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

Posted on November 23, 2015 by skeptvet

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

Posted on November 18, 2015 by skeptvet

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

Posted on November 18, 2015 by skeptvet

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!

 

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Generating Evidence in Private Practice

Posted on November 15, 2015 by skeptvet

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

Posted on November 14, 2015 by skeptvet

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

Posted on November 11, 2015 by skeptvet

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.

Posted in General, Homeopathy | 25 Comments

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

Posted on November 8, 2015 by skeptvet

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.

Posted in Herbs and Supplements | 4 Comments

SkeptVet’s Acupuncture Adventure- Part 5: Anesthesia and Analgesia

Posted on October 30, 2015 by skeptvet

Introduction
The latest lecture in my acupuncture course concerns the use of acupuncture in patients undergoing anesthesia and surgery. Most of the lecture focuses on the potential role of acupuncture in reducing pain or mitigating some of the undesirable effects of sedatives and anesthetics. Use in reducing pain has always been one of the most common and widely accepted of claims for acupuncture, as well as one of the most difficult to validate convincingly given the influence of placebo and other non-specific effects and the challenges of designing effectively blinded acupuncture studies.

The lecturer was, as usual, very clear about not using acupuncture as a substitute for conventional treatment: “Acupuncture has a role in perioperative pain control but should be introduced as an adjunct rather than replacement for conventional anesthesia and analgesia.” She also admitted that the effects of even apparently positive studies were modest (effect sizes of perhaps 10-20%) and that the evidence was only “robust” in her view for needling that employed electrical stimulation.

This is consistent with my view of the evidence that the effects sometimes claimed for acupuncture might be more appropriately seen as effects of electrical stimulation of the nervous system. Reframing the discussion this way might reduce the infiltration of TCM nonsense into attempts to approach the study of electrical stimulation of this sort scientifically, and it might be less likely to give unearned legitimacy to pseudoscience than calling this “acupuncture.”

Studies
A large number of studies were referenced, and I have tried to read as many of these as possible and look at their findings objectively. Several experimental studies do show evidence of potentially beneficial physiological effects, though again the clinical value of these interventions would need to be demonstrated with appropriate clinical research.

Groppetti, A. M. Pecile, P. Sacerdote, V. Bronzo and G. Ravasio. Effectiveness of electroacupuncture analgesia compared with opioid administration in a dog model: a pilot study. British Journal of Anaesthesia 107 (4): 612–18 (2011).

The first study I’ll mention is one I have discussed before. The authors claims to have “demonstrated the ability of electroacupuncture to decrease anaesthetic and analgesic requirements in dogs during and after surgical neutering.” However, as I pointed out in my previous evaluation, the effects were minimal and of questionable clinical relevance, and the comparison treatment was a drug likely to have little or no meaningful analgesic efficacy. At best, the study showed some measures of pain, though not all nor the most objective ones, might respond to electrical stimulation, perhaps as a form of diffuse noxious inhibitory control. This does little, however, to support the idea that acupuncture as traditionally practiced, has significant value as a post-operative analgesic.

To her credit, the instructor of this course did acknowledge some of the limitations of this study, including the poor choice of comparison agent, though she still interpreted the results more charitably than I would.

Langenbach MR, Aydemir-Dogruyol K, Issel R, Sauerland S. Randomized sham-controlled trial of acupuncture for postoperative pain control after stapled haemorrhoidopexy. Colorectal Dis. 2012 Aug;14(8):e486-91.

The authors of this study performed acupuncture and an attempted sham-acupuncture procedure on patients in additional to conventional pain control. The study suffered from all of the usual problems with acupuncture studies. The therapists, of course, were not blinded. Arguably the patients were not blinded either since the acupuncturists judged whether their needling was appropriate based on trying to induce the “de-qi” sensation, a subjective feeling patients often experience with acupuncture. If control subjects did not have a similar sensation, particularly if they had experienced acupuncture previously, then they would be aware of the treatment they were getting. Also, the sham acupuncture involved actual needling, which often seems to have as much effect as needling at chosen or traditional sites.

Finally, the outcome measure, pain, was subjective and so likely subject to potential bias, especially with ineffective sham control. Objective measures, like HR and BP, were not affected.

The primary outcome, a difference in pain scores between conventional and acupuncture groups, was not achieved, so the study essentially failed to show a benefit. However, there was a statistical difference in pain scores between the sham and verum acupuncture groups, which one would expect if patients were able to determine whether they were getting verum or fake acupuncture treatment.

The authors’ bias was clear in their conclusion, which despite the failure to find the primary outcome they had predicted stated, “Although the difference between verum acupuncture and conventional analgesia was not statistically significant, this study has partly confirmed the analgesic efficacy of acupuncture.”

