American Academy of Orthropaedic Surgeons Evidence-Based Review of Arthritis Treatments

I have previously reviewed a number of common alternative therapies for arthritis. The evidence concerning veterinary use specifically is often limited, but for common therapies, like glucosamine and acupuncture, there is often extensive research data in humans. While extrapolation from one species to another should always be viewed with caution, if something is shown by extensive evidence to be useless in humans, this is reason to be skeptical about its value for our pets.

Harriet Hall, at Science-Based Medicine, has recently reported on an extensive evidence review of arthritis therapies published by the American Academy of Orthopedic Surgeons (AAOS).  This review evaluates common therapies, both conventional and alternative, and reinforces the conclusions I have previously come to regarding several of these. In particular, the evidence is clear and strong against the value of both glucosamine and acupuncture. And lest advocates of these immediately assume these conclusions are simply evidence of bias in favor of surgery, since the review was conducted by an organization of surgeons, I will point out that the report is equally critical of conventional surgical treatments that clearly don’t work either. They even cast doubt on the most common pharmaceutical therapy used, simply following where the evidence leads.

While this review by itself is not, of course, the sole and final word on any subject, it is part of a consistent and continually growing body of evidence which shows that several commonly recommended arthritis therapies simply do not work. At some point, hope and the placebo effect will have to give way to reality and we will have to start redirecting our resources away from studying and using such worthless treatments and into more promising therapies.

 

  1. Exercise – strong evidence for effectiveness
  2. Weight loss – moderate evidence for
  3. Acupuncture – strong evidence against
  4. Physical agents (TENS, ultrasound, etc.) – inconclusive
  5. Manual therapy (chiropractic, massage) – inconclusive
  6. Valgus-directing force brace – inconclusive
  7. Lateral wedge insoles – moderate evidence against
  8. Glucosamine and chondroitin – strong evidence against
  9. NSAIDs – strong evidence for
  10. Acetaminophen, opioids, pain patches – inconclusive (this is particularly interesting since acetaminophen is the standard first-choice drug)       
  11. Intraarticular corticosteroid injections – inconclusive
  12. Hyaluronic acid injections – strong evidence against (and if injections are ineffective, those oral diet supplements certainly don’t have a chance)
  13. Growth factor injections and/or platelet-rich plasma – inconclusive
  14. Needle lavage – moderate evidence against
  15. Arthroscopy with lavage and debridement – strong evidence against
  16. Partial meniscectomy in osteoarthritis patients with torn meniscus – inconclusive
  17. Valgus-producing proximal tibial osteotomy – limited evidence
  18. Free-floating interpositional device – no evidence; consensus against

 

Posted in General | 39 Comments

Dental Disease in Dogs and Cats: Does Treatment Improve Health?

A reader recently asked me about the evidence supporting recommended therapy for dental disease in dogs. This is has become a common question given the increasing awareness among pet owners that dental disease is a real and important health problem, and the availability of high quality prophylaxis and treatment.

The American College of Veterinary Dentistry, the organization of board-certified veterinary dental specialists, has a great site with information for pet owners about dental disease. I also find a lot of clear and pretty evidence-based information on the site of Dr. Frasier Hale.

Dental disease is unquestionably common, with some research suggesting it is the most common disease in pet cats and dogs, vying with obesity for the top spot. It primarily takes the form of periodontal disease, and unfortunately it is very difficult to detect or evaluate the severity of this problem in an awake dog. Dogs and cats show few overt symptoms of dental disease. Probing of the tooth sockets and x-rays are necessary, just as they are for humans, to accurately characterize the type and severity of dental disease and determine the appropriate treatment.

Unfortunately, our pets almost never get twice daily brushing and flossing or semi-annual dental cleanings, and they often have very abnormal occlusion (the arrangement and interaction of the teeth in the mouth) as a result of breeding. Toy breed dogs and those with foreshortened faces are at especially high risk of severe dental disease due, in large part, to the same anatomy that makes them appear cute to humans. So proper diagnosis and treatment of dental disease requires general anesthesia, and it is very often necessary to remove infected teeth because the disease is advanced or because the level of care needed to preserve them cannot be accomplished.

Naturally, owners are often anxious or reluctant to pursue care that involves general anesthesia and likely extraction of teeth, due to worries about the safety and comfort of the pet and also due to the high cost of appropriate care. The fact that our pets rarely show recognizable symptoms, even with a level of disease that we know would cause tremendous discomfort in people, also makes it more difficult to convince people that dental care is necessary and beneficial for their pets. While the most obvious reason to pursue this care is that the disease is almost certainly painful, it is sometimes helpful to consider the secondary health risks associated with untreated periodontal disease. I recently took a quick look at the evidence concerning these.

There is pretty strong evidence in humans that untreated periodontal disease is associated with other health problems, notably cardiovascular disease, diabetes, respiratory disease (including infections) and pre-term low-birthweight deliveries. Treatment of periodontal disease leads to clinical improvements in several diseases as well. It is plausible that a similar relationship between dental disease and general health would hold true for cats and dogs, but there is little direct evidence.

At least two studies have identified pathological lesions in specific organs, including the liver, kidneys, and heart (1,2). This demonstrates that periodontal disease is associated with detectable abnormalities in the tissues of these organs. It seems likely that this could also affect the function of these organs and the well-being of the individuals with such lesions, but this was not evaluated  by these studies.

At least one study has taken the next step and evaluated the association between periodontitis and actual disease in another organ system (3). A strong, linear association was identified between dental disease and chronic kidney disease, and while this does not prove dental disease causes kidney disease, it suggests that untreated periodontitis may be an important risk factor for kidney disease in dogs.

A similar study also suggested that periodontal disease may be associated with cardiac disease as well as pathologic lesions in the heart (4). However, there were significant methodological problems with this study, and other investigations have not found a link between dental disease and heart disease in dogs, so there is still controversy about this potential association (5,6).

Finally, one study has looked at common bloodwork variables and measures on inflammation in association with periodontal disease and its treatment (7). A few significant associations were identified, but there was no clear pattern suggesting a causal relationship between periodontitis and any particular disease.

Bottom Line
Dental disease, especially periodontal disease, is very common in dogs and cats. Though affected pets rarely show obvious or severe symptoms, periodontal disease is undoubtedly a source of significant discomfort. The only accurate way to diagnose, characterize, and treat periodontal disease is with a thorough oral examination, dental x-rays, and appropriate cleaning and often extraction or endodontic treatment of infected teeth. This can only be accomplished under general anesthesia.

There is good reason to believe proper prevention and treatment of periodontal disease makes dogs and cats more comfortable. In humans, it is also clear that such prevention and treatment improves health and reduces the risk and severity of other specific diseases. It is likely this is also true in dogs and cats, but the current research evidence regarding this claim is extremely limited.

References

  1. DeBowes LJ, Mosier D, Logan E, Harvey CE, Lowry S, Richardson DC. Association of periodontal disease and histologic lesions in multiple organs from 45 dogs. J Vet Dent 1996; 13:57-60.
  2. Pavlica Z, Petelin M, Juntes P, Eržen D, et al. Periodontal disease burden and pathological changes in organs of dogs. J Vet Dent 2008; 25: 97-105.
  3. Glickman LT, Glickman NW, Moore GE, Lund EM, Lantz GC, Pressler BM. Association between chronic azotemic kidney disease and the severity of periodontal disease in dogs. Prev Vet Med 2011; 99: 193-200.
  4. Glickman LT, Glickman NW, Moore GE, Goldstein GS, Lewis HB. Evaluation of the risk of endocarditis and other cardiovascular events on the basis of the severity of periodontal disease in dogs. J Am Vet Med Assoc 2009; 234: 486-494.
  5. Pavlica Z, Petelin M, Juntes P, Erzen D, Crossley DA, Skaleric U. Periodontal disease burden and pathological changes in organs of dogs. J Vet Dent. 2008 Jun;25(2):97-105.

  6. Peddle GD, Drobatz KJ, Harvey CE, Adams A, Sleeper MM. Association of periodontal disease, oral procedures, and other clinical findings with bacterial endocarditis in dogs. J Am Vet Med Assoc. 2009 Jan 1;234(1):100-7.
     
  7. Rawlinson JE, Goldstein RE, Reiter AM, Attwater DZ, Harvey CE. Association of periodontal disease with systemic health indices in dogs and the systemic response to treatment of periodontal disease. J Am Vet Med Assoc 2011; 238: 601-609.
Posted in Science-Based Veterinary Medicine | 41 Comments

Canine Health from LifeVantage–Protandim by Any Other Name & Still No Real Evidence

I was recently asked to comment on yet another “kitchen sink” mélange of herbs and supplements promoted w/ claims of broad benefits for dogs: Canine Health from LifeVantage. This proved easier than I had expected since the product is identical to Protandim, except for a couple of additional ingredients.

You may recall that Protandim is a supplement which I have reviewed previously (1), and which Dr. Harriet Hall has discussed at Science-Based Medicine several times (2,3,4). The theoretical justification for the product rests on the supposed anti-oxidant and anti-inflammatory properties of the ingredients. None of the ingredients have well-demonstrated benefits or clear evidence that there is negligible risk in using them, though several have interesting properties that warrant further study. It would not at all surprise me if compounds derived from some of these ingredients turned out to have therapeutic value, but that is a far cry from justifying the kind of claims made for this product.

In any case, there is growing doubt about the hypothesis that oxidative damage is a significant cause of many disorders or that anti-oxidants are necessarily safe and beneficial (5,6). And all well-studied anti-inflammatory medications have significant potential risks as well as benefits, so it is almost certain the same would be true for compounds like those in Protandim if these turned out to have significant anti-inflammatory effects.

Of course, it doesn’t appear that scientific research and evidence is necessarily the primary concern for the founder of the company that sells Protandim, based on his own explanation for why he has discovered a miraculous remedy the scientific community has overlooked:

I already mentioned this in Entry #1: Motivations, but it bears repeating here. All the details you’re about to read concerning the development of Protandim mean nothing – absolutely nothing at all – without acknowledging that God used me as a vessel in brining Protandim to fruition. For almost 35 years scientists were looking for this tool after Dr. Joe McCord and Dr. Irwin Fridovich discovered Superoxide Dismutase (SOD) in 1969. For almost 35 years the pharmaceutical industry failed. For almost 35 years the nutraceutical industry failed.

