SkeptVet’s Acupuncture Adventure- Part 6: Neuromodulation of Cranial Nerves

The latest lectures in my acupuncture course have covered the use of acupuncture (and, incidentally, massage and laser therapy) for “neuromodulation” of the twelve cranial nerves. “Neuromodulation” is a somewhat vague term often used to suggest some clinically relevant and likely beneficial effect on the function of the nervous system. More casually, this is described with terms like “give it a boost” or “help that nerve be a happier nerve.” This is a theme in this course, in which the fact that needling, electrical stimulation, and possibly laser stimulation have measurable effects on nerves is assumed to imply clinically meaningful and beneficial effects in patients. As I’ve said before, this is a plausible hypothesis, but it has to be proven with appropriate clinical research, which often turns out not to be the case.

Many of the cranial nerves are not directly accessible, and often they have functions that are not likely to be associated with clinical problems we deal with in veterinary patients. However, some nerves, especially CN V, VII, VIII and X do have functions associated with fairly common and important clinical problems, so modulation of these functions could potentially have clinical value.

Much is made in these lectures of the anatomic relationships between elements of the nervous system, with the implication that these anatomic connections imply relevant functional connections we can manipulate with acupuncture. However, it is important to realize that one can’t reliably infer functional relationships solely form anatomic relationships. Exercise, for example, stimulates gastrointestinal motility despite the lack of a simple and obvious anatomic relationship to predict this. On the other hand, the spinal cord is pretty widely and directly connected to nearly everything in the body, yet the evidence is strong that chiropractic manipulation of the spine has virtually no significant effects on the body apart from the spine itself. The obvious anatomic relationship turns out not to have a corresponding functional relationship.

The real question, of course, is whether there is actual clinical value to acupuncture etc. in patients with problems that we might reasonable suspect could be influenced by modulation of cranial nerves. That seems to be far from clear based on the evidence presented in these lectures.

As an example, the role of acupuncture in controlling seizures is mentioned several times. Direct and indirect stimulation of CN V and CN X are suggested as likely ways to influence seizures due to anatomic and functional relationships between these nerves and the parasympathetic nervous system, which does play a role in controlling seizure activity. And there is evidence that direct stimulation of CN X via an implanted electrical nerve stimulator. However, this is clearly not the same thing as acupuncture. So what does the clinical evidence suggest?

As usual, there is poor evidence in veterinary patients. A couple of uncontrolled studies in dogs have been done. One suggested improvement in seizure frequency, but such improvement has also been seen in epileptic dogs receiving placebo treatment, so uncontrolled studies can’t be taken as reliable evidence of an effect. The evidence is still limited and at high risk of bias in humans, but there is more research, and reviews do not suggest a strong or repeatable clinical benefit.

Cheuk DK, Wong V. Acupuncture for epilepsy. Cochrane Database Syst Rev. 2014 May 7;5:

MAIN RESULTS:
We included 17 RCTs with 1538 participants that had a wide age range and were suffering mainly from generalized epilepsy. The duration of treatment varied from 7.5 weeks to 1 year. All included trials had a high risk of bias with short follow-up. treatment in the included trials.

AUTHORS’ CONCLUSIONS:
Available RCTs are small, heterogeneous and have high risk of bias. The current evidence does not support acupuncture for treating epilepsy.

Yang C, Hao Z, Zhang LL, Guo Q. Efficacy and safety of acupuncture in children: an overview of systematic reviews. Pediatr Res. 2015 Aug;78(2):112-9.

Abstract
We aim to update the evidence for the efficacy and safety of acupuncture for children and evaluate the methodological qualities of these studies to improve future research in this area. We included 24 systematic reviews, comprising 142 randomized controlled trials (RCTs) with 12,787 participants. Only 25% (6/24) reviews were considered to be high quality (10.00?±?0.63). High-quality systematic reviews and Cochrane systematic reviews tend to yield neutral or negative results (P = 0.052, 0.009 respectively). The efficacy of acupuncture for five diseases (Cerebral Palsy (CP), nocturnal enuresis, tic disorders, amblyopia, and pain reduction) is promising. It was unclear for hypoxic ischemic encephalopathy, attention deficit hyperactivity disorder, mumps, autism spectrum disorder (ASD), asthma, nausea/vomiting, and myopia. Acupuncture is not effective for epilepsy. Only six reviews reported adverse events (AEs) and no fatal side effects were reported. The efficacy of acupuncture for some diseases is promising and there have been no fatal side effects reported. Further high-quality studies are justified, with five diseases in particular as research priorities.

Another example was the condition of xerostomia or “dry mouth.”  This can occur with radiation or surgical therapy around the mouth as well as for other reasons, It is hard to assess in veterinary patients and so not a regular target for therapy, but it is used as an example in these lectures of clinical benefits from neuromodulation through acupuncture, in this case of CN IX. However, the evidence in humans does not suggest that the theoretical benefits of acupuncture stimulation of CN IX translate into significant benefits for actual patients with xerostomia.

Jedel E. J Oral Rehabil 2005 Jun;32(6):392-6. Acupuncture in xerostomia–a systematic review.

Abstract
The aim of this systematic review was to assess the efficacy of acupuncture in the management of xerostomia….Three articles met the criteria for inclusion and a criteria list was used to assess the quality of these studies. The studies were considered to be of high quality or low quality in accordance with the criteria list utilized. The results of the trials were considered positive, negative or indifferent based on statistically significant between group differences. The criteria list utilized indicate that one of the three studies was of high quality and it presents indifferent results. One of the two studies of low quality presents positive results and one presents indifferent results. An analysis of the results degree of evidence resulted in no evidence for the efficacy of acupuncture in the management of xerostomia. This systematic review shows that there is no evidence for the efficacy of acupuncture in the management of xerostomia. There is a need for future high quality randomized controlled trials.

Wu X, Chung VCh, Hui EP, et al. Effectiveness of acupuncture and related therapies for palliative care of cancer: overview of systematic reviews. Sci Rep. 2015 Nov 26;5:16776.

Abstract
…There is evidence for the therapeutic effects of acupuncture for the management of cancer-related fatigue, chemotherapy-induced nausea and vomiting and leucopenia in patients with cancer. There is conflicting evidence regarding the treatment of cancer-related pain, hot flashes and hiccups, and improving patients’ quality of life. The available evidence is currently insufficient to support or refute the potential of acupuncture and related therapies in the management of xerostomia, dyspnea and lymphedema and in the improvement of psychological well-being. No serious adverse effects were reported in any study.

Hanchanale S, Adkinson L, Daniel S, et al. Systematic literature review: xerostomia in advanced cancer patients. Support Care Cancer. 2015 Mar;23(3):881-8.

Abstract
CONCLUSION:
Limited published data exists reporting the effectiveness of measures in the treatment of xerostomia in cancer patients. Based on primary research of low quality, firm conclusions cannot be drawn. However, pilocarpine, artificial saliva, chewing gum and acupuncture can be tried based on the available data. This highlights the explicit need to improve our evidence base. Properly constructed randomized controlled trials demonstrating effectiveness of pharmacological and non-pharmacological interventions for dry mouth are required.

Furness S, Bryan G, McMillan R, et al. Interventions for the management of dry mouth: non-pharmacological interventions. Cochrane Database Syst Rev. 2013 Sep 5;9:CD009603.

There were nine studies (total 366 participants randomised) included in this review of non-pharmacological interventions for dry mouth which were divided into three comparisons. Eight studies were assessed at high risk of bias in at least one domain and the remaining study was at unclear risk of bias….There is low quality evidence that acupuncture is no different from placebo acupuncture with regard to dry mouth symptoms, which is the most important outcome …There is insufficient evidence to determine the effects of electrostimulation devices on dry mouth symptoms. It is well known that dry mouth symptoms may be problematic even when saliva production is increased, yet only two of the trials that evaluated acupuncture reported dry mouth symptoms, a worrying reporting bias. There is some low quality evidence that acupuncture results in a small increase in saliva production in patients with dry mouth following radiotherapy….Reported adverse effects of acupuncture are mild and of short duration, and there were no reported adverse effects from electrostimulation.

