Does Injection at Acupuncture Sites Work Better Than Needling Alone?

I’ve recently seen a couple of patients who were treated by Traditional Chinese Veterinary Medicine (TCVM) vets at other hospitals. The records from these vets include the usual pseudoscientific nonsense describing their conditions, such as “Rebellious Spleen Chi” or “Kidney Qi Deficiency.” And these patients have typically been given the usual untested and unregulated herbal remedies TCVM vest use, despite the serious risks these can present (in fact, a local woman was recently killed by a toxic herbal tea from a TCM apothecary shop). And of course, these patients received acupuncture treatment. However, these particular vets seem especially fond of a twist on the usual acupuncture practice that I’ve seen a few times before—the injection of Vitamin B12 into supposed acupuncture points.

I’ve discussed previously the general unreliability of the pre-scientific religion and folklore that make up TCVM theory. I’ve also investigated the evidence concerning acupuncture in exhaustive detail as part of my certification in veterinary medical acupuncture. While there is some limited evidence for possible clinical benefits to a very few needling practices, especially involving electrical stimulation of peripheral nerves, in general the value of acupuncture is probably slight, if any, and the use of TCVM to guide it is worthless. My focus here, then, is whether there is any advantage to injecting vitamins or other substances into purported acupuncture points (which quite likely don’t exist as discrete, consistently identifiable locations anyway; 1, 2).

The Evidence
There is, of course, some research literature comparing acupuncture injection to dry needling. Whether it makes sense to do such studies given the uncertainty about the theory and clinical effects of acupuncture in general is a serious question. In any event, such studies are not going to be very convincing when they only compare injection to standard acupuncture without some form of non-acupuncture or sham acupuncture control group. Often, such studies lack such controls, and so they may well only be comparing one placebo to another.

Another problem with the acupuncture injection literature is the choice, in some studies, to inject pharmaceuticals at proposed acupuncture points. By itself, again without proper control groups for comparison, this is more a comparison of drugs versus acupuncture than acupuncture injection versus plain acupuncture.

Finally, most of the acupuncture injection literature suffers from the usual weaknesses of acupuncture studies, not only lack of appropriate control groups but inadequate blinding, randomization, statistical analysis, or other flaws that leave the studies vulnerable to bias.

Here are a few examples:

Wade C, Wang L, Zhao WJ, et al. Acupuncture point injection treatment of primary dysmenorrhoea: a randomised, double blind, controlled study. BMJ Open. 2016 Jan 5;6(1):e008166. doi: 10.1136/bmjopen-2015-008166.

This one compared three groups:

Vit K injection at acupuncture point on both legs and saline in the buttock
Saline near but not at acupuncture point in both legs and Vit K in the buttock
Saline at acupuncture points on both legs and in the buttock

The goal was to measure changes in discomfort associated with menses. There was some blinding, in that patients and doctors didn’t know what they were injecting, but of course the doctors knew whether or not they were making the injection at an acupuncture point, so at least one group was not blinded for the doctors.

As usual, all groups reported less discomfort that before treatment, so placebo effects were certainly at work. The authors make much of the fact that there was a statistically significant difference between the group getting Vitamin K at acupuncture sites and the other groups. However, the differences between this group and the other two were from 1.1-1.8 points on an 11-point pain scale. By comparison, the control groups both improved by 4.5-5 points on this scale from baseline during the hour after treatment. This means the placebo effects were 4-5 times greater than any effect from the treatment itself, which doesn’t exactly suggest a meaningful real-world treatment effect.

Chen CY, Lin CN, Chern RS, et al. Neuronal Activity Stimulated by Liquid Substrates Injection at Zusanli (ST36) Acupoint: The Possible Mechanism of Aquapuncture. Evid Based Complement Alternat Med. 2014;2014:627342. doi: 10.1155/2014/627342. Epub 2014 Mar 6.

This one starts with the assumption that injection of drugs at acupuncture sites is more effective than acupuncture alone due to some kind of synergistic effects (an unproven assumption, like so many in alternative medicine). The study aims to identify the mechanism of this assumed effect.

The study compared injection of saline, Vitamine B1, Vitamin B12, and bee venom to plain needling at an acupuncture point. The outcome measured was the activity of a gene in the spinal cord (the study was done in rats). The assumption here was that greater gene activity meant greater stimulation at the acupuncture point, though what clinical relevance this would have is not obvious or addressed by the authors.

The results indicated no difference between the various treatments with the exception that bee venom appeared to generate more gene activity in the spinal neurons than the other forms of stimulation. The grand conclusion, then, would be that acupuncture injection is generally no different than plain needling except if you use something specifically designed by nature to irritate nerves like bee venom! It’s hard to see, though, how this sort of research justifies the practice of acupuncture injection in real-world patients.

There are a moderate number of similar studies that have the same sorts of limitations, but none that provide clear, high-quality data suggesting that acupuncture injection has significant clinical advantages over dry needling. Reviews of the acupuncture injection literature for specific medical conditions are typically inconclusive due to the lack of good-quality research. For example:

Wang LL, Guan L, Hao PL, et al. Acupuncture and vitamin B12 injection for Bell’s palsy: no high-quality evidence exists. Neural Regen Res. 2015 May;10(5):808-13. doi: 10.4103/1673-5374.156987.

“Because of study bias and methodological limitations, [our] conclusion is uncertain…”

Wang M, Gao YH, Xu J, et al . Zusanli (ST36) acupoint injection for preventing postoperative ileus: A systematic review and meta-analysis of randomized clinical trials. Complement Ther Med. 2015 Jun;23(3):469-83. doi: 10.1016/j.ctim.2015.03.013. Epub 2015 Apr 13.

“ST36 acupoint injections with various agents may have a preventive effect for POI. Safety is inconclusive as few of included trials reported adverse events. Due to the poor methodological quality and likely publication bias further robust clinical trials are required to arrive at a definitive conclusion.”

Bottom Line
Even overlooking the uncertainties about the meaning of Traditional Chinese Medicine theories and metaphors, the existence of acupuncture points as discrete and definable entities, or the clinical effects of acupuncture per se, there is little evidence to support the idea that injection of various substances at acupuncture points has significant advantages over needling alone at these points. Of course, the injection of drugs at acupuncture points may have greater effects than needling alone, but this is more likely due to the pharmacological effects of the drugs themselves, having little or nothing to do with the identification of the injection site as an acupuncture point.

Posted in Acupuncture | 3 Comments

Should Herbalism Be a Recognized Specialty in Veterinary Medicine?

As regular readers will know, herbal medicine is the area within complementary and alternative medicine I am most sympathetic to. Plants obviously contain chemical compounds that can have significant physiologic effects, for good or ill. And many conventional medicine have been derived from such plant compounds. The idea, then, that the medicinal use of plants and plant-derived substances might have real value is plausible, even likely, in my opinion. So far, very few uses of herbal remedies have been scientifically validated (as distinct from isolated and purified compounds derived from plants and used as drugs). However, I believe there is significant potential in plants as sources of medicines, and I support rigorous scientific research in this area.

Unfortunately, herbal medicine as a discipline is often not focused on scientific evaluation of the potential risks and benefits of herbal remedies. Instead, it tends to be uncritically accepting of truly alternative theories about health and disease and of traditional or anecdotal evidence alone as the foundation for the selection and use of plant products as medicines. Traditional Chinese Medicine (TCM or TCVM for the veterinary variety), the Indian folk tradition of Ayurveda, and other dominant approaches in herbalism often reject scientific principles or evidence in favor of mystical folk models of health and disease, and such herbalists often view scientific evidence only as a tool for gaining wider acceptance of their practices, not for determining which are effective and safe and which are not. As is true in so many areas of CAVM, herbal medicine practitioners tend to find science useful only insofar as it supports their beliefs, but they tend to reject negative findings or the failure to find good evidence for their practices and persist in these beliefs and practices based on personal experience, tradition, and anecdote regardless of what science says.

There are also other serious problems with the area of herbal medicine as it currently exists. There is virtually no regulation and very little scientific investigation of herbal products. When sampled, many herbal products turn out not to contain what they are supposed to contain, and contamination with toxic heavy metals, potentially poisonous plant chemicals, and even conventional pharmaceuticals appears to be common (1, 2, 3, 4, 5). There is evidence that these unregulated and untested remedies cause significant injury and illness (6, 7, 8).

So while I think there is significant medical potential in plants and their incredible array of natural compounds, the herbal medicine industry (and make no mistake, it is a multi-billion dollar industry: 9, 10) as it currently exists is largely unscientific and insufficiently regulated and herbal remedies and supplements have very few proven benefits and some serious risks. The unfortunate tendency of herbalists is to rely on tradition, anecdote, and unscientific folk theories about health to guide their use of untested plant remedies and to utilize science primarily as a marketing tool rather than a necessary means of developing safe and effective herbal treatments. There are certainly individual exceptions, but this is the general character of the industry.

I was therefore both interested and concerned when I recently learned that the American College of Veterinary Botanical Medicine (ACVBM) is in the process of seeking recognition as a veterinary specialty organization. The American Board of Veterinary Specialties (ABVS) is the unit of the American Veterinary Medical Association (AVMA) that recognizes areas of specialization in veterinary medicine and the organizations that certify individual veterinarians as specialists in these areas. Similar organizations perform his function in other countries (such as the European Board of Veterinary Specialisation (EBVS) Australasian Veterinary Boards Council (AVBC)) and in human medicine (e.g. American Board of Medical Specialties  and the European Union of Medical Specialties).

What is a Medical Specialty?
The purpose of official recognition for medical specialties is so that patients and pet owners can know which clinicians are likely to have a high-level of training or expertise in a particular medical area. In human medicine, specialists are often very highly focused on narrow subjects. After more than a decade of education and training, for example, surgeons may only perform a few procedures on one part of the body. While there are some problems with excessive specialization, it is clear that medicine is far too large a body of information, tools, and techniques for any one person to master it all. Specialists do fewer things, and they tend to do them better than more generally trained and experienced doctors.

In veterinary medicine, specialization is less common than in human medicine due to economic factors. Because specialists, and their additional training and experience, are more expensive than general practice vets, many vets without board certification in a specialty will still commonly work in areas that have recognized specialists. I do cardiac ultrasounds, treat cancer with chemotherapy, perform a wide range of surgical procedures, and manage chronic skin conditions despite the fact that there are recognized specialists in the areas of veterinary cardiology, oncology, surgery, and dermatology. There are pros and cons to choosing a specialist or a generalist to treat your pet for particular health issues, but there is no question that specialists have deeper knowledge and greater experience and expertise in their specialty disciplines than I or other general practitioners have.

The concept of expertise is, unfortunately, under some attack generally these days, especially in the U.S. (e.g. 11) There seems to be a feeling that anyone can be an expert, or declare themselves to be, by virtue of their independent study or experience without going through a recognized educational and training program. This applies more in areas in which the subject and outcomes are not clear and distinct. Few people would attempt to fly a jet or perform open heart surgery without the appropriate specialized training because the consequences of inadequate skill and expertise are obvious and dramatic. However, people with little or known scientific or medical training often feel equipped to doubt or deny the consensus among true specialists in areas like climate change or medicine.

In CAVM, the concept of specialization is especially problematic in a different sort of way. Homeopaths, Chinese Medicine vets, even psychics and astrologers will often declare themselves to be “experts” in their fields and deny the legitimacy of criticism from others, regardless of the credentials of critics or the evidence presented, if their critics do not have the same training and experience in these fields. However, if homeopathy and TCVM are just sets of made-up ideas without scientific validity, what is the value of expertise in these subjects?

The analogy I often use is that of the Catholic priest as an expert in Catholicism. There is no question a priest has superior knowledge and experience in the details of the Catholic faith, so in some sense he is an expert. However, if you are a Jew or a Muslim or an atheist, this expertise is not very meaningful, and it is unlikely to convince you that the priest is right about the details of religious controversies. Similarly, while I agree homeopaths know more about homeopathy than I do, I know enough to understand the subject of their expertise is an unscientific fantasy, so I have no obligation to defer to their views on the controversies about it.

