Resveratrol–Still Promising and Unproven, and Now With its Own Scandal

Quite some time ago, I wrote about the substance resveratrol as an ingredient in a nutraceutical intended to treat canine cognitive dysfunction. Here was my conclusion at the time:

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.

The latest reviews of the human literature suggest that the evidence hasn’t changed much; still promising but unproven.

Vang O, Ahmad N, Baile CA, Baur JA, Brown K, et al. (2011) What Is New for an Old Molecule? Systematic Review and Recommendations on the Use of Resveratrol. PLoS ONE 6(6): e19881. doi:10.1371/journal.pone.0019881

The overall conclusion is that the published evidence is not sufficiently strong to justify a recommendation for the administration of resveratrol to humans, beyond the dose which can be obtained from dietary sources. On the other hand, animal data are promising in prevention of various cancer types, coronary heart diseases and diabetes which strongly indicate the need for human clinical trials.

Quackwatch Summary

Epidemiologic studies can find associations between the consumption of foods or dietary supplements and various health outcomes. Animal experiments can demonstrate what can happen in the species tested. However, only human clinical trials can determine whether supplementation is useful for humans. Resveratrol has not been tested in clinical trials, and most clinical trials of other antioxidants have failed to demonstrate the benefits suggested by preliminary studies. Some substances—most notably beta-carotene—have even produced adverse effects. My advice is to ignore the hype surrounding resveratrol and eat a balanced diet that contains adequate amounts of fruits and vegetables.

There doesn’t appear to be any clinical trial literature on the subject in dogs or cats.

An interesting twist to this story involves one of the most visible researchers promoting resveratrol, Dipak Das from the University of Connecticut. In January, Dr. Das was charge by his university with multiple counts of fraud for falsifying and fabricating data. Since then, 12 of his published papers have been formally retracted. He has published 117 articles on the subject of resveratrol, many of which have been cited numerous times, so this could have some impact on the reliability of the evidence concerning resveratrol, though other researchers in the area contend Dr. Das’ work is not central to the field. In any case, it is a fine example of both the dangers of excessive and premature commitment to a hypothesis and promotion of products based on it as well as of the ultimately self-correcting nature of the scientific process.

Posted in Herbs and Supplements | 2 Comments

SuperVets: Entertainment, Education, or Propaganda?

It is a well-known, indisputable, and nearly universally ignored fact that anecdotes in medicine are unreliable when trying to decide which therapies work and which don’t. The experiences of individual patients don’t even reliably tell us what worked or didn’t work in that specific case, and they certainly can’t be trusted to guide our treatment decisions for other patients. Health and disease are complicated, with numerous factors operating simultaneously to affect the outcome of any one patient, and there are a nearly infinite number of ways we can be fooled into thinking something is helpful which does nothing or even makes the problem worse.

The classic example is bloodletting, which was acclaimed as a rational and effective therapy by the greatest minds in medicine for thousands of years despite being not only ineffective but dangerous, sometimes even fatal. But there are many other such examples, both ancient and modern, of how telling stories about single patients leads us into false beliefs. The success of modern medicine, and the dramatic improvement in the length and quality of our lives in the last couple hundred years, is due to the shift from reliance on experience, history, and anecdote and towards trust in rigorous scientific methods for making decisions about medical therapies.

Unfortunately, anecdotes are not only unreliable, they are deeply compelling psychologically. We are storytelling creatures for whom creating and sharing narratives is a powerful way of building and maintaining our beliefs. It is in our nature to trust the stories we hear, especially when those stories agree with beliefs we already hold. So the rational evidence that stories are untrustworthy usually loses out to the emotional impact such tales have.

The only thing more misleading in medicine than an anecdote is a stylishly produced anecdote on television. Yet this is precisely the intended format for a proposed new television program aimed at promoting alternative veterinary therapies. Humbly named “SuperVets,” this program sounds like the perfect storm for swamping reason and science in a flood of emotional storytelling.

According to an interview for the VIN News Service, the idea for the show came from a television producer who is a believer in so-called holistic veterinary medicine. After meeting a couple of veterinarians who offer some unconventional therapies, the producer decided to create a television show that highlights “specialty veterinary medical services that many pet owners don’t realize are available.” Given that the teaser for the program talks about acupuncture, Chinese Medicine, and hyperbaric oxygen therapy, it seems likely that many of these therapies are going to be alternative approaches which have little scientific evidence to support them and so rely primarily on anecdotes for justification.

The format of the show is apparently to present heartwarming miraculous recoveries due to unconventional therapies, with no discussion of the scientific plausibility or research evidence concerning these treatments or any of the reasons why such anecdotes might not accurately represent reality. The teaser focuses on an adorable retriever, with an equally adorable and loving family. Supposedly condemned to death for some unspecified neurological disease by three different veterinarians, the dog is treated by one of the SuperVets with hyperbaric oxygen therapy, and the trailer ends by parading the apparently completely recovered patient before a live audience.

The producer describes this format as a “genre-defying show…staged before a live audience as well as in the field [that] uses real cases to educate viewers.” My understanding of the difference between education and propaganda is that the former includes a reasonably thorough and accurate presentation of information and the limits of our knowledge whereas the latter presents oversimplified narratives with only one possible interpretation. Apparently, the folks behind the show and I use the word “educate” differently.

Of course, there is nothing wrong with using anecdotes to illustrate an idea. It would be foolish to ignore the impact personal stories have on an audience. The trouble is when one uses anecdotes to prove something or to make a case for an idea that scientific evidence suggests is false. Since the show hasn’t been made yet, I can’t be certain that there won’t be thoughtful and informative information about the pros and cons of veterinary therapies, both conventional and alternative. But the teaser doesn’t give any indication this will be the case. And in the words of one of the SuperVets, “through modern veterinary medicine and emerging alternative therapies such as acupuncture and hyperbaric oxygen therapy, there are enough amazing recovery cases to present on the show for an indefinite period.

