PEMF Device for Pets

Posted on October 1, 2009 by skeptvet

Bioelectronics corporation has announced its intent to market a new device for treatment of osteoarthritis in pets. The device, the HealFast®Therapy PetPatch™, is a pulsed electromagnetic field (PEMF) device that attaches over a swollen or painful joint ad is intended to “to reduce swelling, relieve pain and enhance the healing of surgical incisions, accidental wounds, sprains, strains and chronic wounds.”

PEMF devices are widely available for human use, and as usual for CAM nostrums they are based on some suggestive in vitro and laboratory studies and weak clinical trial evidence. Electromagnetic fields do have measurable effects on cells in vitro, and there are some recognized medical uses for them. Some evidence suggests an improvement in outcome for non-union fractures, and there may be some benefit in terms of reduced pain and swelling following surgery. However, overall the evidence for clinical benefit is equivocal, as indicated by a number of review studies:

“All trials examined knee OA and one also performed a separate evaluation for cervical OA patients. The results of this analysis show improvements in all measurements for knee OA, but their clinical significance from a patient’s perspective was questionable. Only two outcomes favoured treatment for cervical OA trial and none were considered clinically important. There were no reported side effects. The reviewers conclude that there is an urgent need for further large-scale studies of pulsed electric stimulation with a focus on knee OA to establish the clinical relevance of treatment.” Cochrane Review

“We cannot make any definitive statements on the effects of electrotherapy for people with acute or chronic mechanical neck disorders (MND). Based on this review of 11 trials and 525 people with MND, the current evidence on Galvanic current (direct or pulsed), iontophoresis, TENS, EMS, PEMF and permanent magnets is either lacking, limited, or conflicting.” Cochrane Review

“McCarthy and colleagues (2006) noted that the rehabilitation of knee osteoarthritis often includes electrotherapeutic modalities as well as advice and exercise.  One commonly used modality is PEMF.  Its equivocal benefit over placebo treatment has been previously suggested.  However, recently a number of randomized controlled studies have been published that have allowed a systematic review to be conducted.  The authors concluded that this systematic review provides further evidence that PEMF has little value in the management of knee osteoarthritis.  There appears to be clear evidence for the recommendation that PEMF does not significantly reduce the pain of knee osteoarthritis.”AETNA insurance company literature summary

“In a randomized, placebo-controlled study, Ay and Evcik (2008) examined the effects of PEMF on pain relief and functional capacity of patients with knee osteoarthritis.  A total of 55 patients were included.  At the end of treatment, there was statistically significant improvement in pain scores in both groups (p < 0.05).  On the other hand, no significant difference was observed within the groups (p > 0.05).  These investigators observed statistically significant improvement in some of the subgroups of Lequesne index (e.g., morning stiffness and activities of daily living) compared to the placebo group.  However, these researchers could not observe statistically significant differences in total of the scale between two groups (p > 0.05).  Applying between-group analysis, the authors were unable to demonstrate a beneficial symptomatic effect of PEMF in the treatment of knee osteoarthritis in all patients.  They stated that further studies using different types of magnetic devices, treatment protocols and patient populations are warranted to confirm the general efficacy of PEMF therapy in knee osteoarthritis and other conditions.” AETNA insurance company literature summary

“Furthermore, in a systematic review on wound care management, Cullum, et al. (2001) concluded that there is generally insufficient reliable evidence to draw conclusions about the contribution of laser therapy, therapeutic ultrasound, electro-therapy and electromagnetic therapy to chronic wound healing.  Flemming and Cullum (2001) also concluded that there is currently no reliable evidence of benefit of electromagnetic therapy in the healing of venous leg ulcers.” AETNA insurance company literature summary

 

This would seem to suggest that a responsible company would make an investment in investigating a promising therapeutic concept in the hopes of eventually finding a beneficial, and presumably profitable, product. Unfortunately, as I’ve discussed before this instead is seen as a perfect opportunity to make a quick buck selling something based on its promised rather than its demonstrated value. What is especially disturbing about the Bioelectronics’ press release is the unabashed trumpeting of the potential profit to be made and the clearly stated intent to market the device directly to consumers, bypassing the veterinarians who presumably might have troubling questions about the evidence behind the company’s claims: “A comprehensive direct to consumer marketing program will support the launch of the new product. The centerpiece of the campaign is a new TV commercial which will begin rolling out next week.”

 

So for those of you who are veterinarians, be prepared for the clients who will soon be coming to you having seen the new commercial. Hopefully, they’ll be seeking you advice, but unfortunately it’s always dissatisfying for client and vet alike to have to answer the glowing testimonials and marketing hype for one of these products by a sober and bland summary of equivocal research evidence. Still, that’s our job!

Posted in Miscellaneous CAVM | 17 Comments

CAM and Religiosity

Posted on September 29, 2009 by skeptvet

I have often referred to CAM as “faith-based medicine” due to its reliance on belief over evidence for validation, and I have commented on my perception that such a belief-based approach resembles religion, for which I have been soundly chastised by some as raising a divisive issue. Nothing stirs passions and animosities like a discussion of religion in America. Nevertheless, while I respect people’s right to believe as they choose, and I see a lot of good come from many religious traditions, there does seem to me to be a strong relationship between various forms of non-evidence based belief. A recent article in the Journal of Alternative and Complementary Medicine would seem to support the link between religion, or at least religiosity, and CAM. Unfortunately, without paying for a subscription, I can only access the abstract and first page, but here are some tidbits:

“Naturopaths and acupuncturists were three times as likely as internists and rheumatologists to report no religious affiliation (35% versus 12%, p<0.001), but were more likely to describe themselves as very spiritual (51% versus 20%, p<0.001) and to agree they try to carry religious beliefs into life’s dealings (51% versus 44%, p<0.01). Among physicians, increased spirituality and religiosity coincided with more personal use of CAM and willingness to integrate CAM into a treatment program.”

“Religion, spirituality, and complementary and alternative medicine (CAM) are related to one another in complex ways. Religious practitioners and CAM supporters are critical of conventional biomedicine’s reductionism and impersonality…Additionally, reflecting religious traditions, CAM supporters see patients as “whole persons—spiritual beings.” Thus, we might expect those who are more religious to be attracted to CAM practices.”

The article does discuss the concern of some fundamentalist members of mainstream religions with the “universal notion of spirituality over particular and concrete practices of religion,” but it does suggest that overall a supernaturalist outlook is correlated with an openness to vitalist, non-scientific approaches to medicine.

We generally believe ourselves in this country to be past the days when one’s religious faith determined one’s beliefs about the ordinary physical world. Most people of faith accept the reality of the geocentric model of the universe, evolution by natural selection, probabilistic quantum mechanics, and many other scientific discoveries that explain phenomena previously given supernatural explanations. CAM, however, is an area in which all too often faith trumps reason, and belief is considered sufficient to validate a practice that cannot be supported by objective scientific evidence.

If we acknowledge the clear connection between a bent towards vague, supernaturalist beliefs and CAM, I think we can strip away the misleading patina of science that disguises much CAM and lends it an undeserved appearance of legitimacy. Certainly, there are CAM proponents  who are committed to a scientific, evidence-based approach, and we should encourage and support these. But when others clearly base their practices on spiritual belief rather than real science, we should make that clear for all to see as well.

 

Addendum

 

A reader was kind enough to forward a complete copy of the article, and there were a few more interesting comments I wanted to pass along. Overall, the article makes a strong case, though with limited data, that CAM use is about worldview more than about safety and efficacy. The authors state “[Astin, JA, 1998] hypothesized that ‘growing interest in alternative medicine may represent a type of cultural (Kuhnian) paradigm shift regarding health beliefs and practice…part of a broader value orientation and set of cultural beliefs, one that embraces a holistic, spiritual orientation to life.” Our finds support this hypothesis.”