Similar results are found when the other main examples of purported neuromodulation of cranial nerves through acupuncture are investigated. What this says to be is that despite plausible anatomic relationships that suggest acupuncture could be useful in altering the function of these nerves to the benefit of patients, it seems to be very difficult to prove in the real world. This might mean we need more and better research, as the reviews usually conclude. Or it might mean that there is no effect to find. Certainly, therapies with a strong and definitive benefit aren’t not usually difficult to validate in clinical research, so the difficulty in showing benefits for acupuncture is reason for some skepticism.

Posted in Acupuncture | 8 Comments

Ahhh, Dr. Google

I’ve always made it a point to remind people that expertise is low-level evidence. Plenty of folks with advanced scientific training hold blatantly untrue, anti-science views. The notion that who you are is sufficient to prove what you claim true is known as the Appeal to Authority fallacy. Being an expert (especially a self-proclaimed one) doesn’t mean your claims should be accepted without further evidence.

However, it is also false that all opinions are equally likely to be true and that expertise carries no evidentiary weight at all. Surgeons do surgery and pilots fly airplanes better than people without training in those fields, and legitimate experts with recognized credentials are more likely to have credible opinions and information about subjects within their area of expertise.

The trick is to balance the excessive respect for expertise that leads to uncritical acceptance of claims contrary to evidence with the illusion that one can make judgements about absolutely anything that are just as sound as people who truly are experts in those subjects. The appeal to authority problem comes up most frequently here, with vets or others in medicine making false claims and expecting them to be accepted without evidence beyond their word. However, in my daily life as a practicing vet, the more common problem I see is the belief that expertise is irrelevant and anyone’s opinion is as likely to be true as that of someone with formal training and experience in medicine.

Just last month, I saw a client who became very angry, and quite abusive, when I refused to prescribe a drug she wanted for her cat. When I tried to explain why the drug was not going to help her pet, and was more likely to do harm than good, she kept saying “That’s just your opinion” and “I read on the internet that he needs that drug.” Though I’ve run into this before, I still found this woman’s faith in the advice of anonymous strangers and random web site above the actual veterinarian who was seeing her and her cat pretty stunning.

Fortunately, just this week I ran across two lovely comments on this problem which I thought I would share. The first is a coffee cup I dearly hope someone will get me for Christmas.

Google search coffee

 

The second is the latest offering from Veterinary Chanteuse Extraordinaire Kelsey Beth Carpenter:

 

Posted in Humor | 7 Comments

Are Homeopaths Innocent Victims of Skeptical Attacks?

Homeopaths often claim they are being unfairly “attacked” when skeptics point out that homeopathy is irrational, pseudoscientific, or simply ineffective. They portray themselves as innocently minding their own business until we spontaneously attack them. This ignores the reality, however, that homeopaths frequently promote homeopathy as an alternative to scientific medicine, and they often do so with their own vigorous criticism of conventional veterinary medicine. Here are a few examples:

Did you know that conventional veterinary medicine (excluding surgical options) and its conventional drug therapies – is capable of relieving symptoms but not curing your pet? If you have a pet you love or farm animals you care for – homeopathy is the only system of veterinary medicine that holds the potential to actually cure animals of disease.
Academy of Veterinary Homeopathy Facebook page

Veterinarians and animal guardians have to come to realise that they are not protecting animals from disease by annual vaccinations, but in fact, are destroying the health and immune systems of these same animals they love and care for. Homeopathic veterinarians and other holistic practitioners have maintained for some time that vaccinations do more harm than they provide benefits.
Dr. Charles E Loops

The model of disease prevention put forth by conventional veterinarians is fundamentally flawed. It is in fact damaging the animals whose owners partake in it.
Dr. Will Falconer

Dr. Preston practiced allopathic medicine for twenty five years before realizing that the vaccinations and drugs she dispensed daily were causing more problems than they ever solved and often to a more severe degree…The drugs prescribed every day were literally destroying healthy organs and shortening lives.

Over the years, drugs and vaccines have made our pets, our beloved companions, seriously sicker and have shortened their natural life span. Why do we so often see premature aging? How do we STOP this trend? Treat holistically!

Epilepsy in dogs and cats can develop at any age. Allopathic veterinarians do not give you any real reason that this develops in your beloved dog or cat.

What the vets don’t realize is that they themselves have very likely created this syndrome with vaccines. Yearly administration of multi-valent vaccines assault the animal’s immune system over and over. More and more animals are developing ‘auto-immune’ diseases and the allopathic community has no idea why.
Dr. Jenifer Preston

Doctors that spend the time to find and promote health take more time in the exam room, and it doesn’t make financial sense. Doctors aren’t rewarded for the health of their patients; they are rewarded when their patients are sick and they need testing and medical intervention. And even the most idealistic and dedicated doctors arrive in the profession with large student loans to pay. Volume of patients, not vitality of patients will pay the bills

Doctors and veterinarians are not trained in nutrition because it will not help them financially. There is much more money in surgery and drugs. We learn our medicine in programs and teaching hospitals that are typically funded by those who have the most to gain financially: the drug companies.
Dr. Barbara Royal

From the AVH Facebook page-

The model of disease prevention put forth by conventional veterinarians is fundamentally flawed. It is in fact damaging the animals whose owners partake in it.

This broken model of disease “prevention” will never change from Dr. WhiteCoat’s side, who sells it:

He refuses to see the possibility of it causing harm.

He’s comfortable in it; change loses to maintaining the status quo.

He profits from providing it and profits again from the disease it causes. From the Academy of Veterinary homeopathy Facebook Page-“There is a big push underway to get pet owners to return to conventional veterinarians… and guess who is paying for it. Yup big pharma and the commercial food companies like Hills… what a surprise!!! Don’t be fooled. Holistic vets actually keep your pets healthy and happy at a fraction of the cost. To find one visit www.theavh.org

“Did you know that when it comes to feline leukemia, EVERY SINGLE vaccine is unnecessary. Why? FeLV is a chronic disease, and vaccines by definition don’t prevent chronic disease. And FeLV is very much an opportunist virus, attacking and setting up housekeeping in only 10% of those exposed. You can imagine these are the weaker, poorly nourished animals, likely eating an unnatural kibble diet.”

We interrupt our normal posts for an important announcement.  The CDC is reporting sharp increases in the number of patients with swine flu. Homeopathic physicians have long used the homeopathic remedy Influenzinum to safely protect their patients from the flu with great success. The normal protocol – Influenzinum 200C – one pellet dissolved in the mouth once a month. In cases where flu is widespread – a dose every two weeks during a period of widespread flu is often advised. There are also an array of wonderful remedies one can take for flu symptoms – again that are safe, quick acting and effective.”

“Allopathic (conventional Western) medical thinking generally seeks immediate gratification: just make the symptom go away. So the patient may be better in the short term, but is usually worse in the longer term. Homeopathy is just the opposite: sometimes the symptoms are worse in the short term (such as with aggravation or the reversal of a previous suppression), but the real benefit is in the longer term.”

 

  • “Treatment with allopathic drugs (antibiotics, steroids, hormones, etc.) should be avoided unless absolutely necessary. The need for drug treatment is actually quite unusual, and should be considered a last resort.”
  • “Dr. WhiteCoat and the monstrously huge pet food industry (sales of $20+ billion per year) would like you to believe you can’t possibly make a raw diet for your pets. They are invested in selling you bags of kibble, cans of mucky meaty glop, and the best marketing of all, “prescription diets” for those health challenges your animals may confront.”
  • “As I look time and again at when my patients started their decline into poor health, I repeatedly see the timing being “about a month” after a round of vaccinations. Not in every case, but in a large percentage of my patient population, this is true.”
  • “What things make your pet more vulnerable to cancer? Anything that impairs immune system function.  The following are, in order of importance, those things your animal receives that cause immune system breakdown:  Vaccination  Heartworm pills  Flea pesticides  Antibiotics”
  • Dr. Will Falconer

AVH standards of practice-

1) Only the remedy that is homeopathic to the patient is to be used.