I would certainly applaud an effort to show, in an enjoyable and compelling way, that veterinary medicine can be a sophisticated and successful enterprise. However, simply showing a series of supposed miraculous cures brought about by alternative medicine when conventional methods have failed or not been tried is purely propaganda, not education in any honest sense.

It isn’t that an entertaining and compelling show couldn’t be made about scientific medicine, complete with acknowledgement of its failures and limitations as well as its enormous success. Carl Sagan’s Cosmos is the paragon of moving, poetic depictions of legitimate science. And folks like Neil DeGrasse Tyson and Richard Dawkins are keeping alive the tradition of simultaneously accurate and beautiful depictions of science. Unfortunately, this project looks does not look to be in that vein. It appears instead to be a case of true believers in unconventional therapies cherry-picking and crafting supporting anecdotes to show a very skewed picture of alternative veterinary medicine. I guess we’ll know for sure if the project eventually makes it to television.

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N-Acetylcarnosine Eyedrops for Cataracts in Dogs and Cats (Can-C, Bright Eyes NAC, etc)

A client recently asked for my opinion about the value of some over-the-counter eye drops purported to treat cataracts in dogs and cats. Not having read much about this product, I did a little research.

What Is It?
There are a number of eye drops marketed for prevention or treatment of cataracts in humans and pets. Most commonly, they contain a chemical called n-acetylcarnosine, which is made up of a couple amino acids and an acetyl group. In vitro research suggests this chemical has anti-oxidant effects, so it has been hypothesized to prevent or reduce the gradual opacification of the lens of the eye through this mechansism. As I have pointed out before, the role of oxidative damage in disease, and the value of anti-oxidant therapies, is a developing area of research. Many of the exuberant and enthusiastic hopes in this area have proven false, so while it is an area deserving further investigation, claiming something is an anti-oxidant is not automatic validation of its safety or benefits (e.g. 1, 2, 3).

Does It Work?
There have been a number of studies of n-acetylcarnosine, both in vitro studies and clinical trials in humans. Interestingly, almost all of these appear to have been published by the same researcher and his team, Dr. Mark Babizhayev. A clinical trial was published in 2001 (and it appears the same data was published again in a different journal in 2002, which if true is quite a significant science no-no). The trial was randomized and controlled in a small number of patients, and it appeared to show significant changes in a number of objective measures of cataract severity.

I am not familiar with the specific techniques used to measure the disease or response to treatment, so I will presume they are standard and appropriate measures for this kind of study. One thing that is not clear from the published report is whether the individuals making these measurements were blinded to the treatment status. This obviously has a significant bearing on the reliability of the results, especially when they stem from only one researcher, as such debacles as the Benveniste affair show.

A number of subsequent papers have been published by Dr Babizhayev and his team, mostly in vitro or lab studies investigating properties of n-acetylcarnosine, not clinical trials. Dr. Babizhayev has also become the leader of a commercial firm marketing n-acetylcarnosine for cataract treatment, and many other uses (including skin care, wound care, respiratory disease, and neurologic disease).

This commercial effort, and the spreading of claims for n-acetylcarnosine to a wide range of apparently unrelated applications, does raise some questions about the reliability of Dr. Babizhayev as the sole source of scientific validation for this compound. Overall, the status of the evidence for use of n-acetycarnosine for cataracts in humans is best summarized by the Royal College of Opthalmology:

 

The evidence for the effectiveness of N-acetyl carnosine eye drops is based on experience on a small number of cases carried out by a Russian researcher team. To date, the research has not been corroborated and the results replicated by others. The long-term effect is unknown.

Unfortunately, the evidence to date does not support the ‘promising potential’ of this drug in cataract reversal. More robust data from well conducted clinical trials on adequate sample sizes will be required to support these claims of efficacy.

Furthermore, we do not feel the evidence base for the safety is in any way sufficient

Unusually, there is actually some clinical trial evidence in veterinary species as well. An uncontrolled, unblended pilot trial has been published on an n-acetylcarnosine product (not the one Dr. Babizhayev sells) in dogs with cataracts.

David L Williams, Patricia Munday. The effect of a topical antioxidant formulation including N-acetyl carnosine on canine cataract: a preliminary study. Vet Ophthalmol. 2006 Sep-Oct;9(5):311-6. The results showed marginal improvement in all groups, though it was only significant in patients with 2 out of 5 types of cataract treated. However, subjectively owners reported improvement in 80% of the subjects.

Dr. Williams  has apparently performed a blinded, placebo-controlled follow-up trial on this product which did not show any benefits (in fact improvements were greater in the placebo group than in the treatment group), showing once again the importance of proper controls for bias, confounding, and other sources of error in clinical trials. Unfortunately, it appears unlikely this trial will be published for reasons which are not completely clear, though one implied issue is that journals are often reluctant to accept papers that show negative results, which are less exciting for readers than positive studies. All of this is, of course, through word-of-mouth among veterinarians, so I cannot confirm it is true.  

Is It Safe?
I have not found any reports of adverse effects from ophthalmic application of N-acetylcarnosine itself, and given its chemical makeup it seems unlikely to be hazardous. As usual, products containing this agent are not regulated as licensed medicines are, and there is no way to ensure label accuracy, proper manufacturing quality standards, or the safety of other ingredients that may be included with the N-acetylcarnosine. 

