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 | 30 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

Dara O’Briain- Humorous Skewering of Homeopathy and “Nutritionists”

Posted on August 23, 2009 by skeptvet

Dara O’Briain is an Irish comedian who often takes a skeptical view of things. This brief video offers a refreshingly frank take on homeopathy and nutritional woo. Be warned, though, that it also contains a good bit of profanity.

Posted in Homeopathy, Humor, Nutrition | 3 Comments

WHO- Homeopathy Not Appropriate for Serious Disease

Posted on August 23, 2009 by skeptvet

The World Health Organization is, like most UN entities, is a highly political creature. It tries to promote health in a bewildering variety of political, economic, and physical environments, and I give it full credit for what it manages to accomplish in the face of such challenges. Unfortunately, it has generally been forced by political and cultural considerations into an unfortunately weak stance on alternative medicine (or as WHO prefers to call it, “traditional,” as inaccurate as that term is for most CAM therapies).

While the official statements of the organization on traditional medicine usually include some reference to the need for validation by scientific evidence, they also tend to take a “more study is needed” approach even to the ridiculous and clearly disproven varieties of CAM. Here is an example of the usual WHO posture:

WHO and its Member States cooperate to promote the use of traditional medicine for health care. The collaboration aims to:

  • support and integrate traditional medicine into national health systems in combination with national policy and regulation for products, practices and providers to ensure safety and quality;
  • ensure the use of safe, effective and quality products and practices, based on available evidence;
  • acknowledge traditional medicine as part of primary health care, to increase access to care and preserve knowledge and resources; and
  • ensure patient safety by upgrading the skills and knowledge of traditional medicine providers.

However, it is nice to see that WHO can be more assertive when the dangers of CAM are especially clear. A number of researcher scientists and doctors associated with Sense About Science issued a statement in June asking WHO to condemn the use of homeopathy in treatment of HIV, TB, malaria, influenza, and infant diarrhea. These serious disease sicken and kill millions, especially in poor nations with limited health care resources, and the statement articulates what should be obvious; that offering clearly ineffective treatments for life-threatening diseases, especially when proven medical therapies exist and resources are limited, is unethical, impedes control of these diseases, and causes a great deal of unnecessary suffering.

In response, a number of WHO officials have issued responses clearly acknowledging that homeopathy is useless, and even potentially harmful, when used in serious diseases.: 

Dr Mario Raviglione, Director, Stop TB Department, WHO: “Our evidence-based WHO TB treatment/management guidelines, as well as the International Standards of Tuberculosis Care (ISTC) do not recommend use of homeopathy.”

Dr Mukund Uplekar, TB Strategy and Health Systems, WHO: “WHO’s evidence-based guidelines on treatment of tuberculosis…have no place for homeopathic medicines.”

Dr Teguest Guerma, Director Ad Interim, HIV/AIDS Department, WHO: “The WHO Dept. of HIV/AIDS invests considerable human and financial resources […] to ensure access to evidence-based medical information and to clinically proven, efficacious, and safe treatment for HIV… Let me end by congratulating the young clinicians and researchers of Sense About Science for their efforts to ensure evidence-based approaches to treating and caring for people living with HIV.”

Dr Sergio Spinaci, Associate Director, Global Malaria Programme, WHO: “Thanks for the amazing documentation and for whistle blowing on this issue… The Global Malaria programme recommends that malaria is treated following the WHO Guidelines for the Treatment of Malaria.”

Joe Martines, on behalf of Dr Elizabeth Mason, Director, Department of Child and Adolescent Health and Development, WHO: “We have found no evidence to date that homeopathy would bring any benefit to the treatment of diarrhoea in children…Homeopathy does not focus on the treatment and prevention of dehydration – in total contradiction with the scientific basis and our recommendations for the management of diarrhoea.”

Certainly, we might hope for more global and definitive statements on the importance of employing strictly evidence-based, scientific medicine in world public health efforts, but it is at least encouraging that when the consequences of a politic, but ultimately irrational, stance are high enough, even such a political organization has to openly acknowledge that science offers a far better hope for reducing human suffering than faith-based approaches such as homeopathy.

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

CAM and the Psychology of Last Resort

Posted on August 16, 2009 by skeptvet

I’ve often thought that the following two maxims apply to American culture generally, but especially to medicine in the US:

1. It is never appropriate to say, “There is nothing that can be done.”

2. Nothing is ever Nobody’s Fault.

The latter, along with simple venality, explains the excessive litigation that helps make human health care so exorbitantly expensive here, though it is far less damaging to veterinary medicine, at least for now. The former, I believe, plays a large role in the popularity of alternative medicine.