They also argue their paper is “another in a growing body of research that underscores the important roles religion and spirituality play in shaping physicians’ clinical judgment.” Personally, I find this idea frightening. I would prefer my doctor to use science and facts as the  basis of clinical judgment, not religious beliefs. Sure, religion may play a role in how a physician approaches personal interactions and ethical questions. But their medical judgment should not be a reflection of their religious beliefs, since science and history illustrate quite clearly that religious approaches to medicine are inferior to scientific approaches. All the holy water and burning sage in the world won’t cure a staph infection.

Finally, the authors give a strategic suggestion which I suspect their peers will be likely to accept readily: “In light of these findings, proponents of CAM may ant to focus their efforts on healthcare providers who are more self-consciously spiritual, and/or focus on spiritual themes, encouraging such providers to consider integration of CAM into their practices.” Having failed to make their case on the basis of evidence, they hope to persuade people to adopt their approaches out of respect for faith and religion. I would like to believe such a strategy would be as unsuccessful as it is misguided, since it clearly will not be in the best interests of patients. I fear, though, such will not be the case.

Posted in General | 9 Comments

From CFI – Paying for Non-Evidence Based Health Care

Posted on September 28, 2009 by skeptvet

The Office of Public Policy of the Center for Inquiry, a think tank an lobby devoted to science and reason in public policy, has issued a report warning of attempts by notorious CAM booster Tom Harkin and others to insert language into health care reform legislation that would prevent “discrimination” against CAM providers. This means that insurance companies, and any public health funding, would be required to pay for services regardless of whether they work! The report discusses Therapeutic Touch as an example, and there’s always the Big Three of CAM (Homeopathy, Acupuncture, and Chiropractic, which are often already paid for by insurance)but it’s not hard to imagine even more ridiculous methods getting protection from “discrimination.” How about faith healing, psychic surgery, aromatherapy, and so on? Isn’t the $2.5 billion in taxpayer dollars we’ve already wasted on the National Center for Complementary and Alternative Medicine enough?!

The report’s conclusion sums up clearly and cogently why we should all contact our representatives and oppose the efforts to use health care reform as a back door to require funding of unproven and outright quack therapies:

“The Center for Inquiry strongly urges that the government should spend no taxpayer dollars in support of any alleged medical treatments or healing protocols, such as Therapeutic Touch, that have no grounding in experiment or in our understanding of basic scientific fact. The United States faces an urgent challenge in attempting to make quality health care available to those who need it, while simultaneously reining in the ballooning cost of medical care. Every dollar of health care funding is needed to provide tested, proven medical treatment to those who require it. It is inexcusable to squander scarce resources by funding unsubstantiated, non-evidence-based medical techniques that have no basis in theory or experiment.”

Here is are sample letters I sent to my senators and representative on this topic. Anyone who wishes to is free to use them as templates for contacting your own legislators on the subject.

Senator X,

I am writing to urge you to oppose a recent amendment to the Health Care Reform Bill offered by Senator Tom Harkin (Sec 2713 Non Discrimination in Health Care, http://help.senate.gov/BAI09I50_xml.pdf). This amendment would force insurers and any government health plan to cover unproven or outright useless alternative medical therapies not based on any reasonable scientific evidence.  As one of your constituents, I strongly support the following statement from a recent position paper on this topic from the Center for Inquiry about this topic:

“the government should spend no taxpayer dollars in support of any alleged medical treatments or healing protocols…that have no grounding in experiment or in our understanding of basic scientific fact. The United States faces an urgent challenge in attempting to make quality health care available to those who need it, while simultaneously reining in the ballooning cost of medical care. Every dollar of health care funding is needed to provide tested, proven medical treatment to those who require it. It is inexcusable to squander scarce resources by funding unsubstantiated, non-evidence-based medical techniques that have no basis in theory or experiment…

any health care reform bill Congress passes should prohibit the use of taxpayer dollars to cover non-evidence-based medicine. CFI further recommends that Congress greatly reduce or eliminate funding for the NIH National Center for Complementary and Alternative Medicine (NCCAM), as a decade of study has shown that most alternative cures work no better than placebos. The United States can ill afford to continue wasting precious resources on unproven – and often disproven – medical techniques.”

The version I sent to my Representative replaced the first paragraph of the above with the one below and was otherwise the same.

I am writing to urge you to oppose recent efforts to include mandatory coverage of unproven alternative medical therapies in the health care reform legislation congress is currently considering. Under the guise of so-called “health care freedom” or “health care choice,” these efforts would force insurers and any government health plan to cover unproven or outright useless alternative therapies not based on any reasonable scientific evidence. As one of your constituents, I strongly support the following statement from a recent position paper on this topic from the Center for Inquiry about this topic:

Posted in Law, Regulation, and Politics | 6 Comments

From Respectful Insolence – New Study on CAM and Vaccines

Posted on September 22, 2009 by skeptvet

Orac at Respectful Insolence has posted a summary of a recent paper examining the relationship between usage of CAM (specifically defined as being treated by chiropractors, naturopaths, acupuncturists, and massage therapists) treatments and vaccine rates. The study looked at children enrolled in two non-Medicaid insurance programs in Washington state, a notoriously woo-friendly place that requires insurance to cover CAM providers. The key findings were stark:

1. ” children using CAM who saw a chiropractor were between 25% and over 40% less likely to have had the four major vaccines studied, against the MMR, chickenpox, diptheria/tetanus, or H. influenzae type B. It was even worse for children who had been under the care of naturopaths. These children were over 75% less likely to have been vaccinated.”

2.  Children who had been cared for by a naturopath had significantly higher incidence of vaccine preventable disease. So did children who had a family member who used CAM therapy.

As Orac points out, it is not possible from these data to determine if the association is due to parents who are suspicious of vaccines seeking our CAM providers rather than science-based medical doctors or if the CAM providers influenced the parents’ decision whether or not to vaccinate. Likely, both factors play a role. And while the study did not find a positive association for use of acupuncture, and did not examine homeopathy, herbal remedies, TCM, or many other CAM modalities, it does support the general contention CAM use is associated with less use of science-based medical care and potentially greater health risk. This should add further weight to the contention that even ostensibly harmless AM methods may contain “hidden harm” in the form of a general belief system or world view that is inconsistent with science and that leads to underutilization of the beneficial medical therapies science offers.

Posted in General, Vaccines | 4 Comments

Nutraceuticals and Cognitive Dysfunction

Posted on September 20, 2009 by skeptvet

There is widespread agreement among veterinary behaviorists, and veterinarians in general, that one consequence of the improved longevity of our patients has been an increase in clinical behavior problems associated with brain aging. Changes in sleep/wake cycles, activity level, housetraining behavior, recognition of familiar humans and other animals, and cognitive abilities are often seen in older pets, and these can severely affect the pets’ quality of life and the relationship between pet and owner. No standardized diagnostic test for these age-related changes exists, and each pet may experience different specific changes in behavior and ability. However, there is enough similarity in the types of changes seen in older pets that it is reasonable to discuss and address them as a syndrome until research allows us to identify more specific categories of age-related dysfunction and to elucidate the specific pathophysiology of each.

Likewise, there are a number of anatomical changes seen in dog and cat brains with age and associated with clinical symptoms or functional deficits. These include reduction in brain mass, cell and axonal degeneration and changes in the relative number of different cell types in the brain, and accumulation of beta amyloid.  In dogs, these changes show some striking similarities with those seen in people with Alzheimer’s and other age-associated cognitive disorders. There are, however, significant differences as well, such as the absence in dogs of the characteristic neurofibrillary tangles seen in humans afflicted with Alzheimer’s disease. Therefore, though the similarities may justify tentatively viewing age-associated cognitive and behavior changes in dogs and humans as sufficiently alike to suggest that research findings in one species may have relevance to the other, we must be careful not to simply assume they are the same disorder with the same pathogenesis or the same response to pharmacological manipulation.

There are no universally or highly effective therapies for age-related cognitive and behavioral dysfunction. Some drugs, such as selegilene, have shown limited ability to improve clinical symptoms, but it is a disorder for which veterinary medicine has little to offer in the way of amelioration. Much more research must be done to understand the causes of the clinical problem and how these may be addressed.