Should Herbalism Be a Recognized Veterinary Specialty?
All of this is intended to provide a context for answering the question, “Should herbalism be recognized as a veterinary medical specialty?” This has to be answered both generally and in terms of the specific application of the ACVBM for recognition as a specialty organization by the ABVS.

In general terms, I think specialty status for herbal medicine is not warranted because the evidence base for the area is too limited and it is still plagued with deep-rooted unscientific concepts and practices. In theory, such an area could be a legitimate scientific specialty if the attitude towards science changes and the evidence base is properly developed, but that is not yet the case. No herbalism specialty is recognized in human medicine or veterinary medicine in the US, Europe, or Australia, which would make recognition of the ACVBM unprecedented.

In terms of the specific application, it is clear after reading it and investigating the provenance and the leadership of this organization that recognition of the ACVBM as a specialty organization would be a serious mistake. I will discuss why in detail below, but this organization is dominated by TCVM vets and key figures in the American Holistic Veterinary Medical Association (AHVMA), a deeply anti-science organization that promotes every imaginable alternative practice, from herbal medicine to homeopathy and faith healing. Most of the leadership practices multiple varieties of CAVM, not only herbal medicine, and many have made worrying comments about science and conventional medicine that suggest they fundamentally don’t accept the principles and practices of science-based medicine. This application is less about making herbalism a scientific specialty within veterinary medicine than it is about getting a foot in the door to obtain the AVMA’s imprimatur of mainstream legitimacy for alternative veterinary medicine of all sorts without demonstrating the truth of their theories or the safety and efficacy of their methods through sound scientific research.

The ACVBM Application for Specialty Status
The ABVC is the AVMA organization that recognizes veterinary medical specialties. It consists of representatives from the existing specialty groups and non-voting members from a couple of other organizations. The ABVS has a detailed description of the standards for obtaining specialty recognition. Unfortunately, and in keeping with the general approach of the AVMA to support veterinarians in virtually anything they choose to do but to assiduously avoid setting standards for veterinary medicine, these criteria go into great detail about the mechanisms and procedures for functioning as a specialty board but make little mention of science or any criteria for judging the legitimacy of a proposed specialty area. Obviously, any organization can follow a template for governance and for administering examinations and such, so being able to meet these standards says nothing about the legitimacy of the subject area. The few sections that seem to address this more important issue are these:

The AVMA American Board of Veterinary Specialties (ABVS) is the umbrella organization for veterinary specialties within the United States. It is composed of one voting representative from each of the AVMA-recognized veterinary specialty organizations, plus non-voting liaisons from the Association of American Veterinary Medical Colleges and the AVMA Council on Education.

For a veterinary specialty organization (or their independent certification board) to be recognized by the AVMA, they must:

Demonstrate that improved veterinary medical services will be provided to the public.

Serve a clearly defined need within the profession.

Represent a distinct and identifiable specialty of veterinary medicine, one that is supported by a base of scientific knowledge and practice that is acceptable to the profession and the public. [emphasis added]

Let’s take a look at the ACVBM application and some of the problems and questions it raises, including the extent to which it might or might not meet the ABVS criteria for recognition.

Would Recognition Improve Veterinary Medical Services to the Public?
The ACVBM medicine asserts that “improved veterinary medical services” will be available to animal owners by the recognition of ACVBM based on the assumption that herbal medicine is a safe and effective tool for improving patient care. Unfortunately, this is not a scientifically demonstrated assertion. The debate about the research evidence for herbal remedies is a complex one, and the devil is in the details. There are many published research studies that appear to show benefits to herbal remedies and supplements. However, there are many published studies support the same claims for homeopathy, but a detailed examination of the literature shows that homeopathy almost certainly has no real benefits at all (12, 13). The ability to cite lots of papers does not by itself show a robust scientific support for a specific medical approach.

While I have not examined the herbal literature in as much detail as that pertaining to homeopathy, I have studied the main textbook for veterinary herbal medicine and looked at many of the specific studies cited in the ACVBM application. The evidence is generally weak and inconsistent, it often does not support the claims it is cited by the ACVBM to support, and overall the body of robust, consistent scientific evidence supporting herbalism that the ACVBM claims does not exist. There is good evidence for a few specific remedies used for a few specific conditions. But there is no evidence to support most of the theoretical foundations on which most herbalists rely. TCVM as a diagnostic and therapeutic system, the concept of “tonics,” the general principle that mixtures of plant compounds given in raw form are safer and more effective than isolated compounds used as drugs, and many other key concepts herbalists rely on run counter to established science or are, at best, unproven beliefs.

So the claim that giving greater legitimacy to the group would enhance the care provided to the public rests on shaky ground. You cannot improve care by calling pseudoscience a specialty, and much of the popular approach to herbalism, especially the dominant approach of TCVM, is pseudoscience.

Is Herbalism Supported by Scientific Knowledge and Practice?
I have already answered this question to a certain extent. There is much scientific evidence relating to specific compounds or remedies, but the vast majority of herbal remedies remain untested outside of lab animals. And the concepts upon which diagnosis and prescribing by herbalists rests are not only not yet validated but typically inconsistent with a scientific understanding of health and disease. However, I want to explore in more detail why the claims to a scientific approach made in the ACVBM application appear disingenuous and generally untrue.

For one thing, the ACVBM claims it would become the specialty responsible for pharmacognosy, the practice of identifying medicinal compounds in plants. This is currently the domain of pharmacology, a recognized specialty area (under the American College of Clinical Pharmacology (ACCP)). The organization also claims it should take over the use of plant-based remedies and supplements for their nutritional effects, an area currently thought to fall in the territory of the American College of Veterinary Nutrition (ACVN). Finally, they claim that their diplomates would be in a better position than specialists in these areas or than diplomates of the American Board of Veterinary Toxicology (ABVT) to recognize and manage the potential toxic effects of plant remedies and their interactions with conventional medicine.

However, while botanical medicine overlaps many other specialties, the depth of knowledge required of a specialist in phytopharmacology and phytomedicine is not covered by any of these. Even the pharmacology College, which might be the closest relation of all the specialties, would concentrate on only a subset of the mechanisms by which herbs work. There are tens of thousands of medicinal plants described in the herbal medicine literature, likely overshadowing the conventional drug pharmacopeia by orders of magnitude. Pharmacology focuses on isolation of a single constituent to characterize and use therapeutically. By contrast, herbalists advocate for the complex actions initiated when a plant or plant extract containing hundreds of compounds – both nutritional and pharmacologic – are in play.

American College of Veterinary Clinical Pharmacology: An important basis of herbal medicine is the pharmacology and mechanisms of actions of plants and plant extracts, however they differ from drugs in their complexity, and in the underlying ethnomedical knowledge base used to prescribe them.. The botanical medicine diplomate can provide context to client and referring veterinarian inquiries, both ethnobotanical and scientific.

American College of Veterinary Nutrition: Functional foods including herbal medicines are being employed in therapeutic diets and products in veterinary medicine. The herbal medicine diplomate will be able to advise on suitable herbs to meet therapeutic needs in product development in the pet food industry and also provide advice on the addition of herbs to diet plans and critical care nutrition to benefit the patient therapeutically.

American Board of Veterinary Toxicology: Toxicologists are familiar with toxic principles of plants. Many of the plants that are considered toxic by toxicologists are also considered therapeutic by botanical medicine specialists, who are necessary to provide this complementary information on plant use and abuse. Herbal medicine specialists will be more informed on dosing that “makes the medicine or the poison”.

However, the basis on which the ACVBM claims it can replace the role of these specialties is a claim of special knowledge specifically derived from areas outside of the realm of science. The claim is essentially that by knowing the folk theories and practices of traditional herbalism, ACVBM diplomates would know more about the safety and use of plant products than specialists who focus on the scientific evaluation of these. The presumption is that folk knowledge is equivalent, if not superior, to scientific knowledge when evaluating the safety and efficacy of herbal remedies. This reveals one of the fundamentally anti-scientific principles that makes much of modern herbal medicine unreliable and unscientific:

[Our vision is to] enhance the integration of scientific, clinical, and traditional knowledge into veterinary medicine practice [emphasis added; This explicitly places folk beliefs on an equivalent level with scientific knowledge.]

An important basis of herbal medicine is the pharmacology and mechanisms of actions of plants and plant extracts, however they differ from drugs in their complexity, and in the underlying ethnomedical knowledge base used to prescribe them. [emphasis added; This reveals the often unmentioned fact that traditional theories and historical practices, rather than scientific evidence, generally guide the prescription of herbal remedies.]

The effective use of herbal medicine often requires knowledge of their ethnobotanical medical uses – or familiarity with the culture and medical system that popularized the use of a medicinal plant. [This assumes such traditional folk knowledge is a reliable guide to the medical use of plants, which is unproven and contradicted by the evidence of history, in which traditional folk medicine has never achieved anything like the effectiveness of science-based medicine.]

The herbal medicine diplomate must have an expanded understanding in the areas including, but not limited, to principles of herbal medicine (whether ethnomedical or scientific principles are being used in decision-making)…

The uniqueness of this new specialty is that it is using treatments outside of the established pharmacological research model, yet still having a strong rational basis in pharmacology. [Unfortunately, it is clear that herbal treatments are often outside the science-based model, but it is not at all clear that most have a rational basis in pharmacology.]

Veterinarian herbalists understand the dosing of herbs because of the variability of the plant medicines and clinical and patient related factors affecting dosing of botanical medicines. The herbal medicines are variable in form and concentrations and bioavailability; knowing how to relate research to the form of herb is important for efficacy and safety. This is distinct from use of drugs with more consistent formulations, but also distinct from the science of clinical nutrition where food ingredients are generally safer than herbal drugs. [Herbs are quite variable in the compounds they contain from batch to batch, which is part of why isolation and standardization of such compounds into drugs has been so much more effective than the historic folk-based empirical use of raw plants. Herbalists only know more about these issues in the sense that they trust traditional wisdom and practice to guide them even without scientific research into the risks and benefits of specific remedies.]

For instance, there are many plants used as traditional “tonics”, intended to invigorate normal organ functions. While some of these traditional tonics and alternatives have recognized activities, such as antioxidation or microbiome support, some are still not well enough understood to classify them in a physiologic or pharmacologic sense. [The concept of a general “tonic” is an unproven folk belief.]

The Role of Traditional Chinese Medicine in the ACVBM
It is clear from the application itself, and even more so from the personnel composing the organizing committee of the ACVBM, that the dominant approach which will be promoted by this group as a specialty board will be TCM. Nearly all of the members of the organizing committee have an affiliation with the Chi Institute, a private school teaching Chinese Veterinary Medicine, include Dr. Husheng Xie, the founder of this company. Most have studied TCVM there, and many are instructors in this method. All but three explicitly advertise their use of TCVM in their own practice. There is no question that TCVM is the foundation for herbal prescribing favored by the leadership of the ACVBM, and it is specifically mentioned several times in the descriptions of the subject matter potential diplomate will need to master. This is much of what is meant by “traditional knowledge” in the ACVBM document.

The problem with this is that TCM is an alternative system for understanding health and disease which is entirely independent from, and inconsistent with, the scientific understanding. It views disease as arising from imbalances of mystical forces, such as Chi or Yin and Yang, and metaphorical humors such as Wind, Damp, Heat, and so on. Diagnoses such as “rebellious Chi” or “Excess Wind” are made based on behavioral and historical information, tongue color and texture, pulse quality, and other unvalidated traditional means. These diagnoses are then used to guide acupuncture treatment and the use of herbs, which are categorized in their effects by taste, appearance, and historical use rather than any scientific analysis of their components or physiologic effects. TCVM is not a specialty area within scientific veterinary medicine, it is an alternative to it. It would make no sense to legitimize this practice by calling it Veterinary Botanical Medicine.