Then God intervened . . . and has taken us on this unlikely, exciting journey.

The bottom line for this supplement hasn’t changed since my original review:

The underlying theory used to promote this product, that anti-inflammatory and anti-oxidant effects are always safe and beneficial, is highly doubtful. There is only weak in vitro and animal model research to indicate that the ingredients in Protandim, or the combination product, have potentially useful effects on cells or biochemical markers. There is absolutely no clinical trial evidence to indicate Protandim has any of the claimed benefits in humans or animals. While the absence of evidence is not proof the product is unsafe or ineffective, it is absolutely a reason to be skeptical of wild claims of miraculous benefits. At best, using this product is simply rolling the dice and hoping for the best.

Like Protandim, CanineHealth is said to prevent or improve a wide range of seemingly unrelated conditions, including problems in the joints, brain, heart, and eyes. It is purported to do so by reducing “oxidative stress.” The difference between the two products is the inclusion in Canine Health of omega-3 fatty acids” and “Type II chicken sternum collagen.” As with Protandim, no details or dosages of these ingredients is disclosed.

The most common source of omega-3 fatty acid supplements is fish oils. There is good evidence that these can improve symptoms of allergic skin disease (7), some weak evidence suggesting a benefit for arthritis treatment (8,9). It has been suggested that their inclusion in diets can improve signs of dementia in dogs, but the mmore specific evidence in human isn’t very supportive(10, 11). It isn’t clear if fish oil is even the source of essential fatty acids in Canine Health, but if it is it has only weak evidence to suggest a benefit, and there is no reason to mix it with all of the other untested stuff in the product.

With regard to Type II Collagen, despite a number of studies there is insufficient evidence to support any benefit of this supplement as a treatment of arthritis in humans (12, 13). There is also no convincing evidence supporting use in dogs.

As for the product itself, the company claims to have paid another organization to conduct a double-blind, placebo controlled clinical study showing “a reduction in oxidative stress, improvement in mobility and improved cognitive function.” Naturally, the results of this study have not been published and the details are not available to the public, so we have to take LifeVantage’s word for the results.

So we have another catchall, anti-oxidant based mixture of herbs and supplements claimed to have wide-ranging benefits but with no convincing scientific evidence supporting these claims. Numerous red flags of quackery are present, and there is heavy reliance on testimonials and celebrity endorsement rather than scientific research to promote the product. None of this is definitive proof that it doesn’t have some or all of the miraculous benefits claimed, only that there is currently no good reason to believe it does. Yet another roll of the dice with our pets’ health.

 

 

 

 

 

 

 

 

Posted in Herbs and Supplements | 70 Comments

Hyperbaric Oxygen Therapy for Pets–What’s The Evidence?

I recently participated in a couple of discussions on a veterinary web forum about hyperbaric oxygen therapy (HBOT) and evidence-based medicine. This technique is being heavily promoted with confident claims of scientifically proven benefits.  I thought, then, that I would take a look at the evidence.

What Is It?
Hyperbaric oxygen therapy involves placing patients in an airtight chamber and raising the atmospheric pressure and oxygen level so that oxygen is dissolved in the blood and delivered to tissues at higher levels than possible in normal atmospheric conditions. It is the treatment of choice for decompression sickness (The Bends) associated with SCUBA diving, but it is also recommended for numerous other medical indications. The Undersea and Hyperbaric Medical Society list 14 indications for which they consider the evidence sufficient to recommend HBOT.

What’s the Evidence?
When pressed, advocates acknowledged that there is virtually no clinical trial data in companion animal or food animal species to support HBOT for specific indications. This should automatically make any recommendations of HBOT tentative at best, and the therapy should essentially be considered experimental.

There is a large amount of in vitro and animal model research suggesting potential benefits of HBOT for a wide range of conditions, and proponents cite this as justification for putting HBOT chambers in veterinary practices and treating patients. Certainly, this evidence suggests HBOT is plausible and worth investigating. I have heard wacky theories for why HBOT should work (one vet once told me it was so successful because it recreated the state of the Earth’s atmosphere before the Biblical flood, when people lived hundreds of years). However, there are sound physiological rationales for the concept supported by good preclinical evidence.

Unfortunately, such pre-clinical research also has significant limitations and is often not consistent with the results of subsequent clinical trials for many therapies. It is necessary but not sufficient for making clinical decisions, and it is primarily intended to suggest that a new therapy is plausible and might work, not to prove that it does work in the real world. We often have to make the best of a bad business and rely on such evidence when there is nothing better, but any recommendations based purely on pre-clinical research must be made cautiously and with appropriate caveats, something HBOT advocates rarely do.

Most of the animal model studies are in rats, mice, and, to a lesser extent, guinea pigs and rabbits. There are a few experimental studies in dogs, cats, and horses (see Veterinary Studies  below). Most of these involve wounds or skin flaps and grafts, and they are by no means universally positive.

Another source evidence frequently used in veterinary medicine when there are no good veterinary studies is clinical trial data from humans. There is significant risk in extrapolation across species lines, but it is an inevitable and important part of veterinary medicine given the reality of limited resources to support target-species clinical trial research. One advocate of HBOT claims that we can have confidence in the value of HBOT because there are many controlled studies in the human literature showing the benefits of hyperbaric oxygen therapy for many conditions.

One outstanding review of the evidence for wound care, tissue trauma, and neurological disease, commissioned for the Washington State Health Care Authority, has recently been published.

It identifies moderate quality evidence to support the use of HBOT for aiding the healing of chronic wounds in diabetics, late radiation tissue injury, multiple sclerosis symptoms, and possibly in affecting mortality (though not long-term function) in traumatic brain injury. The evidence is of poor quality and inconclusive or not supportive for most other indications evaluated.

I have also taken a quick look at other systematic reviews of HBOT (primarily produced by the Cochrane Collaboration, though there are several from other sources) for the last 5 years. This is the most reliable assessment of the balance of the human clinical trial evidence, and it establishes what degree of confidence we should or should not have in the use of HBOT for specific problems (in humans, of course; again direct extrapolation to veterinary patients often changes the picture significantly)

These reviews are listed below. Again, they provide pretty good (though not always strong or consistent) support for adjunctive use of HBOT in treating wounds (in humans, of course). The evidence is fair to poor for other indications.

Is It Safe?
There is little data on the safety of HBOT in companion animals. One protocol was studied in 3 dogs in Japan and appeared to achieve oxygenation targets without obvious side effects.

(Hiroki YANAGISAWA, Eiichi KANAI, Hideki KAYANUMA, Takuo SHIDA, Tsunenori SUGANUMA. Hyperbaric Air Therapy in Dogs for Clinical Veterinary Medicine: A Basic Study. J. Vet. Med. Sci. 73(10): 1351–1354, 2011). However, there is really very little controlled data on possible risks in most companion animal species.

 

The Washington State review provides a nice evaluation of safety data (again in humans) for HBOT, which suggests that it is generally pretty safe but that there are common minor side effects and less common serious side effects.

 

The overall evidence suggests that harms associated with HBOT are generally mild and self-limiting. The majority of reported harms include barotrauma, temporary visual disturbances, and, more rarely, oxygen toxicity. Occasional reports of seizures represent the most serious side effects. The Medical Services Advisory Committee (MSAC) of Australia reported an overall harms incidence rate of 6.3%; 17% incidence of general pain or discomfort during decompression; 4.8% incidence of ear pain; 1.5% incidence of tympanostomy tube placements; 0.9% incidence of persistent ocular changes; 0.6% incidence of ear barotrauma; 0.34% incidence of abdominal pain; and 0.1% incidence of claustrophobia.

Notable indication-specific harms found in the literature include the following:

 ·         Among patients with LRTI, there were reports of ear pain (16% in a trial of 150 patients), transient myopia (3% in one study 8% in another), and confinement anxiety (1.7%).

 ·         Pooled data from 2 trials reported severe pulmonary complications (defined as either, rising oxygen requirements and infiltrates in chest x-ray or cyanosis and hyperpnoea so severe as to imply “impending hyperoxic pneumonia”) among 13% of TBI patients receiving HBOT compared with none in the control groups (RR, 15.57; 95% CI, 2.11-114.72).

 ·         One study reported ear problems among 47% of children with cerebral palsy receiving HBOT versus 22% among controls (P significant but value not reported). Another study reported a 12% seizure rate and found that 35% of patients reported ear problems.

 ·         Another reported that 8% of 50 children stopped treatment due to adverse events, including seizures, and one other study reported 1 seizure in an observational study of 230 patients. 

·         Among patients with MS, a 2011 Cochrane Collaboration review reported 77 patients (55%), across 4 trials, suffered temporary deterioration in visual acuity in the HBOT group versus 3 patients (2.3%) in the sham group (OR, 24.87; 95% CI, 1.44-428.5; NNT, 1; 95% CI, 1-2).

Of course, the most dramatic risk seen in veterinary use of HBOT is the catastrophic explosion of the oxygen chamber. This happened in Florida last year, and both the patient and one of the veterinary staff were killed. While this is clearly a problem with the administration of HBOT, not the technique itself, it is a risk that has to be factored in to any assessment of the pros and cons of the practice.

 

Bottom Line
HBOT is a biologically plausible therapy with substantial in vitro and animal model research to support possible benefits in a variety of conditions. There is, however, almost no clinical trial evidence to support its use in companion animal species. Justification of veterinary use of HBOT comes only from extrapolation from basic principles, pre-clinical research, anecdote, and extrapolation from research in humans, so this should be viewed as an unproven, experimental veterinary therapy.

There are a few indications for which the human clinical trial research provides at least a moderate degree of confidence that HBOT is effective. There are many others for which there is only limited and low-quality evidence and no clear conclusion can be drawn. Not all uses validated in humans are relevant to veterinary use, and most veterinary applications have not been directly studied in people. Overall, the evidence is strongest for adjunctive use of HBOT to facilitate healing of chronic wounds not resolving with standard therapies.

HBOT is generally quite safe, but there are both minor and serious potential adverse effects, and there is some risk associated with the use of the equipment.

