What Is It?
Prolotherapy is a commonly offered alternative treatment for joint, connective tissue, and back pain. The practice consists of injecting substances into painful or dysfunctional joints and connective tissue with the intent of relieving discomfort and restoring function. There is a wide range of substances that are used with a much variation among practitioners of prolotherapy. Examples of these substances include: dextrose or other sugars, Vitamin B12, local anesthetic agents, a wide variety of herbal products, homeopathic remedies, zinc sulfate, the patient’s own blood, and hundreds of others. Often, cocktails of multiple substances are used based on the individual preferences of the practitioner.

The theoretical rationale for the practice is that the substances injected into damaged joints or connective tissue will cause inflammation and chemical or cellular activity that will lead to repair of the affected tissues. (1,2) The logic of this theory is questionable. For one thing, inflammation is a normal physiologic response to tissue injury, and is already present in damaged tissues and joints. However, the evidence is clear that excessive or prolonged inflammation interferes with healing. Arthritis, a disorder prolotherapy is supposed to treat, is by definition chronic inflammation of joints, and this inflammation is known to cause much of the pain and tissue damage associated with arthritis. In general, excessive or chronic inflammation does more harm than good, and many conventional and alternative medical therapies are intended to reduce the deleterious effects of inflammation, so deliberately causing it to induce healing seems a dubious approach.

There are theoretical arguments involving the stimulation of cells involved in healing, such as fibroblasts, or the release of growth factors and other substances that are associated with tissue repair, which might plausibly explain how prolotherapy could be beneficial. However, the in vitro research to date suggests the effects of prolotherapy agents on tissues are broad and non-specific, and such effects are as likely to be harmful as beneficial. The underlying theory is questionable but not impossible. However, without a clearly demonstrated physiological mechanism and consistent animal model and clinical research evidence, it is not enough to justify the use of this therapy or the claims often made for it.

Does It Work?
There have been a number of studies and reviews investigating the use of prolotherapy in humans, and more are ongoing. Overall, the evidence has been mixed and of generally low quality. A Cochrane Review of prolotherapy for lower back pain examined five studies involving 366 people.(3) The review concluded,

There is conflicting evidence regarding the efficacy of prolotherapy injections for patients with chronic low-back pain. When used alone, prolotherapy is not an effective treatment for chronic low-back pain. When combined with spinal manipulation, exercise, and other co-interventions, prolotherapy may improve chronic low-back pain and disability. Conclusions are confounded by clinical heterogeneity amongst studies and by the presence of co-interventions.

The insurance companies Aetna and Cigna and the Veterans Administration have published extensive reviews of the scientific literature on prolotherapy.(4,5,6) The reviews conclude:

Aetna:

Aetna considers prolotherapy (also known as proliferant therapy or proliferation therapy) experimental and investigational for any indications because there is inadequate evidence of its effectiveness.

Cigna:

Medical studies in the literature evaluating this technology present few randomized, double-blind clinical trials that had adequate sample size and controls and that used objective outcome measures. Additionally, studies have not successfully supported the use of prolotherapy as an effective treatment for joint or ligament instability. Furthermore, several systematic reviews, a Cochrane review, and technology assessments have reported prolotherapy injections have not been proven to be as effective as or more effective than placebo injections. Additional randomized studies are needed to evaluate the efficacy of prolotherapy for joint or ligament instability. The evidence in the peer-reviewed, published scientific literature is insufficient to support the use of prolotherapy for any therapeutic indication.

Veterans Administration

Although proponents have advocated the use of prolotherapy for a range of indications, relatively few clinical uses have been studied systematically or published in the peer-reviewed literature. Results of the most recent systematic reviews are inconclusive for demonstrating the effectiveness of prolotherapy for treatment of musculoskeletal pain, and new evidence from case series would not alter these conclusions. The majority of published experimental studies have included conservative therapy with prolotherapy for relief of chronic low back pain, and to a lesser extent, osteoarthritis of the knee with varying results. Sample sizes have been insufficient on which to base national policy decisions.