As always, when there is a poorly understood problem with no ready medical solution, potential therapies abound and the standards of evidence required to justify their marketing and use are generally low. A number of nutraceutical products, vitamins or other dietary supplements used with the intent of achieving a beneficial pharmacological effect, are marketed for age-associated behavioral problems. Most of these are supported by reasonable theoretical rationales, suggestive in vitro research, some promising laboratory animal studies, and limited clinical research with few subjects and generally poor methodological quality.

As with probiotics, these remedies fall in an intermediate category between CAM and scientific medicine. There is reason to believe they may eventually prove useful, but the available data is not currently adequate to demonstrate this, and it is certainly not adequate to justify producing and selling such products to the general public. But manufacturers of neutraceuticals consider the time between the proposal of a hypothesis that a supplement might be beneficial and the accumulation of sufficient data to decide the truth as a golden time for marketing. As a recent article from the Los Angeles Times news service put it regarding one of these compounds:

For the purveyors of vitamins, minerals and herbal remedies, that is a five- to seven-year opportunity not to be missed. Consumers’ dreams of forestalling the ravages of age have been engaged, and they will buy and swallow anything that gleams with the luster of science. While they wait for science to flesh out resveratrol’s promise, consumers’ demands for the stuff can be built, tapped and satisfied with products that offer plenty of promise but tread lightly around the preliminary state of the scientific evidence.

“There’s a watershed time for a good nutraceutical,” says Dr. Joseph Maroon, a University of Pittsburgh neurosurgeon, author of a book titled “The Longevity Factor” and co-founder of a company, Xenomis, which rolled out a line of resveratrol-based supplements last May.

Resveratrol, in short, stands at the juncture of hope, profit and scientific promise — a social phenomenon galloping ahead of research that is undeniably intriguing but very incomplete.

Most of the products marketed for cognitive and behavior problems in older pets are combinations of multiple substances, which makes any rigorous scientific evaluation of them difficult. It is also the case that many of the studies available have been sponsored or conducted by companies marketing the product being tested, and while this does not invalidate the results, it is well-documented that such studies are more likely to be positive than independently conducted research.

Hill’s Pet Nutrition has created a veterinary diet fortified with Vitamins C and E, L-carnitine, omega-3 fatty acids, and lots of fruit and vegetable ingredients. The company has published results of several studies which support the contention that the diet has some protective benefits in terms of cognitive decline and age-associated behavior problems. It is impossible to identify which ingredients, singly or in combination, might account for this effect, but the evidence is good that there is some clinically significant benefit. As always, replication by independent investigators would strengthen the case, and further research to identify which components of the diet are of relevance would be useful.

Other products, such as CEVA Animal Health’s Senilife and VetPlus’ Aktivait, contain multiple ingredients each proposed to prevent or treat age-related cognitive dysfunction via plausible mechanisms based on in vitro or laboratory animal studies. Again, which if any of these ingredients might actually be beneficial is impossible to determine from clinical studies using the combination product. And so far the clinical research evidence is weak, consisting mostly of small, inadequately controlled trials often sponsored by the manufacturer. I will try to discuss each ingredient independently and then review the available literature on some combination products.

Phosphatidylserine-

Phosphatidylserine (PS) is a phospholipid that occurs in cell membranes. It is hypothesized, based on laboratory studies, to facilitate normal function of nerve cell membranes and influence levels of various neurotransmitters. A 2003 FDA report reviewed the clinical literature in humans and concluded that the evidence did not support assertions that this compound has preventative or treatment benefit for cognitive dysfunction and dementia in people. The agency did approve a highly qualified claim for the product:

Dementia claim and disclaimer:

“Consumption of phosphatidylserine may reduce the risk of dementia in the elderly.

Very limited and preliminary scientific research suggests that phosphatidylserine may reduce the risk of dementia in the elderly. FDA concludes that there is little scientific evidence supporting this claim.”

Cognitive dysfunction claim and disclaimer:

“Consumption of phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly.

Very limited and preliminary scientific research suggests that phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly. FDA concludes that there is little scientific evidence supporting this claim.”

One important caveat to the data the FDA analyzed is that most research has been done on PS derived from bovine brain tissue. Due to the risks of acquiring bovine spongiform encephalopathy (BSE or “Mad Cow Disease”) from this source, the FDA prohibited its use, and the proposed commercial products contain PS derived from soybeans. The plant derivative differs structurally from bovine-derived PS, so there is some question about whether data regarding one is applicable to the other. I was not able to identify the source of the PS in the various veterinary products and research trials.

I was also not able to find any veterinary clinical trials for cognitive dysfunction examining PS alone. It is included in a couple of combination products, including Senilife and Aktivait. As discussed below, the clinical research evidence for these products is weak. No evidence regarding the safety of the substance was found, apart from the theoretical concerns about BSE discussed in the FDA report.

Ginkgo Biloba-

This is a very popular herbal product which is purported to have a wide range of beneficial effects on cognition, memory, depression, anxiety, tinnitus, and headache. It has vasodilatory effects and acts as a scavenger of oxygen free radicals in vitro and in laboratory animal studies. The clinical trial evidence in humans does not support a beneficial effect for cognitive impairment or dementia, as summarized in a Cochrane review below.

Many of the early trials used unsatisfactory methods, were small, and publication bias cannot be excluded. Overall, evidence that Ginkgo has predictable and clinically significant benefit for people with dementia or cognitive impairment is inconsistent and unreliable. Of the four most recent trials to report results, three found no difference between Ginkgo biloba and placebo, and one reported very large treatment effects in favour of Ginkgo biloba

The review also concluded that there were no significant safety concerns for it’s use. The NCCAM summary of this product indicates no benefit seen even in a large NCCAM sponsored study of Alzheimer’s patients, and lists a number of possible toxic effects.

Again, I have found no veterinary clinical trials looking at Ginkgo biloba alone as a preventative or treatment for age-associated cognitive and behavior problems. It is included in Senilife, which I discuss below has limited weak evidence to support a beneficial effect.

Resveratrol-

Resveratrol is a chemical extracted from grapes that has been touted as a general anti-aging panacea. There are numerous in vitro and lab animal studies that suggest the compound may act as an antioxidant and have a variety of effects promoting and inhibiting the expression of a number of genes. There is mixed evidence in lab animals that it may prolong life and inhibit, or in some cases promote, cancer. Human clinical trials for a number of possible uses are ongoing, but no data is available to suggest safety or efficacy for any particular use.

Likewise, there are apparently no veterinary clinical trials of resveratrol alone for cognitive and behavior dysfunction. As the newspaper article quoted above suggests, it is a promising but unproven compound which has been marketed well in advance of reliable evidence to its safety and efficacy. Resveratrol is an ingredient in Senilife, which has only weak supporting research evidence for clinical benefit in veterinary patients.

Pyridoxine (Vitamin B6)-

Pyridoxine is believed to have anti-oxidant properties and may be a co-factor in the synthesis of some neurotransmitters. According to a Cochrane review, clinical research in humans has not demonstrated any benefit in terms of mood or cognition in elderly people, and no high-quality studies are available investigating its use for dementia or cognitive impairment.

Two trials of vitamin B6 supplements for healthy elderly people qualified for this review, with no beneficial effects on mood or mental function detectable. Homocysteine levels were not assessed. No ill effects of vitamin B6 were observed. No trials studying effects of vitamin B6 treatment for people with dementia or cognitive impairment were identified.

The NCCAM has also published an evidence review which concludes, “Human studies were generally of poor quality. Weak evidence suggests possible benefits of B1 supplementation and injected B12 in AD. The effects of B6 and folate are unclear. Overall, dietary intake studies do not support an association between B vitamin intake and AD. Studies evaluating B vitamin status were mostly inadequate due to poor study design. Overall, studies do not support an association between B vitamin status and age-related neurocognitive disorders.”