Everyone will interpret this evidence differently in light of their own understanding of how research evidence should be integrated into clinical decision making. For my part, it suggests to me that HBOT is a promising therapy for a variety of indications but not clearly demonstrated effective for very many even in humans, and the veterinary evidence is too weak to be very useful in making recommendations. I would certainly like to see more and better research evidence before there is widespread use of this technique.

Companion Animal Studies

1.      Baumwart, C. A.Doherty, T. J.Schumacher, J.Willis, R. S.Adair, H. S., IIIRohrbach, B. W. Effects of hyperbaric oxygen treatment on horses with experimentally induced endotoxemia. American Journal of Veterinary Research. 2011 72 9 1266-1275

Objective – To determine the effectiveness of preinduction hyperbaric oxygen treatment (HBOT) in ameliorating signs of experimentally induced endotoxemia in horses. Animals – 18 healthy adult horses. Procedures – Horses were randomly assigned to 1 of 3 equal-sized treatment groups to receive normobaric ambient air and lipopolysaccharide (LPS), HBOT and LPS, or HBOT and physiologic saline (0.9% NaCl) solution. Horses were physically examined, and blood was obtained for a CBC and to determine concentration or activity of plasma tissue necrosis factor-?, blood lactate, and blood glucose before the horses were treated with HBOT and then intermittently for 6 hours after administration of LPS or physiologic saline solution. Results – All LPS-treated horses developed signs and biochemical and hematologic changes consistent with endotoxemia. Treatment with HBOT significantly ameliorated the effect of LPS on clinical endotoxemia score but did not significantly improve other abnormalities associated with endotoxemia. Conclusions and Clinical Relevance – The protective effect of HBOT was minimal, and results did not support its use as a treatment for horses prior to development of endotoxemia.

2.      Holder, T. E. C.Schumacher, J.Donnell, R. L.Rohrbach, B. W.Adair, H. S. A. Effects of hyperbaric oxygen on full-thickness meshed sheet skin grafts applied to fresh and granulating wounds in horses. American Journal of Veterinary Research. 2008 69 1 144-147

Objective – To determine the effects of hyperbaric oxygen therapy (HBOT) on full-thickness skin grafts applied to fresh and granulating wounds of horses. Animals – 6 horses. Procedures – On day 0, two 4-cm-diameter circular sections of full-thickness skin were removed from each of 2 randomly selected limbs of each horse, and two 4-cm-diameter circular skin grafts were harvested from the pectoral region. A skin graft was applied to 1 randomly selected wound on each limb, leaving the 2 nongrafted wounds to heal by second intention. On day 7, 2 grafts were harvested from the pectoral region and applied to the granulating wounds, and wounds grafted on day 0 were biopsied. On day 14, 1 wound was created on each of the 2 unwounded limbs, and the wounds that were grafted on day 7 were biopsied. All 4 ungrafted wounds (ie, 2 fresh wounds and 2 wounds with 1-week-old granulation beds) were grafted. The horses then received HBOT for 1 hour daily at 23 PSI for 7 days. On day 21, the grafts applied on day 14 were biopsied. Results – Histologic examination of biopsy specimens revealed that grafts treated with HBOT developed less granulation tissue, edema, and neovascularization, but more inflammation. The superficial portion of the graft was also less viable than the superficial portion of those not treated with HBOT. Conclusions and Clinical Relevance – The use of HBOT after full-thickness skin grafting of uncompromised fresh and granulating wounds of horses is not indicated.

3.      Kerwin, S. C.Lewis, D. D.Elkins, A. D.Oliver, J. L.Hosgood, G.Pechman, R. D., Jr.Dial, S. L.Strain, G. M. Effect of hyperbaric oxygen treatment on incorporation of an autogenous cancellous bone graft in a nonunion diaphyseal ulnar defect in cats. American Journal of Veterinary Research. 2000 61 6 691-698

12 mature cats were used to determine whether hyperbaric oxygen treatment (HBOT) would affect incorporation of an autogenous cancellous bone graft in diaphyseal ulnar defects. Bilateral non-union diaphyseal ulnar defects were created in each cat. An autogenous cancellous bone graft was implanted in 1 ulnar defect in each cat, with the contralateral ulnar defect serving as a non-grafted specimen. Six cats were treated by use of hyperbaric oxygen at 2 atmospheres absolute for 90 min once daily for 14 days, and 6 cats were not treated (control group). Bone labelling was performed, using fluorochrome markers. Cats were killed 5 weeks after implanting, and barium sulfate was infused to evaluate vascularization of grafts. Ulnas were evaluated by use of radiography, microangiography, histological examination, and histomorphometric examination. Radiographic scores did not differ between treatment groups. Microangiographic appearance of grafted defects was similar between groups, with all having adequate vascularization. Differences were not observed between treated and non-treated groups in the overall histological appearance of decalcified samples of tissue in grafted defects. Mean distance between fluorescent labels was significantly greater in cats given HBOT than in non-treated cats. Median percentage of bone formation in grafted defects was significantly greater in cats given HBOT. Hyperbaric oxygen treatment increased the distance between fluorescent labels and percentage of bone formation when incorporating autogenous cancellous bone grafts in induced non-union diaphyseal ulnar defects in cats, but HBOT did not affect revascularization, radiographic appearance or qualitative histological appearance of the grafts.

4.      Hosgood, G.Hodgin, E. C.Strain, G. M.Lopez, M. K.Lewis, D. D. Effect of deferoxamine and hyperbaric oxygen on free, autogenous, full-thickness skin grafts in dogs. American Journal of Veterinary Research. 1995 56 2 241-247

Free, autogenous, full thickness skin grafts were applied to 10 dogs; 5 dogs were given an iron chelator, deferoxamine 10% hydroxyethyl pentafraction starch (DEF-HES; 50 mg/kg of body weight,i.v.), and 5 dogs were given an equal volume of 10% hydroxyethyl pentafraction starch (HES) in 0.9% saline solution (5 ml/kg, i.v.). All dogs (DEF-HES/HBO and HES/HBO treated) were exposed to 60 minutes of hyperbaric oxygen (HBO) at 2 atmospheres absolute pressure twice daily for 10 days, beginning the day of surgery. The percentage of viable graft on day 10 was lower in HES/HBO treated dogs (mean + SD; 13.3 + 21.3%; median, 3.0%) than in DEF-HES/HBO treated dogs (64.7 + 39.2%; 88.3%). There was a positive correlation between percentage of viable graft (on day 10) and percentage of haired skin on the graft site (on day 28) for all dogs. Perivascular aggregates of foamy cells were observed in the superficial and reticular portions of the dermis and in the subcutaneous tissue on both surfaces of the panniculus muscle in the graft sites of DEF-HES/HBO treated dogs. These cells were also observed in the dermis, and in some viscera of DEF-HES/HBO treated dogs. Deferoxamine appeared to attenuate the detrimental effect of HBO and HES on survival of free skin grafts. It is concluded that the clinical use of HBO and DEF-HES is not recommended because it failed to improve the survival of free skin grafts.

5.      Kerwin, S. C.Hosgood, G.Strain, G. M.Vice, C. C.White, C. E.Hill, R. K. The effect of hyperbarbic oxygen treatment on a compromised axial pattern flap in the cat. Veterinary Surgery. 1993 22 1 31-36

A pedicile skin flap based on the caudal superficial epigastric artery was created in 12 cats. The artery was ligated and the vein left intact. Six cats were treated with hyperbaric oxygen at 2 atm absolute for 90 minutes daily for 14 days, starting the day after surgery. Skin flap colour was significantly better in the treated cats on days 1, 2, and 3. The amount of exudate was significantly less in the treated cats on day 3. There was no difference in the amount of swelling between treated and nontreated control cats. Although 5 of 6 of the treated cats had 100% skin flap survival, there was no significant difference in total flap survival between treated and nontreated control cats.

Systematic Reviews of HBOT for Wounds in Humans

1.      Systematic review of the effectiveness of hyperbaric oxygenation therapy in the management of chronic diabetic foot ulcers.

Liu R, Li L, Yang M, Boden G, Yang G. Mayo Clin Proc. 2013 Feb;88(2):166-75. doi: 10.1016/j.mayocp.2012.10.021.
Thirteen trials (a total of 624 patients), including 7 prospective randomized trials, performed between January 1, 1966, and April 20, 2012, were identified as eligible for inclusion in the study. Pooling analysis revealed that, compared with treatment without HBO, adjunctive treatment with HBO resulted in a significantly higher proportion of healed diabetic ulcers (relative risk, 2.33; 95% CI, 1.51-3.60). The analysis also revealed that treatment with HBO was associated with a significant reduction in the risk of major amputations (relative risk, 0.29; 95% CI, 0.19-0.44); however, the rate of minor amputations was not affected (P=.30). Adverse events associated with HBO treatment were rare and reversible and not more frequent than those occurring without HBO treatment (P=.37).

This meta-analysis reveals that treatment with HBO improved the rate of healing and reduced the risk of major amputations in patients with diabetic foot ulcers. On the basis of these effects, we believe that quality of life could be improved in selected patients treated with HBO.

 

2.      Hyperbaric oxygen therapy for treating chronic wounds

Kranke P, Bennett MH, Martyn-St James M, Schnabel A, Debus SE
April 18, 2012
This review update of randomised trials found that HBOT seems to improve the chance of healing diabetes-related foot ulcers and may reduce the number of major amputations in people with diabetes who have chronic foot ulcers. In addition this therapy may reduce the size of wounds caused by disease to the veins of the leg, but the review found no evidence to confirm or refute any effect on other wounds caused by lack of blood supply through the arteries or pressure ulcers.

 

3.      A systematic review of the effectiveness of interventions in the management of infection in the diabetic foot.

Peters EJ, Lipsky BA, Berendt AR, Embil JM, Lavery LA, Senneville E, Urban?i?-Rovan V, Bakker K, Jeffcoate WJ. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:142-62. doi: 10.1002/dmrr.2247.
There was no improvement in infection outcomes associated with hyperbaricoxygen therapy.