These reviews are particularly useful as sources of references to studies examining prolotherapy. Reviewing the studies cited in these summaries, it is clear that the majority of positive results stem from trials without proper controls: randomization of subjects, placebo or no treatment control groups, proper blinding, etc. And because the agents used and other aspects of the treatments are inconsistent between studies, it is difficult to compare studies or to generalize from one study to a different prolotherapy treatment approach, and it is impossible to combine small studies in meta-analyses that might have greater power to determine if the treatment is truly effective.

It  is often the case that smaller and less rigorously designed studies tend to have positive conclusions. As the quality and quantity of research improves, many of these results turn out not to be trustworthy. Prolotherapy in humans is currently supported by a limited quantity of low-quality research. Until stronger evidence accumulates, if it does, the practice should be viewed as an experimental therapy of unknown benefits and reserved for circumstances in which conservative management and established conventional therapies are unsuccessful.

As is also often the case, there are absolutely no rigorous, controlled clinical studies of prolotherapy in dogs and cats. The use of this approach in pets is based entirely on anecdotal evidence, which is highly unreliable, and on extrapolation from human medicine, in which the practice has little supportive evidence and is not widely accepted as a legitimate therapy. Prolotherapy might be justifiable as an experimental intervention in cases in which better studied therapies with more established physiological rationales have failed or cannot be used, but it should not be marketed with strong claims of “proven” benefits, and it should not be used in lieu of conventional treatment.

 Is it Safe?
Any injection into a joint must be done with careful attention to technique to avoid introducing infection or damaging tissues, and sedation may be necessary for such treatments, so these are risks associated with but not unique to prolotherapy treatment of joints. In humans, there have been limited efforts to assess the risks of prolotherapy. One survey of practitioners of this treatment has been reported.(7)

Dagenias et al. (2006) studied the effects and adverse events related to prolotherapy for back and neck pain. The authors conducted a practitioner postal survey evaluating prolotherapy for back and neck pain in the United States and Canada. Surveys were mailed to members of the American Academy of Orthopaedic Medicine (AAOM) and the American College of Osteopathic Pain Management and Sclerotherapy (ACOPMS), both closely affiliated with prolotherapy conference, in addition to nonmembers attending the 2004 AAOM annual conference. A 50% response rate was obtained. The authors published that the side effect with the highest estimated median prevalence was temporary post-injection pain (70%), stiffness (25%), bruising (5%), and temporary numbness (1%). The most commonly reported adverse events (total of 472) were spinal headache (n=164), pneumothorax (n=123), temporary systemic reactions (n=73) and nerve damage (n=54). A total of 69 adverse events required hospitalization, and five resulted in permanent injury, secondary to nerve damage. Almost 98% of the respondents held MD or DO degrees, and 83% were board certified in related disciplines. The authors concluded that to better assess the true risk of adverse events related to prolotherapy, further well-designed clinical trials that are designed to over-come bias inherent to practitioner surveys are needed.

Overall, prolotherapy likely presents a low to moderate risk depending on the agents used and the skill and experience of the practitioner.

Bottom Line
Prolotherapy is a purported treatment for connective tissue and joint pain and disability. It involves injecting substances which induce inflammation and other chemical and cellular reactions into affected tissues. These reactions are theorized to relieve pain and improve function. The logic of this theory is questionable, and no clear mechanism for beneficial effects from prolotherapy has been described, but it is possible that the theory could be valid.

The clinical research on prolotherapy in humans is generally of low quality and results have been mixed. There is great variation in the techniques used by different investigators, so it is difficult to compare or generalize between studies.

There is virtually no controlled research investigating prolotherapy in companion animals, and all claims made for safety and efficacy in these species are based solely on anecdotal evidence.

The use of proltherapy in pets should be viewed as experimental with unknown risks and benefits. Such treatments should be reserved for patients that have significant symptoms that have failed to respond or cannot be treated by conventional means.

References
1. Banks, A.R. A rationale for prolotherapy. Journal of Orthopaedic Medicine. 1991;13(3). Accessed at http://www.prolotherapy.com/articles/banks.htm July 13, 2011.