While some few people reject science entirely, and turn to alternative approaches for ideological reasons, most people accept and eagerly take advantage of mainstream scientific medicine when possible. However, the epistemological and ethical nature of science is such that those of us who practice scientific medicine are obliged to admit to what we don’t know, and we are obliged to tell patients or clients when science has no answers nor effective diagnostic or therapeutic options. Alternative approaches based on faith, intuition, mysterious and undetectable forces, and so on are under no such obligation. So many people turn to CAM at the point where science has nothing satisfactory to offer them.

Accepting the inevitability or intractability of disease and death with only comfort measures to ease the passage is not an option for many people raised in the can-do, American culture. We are accustomed by our history and national temperament to subduing nature and continually improving our condition. Ironically, the successes of scientific medicine have contributed greatly to the expectation that there will always be an answer and a cure. And, of course, the natural drive to live impels us to reject any acceptance of dying as long as we can maintain the illusion that there is real hope.

All of this informs not only why people turn to CAM, but also how we handle people who have made such a choice out of desperation. One school of thought is that any comfort possible should be given those for whom no real meaningful therapy is available. If they feel better, despite the lack of any real, measurable change in their condition, that has real value. This is part of the argument for taking advantage of the placebo effect, and it has some merit, at least in human medicine. I have serious doubts, however, about the ethics of this approach in veterinary medicine, where the comfort obtains only for the owner, while the patient continues to suffer.

We must realize that allowing the comfort of false belief is not without risks. What’s the Harm is full of stories of people who died with much unnecessary suffering because accepting the palliative care scientific medicine had to offer was an acknowledgement of the inevitability of death, and so they chose the false hope of CAM treatments. Some alternative therapies have known risks, and because they are not adequately studied others may have risks we are unaware of. There is even some evidence that cancer patients who use CAM have worse outcomes than those who do not, possibly because they take less full advantage of scientific therapies or because of the deleterious effects of CAM therapies.

Nevertheless, we also have to acknowledge and have compassion for the fear and suffering that leads people to choose unproven therapies as a last resort. Discussions about the inevitability of death and the limits of human knowledge and technology are hard to have in our culture, but I don’t think they need be off limits for health care providers. Certainly, it is not appropriate or useful to challenge someone’s philosophical or metaphysical beliefs in a health care setting, but when we tell someone that the CAM straw they are grasping at is unlikely to help and has the potential to harm, I think it helps to acknowledge the feelings that lie behind the grasping and to offer the same kind of simple human comfort that CAM providers often give, without the concomitant false hope.  

I recently met a smart, clever man living with diabetes who had written a very funny song about the Placebo Effect. He has spent much time and energy looking at the best way to manage his disease, and he has done his best to rationally evaluate the recommendations both of his doctors and of the friends, family, and strangers who promote alternative approaches. This has engendered a certain frustration and a bit of pessimism about the ability of human beings to understand and manage the complexities of living organisms and their diseases.

While we didn’t agree entirely on the reliability of scientific knowledge or the meaningful differences between CAM and scientific medicine, I was impressed by his intelligent and thoughtful approach to epistemological questions which had a sharply personal significance for him. Our conversation helped me to better understand the psychology behind people reaching for what seem to me to be clearly useless, irrational therapies. Contrary to the mythology CAM providers often promote, science-based medicine providers do care about the whole patient and the totality of their well-being, and this compassionate “holistic” attitude must always be at the center of our attempts to provide the best care and educate our clients/patients about the difference between science-based and faith-based medicine. If we understand and acknowledge the legitimacy of the needs that lead people to unproven therapies, perhaps we can better steer them to those approaches that are the most likely to benefit them.

Posted in General | 10 Comments

Evolution Diet – Selling Food with Fear and Lies

Posted on August 12, 2009 by skeptvet

I was recently asked to comment on an advertising card for Evolution Diet. There are a number of claims made, and because they are vague and wildly inflammatory, it is difficult to address them in an evidence-based manner, but I’ll do my best.

1. “Up to 30% Longer Life Expectancy”. This is in large, colored type adjacent to the name of the diet and a picture of a puppy and kitten. No evidence is presented on the card or the various websites associated with the company or the CEO Eric Weisman. Much is made of a couple of studies linking calorie restriction to some increase in life expectancy in various experimental animal studies. This is an interesting area of research, but it has no connection to the implied benefits of feeding this diet.