 

4.      Hyperbaricoxygen therapy: solution for difficult to heal acute wounds? Systematic review.
Eskes AM, Ubbink DT, Lubbers MJ, Lucas C, Vermeulen H. World J Surg. 2011 Mar;35(3):535-42. doi: 10.1007/s00268-010-0923-4.
We included five trials, totaling 360 patients. These trials, with some methodologic flaws, included different kinds of wound and focused on different outcome parameters, which prohibited meta-analysis. A French trial (n = 36 patients) reported that significantly more crush wounds healed with HBOT than with sham HBOT [relative risk (RR) 1.70, 95% confidence interval (CI) 1.11-2.61]. Moreover, there were significantly fewer additional surgical procedures required with HBOT (RR 1.60, 95% CI 1.03-2.50), and there was significantly less tissue necrosis (RR 1.70, 95% CI 1.11-2.61). In one of two American trials (n = 141) burn wounds healed significantly quicker with HBOT (P < 0.005) than with routine burn care. A British trial (n = 48) compared HBOT with usual care. HBOT resulted in a significantly higher percentage of healthy graft area in split skin grafts (RR 3.50, 95% CI 1.35-9.11). In a Chinese trial (n = 145) HBOT did not significantly improve flap survival in patients with limb skin defects. HBOT, if readily available, appears effective for the management of acute, difficult to heal wounds. 

 

5.      Hyperbaric oxygen therapy for acute surgical and traumatic wounds
Eskes A, Ubbink DT, Lubbers M, Lucas C, Vermeulen H
February 16, 2011
This review did not find any high quality research evidence showing that HBOT is beneficial for wound healing. Two poor quality studies suggested benefits associated with HBOT. The first in patients with crush injuries, showed improved wound healing and fewer adverse outcomes. The second reported improved survival of split skin grafts. A third trial reported no benefits associated with HBOT for skin grafts.

Further, better quality research is needed to determine the effects of HBOT on wound healing.

 

6.      Hyperbaricoxygen therapy for wound healing and limb salvage: a systematic review.

Goldman RJ. PM R. 2009 May;1(5):471-89. doi: 10.1016/j.pmrj.2009.03.012.

This article is a systematic review evaluating published clinical evidence of the efficacy of hyperbaricoxygen therapy (HBOT) for wound healing and limb salvage… The author evaluated 620 citations, of which 64 reported original observational studies and randomized controlled trials (RCTs) on HBOT and healing outcomes. All citations with 5 subjects were selected for full text review (44 articles) and evaluated according to GRADE criteria for high, medium, low, or very low level of evidence. A Cochrane review identified 1 additional study with a low level of evidence….For patients with diabetic foot ulcers (DFU) complicated by surgical infection, HBOT reduces chance of amputation (odds ratio [OR] 0.242, 95% CI: 0.137-0.428) (7 studies) and improves chance of healing (OR 9.992, 95% CI: 3.972-25.132) (6 studies)…HBOT is associated with remission of about 85% of cases of refractory lower extremity osteomyelitis, but an RCT is lacking to clarify extent of effect. There is a high level of evidence that HBOT reduces risk of amputation in the DFU population by promoting partial and full healing of problem wounds. There is a moderate level of evidence that HBOT promotes healing of arterial ulcers, calciphylactic and refractory vasculitic ulcers, as well as refractory osteomyelitis. There is a low to moderate level of evidence that HBOT promotes successful “take” of compromised flaps and grafts.

Systematic Reviews for Other Indications in Humans

Systematic review of agents for the management of gastrointestinal mucositis in cancer patients.
Gibson RJ, Keefe DM, Lalla RV, Bateman E, Blijlevens N, Fijlstra M, King EE, Stringer AM, van der Velden WJ, Yazbeck R, Elad S, Bowen JM; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Support Care Cancer. 2013 Jan;21(1):313-26. doi: 10.1007/s00520-012-1644-z. Epub 2012 Nov 10.
…the panel suggests the use of hyperbaricoxygen as an effective means in treating radiation-induced proctitis.

 

Does hyperbaric oxygen therapy improve the survival and quality of life in patients with traumatic brain injury?
Bennett MH, Trytko B, Jonker B
December 12, 2012
The effectiveness of HBOT on the recovery of brain-injured patients is uncertain. There is also concern regarding potential adverse effects of the therapy, including damage to the ears, sinuses and lungs from the effects of pressure, temporary worsening of short-sightedness, claustrophobia and oxygen poisoning.

In an attempt to address the uncertainty surrounding the use of HBOT, the authors of this review identified all studies which were randomized controlled trials investigating the effects of HBOT in traumatically brain-injured people of all ages.

The authors found seven eligible studies involving 571 people. The combined results suggest that HBOT reduces the risk of death and improves the level of coma; however, there is no evidence that these survivors have an improved outcome in terms of quality of life. It is possible, therefore, that the overall effect of hyperbaric oxygen is to make it more likely that people will survive with severe disability after such injuries. The authors conclude that the routine use of HBOT in brain-injured patients cannot be justified by the findings of this review.

Due to the small number of trials with a limited number of people, it is not possible to be confident in the findings. Further large, high quality trials are required to define the true extent of benefit from HBOT.

 

Using oxygen at high pressure (in a compression chamber) for the treatment of broken bones
Bennett MH, Stanford RE, Turner R
November 14, 2012
This review found no evidence from randomised trials to support or refute the use of hyperbaric oxygen therapy to avoid or treat poorly healing broken bones. However, in this update, we found three ongoing randomised trials that are likely to provide some evidence to inform on the use of hyperbaric oxygen therapy in the future.

 

Hyperbaric oxygen therapy for vascular dementia
Xiao Y, Wang J, Jiang S, Luo H
July 11, 2012
This review included one randomised controlled trial of poor methodological quality involving 64 patients with VaD who were also taking donepezil. Safety assessment was not mentioned at all. Although the authors reported cognitive benefit, this trial alone cannot be taken as evidence of efficacy. Further well-designed randomised controlled trials are needed.

 

Ghanizadeh A.  Hyperbaricoxygen therapy for treatment of children with autism: a systematic review of randomized trials.
Med Gas Res. 2012 May 11;2:13. doi: 10.1186/2045-9912-2-13.
The electronically search resulted in 18 title of publications. Two studies were randomized, double-blind, controlled-clinical trials. While some uncontrolled and controlled studies suggested that HBO therapy is effective for the treatment of autism, these promising effects are not replicated. Therefore, sham-controlled studies with rigorous methodology are required to be conducted in order to provide scientific evidence-based HBO therapy for autism treatment.

 

Hyperbaric oxygen therapy (HBOT) for the treatment of the late effects of radiotherapy
Bennett MH, Feldmeier J, Hampson N, Smee R, Milross C
May 16, 2012
We found some evidence that LRTI affecting the head, neck and lower end of the bowel can be improved with HBOT. There is little evidence for or against benefit in other tissues affected by LRTI. Our conclusions are based on 11 randomised trials with a limited number of patients. Further research is needed.

 

High pressure oxygen breathing during radiotherapy for cancer treatment
Bennett MH, Feldmeier J, Smee R, Milross C
April 18, 2012
Breathing oxygen while at raised pressure in a closed chamber (hyperbaric oxygen or HBO) may increase the effectiveness of radiotherapy and thus improve mortality and reduce tumour regrowth. We found some evidence that people with head and neck cancer are less likely to die within five years if they are treated this way, and evidence that regrowth of tumour at the original site is less likely for head and neck, and cervical cancer. However, Hyperbaric oxygen therapy (HBOT) may only be effective when radiotherapy is given in an unusually small number of sessions, each with a relatively high dose. HBOT does not appear to work for other cancers studied. Our conclusions are based on 19 randomised trials with over 2000 patients.

 

Hyperbaricoxygen treatment for inflammatory bowel disease: a systematic review and analysis.
Rossignol DA. Med Gas Res. 2012 Mar 15;2(1):6. doi: 10.1186/2045-9912-2-6.
Thirteen studies of HBOT in Crohn’s disease and 6 studies in ulcerative colitis were identified….Twelve publications reported using HBOT in animal models of experimentally-induced IBD… Although most publications reported improvements with HBOT, some studies suffered from limitations, including possible publication and referral biases, the lack of a control group, the retrospective nature and a small number of participants.

HBOT lowered markers of inflammation and oxidative stress and ameliorated IBD in both human and animal studies. Most treated patients were refractory to standard medical treatments. Additional studies are warranted to investigate the effects of HBOT on biomarkers of oxidative stress and inflammation as well as clinical outcomes in individuals with IBD.

 

A systematic review of interventions to enhance the healing of chronic ulcers of the foot in diabetes.
Game FL, Hinchliffe RJ, Apelqvist J, Armstrong DG, Bakker K, Hartemann A, Löndahl M, Price PE, Jeffcoate WJ. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:119-41. doi: 10.1002/dmrr.2246.
The present report is an update of the earlier IWGDF systematic review, but the conclusion is similar: that with the exception of HBOT and, possibly, negative pressure wound therapy, there is little published evidence to justify the use of newer therapies. This echoes the conclusion of a recent Cochrane review and the systematic review undertaken by the National Institute for Health and Clinical Excellence Guidelines Committee in the UK. Analysis of evidence presents considerable difficulties in this field particularly as controlled studies are few and the majority are of poor methodological quality.

 

High pressure (hyperbaric) oxygen therapy for Bell’s palsy
Holland NJ, Bernstein JM, Hamilton JW
February 15, 2012
Our searches revealed no trials that met the inclusion criteria for the review. We found very low quality evidence from one trial to suggest that hyperbaric oxygen therapy might be beneficial for moderate to severe Bell’s palsy. The quality of evidence from this trial was very low because the assessors of facial function were aware of which treatment each participant had been given, which introduces a high risk of bias. There is therefore no high quality evidence on which to base conclusions about the efficacy of hyperbaric oxygen therapy in Bell’s palsy.

 

Hyperbaric oxygen therapy, which involves people breathing pure oxygen in a specially designed chamber, for the treatment of multiple sclerosis
Bennett MH, Heard R
August 10, 2011
The review of nine trials found no consistent evidence that HOBT can improve disability or modify the progression of MS. There is little need for further research.