2) Drugs and methods of treatment which are not homeopathic to the case are to be avoided because of the possibility of interference with the progress of cure.

 

Examples of truly dangerous practices recommended by homeopaths-

I’m building a custom homeopathic emergency kit, with remedies that will get your animal well in the common emergencies you are likely to confront. Things like:

  • parvo
  • vomiting after eating spoiled food
  • bee stings and worse, the allergic reactions to them that can shut off airways
  • burns
  • injuries: car accidents, tails in a car door, sprains, etc.
  • bite wounds, cuts, gunshot wounds
  • bloat
  • pain from overexertion
  • splinters, fox tails, thorns
  • abscesses
  • shock

 

Imagine: your dog or cat or horse finds herself suddenly in a crisis, and you can treat that crisis on the spot, with powerful medicine that’s got a long history of curing people and animals quickly and effectively.

 In most cases, you’ll likely be able to avoid a trip to the emergency vet, and all the stress and side effects and expense that goes with that. In the worst case scenario, you’ll give a remedy on the way, and help the healing process get a great start before you arrive. You might even arrive at the E.R. and be told you can head home, everything’s well, thanks to your efforts on the spot.

The Top Five Ways to Healthy Pets  (doing the opposite has been the biggest predictor of illness and dying too soon that I’ve seen in my 30+ years of practice)

  1. Stop Vaccinating Them.
  2. Feed Them What Their Ancestors Ate.
  3. Stop Using Pesticides to Kill Fleas.
  4. Stop Using Poisons for Heartworm Prevention.
  5. Give Them Raw Bones (for the whitest teeth and freshest breath ever).

Imagine avoiding risky vaccinations while getting very strong immune protection against parvo and distemper, the two potentially deadly diseases of puppies.

You know vaccinations are grossly over provided in our broken system of veterinary medicine. The pushing of vaccinations by Dr. WhiteCoat throughout your animal’s life doesn’t add to her immunity…And you know that vaccines are harmful. Chronic disease often follows vaccination, even a single vaccination.

A lecture on parvo by Dr. Todd Cooney lit us up, as he showed us statistics from his homeopathic practice in Indiana that the vaccinated pups had less chance of surviving parvo than those not vaccinated for that disease!

Parvo vaccine itself was immune suppressive.

Parvovirus was ubiquitous in the environment.

Animals treated homeopathically when sick with parvo had far better survival rates than those treated with the usual drugs.

Distemper was prevented by taking pups to a known wildlife area where raccoons with distemper lived.

Dr. Rosemary Manziano learned of the outbreak of canine distemper in raccoons in her area through the CDC. She boldly suggested to her puppy owners over a period of 11 years that they visit a pond known to be a hangout for these raccoons. After a brief period of sniffing around the bushes and maybe drinking the water, the pups were brought home.

This was repeated a week later, and on the third week, the good doctor would test for distemper titers, the evidence of immune response. Lo and behold, these pups had fantastic titers indicating strong immunity! And, in case you’re wondering, not one puppy ever got sick in the least. This happened in well over a hundred pups and was, as Dr. Manziano called it, “fool proof immunization.”

After eleven years, it stopped working. She assumed that the disease in raccoons had run its course, natural resistance having been gained by their population.

Dr. Manziano suggested that her new pup owners who wanted natural immunization take short, five minute visits to the most popular dog parks. Those parks with the highest dog traffic were recommended

A collection of anecdotes claiming homeopathy should be used to treat life-threatening disease-
Cooney, T. Homeopathic treatment for epidemic diseases: Focus on parvo and distemper. Integrative Veterinary Care. 2015;5(4);54-58.

Regarding heartworm prevention-
Over the years at holistic and homeopathic conferences, various veterinarians have reported problems with each of the preventatives.

[I] have seen few problems. One was a Boston Terrier who tried to re-landscape the yard, moving heavy boulders until we stopped the preventative.

From the AHVMA conferences, many holistic veterinarians feel that dogs do fine [without preventatives].  We all agree that the drug companies are suggesting doses too high and too often.

Keep you dog as healthy as possible using homeopathic principles.  A healthy dog will kill those migrating larvae…The solution is to make your dog as healthy as possible by vaccinating the least, feeding the best diet (probably a raw meat…and treat the energy problem…Homeopathy is great for this. A healthy dog will be very unlikely to be ill from heartworms.

Your dog could become infected…yet not be ill from the infection at all…. A healthy body should tolerate a low level of parasites. Therefore, many clients choose to use no preventative and I support them in that choice.

If you are very afraid of your dog getting heartworms, give the preventative carefully. Observing your dog will give you clues that you need to try one of the other preventatives or use none at all….Learn how to ask yes/no questions of the universe B dowsing, pendulum, intuition, applied kinesiology talks of checking with nature for all your decisions in life and teaching a yes/no finger method)….You can certainly do energy healing after giving a preventative such as Reiki or Healing Touch which you can learn top [sic] do yourself or go to a practitioner.

Herbs and homeopathic treatment for adult heartworms are about 75% effective.

Most dogs seem to recover from heartworm infection without the conventional drugs and without serious heart problems. There is, of course, a risk that your dog has an energy weakness for heart problems and if infected, will have serious problems.  A healthy dog will usually have no heart problems and the worms will die in a year or so on their own.

 

 

 

 

 

 

 

 

Posted in Homeopathy | 6 Comments

Two New Campaigns in the UK to Protect Patients & Clients from Veterinary Homeopathy

A couple of years ago, I was very involved in an effort to get the American Veterinary Medical Association (AVMA) to publically acknowledge that homeopathy has been proven to have no value beyond placebo effects and to discourage its use in animals. This was modeled on the successful effort of the Australian Veterinary Association (AVA) to institute a similar statement. Despite the overwhelming evidence, support from some veterinary groups, and even the acknowledgement of the AVMA’s own Council on Research that there is no evidence to support the use of homeopathy, the AVMA caved to political expediency and monetary interests, and the resolution was defeated.

Since then, there have been a number of positive developments in the struggle against this dangerous superstition. The Food and Drug Administration (FDA) is reviewing the exception to safe drug regulations that homeopathy has by historical accident, and the Federal Trade Commission (FTC) has expressed concerns about the inherent fraud in advertising an ineffective medical treatment. The Australian National Health and Medical Research Council (NHMRC) has published an extensive and rigorous review which concluded, like the British House of Commons Science and Technology Committee review before it, that homeopathy doesn’t work. The U.K. National Health Service (NHS) appears poised to ban use of homeopathy under the national healthcare system.

Several systematic reviews, written by avowed advocates for homeopathy, have failed to find any reliable evidence for benefits in veterinary patients despite decades of use and research (e.g 1, 2). And recently the power of the evidence and the recognition of the danger to veterinary patients has led to two different campaigns in the U.K. to limit the veterinary use of homeopathy.

The first is an open letter to the Royal College of Veterinary Surgeons (RCVS) and a petition asking for a ban on the veterinary use of homeopathy. The letter begins by reminding the RCVS of the evidence that homeopathy has no real clinical effects, and then makes the following case:

…we believe the use of homeopathic remedies by veterinary surgeons is potentially dangerous for several reasons.

The biggest danger of homeopathy is not that the remedies are ineffective, but that some homeopaths are of the opinion that their therapies can substitute for genuine medical treatment. This is at best misleading, and at worst may lead to unnecessary suffering and death…Members of the public put their trust in veterinary surgeons because they assume that their medical knowledge and training was gained during an accredited degree at an accredited university. They do not assume that they will be offered the veterinary surgeon’s personal beliefs in therapies that have absolutely no basis in science

We would argue that permitting veterinary surgeons to prescribe homeopathic remedies is severely contrary to the public and animal health interest.  In our opinion, homeopaths should not be able to use their membership of the RCVS to promote either the validity of the treatment or the fee for it. 