There are, of course, other herbalist approaches represented in the leadership of the ACVBM. Some also promote Western Herbalism, and this is mention along with Chinese medicine in the application. However, this is simply a different, but equally unscientific, set of folk traditions about the use of plants to treat disease, and again not a scientifically legitimate therapeutic approach. Some members of the committee do also advocate a conventional scientific understanding of plants as potential medicine, but even they rely primarily on traditional means of selecting and using herbal remedies, viewing science as following rather than leading the way in developing herbal medicine.

The ACVBM as a Trojan Horse for Alternative Medicine
The background, writings, and practices of the members of the ACVBM organizing committee quickly makes it clear that this effort involves more than strictly herbal medicine. As I mentioned, almost all of the members practice acupuncture and Chinese Medicine generally, not simply the use of Chinese herbal products. Nearly all of them are also members of the American Holistic Veterinary Medicine Association (AHVMA). This organization promotes all CAVM practices, not only herbal medicine, and they have been on the forefront of defending and promoting homeopathy, energy medicine, faith healing, and many other pseudoscientific or unscientific practices. Many are also affiliated with the College of Integrative Veterinary Therapies (CIVT), which teaches courses not only in Chinese and Western folk herbalism but acupuncture, alternative nutrition, homeopathy and homotoxicology, and other alternative approaches. A majority even list homeopathy as part of their practice. These are not merely individuals with expertise in botanical medicine but committed advocates and practitioners of a wide range of alternative and unscientific methods.

Finally, in their teaching and advocacy of alternative therapies, a number of the leaders of the ACVBM have expressed views about science or scientific veterinary medicine that appear to contradict the claim of the ACVBM application that scientific evaluation and use of herbal remedies will be a focus of the group. I have listed the members of the committee, some of their professional affiliations, some of the CAVM methods they advocate, and some of the comments they have made that should concern the ABVS. I don’t mean to suggest that these individuals are not smart, educated, caring veterinarians, as they most certainly are. However, I believe they share an ideological approach to veterinary medicine that is at odds with science and, therefore, ultimately not in the best interests of patients or the profession. I also believe that their purpose in seeking specialty recognition for the ACVBM is to obtain the appearance of a scientific legitimacy to herbal medicine, and to a wider array of alternative medicine practices, that has not been earned through rigorous scientific evaluation.

Bottom Line
I believe there is great potential in plants and plant-derived compounds to provide safe and effective medicines for veterinary patients. However, current dominant views and practices in herbal veterinary medicine, especially those from the folk traditions of Traditional Chinese Medicine, Ayurveda, and traditional Western herbalism, are unproven and frequently unscientific. Herbal remedies are frequently mislabeled or contaminated with potentially harmful ingredients, and without greater research and regulation, they are unpredictable and sometimes dangerous to patients.

The ACVBM is led by a group of veterinarians with a long history of supporting and advocating alternative medicine generally, not only herbal medicine. Many belong to the AHVMA, practice homeopathy or other unscientific and unproven or clearly ineffective therapies, and several have expressed views about science and conventional medicine inconsistent with status as board-certified veterinary specialists. There are members who I believe have a genuine commitment to scientific evaluation of herbal remedies, but they are a small minority and they are, at the least, willing to accede to the promotion of unscientific ideas in CAVM.

The recognition of ACVBM as a specialty board would be a mistake. It would create, in the eyes of other veterinarians and animal owners, the appearance of scientific legitimacy to unproven and inherently unscientific herbal medicine theories and practices. And it would undoubtedly be a foothold for the spread of even more dramatically unscientific alternative medicine practices under the color of specialized expertise. Herbalism has not been recognized as a legitimate medical specialty in human or veterinary medicine in Europe, Australia, or the United States because the evidence does not exist to validate most of the theories and practices involved. The purported expertise this certification would recognize is largely a mastery of ideas and information not consistent with nor validated by scientific methods. Scientific evaluation of plant medicine should continue as part of the normal course of medical and pharmacologic research.

Sample Letter to ABVS
Below I have copied a letter I will send to the ABVS opposing recognition of the ACVBM as a specialty organization. I encourage anyone else who shares my concerns to contact the ABVS as well, and you are welcome to use any or all of the text of my letter or the information posted here. Comments from the public will be accepted until September 1, 2017.

American Board of Veterinary Specialties
c/o Mr.David Banasiak
1931 N. Meacham Rd, Suite 100
Schaumburg, IL, 60173

Dear Mr. Banasiak:

I am writing to oppose the recognition of the American College of Veterinary Botanical Medicine (ACVBM) as a veterinary specialty organization. The ACVBM does not meet the core criteria set forth by the ABVS, and recognition would not be in the best interests of animal owners nor the veterinary profession.

Botanical medicine is not recognized as a medical specialty, in human or veterinary medicine, in the U.S., Europe, Australia, or most other scientifically advanced nations because the research evidence concerning herbalism and botanical remedies does not support this status. Prescribing practices are largely untested and based on folk medicine beliefs and traditions, and most herbal products are untested and un-regulated. Very few herbal therapies have been validated by the type of high-quality clinical trial evidence typically required for pharmaceutical medicines. Problems with mislabeling and contamination by toxic adulterants and pharmaceuticals is frequently reported for herbal products, with documented harm to patients. While there is great potential for medicinal use of plant-derived compounds, this potential can best be realized through pharmacognosy and other conventional forms of scientific research under the auspices of clinical pharmacology, toxicology, and other existing medical specialties.

The primary distinction the ACVBM offers between its approach and current conventional research and application of herbal remedies is the use of “traditional knowledge” to guide herbal prescribing. This means that the theories and practices of folk medicine traditions are considered sufficient to guide the use of herbal medicines, even when controlled research evidence is unavailable or contradicts traditional theory and practice. Almost none of this “traditional knowledge” has been validated by controlled research, and much of it is incompatible with established scientific principles and knowledge.

Illustrating the reliance of the ACVBM on unscientific principles is the affiliations and practices of the members of the ACVBM Organizing Committee. Nearly all are affiliated with the Chi Institute or other Chinese Medicine organizations, and most are practitioners of Traditional Chinese Medicine (TCM). TCM is an alternative system for understanding health and disease which is entirely independent from, and inconsistent with, science-based medicine. It views disease as arising from imbalances of mystical forces, such as Chi or Yin and Yang, and metaphorical humors such as Wind, Damp, Heat, and so on. Diagnoses such as “Rebellious Chi” or “Excess Wind” are made based on behavioral and historical information, tongue color and texture, pulse quality, and other traditional means. These diagnoses are then used to guide the use of herbal products, which are categorized in their effects by taste, appearance, and historical use rather than any scientific analysis of their components or physiologic effects. TCVM is not a specialty area within scientific veterinary medicine, it is an alternative to it. Recognizing the ACVBM would effectively identify TCM herbalism as a legitimate scientific medical practice without appropriate evidence to support this status.

Additionally, a majority of the ACVBM leadership is also affiliated with the American Holistic Veterinary Medical Association (AHVMA), and many have served in the leadership of this group. The AHVMA promotes and defends every type of alternative medicine, from herbalism and acupuncture to homeopathy and faith healing. Most of the Organizing Committee members promote or utilize numerous alternative therapies other than herbal medicine, and many have been publicly critical of conventional and evidence-based medicine and have recommended greater reliance on traditional knowledge and personal experience. These views do not support a rigorous scientific standard for developing safe and effective therapies and would not promote more evidence-based and higher-quality patient care.

The best way to develop the potential of plant-based medicines is to continue rigorous scientific research into herbal remedies, based on established scientific principles and methods. This progress can best be accomplished through the existing veterinary specialty areas. Traditional use may suggest testable hypotheses, but it is not a reliable guide for prescribing. Recognition of the ACVBM would be counterproductive in encouraging folk medicine-based approaches and in giving the ABVS imprimatur of scientific legitimacy to theories and practices which do not merit it. This would mislead veterinarians and animal owners and encourage the promotion of unscientific alternative practices.

Members of the ACVBM Organizing Committee:

Signe Beebe
CAVM Affiliations- Chi Institute, AHVMA, several TCM and integrative medicine organizations
Other CAVM Methods- TCVM, Reiki, IV vitamin C for cancer, prolotherapy

Ihor Basko
CAVM Affiliations- AHVMA
Other CAVM Methods- TCVM, homeopathy, alternative nutrition
In response to an article I wrote critical of the AHVMA-

“If you were a legitimate blog looking for the Truth and not a shill for the pharmaceutical companies, you would have researched both sides of any issue.”

“Keeping comments and ideas one sided and supported pharmaceutical and commercial pet food monopolies which have been raking in the money for many decades. Threatened financially and ideologically, they must resort to political tactics of attack, shock and awe using headlines inspired by the National Inquirer or some other ladies gossip rag.”

Shauna Cantwell-
CAVM Affiliations- Chi Institute, AHVMA
Other CAVM Methods- TCVM, electrotherapy, chiropractic, homeopathy/homotoxicology
In a CE lecture, Dr. Cantwell suggests that “clinical wisdom” is ahead of science and sufficient to act on while we watch for science to catch up to our knowledge.

“…the question remains as to whether clinically the data support effectiveness, and whether the right questions are being asked to produce illustrative data. Evidence-based medicine is the integration of the best research evidence with clinical expertise and patient needs. Research in this field has yet to catch up with clinical wisdom.”

Cynthia Lankenau-
CAVM Affiliations- Chi Institute, CIVT, AHVMA
Other CAVM Methods-TCVM, chiropractic, homeopathy/homotoxicology, Reiki, Shamanism
“I am very encouraged by the acceptance in some corners of the conventional world, enough to truly hope and believe that every veterinary college in the future will offer training in all alternative modalities, minimize drug use, and truly practice wellness maintenance medicine.  But I see two problems both created from greed.  I am nervous that when the conventional world realizes the loss of income from animals being truly healthy, they might wage an aggressive smear campaign.”

Rob Silver
CAVM Affiliations- AHVMA , Chi Institute
Other CAVM Methods- TCVM, homeopathy

Recommends, “a patient-specific prescription of Chinese herbs, based on tongue, pulse and behavioral assessments.”

“Chinese medicine assigns emotions to each of the Zang-Fu organs. The practitioner can assess aspects of those organs disharmony by observing their patient’s emotional expressions and through conversation. Animals speak to us of their emotional landscapes by means of their behaviors. Some emotions and behaviors are fairly easy to assess. Anger, as an expression of liver imbalance, for instance, can manifest as an act of aggressiveness in a dog or cat….There are a number of Chinese prescriptions that can help to address these Zang imbalances.”

Steve Marsden-
CAVM Affiliations- AHVMA, CIVT
Other CAVM Methods-TCVM, homeopathy, chiropractic, naturopathy
Examples of prescribing style:

“When we want to both tonify Blood and pull off fluid, Dang Gui Shao Yao San is a consideration”

“Given the overt Blood deficiency and history of chronic vomiting, I’d wonder about adding in Yi Guan Jian.”

“I agree with your Damp Heat assessment, and would suggest starting with Si Miao San…I hear what you’re saying about coolness. However, long term damage to Blood and Yin by Damp Heat can create Blood deficiency, and with that a superficial chilliness. If you’re quite sure, however, that he’s too cold, then I’d wonder about Chu Shi Wei Ling Tang. This augmentation of Wei Ling Tang might address the skin condition, even as the Wei Ling Tang at its core addresses long term IBD and even the insulin resistance characteristic of Cushings. So, for a Cold, dog (with, for example a cold tongue and overt sun-seeking), it would be my first choice.”

“Homeopathic Ferrum metallicum 30C can be helpful in animals vomiting their food undigested hours after eating.”