 

Hyperbaric oxygen may reduce the risk of dying, the time to pain relief and the chance of adverse heart events in people with heart attack and unstable angina
Bennett MH, Lehm JP, Jepson N
August 10, 2011
We first searched the literature in 2004 and most recently in June 2010, finding one further study. Overall,we found some evidence that people with ACS are less likely to die or to have major adverse cardiac events, and to have more rapid relief from their pain, if they receive hyperbaric oxygen therapy as part of their treatment. However, our conclusions are based on six relatively small randomised trials (five of which included only patients with confirmed heart muscle death). While HBOT may therefore reduce the risk of dying, time to pain relief and the chance of adverse heart events in people with heart attack and unstable angina, more work is still needed to be sure that HBOT should be recommended.

 

There is insufficient evidence to support the use of hyperbaric oxygen for treatment of patients with carbon monoxide poisoning
Buckley NA, Juurlink DN, Isbister G, Bennett MH, Lavonas EJ
April 13, 2011
the review of published trials found conflicting, potentially biased, and generally weak evidence regarding the usefulness of hyperbaric oxygen for the prevention of neurological injury.

 

Hyperbaric oxygen as an additional treatment for malignant otitis externa
Phillips JS, Jones SEM
February 16, 2011
The review found no trials to demonstrate that the addition of hyperbaric oxygen therapy offers a better outcome than the treatments alone. Further research is required.

 

Efficacy of pre- and postirradiation hyperbaricoxygen therapy in the prevention of postextraction osteoradionecrosis: a systematic review.
Fritz GW, Gunsolley JC, Abubaker O, Laskin DM. J Oral Maxillofac Surg. 2010 Nov;68(11):2653-60. doi: 10.1016/j.joms.2010.04.015. Epub 2010 Aug 19.
Most of the studies had a small sample size, lacked specific inclusion and exclusion criteria, did not report the interval between radiation and extraction, and provided limited information on the method of extraction. There was also variation in HBO protocols, radiation dosage, the use of antibiotics, and the use of adjunctive cancer therapy.

On the basis of the best available evidence, there is currently insufficient information to show that the use of HBO reduces the incidence of osteoradionecrosis in irradiated patients requiring tooth extraction.

 

Hyperbaric oxygen therapy for delayed onset muscle soreness and closed soft tissue injury
Bennett MH, Best TM, Babul-Wellar S, Taunton JE
June 16, 2010
Our review included nine small trials, involving a total of 219 participants. Two trials compared HBOT versus sham therapy on ankle sprain and knee sprain respectively. Neither trial provided sufficient evidence to determine if HBOT helped people with these injuries. The other seven trials examined the effect of HBOT on muscle injury following unaccustomed exercise. There was no evidence that HBOT helped people with muscle injury following unaccustomed exercise, but some evidence that people given HBOT had slightly more pain. Further research on HBOT is not a high priority given the variety of other treatment interventions available.

 

Normal pressure oxygen therapy and hyperbaric oxygen therapy for migraine and cluster headaches
Bennett MH, French C, Schnabel A, Wasiak J, Kranke P
October 7, 2009
In our review, we found some weak evidence to suggest that HBOT helps people with acute migraine headaches and possibly cluster headaches, and that NBOT may help people with cluster headache. We found no evidence that either can prevent future attacks. Because many migraines can be treated simply with appropriate drug therapy, further research is needed to help choose the most appropriate patients (if any) to receive HBOT.

 

Little evidence that burns patients benefit from hyperbaric oxygen therapy
Villanueva E, Bennett MH, Wasiak J, Lehm JP
October 7, 2009
The review found only two randomised trials, with only a limited number of patients. There was no consistent benefit from HBOT, but one trial did suggest an improvement in healing time. Overall, there is little evidence to support or refute the use of HBOT for burns patients. More research is needed.

 

Hyperbaric oxygen therapy for acute ischaemic stroke
Bennett MH, Wasiak J, Schnabel A, Kranke P, French C
October 7, 2009
There is little evidence that stroke patients benefit from hyperbaric oxygen therapy….Our review found only six randomised trials involving 283 participants. Too few patients have been studied to say whether or not HBOT decreases the chance of dying and only three trials suggested any improvement in the ability to do everyday tasks. Overall, there is currently little evidence to support the use of HBOT for stroke patients.

 

Interventions for replacing missing teeth: hyperbaric oxygen therapy for irradiated patients who require dental implants
Esposito M, Grusovin MG, Patel S, Worthington HV, Coulthard P
October 8, 2008
We could only identify one study including a limited number of patients. This study suggested that the use of hyperbaric oxygen (HBO) therapy for patients who require dental implants after radiotherapy is of no apparent clinical benefit….More reliable studies are needed to provide the final answer to this question.

 

 

Posted in Science-Based Veterinary Medicine | 10 Comments

Evidence Update–Homemade Diet Recipes for Your Pet are Unreliable

I have previously discussed studies of recipes for homemade diets, from books and the internet, which show that these diets are rarely nutritionally adequate or reliable in terms of consistently providing predictable levels of critical nutrients. Recipes for kidney disease, cancer diets, and raw diets have all been evaluated and found wanting. Now the largest study yet looking at the nutritional adequacy of homemade diet recipes has been published and—surprise, surprise—it has found that almost none of the recipes evaluated provide recommended levels of important nutrients.

Stockman, J. Fascetti, AJ. Kass, PH. Larsen,JA. Evaluation of recipes of home-prepared maintenance diets for dogs. Journal of the American Veterinary Medical Association. 2013;242(11): 1500-1505.

Two-hundred  recipes were evaluated, including 129 written by veterinarians. The vast majority were vague about ingredients, feeding instructions, or the details of recommended supplements. Only 5 recipes could be interpreted as providing adequate levels of all essential nutrients as established by the National research Council guidelines, and only 9 recipes met the nutrient standards of the Association of American Feed Control Officials (AAFCO).

Despite common claims that nutritional adequacy can be met by rotating through a variety of foods even if no specific recipe is complete in itself, the authors found that when such groups of recipes were evaluated, they still did not provide a nutritionally complete diet even when fed in rotation as directed. Even though most recipes written by veterinarians were incomplete, those recipes provided by non-veterinarians were significantly more likely to be incomplete and were more likely to have more severe deficiencies. All 4 recipes written by board-certified veterinary nutritionists were complete. This pretty clearly demonstrates that claims veterinarians are not better qualified than lay people to make nutritional recommendations are nonsense. The best source of advice about pet diets is a veterinary nutritionist, and the second best source is your veterinarian.

 

 

 

Posted in Nutrition | 30 Comments

Australian Government Cracks Down on Bogus Claims for “Black Salve”

One of my most popular (and unpopular) articles concerns the quack cancer remedy Neoplasene. This is one of a family of herbal derivatives called bloodroot, and it has never been shown to be a safe and effective therapy for cancer. Though there are some in vitro studies showing bloodroot derivatives kill cancer cells, so does bleach. This is not sufficient to make it a safe and effective medicine. There is also ample evidence that it can cause severe damage to patients.

In an example of the consilience of different forms of quackery, apparently the anti-vaccine organization with the Orwellian name of the Australian Vaccination Network has been promoting a bloodroot derivative known as “Black Salve” as a cancer therapy. And in an example of an unusual, and much welcome, demonstration of reason and backbone by a government regulatory authority, they have been told to stop by the Therapeutic Goods Administration. What’s important about this is that the TGA is definitively informing the public that there is no reliable evidence these bloodroot remedies are safe and effective and that it is a form of fraud to claim that they are.

Here are some examples of the refreshing language in the TGA decision:

Black Salve Doesn’t Work
The Advertiser was not able to produce valid supporting evidence in relation to their claims, nor was there any referenced or highlighted medical evidence in the advertisement to support the representations. The advertisement promoted ‘black salve’ as a ‘safe, effective, natural remedy…used for over 2,000 years to treat skin cancers and other cancerous conditions, leading to a total remission of the disease.‘ The Delegate considered that, based on these statements, consumers would be entitled to expect that ‘black salve’ will cure them of cancer when, in fact, there is no credible, reliable clinical or scientific evidence to demonstrate that the product is effective in the treatment of any cancer. The Delegate found the advertisement was unverified, was not correct and raised unrealistic and unwarranted expectations of product effectiveness

Black Salve Is Not a Substitute for Real Medicine
The Delegate considered that statements made in the advertisement could lead to consumers inappropriately relying on ‘black salve’ to treat skin cancer to the exclusion of clinically proven conventional medicine and that the suggestion that ‘black salve’ will ‘help people cure their own cancers‘ may lead to self-diagnosis and a failure to seek out proper medical attention for a potentially fatal disease. The Delegate found the advertisement was likely to lead to inappropriate treatment of a potentially serious disease and was misleading

You Shouldn’t Sell Snake Oil By Making People Fear Real Medicine
The advertisement used language that, in the Delegate’s view, would bring about fear or distress by making people fearful of the consequences if they did not use ‘black salve’ or, alternatively, if they relied on conventional medicine for treatment.

Black Salve is Dangerous
The advertisement promoted ‘black salve’ as a ‘safe, effective, natural remedy‘ and that it was ‘time-tested‘. The advertisement does not mention that ‘black salve’ can cause harm or has any side effects, nor did it advise the consumer that ‘black salve’ can burn the skin (which may require medical attention) and can cause permanent scarring…misdiagnosis by a consumer would cause greater harm to themselves and that by not seeking appropriate medical help, incorrect application of “black salve” could cause extensive, irreparable damage to their skin.

Despite some pro forma caveats, Neoplasene is sold with essentially the same kind of unsupported claims exaggerating the evidence for its own safety and efficacy. Would be nice to see this sort of warning on site selling other bloodroot derivatives?

 

RETRACTION

An advertisement promoting illegal therapeutic goods under the name “Black Salve”, which we published on this website, should not have been published. In publishing the advertisement, we misled and abused the trust of consumers

In the advertisement we unlawfully made claims that Black Salve is safe, and that it can be used as an effective treatment for cancers including skin cancer. We also claimed that cancer medicines are harmful and cause cancer, and are ineffectual

A complaint about the advertisement was recently upheld by the Complaints Resolution Panel. We provided no evidence whatsoever to support the claims we made, and the Panel found that the claims were unlawful, misleading, and unverified and breached the Therapeutic Goods Advertising Code (Code).

The delegate of the Secretary for the purposes of regulation 9 of the Therapeutic Goods Regulations 1990 also found that the claims and representation in the advertisement were unlawful, inaccurate and misleading in breach of the Code.