While these reviews did not find evidence of health risks with pyridoxine supplementation, neurologic disorders have been reported with pyridoxine supplementation in humans and in dogs (Study 1, Study 2). No clinical trials were found investigating pyridoxine use for treatment or prevention of age-associated behavior disorders. It is a component of Senilife.

Vitamin E-

Vitamin E is purported to have benefits in a number of conditions due to its anti-oxidant properties. However, a Cochrane review of the research regarding the compound and Alzheimer’s Disease or cognitive impairment in humans found:

To date only one randomized controlled trial has assessed the efficacy of Vitamin E in the treatment of AD patients and only one assessed the role of Vitamin E in patients with mild cognitive impairment (MCI). In the Vitamin E study for moderately severe AD patients a lower number of those taking Vitamin E declined to incapacity over a two year period compared with the placebo group. However, AD patients taking Vitamin E experienced a greater number of falls. In the MCI study, Vitamin E 2000 IU daily produced no significant difference in the rate of progression to AD compared to the placebo group… There is no evidence of efficacy of Vitamin E in the prevention or treatment of people with AD or MCI. More research is needed to identify the role of Vitamin E, if any, in the management of cognitive impairment.

No clinical trials have been done on Vitamin E for cognitive dysfunction in veterinary patients. As I’ve previously discussed, Vitamin E supplementation has been shown to have potential risks, including increasing the risk of heart failure and possibly cancer.

S-Adenosylemethionine (SAMe)-

SAMe is a molecule already present in the body that has anti-oxidant properties and that is involved in the synthesis and regulation of some neurotransmitters. It also appears to play a role in the regulation of nerve cell membrane structure and function. There is some in vitro and laboratory animal evidence suggesting it might be of benefit in cognitive disorders in humans, though the clinical trial evidence is limited and mixed.

A small, short-term study sponsored by Virbac Laboratories investigated the use of SAMe to reduce symptoms of age-related cognitive dysfunction. Despite its limitations, the study was well-designed and showed convincing evidence for an improvement in daytime activity and possibly some improvement in sleep problems. It did not show any benefit for confusion or disorientation. No adverse effects were seen in the study subjects. Further study of this compound is certainly warranted.

Co-Enzyme Q10-

A component of the energy production pathways in mitochondria, CoQ10 has been suggested to be of value in Alzheimer’s disease in humans. The laboratory animal study evidence is mixed, with some trials showing reduction in beta amyloid in mice and others showing no effect or even a worsening of cognitive function in mice. A 2003 review found no reliable evidence of benefit in humans and suggested more study is needed. No trials appear to have been conducted in aged dogs or cats with cognitive dysfunction. The compound is an ingredient in the combination product Aktivait. 

 

Combination Products-

 The manufacturer of Senilife indicates in its marketing literature that some sort of research demonstrates the efficacy of the product. There are lots of charts and graphs and “percentage improvement” numbers, but no information about study subjects, protocol, blinding, placebo control, or anything else that would allow evaluation of this purported data. However, there have been some clinical studies published looking at the product. An open-label study of eight dogs done in Italy showed some beneficial changes in some clinical parameters. Of course, this is a very weak level of evidence appropriate only for suggesting that further study is warranted.

 Another study looked at Senilife in a group of nine laboratory beagles ranging from 7-13 years of age and evaluated performance on a short-term memory test. The study reported marked improvement in performance of the animals on the supplement. However, the study was small, examined a laboratory cognition task that might or might not have relevance to clinical disease, and was not randomized or blinded. It also utilized a crossover design, which is inappropriate for a progressive disorder such as age-associated cognitive dysfunction. Additionally, during the second phase in which the original treatment group became the control group, there was no difference in the performance of this group between treatment and control. The authors interpret this as a persistent effect of treatment, but they did not clearly eliminate other possible explanations, such as differences between the groups not related to the intervention.

Another combination product, called Aktivait is marketed for age-relative cognitive and behavior problems. It contains the essential fatty acids DHA and EPA, N-acetyl cysteine, Vitamin C, L-carnitine, Vitamin E, Coenzyme Q10, phosphatidylserine, and selenium. A clinical trial of 41 dogs has been published which found a benefit for some measures of dysfunction in naturally occurring disease. The trial was randomized, placebo-controlled, and double-blinded. It reported significant improvements in some measures (daily scores for activity and recognition of owner and global score for housetraining) but not others (daily scores for sleep disturbances, social interaction, incidents, locations, and substrates for inappropriate toileting and global scores for disorientation, sleep patterns, and social interaction). This suggests that the authors conducted multiple comparisons and focused only on those that showed a positive effect while downplaying the majority that did not, but they way the data is presented it is not clear if this is the case. The study also reported that for one of the assessments which improved, housetraining, the treatment group had a significantly higher rate of problems that the placebo group at the beginning of the trial, so the groups were clearly not matched properly for this measure.

So far, the available evidence for Senilife and Aktivait is suggestive of benefit but generally very weak. This is always the case in the early stages of investigating a potential therapy, and does not reliably indicate what the results of larger, better-designed studies will determine to be the real truth. However, there are serious ethical questions associated with marketing and selling such remedies on the basis of such weak evidence given the large proportion of therapeutics that show early promise and later turn out to be useless or even dangerous. I certainly support further study of possible interventions for age-associated cognitive and behavioral problems, but I think such research would be better done on elucidating the underling pathophysiology and on single interventions targeted at understood elements of the syndrome, rather that clinical trials of shotgun-type combinations therapies supported by companies looking to sell these products.

References

Araujo, J., Lansberg, G., Milgram, N., Miolo, A. Improvement of short-term memory performance in aged beagles by a nutraceutical supplement containing phosphatidylserine, Ginkgo biloba, vitamin E, and pyridoxine. Canadian Vet J, 49(4):379-385; 2008.

Dalton, K., Dalton, MJT., Characteristics of pyridoxine overdose neuropathy syndrome, Acta Neurol Scand 76:8-11, 1987.

Dodd, CE., Zicker, SC., Jewell, DE. Can a fortified food affect the behavioral manifestations of age-related cognitive decline in dogs? Vet Med 98:396-4080; 2003.

Heath, S. et al. Nutritional supplementation in cases of canine cognitive dysfunction: Results of a clinical trial, Proceedings 29th World Congress of the Small Animal Veterinary Association, 2004.

Osellaa, M/C, et al. Canine cognitive dysfunction syndrome: Prevalence, clinical signs and
treatment with a neuroprotective nutraceutical. Read online Sept. 20, 2009 at  http://www.crashinggoodtime.com/CDS.html
Reme, C.A., et al. Effect of S-adenosylmethionine tablets on the reduction of age-related mental decline in dogs: a double-blinded, placebo-controlled trial. Vet Ther 9(2):69-82; 2008.

Posted in Herbs and Supplements | 35 Comments

The Gonzalez Trial – The Cost of Studying The Unlikely

Posted on September 9, 2009 by skeptvet

 First, I just wanted to point out that I have added another example to the list of harm done by use of CAM. In this case, it’s a tragic story about a young women suffering needlessly yet unwilling to give up on useless therapy.

On a larger scale, but just as tragic and infuriating, the results are available for the NCCAM-funded study of the Gonzalez cancer therapy.* Dr. Kimball Atwood has written extensively about the therapy and the NCCAM trial (The Ethics of “CAM” Trials: Gonzo Part I, II, III, IV,V, VI, and VII). Despite a host of serious ethical concerns, which Dr. Atwood has detailed extensively, the government funded a study in which people were allowed to elect a CAM therapy with no scientific plausibility or standard chemotherapy for their pancreatic cancer. It should surprise no one that the outcome clearly shows the Gonzalez regime to be ineffective. People on conventional chemotherapy lived 3 times longer than those on CAM treatment (14 months vs 4.3 months), and contrary to the usual CAM propaganda about cancer therapy, those who elected the alternative regime had a significantly poorer quality of life for those 4 short months.

