to harmful levels is negligible.

Bottom Line
Under normal circumstances, dogs and cats need extremely small amounts of dietary Vitamin K. At the low levels of supplementation in commercial foods, menadione is a safe source of this Vitamin K. Toxic effects can be seen when enormous quantities are given to an animal or when menadione is used injectably, but there are no documented cases of any harmful effects from dietary supplementation of menadione in commercial pet foods. The three veterinary nutritionists and one veterinary toxicologist I consulted on this
issue all agreed that there is no evidence of any significant risk from menadione in commercial pet foods. The concerns about this supplement seem to stem almost entirely from the appeal to nature fallacy and from the mistaken belief that substances are inherently either safe or toxic regardless of dose or route of exposure.

 

Posted in Nutrition | 57 Comments