2. According to this advertisement, the pet food industry “provides a convenient way for the disposal of slaughterhouse toxic wastes unfit for human consumption” “hard to digest, nutrient deficient toxic ingredients include: intestines, udders, stomachs, lungs, heads…drugs and pharmaceuticals (antibiotics, hormones)…euthanized pets.”

A wild string of fallacies, nonsense, and outright lies. It is true that some parts of animals that people think of as icky are used to make pet food. But if lungs, intestines, stomachs, eyeballs and so on are all toxic, then why aren’t they poisoning all those cats who hunt rodents and birds, or for that matter every other carnivore that eats them routinely in the wild? Of course, Mr. Weisman would say they are, but the logic behind claiming that an obligate carnivore like a cat or ferret is healthiest if fed a vegan diet is bizarre and indefensible.

Antibiotics and drugs used in agricultural animals (which are then used to make pet food) are regulated very tightly because we eat the meat from these animals, and there isn’t any more of these things in the pet food that isn’t also in the steak we eat, which is to say little to none under normal circumstances. There are some real and serious issues about what we feed to animals intended for consumption, but these have little to do with the claims Evolution Diets makes.

The pentobarbital thing I addressed in my previous discussion of nutritional myths, and you can find the details on the FDA web site. In short, miniscule amounts were found in some (not “all”) foods tested, but no traces of dog or cat DNA were found in these foods, and there are separate companies and facilities involved in rendering companion animals and agricultural animals used to make pet food, so it’s pretty darned unlikely there are regularly pets in pet food. No one is sure where the pentobarbital comes from, but it’s possible a euthanized horse occasionally makes it into a rendering plant that provides ingredients for pet food. This is obviously not desirable, but it has also not been shown to represent a real health risk.

Is the amount of pentobarbital in some pet foods  toxic? Pretty unlikely. The FDA calculated the maximum exposure and determined it was far too low to represent a danger. And contrary to what purveyors of the naturalistic fallacy generally think, dose matters in toxicology. Enough oxygen or water can kill you, though these are essential for life, and we all get tiny amounts of “natural” and synthetic substances in eating, drinking, and breathing all the time and always have. Common herbs and spices used in cooking have been linked to cancer, as long as they are fed in obscene amounts to rats. Does that mean we’re all going to die of oregano poisoning?  It’s a big leap from saying tiny amounts of possibly toxic things are present to showing that there are health consequences to this, and this hasn’t been shown here.

3. “…millions of Dogs and Cats suffer and die each year from cancers, kidney/liver failure, heart disease, etc” and “scientific studies demonstrate that there are nutrient deficiencies for immune system, cardio-vascular and urinary tract precursor proteins in all basic meat, poultry, and fish-based pet foods.”  I’d love to take a look at these studies, as I’m sure would all the veterinary nutritionists who don’t seem to be aware of them.  AAFCO sets standards which all major manufacturers follow for nutrient content in foods, and I’m not aware of any evidence that every dog food made except this company’s is nutrient deficient and causes disease.  The advertisement states the food is “complete and balanced for all life stages,” which at least claims compliance with AAFCO guidelines, just like every other commercial pet food.

As for the implication that cancer, kidney failure, liver failure, and heart disease in pets are somehow due to toxic ingredients or nutritional deficiencies in foods, well they just made that up. It is the most egregious kind of unfounded fear mongering with no evidence provided to support it.

4. “Literally, all major commercial pet food brands and suppliers, including most brand names, have been involved in major pet food recalls that have sickened and killed millions of Dogs and Cats in the U.S.” “Never a Recall!”

I’m not sure it’s possible to check the accuracy of these claims. Certainly, many pet foods have been recalled at one time or another, but I think it would be hard to show that all foods except this one have been. And the implication that this implies the foods are killing dogs and cats is nonsense. Most recalls are precautionary and no actual harm is ever found. And in those cases where some contaminate is actually present, a recall is an example of a responsible action that saves lives. The melamine incident, which I suspect is being referred to,  involved a non-animal ingredient (what was supposed to be wheat protein but got adulterated with the melamine). Wheat and corn gluten meal are the first two ingredients on several of the Evolution Diets, and while I don’t know where they get these, the issue of contamination is just as likely to come up for this company as any other.

Interestingly, in 2003 a recall of Go! Natural pet food was conducted due to a number of cases of acute liver failure associated with the food. The underlying cause was never found, but the company manufacturing the food continues to tout it as healthier based on claims about “good” and “bad” ingredients very similar to those made on the Evolution Diet site. Simply claiming something is healthy and natural provides no assurance that it is safe or healthy.