Hubert Karreman-
CAVM Affiliations-none found
Other CAVM Methods- numerous (see comment)

In a newsletter, Dr. Karrman provides this view of CAVM:

“My opinion is that we should use whichever mode of treatment that we feel intuitively drawn to.”

“A short listing of CAVM groupings with specific some examples follow: food therapy – preventive nutrition, therapeutic nutrition, glandular therapy and orthomolecular medicine; manual therapy – massage, acupressure, acupuncture, osteopathy, chiropractic, and physical therapy; biological therapy – hyper-immune plasma, hyper-immune eggs, serum therapy, bee sting therapy, and pharmaceutically reared leeches and maggots; botanical therapy – western herbal medicine, traditional Chinese medicine, essential oils and aromatherapy; energy medicine –  Christian laying-on of hands, classical homeopathy, homotoxicology, Bach flower remedies and non-traditional homeopathy. This is not a complete list of course and there are combinations of treatment, like injecting homeopathic remedies at acupuncture points.

In approaching cases and coming up with possible solutions, I like to use hands-on touch to sense where problems may be, careful observation, heightened sense of smelllisten for subtle sounds (with a stethoscope) and intuition to pin point problems. Then I choose from whichever CAVM treatment seems best for each case. Anyone can do this. And while it’s satisfying to be part of a successful outcome, I don’t feel it’s actually me that gets the patient better – that is up to Holy Spirit. I am just a channel for healing to hopefully occur. You can be, too. Using natural therapies honors God’s creation.”

Constance DiNatale-
CAVM Affiliations-Chi Institute, AHVMA
Other CAVM Methods- TCVM, homeopathy, chiropractic

Barbara Fougere-
CAVM Affiliations- AHVMA, Chinese Medicine organizations, CIVT
Other CAVM Methods- TCVM, homeopathy, chiropractic
“The greatest joy of being involved in naturopathic oncology is that our toolbox is so much larger than the one other veterinarians draw upon. It is empowering to know that there is always something more than can be done to help our patients, and even more phenomenal to be able to improve their health well beyond expectations, and create “spontaneous remissions”—something that the veterinary paradigm says is impossible…”

“The diagnosis of cancer is important, but the definitive diagnosis is not central to our approach…We need to address all aspects of health and well-being, including physical factors…environmental factors, spiritual aspects, and even genetic factors.”

“From a naturopathic perspective, cancer arises from an imbalance or accumulation of toxicity…”

“Ideally, herbs are prescribed according to the patient’s vitality, energetics, symptoms, concurrent treatments, prognosis, and diagnosis.”

“Detoxification is an herbal medicine principle in cancer treatment, because cancer is thought to be the end result of accumulated toxins in the body.”

Susan Wynn
CAVM Affiliations- Chi Institute, AHVMA, CIVT
Other CAVM Methods- TCVM
Comments- Dr. Wynn seems to be one of the few members who seems to have a consistent and real regard for the value of scientific evaluation of alternative therapies, including herbal medicine, though she still gives significant deference to traditional practices.

Joyce Harman-
CAVM Affiliations- Chi Institute, AHVMA, CIVT
Other CAVM Methods- homeopathy, chiropractic
“Western herbology is based on observations from centuries of experience along with an understanding of the pharmacology of the herbs and modern research. Many of the old texts, from the 1800’s and earlier are still valid sources of information as the authors of the day wrote detailed observations about cases they treated.”

“Make your assessment based on the modality you know well or think will be the best one to start with (i.e.: what is the imbalance?) Ex: Chinese-Spleen Qi deficiency; allopathic–elevated liver enzymes, homeopathic–weak vital force with watery diarrhea, etc.”

Huisheng Xie-
CAVM Affiliations- Founder of Chi Institute, also owns a Chinese Herb supply business
Other CAVM Methods- TCVM
According to Huisheng Xie, the leading figure in veterinary TCM in the United States, “no disease occurs if Yin and Yang maintain a relative balance.”

Here are a couple of examples from Dr. Xie’s TCVM textbook illustrating how the method is used to guide diagnosis and prescribing.

1. Signalment: Seven year old, female spayed Labrador Retriever

Primary Complaint: Separation Anxiety

History and Physical Findings: From a Western perspective, the dog has all the signs of separation anxiety. Acupuncture treatment did not help much. She has been on the herbal formula Long Dan Xie Gan Wan for signs of Liver Stagnation. Her tongue is slightly red and dry and her gums are tacky. Her eyes are red. Her pulses are thready and fast.

Assessment: This is a Yin Deficiency Pattern (Deficient Heat), specifically a Heart Yin Deficiency pattern. The Yin Deficiency can be determined from the red, dry tongue (Heat signs) and the thready and fast pulse. The association with the Heart is based on the major complaint of separation anxiety because this is due to a Shen (Spirit or Mind) disturbance. Of the five Yin organs, the Heart is the one that houses the Shen. Separation anxiety and other behavior problems are mostly related to the Heart. The treatment strategy is to balance Yin and Yang by enhancing Yin. The acupuncture points An Shen, HT-7, Da Feng Men, and KID-3 as well as the herbal formula Shen Calmer (Modified Tian Wan Bu Xin Dan) are recommended for this case.

  1. Signalment: A thirteen year old female spayed American Eskimo dog.

Problem List:
a. Cushing’s disease which has been treated with Mitotane for the past four years.

  1. Seizures which began last month and clustered about once a week.
  2. Hypothyroidism
  3. Generalized stiffness with weak hind end. There is no limping, but the dog’s gait is very stiff. The dog takes three to four steps then huffs and puffs and lies down.
  4. Generalized lethargy, weakness, lack of energy.

Physical Findings: Pulse is thin and fast; Ravenous appetite and thirst; Bilateral cataracts; Deafness; Panting Constantly; Poor teeth and gums; Rose colored thin ocular discharge; Stool dark brown and foul smelling; Chronic urinary incontinence, all day, all the time; Draining pressure sore on left hip; Pot-bellied with muscle wasting; Tongue is pink with thin coating

Assessment: This can be considered a Deficient Heat (Yin Deficiency) condition, with a Qi Deficiency and Internal Wind. The old age, weakness, urinary incontinence and lethargy indicate a Qi Deficiency. The fast pulse, thirst, ravenous appetite, constant panting and foul smelling stool can indicate Heat. Seizures are caused by Internal Wind.

The treatment strategy is to use acupuncture to balance Yin and Yang by enhancing Yin and clearing the Wind. In addition, acupuncture can be used for the stiffnedd while using Chinese Herbal medicine for the internal organ problems. Acupuncture points such as GB-20, LIV-3 and GV-20 may be beneficial for the seizures (Wind). The points KID-3 and SP-6 may be beneficial for Yin. Two herbal formulas may be beneficial: Tian Ma Gou Teng Yin for Internal Wind and Suo Quan Wan for incontinence and Kidney Qi Deficiency.

Nancy Scanlan
CAVM Affiliations- CIVT, AHVMA, Chi Institute
Other CAVM Methods- homotoxicology/homeopathy; As leader of the AHVMA, Dr. Scanlan vigorously opposed the AVMA HOD resolution identifying homeopathy as unscientific and ineffective.

”While the ‘find it and kill it’ Western medical approach may work for infectious diseases, holistic medicine takes preventative measures by treating the whole body…Holistic veterinary care can be much more effective when treating chronic illnesses like heart disease.”

“When traditional medicine looks on disease and physiology as circular, as seen in the Five Element cycle of Traditional Chinese Medicine (TCM), different practitioners may decide to attack the same disease process at different parts of that cycle. The treatments may be seen as different by conventional medicine, but…final conclusions should be based on two criteria: were the cases treated successfully, and were all cases within the series consistent based on the traditional, not the conventional, view?”

“In order for acceptance to occur, initial research may need to be more standardized…the fact that a remedy consistently “improves” (to the conventional eye) symptoms of a specific “disease” (as defined by conventional medicine) may open the door to acceptance of homeopathy as a valid part of integrative medicine.:”

“Echinacea…has usually been studied with the expectation that it will increase immune reactions in some way. However, it may have more of an immune-modulating effect, as evidence by at least one trial showing a decrease in WBC activity. Instead of viewing this as conflicting evidence, it would be better to examine herbal tradition…to see whether this herb has been used as an immune “normalizer.” If so, the conflicting evidence is actually supporting evidence for the original premise.” [In other words, any result can be viewed as supporting the hypothesis if we simply interpret it through the correct lens.]

“AHVMA maintains that one must include an expert in any discussion of a treatment modality… Experts are those who use the modality in practice, and who are invited by practitioners of CAVM to lecture and write about its use.”[This view of expertise suggests only those who have an a priori belief in a method and elect to train in and use it are qualified to judge its value. This is the perfect closed shop for unproven or unscientific methods.]

Richard Palmquist-
CAVM Affiliations- CIVT, AHVMA, Chinese medicine organizations
Other CAVM Methods- homeopathy, energy medicine
Dr. Palmquist often comments on the relationship between tradition, experience, faith, and science, and he makes little distinction between them other than to sometimes suggest scienceis the least useful.

“Acupuncture reconnects and balances Life energy.… Energy medicines such as homeopathy, homotoxicology, Reiki, craniosacral therapy, and others align the physical, mental, and spiritual portions of the organism. Yes, I did say spiritual and that is a big part of holistic medicine-recognizing the spiritual nature of Life.”

“Scientific advance can be fueled by a few people who have experienced the impossible and who care enough to investigate and share.”

“When we use “science” to kill hope by stopping progress we find real harm occurring.”

“When a miracle surpasses our science, we can deny the miracle or use our science to pursue improved understanding. It’s a choice… Thanks for believing in miracles.”

“Miracles provide us the opportunity to see and share the unexpected as we gain insight into new relationships. RT if u believe in miracles.”

“Placebo effect (that means YOU) are responsible for HALF of a drug’s effect. How about making more of YOU!?”

“90.1 percent of AVMA delegates voted against the anti homeopathy resolution. Veterinarians free to pursue whatever tools needed to help.”

“In the end we do not heal from finding out what is wrong. We heal when we find and connect what is right with our lives.”

“We will have health reform when doctors become team members celebrating and developing potential and not simply pill prescribers.”

“People who are sure they know how the universe works are often in for a surprise. “Scientists” often fight what turns out to be right.”

Donna Raditic-
CAVM Affiliations- CIVT, AHVMA
Other CAVM Methods- chiropractic, homeopathy

Carmen Colitz-
CAVM Affiliations- Chi Institute, AHVMA
Other CAVM Methods- unclear
Dr. Colitz has been involved in the development of Ocul-glo, one of the few herbal/nutritional supplements in the veterinary market that has good quality evidence for its effectiveness. Like Dr. Wynn, her approach seems to be more consistent with good scientific practice. However, she has also allowed her name to be associated with comments like those below, in articles from the Integrative Veterinary Care Journal which were co-authored by Dr. Colitz.

“Besides optimizing nutrition, losing weight, and getting proper daily exercise, daily insulin is needed in most patients to control hyperglycemia unless optimally treated with homeopathy or TCVM.  It is estimated that 68% to 75% of dogs with diabetes will develop cataracts within a year of diagnosis, despite the best of care.”

“Once diabetes is diagnosed, support includes specific antioxidants, proper diet, homeopathy, TCVM and aldose reductase inhibitors.”

“Anecdotally, homeopathic veterinarians have seen resolution of cataracts with careful prescription of the homeopathic medicines that match the constitution of the dog or cat.”

“Careful monitoring for changes by veterinarians using homeopathy or TCVM, or frequent exams by a veterinary ophthalmologist, are recommended to avoid negative changes that can occur due to lens-induced uveitis.”

Posted in Herbs and Supplements | 16 Comments

Overview of the Evidence for Probiotics in Cats and Dogs

I have written about the subject of probiotics several times before, and this is one of the most interesting and active areas of research in scientific veterinary medicine. Unfortunately, probiotics are also illustrative of the unreliability of unregulated veterinary health products and the kinds of excessive claims often made without real evidence for such products.