Bottom Line
The theoretical arguments for why this drug might be useful I the treatment of canine cataracts are plausible but largely unproven. There is limited clinical trial evidence in humans suggesting a benefit, but this has not been replicated and is at high risk of bias. The limited clinical trial evidence available in dogs does not suggest a benefit. There are minimal safety concerns with products containing N-acetylcarnosine.

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Coffee Enemas for Pets: A Very Dangerous Idea!

The therapies I write about range widely from the likely beneficial, to the plausible but mostly untested and over-marketed, to the implausible and even completely ridiculous. The subject of this post is in the last category, and it is a treatment I have not yet addressed because, thankfully, it is seldom recommended even by proponents of the more extreme varieties of alternative medicine. However, Dr. Carol Osborne, a prolific advocate for unproven and pseudoscientific therapies, has latched onto this one in a recent blog post, Could a Coffee Enema Save Your Dog’s Life? For those of you who don’t have time to slog through the rest of the post, I’ll give you the answer now: No. But it could take your dog’s life.

Dr. Carol begins, as proponents of such nonsense treatments so often do, with a meaningless heartwarming anecdote.

Dr. Carol Osborne has seen first-hand the effects a coffee enema can have a dog – and in one particular case, the effect was nothing short of miraculous. When a friend and clients dog suffered acute liver failure, other veterinarians recommended euthanasia. Unable to part with her pet without at least a second opinion, the pet’s owner contacted Dr. Carol as her last resort. In addition to the administration of intravenous fluids, Dr. Carol gave the small dog a coffee enema. Not only did the dog improve, he began to thrive.

Anyone who follows this blog is familiar with the unreliability of such stories, and all the reasons why bogus therapies may seem to work when they really don’t. Acute liver disease is a classic example of a problem which often, and sometimes unexpectedly, resolves on its own with only supportive care (such as IV fluids), due to the regenerative capacity of the liver. I always find it strange that proponents of alternative medicine frequently talk about the body’s innate healing abilities and yet always seem fine taking the credit when a patient gets better.

The arguments Dr. Osborne gives for why this therapy ought to be helpful are no more valid or convincing than the opening anecdote.

Coffee, when administered via enema, stimulates the production of glutathione by the liver. Glutathione is required by the liver to function properly. When the liver fails, glutathione production ceases. By stimulating production of this vital nutrient, the coffee enema helps the liver to once again perform.

Coffee enemas also work as a detox… 

The walls of the intestines, once thin and clean, will become thicker over time with the debris that sticks to the walls preventing the body from digesting and absorbing vital nutrients.

If something is not done to counteract the thickening of the intestinal walls due to residue and debris the pet or person will gradually begin to lose their energy and the ability to function normally…  

Interesting theory. Also complete nonsense.

Glutathione is, of course, present in the liver and important for normal liver functioning, along with thousands of other chemicals. The evidence does not support the assertion that coffee enemas increase glutathione levels in humans. (1) There is mixed evidence for changes in glutathione levels from oral coffee intake, with some human and rat studies finding and increase and others not. (2) There is no evidence that coffee can increase this enzyme in dogs. And there is no evidence that any increase in glutathione which might happen from some kind of intake of coffee has meaningful clinical benefits. So this claim is probably wrong and would be of questionable significance even if it were true.

The argument that coffee enemas are “detoxifying” is based on the vague and mythological understanding of “toxins” that underlying many quack therapies. This mythology is not a legitimate understanding of the cause of disease, and it is not a sound rationale for coffee enemas. (3, 4, 5) The colon is not a primary site of digestion and absorption of nutrients, though there are some nutrients that are absorbed there (notably B vitamins) as well as water. And it does not become caked with debris over time which impedes its functioning. The notion that we are fundamentally incapable of normal health without some periodically flushing out our large intestine is simply ridiculous.

So is there any evidence that coffee enemas have health benefits despite the lack of a plausible theory why they should? Nope! The subject has been debated in human medicine for some time, particularly due to claims that coffee enemas can be beneficial in cancer treatment. There is no credible evidence to support this claim and clear evidence against it. (6, 7, 8, 9, 10) And, of course, there is no clinical research of any kind in dogs or cats to test this therapy. And there shouldn’t be!

While not having shown any benefits, coffee enemas unquestionably can cause harm. There are numerous reports of serious harm done to human patients, including dehydration and electrolyte disturbances, tears of the colon and rectum, burns in the colon and rectum, infections transmitted by the procedure, and death. (11, 12, 13, 14, 15)

The fact that caffeine, a prominent chemical in coffee, is a well-known and serious toxin in dogs makes the notion of coffee enemas in these species even more insane, if that is possible.

While it seems as if it shouldn’t even need to be said, clearly coffee enemas for pets are a bad idea. The theoretical reasons for using them range from unproven to completely crazy, there is no evidence in humans or veterinary patients of any benefits, and there is ample evidence of potentially serious harm, including death. Recommending this treatment for pets is irrational to the point of being indefensible.

References

  1. Teekachunhatean S, Tosri N, Sangdee C, Wongpoomchai R, Ruangyuttikarn W, Puaninta C, Srichairatanakool S. Antioxidant effects after coffee enema or oral coffee consumption in healthy Thai male volunteers. Hum Exp Toxicol. 2012 Jan 16. [Epub ahead of print]
  2. http://www.ncbi.nlm.nih.gov/pubmed?term=coffee%20glutathione
  3. Chen TS, Chen PS. Intestinal autointoxication: A gastrointestinal leitmotive. Journal Clinical Gastroenterology 11:343-441, 1989.
  4. Green, S. A critique of the rationale for cancer treatment with coffee enemas and diet. JAMA. 1992,Dec 9; 269(13),1635-6.
  5. Ernst, E. M.D., Ph.d., F.R.C.P. (Edin). Colonic Irrigation and the Theory of Autointoxication: A Triumph of Ignorance over Science. Journal of Clinical Gastroenterology. 24(4):196-198, June 1997. (Make sure to follow the references to the primary sources).
  6. Alison Reed, Nicholas James and Karol Sikora. Mexico: Juices, coffee enemas, and cancer. The Lancet. Volume 336, Issue 8716, 15 September 1990, Pages 677-678.
  7. M. E. Shils and M. G. HermannBull . Unproved dietary claims in the treatment of patients with cancer.N Y Acad Med. 1982 April; 58(3): 323–340.
     