It is true that the conventional therapy for this disease does not offer great hope for people with this disease. And the patients who followed the Gonzalez treatment did so by their own choice (the trial was originally randomized, but most patients refused to accept random allocation to treatment groups). But as I’ve argued before, the understandable desperation of people in this situation does not justify giving them false hope for help from methods unlikely to be of any real benefit. And the irrational pursuit of such hope cost the people in the CAM arm of this study almost a year of life on average and a great deal of suffering. Of course, it is difficult to argue that people should not be permitted to choose irrational hope over bleak reality. but it seems obvious that doctors who encourage such a choice by promoting, or refusing to critique, such therapies are failing in their duty to their patients. And this study illustrates nicely how NCCAM is complicit in this by giving a patina of legitimacy to bogus treatments.

CAM proponents frequently argue that unless their methods have been thoroughly investigated by large, well-designed and well-conducted clinical trials, critics of them are not adhering to their own standards of evidence. Because some ideas which seemed implausible in the past turned out to actually be true, they argue that any attempt to focus our research efforts based on scientific plausibility is mistaken. Such an argument seems very effective in supporting the work of NCCAM and in getting a foothold for unlikely therapies in mainstream medicine, but it is riddled with weaknesses.

Firstly, it ignores the fact that most ideas which seem implausible at first really are wrong, and they fail when tested. The fact that there are exceptions, and that the availability bias makes them seem more representative than they really are, does not support investigating anything and everything regardless of its provenance or consistency with well-established scientific principles. The argument also would require our desperately limited resources for scientific research to be spent indiscriminately, especially on popular or catchy ideas rather than the more mundane concepts that have a solid foundation in basic science and pre-clinical research.

As this study shows, testing anything and everything also exposes test subjects to avoidable risk and suffering. Even in cases where there is little hope in mainstream, scientific therapy there is no reason to think the false hope CAM offers is the better choice. No CAM therapy which is implausible or mysterious in its principles, or outright contrary to what we understand about the universe, has demonstrated under rigorous clinical testing to be the miracle its proponents have claimed for it. Progress comes far more often from laborious and careful work building on what is known than from wild guesses by lone geniuses.

Lastly, the clinical testing of implausible CAM methods seems likely to be futile even when the results are as clear and stark as in this trial. One might hope that this study will dissuade people from pursuing the Gonzalez therapy, and even cause them to question the underlying marketing of CAM methods, which use anecdote and the limitations of scientific medicine to claim far more than they can really provide to sick people or animals. But the past does not suggest this will be true. Faith-based medicine ultimately does not rely on empirical validation, and its followers rarely accept any evidence that they are mistaken. The spinning of these trial results will likely begin shortly, and the proponents of the method will continue to offer it, and it’s false hope, to vulnerable cancer patients without a qualm.

 

*Pancreatic Proteolytic Enzyme Therapy Compared with Gemcitabbine-based Chemotherapy for the Treatment of Pancreatic Cancer

John A. Chabot, Wei-Yann Tsai, Robert L. Fine, Chunxia Chen, Carolyn K. Kumah, Karen A. Antman, and Victor R. Grann*

From the Herbert Irving Comprehensive Cancer Center, Department of Medicine and Surgery, College of Physicians and Surgeons; and Departments of Biostatistics, Epidemiology, and Health Policy and Management, Joseph L. Mailman School of Public Health, Columbia University, New York, NY; Boston University Medical Center, Boston, MA; and Department of Statistics, National Cheng-Kung University, Taiwan.

* To whom correspondence should be addressed. E-mail: vrg2@columbia.edu

Purpose: Conventional medicine has had little to offer patients with inoperable pancreatic adenocarcinoma; thus, many patients seek alternative treatments. The National Cancer Institute, in 1998, sponsored a randomized, phase III, controlled trial of proteolytic enzyme therapy versus chemotherapy. Because most eligible patients refused random assignment, the trial was changed in 2001 to a controlled, observational study.

Methods: All patients were seen by one of the investigators at Columbia University, and patients who received enzyme therapy were seen by the participating alternative practitioner. All met strict clinical criteria for eligibility. Of 55 patients who had inoperable pancreatic cancer, 23 elected gemcitabine-based chemotherapy, and 32 elected enzyme treatment, which included pancreatic enzymes, nutritional supplements, detoxification, and an organic diet. Primary and secondary outcomes were overall survival and quality of life, respectively.

Results: At enrollment, the treatment groups had no statistically significant differences in patient characteristics, pathology, quality of life, or clinically meaningful laboratory values. Kaplan-Meier analysis found a 9.7-month difference in median survival between the chemotherapy group (median survival, 14 months) and enzyme treatment groups (median survival, 4.3 months) and found an adjusted-mortality hazard ratio of the enzyme group compared with the chemotherapy group of 6.96 (P < .001). At 1 year, 56% of chemotherapy-group patients were alive, and 16% of enzyme-therapy patients were alive. The quality of life ratings were better in the chemotherapy group than in the enzyme-treated group (P < .01).

Conclusion: Among patients who have pancreatic cancer, those who chose gemcitabine-based chemotherapy survived more than three times as long (14.0 v 4.3 months) and had better quality of life than those who chose proteolytic enzyme treatment.

Posted in General, Miscellaneous CAVM | 2 Comments

What’s the Harm?

Posted on September 6, 2009 by skeptvet

CAM proponents aggressively market their approaches with the assurance, often absolute and without qualification, that their methods never cause harm. And perhaps the most common response to critiques of CAM from people who consider themselves mildly skeptical of it but who do not have strong opinions about it is “Well, it probably doesn’t work, but at least it’s harmless.” So it appears that the notion CAM is safe, whether effective or not, seems widely established. Unfortunately, it’s often not true. Any therapy that has any actual influence on the body’s processes will also have the potential for unintended effects, some of which may do harm. And even therapies which have no effect, such as homeopathy, can be indirectly harmful in delaying diagnosis or real treatment.

The following links and articles are resources illustrating some of the harm CAM methods can do, directly and indirectly. It is by no means comprehensive, and it certainly is not a scientific assessment of the risks and benefits of any particular therapy. The purpose is simply to make it clear that it is by no means difficult to find evidence of harm caused by almost any CAM therapy, so when we evaluate these approaches we must balance any possible benefits they have against any possible risks, regardless of the exaggerated claims for safety their proponents often make.

 

General CAM Use:

Association between CAM use and decreased success of IVF in Holland.

Association between CAM use and decreased survival in cancer patients in Norway.

General collection of anecdotes about people harmed, directly or indirectly, by CAM use.

SBM– Risks of various CAM therapies.

Bostrom, H. Rostrom, S. Quality of alternative medicine–complications and avoidable deaths. Qual Assur Health Care. 1990;2(2):111-7.

 

Acupuncture

 

Cho YP, Jang HJ, Kim JS, Kim YH, Han MS, Lee SG. Retroperitoneal abscess complicated by acupuncture: case report. J Korean Med Sci. 2003 Oct;18(5):756-7.  

Choo DC, Yue G Acute intracranial hemorrhage in the brain caused by acupuncture. Headache 2000 May;40(5):397-8.

Chung SJ, Kim JS, Kim JC, Lee SK, Kwon SU, Lee MC, Suh DC. Intracranial dural arteriovenous fistulas: analysis of 60 patients. Cerebrovasc Dis 2002 Feb;13(2):79-88

Cole M, Shen J, Hommer D. Convulsive syncope associated with acupuncture. Am J Med Sci 2002 Nov;324(5):288-9

Ernst E, Sherman K. Is acupuncture a risk factor for hepatitis? Systematic review of epidemiological studies. J Gastroenterol Hepatol. 2003 Nov;18(11):1231-6.

Ernst E, White AR. Prospective studies of the safety of acupuncture: a systematic review. Am J Med 2001 Apr 15;110(6):481-5

Iwadate K, Ito H, Katsumura S, Matsuyama N, Sato K, Yonemura I, Ito, Y. An autopsy case of bilateral tension pneumothorax after acupuncture. Leg Med (Tokyo). 2003 Sep;5(3):170-4.  