Skarda, RT. Tejwani, GA. Muir, WW III.  Cutaneous analgesia, hemodynamic and respiratory effects, and ?-endorphin concentration in spinal fluid and plasma of horses after acupuncture and electroacupuncture. AJVR. 2002;63(10):1435-1442.

This study rotated a small number of horses through three conditions- needling, needling with electrical stimulation, and no treatment. The primary outcome tested with a skin twitch or avoidance response to a heating element placed on the skin, intended to be a measure of pain response.

There was no blinding, and both the stimulus (a heating element manually held on the horses’ skin) and the response (skin twitch or avoidance movement) have some element of subjectivity, bias cannot be ruled out. The authors recognized this, but though they chose to have all assessments done by the same investigator to minimize individual variation, they did not blind this assessor to the treatment.

The authors reported that horses tolerated higher temperatures before reacting with needling and electrical stimulation than with no treatment. There was not sham acupuncture treatment, and beta-endorphin levels did not differ among the groups.

Culp LB, Skarda RT, Muir WW 3rd. Comparisons of the effects of acupuncture, electroacupuncture, and transcutaneous cranial electrical stimulation on the minimum alveolar concentration of isoflurane in dogs. Am J Vet Res. 2005 Aug;66(8):1364-70.

This study rotated 8 laboratory beagles though three conditions: needling, needling with electrical current applied, electrical current applied through electrodes placed on the skin as would be done for transcutaneous electrical nerve stimulation (TENS) in humans. The subjects were anesthetized, and the goal was to determine if the minimum alveolar concentration (MAC), that is the level of gas required to achieve full anesthesia, was reduced by the treatments.

All three treatments apparently reduced the MAC (8.4% for needling, 10% for needling with electrical stimulation, and 13.4% for TENS). According to the authors, needling with electrical stimulation and TENS reduced MC by a statistically significant amount while needling alone did not, though the appropriate statistics were not reported in the paper. This would appear to show that any effect was due to the electrical stimulation, regardless of how it was applied, not to “acupuncture” per se. Most other values measure, such as heart rate, blood pressure, etc., did not show significant effects.

It is difficult to see how this study could be viewed as validating acupuncture as an analgesic or anesthetic treatment, though again it does support the idea that electrical nerve stimulation, done  through “acupuncture” needles or by other means, may have some useful effects.

Suo XY, Du ZH, Wang HS, Li JG, Wang YL, Yao SD, Chen WM. The effects of stimulation at acupoint ST36 points against hemorrhagic shock in dogs. Am J Emerg Med. 2011 Nov;29(9):1188-93.

This was, by far, the most compelling paper discussed in this course so far. Though the model used is disturbing on an ethical level, it does appear to show some unequivocal and potentially significant effects. Thirty dogs were divided into 5 groups (whether they were randomly divided is not stated). One group was anesthetized and had unspecified surgical procedures. The other groups were all anesthetized and had a sufficient volume of blood removed do induce a state of circulatory shock. Of these, some were treated with needling and electrical stimulation at a designated acupuncture point (“electroacupuncture”), some were given needling and electrical stimulation at a supposed “non-acupuncture” location, some were given the electroacupuncture after the vagus nerve was severed, and some were placed into shock and received no treatment. The goal was to identify objective physiological responses to the treatments that would reduce the effects of the induced shock state.

All of the measures of cardiovascular function (such as blood pressure) and other indicators of shock (such as blood lactate level) were significantly improved by the electroacupuncture treatment compared to no treatment, and none were significantly altered by the non-acupuncture electrical stimulation. Most interestingly, the effect of the electroacupuncture was abolished by cutting the vague nerve, suggesting a mechanism by which the electrical stimulation of the nervous system could have influenced the response to the induced shock. Some, though not all, of the differences with electroacupuncture were large enough to potentially be clinically relevant.

Clearly, this model shows that the electroacuuncture treatment had objective and significant physiologic effects on dogs with induced hemodynamic shock, and in demonstrating the effects can be blocked by vagus nerve transection it provides a plausible mechanism for these effects im terms of stimulation of the autonomic nervous system. However, there are several features of this study which raise questions.

There was, for example, no needling without electrical stimulation, which is how acupuncture is often done. As I have pointed out repeatedly, the best evidence for objective and potentially meaningful biological effects for acupuncture come from studies using electrical stimulation, and it seems quite likely that it is this stimulation, rather than the use of needles or the selection of needling locations according to traditional methods that is responsible for any real benfits electroacupuncture might have. In many studies, other kinds of electrical stimulation, such as conventional TENS, have effects equivalent to electroacupuncture, which supports this interpretation. However, as in this study some research suggests that the selection of locations for electrical stimulation, with or without needling, may sometimes make a difference in the effects seen.