The health of animals is totally in the hands of the humans charged with their care, so it would appear to be unethical to withhold mainstream medicine and inflict alternatives on creatures that have no choice in the matter.

To summarise, we believe the RCVS should not allow members to prescribe homeopathy because:

  • it is an animal welfare issue

  • it devalues conventional treatments

  • it devalues conventional qualifications

  • it undermines public confidence in mainstream medicine

  • it would differentiate veterinary surgeons from unlicensed healers

  • the veterinary profession would take a lead, forging the way for our human medical counterparts to do the same.

This effort includes a public petition supporting the campaign, and I urge everyone to SIGN HERE.

The second independent effort, also in the U.K., is the Campaign for Rational Veterinary Medicine. This campaign also begins by acknowledging the indisputable scientific evidence that homeopathy is useless and petitioning the RCVS to change policy. However, rather than a ban, the Campaign for Rational Veterinary Medicine has a more limited set of objectives in its petition:

I ask that the Royal College of Veterinary Surgeons (RCVS):

  1. Produces a public position statement on homeopathy

EXAMPLE: The Royal College of Veterinary Surgeons has reviewed the evidence concerning homeopathy and concluded that it is ineffective in animals.

Homeopathic remedies have not been, and are not, subject to the same testing of efficacy, safety and quality as conventional medical products.

It has been demonstrated that some people respond to homeopathic treatment because of their belief in it (the so-called ‘placebo’ effect), and the College recognises that people who have benefited in this way may wish to try homeopathy on their animals.

Animals cannot respond to treatment because of their belief in a treatment, so they cannot benefit from the placebo effect. 

In addition, there is proven existence of the ‘caregiver placebo effect’, where an owner (or indeed a veterinary surgeon) believes that the animal is responding to treatment when in fact they are not.

For the above reasons, the College considers it unethical to use homeopathy as a first line treatment in animals, or in place of treatment based on proven medicines and rational scientific principles.

2. Requires veterinary surgeons who prescribe homeopathic remedies to get owners to sign a consent form, prepared by the College, giving the College’s views on the ineffectiveness of homeopathy.

3. Enforces the requirement that veterinary surgeons abide by the Advertising Standards Authority regulations concerning the advertising of medical treatments.

4. Requires that advertising or promotion of homeopathy by a veterinary surgeon is accompanied by an abbreviated version of the RCVS position statement.

EXAMPLE: The Royal College of Veterinary Surgeons has reviewed the evidence concerning homeopathy and concluded that it is ineffective in animals. It should not be used as a first line treatment, or in place of treatment based on proven medicines and rational scientific principles.

The Campaign for Rational Veterinary Medicine is also focusing its efforts more narrowly, on veterinarians licensed in the U.K. under the RCVS.

Both of these efforts reflect a growing awareness that homeopathy is not only medically useless but actively dangerous and deceptive and that it is unethical to offer it to veterinary patients. The only reason that such a practice has persisted into the era of scientific medicine is through the power of belief over reason and the political and economic forces that prevent sensible regulation to prevent selling unproven or ineffective therapies to patients. While I am cautious in my expectations for these campaigns, I am thrilled to see others taking up the cause, and I absolutely support these efforts. If they are successful, perhaps the AVMA will finally be sufficiently embarrassed by the prospective of the U.S. being the last major developed nation to protect veterinary patients from this superstition and will again consider taking a stand.

 

 

 

 

 

 

Posted in Homeopathy | 12 Comments

Lysine Doesn’t Help Cats with Viral Upper Respiratory Infections

A new systematic review has appeared discussing one of the most widely and longest used supplements in small animal medicine, the amino acid lysine, which is used to prevent and treat upper respiratory infections in cats caused by Feline Herpesvirus. I’ve only looked at the evidence concerning this supplement once in the past, and here was my conclusion at the time:

Lysine is an amino acid which is hypothesized to be useful in the prevention and treatment of Feline Herpesvirus (FHV-1) infections. This virus is extremely common, and many cats will be exposed and become infected as kittens. Clinical symptoms include sneezing, nasal congestion, and conjunctivitis, and they range from mild and self-limiting to very severe. Most cats will get over the initial infection, but many remain chronically infected. With suppression of immune function from stress, medication, or disease, the virus can re-emerge and cause symptoms again. A small subset of cats may develop chronic, ongoing symptoms associated with this infection. Vaccination reduces the severity of symptoms but does not prevent infection.

Lysine is proposed to interfere with the replication of FHV-1 by blocking the uptake of another amino acid, arginine. There are theoretical concerns that lysine supplementation could make cats arginine deficient, but experimental studies suggest this is unlikely in practice. So it appears to be safe, but does it work?

Well, maybe. For once, numerous studies have been done, but there is no clear, consistent pattern of results. Some show that oral supplementation is ineffective and might even make infection worse (Drazenovich, 2009; Rees, 2008; Maggs, 2007). Others do seem to demonstrate some benefit (Maggs, 2003; Stiles, 2002). So while lysine supplementation appears to be safe and there is a plausible rationale for its use, no definitive conclusion about its efficacy is justified.

The new review is less optimistic than my earlier assessment:

Sebastiaan Bol, Evelien M. Bunnik. Lysine supplementation is not effective for the prevention or treatment of feline herpesvirus 1 infection in cats: a systematic review. BMC Veterinary Research 2015, 11:284

Taking all results discussed in this systematic review together, we conclude that lysine supplementation does not have an inhibitory effect on FHV-1 replication in the cat. The scientific data do not support lysine supplementation or additional research with cats, as has been advocated by some…Based on the complete lack of scientific evidence for the efficacy of lysine supplementation, we recommend an immediate stop of lysine supplementation for cats. Lysine supplementation is not effective to prevent cats from becoming infected with FHV-1, it does not decrease the chance of developing clinical signs related to active FHV-1 infection, and it does not have a positive effect on the clinical course of its disease manifestations. In fact, results from two clinical trials with cats even suggest that excess dietary lysine may have an enhancing effect on FHV-1 replication. Positive findings, either for HHV-1 or FHV-1, were the result of poor study design and could not be replicated in well-controlled, larger studies. Furthermore, the proposed mechanism of action of lysine-arginine antagonism does not work in cats and its result, lowering arginine levels, would be highly undesirable.

The table below from the article illustrates the evidence evaluated in this review:

lysine table 1

Interestingly, most systematic reviews are reluctant to make active recommendations even when the lack of evidence is quite clear. The general thinking is that one can only prove a therapy does work, one cannot prove it does not. Certainly, additional evidence can always appear that shifts the probabilistic conclusions of science in one direction or another. However, we must make practical decisions about the risks and benefits of treatments based on the evidence we have, and at a certain point we must be willing to decide that enough is enough, that adequate negative evidence has accumulated to merit rejecting a therapy. These authors clearly felt that point had been reached for lysine and FHV-1 infection.

The following table gives their reasoning for discontinuing the use of lysine. (Based on the lack of supporting evidence and my own negative clinical experience with it, I have not routinely recommended it for quite some time).

 

lysine table 2

Posted in Herbs and Supplements | 74 Comments

Your Dog Ate Weed

Marijuana toxicity in dogs has always been a fairly common problem seen in veterinary emergency medicine. With the increasing availability of pot due to changes in various state laws, there are reports of an increase in these cases coming to veterinary emergency rooms. The hoped-for but as yet unproven medical benefits of marijuana in dogs has also encouraged some people to try marijuana products for their dogs, with some potential risks. All of these are serious issues. However, humor is key for coping wit the stresses of veterinary medicine, and a new song from a popular veterinary chanteuse has taken on this subject in a melodious and lighthearted, yet quite accurate, way. Enjoy!

 

Posted in Humor | 1 Comment

Generating Evidence in Private Practice

This is the proceeding and slides from a talk I gave at the ABVP Symposium in 2015.