Kirchgatterer A, Schwarz CD, Holler E, Punzengruber C, Hartl P, Eber B  Cardiac Tamponade Following Acupuncture. Chest 2000 May;117(5):1510-1511

Laing AJ, Mullett H, Gilmore MF. Acupuncture-associated Arthritis in a Joint with an Orthopaedic Implant J Infect 2002 Feb;44(1):43-4

Nambiar P, Ratnatunga C. Prosthetic valve endocarditis in a patient with Marfan’s syndrome following acupuncture. J Heart Valve Dis 2001 Sep;10(5):689-90

Peuker E  Case report of tension pneumothorax related to acupuncture. Acupunct Med. 2004 Mar;22(1):40-3.

Saw A, Kwan MK, Sengupta S. Necrotising fasciitis: a life-threatening complication of acupuncture in a patient with diabetes mellitus. Singapore Med J. 2004 Apr;45(4):180-2.

Sun CA, et al. Transmission of hepatitis C virus in taiwan: prevalence and risk factors based on a nationwide survey. Sun J Med Virol 1999 Nov;59(3):290-6

Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, Willich SN. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed. 2009 Apr;16(2):91-7. Epub 2009 Apr 9

Woo PC, Leung KW, Wong SS, Chong KT, Cheung EY, Yuen KY. Relatively alcohol-resistant mycobacteria are emerging pathogens in patients receiving acupuncture treatment. J Clin Microbiol 2002 Apr;40(4):1219-24

Yamashita H, Tsukayama H, White AR, Tanno Y, Sugishita C, Ernst E. Systematic review of adverse events following acupuncture: the Japanese literature. Complement Ther Med 2001 Jun;9(2):98-104

 

Chiropractic:

SBM–Neck Manipulation:Risk vs Benefit

SBM–Chiropractic’s Pathetic Response to Stroke Concerns

SBM–Chiropractic and Stroke: Evaluation of One Paper

SBM–Chiropractic and Stroke 

Vitamins & Supplements

 

:

Vitamin C can interfere with chemotherapy. 

Vitamin E can increase cancer risk.

Vitamin E not useful for prevention for prostate cancer and can increase risk of congestive heart failure.

Vitamin supplements may associated with overall increase in mortality and no benefit in preventing gastrointestinal cancer. 

 

Herbal Preparations, Including Ayurvedic and Traditional Chinese Medicine (TCM) Herbs

 

Aliye Uc, MD, Warren P. Bishop, MD, and Kathleen D. Sanders, MD, Camphor hepatoxicity. South Med J 93(6):596-598, 2000,

Berberine. Inbaraj JJ, Kukielczak BM, Bilski P, Sandvik SL, Chignell CF.   Photochemistry and photocytotoxicity of alkaloids from Goldenseal (Hydrastis canadensis L.) Chem Res Toxicol 2001 Nov;14(11):1529-34

Burkhard PR, Burkhardt K, Haenggeli CA, Landis T. Plant-induced seizures: reappearance of an old problem. J Neurol 1999 Aug;246(8):667-70

Coon JT, Ernst E. Panax ginseng: A Systematic Review of Adverse Effects and Drug Interactions. Drug Saf 2002;25(5):323-44 Drug Saf 2002;25(5):323-44

Cupp MJ  Herbal remedies: adverse effects and drug interactions. Am Fam Physician 1999 Mar 1;59(5):1239-45

Debelle FD, Vanherweghem JL, Nortier JL. Aristolochic acid nephropathy: a worldwide problem. Kidney Int. 2008 Jul;74(2):158-69. Epub 2008 Apr 16.

Emery DP, Corban JG  Camphor toxicity. J Paediatr Child Health 1999 Feb;35(1):105-6

Ernst E Adverse effects of herbal drugs in dermatology. Br J Dermatol 2000 Nov;143(5):923-

Fugh-Berman A Herb-drug interactions. Lancet 2000 Jan 8;355(9198):134-8

Huang WF, Wen KC, Hsiao ML. Adulteration by synthetic therapeutic substances of traditional Chinese medicines in Taiwan. J Clin Pharmacol. 1997 Apr;37(4):344-50

Lai MN, Lai JN, Chen PC, Tseng WL, Chen YY, Hwang JS, Wang JD. Increased risks of chronic kidney disease associated with prescribed Chinese herbal products suspected to contain aristolochic acid. Nephrology (Carlton). 2009 Apr;14(2):227-34.

Lawrence JD.  Potentiation of warfarin by dong quai. Page RL 2nd, Pharmacotherapy 1999 Jul;19(7):870-6

Means C.  Selected herbal hazards. Vet Clin North Am Small Anim Pract 2002 Mar;32(2):367-82

Norred CL, Finlayson CA Hemorrhage after the preoperative use of complementary and alternative medicines. AANA J 2000 Jun;68(3):217-20

O’Connor A, Horsley CA. Yates, KM “Herbal Ecstasy”: a case series of adverse reactions.  N Z Med J 2000 Jul 28;113(1114):315-7

Pittler MH. Ernst, E Risks associated with herbal medicinal products. Wien Med Wochenschr 2002;152(7-8):183-9

Poppenga RH. Risks associated with the use of herbs and other dietary supplements. Vet Clin North Am Equine Pract. 2001 Dec;17(3):455-77, vi-vii

Pies R  Adverse neuropsychiatric reactions to herbal and over-the-counter “antidepressants”. J Clin Psychiatry 2000 Nov;61(11):815-20

Prakash S, Hernandez GT, Dujaili I, Bhalla V. Lead poisoning from an Ayurvedic herbal medicine in a patient with chronic kidney disease. Nat Rev Nephrol. 2009 May;5(5):297-300.

Raman P, Patino LC, Nair MG. Evaluation of metal and microbial contamination in botanical supplements. J Agric Food Chem. 2004 Dec 29;52(26):7822-7

Ruschitzka F, Meier PJ, Turina M, Luscher TF, Noll G  Acute heart transplant rejection due to Saint John’s wort. Lancet 2000 Feb 12;355(9203):548-9

Saper RB, Phillips RS, Sehgal A, Khouri N, Davis RB, Paquin J, Thuppil V, Kales SN. Lead, mercury, and arsenic in US- and Indian-manufactured Ayurvedic medicines sold via the Internet. JAMA. 2008 Aug 27;300(8):915-23.

Shad JA, Chinn CG, Brann OS Acute hepatitis after ingestion of herbs. South Med J 1999 Nov;92(11):1095-7

Smolinske SC J Am Med Womens Assoc 1999 Fall;54(4):191-2 Dietary supplement-drug interactions.

Yang HY, Wang JD, Lo TC, Chen PC. Increased mortality risk for cancers of the kidney and other urinary organs among Chinese herbalists. J Epidemiol. 2009;19(1):17-23. Epub 2009 Jan 22.

Zhang SY, Robertson D. A study of tea tree oil ototoxicity. Audiol Neurootol 2000 Mar-Apr;5(2):64-8

Kidney failure from aristolochia in TCM herbals preparations.

Lead, mercury and arsenic in herbal preparations.

Lead in TCM preparations.

Lead in ayurvedic preparations.

Lead in herbal preparations.

Tea Tree Oil Can be toxic to cats.

Toxic metals in Brazilian herbal preparations.

Contamination of herbal products with undisclosed pharmaceuticals.

 

Anecdotes and Victims Groups

 

General collection of anecdotes about people harmed, directly or indirectly, by CAM use.

Anecdotes of people who suffered illness or death from vaccine-preventable illnesses because they were not properly vaccinated.

Victims of Chiropractic Abuse

Chiropractic Treatment and Stroke

A site which collects government reports of the incidence of vaccine-preventable illnesses to illustrate the danger of inaccurate and hysterical information provided by anti-vaccine activists such as Jenny McCarthy.

Anecdotes of people who suffered illness or death from vaccine-preventable illnesses because they were not properly vaccinated.