This study also does not provide direct evidence of a clinically relevant therapy. Clearly, one would not subject a dog in naturally occurring hemorrhagic shock to 30 minutes of electroacupuncture as a primary therapy, when there is far stronger evidence at all levels that fluid replacement and other interventions are more effective and appropriate. Electrical stimulation such as used in this laboratory odel might be a useful adjunctive treatment in such a situation, though from a practical perspective I suspect it would be logistically challenging to employ needling and electrical stimulation to a critical patient receiving intensive care in an emergency hospital setting.

However, this study does provide the best evidence I have yet seen for effects of electrical stimulation through acupuncture needles that might be significant and useful. It reinforces that there is some plausibility to the use of such needling and electrical stimulation even if it has little to do with traditional acupuncture methods.

Acupuncture Anesthesia
For the first time in this course, the lecturer did stray into what I consider complete nonsense by suggesting, albeit somewhat hesitantly and obliquely, that acupuncture might be effective as the sole form of anesthesia for some surgical procedures. She did not appear to be suggesting this actually be done in veterinary patients, but she did appear to believe some of the bogus claims that in China “acupuncture anesthesia” has been convincingly demonstrated to work. This is a popular misconception that has been debunked in detail elsewhere:

The ‘Acupuncture Anesthesia’ series from Science-bases Medicine:

  1. “Acupuncture Anesthesia”: A Proclamation from Chairman Mao (Part I)
  2. “Acupuncture Anesthesia”: A Proclamation from Chairman Mao (Part II)
  3. “Acupuncture Anesthesia”: A Proclamation from Chairman Mao (Part III)
  4. “Acupuncture Anesthesia”: A Proclamation from Chairman Mao (Part IV)
  5. ‘Acupuncture Anesthesia’ Redux: another Skeptic and an Unfortunate Misportrayal at the NCCAM

The article Nonsense with Needles from the Acupuncturewatch site also covers this claim in detail. The bottom line is that investigations of claims for the use of acupuncture as a sole anesthetic agent in China uncover a large number of reasons to disbelieve these claims:

  1. Patients receiving acupuncture anesthesia almost always receive conventional sedatives (such as phenobarbitol), narcotic pain medications (such as meperidine), and local anesthetics in addition to acupuncture.
  2. Only 5-10% of  surgical cases employ acupuncture anesthesia, and only healthy, young, adult patients undergoing relatively straightforward procedures are selected. These are the patients most willing and able to withstand procedures with incomplete or inadequate pain control. We must remember, people can endure surgical procedures without any anesthesia or pain control, and they have done so for thousands of years before the invention of modern anesthetics and pain control drugs. It is dangerous and, in this day and age, unnecessary, but it is possible.
  3. Witnesses from outside China who have seen these procedures often report signs of discomfort in patients who, for cultural and political reasons, are not free to honestly acknowledge or report their discomfort.

Bottom Line
The evidence discussed in this lecture generally does not support a claim of significant beneficial effects for acupuncture, defined simply as needling traditional points, in anesthetic and surgical patients. However, there is some evidence that electrical stimulation through acupuncture needles does have some objective and potentially useful physiologic effects. As I have often said, isolating and validating these effects in clinical patients, and separating them from the mythology attached to traditional acupuncture would be useful, but it is quite challenging given the dense concretion of ideology and faith-based practices associated with acupuncture.

In general, the instructors of this course have been measured and reasonable in their claims and have relied on scientific evidence to support them, though they do seem to interpret this evidence more favorably than seems justified to me. The only significant lapse in the science-based perspective I have seen so far has been the apparent acceptance of claims regarding acupuncture anesthesia in China, claims which are clearly false.

Posted in Acupuncture | 4 Comments

Antioxidants for Pets- It’s Complicated

Posted on October 25, 2015 by skeptvet

The subject of anti-oxidants comes up fairly often on this blog. This is largely because the oxidation and free-radicals are often viewed as fundamentally destructive forces responsible for aging and many types of illness, and preventing the malign effects of these compounds by introducing anti-oxidants in the diet or as supplements is often lauded as a near miraculous way to prevent and treat disease. As is so often the case, however, the truth is far more complexed, nuanced, and riddled with uncertainties. The basic chemistry of what free-radicals and antioxidants are is well-described in this Wikipedia article.