The attention of consumers is directed to the safety information from the Therapeutic Goods Administration at: Black salve, red salve and cansema on the TGA website.

 

Posted in Herbs and Supplements, Law, Regulation, and Politics | 2 Comments

Evidence Update–Is Surgery Really Necessary for Dogs with Cruciate Ligament Ruptures?

A couple of years ago, I wrote about the question of whether or not surgery was better than medical management for dogs with cranial cruciate ligament (CCL) disease. Here was my conclusion at that time:

As is almost always the case, the evidence is not of the highest possible quality or unequivocal, but this does not exempt us from having to draw conclusions and make recommendations to our clients. My interpretation of the available evidence is that overall, cruciate ligament disease causes significant arthritis and loss of function when untreated. For most dogs under 15kg, conservative management (primarily restricted activity for 3-6 weeks, achieving and maintaining and appropriate body weight, and possibly physical therapy and pain medication) can achieve acceptable comfort and function. In larger dogs, significant arthritis is inevitable and dysfunction is extremely likely without surgical treatment. No single surgical technique is clearly superior, so the choice of specific surgery should be determined by the judgment of the individual surgeon and the needs of the owner.

A recent research article has added an important piece of evidence concerning this subject, and while supporting the value of surgery it does weaken somewhat the case against medical treatment for large dogs.

Wucherer, KL. Conzemius, MG. Evans, R. Wilke, VL. Short-term and long-term outcomes for overweight dogs with cranial cruciate ligament rupture treated surgically or nonsurgically. Journal of the American Veterinary Medical Association 2013;242(10):1364-72.

The authors interpretation of the results supports the argument that both surgical and nonsurgical treatment can be successful, even in overweight large-breed or giant-breed dogs, but that surgery appears to provide a better outcome.

Overweight dogs with CCLR treated via surgical and nonsurgical methods had better outcomes than dogs treated via nonsurgical methods alone. However, almost two-thirds of the dogs in the nonsurgical treatment group had a successful outcome…

Overall, I agree with their conclusion, though I would probably place less confidence in it than the authors do.

The Study
Forty overweight large-breed or giant-breed dogs with unilateral rupture of a CCL were recruited and randomized to either medical therapy alone (a weight loss program, individualized physical therapy, and daily use of a nonsteroidal anti-inflammatory medication) or medical therapy plus surgical therapy (TPLO). Outcomes were assessed at 6 weeks, 12 weeks, 24 weeks, and 52 weeks after the beginning of the study.

There was a high rate of drop out (5 digs by 6 weeks, 11 dogs by 24 weeks, and 17 dogs by 52 weeks). The majority of these dogs (11/17) dropped out due to CCL rupture in the opposite leg, and there was no overall difference in dropouts between the two groups (9 in surgical group and 8 in non-surgical group).

Both subjective outcome measures (surveys of owner perception of their dogs’ pain and lameness and pain scores generated by the investigators) and objective outcome measures (body weight, body fat, body condition scores, and several measures generated by force-plate analysis) were evaluated at the beginning of the study and in the dogs still participating at each follow-up point.

The Results
No adverse effects were reported for the weight loss diet, the NSAID therapy, or the physical therapy. A few minor complications associated with TPLO surgery were reported at rates consistent with those reported in other studies.

The weight loss program did result in decreases in body condition score and percent body fat for both groups, and there were no significant differences between the two groups. Interestingly, while total body weight did decline slightly for both groups, the decrease was not statistically significant for either, and there was no difference between the groups.

Subjective measures, both owner and investigator assessed, improved significantly for both groups. There were no differences between the groups in the subjective outcomes assessed by the investigators. The surgery group had significantly lower scores for pain severity and interference than the non-surgical group only at the 52-week evaluation. Some differences between the groups in visual analog pain scale assessment by owners were reported, but how many measures were assessed and which ones differed were not reported, and no statistical analysis of these differences was reported, so it is difficult to assess this outcome measure.

Of the several force-plate measures assessed (5 or 6 measures; it isn’t clear from the paper), only one differed between the groups, and this difference was significant only at two of the four assessment points (24 weeks and 52 weeks).

The investigators also created a composite measure of “successful outcome,” defined as achieving both a specific force-plate measure that was >85% that of a normal dog and a subjective, owner-assessed improvement in lameness and quality of life >/= 10%. The dogs in the surgical group had higher “successful outcome” scores at all assessment points, but this only reached statistical significance at 24-week evaluation.

Strengths of the Study
Overall, this was a well-designed study. The use of both subjective and objective outcome measures, random assignment of treatment, an aggressive and consistent medical therapy program, and partial standardization of surgical treatment all reduce the risk of bias, confounding, and other error in the study. The consistency of several reported variables (such as surgical complication rate) with those reported in other studies increases the confidence one can have in the results. And the attempt to verify compliance with the weight loss aspect of medical therapy is an important part of any study employing this therapeutic approach.

Limitations and Caveats
A significant limitation is the lack of blinding of owners or investigators to treatment group. While blinding would be difficult, and possibly unethical due to the need for a sham surgery component, the lack of blinding introduces significant risk of information bias, particularly in the subjective outcome measures.

There was some individualization of surgical procedure and physical therapy treatments employed, which means not all subjects had the same treatment. If some techniques used work better than others, or if the selection of technique to be used is associated with the likelihood of a good or bad outcome, this could generate an erroneous impression of the differences between the surgical and non-surgical treatment groups.

The biggest limitation of the study was probably the high dropout rate. In general, dropout rates greater than about 20% are considered to severely compromise the data, and the overall dropout rate was 42.5% in this study. Though the number of dropouts were evenly distributed between the two groups, this does not mean the dropouts did not introduce bias into the results. If those patients who dropped out, most because they developed a second CCL rupture in their other leg, differed in terms of their underlying disease or response to treatment from the subjects who stayed in the study, this could have significantly altered the findings.

Also, as the authors themselves point out, the dropouts caused a significant loss of power in the study (though no power analysis is presented in the report), and this could lead to a failure to detect a difference between the groups. Overall, the dropouts significantly weaken the confidence we can place in these results.

Bottom Line
This study does provide some support for the contention that overweight, large-breed or giant-breed dogs have better long-term outcomes when treated with both surgery and non-surgical therapy rather than with non-surgical therapy alone. However, the limitations in these data are great enough that the case for preferring surgical intervention is not strong. The non-surgically treated patients had overall very good outcomes that, at most time points and by most measures, did not differ significantly from the patients who received surgical treatment. Additional evidence would be required to make a strong statement that overall surgery is superior to aggressive medical therapy.

While it is reasonable to tell dog owners that there is some evidence their pets will benefit more from having surgery than not having it, we must also inform them that most dogs will have a good long-term outcome even without surgery. And it is important to emphasize that even with surgery, aggressive management of weight and physical therapy are important elements of  comprehensive and successful treatment. For those owners who cannot afford surgery, or those patients who are not good candidates, there are still effective therapies that can be offered.

Posted in Science-Based Veterinary Medicine | 103 Comments

Plechner Syndrome and the Art of Making Stuff Up

Most proponents of so-called complementary and alternative medicine (CAM) are ordinary, reasonable people, even when promoting beliefs that may be dubious or even thoroughly incredible. However, occasionally I run across one of those individuals with not only a bizarre understanding of health and disease but a bizarre sense of their own relationship with veterinary medicine. Individuals like Dr. Gloria Dodd and Eric Weisman (1,2,3) appear to see themselves as misunderstood geniuses, martyrs whose insights and efforts to improve the world are resented by the less enlightened and attacked by nebulous conspiracies dedicated to preserving their power and income by suppressing simple, cheap cures for disease.

Many of the warning signs of quackery are related to these narcissistic and self-serving narratives (including the Galileo Complex, the David and Goliath Myth, and the Dan Brown Gambit). While an exaggerated sense of self-importance and a persecution complex are not guarantees that the ideas a person is promoting are nonsense, they certainly should raise a red flag and lead one to pay even closer attention to the amount and quality of evidence behind these ideas. All too often, it appears that ego alone is all the evidence these folks need.

That seems to be the case for Dr. Al Plechner. Dr. Plechner is a California veterinarian who appears to have discovered the cause and the cure for most serious medical conditions not already curable by scientific medicine. He calls his one true cause of disease Atypical Cortisol Imbalance (ACIS), though he usually refers to it as Plechner Syndrome.

What’s The Problem?

Dr. Plechner begins his somewhat vague argument by referring to the “Medical Ice Age.”

The MEDICAL ICE AGE relates to the gradual breakdown of ourselves, our animals, and our earth. As this gradual breakdown is occurring, a concentration of predisposing factors of poor health are being created. Not only are we seeing entire families of people developing allergies, auto-immunity, and cancer, but we are also seeing even a faster progression of diseases in our animals due to indiscriminant breeding, and breeding without function. The lack of concern for our earth has further allowed for environmental breakdown, contamination of our soils and waters, and the development of an unstable atmosphere…

With this present day destruction, a potentially dangerous cortisol deficiency is being created in our bodies which allows the immune system not to protect people and animals, but instead allows the loss of recognition of the body’s own tissue by these cells, resulting in allergies, auto-immunity, and cancer. This is called, PLECHNER’S SYNDROME. The identification and control of this syndrome may slow down the MEDICAL ICE AGE which threatens our existence.

He goes on to describe ACIS or “Plechner’s Syndrome” and how he believes it is related to disease:

ATYPICAL CORTISOL IMBALANCE SYNDROME (ACIS) (PLECHNER’S SYNDROME) DESCRIBES A DEFICIENCY IN THE PRODUCTION OF CORTISOL FROM THE MIDDLE LAYER ADRENAL CORTEX AND ITS INABILITY TO PROVIDE ACTIVE (WORKING) CORTISOL WHICH IS THE UNDERLYING CAUSE OFATYPICAL CORTISOL IMBALANCE SYNDROME (ACIS) (PLECHNER’S SYNDROME) AND THE MEDICAL ICE AGE. This shortage of active (working) cortisol leads to a domino effect through the deregulation of thyroid hormones leading to the production of excess ESTROGEN and the deregulation of the immune system and all of the diseases and maladies this resulting faulty immune system creates.