 

Books

 

Natural Causes: Death, Lies and Politics in America’s Vitamin and Herbal Supplement Industry by Dan Hurley.A detailed look and the politics, economics, and risks of the dietary supplement, vitamin, and herbal medicine industries

Trick or Treatment: The Undeniable Facts about Alternative Medicine by S. Singh and E. Ernst
An outstanding review of many CAM practices from and evidence-based perspective which includes assessment of the risks, particularly for acupuncture, homeopathy, chiropractic, and herbal medicines.

The Desktop Guide to Complementary and Alternative Medicine: An Evidence-based Approach Edited by E. Ernst, M. Pittler, B. Wider An exhaustive and authoritative review of the evidence and risks for many CAM treatments, including detailed references.

Posted in General, Miscellaneous CAVM | 3 Comments

From SBM – Why Unproven Does Not Mean Harmless

Posted on September 2, 2009 by skeptvet

This post examines a study suggesting that CAM use may decrease the success rate of in vitro fertilization efforts. It is similar to a previous study suggesting CAM use is associated with shorter life expectancy in cancer patients in that it is not definitive, but it raises the real concern that inadequately researched therapies may not be benign. It is common for veterinarians and other health care providers who do not use CAM themselves to be apathetic about it’s use by others because they assume that even if it is ineffective, it probably isn’t harmful. More and more evidence is accumulating that this is untrue, and when even a low risk is balanced against no benefit, the rational and ethical choice is to avoid the therapy.

Posted in General, Miscellaneous CAVM | 1 Comment

Woo U. — CAVM as Continuing Education for Veterinarians

Posted on August 31, 2009 by skeptvet

Veterinarians are required by the state laws that control their licensure and scope of practice to keep up with changes in the body of knowledge  and techniques that makes up veterinary medicine. Such continuing education is a requirement for all vets, and most actively seek out more than the minimum requirement because they genuinely wish to continually improve the care they provide. However, because there is a political dimension to continuing education, and government bodies are involved in establishing what constitutes legitimate training for the purposes of meeting the legal requirements, the process invariably is influenced by the same sorts of unscientific ideologies that allow for insurance reimbursement for unproven therapies and that prevent sensible regulation of dietary supplements. This is sadly, and yet humorously evident in the offerings at the upcoming American Holistic Veterinary Medical Association  (AHVMA) annual conference, to be held in Fitchburg, MA September 12-15 of this year.

The national standard for accreditation of veterinary continuing education is the Registry of Approved Continuing Education (RACE) established by the American Association of Veterinary State Boards (AAVSB). Most state veterinary medical boards require continuing education courses submitted for maintenance of state licensure be RACE certified. The 2009 AHVMA conference has applied for RACE certification, but this has not yet been officially granted. However, the organization’s 2008 conference was approved, and there do not appear to be any substantive difference in the content of the two conferences.

According to its website, “The American Holistic Veterinary Medical Association explores and supports alternative and complementary approaches to veterinary healthcare, and is dedicated to integrating all aspects of animal wellness in a socially and environmentally responsible manner.” Like most industry organizations, the group engages in lobbying for its agenda, supports social and business networking among members, publishes a journal, and promotes its vision of veterinary medicine. It also provides continuing education opportunities consistent with its CAVM-centered philosophy.

All of this is impressive considering that no clear, consistent definition for “holistic” exists.  It is a warm a fuzzy marketing term that seeks to promote unproven therapies alongside, or even in place of, scientific medicine by peddling the nonsense that somehow science-based medicine somehow ignores the person and just treats the body or treats just symptoms not diseases or their causes. I’ve never actually met a veterinarian who considers the patient irrelevant to the health of the knee or the gallbladder or the white blood cell, but CAVM practitioners like to suggest that such myopia is the only alternative to embracing vitalism and faith-based medicine.

As to the substance of the continuing education offered by the AHVMA, it is an eclectic hodgepodge of methods and philosophies that seem to have little in common beyond their lack of sound supporting evidence. There are, of course, classes on the Big Three of CAM, acupuncture, chiropractic, and homeopathy. Bach Flower Therapy gets some play, and there are some anti-vaccine offerings. The summary for a lecture titled Equine Disease Manifestations from Rabies Vaccination sounds fair and balanced:

“In western N.Y., there has been a true spread of Rabies in the raccoon population. In response to this threat, the state instituted an oral Rabies vaccine drop throughout western N.Y. and requires any horse that steps foot on state land to have an annual Rabies immunization. The result seen from this aggressive immunization procedure is an increase in physical, mental, and spiritual disease in our equine companions. Many of these diseases seem to be not only a combination of an acute reaction to the attenuated rabies virus with a worsening of the animals underlying chronic disease but also new intense emotional diseases that have not been seen. Many of the disease seen are hind leg weakness and lameness, severe mental aggressions and fears, including a almost intentional harm to the rider, and choke. Cases with the homeopathic treatment will be discussed.” [emphasis mine]

Some of the details of the offerings on homeopathy were new to me. The science of homotoxicology apparently warrants its own seminar. According to one site, in homotoxicology “diseases are considered to be ultimately caused by toxins, whether toxic chemicals, bacterial exotoxins, biological endotoxins, post-traumatic cellular debris and also byproducts of the bodies metabolic processes. Furthermore, disease symptoms are said to be the result of the body’s attempt to heal itself and should not necessarily be suppressed.” As usual, the answer to the ill effects of these toxins on the body is to give people water that once contained a few molecules of something that Hahnemann or somebody else once said might cause symptoms like those thought to be caused by the toxins. I am particularly impressed by this testimonial from one of the doctors presenting at the seminar:

“A series of seemingly random events led to my initial foray into homotoxicology, and unexpectedly good results from the therapy intrigued me. I had to know the reasoning, theory, and therapeutics of this medical art. It has consumed my interest for many years, with more magic still to be learned.”[emphasis mine]

 

And speaking of toxins, did you know this?

“The recent increase of animal shoulder and hip mobility restrictions can be attributable to nutrition. “Leaky Gut” syndrome, caused by intestinal GLUTEN, creates protection mechanisms altering gait mechanics. Glycoproteins in gluten have a “glueing”[sic] effect, reducing healthy tissue motility. Osteopathic techniques and modified diets can substantially impact symptoms.”

The conference also promises to discuss the homeopathic concept of the tubercular miasm, defined elsewhere thusly, ” A miasm is not an infection or an intoxication, but a vibratory alteration of man’s vital energy, determining the biological behaviour and general constitution of the individual.” The AHVMA lecture specifically addresses treating this miasm with “remedies sourced from insects.” Yummy!

But consistent with the “holistic” commitment to never critically judging the plausibility or soundness of any idea, the offerings go well being what might be called “mainstream woo.” There is a lecture titled “Plant Spirit Medicine – Deepening Your Relationship with Plants.” Another set of lectures for veterinary technicians involves “Using the Bioenergetic Field to Empower Your Life Personally and Professionally” and considering “How Your Bioenergetic Field Affects Your Patients.” There’s also “The Science of Energy  Medicine,” which “will discuss the underlying mechanism of biofield theory with special attention to quantum physics and wave theory.”

My two favorites, though, might generate some controversy even among proponents of CAM. The first is a lecture entitled “Spiritual Nemenhah Indian Adoption as it relates to legal adoption.” The Nemenah cult is the group that achieved some notoriety when 13 year old David Hauser chose to stop receiving chemotherapy for his lymphoma and was temporarily taken into hiding by his mother. His parents are members of this faux Native American religious group that emphasizes alternative medicine. Even some proponents of CAM have balked at supporting the groups extreme approach. The AHVMA lecture sounds like a “health care choice” gambit to avoid federal laws regulating medical therapies and drugs:

“As an adopted member of the Nemenhah (“village of healers”) Band, I will explain how adopted members can obtain a significant level of protection from CODEX and other laws which are threatening our health liberties.The Nemenhah Indian Band was established as an Indigenous Group based on traditional writings which integrate “medicine and religion as one” under Indian belief. By Congressional and International law Indians are offered unique protection under recent preeminent treaty. Those who manufacture or dispense herbs, homeopathy, nutrients and any other emerging natural healing modality, will be interested to know their products and practice can be protected under Nemenhah Band legal protection.” [emphasis mine]

The ethical and legal questions this lecture raises strike me as significant, and the implicit endorsement of the AHVMA of what amounts to a call to defy federal health and consumer protection laws casts a rather sinister light on the organization’s agenda.