Finally, if you check out the web site for the company producing this diet, you might get a hint of the ideology behind this product from the CEO’s diatribe on the evils of mainstream medicine, and the reason why we could all stop getting sick and dying if we just followed the messianic vision of the CEO of this company, Eris Weisman. Here’s a sample:

“One of the most important reasons why many veterinarians do not like Evolution Diet Pet Foods is because people using them have much healthier pets.  When pets become healthier, they become much less dependent on veterinary services and vets make much less money. Sadly, most medical doctors and veterinarians are more concerned about their income then your health or the health of your pet(s) respectively.”

What do you think? Sound like the vets you know? So, once again, it’s the small visionary against the evil establishment, who are all crooked and deluded. He talks at length about how his vision would save humans as well as pets from our toxic environment, and the increase in health and longevity brought about by science and medicine in the last 150 years appears to have escaped him. A messianic version of the David and Goliath complex.

Mr. Weisman is an interesting character. He claims a number of academic credentials, including “2 Diplomats[sic] and a Doctorate in post-graduate Health Sciences at Northwestern Health Sciences University in Minnesota…[and] a National Board Diplomat[sic] for his Post Graduate Work in Health Sciences.” The university he refers to is a college of chiropractic, acupuncture, and oriental medicine, and while I can find no reference to the graduate programs Mr. Weisman claim to have completed, it is possible they are offered there. Likewise, I can find no sign of a National Board of Health Sciences for him to be a diplomate of, but I suppose it might exist. He also claims to have been “a physician in private practice using Vitamin, Botanical, Nutraceutical & Nutrition Therapy for Humans” and makes references to time in medical school, but he doesn’t use M.D. and he recommends Naturopathy, so it is impossible to tell whether he was a true physician or a Naturopath.

In any case, despite offering these credentials, Mr. Weisman disdains formal academic training and the medical profession generally. He says:

“I was not a great student until my later years in post graduate school.  Part of the problem I faced in the schools I attended was my constant need to question why things were being taught and if they were true in the first place. 

It took me decades to realize that many of the courses taught in schools are based on misinformation and half truths much like television and newspapaer[sic] news.  It wasn’t because the teaching staff suddenly decided to inform me, it was because I studied alternate books with different information that opposed what I was being taught in various schools, colleges and universities.”

He clearly likes to portray himself as a misunderstood visionary, as is so often the case for people selling quackery. He begins his essay on the “VETERINARY & HUMAN MEDICINE IN CRISIS and How I Have Extended and Improved Quality Of Life in Cats, Ferrets, Dogs and Humans with Supplements & Nutrition” with a dedication to a number of famous vegetarians, including Max Gerson, originator of the infamous Gerson cancer therapy which, along with its offspring the Gonzalez Protocol, is a shining example of abusing the desperation of cancer patients and torturing them with uncomfortable and irrational diet, coffee enemas, and other nonsense that only magnifies their suffering without treating their disease. He frequently reminds us that most doctors are either simple greedy liars or brainwashed by the media, since we all know “Television and Radio are very powerful influences that easily manipulate most human minds:  Except for people like myself.”

Mr. Weisman is clearly driven by the quasi-religious belief that he has a unique insight into the conspiracy of government and industry that exists to keep people and animals ill for profit and to keep them under control. He refers to painful experiences in his own past, including his mother’s mental illness, which he attributes to electroconvulsive therapy experiments performed on her by the CIA and the Canadian Psyschiatric Association*, and the death of his father from heart disease which he attributes to eating meat, fish, and poultry and to the deliberate refusal of doctors to properly resuscitate him from the last of his many heart attacks.* *

Like all of us, he has suffered painful losses of loved ones and had to watch suffering and disease that could not be prevented or cured. But his reaction to this is to reject science, to blame his pain on the deliberate evil and lack of vision of the rest of the world, and then to invent his own reality in which he has simple answers that will make the pain go away. That may be understandable for him as a human being, but it is not justification for selling that private, and false vision to others through hysterical scare tactics and fear mongering, as well as defamation of the medical profession and outright lies. The diets he sells may or may not be perfectly adequate, acceptable pet foods, but they are not the key to preventing or curing death and disease that he claims. And the rest of the pet food industry, of which he is a part despite his protestations, may not be any better than any other collection of people or companies, but it is not the sinister conspiracy deliberately marketing death and disease that he portrays.