…The fact that these hormones (ALDOSTERONE and ADRENAL ESTROGEN) are present relates to whether the CORTISOL and THYROID HORMONES are working, and not the ESTROGEN and ALDOSTERONE, otherwise the electrolytes and the antibodies would not be working. The comparative levels refer to the CORTISOL and IMMUNOGLUBULINS and this is why it is so important to do comparative levels, including those secretions which are regulated by active (working) hormone.

This supposed endocrine disorder is identified as the underlying cause for many seemingly unrelated diseases, including:

Food Allergies: “You must realize that food sensitivities may only occur secondarily to Plechner’s Syndrome, which is a hormonal antibody defect. If this syndrome is damaged and uncontrolled, eventually the patient will develop food sensitivities to all food.”

Skin Allergies and Infections: “Most dog skin problems seem to come from a hormone antibody imbalance referred to as Plechner’s Syndrome.”

Vomiting in Cats: Of course, food allergies can cause vomiting, and this has already been attributed to Plechner Syndrome. But apart from this problem, “The 2nd most common reason why cats vomit is due to a hormonal antibody imbalance.”

Cancer: “What then is the cause of this uncontrolled tissue growth called cancer? It occurs because of a endocrine-immune imbalance that leads to a deregulated immune system. This endocrine-immune imbalance begins with a defective or deficient cortisol which is produced in the middle layer adrenal cortex.”

Feline Viral Leukemia: “…feline-leukemia victims usually suffer from a hormone imbalance. In treating more than 2,000 cases, Plechner has discovered that with an individualized hormone-replacement plan, dietary changes and regulation, the virus can be controlled, if detected early enough. There are cases in which leukemia-positive cats have become negative after several weeks of treatment, although veterinary textbooks say this is impossible.”

Other Retroviral Infections: “The cats and humans that suffer from these viruses [retroviruses], like HIV, FIV, FIP and FELV, all have a hormonal-antibody deficiency caused by the Plechner Syndrome.”

Bladder Infections:  “Chronic bladder infections in cats are caused by a hormonal antibody imbalance which as yet has not been realized.”

Dental Disease: “The plaque, on the actual tooth may not be causing a problem unless the plaque is great enough to cause the gum associated with that tooth, to cause a gingival recession leading, to an exposed tooth root problem, causing the problem, but rather a hormonal antibody imbalance that is leading to a deficiency of the protective antibody for the gums?”

Inflammatory Bowel Disease: “The cause of the IgA imbalance, IBD and other associated diseases, come from a middle layer imbalance in natural cortisol, produced by the middle layer, adrenal cortex.”

High Cholesterol: “I have found in people and animals, that when there is a cortisone imbalance, the pituitary stimulation causes an increase of total estrogen in male and female patients from the inner layer of the adrenal cortex. This in turn binds the use of thyroid hormone, and reduces the metabolism of the liver where cholesterol utilization and breakdown occurs. Automatically you can see why cholesterol levels may remain high, even after you have done everything that had been recommended.”

Epilepsy: “However, my research studies have allowed me to discover a syndrome involving elevated adrenal estrogen, causing an inflammation of all the endothelial cells that line the arteries of the body. When this elevated level of adrenal estrogen, including ovarian estrogen, causes inflammation of the cerebral arteries, a migraine headache or epileptic seizure can occur…In animals that have had their ovaries removed and in males with no ovaries, this same elevated adrenal estrogen can occur, causing the majority of epileptic seizures in animals and other catastrophic diseases.”

Cherry Eye: “What is cherry eye? This is a condition seen in dogs that relates to the tissue near the inner area of the eye. At the inner portion of the white of the eye, is a membrane that is a remnant of amphibians. In amphibians, this is a membrane that covers the actual eye, and allows the amphibians to see under water. In dogs, there is only a small remnant. But in this remnant, there is a small lymph node, often referred to as the Hardarian gland. When Plechner’s Syndrome is present, it creates an antibody deficiency. When this occurs this small gland increases in size to make up for the antibody imbalance and can reach a size when it can actually abrade the cornea and definitely needs to be removed. At this time, you should insist that your healthcare specialist, remove the other lymph node even if it not enlarged. It will enlarge later and have to be removed, unless you correct Plechner’s Syndrome.”

Plechner Syndrome is also credited with a causal role in female infertility and poor breeding performance, Sudden Acquire Retinal Degeneration Syndrome (SARDS), “Rage Syndrome,” and infestations with fleas and ear mites.

And how is this syndrome detected when it can cause so many seemingly unrelated disorders? Why a simple blood test, of course. It has to be sent to the one lab he trusts, one which will measure the particular kinds of hormone levels he believes are important (which most labs don’t measure since most endocrinologists don’t agree with his assessment), but otherwise it is easy to identify this one underlying cause of many, if not all, diseases.

While Dr. Plechner identifies his eponymous syndrome as the root of most disease, he only speculates about what causes the syndrome itself: “It may be caused by genetics, exposure to toxins, stress, aging, lack of sleep, or in combinations thereof.”

And he does identify a few other causes of ill health, though most he mentions do ultimately cause disease by generating Plechner Syndrome. He feels there are “toxins” in the environment and in pet foods, though he only identifies a few specific substances (plastics, parabens, fluoride, and of course genetically modified food crops). He also considers inbreeding to be one possible cause of Plechner Syndrome, and he has a lot of concerns about radiation. And he recommends dosing the amount of vaccine given by size, in a purely subjective way despite the complete irrationality of this approach, presumably because “too much” vaccine would be harmful.

What’s The Solution?

What does Dr. Plechner recommend as treatment for Plechner Syndrome? The mainstay of his treatment is a lifelong supplementation of cortisol and thyroid hormone for any species, both as a treatment and a preventative measure. He may use the laboratory tests he recommends to guide the specific dosing he uses, but it seems clear that he isn’t really diagnosing Plechner Syndrome since he already knows it is always present; “Every patient I have been involved with, whether dogs, cats, horses or people, all have an identifiable, hormonal antibody imbalance.”

He also recommends calcium Montmorillonite clay as a panacea for numerous conditions, including: kidney disease, nutritional disorders, “detoxification” and chelation of supposed toxins, osteoporosis, urinary tract infections, radiation poisoning, skin disease, burns and wounds, gastrointestinal upset, and more.

And finally, he tosses in a hodgepodge of other alternative therapies, including homeopathy, another “magic water” called Kangen Water, and digestive enzymes.

So Why Isn’t Everybody On Board?

The first question one should always ask about any hypothesis or new approach to health and diseases is “What’s the evidence for this?” Here’s what Dr. Plechner says:

1. I have created a successful treatment program that has helped approximately 150,000 dogs, cats, horses and people. These were patients, not only at my hospital, but in healthcare facilities throughout the world.

2. My clinical studies also show that there are high levels of total estrogen in all female dogs that are diagnosed with cancer… although these dogs no longer have their ovaries.

3. Every cancer patient I have ever been involved with, whether it be animal or human, has an elevated level of total estrogen that is not indicated with standard estrogen testing.

4. Through my clinical studies over the past 50 years, I have been able to identify a genetic and acquired endocrine immune imbalance, which can be easily corrected so that the retrovirus will not end the life of a patient.

5. With my clinical studies I have found that 80 % of the causal control will not need antiepileptic drugs to control their seizures however 20 % even on hormone regulation of the seizures may need to stay on antiepileptic drugs.

Wow, these are pretty impressive research results! Let me just have a look at the published reports so I can get all the details….

….

….

Hmm, I’m not finding any published research studies. I wonder why that is….

As a clinician, my patients are my primary concern. For that reason I have not conducted controlled studies where one group of patients receives treatment and another group, for comparison, receives a placebo. I cannot in good conscience deny treatment to suffering animals who I know will benefit from that treatment.

Please realize that my clinical studies have not been accepted by my peers.

Oh, there aren’t any controlled studies, published or unpublished. By “clinical studies” he means “in my personal experience.” The theoretical foundation of Plechner’s Syndrome and the evaluation of clinical efficacy of its treatment is empirical. In other words, he made it all up!

An examination of the articles and information on Dr. Plechner’s web site reveals that he invented the entire theory and decided he was right based entirely on clinical experience and anecdotes. He has neither the inclination nor the training to conduct controlled scientific research, so his claims are purely faith based. He quotes numbers and percentages, but there is no evidence that these are based on anything more than his own imagination.

It is often pointed out, quite rightly, that science doesn’t know everything, and our understanding of phenomena as complex as living organisms is likely to always be incomplete. However, the incompleteness of knowledge is not the same thing as total ignorance, nor does it mean that absolutely anything can be true. We don’t entirely understand how gravity works at the subatomic level, but that doesn’t mean we can simply imagine ourselves into a real ability to fly if we leap off a tall building.

Endocrinology, the study of glands and hormones, is an enormous field with huge amounts of highly detailed knowledge based on centuries of scientific study. While we don’t know everything, Dr. Plechner’s theory is fundamentally inconsistent with what we do know and so is highly unlikely to be true. Perhaps through pure imagination, study, and uncontrolled personal experience, one man has discovered a fundamental principle of endocrinology that will overturn decades, even centuries of established science. Or, perhaps he is mistaken. Which seems the more likely?

Beyond the fundamental implausibility of his theory and the complete absence of any pre-clinical or clinical trial research to support it, Dr. Plechner’s claims raise many of the red flags of quackery.

  1. The Galileo Complex: As already pointed out, his characterization of himself as a misunderstood visionary ahead of his time qualifies as a manifestation of the Galileo Complex.
  2. The David and Goliath Myth, and the Dan Brown Gambit: Dr. Plechner appears to believe that the medical profession is deliberately resisting his ideas out of selfish and venal motives:

How would you feel if you found out that they’ve discovered a cure for cancer but they’re not going to let anyone know about it? I’m sure you’re all responding to this question by attacking it. “Why would they do that?” “That makes no sense!” “What about the money they could make?”

I could answer all of your objections by stating a single fact. The profits that a cancer cure would accrue wouldn’t even come close to the profits made by all of the cancer treatment drugs and the associated services involved in treating cancer. Sad to say, the treatment of cancer has proven itself to be, a tremendously successful revenue builder. Why wouldn’t you keep a possible cure under wraps?

But of course, this is purely a hypothetical question. We couldn’t possibly believe that our medical institutions could be callously driven by the pursuit of profit. Why, they’re as ethical as our great financial institutions are and look at how successful they’ve been.