The concept that free-radicals cause damage to cells and tissues and that antioxidants, produced by the body and ingested in foods, can help to mitigate this damage is a simple and relatively sound idea. This can be easily demonstrated in test-tube experiments and laboratory animals. However, extensive research has not generally supported the extension of this idea to the extremes it is often taken to by proponents of alternative diets and supplements who rely on the idea to promote their beliefs. In fact, such research has often found that antioxidants can actually cause harm, such as increasing cancer risk, and interfere with medical treatment, such as chemotherapy for cancer. It turns out, the body sometimes uses oxidation and free-radicals as a tool of the immune system, and suppressing these is not always a good thing even when it can actually be done. Life is always more complicated than our desire for simple answers leads us to imagine.

In terms of pet foods, a variety of antioxidants are used as preservatives and for presumed nutritional benefits. There is certainly evidence to support the use of antioxidants as food preservatives, though not to support the claims alternative medicine advocates often make that “natural” antioxidants, such as Vitamin E, are safer than “artificial preservatives.” The evidence is a lot less clear, however, about the purported health benefits of antioxidants added to food or given as supplements. A living organism eating food with thousands of chemical compounds in it over years is vastly more complex than the simple, in vitro models often used to support claims of health benefits from antioxidants.

Because health effects over long periods of time are difficult to measure, and to associate with particular substances in food, proxy markers of the effects of antioxidants are often used in studies of dietary supplementation. However, it is not clear how reliable such markers are in predicting the benefits to health and longevity that really matter, and studies using proxy markers cannot be viewed as proof that a supplement has a real benefit. Similarly, studies that evaluate supplements by measuring markers of immune function or other proxy values do not necessarily prove these supplements have clinically meaningful benefits.

There is little direct research on antioxidant supplementation, in food or as nutritional supplements, for producing health benefits in dogs and cats. A handful of studies show some potentially promising effects on proxy markers, and a couple seem to show some clinical benefits, but the evidence is scant and weak. The harmful effects of antioxidant supplementation in humans has only emerged with studies of large numbers of individuals over periods of time far longer than typical veterinary trials, so while few specific safety risks are known for common antioxidants, the assumption of safety made for most is not justified.

The bottom line is that most of the claims concerning the benefits of antioxidants are based on theory or indirect and limited evidence. The specific antioxidant given, the form in which it is given, the other components of the diet, the species, health status, and individual makeup of each animal, and many other factors all influence the effects of antioxidants. Whether such effects are strong enough to be clinically significant, and whether they are beneficial or harmful if they do have a real effect, is a complicated question, and simplistic, strong claims are not justified.

Here are previous posts related to this subject:

The Myth of Antioxidants?

Resveratrol 1

Resveratrol 2

Resveratrol 3

Resveratrol 4

USDA Confronts Misleading Hype about Antioxidants in Foods

More Evidence Antioxidants May Increase Cancer Risk

Canine Nutrigenomics by Dr. Jean Dodds; Science as Windodressing

Evidence Concerning Vitamin and Mineral Supplements-Safety and Efficacy

Ocu-Glo 1

Ocu-Glo 2

SELECT- An Example of Why Clinical Trials Aren’t Just the Icing, They Are the Cake

 

And here are a few publications discussing the limited evidence regarding antioxidants and pets:

Antioxidants in Veterinary Nutrition. Steven C. Zicker, Karen J. Wedekind, Dennis E. Jewell. Vet Clin Small Anim 36 (2006) 1183–1198.

Acetyl-L-carnitine and alpha-lipoic acid supplementation of aged beagle dogs improves learning in two landmark discrimination tests. Milgram NW, Araujo JA, Hagen TM, Treadwell BV, Ames BN. FASEB J. 2007 Nov;21(13):3756-62.

Chronic antioxidant and mitochondrial cofactor administration improves discrimination learning in aged but not young dogs. Siwak CT, Tapp PD, Head E, Zicker SC, Murphey HL, Muggenburg BA, Ikeda-Douglas CJ, Cotman CW, Milgram NW. Prog Neuropsychopharmacol Biol Psychiatry. 2005 Mar;29(3):461-9.

Learning ability in aged beagle dogs is preserved by behavioral enrichment and dietary fortification: a two-year longitudinal study. Milgram NW, Head E, Zicker SC, Ikeda-Douglas CJ, Murphey H, Muggenburg B, Siwak C, Tapp D, Cotman CW. Neurobiol Aging. 2005 Jan;26(1):77-90.

Influence of dietary antioxidants and fatty acids on neutrophil mediated bacterial killing and gene expression in healthy Beagles. Hall JA, Chinn RM, Vorachek WR, Gorman ME, Greitl JL, Joshi DK, Jewell DE. Vet Immunol Immunopathol. 2011 Feb 15;139(2-4):217-28.