GENERATING EVIDENCE IN PRIVATE PRACTICE

INTRODUCTION
“…the practitioner is an essential part of the total research effort undertaken by our profession and, further, that the barriers between academic and practice life should be lowered so as to integrate the various activities we often designate as “academic”, and practice, research teaching and clinical disciplines.” (Rossdale, 1978)

In a prescient and eloquent article published nearly forty years ago, renowned equine veterinarian Peter Rossdale made the case for encouraging research in private practice. Dr. Rossdale, later an advocate for evidence-based veterinary medicine, recognized the benefits of clinical research in practice to individual veterinarians and the profession as a whole as well as to our patients, who have the most to gain from the production of better research evidence and the development of more effective clinical interventions. The barriers between the domains of research, teaching, and clinical practice, and especially the chasm between academic and private practice, waste talent and resources and retard the production of useful research evidence needed to improve the quality of patient care.

The benefits of conducting research in practice include not only the production of more research evidence but of more clinically relevant and applicable evidence. Clinicians in practice are in the best position to recognize the questions and problems of greatest importance to patient care. While basic research and cutting edge investigations of novel phenomena are ultimately critical to the advancement of medical science, the most pressing and immediate information needs of clinicians often go unmet when those most removed from routine clinical practice set the agenda for research.

Research in practice also has the benefit of improving the scientific literacy of clinicians, giving them greater insight into how the foundational knowledge underlying their clinical practices is produced and what are its limitations. Inappropriate use of diagnostic and therapeutic interventions often stems from a failure to fully understand basic principles of epidemiology, statistics, and other elements of the generation and application of scientific knowledge in medicine. Training clinicians as scientists as well as healthcare providers can improve the depth and sophistication of their understanding of research evidence and how it can be most effectively used to provide optimal patient care.

Integrating research into practice can also have direct personal benefits for practitioners. As Dr. Rossdale put it, “we must provide an outlet for the creative faculties…’students trained in high professional standards may have difficulty in applying these standards to practice.’ And it is this challenge which is recognized by every graduate who turns away from practice, disillusioned by his or her inability to find satisfaction in a situation where the means are not justified by the end that is, where the expectations of training are dashed by the reality of practice.” We can recruit and retain the best minds in veterinary medicine, keep then engaged and motivated, and improve the knowledge base of the profession and the quality of patient by encouraging private practitioners to be researchers and teachers as well as clinicians.

PRODUCING RESEARCH EVIDENCE IN PRACTICE
While the current barriers between academic and private practice, and the paucity of research activities among clinicians outside academia, are unnecessary impediments to the production of more and better research evidence, it is true that some differences between these domains are intrinsic and inevitable. The tangible and intellectual resources available in large institutions with access to large patient populations and those clients most motivated to participate in research do allow academics to engage in types of research activity not practical for clinicians in private practice. Studies requiring expensive equipment, specialized expertise and input from researchers outside of veterinary medicine, and either large numbers of patients or patients with rare diseases, cannot realistically be designed and conducted exclusively in private practice.

Private practice veterinarians could still participate in such studies, as physicians often do, under the auspices of projects coordinated and managed by academic institutions or private industry with the necessary resources. If such distributed, multi-center trials were more common and involved patients in primary or private specialty practice, the amount and applicability of the evidence produced would be improved. This could be a practical method of producing research evidence if a sufficient initial investment were made in setting up networks of practices with appropriately trained clinicians coordinated and supported by academic or industry researchers.

However, there are a number of types of useful research evidence that can be produced in private practice with minimal support from research specialists. These vary in how difficult or costly they are to produce, and how much training and research expertise is required of clinician-researchers. And all good quality research conducted in practice does require clinicians to be familiar with the methodological features of the type of research evidence they wish to generate in order to ensure useful and reliable results with minimal bias. The necessary knowledge and skills can be obtained independently from existing resources, but research in practice could be greatly facilitated by more resources and support from academic researchers and better training of veterinary students in the importance of research and evidence-based medicine methods to high-quality clinical practice.

Clinical Audit
Arguably, clinical audit is not really a type of research in that it is not intended to generate new knowledge but to evaluate the effectiveness of clinical practices in a particular setting relative to other settings or to some accepted standard. However, clinical audit generates important information about the success and limitations of practices in a specific setting, which is necessary in identifying important research questions and areas worthy of investigation. It can also be a simple way of generating observations that can stimulate hypothesis generation or the development of clinical questions for future research. And it provides an opportunity to learn about standardized data collection and to set up mechanisms for collecting and handling data that can also be used for original research.

In brief, clinical audit is typically a cyclical process in which one identifies a practice to evaluate and a standard of comparison for the practice, then collects data prospectively or retrospectively to determine the difference between the practice as implemented and the standard. (Figure 1) If necessary, changes are made following analysis of the result and future repetitions of the audit cycle are conducted to assess improvement.

clinical audit diagram

Figure 1. The process of clinical audit (from Dunn, 2012)

The clinical audit process can be used to assess the success or failure of therapeutic interventions or the degree to which the implementation of specific practices are consistent with recommended standards or guidelines. In my practice, for example, we implemented the RECOVER guidelines for small animal CPR (Fletcher, 2012) and then conducted a clinical audit to compare out rates of return of spontaneous circulation and survival to discharge with those reported in the literature. We then reported these data as an example of the impact of the implementation of a clinical practice guideline on outcomes in a private practice, thus adding to the relevant evidence base. (Yagi, 2014)

In veterinary medicine, there will often be no clear gold standard against which to compare the results of audit findings. However, the findings themselves can be useful data not only within the practice but to other clinicians. The results of clinical audits can help in the development of practice standards by showing us where we are now, and they can help identify clinical problems for which controlled prospective research evidence is needed. Clinical audit can also provide clinicians with insight into their own information needs and deficiencies, and with knowledge and experience needed to engage in other research activities. Most importantly, of course, such audits improve patient care.

Case Reports/Series
The type of research evidence private practice clinicians have traditionally bene most likely to produce is the case report or case series. These are descriptions of individual cases or groups of cases with the same clinical problem or subject to the same intervention. Since there are no controls for bias or other sources of error, these reports are appropriate only for suggesting hypotheses to be investigated through controlled research. Case reports and series are low-level, unreliable evidence and should only be used to guide clinical practice with great caution and in the absence of any better quality evidence.

However, such reports are relatively easy to produce, and they provide valuable information about new and uncommon clinical problems or interventions.

Observational Studies
Observational studies do typically involve comparisons among groups of patients subject to different treatments or exposures related to health conditions. They are stronger evidence than uncontrolled case series, but they do not allow for randomization or other important bias control methods, so the conclusions of such studies must still be viewed with some caution and skepticism.

Observational studies can vary from relative simple retrospective analysis of information already collected to complex prospective study designs. Even relatively simple studies assessing the incidence or prevalence of particular health conditions, for example, would contribute significantly to filling information gaps in veterinary medicine. More complex study designs can also generate information about causal relationships between exposures and disease or interventions and outcomes.

Observational studies have particular appeal in private practice because they do not require deliberate, random assignment of subjects to treatment and control groups and the use of placebo treatments, which many clients might be reluctant to consent to. They are often simpler and less costly to conduct than interventional studies, but training and expertise in the relevant research methods is still essential to ensure effective design and execution of observational studies and the production of reliable, useful information.

The development of electronic medical records systems (EMR) has facilitated observational research in human medicine by simplifying the collection and retrieval of data. Properly designed EMR systems in veterinary medicine would make many types of observational research economically logistically feasible for private practice clinicians. Such systems are rare today. However, there are a number of veterinary EMR providers and a fair degree of competition among them, and it is possible that if the capacity to easily collect data and configure such systems for research purposes were widely demanded, manufacturers might be willing to provide these features.