  8. Brown BT. Treating cancer with coffee enemas and diet. JAMA. 1993;269:1635-1636.
  9. Cassileth, B. Gerson Regime. Oncology, Volume 24, Issue 2, 2010 Page 201.
  10. Atwood, K. “Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part I: Results). Science-Based Medicine Blog, Accessed May 13, 2012 at http://www.sciencebasedmedicine.org/index.php/gonzalez-regimen-for-cancer-of-the-pancreas-even-worse-than-we-thought-part-i-results/
  11. Keum, B. et al. Proctocolitis caused by coffee enemasAm J Gastroenterol. 2010 Jan;105(1):229-30.
  12. Lee, C.; Song, S.; Jeon, J.; Sung, M.; Cheung, D.; Kim, J.; Kim, J.; Lee, Y. (2008). Coffee enema induced acute colitis. [The Korean journal of gastroenterology] Taehan Sohwagi Hakhoe chi 52(4): 251–254
  13. Eisele, J.; Reay, D. (1980). Deaths related to coffee enemas. JAMA: the Journal of the American Medical Association 244(14): 1608–1609.
  14. Sashiyama, H.; Hamahata, Y.; Matsuo, K.; Akagi, K.; Tsutsumi, O.; Nakajima, Y.; Takaishi, Y.; Takase, Y. et al (2008). Rectal burn caused by hot-water coffee enema. Gastrointestinal Endoscopy 68(5): 1008–1009
  15. Jones LE, Norris WE. Rectal burn induced by hot coffee enema. Endoscopy.2010;42 Suppl 2:E26.

 

Posted in General | 36 Comments

Bowen Technique for Animals

A reader recently asked me to look into a manipulative technique marketed for both humans and veterinary patients, Bowen Technique. This turned out to be a bit easier than I expected as there are already a couple of excellent evidence-based reviews of the approach available. My own searches of PubMed, the Cochrane Reviews, and other literature resources did not turn up anything not already covered in these reviews, so I will primarily refer to their assessments.

The Second Sight Blog-
Bowen Therapy 1: Introduction
Bowen Therapy 2: Evidence

A Canna’ Change the Laws of Physics
Bowen Therapy and the ASA

What Is It
Apparently, Bowen therapy is the invention of yet another self-taught misunderstood genius, this time in Australia. Tom Bowen invented a technique whereby the therapist gently massages certain key points, which may or may not be associated with acupuncture points (which are themselves likely imaginary), meridians, chakras, and other such mystical energy medicine concepts. This supposedly alerts the brain to the presence of a problem which it somehow did not otherwise know about (despite the pain or other symptoms which brought the patient to the therapist), and the brain then repairs the damage on its own. Apparently, the brain is shy because it is supposedly necessary for the practitioner to leave the room periodically during treatment so the brain has the opportunity to respond to the messages they are sending it.

The review at Second Sight goes into more detail, evaluating the theoretical explanations on the Bowen web site, but the bottom line is that these explanations are vitalistic and pseudoscientific, along the lines of those for other similar energy therapies such as traditional acupuncture, Reiki, healing touch, and so on.

Does It Work?
From the point of view of plausibility, there is no reason to think this therapy is effective. The theoretical explanations for it are inconsistent with established science. And as usual, for the veterinary applications of Bowen Technique, I have not found a single published study of any kind. Unless one exists that I am unaware of, the use of this technique in animals is based solely on anecdotal experience, which is deeply unreliable.

There have been a handful of clinical trials in humans, which the blogs cited above review in detail. My own reading of them agrees with these reviews. Almost all are uncontrolled studies highly subject to bias. If you apply a treatment to a bunch of people and something changes about their health, you can’t simply assume the treatment is the reason. So most of these are useless for establishing safety or efficacy.

There is one controlled trial which evaluate the use of Bowen therapy on healthy volunteers by measuring their hamstring flexibility before and after treatment. The study does show that healthy people will stretch farther after they think they’ve received a treatment to enhance flexibility compared to people who haven’t been given any treatment. This doesn’t really say anything at all about whether Bowen technique has any physiological effects or any benefits in treating disease.

Is It Safe
There is no evidence concerning safety for this method. Some practitioners subscribe to the “healing crisis” notion also found in homeopathy, where patients are expected to get worse as a sign they are responding to treatment, so some negative symptoms have been reported anecdotally after treatment. However, without controls or systematic monitoring, there is no way to know if these experiences have anything to do with the treatment.  Of course, with Bowen therapy as with most unproven and implausible approaches, the risk that comes with applying an ineffective therapy and failing to seek real medical care in a timely fashion must be considered.

Bottom Line
There is no good reason to think this approach works based on the theoretical explanations offered for it, which are unproven and mostly pseudoscientific or vitalistic. There is no evidence for or against it in veterinary species, apart from unreliable anecdotes. There is no controlled clinical research in humans showing a benefit, though uncontrolled trials with high risk of bias appear to show some effects. And there is no evidence concerning the safety of the practice. A classic case of a therapy made up out of thin air by a lone “visionary,” the claims for which must be taken entirely on faith.