An excellent new review of probiotics in small animal medicine has just been published. By way of leading up to the evidence and conclusions of this review, first I will give a quick review of my past articles on this subject:

Veterinary Probiotics, 2009

  • A normal microbial flora is beneficial, and perturbations in the normal flora are associated with disease, so the principle that manipulating the microbial ecology can affect health is reasonable.
  • The normal microbial flora is complex and poorly understood, so how to appropriately manipulate it to achieve health benefits is not yet clear.
  • Clinical studies in humans are mixed, showing benefits from some probiotic products for some conditions, no benefit in other cases, and inconclusive results for many products and conditions.
  • There is little reliable research in companion animals regarding the safety or efficacy of probiotic products.
  • The risks of probiotics are probably very low. Individuals with compromised immune systems are at greatest risk and should not be exposed to probiotics. There is some limited potential for these products to cause disease even in healthy individuals.

Probiotics for Herpesvirus Rhinitis, 2010

  • So overall, the study provides little support for the thesis that Fortiflora boosts general immune function in a way that would be clinically useful for cats with FHV-1 rhinitis.
  • The argument that probiotics “boost the immune system” in general is not a very convincing one, as illustrated in acritique of the concept by Dr.Mark Crislip at Science-Based Medicine.
  • There is no clinical trial evidence that shows resistance to infectious disease can be enhanced in a healthy, normal person.
  • Probiotics undoubtedly have some benefits, however the GI microflora and its role in immune function is a dazzlingly complex subject which science is only beginning to understand. Most of the normal organisms present in healthy people and animals have not been identified, and the ecological niche or function of these organisms isn’t known. The effect of tinkering with this complex system without understanding it is ultimately unpredictable, and the assumption that such tinkering must be beneficial is unwarranted.
  • As our basic understanding of the topic improves, I hope targeted probiotic therapies for specific problems will continue to emerge. But at this point, there is little scientific justification for the widespread use of such products for nearly any condition with the assumption of safety and efficacy.

Primal Defense- An Example of Why I am Suspicious of Probiotics, 2010

  • The use of science to try and justify Mr. Rubin’s unscientific nutritional theories are pure marketing, taking advantage of the respectability that real science has earned through the results it produces. His approach is ultimately based, as so much CAM is, on personal revelation, and supported primarily through anecdote and testimonial….Such a marketing approach can turn a potentially legitimate, if not yet ready for primetime, therapy like probiotics into pure quackery.
  • Companies like Garden of Life illustrate why the unregulated supplement industry (aka Big CAM) is not onlynot entitled to the assumption of better ethics that they often receive, but it quite likely gets away with even more ethically questionable practices than the mainstream medical and diet industries, which are at least better supervised and regulated.

Encouraging Studies on Probiotics for Canine Diarrhea, 2010

  • So these studies do provide some support for the potential benefits of probiotics for acute, self-limiting diarrhea in otherwise healthy dogs. The better of the two studies provides pretty good quality evidence for this use, though more work will have to be done to see if these results are confirmed in other populations and more real-world circumstances. The second study provided a hint of an effect, but the results were weak and not particularly convincing.
  • Overall, I’m still cautiously optimistic about probiotics, at least for acute, self-limiting diarrhea, and these studies encourage that optimism. Clearly, there is much more work to be done to define which organisms in what doses will benefit which patients, but as long as we are careful not to imagine these products as some kind of panacea and go beyond the available data, they seem to be reaching a point where judicious clinical use is reasonable.

Veterinary Probiotics- Sloppy Labeling and Poor Quality Control, 2011

  • This study does not directly address the question of whether or not probiotics in general are actually safe and beneficial for clinical use in dogs or cats. But it does highlight that even if they are, most of the veterinary probiotics currently available are inadequately or improperly labeled and do not have meaningful numbers of active bacteria in them anyway. A lack of research evidence combined with a lack of effective regulation, due primarily to the lobbying efforts of the supplement industry, undermine the potential value of these therapies and make confident routine use of the products now on the market nearly impossible.

Probiotic Fortiflora Not Apparently Very Helpful in Preventing Diarrhea in Shelter Animals, 2011

  • For the dogs, there was no significant different in the incidence of diarrhea between those getting the Fortiflora and those receiving the placebo regardless of how the data was analyzed. The overall incidence of diarrhea in both groups was lower than expected for reasons that were not identified.
  • In the cat groups, the overall incidence of diarrhea was no different between the probiotic and placebo groups. However, when the data was broken down to compare the proportion of cats having diarrhea for more than 2 days, this was lower in the probiotic group than in the control group, though the level of significance was not dramatic (P=0.0297 with a cutoff of <0.05).

European Food Safety Authority Rejects Prostora, A Probiotic for Dogs, 2013

  • In terms of the efficacy of the product, the EFSA concluded that it could not reach a definitive judgment. According to the report, eight research studies were submitted in support of efficacy. Five of these were rejected for inadequate methodology (lack of a control group, for example). The three evaluated (including one I have reviewed here) did show some evidence of a beneficial effect. However, the effects were inconsistent and not always strong enough to be meaningful even if statistically significant.
  • Apparently, the organism in Prostora has shown some resistance to the antibiotic clindamycin. A number of genes that confer antibiotic resistance have been identified, and some of these can be transmitted from one bacterium to another. The specific source of the resistance to clindamycin seen in the Prostora bacterium is not known, so it is not clear if this resistance could be transmitted to other bacteria in animals or people exposed to Prostora.
  • Because of this uncertainty, and the serious and growing problem of antibiotic resistance in infectious organisms, the EFSA chose not to approve the sale of Prostora in the EU.
  • As I have often said about probiotics, because they clearly have the ability to affect the health of people and animals, they undoubtedly have risks as well as benefits. The devil is in the details, and they should neither be rejected out of hand nor embraced unquestioningly as beneficial. The specific risks and benefits of particular organisms for particular health conditions in particular species have to be understood through the careful and laborious process of scientific research. There is nothing intrinsically “alternative” about the use of microorganisms to affect health, but the indiscriminate use of them in the absence of appropriate scientific evaluation would be a mistake in the tradition of the worst kind of alternative medicine.

Probiotics in Horses, 2014

  • The authors conclusions are these:
    Although probiotics have shown promise in the treatment of selected diseases in humans, the evidence that they can be used to control diseases in horses so far is weak.Based on lack of regulation regarding quality control of commercial products, use of over-the-counter products is questionable, particularly in the absence of scientific information on safety and clinical efficacy.

    Despite all of these limitations, probiotics generally are regarded as safe, cost effective and easy to administer. Therefore, additional research is warranted to test possible applications in equine veterinary practice.

  • Very similar conclusions likely apply to the use of probiotics in small animals. They are probably low risk and are relatively easy to use and inexpensive. In most cases, there is little evidence that they have significant benefits, but their use for some conditions, such as diarrhea, is reasonable given the limited but suggestive evidence available so far.

Clearly, over time I have gradually become more optimistic about the potential for probiotics as the evidence has accumulated. Unfortunately, the evidence is still quite limited and weak in small animals, and the issue of quality control and regulation has not been solved, so there is still significant uncertainty in the use of probiotic products in patients.

The recent review addresses some of the same studies I have discussed, as well as additional research. It is a sound, science-based summary of where we are today in terms of the scientific study and use of probiotics in small animal medicine.

Jugan MC. Rudinsky AJ. Parker VJ. Gilor C. Use of probiotics in small animal veterinary medicine. JAVMA. 2017;250(5):519-528.

The authors begin by discussing the general issues of investigating probiotics, including the problems with labeling and quality control, the importance of focusing on specific organisms and specific health conditions as well as recognizing the limitations of in vitro and artificial research models in predicting the effects in actual patients:

All 8 veterinary products evaluated in 1 study contained concentrations for individual microorganisms that were < 2% of label claims; such products also contained unlisted, potentially pathogenic genera (eg, Staphylococcus spp and Pediococcus spp). More recent studies on veterinary probiotic content have provided similar findings.

In vitro studies are useful for generating hypotheses for in vivo studies, but their clinical applicability is extremely limited ….

Importantly, the effect of a probiotic in a specific clinical context is likely unique to that context. For example, one cannot extrapolate the effect of a probiotic in dogs with a specific disease from results of studies on healthy dogs or on dogs with another disease.

Although studies of healthy dogs and cats frequently provide apparently positive effects of probiotics, the implication for disease states is unknown.

The authors then review the few studies that have been done in specific subject areas:

Acute GI Conditions

Overall, studies of dogs and cats with acute diarrhea provide weak evidence for the exclusive use of probiotics, yet provide substantial evidence for preventable stress-induced diarrhea…Evidence for use of probiotics in dogs and cats with naturally occurring acute diarrhea is lacking.

Chronic GI Conditions

Overall, there currently is no definitive evidence that probiotics are effective for dogs with chronic diarrhea, especially not dogs with more severe IBD.

Probiotics in Puppies and Kittens

Studies of puppies and kittens have limitations similar to those for studies of adult dogs and cats, including small numbers of subjects, limited evaluations for disease states, and limited control populations for direct comparison. One important feature, which is highlighted when puppies and kittens are concurrently evaluated, is that important species differences in response to probiotics exist; therefore, evidence from one species cannot automatically be extrapolated to another species. Probiotics are also likely to have different effects in immature animals than in adult animals because the GIT microorganism population transitions to the adult microorganism population during development in immature animals.

Kidney Disease in Cats
I have discussed several studies looking at the probiotic Azodyl, and despite the anecdotes and angry denials of some users, there is no reason to think this product has any benefits. The authors of this review appear to agree:

Taken together, the effect of probiotics on renal function in these studies is questionable.

…there currently are no indications for administration of probiotics to cats with chronic kidney disease.

General Conclusions
The overall assessment of the evidence in this review is pretty similar to my view that the evidence is limited and weak and, while encouraging for some conditions and organisms, is not yet clear about the real benefits, if any, of probiotics. Further research is certainly warranted, and clinical use may be appropriate in some circumstances, but we have yet to convincingly demonstrate meaningful benefits of probiotics to prevent or treat illness in dogs and cats.

….most studies have limitations, including the number of subjects, extent of population characterization, appropriate characterization of underlying disease, control of potential confounders (diets and other environmental effects), and comprehensive examination of potential outcome measures. Also, many studies are uncontrolled or use inappropriate or incomplete control groups.

A clear role for administration of probiotics to dogs and cats is not evident on the basis of the current literature. Evidence in healthy dogs, as well as dogs with GIT and non-GIT illness, suggests some effect of probiotics on the GIT microbial population,…but there are no clear clinical benefits. Similar but weaker evidence is available for cats, but with fewer controlled studies.

Although general conclusions can be drawn for a specific study population, results were variable among studies, and some studies indicated no effect of probiotics.

Currently, evidence suggests that administration of probiotics may play a role in animals with acute GIT disease, especially stress-induced diarrhea, mainly for decreasing the time until resolution of clinical signs when compared with outcomes for standard treatments.

Results for studies of dogs with chronic enteropathies are more difficult to interpret because they are typically confounded by administration of concurrent treatments.

On the basis of examination of the current data, no specific product can be recommended for use. Effective probiotic species are likely disease- and individual-specific microorganisms. Because of questions regarding accuracy of product labeling, products should be evaluated by outside laboratories. Longterm outcomes and administration periods require evaluation for both safety and efficacy.

Risks of Probiotics
The authors are clear that the existing evidence, while limited and weak with regard to benefits, does not suggest any common or serious risks, and I agree:

No substantial adverse effects were noted after probiotic administration in any of these studies, which suggests relative safety over a short period for the microbial populations evaluated.

Bottom Line
This review provides a concise survey of the probiotic research in dogs and cats to date, including an appraisal of the significant weaknesses and limitations on the existing studies. The bottom line is consistent with my own view of the literature.