“We are all academics in that we subscribe by our training and our aspirations to scientific objectivity; we are all teachers in that we are anxious to impart our knowledge and wisdom to our colleagues and our successors; we are all practitioners of the veterinary art in one form or another. And each of us have a vested interest in research.” (Rossdale, 1978)

REFERENCES
Dunn, J. Clinical audit: A tool in defense of clinical standards. In Practice. 2012;34:167-169.

Fletcher, D. et al. RECOVER evidence and knowledge gap analysis on veterinary CPR.

Part 7: Clinical guidelines. J Vet Emerg Crit Care. 2012; 22(S1):S102–S131.

Rossdale, PD. Combining research with veterinary practice. Can Vet. J. 1978;19(12):327-330.

Yagi, K. (2014 September ) How RECOVER changed us. International Veterinary Emergency and Critical Care Symposium, Indianapolis, IN.

Generating Evidence in Private Practice to post title`

 

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Pragmatic Evidence-based Veterinary Medicine in Private Practice

These are the proceedings and slides for a lecture I gave at the 2015 symposium of the American Board of Veterinary Practitioners.

PRAGMATIC EVIDENCE-BASED VETERINARY MEDICINE IN PRIVATE PRACTICE 

WHAT IS EVIDENCE-BASED MEDICINE (EBVM)?
Evidence-based veterinary medicine (EBVM) is the formal, explicit application of the philosophy and methods of science to generating understanding and making decisions in veterinary medicine. It is often associated with academic research and university or specialty practice. However, EBVM also provides a perspective and a set of behaviors veterinarian in clinical practice can employ to control bias, reduce errors, and manage information more efficiently in general practice as well.

WHAT CAN EBVM DO FOR ME?
In the private practice setting, where limited time and resources and the agendas of our clients constrain our actions, EBVM can facilitate better clinical decision making and improve patient care, aid in managing uncertainty, communicating effectively with clients, and establishing habits to facilitate ongoing learning and improvement throughout one’s career.

The main benefit of employing EBVM techniques is having better information on which to base our clinical practice. When there is good quality evidence to help us evaluate diagnostic and therapeutic interventions, EBVM helps us find this evidence and learn how to use it to inform our decisions. When, as is often the case, the evidence is poor in quality and quantity, understanding this helps us to avoid the risks of unjustified certainty and be mindful of the need for flexibility and lifelong learning in clinical practice.

Better information, and more informed decision making, leads to better patient care. There is evidence from human medicine that the implementation of evidence-based clinical practice guidelines and other EBM tools improves patient outcomes, and this is the goal of EBVM as well.

Finally, EBVM can help practitioners meet our ethical obligations to patients and clients. We have a duty to our patients to provide the best care possible, and EBVM facilitates this. We also have a duty to provide truly informed consent to our clients. Only by understanding the evidence behind our recommendations, and having a clear view of the degree of uncertainty present, can we effectively guide clients in making decisions for their animals.

THE STEPS OF EVIDENCE-BASED PRACTICE
Evidence-based practice involves following a set of explicit steps to integrate formal scientific research information with the individual circumstances of each case to facilitate decision making. The busy practitioner will clearly not be able to execute each step for every problem in every case, nor is this necessary. But by regularly employing the EBVM process, we build and maintain a knowledge base that informs our decisions.

Of course, every veterinary clinician already has extensive knowledge and opinions that inform his or her practice. However, without EBVM, our knowledge base is haphazard and uncritically derived from sources of unknown or low reliability. EBVM allows us to have greater confidence in the knowledge we rely on when making recommendations for individual patients.

These are the basic steps of EBVM:

  1. Ask useful questions
  2. Find relevant evidence
  3. Assess the value of the evidence
  4. Draw a conclusion
  5. Assign a level of confidence to your conclusion

Asking Useful Questions
Vague or overly broad questions impede effective use of research evidence in informing clinical practices. “Does drug X work?” or “What should I do about disease Y?” are not questions that are likely to lead to the recovery of useful information from published research. There are a number of schemes for constructing questions the scientific literature can help answer. One of the easiest is the PICO scheme.

P– Patient, Problem
Define clearly the patient in terms of signalment, health status, and other factors relevant to the treatment, diagnostic test, or other intervention you are considering. Also clearly and narrowly define the problem and any relevant comorbidities. This is a routine part of good clinical practice and so does not represent “extra work” when employed as part of the EBVM process.

I-Intervention
Be specific about what you are considering doing, what test, drug, procedure, or other intervention you need information about.

C– Comparator
What might you do instead of the intervention you are considering? Nothing is done in isolation, and the value of most of our interventions can only be measured relative to the alternatives. Always remember that educating the client, rather than selling a product or procedure, should often be considered as an alternative to any intervention you are contemplating.

O– Outcome
What is the goal of doing something? What, in particular, does the client wish to accomplish. Being clear and explicit, with yourself and the client, about what you are trying to achieve (cure, extended life, improved performance, decreased discomfort, etc.) is essentially in evidence-based practice.

FIND RELEVANT EVIDENCE
Experienced clinicians typically have opinions on the value of most interventions they routinely consider. Unfortunately, we rarely know where those opinions originally came from or how consistent they are with the current best scientific evidence. And given the constraints of time and resources, practitioners will rarely have the ability to find and critically evaluate all the primary research studies relevant to a particular question. Fortunately, there are sources of evidence that can provide reliable guidance in an efficient, practical manner.

The best EBVM resource for busy clinicians is the evidence-based clinical practice guidelines. These are comprehensive evaluations of the research in a general subject area that explicitly and transparently identify the relevant evidence and the quality of that evidence and make recommendations with clear disclosure of the level of confidence one should place in those recommendations based on the evidence.

Sadly, many guidelines produced in veterinary medicine are not evidence based but opinion-based (so-called GOBSAT or “Good Old Boys Sat At a Table” guidelines). These are no more reliable than any other form of expert opinion. Excellent examples of truly evidence-based guidelines are those of the RECOVER Initiative for small animal CPR and the guidelines produced by the International Task Force for Canine Atopic Dermatitis.

After evidence-based guidelines, the next most useful resources are systematic reviews and critically-appraised topics (CATs). These are more focused but still explicit and transparent reviews of the available evidence on specific topics. Systematic reviews can be identified by searching the VetSRev database, a free online resource produced by the Centre for Evidence-based Veterinary Medicine (CEVM) at the University of Nottingham. Unfortunately, getting full-text copies of these reviews can be challenging for vets not at universities, but there are a number of options depending on where one practices.

Critically appraised topics are also produced by CEVM and freely available on the web as BestBetsforVets. There are a number of other free CAT resources, including the Banfield Applied Research and Knowledge web site.

Finally, primary research studies are a useful source of guidance for clinicians, though they take more effort and expertise to find and critically evaluate.

ASSESS THE VALUE OF THE EVIDENCE
The most challenging part of the EBVM process for vets in practice is critical appraisal, learning to identify important limitations in published research study that affect how confident we can be in the conclusions and how relevant they are to our patients. There are resources available to teach these skills, and hopefully this will become more common in veterinary colleges, but for most practitioners pre-appraised evidence, such as guidelines and systematic reviews, will be more useful.

The clinician still has an important role, however, in determining the relevance of research evidence to individual patients. The details of a patient’s medical condition, the values, goals, and resources of the owner, and the expertise and resources available to the veterinarian all determine the degree to which a particular conclusion based on formal research is applicable to a given patient. The role of EBVM is not to replace clinician judgment with automatic reliance on published research but to ensure the clinician has the best available information and understands clearly what is known and not known when tailoring the evidence to the needs of individual animals.

DRAW A CONCLUSION
Ultimately, the job of a veterinarian is to guide the client in making decisions about care for their animals. When the clinician is aware of the existing evidence and its limitations and clearly appreciates the degree of uncertainty, then he or she can best help the client to understand their options. Making evidence-informed decisions and clearly communicating with clients about the needs and choices for their animal is the core of clinical veterinary medicine, and this is what the tools and methods of EBVM exist to support.