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CAM and Prostate Cancer: Study Findes no Effect on Outcome or Patient Satisfaction

The subject I focus on most often when discussing the value of CAM therapies is whether or not they are safe and effective. That is, do they generate a measurable improvement in objective measures of illness with acceptable side effects? Of course, they may make the patient feel better without actually being any better physically (e.g. this asthma study), through placebo effects of various kinds. One could argue that is a meaningful benefit, however it also represents a risk. Mistakenly believing a therapy is effective when the ritual of giving the therapy is generating the appearance of a benefit without altering the disease in the patient’s body can lead to inappropriate use of potentially harmful therapies and avoidance of truly effective treatments.

An issue that I don’t often address is the question of whether or not patients (or in the veterinary context, clients) are satisfied with the care they receive. This is an important concern, particularly since poor patient satisfaction is probably one of the factors driving people to seek CAM therapies regardless of the evidence concerning their safety and efficacy. It might be that would be less likely to seek unproven or bogus therapies in addition to, or in lieu of, science-based medicine if conventional medicine could do a better job of helping people cope with their disease.

There are efforts to do this, under the label of “patient-centered care,” though there are also efforts to turn this movement into a Trojan horse for providing unproven therapies just because patients sometimes want them. However, the assumption is often made that CAM generally makes patients happier than conventional care, and I’ll admit I am often inclined to believe this is true. But this impression is not based on much evidence, so I’m always keeping an eye out for research that addresses the question of whether or not patients using CAM are more satisfied with their care than patients who are not.

I recently ran across an article that addresses both the issue of CAM efficacy and of patient satisfaction with CAM treatment.

Scott D. Ramsey, Steven B. Zeliadt, Catherine R. Fedorenko, Megan E. Fairweather, Cara L. McDermott, David F. Penson, Stephen K. Van Den Eeden, Ann S. Hamilton, Neeraj K. Arora. Complementary and Alternative Medicine Use, Patient-reported Outcomes, and Treatment Satisfaction Among Men With Localized Prostate Cancer. Urology. 2012; 79(5):1034–1041.

The study recruited men newly diagnosed with prostate cancer in California and Washington state and surveyed them about CAM use and about their satisfaction with their treatment at diagnosis and 6 months later. The survey also evaluated patients’ functional outcome after treatment. These data were then analyzed to determine the variables that were associated with functional outcomes and patient satisfaction.

One problem that arises in surveys of CAM is defining what constitutes CAM. In other surveys (e.g. 1, 2), CAM use appears much higher when one counts practices that are not always properly understood as medical therapies, such as spiritual practices and some nutritional, exercise, or relaxation techniques. In this study, 52% of men reported CAM use when the following interventions were included.

Special diets, such as low fat or mostly vegetarian diet
Herbs or dietary supplements (such as saw palmetto, lycopene supplements, or selenium). High-dose vitamins or mega vitamins (such as vitamin E) (do NOT include 1-a-day multivitamins)
Homeopathy
Movement or physical therapies, such as yoga, tai chi, massage, chiropractic therapy Oriental therapies, such as acupuncture, acupressure, qigong, or shiatsu Mental health counseling or psychotherapy
Personal prayer
Faith healing, laying on of hands, or any other spiritual or religious group experience Mind/body therapies such as guided imagery/visualization, biofeedback, meditation, Relaxation techniques, hypnosis/hypnotherapy, energy healing, therapeutic touch, or music therapy

 

This list illustrates the questionable “big tent” approach to defining CAM. I am a vegetarian, I meditate, and I have occasionally had a massage, but I did not seek any of these as medical treatments, and I would not consider myself as using CAM as a result. Likewise, prayer and psychotherapy hardly seem like activities predominately aimed at treating disease. Though they may have some impact on health, and certainly one’s sense of wellbeing, it is a mistake to lump together nonsense like homeopathy, unproven but plausible therapies, and activities intended to be comforting as if they were all the same thing.

The authors did acknowledge this problem to a certain extent, and they conducted several of their analyses both including and excluding prayer. For example, when prayer was excluded from the definition, only 39% of subjects reported CAM use. I imagine the number would be even lower if psychotherapy, massage, and other such activities that have little to do with most forms of alternative medicine were excluded.

Unsurprisingly, CAM use was not associated with any difference in functional outcomes, such as urinary continence, sexual function, and bowel function. There were clear differences in these variables based on which, if any, conventional therapy was employed.

Perhaps more of a surprise is the finding that CAM use was not associated at all with patient satisfaction. Most men were satisfied with the care they received (78% reported completely or very satisfied), and the variables that seemed most strongly associated with this were measures of the quality of the communication between doctors and patients.

The authors also cite a number of previous studies of CAM use in patients with prostate cancer, which also suggest that the automatic association between CAM and patient satisfaction may not be justified.

For example, Eng et al asked patients with recently diagnosed prostate cancer who used CAM about their perceptions of its effectiveness. More than one half (60%) of the respondents believed they were better or a lot better on measures of energy level, stress, sense of control over disease, and PSA level. The remainder reported that their CAM therapies had no effect or worsened these measures. When asked whether their use of CAM therapies minimized the side effects of conventional treatments, one third of the CAM users (34%) reported improvement, 56% reported no effect, and 10% reported they believed the CAM treatments had made their side effects worse. Ponholzer et al found CAM users reported lower treatment satisfaction, quality of life, and health status than patients who did not use CAM.

Certainly, one study such as this is by no means definitive regarding either the effectiveness of CAM therapies or their impact on patients’ perceptions of their care. But it is one more piece of evidence to consider in evaluating these issues.

 

 

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Evidence-Based Evaluation of Alternative Medicine

This presentation, originally given as a continuing education talk at Kansas State University, discusses the evaluation of alternative medicine, particularly veterinary alternative practices, from a science-based perspective. It is divided into three parts, and these are available both as the narrated videos below and as Powerpoint slide presentations, which can be viewed with or without the narration.