Finally, “holistic” veterinary medicine apparently goes beyond the mere healing of animals with unproven therapies. The greater goal is apparently to heal our hospitals and even the Earth itself (herself?), according to a lecture entitled “Geopathic Stress and Earth Acupuncture–Sick buildings and Sad Houses.”

“During this outdoor demonstration identifying and correcting geopathic stress with earth acupuncture techniques, participants will have an opportunity to find earth meridians using dowsing rods, and directly perceive both healthy and unhealthy landscape chi before and after treatment.”

As humorous as much of this is, verging as CAVM so often does on self-parody, it is sobering to realize that this sort of nonsense has been officially approved as continuing education credit. How can a regulatory structure possibly protect the public and their pets and still allow veterinarians to maintain their licenses by studying Earth Acupuncture and Bioenergetics, or by attending lectures that blame animal illness on vaccination or obscure “toxins” or that actively encourage veterinarians to evade federal law by joining a faux Native American cult that encourages parents to deny life-saving therapy to their children with cancer? One of the reasons why a neutral, live-and-let live attitude towards faith-based medicine doesn’t seem to me an acceptable stance is the kind of real danger that this sort of thinking represents to our patients. Danger that is magnified dramatically by the official imprimatur of regulatory agencies that are supposed to protect our health but who set standards based on popularity rather than science.

 

 

 

Posted in General | 23 Comments

Orthomolecular Medicine- Big Talk, Little Evidence, Real Risk

Posted on August 24, 2009 by skeptvet

One of the most impressive-sounding labels for an unproven alternative therapy is Orthomolecular Medicine. And the origin of the term, coined by Nobel laureate Linus Pauling, gives it added gravitas. As it turns out, though, it’s just a fancy way of claiming that there are medical benefits to giving high doses of vitamins above and beyond the ordinary, and quite small amounts necessary for normal health. Proponents of this concept argue that many diseases are due to undetected vitamin or mineral deficiencies, usually attributed to the unspecified evils of modern life or industrial agriculture. They also seem to follow the philosophy that if a little is good, more is better in arguing that extremely high doses of essential micronutrients can treat or prevent illness.

It is culturally difficult to argue against the benefits of vitamins, or to suggest they might cause harm. The memory of a time in which people in Western societies were routinely deficient in micronutrients, and when supplementation provided seemingly miraculous benefits, is still accessible. And there are still places in the world in which the poor not only do not have our nutrient-excess health problems but in which vitamin deficiencies are still common, and supplementation can be beneficial. Recent surveys suggest vitamins are seen as generally benign even by doctors, who commonly use them as placebo therapy.

However, the grand claims made in the 1970s by Pauling and others about the benefits of megadoses of vitamins have had a long time to prove themselves, and they have so far failed to do so. In human medicine, the loosely-organized set of theories called Orthomolecular Medicine has passed through the classic stages of CAM research:

1. An untested idea

2. An idea with support from a few random in vitro and animal model studies

3. An idea with a few supportive findings in small, poorly designed clinical studies

4. An idea clearly debunked in larger and better-designed studies but whose proponents cling to it tenaciously despite the lack of evidentiary support because they see themselves as visionaries ignored or oppressed by the unimaginative and venal mainstream medical establishment.

In veterinary medicine, as usual, not all of the stages are well-represented. The closest I have been able to find to Stage 3 are some case reports and papers from the 1970s that are long on grand theorizing and short on data by Dr. Wendell Belfield. These are balanced by a number of in vitro and animal model studies showing the implausibility or potential dangers megadoses of vitamins, but to my knowledge well-designed, adequately powered clinical trials have not been done to definitively prove or disprove any of the claims orthomolecular practitioners make. In my opinion, this is as it should be since the basic plausibility, the in vitro data, and the data from human medicine all argue against wasting resources on something so unlikely to prove safe and effective, but it is always nice to be able to show with solid data that likely nonsense truly is nonsense.

Since there do not appear to be definitive studies, I have put together some information of a cautionary nature about some commonly advocated vitamin therapies. This is certainly not a comprehensive literature review, nor do I claim it is the final word on megadose vitamin therapy. I have selected cautionary research to illustrate the potential risks of orthomolecular therapies and to remind everyone why the burden of proof is properly on proponents of this approach to justify their extravagant claims. It is also important to emphasize that the use of vitamins in high doses to prevent or treat disease is essentially using these compounds as drugs. They are not “nutritional” therapies when given above the recognized necessary amounts but active pharmaceuticals, and as such any possible benefits will come with associated risks and side effects.

 

Vitamin A

As a fat-soluble vitamin, Vitamin A can accumulate over time, making reaching dangerous levels more likely. As for most vitamins, there are clear benefits to appropriate amounts, and supplementation sometimes shows benefit for people in impoverished environments with inadequate nutrition, but the evidence does not support benefits for supplementation of healthy people with adequate diets or clear benefits for treating non-deficiency diseases.

Excessive dietary Vitamin A can worsen osteoporosis and raise the risk of hip fractures.

A nice summary of the risks of Vitamin A, including neurologic disease, birth defects, and osteoporosis.

A Cochrane Review that presents mixed evidence for the possible benefit of Vitamin A for reducing mortality in children with measles.  However, another review found no benefit for non-measles pneumonia.

A Chochrane Review showing Vitamin A does not reduce transmission of HIV from mother to offspring.

A Cochrane Review that found no value in Vitamin A for preventing lower respiratory tract infections in children, and even a few studies showing and increase risk with supplementation.

 

Vitamin C

The original megavitamin Linus Pauling promoted obsessively in his later years. The most extensively studied claims of orthomolecular practitioners are those relating to Vitamin C, and these are the claims that have been most soundly disproven. In addition, recent evidence illustrates the real risks of large doses of Vitamin C.

Vitamin C can interfere with the effectiveness of chemotherapy.

A pair of detailed reviews and refutations of a couple of papers purporting to finally show some value to megadoses of Vitamin C . First Post Second Post 

A paper showing Vitamin C not helpful, and potentially exacerbating for hypertrophic osteodystrophy in dogs.

No evidence oral Vitamin C improves immune system parameters in dogs.

Cochrane Reviews-Evidence does not support Vitamin C for prevention or treatment of the common cold and is generally absent or of unreliable quality for the use of Vitamin C in prevention or treatment of pneumonia, tetanus, and asthma.

 

Vitamin D

There is a great deal of interest in the potential of this vitamin to reduce cancer risk. However, the evidence so far is mixed, with some studies showing a decreased risk (e.g. colon cancer), little or no change in risk (e.g. breast, prostate, and others), and even some increase in risk (e.g. pancreatic cancer among smokers). Excessive amounts can cause kidney stones, abnormal heart rhythms, and other serious side effects. This is one substance for which I think there is justification to conducting further research.

 

Vitamin E

In this study, Vitamin E use increased the risk of lung cancer.

A pair of studies that showed Vitamin E had no protective benefit for prostate cancer and increased the risk of heart failure.

 

Multivitamins and Miscellaneous

A systematic review and meta-analysis published in the Lancet that suggests not only do antioxidants and Vitamin A and E supplements not prevent cancer, they may actually increase mortality risk.

A large study that found no benefit to multivitamin supplements for older women.

Neurologic toxicity with oral supplementation of Vitamin B6 in dogs.

Extensive research into orthomolecular claims in neurologic and psychiatric disease has found no evidence of benefit.

Posted in Herbs and Supplements, Nutrition | 10 Comments