  • There are few studies, and those that have been done have significant limitations and often conflict.
  • There is reasonable evidence for some clinical benefit in acute diarrhea associated with stress or antibiotic use.
  • There is no high-quality, consistent evidence for most suggested uses of probiotics.
  • The unregulated probiotic products on the market today are plagued with inaccurate labeling and poor quality control. This means that even if probiotics might be beneficial in some cases, it is unclear if the actual products available could achieve these benefits.
  • There do not yet appear to be significant risks to probiotics, though the evidence for this safety also quite limited.


Posted in Herbs and Supplements, Topic-Based Summaries | 7 Comments

Evidence Update: Still No Good Evidence to Support Yunnan Baiyao

I originally wrote about the Chinese herbal product Yunnan Baiyao in 2010, concluding at that time that the evidence supporting its use to reduce bleeding was poor and largely anecdotal:

So we have a treatment with uncertain and unregulated ingredients, no demonstrated plausible mechanism of action, a few in vitro and lab animal studies in journals of questionable reliability, a few small human clinical trials in similarly questionable sources, and two very small veterinary trials in equids which found no effect except possibly on a poorly reliable and subjective test of blood clotting.

I reviewed the literature again in 2016, finding a few new studies which did nothing to strengthen the case for this product:

Despite some suggestive in vitro and low-quality studies, the best evidence available so far does not support that Yunnan Baiyao has any benefit for dogs. The fact that it is unregulated, that there is demonstrated inconsistency in the mineral and metal contents of Yunnan Baiyao from different sources, and that the ingredients are still kept secret by the manufacturers, should also give clinicians pause in considering this for their patients.

Though it hasn’t been very long since my recent review, I ran across another study looking for possible effects of Yunnan Baiyao on one aspect of blood clotting, platelet function and the Buccal Mucosal Bleeding Time (BMBT), which involves measuring the time for bleeding to stop after a standardized cut is made in the gums. Like most of the studies in veterinary patients so far, this one found no reason to believe Yunnan Baiyao can stop hemorrhage.

Frederick J, Boysen S, Wagg C, Chalhoub S. The effects of oral administration of Yunnan Baiyao on blood coagulation in beagle dogs as measured by kaolin-activated thromboelastography and buccal mucosal bleeding times. Can J Vet Res. 2017 Jan;81(1):41-45.

In a randomized controlled crossover trial 8 beagle dogs were given either placebo or 1000 mg of YB orally every 12 h for 5 consecutive treatments. Blood was drawn 24 h before treatment and 2 and 24 h after the last treatment, and the BMBT was measured in each sample in duplicate…There were no adverse effects of treatment and no significant differences between the control and treatment BMBTs or [platelet function] parameters at any time point….Thus, at the dose and frequency of administration in this study YB did not appear to have any clinically significant effects on the measured coagulation parameters.

As I always take care to emphasize, no single study is sufficient evidence to definitively answer most medical questions. But despite the anecdotes that seem so persuasive to many owners and veterinarians, the gradual accumulation of evidence is not encouraging. And though no obvious harm has yet been found, the fact remains that the ingredients in this remedy are not standardized or tested for quality of contamination, and since this would certainly be considered unacceptable and illegal for any conventional medicine, it is hard to justify using it when the chances of significant benefits appear to be quite low.

Posted in Herbs and Supplements | 1 Comment

Evidence Update: Finally a Clinical Trial of Cranberry Supplements for Urinary Tract Infections in Dogs

One of the recurring subjects I have covered on this blog is the contention that cranberry supplements can help prevent or treat urinary tract infections. Each time I address the subject, the evidence points to pretty much the same general conclusion:

March, 2012

There is weak theoretical justification for using cranberry products for UTIs, though none of the supporting preclinical evidence involves dogs or cats. There is conflicting clinical trial evidence in humans, and no clinical studies in dogs and cats.

October, 2012

This [Cochrane] review indicates pretty clearly that overall, cranberry juice is not effective in preventing UTIs despite theoretical reasons why it might be. This illustrates, yet again, why we cannot rely on extrapolation from pre-clinical or in vitro studies to tell us what will work in actual patients.

April, 2016

The in vitro portion of this study is consistent with existing research that suggests cranberry extracts may reduce the ability of some bacteria to stick to the lining of the urinary tract. This could theoretically help prevent some urinary tract infections, though clinical research in human patients suggests this doesn’t really work to a significant extent in living people.

The portion of the study looking at prevention of UTIs in actual dogs, unfortunately, doesn’t help establish what benefit, if any, this product might have.

So basically, while there is a plausible argument that cranberry supplements might be helpful based on lab research, clinical studies don’t seem to show they actually do much in real human patients, and there isn’t any real research in veterinary patients. Fortunately, the last part of that conclusion is now less applicable, thanks to a newly published clinical trial in dogs. Unfortunately, the results of the trial tend to support the existing human literature which has failed to find any real-world benefits.

N.J. Olby, S.L. Vaden, K. Williams, et al. Effect of Cranberry Extract on the Frequency of Bacteriuria in Dogs with Acute Thoracolumbar Disk Herniation: A Randomized Controlled Clinical Trial. J Vet Intern Med 2017;31:60–68.

This study specifically evaluated cranberry extract as a method for preventing bacterial urinary tract infections in dogs with newly acquired neurologic dysfunction due to herniated intervertebral disks damaging their spinal cords. Dogs with this condition are predisposed to such infections, and it was hoped the supplement would reduce this risk. The supplement used, Crananadin, was the same I reviewed in my original post on this subject.

The study employed excellent methodology, with appropriate randomization, blinding, placebo control, and pre-determined objective outcome measures. The results were clear and consistent. The cranberry group actually had a higher rate of infections than the placebo group, though the difference was not statistically significant. And though pre-clinical evidence suggests cranberry supplements might be most likely to be useful with E. coli infections, there was no statistical difference between the groups in the rate of this type of infection, with most occurring in the cranberry group. The study was ultimately smaller than the investigators initially intended because an interim analysis clearly showed no trend towards any benefit and very little chance that a benefit would be seen even if more animals were enrolled.

While no single study should be the final word on any complex medical question, this trial is about as strong a clear a negative finding as one can get. And given the similar failure to find significant benefits in many human trials, it adds to a growing body of evidence suggesting that cranberry supplements are not useful in preventing or treating urinary tract infections. While additional studies may help clarify the issue, especially those involving different types of supplement and different patient populations, at some point consistent failure to find a benefit has to be seen as a reason to question the wisdom of expending scarce research resources on studying the question. We aren’t, in my view, quite at that point yet, but at least clinicians should be clear with pet owners that the evidence does not look good for cranberry supplements, and these should not be relied on in lieu of effective monitoring and medical treatment.

Bottom Line
Despite some promising laboratory studies suggesting cranberry supplements might help prevent or treat urinary tract infections, the evidence of studies in clinical patients has been disappointing. Conflicting studies in humans suggest, on balance, that there is probably no significant benefit. And now a high-quality clinical trial in dogs has failed to find any effect, even in the the of infections the pre-clinical research most strongly suggested there should be one.

While the risks of cranberry supplements are probably negligible, pet owners should understand, and veterinarians should make in clear to their clients, that there is no good reason to believe they have any real value in preventing or treating urinary tract infections.

Posted in Herbs and Supplements | 3 Comments

Music Therapy for Dogs: Does Your Dog Really Prefer Reggae to Pop?

Playing music has become a popular method for reducing stress in animals who are hospitalized or kenneled. A couple of years ago, I reported on a review of the literature investigating this practice. The conclusion of that review was this:

The studies described above support the idea that physiological and neurochemical changes can result from music exposure. Music’s ability to improve learning and memory and diminish stress suggests that music can result in positive physiologic effects. Other studies, however, suggest that music has no observable effect or can have a detrimental effect on animals. There is not yet sufficient evidence to suggest that animals react physically to music in a way that can be manipulated predictably and consistently.

Since then, a few new studies have been published, and I want to briefly review two of them since once has been making headlines recently.

Well, not exactly….

The first study was published in 2015.

Bowman, F.J. Dowell, N.P. Evans. ‘Four Seasons’ in an animal rescue centre; classical music reduces environmental stress in kennelled dogs. Physiology & Behavior, Volume 143, 1 May 2015, Pages 70-82

In this experiment, 50 dogs at two rescue shelters were assigned to be monitored during a period with no auditory stimulus and a period in which classical music was played. Heart rate monitors were used to measure heart rate variability (HRV), salivary cortisol levels were measured, and behaviors, such as time spent standing or lying down and barking, were observed. The hypothesis was that these proposed measures of stress would improve during the time the classical music was being played.

The results were mixed. The cortisol levels were too variable to show any association with the music. Cortisol has long been used as a measure of stress, but it is highly problematic and often cannot be convincingly shown to truly represent the level of stress an animal is experiencing at a given time. HRV showed some changes that might be consistent with a reduction in stress, though the exact significance of this measure in the well-being on dogs hasn’t been definitively shown either. And finally, the behavioral measures suggested the music reduced possible signs of stress. During the music condition, dogs appeared to lie down more and bark less.

There were a number of limitations to this study. While two groups of dogs experienced the music and silent conditions in different orders, it is not clear how the animals were selected for the study in the first place. And the authors acknowledge that not all animals were available for all observation times or finished the study, but no details on this are reported. And it is not stated whether observers were blinded to the treatment, which is key when using behavioral observations as a measure of effect. Finally, the study appeared to show that the effects of the music treatment that were observed only lasted as little as one day, and that continuing to play the same music beyond this time had no effect.

Overall, this study adds a bit of evidence to suggest that classical music might have some effects on dog behavior. However, while some findings are consistent with other studies, some are not. And the significance of some of the measures used and the changes seen are not clear.

The second study was done by the same group in the same facilities on a smaller group of dogs (38).

Bowman, F.J. Dowell, N.P. Evans. The effect of different genres of music on the stress levels of kennelled dogs. Physiology & Behavior, Volume 171, 15 March 2017, Pages 207-215

The methods used were very similar. However, the major difference was that a period of observation when no music was played both preceded and followed the period of music exposure. In addition, the genre of music varied each day during the music exposure period. Also, cortisol levels were measured in urine rather than saliva, which it was hoped would reduce the individual variability a bit. Otherwise, the circumstances and the limitations were similar to the previous study.

The results again showed changes in HRV that were suggestive of a reduction in stress during the music condition. Some behavioral changes were also observed that matched those seen in the previous study (an increase in time spent lying down, for example), but other behavior changes seen previously were not seen in this study (for example, there was no reduction in barking during the music condition). Finally, the cortisol levels showed a changed that was the reverse of what would be expected, showing an increase during the music condition as would be expected with an increase in stress. There were some small differences in HRV and behavior between different genres of music, but there was no clear, large, consistent evidence that one genre is better than another.

This figure illustrates how really small the differences between silence and music, and between different genres of music, were in this study. While some of these differences were statistically significant, that does not automatically mean they were clinically meaningful.

These mixed results illustrate the general level of uncertainty regarding the effects of music on stress in dogs. While they can be interpreted to suggest a benefit (as the authors do), the size of the effect is small and the pattern of changes varies enough from study to study that it is hard to be certain there is really a consistent effect. And since several of the measures used in these studies may or may not actually reflect stress experienced by the dog (such as HRV and cortisol levels), changes in those measures may not reflect real improvement.

This raises the bigger question of how do dogs really benefit from the kinds of effects seen in these studies? Behavioral and physiologic measures suggest they might be showing less of a stress response, and presumably that implies they feel less anxious or fearful, but of course it is really difficult to confidently judge how an animal feels from such proxy measures. And is a small reduction in stress for a few days a meaningful improvement in welfare? Would it be more worthwhile to focus on interventions that have measurable impact on health, adoptability and the behavior problems that keep pets from finding lifelong homes, etc?