I would like to think the Evolution Diet marketing strategy sufficiently absurd on the face of it that it would fail, but clearly this isn’t the case. Smart, well-intentioned pet owners can be fooled and frightened by the unfounded claims and accusations Mr. Weisman makes. Hopefully, demonstrating the lack of evidence, and the bizarre agenda and worldview behind his statements will help people make their own, sound decisions about how to best care for their animal companions.

 

 

*”When a child, I dreamt that I could one day free my mother from her long term illness that was caused by an experimental “medical” study procedure (she was made a subject without her permission).  I hoped that the knowledge I would accrue from different colleges and universities would help me achieve this goal. 

I only found out that my mother was a forced participant in a series of electro-convulsive shock experiments at a Canadian Hospital after I saw an extensive film documentary on CIA studies that resulted in litigation.  The litigation was a result of unsuspecting hospital patients being used as subjects for various forms of torture and abuse at three Canadian Hospitals.  I went back into my mother’s medical file to find out that she was at the same hospital at the same time refered to in the documentary.  In the files were references to a series of electro convulsive shock treatments she recieved at that Hospital over a two month period. 

According to the documentary, the CIA and Canadian Psychiatric Association conducted interogation and brain washing experiments on unwitting patients at the same Canadian Hospital my mother went to for a mild case of post partum depression.  After my father brought her to that hospital, she was treated with high doses of electro-convulsive shock for her simple problem of unhappy mood linked to increased responsibility with my sister’s birth.  During her two months of treatment, she developed a permanent form of advancing dementia from which she never recovered and increased as she aged. 

From the bright, intelligent, pretty and generous woman she was, I remember how sick and dull her personality seemed after she came back from her long stay at that hospital.  I remember that she was never the same bright person she was before she went in, but I had no complete understanding of why until the summer of 1993 after watching that televison CIA law suit documentary and delving into my mother’s medical records.  As I watched the documentery in awe, I did not know then that my mother was going to die from some of the related injuries she sustained in that study just three years later (1996).”

 

**”It was a cool, wet and dark October Morning in Toronto at about 1:00 AM in 2004.  I pulled my father’s car into the Sunnybrook Hospital Parking lot ramp near the front Emergency Entrance and stopped next to a concrete parking wall. I turned off the engine and looked at my pretty twenty-three year old neice Angela and said, “I don’t think he made it.”  I was preparing myself for the worst.  

Angela was crying “They’re doing all they can to resusitate him, aren’t they?”

Tears had welled up in my eyes.  “It looks like a Dog and Pony Show to me.  The doctors told me that they did not think he was a good candidate for resusitation.  The On Call Doctor told me he did not want to resusitate him.  He said that Dad would not make it, but I promised Dad I would have it done. It was the last thing he asked me to do.  The doctor told me that Dad has so many forms of organ failure…his heart especially:  He has little chance of making it.  Just the way they put him on that table in the resusitation room tells me it’s over.  That had him lying in a fully recombant position even though he has pneumonia.  With all that fluid in his lungs, how can he even breath or be resusitated in a fully recumbant position.  I don’t think they were really giving him a chance to make it.” 

Angela jutted her head forward and cocked it to the left, looking straight into my eyes, “You think that they would just let him die and make it look like they were going to help him?”

“I think they do this kind of thing every day in hospitals throughout the US and Canada…

I said, “I hope you are going to change your diet.  This might be your last chance Dad.  I really mean it Dad.  I don’t think you are going to make it next time.  You’ve got to change your diet for real this time.  I can tell by the way you have been forgetting things that you are in trouble…and you haven’t been answering my pahone calls.  You just got out of the hospital for heart failure.  Don’t you know that everytime you eat meat, poultry, fish or dairy products that you progressively block all of your arteries.  It’s very serious because the most important arteries that are being blocked are in your heart and brain.  Dad you’ve got to stop eating that stuff…you’ve had five heart attacks and it’s animal fat and animal cholesterol that have caused each one.  I don’t want you to die.  That’s why we came to visit you.  Lynn and I want you to change your diet now.  You’ve got to stop blocking your arteries with animal fat and cholesterol…

Flash forward to that cool, wet, dark October Morning. My niece and I entered the special resusitation room and looked at my Dad’s still warm, but lifeless body.  He still had a large ortho-pharyngeal tube poking out of his motionless mouth.  He looked so still.  It was so unlike him. He was a man that lived life to the fullest.  If he would have only taken meat, poultry and fish out of his diet when I had spoken to him six months earlier.  I knew that he would still be here.  Animal fat and cholesterol are what progressively killed his organs by blocking his arteries.” 

 

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