The effect of vitamin C supplementation in healthy dogs on antioxidative capacity and immune parameters. Hesta M, Ottermans C, Krammer-Lukas S, Zentek J, Hellweg P, Buyse J, Janssens GP. J Anim Physiol Anim Nutr (Berl). 2009 Feb;93(1):26-34.

A combination cocktail improves spatial attention in a canine model of human aging and Alzheimer’s disease. Head E, Murphey HL, Dowling AL, McCarty KL, Bethel SR, Nitz JA, Pleiss M, Vanrooyen J, Grossheim M, Smiley JR, Murphy MP, Beckett TL, Pagani D, Bresch F, Hendrix C. J Alzheimers Dis. 2012;32(4):1029-42.

Supplemental vitamin C appears to slow racing greyhounds. Marshall RJ, Scott KC, Hill RC, Lewis DD, Sundstrom D, Jones GL, Harper J. J Nutr. 2002 Jun;132(6 Suppl 2):1616S-21S.

Effect of feeding a weight loss food beyond a caloric restriction period on body composition and resistance to weight gain in dogs. Floerchinger AM, Jackson MI, Jewell DE, MacLeay JM, Paetau-Robinson I, Hahn KA. J Am Vet Med Assoc. 2015 Aug 15;247(4):375-84.

Effect of feeding a weight loss food beyond a caloric restriction period on body composition and resistance to weight gain in cats. Floerchinger AM, Jackson MI, Jewell DE, MacLeay JM, Hahn KA, Paetau-Robinson I. J Am Vet Med Assoc. 2015 Aug 15;247(4):365-74

 

 

Posted in Topic-Based Summaries | 1 Comment

Unregulated Herbal Products and Supplements Send 23,000 People to the Emergency Room Annually in the U.S.

Posted on October 15, 2015 by skeptvet

Many times, I have written about the risks of herbal remedies and dietary supplements, and about the folly of not regulating these and requiring the scientific testing for safety and efficacy that is required of real medicine (e.g. 1, 2, 3, 4, 5). A recent article in the New England Journal of Medicine adds further evidence to the risks of such unregulated products.

Geller, A. et al. Emergency Department Visits for Adverse Events Related to Dietary Supplements. N Engl J Med 2015; 373:1531-1540

This study found that the major causes of harm from supplements included accidental ingestion by children, and heart problems in young, otherwise health adults using them for weight loss or for greater “energy.” However, even micronutrients were responsible for emergency room visits and hospitalizations in older Americans.

Nothing that has a measurable effect on the body, even if it has benefits, is without risk, and these products won’t be safe or useful until we require manufacturers to produce reliable scientific evidence about their effects before they are allowed to sell them.

Methods

We used nationally representative surveillance data from 63 emergency departments obtained from 2004 through 2013 to describe visits to U.S. emergency departments because of adverse events related to dietary supplements.

Results

On the basis of 3667 cases, we estimated that 23,005 (95% confidence interval [CI], 18,611 to 27,398) emergency department visits per year were attributed to adverse events related to dietary supplements. These visits resulted in an estimated 2154 hospitalizations (95% CI, 1342 to 2967) annually. Such visits frequently involved young adults between the ages of 20 and 34 years (28.0% of visits; 95% CI, 25.1 to 30.8) and unsupervised children (21.2% of visits; 95% CI, 18.4 to 24.0). After the exclusion of unsupervised ingestion of dietary supplements by children, 65.9% (95% CI, 63.2 to 68.5) of emergency department visits for single-supplement–related adverse events involved herbal or complementary nutritional products; 31.8% (95% CI, 29.2 to 34.3) involved micronutrients. Herbal or complementary nutritional products for weight loss (25.5%; 95% CI, 23.1 to 27.9) and increased energy (10.0%; 95% CI, 8.0 to 11.9) were commonly implicated. Weight-loss or energy products caused 71.8% (95% CI, 67.6 to 76.1) of supplement-related adverse events involving palpitations, chest pain, or tachycardia, and 58.0% (95% CI, 52.2 to 63.7) involved persons 20 to 34 years of age. Among adults 65 years of age or older, choking or pill-induced dysphagia or globus caused 37.6% (95% CI, 29.1 to 46.2) of all emergency department visits for supplement-related adverse events; micronutrients were implicated in 83.1% (95% CI, 73.3 to 92.9) of these visits.

Conclusions

An estimated 23,000 emergency department visits in the United States every year are attributed to adverse events related to dietary supplements. Such visits commonly involve cardiovascular manifestations from weight-loss or energy products among young adults and swallowing problems, often associated with micronutrients, among older adults. (Funded by the Department of Health and Human Services.)

 

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