Finally, there is the question of whether music does any harm to these dogs. Certainly, we’ve all been trapped listening to someone else’s music we couldn’t stand, and it can be a miserable experience. Before we force dogs similarly trapped in kennels or hospitals to listen to music, we want to be certain we aren’t making their experience worse. Unfortunately, these studies don’t appear to look specifically for negative effects. The fact that cortisol levels in the second study changed in a way you would predict with an increase in stress was dismissed as insignificant, but we should at least consider the possibility it represented the reaction of the dogs to the music more accurately than the more subjective behavioral measures. I tend to agree with the authors that cortisol levels are notoriously unreliable markers of stress, but if we choose to use them in studies like this, we can’t simply choose to interpret the numbers in the way most congenial to our pre-existing hypotheses.

Bottom Line
These new studies at a little bit of evidence to that covered in the review I wrote about previously. In general, they do suggest that some kinds of music, such as classical and “soft rock,” might help reduce arousal, stress, and anxiety in dogs in a rescue shelter. Overall, however, the evidence for this hypothesis is still weak.

There is little evidence of any harm from most music interventions, though unfortunately this is not always something investigators specifically look for.

On balance, then, I think it is possible that music might have some benefits for dogs in stressful circumstances, such as boarding kennels, hospitals, and shelters, but this is by no means clearly proven. The risk is also likely quite low, so there is probably little harm in using quiet music for this purpose so long as it is not substituted for other, more comprehensive approaches to reducing stress and anxiety.







Posted in General | 4 Comments

Evidence Update- New Review of Medical Marijuana Research

I have addressed the question of medical marijuana and the use of other cannabis-derived medicinal products twice before. My conclusion in 2013 was this:

The current research evidence supports a couple of uses in humans, including treatment of nausea and poor appetite and possibly pain. Most other uses are poorly supported by clinical research. And there are unquestionably side effects that make marijuana often less useful than isolated cannabinoids or other unrelated treatments.

There is virtually no useful research evidence in companion animals, so any use of cannabis products is based entirely on theory and extrapolation from the limited research results in humans. Canna-Pet as a specific product, is being marketed with very dramatic and aggressive claims about safety and efficacy that do not appear to be supported by specific research on the product but, again, are based entirely on theory and anecdote, both notoriously unreliable sources of evidence.

There are recognized behavioral and medical risks associated with marijuana use in humans. While the behavioral risks do not apply to use in companion animals, and the medical issues associated with THC do not apply to products with negligible amounts of this compound, the risks of cannabis-derived compounds in dogs and cats are largely unknown. Any use of such products, then, should be undertaken with a clear understanding of the high levels of uncertainty about the results, and claims should not be made for these products that go beyond the available evidence.

When I looked again in 2016, I found no further research in veterinary patients, and the basic bottom line had not changed. We often must extrapolate from research in humans to clinical practice in veterinary medicine because we often don’t have the research we need in our own patients to guide us. This is necessary, but it is also risky. Humans are not dogs or cats, and while there are many similarities in basic physiology and in disease and response to treatment, there are also critical differences. The ibuprofen or sugarless gum that is safe for us will easily kill our pets. And the problems with blood lipids and cardiovascular disease that are a major source of human suffering and death are virtually non-existent in our canine and feline companions. So we must also be aware of the risks of leaping from evidence in humans to evidence in veterinary patients even when we have no choice but to make such a leap.

In the case of marijuana and other cannabis-derived products, there is still effectively no research on the risks and benefits in companion animals. Unfortunately, this has not stopped an explosion of marketing of cannabis products to pet owners, with no testing or regulation to ensure safety and efficacy. This is a dangerous situation. The evidence of risks and benefits in humans can help us to some extent to guess at the effects in companion animals, though unfortunately we cannot know how accurate these guesses will be without doing the careful work of rigorously studying these products in the actual species in which we are thinking about using them.

As for the human evidence, on that front there is some good news. The stigma that has hampered research for so long is waning, which is beginning to open the doors to researchers investigating the real effects of the many compounds found in cannabis. And a new review has just been produced which clearly and comprehensively summarizes the existing evidence, making it a lot easy to see the potential risks and benefits that we should focus on investigating in dogs and cats.

The National Academies of Sciences, Engineering, and Medicine. The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research (2017)

This review does the valuable work of comprehensively searching the research literature and then grading the strength of evidence for specific uses. Here is the grading scale the report uses:

Conclusive Evidence
For this level of evidence, there are many supportive findings from good-quality studies with no credible opposing findings. A firm conclusion can be made, and the limitations to the evidence, including chance, bias, and confounding factors, can be ruled out with reasonable confidence.

Substantial Evidence
For this level of evidence, there are several supportive findings from good-quality studies with very few or no credible opposing findings. A firm conclusion can be made, but minor limitations, including chance, bias, and confounding factors cannot be ruled out with reasonable confidence.

Moderate Evidence
For this level of evidence, there are several supportive findings from good- to fair-quality
studies with very few or no credible opposing findings. A general conclusion can be made, but limitations, including chance, bias, and confounding factors cannot be ruled out with reasonable confidence.

Limited Evidence
For this level of evidence, there are supportive findings from good- to fair-quality studies with most favoring one conclusion. A conclusion can be made, but there is significant uncertainty due to chance, bias, and confounding factors.

No or Insufficient Evidence
For this level of evidence, there are mixed findings, a single poor study or health endpoint has not been studied at all. No conclusion can be made because of substantial uncertainty due to chance, bias, and confounding factors.

This is a reasonable and fairly user-friendly scheme for categorizing the strength of the research evidence for or against specific proposed risks and benefits. The summary of the study lists the specific risks or benefits that were reviewed and classified according to this scheme. The benefits and risks are divided into several categories. There are too many to list here, but I will highlight those for which the evidence is at moderate or better and which might be relevant to veterinary patients (meaning, I will skip uses of cannabis for diseases not seen in dogs and cats or risks, such as auto accidents or risks from smoking marijuana, which obviously don’t apply to these species.)

Therapeutic Benefits:
Treatment of chronic pain in adults (cannabis)
Treatment of chemotherapy-induced nausea and vomiting (oral cannabinoids)

Lower birth weight with maternal use
Impairment of cognition, including learning, memory and attention with acute use
Variable increase in risk of development or in symptomatic worsening of various psychiatric disorders (relevance to behavior problems in veterinary patients?)

That’s pretty much it. There are plenty of other risks and benefits with at least moderate evidence that appear only to be relevant to humans. And there are many risks and benefits which could be relevant to veterinary patients but for which the evidence in humans is weak or insufficient to draw any conclusions. And, as I keep pointing out, there is virtually no evidence for any of the many different products out there that directly evaluates risks and benefits of those products in dogs and cats.

So right now, we are at a place where the hype and the marketing far exceed the real evidence that cannabis-based products are safe and useful for our pets. Using them could be worthwhile, but currently it is essentially rolling the dice, an uncontrolled individual experiment that could also make the patient’s life worse. Hopefully, further research will elucidate the real harms and benefits for our pets so we can make sound decisions about the appropriate role of cannabis-based products in veterinary care.




Posted in Herbs and Supplements | 14 Comments

Evidence Update: Does Dry Food Increase the Risk of Diabetes in Cats?

A perennial question in veterinary nutrition is the relative pros and cons of dry commercial diets. In particular, pet owners and vets alike have a lot of questions about the nutritional value and potential risks of dry food for cats. The argument is often made by proponents of alternative diets that, as obligate carnivores, cat cannot utilize the carbohydrates in commercial diets and, in fact, these contribute to disease. There is no question that cats are carnivores, and it is reasonable to suppose plant foods may not be nutritionally ideal for them. However, the naturalistic fallacy, that says whatever happens in nature is somehow perfect and ideal, is also at play in this issue. And there is evidence that properly prepared plant foods can contribute to a healthy diet for cats, though it seems that strictly vegetarian diets are unlikely to meet all of a cat’s nutritional needs.

As for the role of dry commercial foods in disease, there is very little evidence to go on, despite the widespread, often inflexible opinions many people have on the subject. About five years ago, I reported on an expert consensus document put out by the American College of Veterinary internal Medicine (ACVIM), which addressed this question. Here were the conclusions of that group of experts:

  1. Are dietary carbohydrates an essential or required nutrient for cats?
    Answer- No. Based on a good quality and quantity of evidence, most cats do not require dietary carbohydrates. There are some simple sugars in feline milk, so it is possible that nursing kittens may require these but no clear deficiency has been demonstrated.
  2. Can cats effectively utilize dietary carbohydrates for energy and nutrition?
    Answer- Yes. Based on a good quality and quantity of evidence, cats can effectively digest, absorb, and utilize dietary carbohydrates.
  3. Do dietary carbohydrates in the diet cause obesity?
    Answer- No. The cause of obesity in almost all cats is excessive calorie intake irrespective of whether the calories come from protein, fat, or carbohydrate. In fact, low carbohydrate foods may be more likely to lead to obesity if they are higher in fat than regular diets.
  4. Do dietary carbohydrates contribute to the development of diabetes?
    Answer- The consensus was that they do not, however the research evidence is very limited and not always consistent. The consensus was that even if carbohydrates do play a role as a risk factor for diabetes, this is dwarfed by the much more important factor of obesity.
  5. Are low-carbohydrate diets useful in the management of feline diabetes?
    Answer-Maybe. The evidence is limited and conflicting, and the committee did not achieve a consensus.

I have generally encouraged clients to feed their cats canned rather than dry food when possible because there is at least some reasonable theoretical argument for doing so. However, in the absence of strong evidence, I do not make a crusade out of this as some vets do.

Recently, a new study was published addressing one aspect of this issue, the potential association of diet with the occurrence of diabetes in cats. The theory is sometimes advanced that the carbohydrates in dry diets encourage obesity and create stress on the pancreas, the organ which produces insulin, and that this increases the risk of diabetes for cats eating such diets. Again, there has not so far been much actual evidence that this theory is correct, but the new study does contribute some. As always, the study has strengths and weaknesses which influence how much weight we should give the results and conclusions.

M. € Ohlund, A. Egenvall, T. Fall, H. Hansson-Hamlin, H. R€ocklinsberg, and B.S. Holst. Environmental Risk Factors for Diabetes Mellitus in Cats. Journal of Veterinary Internal Medicine. online early view January, 2017

The study was a case-control design. This means that a database of cats (in this case, those covered by a Swedish pet insurance program) was analyzed to identify cats with diabetes (cases) and those that were as similar as possible in other respects but did not develop diabetes (controls), and any available lifestyle information was compared to see what occurred more often in the cases than the controls, and vice versa. This can identify factors associated with the occurrence of diabetes.

It is important to recognize up front that such studies cannot establish causal relationships, and they are subject to a variety of sources of error, some of which I will discuss relevant to this particular study. They are a useful tool, however, for identifying potential risk factors for disease.

The first issue is the population of cats involved. Cats in Sweden who are covered by health insurance could differ in a variety of relevant ways from other populations of cats. Any associations found for such cats may or may not apply to, say, indoor cats in San Francisco or barn cats in Texas.

The other major concern is that the data consisted entirely of owners’ answers to a questionnaire, not medical records. That means that the study relied on owners correctly remembering medications their cats had been given, characterizing their diet history and eating habits, and reporting other lifestyle details that were then analyzed for associations with the occurrence of diabetes. Studies of human patients and their caregivers and family members show that our memories of such things are often highly unreliable and influenced by the very factors such studies are trying to evaluate. Owners whose cats have developed diabetes are likely to remember their cats’ medical and dietary histories differently than those whose cats don’t have this disease, and this can influence the associations seen in the data.