ASSIGN A LEVEL OF CONFIDENCE TO YOUR CONCLUSIONS
Often, the relevant research evidence is incomplete or flawed, and sometimes there is little or no such evidence applicable to a given patient’s needs. EBVM is still useful in this situation, because it allows us to clearly, systematically identify and communicate the uncertainty inherent in our work.

It is also important that we openly discuss with clients our use of evidence to inform our recommendations. Research has suggested that clients want to be told about the uncertainties involved in the treatment of their animals, and that discussing this does not reduce their confidence in their veterinarians. Clients also identify truthfulness as their highest priority in communication with their vet. By explicitly discussing our process in identifying and evaluating relevant evidence, we enhance our clients’ understanding of the role we play, and we help them to appreciate the value of our expertise, not only the products and procedures we sell.

EBVM AND THE PRIVATE PRACTITIONER
The job of the private-practice clinician is to be informed about the research evidence relevant to their patients’ needs and to think critically about this evidence and the uncertainty it contains. It is also the role of practitioners to communicate clearly with clients about this information and guide them in making informed decisions. Ideally, general practitioners can also contribute by sharing what they learn in applying the EBVM process. Critically appraising individual studies or synthesizing the literature on particular questions will create useful information that can then be shared with colleagues.

Properly applied and with adequate support, EBVM can enhance the quality of information supporting the decisions and recommendations of vets in clinical practice. This not only reduces stress and wasted effort for veterinarians but improves client communication and patient care.

 

pragmatic EBVM

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Dr. Christina Chambreau: Another Homeopath Giving Bad Advice about Heartworm Disease

Dr. Christina Chambreau is a veterinary homeopath about whom I’ve written before (1,2) because she is both an advocate for magical, pseudoscientific nonsense and against science-based medicine. I have also written about the dangerous advice alternative practitioners, especially homeopaths, often give about the prevention and treatment of heartworm disease, a potentially fatal parasitic infection (3). I recently came across an article which brings these two subjects together, and reminds us why no one who believes in homeopathy should ever be trusted with the healthcare of your pet no matter how much they protest that they are really believers in science or scientific medicine.

Scientific Heartworm Prevention and Treatment
As is the case with vaccines, it is ironic that alternative practitioners try to sow fear and mistrust about the very therapies that have been so successful at preventing and treating a disease which so-called “natural,” pre-scientific practices like homeopathy and herbal medicine were never able to successfully control. They are, of course, correct on the basic point that these agents can have side-effects. Nothing with any effect at all is without side-effects in medicine. That is just the reality of tinkering with systems as complex as living beings. However, the frequency and severity of the risks are consistently less than alternative vets claim, and they ignore the very substantial benefits that offset these.

The best source of science-based information concerning prevention and treatment of heartworm disease is the American Heartworm Society (AHS). Yes, this organization has ties and sponsorship from companies that produce heartworm medications (as one small part of their often multi-billion dollar business) as well as companies that provide heartworm testing and unrelated veterinary products. Does that mean there is some potential for bias? Of course. Does that mean that none of the controlled scientific research done by or referred to by the AHS in making its recommendations is valid and it should all be ignored in favor of the haphazard personal experiences of a few alternative vets? Of course not!

Financial bias can have a subtle influence on both scientific data and the opinions of individuals. But there is nothing unique about the relationship between the AHS and pharmaceutical companies or other industries. Disclosure helps doctors and pet owners be aware of the risks of such relationships, but it is not an excuse to ignore good quality scientific evidence, which contains mechanisms to limit the influence of financial bias. And the alternative veterinary community has exactly the same sort of sponsorships and other financial arrangements with herbal medicine companies, homeopathy manufacturers, makers of other products used in alternative medicine, and schools teaching alternative therapies. These folks are no less under the influence of financial and other forms of bias than anyone else, they simply choose to claim they are and that their opinions and experiences are somehow more reliable than scientific research.

The AHS guidelines for preventing and treating heartworm disease have proven to be very successful at maximizing benefits and minimizing risk, and they are continuously updated and improved as new research is done. The opinions, experiences, and faith of “holistic” vets in pseudoscientific nonsense like homeopathy or unproven hypotheses like herbal remedies are not a trustworthy substitute for science-based guidelines.

Chambreau on Science-based Methods
Of course, in order to promote her own alternative to scientific medicine, Dr. Chambreau has to begin by attacking conventional practices, as alternative vets so often do.

The drugs adversely affect many dogs.  Any symptoms can become worse (weakened vital force produces many symptoms).

And her evidence for this is?

Over the years at holistic and homeopathic conferences, various veterinarians have reported problems with each of the preventatives.

[I] have seen few problems. One was a Boston Terrier who tried to re-landscape the yard, moving heavy boulders until we stopped the preventative.

From the AHVMA conferences, many holistic veterinarians feel that dogs do fine [without preventatives].  We all agree that the drug companies are suggesting doses too high and too often.

Hmmm. So despite the scientific research that shows the incidence of adverse effects form heartworm preventatives to be extremely low, a few CAVM vets at a conference think they’ve seen problems, including the obvious side-effect of dogs pushing rocks around because of the toxic meds they were taking. What could be more convincing evidence?

Chambreau on Preventing Heartworm Disease

Keep you dog as healthy as possible using homeopathic principles.  A healthy dog will kill those migrating larvae…The solution is to make your dog as healthy as possible by vaccinating the least, feeding the best diet (probably a raw meat…and treat the energy problem…Homeopathy is great for this. A healthy dog will be very unlikely to be ill from heartworms.

In high mosquito hours of the day stay in or use an herbal repellent.

Your dog could become infected…yet not be ill from the infection at all…. A healthy body should tolerate a low level of parasites. Therefore, many clients choose to use no preventative and I support them in that choice.

If you are very afraid of your dog getting heartworms, give the preventative

carefully. Observing your dog will give you clues that you need to try one of the other preventatives or use none at all….Learn how to ask yes/no questions of the universe B dowsing, pendulum, intuition, applied kinesiology talks of checking with nature for all your decisions in life and teaching a yes/no finger method)….You can certainly do energy healing after giving a preventative such as Reiki or Healing Touch which you can learn top [sic] do yourself or go to a practitioner.

Ok, so the best option is to use magic and untested alternative dietary strategies to keep your dog health, and then just don’t worry about it. Your dog might not get heartworms, and if he or she does, all the magic will make it just a minor problem. This is ignorant and dangerous nonsense, of course. There is no evidence raw diets help ward off parasites, homeopathy is completely useless voodoo, and “energy medicine” is just religion masquerading as healthcare. Heartworm disease, on the other hand, is a serious and often fatal malady that can easily kill your pet if appropriate prevention and treatment are not used. This kind of willful blindness to facts and wishful thinking substituting for medical advice is deeply unethical.

As for herbal mosquito repellants, this is at least a suggestion that could be effective if particular remedies were tested to see if they effectively repel fleas, but so far there is no such evidence, so it’s just more wishful thinking. None of the suggestions Dr. Chambreau makes for heartworm prevention have any basis in reality except the use of conventional preventatives, which she presents with unjustified fear-mongering and then suggests be accompanied by several varieties of quackery: Dowsing is superstitious nonsense, Reiki is more faith healing, and applied kinesiology is a delusion or a scam.

Dr. Chambreau on Heartworm Treatment
Treatment of heartworm disease is risky. While the medications used to kill heartworms do have some potential risks, the benefits of treating the disease far outweigh these. And the most significant risk is from the death of the heartworms themselves, which is going to apply to any therapy that is effective, “natural” or not. However, Dr. Chambreau leaps into recommendations that are pure fantasy with no hesitation, as usual.

Herbs and homeopathic treatment for adult heartworms are about 75% effective.

Most dogs seem to recover from heartworm infection without the conventional drugs and without serious heart problems. There is, of course, a risk that your dog has an energy weakness for heart problems and if infected, will have serious problems.  A healthy dog will usually have no heart problems and the worms will die in a year or so on their own.