Part 1. Science Works: How We Go Wrong and How Evidence-Based Medicine Can Set Us Right

The first segment illustrates the limitations of unstructured evaluation, such as personal experience, trial and error, and historical traditions, and introduces the principles and techniques of evidence-based medicine.

Part 1 Powerpoint Presentation

 

Part 2. What is Complementary and Alternative Medicine?

The second part of this series investigates the philosophy and ideology of alternative medicine in preparation for applying the principles and techniques of evidence-based medicine to these practices.

Part 2 Powerpoint Presentation

 

Part 3. Apply a Science-Based Approach to Evaluating Specific Alternative Practices

The final part of the presentation applies a systematic science-based evaluation to several examples of alternative medical approaches, incuding Reiki, Homeopathy, and Probiotics.

Part 3 Powerpoint Presentation

 

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Acupuncture Points: Do They Exist?

There are many levels at which one can, and should, evaluate a proposed medical treatment. Certainly, high level and high quality clinical trial research is likely to be the deciding factor for many interventions. But another important thing to look at, especially when interpreting mixed results or generally poor quality clinical trials, is the underlying mechanism proposed for a therapy. If it contradicts well-established science or cannot be convincingly demonstrated to be correct, this raises the bar even higher for clinical research evidence.

When it comes to acupuncture, the clinical research evidence is vast and highly variable in terms of quality and results. Overall, the preponderance of the evidence seems to support the conclusion that acupuncture is not superior to placebo treatment and exerts very broad, non-specific physiological effects indistinguishable from other kinds of mild traumatic or irritating stimulation (e.g. 1, 2, 3).

One way to help decide whether extensive further efforts to sort out potential clinical benefits of acupuncture through expensive and laborious clinical trials is to look at the potential justifications for why the practice might or might not be helpful. Obviously, anecdotes and testimonials are the primary reason people believe in the usefulness of acupuncture despite the lack of strong support from clinical research. However, these are only useful in generating hypotheses in medicine, not in proving or disproving them. Every therapy every used has been able to claim anecdotal evidence of an effect, and since it’s clear that many therapies turn out not to actually work when objectively studied, reliance on anecdotal evidence is a big mistake.

There are a couple of ways to approach the theoretical explanation of possible mechanisms for acupuncture. The traditional explanations are purely vitalistic. Mystical life energy (Ch’i) that is undetectable by scientific means, explanations about balancing non-physical, spiritual concepts such as Yin and Yang, metaphorical explanations involving Heat, Cold, Damp, Wind and so on are all part of the theoretical structure many practitioners use to explain and justify so-called Traditional Chinese Medicine, including acupuncture. These explanations are part religion, part folklore, and no scientific examination suggests they have any physical reality or any relevance to health and disease as it is understood in scientific medicine. Employing such explanations makes one’s practice essentially a religious rather than a medical one.

However, other acupuncture advocates claim a solidly scientific explanation for the proposed effects of acupuncture, involving identifiable anatomic structures, such as nerves, biochemical effects involving substances naturally produced in the body, and so on. This is a more promising theoretical approach, but despite some effort, there is not yet a consistent and convincing body of evidence to validate the clinical practice of inserting needles in specific locations (with or without twirling them, burning herbs on them, passing electrical current through them, and all the other varieties of acupuncture seen) in order to effect health. Putting needles in animals undoubtedly has some measurable physiological effects. But whether these are specific, predictable, controllable effects that have a meaningful impact on health is not established.

One question that has been investigated many times is whether the supposed acupuncture points, specific locations on the body where insertion of needles is proposed to have a particular effect, can be consistently identified by acupuncturists or associated with identifiable anatomic structures.  Even among those who believe acupuncture to be clinically useful, there is controversy about whether specific locations for needle insertion are real or necessary (e.g. 3), and of course some acupuncturists argue that acupuncture points do not need to correspond to identifiable anatomic or functional locations since they follow the vitalist model in which the focus of acupuncture is on the Ch’i rather than the body per se.

There are some scientific papers that purport to identify real structures or other measurable characteristics at some traditionally used acupuncture points. Many of these reports come from China, where negative studies about acupuncture (or other alternative therapies) are almost never published, so the potential for bias in this source has to be considered. A review of the literature presented at the 2000 meeting of the American Association of Equine Practitioners by veterinarian David Ramey found no consistent body of scientific evidence to support the notion of specific identifiable functional or anatomic acupuncture points. A recent paper seems to add support to this conclusion.

A.F. Molsberger, J. Manickavasagan, H.H. Abholz, W.B. Maixner, H.G. Endres. Acupuncture points are large fields: The fuzziness of acupuncture point localization by doctors in practice. Eur J Pain. 2012 Apr 10 [Epub ahead of print]

This study took the approach of testing whether properly trained and experienced acupuncturists could consistently identify commonly used acupuncture points on a single patient. Twenty-three common points were selected and identified by the 71 test subjects. The area within which specific points were identified by 95% of the acupuncturists ranged from 2.7cm in diameter to 41.4cm in diameter.  Because of the variability with which experienced acupuncturists identified common acupuncture points, the authors concluded that to stimulate fake points as a placebo control for a clinical trial, it would be best to stimulate the skin at least 6cm away from the spot identified as the real point on the face or hands and at least 12cm away from a proposed real spot anywhere else on the body.