The authors are, of course, aware of and openly address these limitations:

Limitations of our study are mainly related to the study design, especially the problems with dietary recall bias and the difficulties for owners to accurately assess their cat’s body condition. Owners of diabetic cats can be more prone to remember events preceding the cat’s diagnosis of DM [diabetes] because of a recall bias, causing a type I error. They can also have more knowledge about DM and be more aware of the risk factors for disease, which might influence their responses. For example, owners of diabetic cats are more likely to be aware of their cat’s body condition, and also of the dangers of obesity. Moreover, owners of diabetic cats are asked about circumstances the year preceding their pet’s diagnosis of DM, which can be several years back in time. This differs from the control group, whose replies refer to the last year in the cat’s life, in general more recently.

Such limitations do not, of course, invalidate the research. All research has some sources of error that cannot be perfectly controlled. This is why consistency in findings across studies by different investigators and using different designs is crucial to arriving at an accurate understanding. However, we always need to incorporate an awareness of these sources of error into our interpretation of research studies and try not to blindly rely on the results of any one.

And what were the results of this study? A number of factors were associated with either a greater or lesser risk of diabetes. Breed and sex and previous use of corticosteroid medications were factors that have been associated with diabetes in other studies and were in this research as well. With regard to medication, however, no details about type of steroid, dose, or frequency were available, and the association relied entirely on owner memory, so this is not a particularly useful finding in terms of guiding the use of such medications.

There were some associations with diet and diabetes, but these were complex and not entirely clear. Partly, this is because obesity is a well-established risk factor for diabetes, and the association between type of diet and occurrence of diabetes seems to vary with body weight (again, with both diet and body weight determines solely by owner memory and judgment). Here is one example from the paper.

The only association that is statistically significant (the confidence interval does not include 1) is the comparison of dry food and wet food only in cats of normal weight. A couple of others are close, but it is impossible to tell if these would achieve statistical significance under different circumstances. The more important question, however, is do the pattern of results make sense? If dry food increases the risk of diabetes, shouldn’t this be the case for cats of all body weights? Of is the role of obesity so great that it swamps any effect of diet, so diet only shows up as a risk factor in cats of normal weight? The authors are very reasonable and circumspect in how they address these findings, and they are clearly aware that the implications of these results need to be sorted out in the context of the existing literature and, ideally, through further research.

The association of DM risk with dry food diet in normal weight cats is to our knowledge previously not reported, and it has earlier been proposed that the proportion of dry food in the diet might not be a risk factor for DM. However, because cats are obligate carnivores, whose natural diet consists mainly of protein- rich animal prey, it has been hypothesized that a high carbohydrate diet such as commercial dry food might put an increased demand on the cat’s insulin secretion, thereby predisposing them to the development of DM….

In our study, an effect of type of diet was found only in cats with a normal body condition, suggesting that for overweight cats, the risk of the obesity per se is more important than the type of diet….

Our results should be interpreted with caution, as the macronutrient content in food given to cats in our study is unknown, although a typical commercial dry diet generally contains more carbohydrates than a typical wet diet. It is also possible that the difference between dry and wet food detected in our study might relate to a protein effect rather than a carbohydrate effect, as it is not possible to alter one macronutrient without another.

The study also found some associations suggesting being indoors might increase the risk of diabetes. However, this involves a number of potential confounding factors, and only one of these was directly evaluated. Obviously, if obesity is a known risk factor and indoors cats are more likely to be obese, due perhaps to constant access to food or lower levels of activity, then being indoors would be associated with diabetes without being directly causal. Indoor cats kept lean would not be at higher risk just because they are indoors in obesity is the intervening condition.

In this study, the results were presented only in terms of the interaction between indoor status and activity level (again,  reported by owners, who may well not characterize their cats’ levels of activity accurately; who sits home and monitors their cat’s activity all day, and who sees what their cat is doing when it is outside all the time?). Cats reported to have moderate or low levels of activity seemed less likely to have diabetes if allowed outdoors, whereas outdoor access did not seem associated with diabetes in cats reported to be active.

This is an interesting finding, but incomplete and in need of a lot more direct study to find the direct and modifiable risk factors involved. (Not to mention the question of whether the overall health and longevity of cats is better when kept indoors or allowed outdoors. Even if indoor-only cats are at greater risk for diabetes, they may be healthier overall and live longer than outdoor cats because they are protected from infectious disease, parasites, trauma, and predation.)

Undoubtedly, some anti-vaccine activists will make much of the association seen between vaccination and diabetes in this study. However, there are many reasons to be skeptical of this association. Apart from all the study limitations already noted, there is no plausible mechanism by which vaccines could lead to diabetes (unlike, say, obesity or dry food), the vast majority fo the cats were vaccinated (93%), and this seems more likely to be a spurious associated confounded by the fact that cat owners who take their pet to the doctor more often are both more likely to have them vaccinated and more likely to have diabetes diagnosed than owners who don’t see the vet much and tend not to pay for vaccines or diagnostic tests. Here’s what the authors say about this issue:

An association with an increased risk of DM was seen in fully vaccinated cats compared with unvaccinated cats, but the proportion of unvaccinated cats in the study population was low (7%). There are no supporting evidence that vaccines cause DM in cats, and the association detected in our study should not be interpreted to support a decision not to routinely vaccinate cats. The finding can be explained by diabetic cats having had more visits to a veterinarian than control cats, and can also refer to a recall bias because owners of diabetic cats could be more aware of their cat’s health and vaccination status than owners of healthy cats.

Bottom Line
Overall, this study is a preliminary step in looking for lifestyle factors that might increase the risk of diabetes in cats. It is plausible that dry foods, for example, could be a risk factor, and this study makes more focused investigation of that hypothesis clearly worthwhile. However, there are a lot of limitations to the study and unanswered questions, so this study clearly cannot be taken to prove any such causal relationship. It also appears to show an association between vaccination and diabetes, and this is almost certainly a spurious relationship caused by uncontrolled confounding and other study limitations, which illustrates why these results have to be taken with a grain of salt, or perhaps even a few grains.

Posted in Nutrition, Science-Based Veterinary Medicine | 4 Comments

New Review Reminds us Doctors are Lousy at Predicting Benefits and Harms of their Tests and Treatments

One of the major focuses of my criticism of both science-based and alternative medicine is the failure of doctors to recognize their own limitations. There are innumerable cognitive biases and other sources of error that interfere with accurate and effective clinical decision-making. And there are many reasons why uncontrolled observations, whether by doctors or anyone else, are unreliable and inferior to controlled scientific research when trying to understand the causes of disease and the effects of healthcare treatments. The problems caused by opinion-based and faith-based medicine, including the issue of overdiagnosis and overtreatment in mainstream medicine and the persistence of ineffective treatments, especially in alternative medicine, are directly related to our tendency as individuals to trust our own judgment and beliefs far beyond their real reliability.

A new review of studies involving medical doctors illustrates this problem, and reminds us why we have to rely more on science and less on our own opinions and beliefs if we want to provide the best care for our pets and patients.

Hoffmann TC, Del Mar C. Clinicians’ Expectations of the Benefits and Harms of Treatments, Screening, and Tests: A Systematic ReviewJAMA Intern Med. Published online January 09, 2017. doi:10.1001/jamainternmed.2016.8254

This review looked at studies evaluating how well MDs did at predicting the likely benefit or harm to patients of tests and treatments compared with controlled research. The findings starkly illustrated that, “clinicians rarely had accurate expectations of benefits or harms of the interventions, with inaccuracies in both directions, although they more often overestimated rather than underestimated benefits and underestimated rather than overestimated harms.”

The magnitude of this effect was impressive.

Among the studies comparing benefit expectations…most participants provided correct estimation for only 3 outcomes (11%). Of the studies comparing expectations of harm …a majority of participants correctly estimated harm for 9 outcomes (13%). Where overestimation or underestimation data were provided, most participants overestimated benefit for 7 (32%) and underestimated benefit for 2 (9%) of the 22 outcomes, and underestimated harm for 20 (34%) and overestimated harm for 3 (5%) of the 58 outcomes.

Guessing the correct benefit or risk less than 15% of the time and overestimating benefits by 32% and underestimating harm by 34% is a recipe for ineffective, even dangerous care. Though this is a study of MDs, there is no reason to think vets would do any better, and in fact it is likely that vets would perform worse than MDs and alternative medicine practitioners would do worse than those practicing science-based medicine. Vets generally have less pressure to know and conform to evidence-based standards than MDs due to less regulation and litigation. And alternative practitioners are, at best, often uninterested in scientific evidence and sometimes actively hostile to it.

The direction of the effect was also interesting, and consistent with what we know about how the human mind works. As doctors, we overestimate the benefits of our actions and underestimate the risks because we feel pressure to act and to fix things and because we need to believe we are helping our patients effectively. We are quite worried about causing harm, but we also worry more about the risks of not acting than of taking action.

The finding of more instances of clinicians underestimating harms and overestimating benefits than the opposite provides some support for the existence of therapeutic illusion (“an unjustified enthusiasm for treatment on the part of both doctors and patients,” which is a proposed contributor to the inappropriate use of interventions. Other potential contributors include the often-misleading portrayal of intervention benefits and absence of harms data in journal articles and information from commercial sources, such as pharmaceutical advertisements in medical journals.

We found much more focus on assessing expectations about harm than benefit (67% of studies measured harm expectations only) in contrast to our review5 of patient expectations where most studies (63%) focused on benefit expectations. Clinicians may be more sensitive to harming patients rather than just not providing benefit, which may stem from a fundamental concern of primum non nocere: the primary duty of doing no harm. Medicolegal concerns may also influence clinicians to place greater emphasis on the risks of not doing something rather than the risk of harm from intervening.

The response to this kind of information is not, of course, to give up on medicine. Medical care is tremendously effective at reducing suffering and death. The takeaway message is that individual observation and judgment should always be supported and informed by scientific research, which does a better job at evaluating the causes of disease and the effects of treatments than our ad hoc observations.

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New York and FTC Tired of Prevagen False Claims (which are the same as for the veterinary version, Neutricks)

I have written several times about Neutricks, a supplements marketed for cognitive dysfunction in dogs:

Neutricks: Another Nutraceutical for Canine Cognitive Dysfunction

Evidence Update:  Old Tricks Used to Massage Neutricks Study Data

Evidence Update: Neutricks Still up to Same Old Tricks

This supplement has become the paragon of snake oil supplements for its dramatic claims supported by anecdote and shoddy science. The company and its founders have been warned by regulators about their blithe disregard for unsupported claims about the product, and now the Attorney General of New York and the Federal Trade Commission (FTC) have filed a lawsuit to stop the fraudulent marketing of the human version of this product, Prevagen.

Such vigorous action is rare in the current anti-regulatory climate, and it is encouraging to see an effort like this to protect consumers from false advertising, even if it currently is only aimed at consumers of the human version of the product. The New York AG was quite blunt in describing the suit:

“The marketing for Prevagen is a clear-cut fraud, from the label on the bottle to the ads airing across the country,” the New York Attorney General Eric Schneiderman said in a statement. “It’s particularly unacceptable that this company has targeted vulnerable citizens like seniors in its advertising for a product that costs more than a week’s groceries, but provides none of the health benefits that it claims.”

The FTC was equally direct:

According to the FTC, the makers of Prevagen relied on a single study to back up their false claims. And the study didn’t even show that Prevagen improved memory better than a placebo. To make matters worse, the FTC and New York Attorney General allege that the company behind Prevagen was actively targeting seniors who were struggling with deteriorating memory.

“The marketers of Prevagen preyed on the fears of older consumers experiencing age-related memory loss,” Jessica Rich, director of the FTC’s Bureau of Consumer Protection, said in a statement. “But one critical thing these marketers forgot is that their claims need to be backed up by real scientific evidence.”

Even in this supposed “post-fact” era, it is good to see that at least some in government recognize the need for real scientific evidence for healthcare products to protect consumers from snake oils like this. Hopefully, if this suit is successful, the same principles of consumer protection and scientific will be applied to the veterinary market and pet owners, though sadly standards are often lower for pet products.

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