So despite the overwhelming evidence that homeopathy is nothing but a placebo, she claims a high success rate for it as a heartworm treatment. She also suggests herbal remedies are effective, and while this is more plausible, it has not yet been demonstrated that any herbal treatments are as safe or effective as conventional treatment. Of course, she makes the even more ridiculous claim that a healthy dog won’t need treatment, and then tries to weasel out of responsibility for any dogs who suffer from heartworm infestation by claiming they have an “energy weakness for heart problems,” which is a meaningless bit of misdirection to justify the failure of ineffective or unproven treatments.

Bottom Line
The sort of nonsense Dr. Chambreau recommends is often dismissed even by skeptics as fundamentally harmless because homeopathy, Reiki, and many other such interventions don’t actually do anything at all, so they can’t directly harm patients. But the danger of telling pet owners to avoid safe and effective preventatives and treatments for serious disease is great, and substituting magic and wishful thinking for medicine is both dangerous and unethical. It is hard to understand why vets who put pets in unnecessary danger in this way can get away with doing so, but the best those of us committed to science-based medicine can do about it is expose their bad advice for what it is and hope pet owners will be skeptical and wary of this kind of quackery.

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Oximunol is now Vivamune, and Still More about Marketing & Profit than Science

The faux science journal Integrative Veterinary Care has recently been pushing a supplement called Vivamune on their Facebook page, so I thought I’d investigate and see what the product was about. It turned out to be an interesting look into the business side of the supplement market.

Vivamune, currently marketed by a company called Avivagen, turns out to be a repackaging of Oximunol, a supplement marketed by a company call Chemaphor (of which Avivagen is a subsidiary). I wrote about Oximunol/Vivamune way back in 2010, and at the time the product was a nice example of marketing outstripping science in the supplement arena. Sadly, the changes in name, ownership, and marketing strategy that have occurred since, and even the scant additional research published in the intervening 5 years, have not changed the basic fact that this product relies on taking a tiny bit of promising but limited science and using it to cash in on the hopes and fears of pet owners.

What is Vivamune/Oximunol?
The core idea behind this supplement is a number of chemicals collectively identified as OxC-beta by the company. These are produced by oxidation of beta-carotene, the pigment that gives carrots their characteristic color and which is a precursor of Vitamin A. The theory, which is perfectly plausible, is that these compounds have biological effects which might enhance the function of the immune system and influence inflammation. However, as usual the statements made by the company in its marketing are much more exciting and dramatic than this humble hypothesis.

Vibrant health made simple

Revolutionary immune supporting active ingredient

Many beneficial health effects

Promotes normal mobility, and relieves occasional stiffness especially in older pets

Soothes skin-related issues associated with seasonal allergies

In pets, OxC-beta supports overall vitality and energy, mobility and joint function, as well as a healthy skin, coat and gut.

Results observed in food animals include healthier growth, better utilization of feed and decreased morbidity. In food animals, it is intended that use of OxC-beta avoids the feeding of antibiotics.

The claims made are pretty vague, as required both by supplement regulations which allow only “support” claims rather than specific treatment claims and also, as we will see, by the lack of specific evidence to support more specific claims. Nevertheless, the implication of wide-ranging and dramatic health benefits is clear. All the usual marketing buzzwords can be found as well, including “holistic,” “natural,” “organic,” and so on. The company does appear, however, to have abandoned some of the language used in marketing Oximunol which suggested their product might have a role in preventing or treating cancer.

Though the company is still marketing to pet owners, the emphasis appears to be on the potentially much more lucrative livestock market, and ultimately the human supplement market. The goal is apparently to market OxC-beta as a growth promoter in food animals, to replace the use of antibiotics for this purpose, which is being limited and in some cases banned by regulatory authorities due to concerns about antibiotic-resistance.

“In OxC-beta, we have discovered a natural alternative technology to antibiotics that we’re now targeting to improve productivity in livestock,” president and CEO, Cameron Groome, says… “We can quickly turn on enough OxC-beta production to generate tens of millions of dollars of revenue,” Mr. Groome suggests. “What we need to do is complete the sales cycle with those companies that can become multimillion dollar customers. That’s what we’re doing now…”

Does It Work?
The Vivamune/Oximunol marketing emphasizes the scientific credentials of the company’s leaders and the scientific basis for their product and claims:

Scientifically formulated

Rigorously researched and developed in Canada by a dedicated team of chemists, biochemists and veterinary immunologists

We have already had three peer-reviewed scientific papers published in leading journals on its chemistry and biology

The reality is a bit less impressive.

My original article on Oximunol was prompted by a press release suggesting an in-house “clinical trial” had been conducted on the product and that “A full report of the study is being prepared for submission for publication in a peer-reviewed journal.” I have not been able to find any evidence that this study has been published beyond the company’s own marketing statements in the intervening five years.

There are a number of published studies referred to on various Avivagen web pages and in other press releases. One paper in PLOS One presents some in vitro and lab mouse data indicating OxC-beta has some physiologic effects. Another study published in the American Journal of Veterinary Research found evidence for some effects of OxC-beta on white blood cells in vitro and in the lungs of Holstein calves. A study in poultry presented at a conference in Korea suggested some protective effects against a bacterial infection of the intestines, and another unpublished Korean study in pigs suggested OxC-beta might have growth promoting properties. The company has announced additional livestock studies in Asia, where it appears to be focusing its marketing efforts.

This research certainly suggests the chemicals in OxC-beta have measurable effects, and that some of these effects might be useful in preventing disease or promoting health. But as usual, the research is preliminary and very limited, and it does not justify widespread use of this supplement, especially in pets. There are still no clinical studies showing any benefits of any kind for dogs and cats, and only the most preliminary studies showing any benefits in food animals that might justify widespread use or effectively replace antibiotics as growth promoters in feed. The exuberance of the advertising has more to do with marketing and profits than with science.

Is It Safe?
As I often have to remind people, the absence of strong evidence for benefits from a medical therapy also means an absence of strong evidence for safety. The use of marketing terms like “natural” and “organic” are not reliable indicators of whether or not a product is safe. And while the chemicals in OxC-beta are derived from a food which, in itself, is safe to eat in reasonable amounts (though you can turn your skin yellow from eating too many carrots) that doesn’t mean the supplement is automatically safe.

Vitamins and other “natural” substances found in foods can cause serious harm if taken in quantities larger than normally found in food. The makers of OxC-beta specifically market the supplement on the basis that it contains far more of the chemicals they are interested in that one could get from a normal diet: “ While the process of carotenoid oxidation occurs naturally in the plant world (and to at least some extent in animals), the products of that oxidation reaction are present in such minuscule amounts that it would be physically impossible to get the full benefit just by increasing vegetable consumption.” The possibility of some risk cannot be ruled out except with appropriate research.

Avivagen claims to have run safety studies on dogs at ten times the recommended dose, but these do not appear to have been published or submitted for any regulatory review. The studies that have been published in other species do not report any significant side effects, but these are limited studies on small numbers of animals, which we all know from the experience of the pharmaceutical industry do not always guarantee safety in the much larger and more diverse general population, and most are funded or run by the company marketing the supplement.

Bottom Line
The idea that oxidation products of beta-carotene might have beneficial health effects is certainly plausible, and there is some preliminary data to support this. However, this product has been marketed as all-purpose tonic for pets for at least five years under two different names, and the manufacturer has yet to provide any reasonable published evidence of meaningful benefits in dogs and cats. And while there is slightly more evidence to suggest usefulness in some food animals, even this is not robust enough to justify widespread use.

The company repeatedly claims to be committed to a science-based approach and yet clearly acts in ways that have more to do with economic goals than scientific priorities. This is yet another example of the fact, which many users of dietary supplements fail to understand, that companies in the supplement business are no less motivated by profit and no more committed to the welfare of patients than pharmaceutical companies. The fact that they deal in largely unregulated substances they may label “natural” does not make their products safer nor their motives any purer than those of the conventional pharmaceutical business.

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