Of course, the authors are acupuncturists and so must find a way to interpret these results that is supportive of acupuncture as a therapy. Their conclusion is that it would be more meaningful to talk about “acupuncture fields” rather than acupuncture “points.” Since the variance in the size of the area within which supposed points were identified was not associated with the experience or training of the doctor, and could not have been associated with individual differences between patients since the same patient was examined by all the doctors, it seems more reasonable to interpret the results as indicating that no specific locations associated with traditional acupuncture points can be reliably identified even by trained acupuncturists. Likely, such points don’t exist as anatomical or functional entities, especially given the lack of convincing and consistent evidence for their existence despite decades of study.

This by itself does not invalidate acupuncture as a clinical practice. However, it has bearing on the study and evaluation of acupuncture. Many studies using supposed “sham” acupuncture points may now be reinterpreted. Acupuncturists will likely interpret these results to mean that the lack of difference between effects in groups where “real” acupuncture points were used and those in which “sham” points were used is actually due to the fact that both groups benefitted from stimulation in the same “acupuncture fields.” Skeptics like myself are more likely to view this as indicating that “sham” acupuncture points are not a legitimate placebo control since specific acupuncture points can’t even be shown to exist, and so trials comparing real and fake points are simply poorly controlled. In any case, it suggests that if the central tenet of most acupuncture treatment, stimulation of the body in specific locations, is invalid because even acupuncturists don’t know where these locations are, then the concept of acupuncture as a meaningful therapy is even less convincing.

Posted in Acupuncture | 3 Comments

More Misleading and Unethical Advertising for Alternative Veterinary Medicine

I’ve written before about the unethical and misleading negative advertising that so often characterizes the promotion of alternative veterinary medicine. But I ran across another example that set my teeth on edge and illustrated a particular problem I have with this kind of thing.

Dr. Karen Becker, a prominent CAVM vet who writes for one of the most notorious sites promoting quackery through denigrating conventional medicine, Mercola.com, recently blogged about the much-reported decline in veterinary office visits. In this article, she makes a number of assumptions for which there is little or no evidence, and several accusations about the inadequacy of conventional veterinary care.

The accusations essentially amount to saying that conventional medicine ignores preventative care apart from given vaccinations and selling pest-control products, both of which Dr. Becker frequently cites as significant health hazards for our pets.

Perhaps a reason for fewer vet visits is the new canine vaccination guidelines which will hopefully put an end to the dangerous and unnecessary practice of yearly re-vaccinations.

I suspect another reason (aside from today’s tough economic climate), is because many traditionally trained DVMs practice ‘reactive’ veterinary medicine.

This means they don’t have much to offer pets unless and until they’re good and sick…

…preventive medical care in the mainstream veterinary community has evolved to mean not much more than yearly vaccines and chemicals to discourage pests and parasites like fleas, ticks and heartworm.

There is rarely discussion between vets and pet owners about nutrition (because vet students receive almost no education in the subject), exercise and other physical therapies, or the importance of a strong, resilient and balanced immune system.

This also raises the cliché about conventional veterinarians being ignorant in the area of nutrition, which is nonsense. The definition of ignorance most likely meant here, is simply a failure to agree with specific theories about what constitutes a healthy diet, including the unsubstantiated beliefs often promoted about the benefits of raw diets, the dangers of grains, and so on.

This then leads to the suggestion that alternative veterinarians do a better job of preventative care, because they promote “wellness” therapies.

For some reason the methods used to maintain a pet’s vibrant good health – everything from species-appropriate nutrition to maintenance chiropractic care to homeopathic remedies and herbal supplements – fall into the category of ‘alternative medicine.’

Isn’t it strange that natural modalities used not to cure illness (although they do that, too), but to maintain health are thought of as ‘alternative,’ yet chemical drugs and invasive surgery are considered mainstream health care?

Actually, it isn’t strange at all. There is no reliable scientific evidence for the preventative health benefits of maintenance chiropractic care, homeopathic remedies or herbal supplements. These products are touted as “wellness” care based solely on the personal beliefs of the vets who use them and the beliefs of previous generations of vets and animal owners. This is the same level of evidence that has supported such winning strategies as bloodletting, purging, and animal sacrifice as preventative health measures.

What is strange is that someone with medical training can so blithely denigrate preventative and therapeutic methods proven to work and wonder at the failure of mainstream medicine to accept without proof her belief that these alternative therapies are better.

I recommend twice yearly wellness examinations to my Natural Pet clients.

A thorough nose-to-tail professional checkup every six months is the best way for you and your vet to detect and stay on top of any changes in your pet’s health. This is especially true for older pets.

This is undoubtedly great for the bottom line, but again there is no evidence that biannual or annual wellness examinations recommended for all pets is an effective or efficient strategy for preventing disease or extending length and quality of life. In humans, the evidence in fact is building against the value of annual exams for well people. There is no evidence either way in veterinary medicine, so while I myself think it likely that regular examinations could have some benefit, there is no objective reason for a strong recommendation of this kind. And certainly such visits are not a substitute for the “chemical drugs” and vaccinations that have been far more effective than any other measure and reducing disease and preserving health in our companion animals.

…Proactive vets are typically obsessive about clinical pathology…most proactive vets recommend annual vector borne disease testing instead of waiting until lyme disease has set in, causing incurable auto-immune polyarthritis.

This is a completely irrational and baseless recommendation. Screening tests without an appropriate reason for doing them waste money and cause far more harm than they prevent. There is a strong movement in human medicine now to reduce exactly this kind of misguided thinking. So to imply that the care such alternative vets provide is superior to that of conventional veterinarians because the former recommend unproven preventative measures and unnecessary testing is misleading and unethical. Given the complaints so often made by CAM vets about the purported financial motivation behind many mainstream practices, it is quite ironic that this sort of advertising promotes far more aggressive, and likely expensive, use of approaches with no proven value.