The frightening fact is that a cancer cure could prove to be financially disastrous to the pharmaceutical and all of the other dependent medical industries.

The One True Cause of Disease: He believes his insight explains many apparently unrelated conditions with a single, simple answer that all other doctors and scientists have somehow overlooked.

Remember, many healthcare professionals will treat the EFFECTS of the illness or disease, but not the ROOT CAUSE cause of it.

It is no longer enough to say that my Veterinarian or Health Care Professional did the best that they could. There is another way. You as a pet owner or as a patient need to DECIDE FOR YOURSELF if you or your pet want to be just another statistic.

PLECHNER’S SYNDROME ADDRESSES AND TREATS THE ROOT CAUSES OF CATASTROPHIC ILLNESSES AND NOT JUST THE MEDICAL EFFECTS. It has the potential to help millions of animal or human patients to realize their dreams of better health and greater longevity.

Other Red Flags from Dr. Walt’s List:
Is the product or practice promoted as a “Major Breakthrough,” “Revolutionary,” “Magic,” or “Miraculous”?

Is only anecdotal or testimonial evidence used to support claims of effectiveness?

Is the treatment said to be effective for a wide variety of unrelated physiological problems?

Is the product a quick and easy fix for a complicated and frustrating condition?

Is the treatment said to be effective for a wide variety of unrelated physiological problems?

Is the product a quick and easy fix for a complicated and frustrating condition?

Who Is This Guy?

While I don’t believe personal details about someone are key to evaluating the legitimacy of their scientific claims, they can be informative, particularly after the claims have clearly failed the tests of plausibility and scientific evidence and contain so many red flags of nonsense. Dr. Plechner provides a brief biography on his web site. In it, he discusses a number of dramatic experiences with the medical profession which might be expected to generate some suspicion of mainstream medicine:

1. One afternoon, when I was just seven years old, I was playing in the alley behind our house when a car came speeding up the alley and then ran over my four-year-old sister. The next door neighbors were both physicians and were home at the time. They rushed out and wrapped up my little sister in a blanket and headed straight to the nearest hospital. The interns and residents at the hospital were in a meeting at the time and were, “too busy” to attend to her massive head trauma. By the time we reached the next hospital, she had died .What a sad example for a seven-year-old child to suddenly realize that taking the, “Hippocratic Oath” must mean that you are a, HIPPOCRITE. Can you imagine what must have gone through my child’s mind seeing a hospital who did not care if a little girl died or not? 

2. One afternoon, when I was eleven-years-old, my Dad had gone to the hospital for an injection of a bronchiole dialator for his asthma called, “Aminophyline”. He suffered from a horrible allergic reaction and died within a few minutes.

3. After five years of hard work I then applied to medical school. I had hoped that just maybe I could help stop those unnecessary tragedies that befell my Dad and little sister.

At the end of my first year in medical school, I developed a horrible upset gut. The Dean of Men attributed my problem to, “freshman nerves”. After losing forty pounds, and a lot of my hair, and after being given two weeks of Paragoric, I looked at myself in the mirror and said, “self, you are going to die”. I went to see the Dean of Men the next morning, and I was so dehydrated that I spoke with a, “clicking sound”. He said to me that I could go into Public Health because it would be much less stressful…I looked like I had just come from a Concentration Camp.

I went to see my physician who with serum titers and my clinical symptoms diagnosed me with typhoid fever. My physician was livid that this, “Third World” disease could have been missed in a “high powered medical school”?

He also describes how he came to “discover” Plechner’s Syndrome. His mother was treated surgically for breast cancer, including removal of her adrenal glands and ovaries. She was on steroid replacement therapy, and Dr. Plechner’s independent reading convinced him she needed thyroid hormone supplementation. He convinced her doctor to provide this and took her subsequent good health as proof of his theories.

Is It Safe?

Since there is no research data whatsoever concerning the diagnosis and treatment of Plechner’s Syndrome, it is impossible to directly evaluate the risks of this approach. However, the glucocorticoids and thyroid hormone supplements Dr. Plechner recommend have well-recognized and potential serious side effects. While he claims that such side-effects will not occur at the doses and with the particular combinations of drugs he recommends, it must be remembered that the physiological arguments for why this is are not consistent with what the rest of the scientific community believes is the way the endocrine system works, and there is no controlled scientific evidence to show the disease he is treating even exists or that the treatment is safe or effective.

Using real drugs to treat a quite likely imaginary disorder is not a sensible way to care for our pets and our patients. While these drugs often make pets look or feel better in the short term, regardless of whether the imagined “imbalance” exists, this comes at the price of both risk from the drugs themselves and the risk of ignoring, masking, or simply overlooking  other real, and possibly treatable, disorders.

Bottom Line

Plechner’s Syndrome is an implausible hypothesis that conflicts with well-established scientific understanding of endocrinology. There is absolutely no supporting scientific data showing this theoretical disorder exists or that the proposed treatment is effective. Dr. Plechner is content with anecdotes, testimonials, and his own belief as sufficient evidence for his claims and has no intention of testing them through controlled scientific investigation. Most veterinary scientists, who generally prefer research data to storytelling, do not accept his claims.

Dr. Plechner, of course, feels this is due mostly to the veterinary profession’s fear that if his miracle cure is real it will lead to fewer sick patients and less income for veterinarians. This ridiculous and offensive suggestion is just one of many warning signs that he is promoting nonsense.

Dr. Plechner undoubtedly believes, genuinely and fervently, that he has “discovered” an important cause of disease that the rest of the scientific and medical professions have overlooked or suppressed, and he has convinced some clients and even other veterinarians of his claim. However, in the absence of any legitimate or compelling scientific evidence, despite apparently miraculous results, his treatment has not been accepted by the rest of the veterinary profession.

Just as there is no scientific evidence that Plechner’s Syndrome exists or that the proposed treatment for it works, there is no evidence to allow us to judge the safety of the approach. Using real drugs to treat a quite likely imaginary disorder is not a sensible way to care for our pets and our patients.

Posted in General | 224 Comments

Acupuncture–Not for the Faint of Heart

Posted in Humor | Leave a comment

Univ. of Tennessee Veterinary School Recognizes “Excellence” in Alternative Medicine

The University of Tennessee School of Veterinary Medicine is one of the most noticeable academic institutions that appears to have been co-opted for the promotion of pseudoscientific veterinary medicine (along with Louisiana State and the University of Florida). I have written previously about the Integrative Medicine program at UT and the $10,000 grant the college received from the American Holistic Veterinary Medical Foundation (AHVMF) explicitly for promoting (not studying) alternative therapies. Now, the university has presented its Distinguished Alumni award to two self-proclaimed “holistic” veterinarians. And these doctors were not honored despite their promotion of mystical pseudoscience but specifically because of it:

Dr. Marc Smith of Natchez Trace Veterinary Services and Dr. Casey Damron of White Oak Animal Hospital were recently honored with the “2012 Distinguished Alumni” Award at UT College of Veterinary Medicine in Knoxville, TN, for the creation of Pet-Tao Pet Foods and their service in the field of Alternative Veterinary Medicine.

Curious as to what about the creation of a pet food company might have merited such an award, I took a look at the Pet-Tao Foods web site. It is unashamedly dedicated to an approach to veterinary nutrition and health founded in the mystical nonsense of so-called Traditional Chinese Veterinary Medicine (TCVM). 

Our diets are truly “holistic” because each and every ingredient is chosen according to two Eastern theories that define the term “holistic” – Yin/ Yang and The Five element theory. No other pet food company has this unique perspective, experience, or credibility.

The theory [of TCVM] states that all naturally occurring events in the universe have two opposite aspects: male & female, up & down, hot & cold, dark & light. These opposing aspects are interdependent, dynamic and constantly struggling to maintain balance with each other…Food is a powerful determinant in the body’s struggle to maintain health and the balance of Yin and Yang.

In Traditional Chinese Veterinary Medicine, the five element theory explains the intricate relationships between the five naturally occurring elements in the environment: Metal, Water, Wood, Fire and Earth…When using this theory in regard to foods, one can control how organs function in the body.  For example, a geriatric dog with increased liver enzymes should be fed LIVER according to the 5 element theory. Feeding liver promotes liver function and healing while re-establishing balance of the liver with respect to other organs.

In keeping with this fanciful and completely unscientific approach to nutrition, the company does not produce foods for specific nutritional needs or medical conditions as understood in scientific medicine, but for balancing Yin & Yang and the Five Elements. This allows them to recommend a limited set of diets for any medical conditions regardless of the cause or the specific nutritional composition of the diet based entirely on their assessment of the degree of imbalance in these mystical principles identified in a TCVM evaluation (which is itself a complex and completely subjective evaluation of the tongue, the pulse, and other physical and historical factors according to rules based entirely on tradition and trial-and-error). The company’s diets include:

  • Harmony (Balanced) – No health problems, IBD.
  • Chill (Yin Diet) – Yin deficiency, panting, pacing at night, restlessness, cool seeking, hot environments, over-energetic dogs.
  • Zing (Blood Diet) – Blood deficiency, dry flaky skin, cracked dry footpads, anemia.
  • Blaze (Qi Diet) – Qi deficiency, tires Easily, warm seeking, chronic diarrhea, cold environments.
  • Soothe – Limited ingredient cooling diet.

It is probably unnecessary to point out that there is no scientific evidence to support the practice of selecting food ingredients to balance Yin/Yang or the Five Elements. This is an entirely mythological folk model similar, and likely historically related, to the Greek system of Humoral Medicine that led to the now mostly abandoned practices of bloodletting, purging, and other methods of  “balancing” the vital humours to manage health and disease.

The fact that veterinarians who are thoroughly trained in scientific medicine and who are often, at least in my experience, practicing perfectly competent science-based medicine, are able to believe in such nonsense and use it in their clinical work is a bit of an embarrassment to the profession. However, the fact that a mainstream university research and teaching institution sees the promotion of such mystical anachronisms as worthy of lauding with an award for “excellence” is much worse. This lends a thoroughly undeserved aura of legitimacy to ideas that belong on the rubbish heap of medical history along with the treatment of infection by bloodletting and of epilepsy by application of leeches.

 

 

Posted in General | 13 Comments