 

 

 

 

Posted in General | 47 Comments

Credulous, Superficial Media Coverage of Veterinary Alternative Medicine

The media loves to run cute human interest pieces on alternative medicine for animals. Reporters are seldom interested in the complexities or nuance of the evidence, but they love the warm, fuzzy, and slightly humorous image of alternative medicine applied to pets. In the name of “balance,” they usually include a quote from a token skeptic, though this is generally buried in an avalanche of quotes from CAM supporters, and often is edited and positioned to seem as unconvincing and unsympathetic as possible.

More and more often, I’m being asked to be that token skeptic. It’s not a very satisfying role, since the chances are slim of seeing a final article that reflects the reality of veterinary CAM as a marginalized practice with little convincing scientific evidence behind it. Still, presumably having even a sanitized token skeptical voice in these pieces is better than having none. Right? Hmm, well I hope so anyway.

Here are a couple of examples.

This piece from New York Magazine, preciously titled Dogupuncture, includes 4 positive quotes, 1 negative quote, and a graphic right up front purporting to show the rising popularity of acupuncture among vets. Out of all that I have written about acupuncture, the quote chosen was the conclusion from a systematic review which concluded there was insufficient evidence to reach a conclusion!

I have added a comment to give at least a bit of a response to some of the inaccurate implications of the pices, but that will likely only draw more angry responses from “satisfied customers” of veterinary acupuncture, rather than start a substantive discussion of the evidence.

The claim of ancient veterinary acupuncture is false: http://skeptvet.com/Blog/2010/07/the-history-of-ve… And it’s irrelevant anyway since bloodletting and slavery have been around as long or longer, and that doesn’t make them good ideas.

Even though animals don’t have beliefs about their care, there are absolutely placebo effects in veterinary care. The simplest is the Placebo by Proxy, in which the owner or vet thinks the pet is better because they want or expect it to be, and after all they are the ones who decide if the pet looks like it feels better. There is also Regression to the Mean, the Hawthorne Effect, Classical Conditions, Non-Specific Effects of Human Contact and many other factors that make bogus therapies look like they work.

Even in humans, acupuncture has not been shown to be more effective than fake acupuncture, and the evidence is even weaker in animals. (http://skeptvet.com/Blog/category/acupuncture/)

The bottom line is that belief in acupuncture, the popularity of acupuncture, and the length of time people having beein using acupuncture are all meaningless in terms of deciding whether or not it is useful. And despite decades or trying and a huge number of studies, scientific evidence still hasn’t shown it to be any better than placebo in controlled trials.  So the strength of the evidence for acupuncture is no better than that for faith healing, psychics, bloodletting, and lots of other healthcare practices that lots of people have believed in for a long time.

Unfortunately (for our pets), these things last because we so easily fool ourselves, and unreliable personal experiences are far more compelling emotionally than scientific data.

I’ve written previously about a Veterinary Practice News article on the Academy of Veterinary Homeopathy lawsuit against the American Association of Veterinary State Boards. It too is an example of a clearly one-sided piece with a token skeptic selectively cited in order to portray the skeptic position as weakly as possible.

The Veterinary Practice News reported on this lawsuit in early August. In a roughly 2000 word article, the author extensively quoted five supporters of homeopathy and of the lawsuit. She also quoted an official at the AAVSB who was not free to comment on pending litigation. And finally, she interviewed me for the article as the sole critic of the AVH position.

I was quoted as saying that homeopathy was not a science-based intervention, which is accurate. I was also quoted as saying that, “Alternative medicine providers are often better at treating psychological aspects of a medical incident an owner is dealing with, and there’s no doubt they are caring and compassionate…”This is partially correct in that I did acknowledge that alternative practitioners are undoubtedly as caring and compassionate as other veterinarians, but it misrepresents the point I was making that the reason methods like homeopathy are popular with a small percentage of the pet-owning public is not because they actually work but because of the psychological effects, essentially a placebo-by-proxy, that the interaction with the practitioner has on the owner.

Lastly, I was quoted as saying that, “these therapies are not taught in veterinary schools.” This is followed by a “gotcha” list of veterinary schools that offer elective courses in “integrative medicine” or have “holistic medicine” student organizations. This is clearly intended to undermine the credibility of my comments. However, this is again a manipulative misrepresentation of my position.

Homeopathy is clearly not part of the core veterinary curriculum, nor is it generally accepted as a valid approach to medicine at U.S. veterinary colleges. The AVH does not dispute this in their complaint. And of the four veterinary schools (out of 28 in the U.S.) mentioned in the article as having “elective courses in CAVM or integrative veterinary medicine,” I could not find any that actually do have a course in homeopathy, though CSU does offer an elective called “Critical Overview of Complementary and Alternative Medicine” taught by Narda Robinson, who is a vocal critic of homeopathy. It is possible, of course, that a couple of schools do have credulous individuals on faculty who teach that homeopathy is scientifically legitimate, but if so these represent a rare minority opinion which is discounted by the overwhelming majority of veterinary scientists. The article was a barely disguised propaganda piece for the AVH position with only a superficial nod towards the idea of journalistic neutrality.

There are a few other similar pieces I’ve been involved with that haven’t come out yet, but only one that I expect may be of higher quality than the usual sort like these.

Perhaps it’s the intrinsic character of the subject matter. Alternative medicine presents a simplistic and comforting face, and science is naturally complicated, ambiguous, and seemingly hypercritical. Or perhaps it’s the declining number of well-trained reporters specializing in science-journalism. After all, most veterinary stories appear in the Lifestyle section of magazines and newspapers, where the standards are lower than in the science, health, or news sections. In any case, as long as even a token skeptical voice is included, perhaps this will at least offer some comfort to those who value the messy truth over a good story.

Posted in General | 8 Comments