2. Robinson, NG. Prolotherapy for pain. 2007. Accessed    at http://csuvets.colostate.edu/pain/Articlespdf/Prolotherapy%20for%20Pain.pdf July 13, 2011.

3. Dagenais S, Yelland MJ, Del Mar C, Schoene ML. Prolotherapy injections for chronic low-back pain. Cochrane Database of Systematic Reviews 2007, Issue 2.

4. Aetna. Clinical Policy Bulletin: Prolotherapy. Last revised May 24, 2011. Accessed at http://www.aetna.com/cpb/medical/data/200_299/0207.html July 13, 2011.

5. Cigna HealthCare Coverage Position: Prolotherapy. Last revised December 15, 2006. Accessed at http://stage.cigna.com/health/provider/medical/procedural/coverage_positions/medical/mm_0006_coveragepositioncriteria_prolotherapy.pdf July 13, 2011.

6. Adams E. Bibliography: Prolotherapy for musculoskeletal pain. Boston, MA: Veterans Administration Technology Assessment Program (VATAP); April 2008.

7. Dagenais S, Ogunseitan O, Haldeman S, Wooley JR, Newcomb RL. Side effects and adverse events related to intraligamentous injection of sclerosing solutions (prolotherapy) for back and neck pain: A survey of practitioners. Arch Phys Med Rehabil. 2006 Jul;87(7):909-13.

One of the most frustrating problems with the promotion of alternative medicine and approaches that have not been validated through appropriate scientific testing is that proponents often feel free to make sweeping claims about safety and efficacy despite the
absence of evidence to support these. Personal experience, tradition, or
suggestive pre-clinical research are touted as “proof” of these claims, rather than as the suggestive but poorly reliable bits of evidence they actually are.

Responsible, science-based practitioners are ethically bound to acknowledge the imitations in our knowledge and in the evidence supporting our practices (though being imperfect human beings, of course we may sometimes fall short in this). But practitioners
of alternative approaches can much more aggressively market their practices
beyond the claims justified by good research data, either because they accept
anecdote, intuition, tradition, and personal experience as sufficient evidence,
or sometimes because they disdain the whole epistemological enterprise of mainstream science.

Unfortunately, pet owners and other consumers of veterinary products and services don’t generally evaluate the validity of medical claims from a rigorously evidence-based perspective. In fact, a survey published in the journal Integrative Cancer Therapies, found that scientific evidence was not highly valued by cancer patients investigating
alternative medicine and that anecdotes, information from friends or the Internet, and other sources with low reliability were more highly valued.

Of course, this shouldn’t be surprising. I don’t have the knowledge or expertise to effectively evaluate the competing claims of rival economists, art critics, or automobile mechanics, and we shouldn’t expect every human patient or pet owner to be an expert on
medicine, statistics, epistemology, or the other areas of knowledge and training required to evaluate the evidence and determine the validity of scientific hypotheses and medical claims. That is, after all, our job as doctors. There is a strong ethical duty on the part of doctors to communicate the true state of the evidence for therapies their patients or clients might choose.

However, if we neglect to take this responsibility seriously and accept lower-quality standards of evidence as sufficient, the claims we make are going to be just as persuasive to our clients as those that are actually founded on high-quality scientific evidence.
There is, in fact, a significant advantage to being unconstrained by the limitations and inevitable ambiguities and complexities of scientific evidence when making claims about our treatments. If the only basis needed to claim your interventions work better than anybody else’s is that you believe they do, you are free to say about anything and say it with confidence!

A classic example of this is the blog of a prominent advocate for “integrative” veterinary medicine. This veterinarian makes extensive use of the “bait and switch” approach to
marketing alternative therapies. He advocates many conventional treatments and
then adds unproven “natural” therapies to these. Any positive outcomes are credited to the added natural therapies, rather than the conventional treatment or normal individual variation among patients. However, negative outcomes, such as cancer developing despite the use of natural remedies promoted as protective, are never cited as evidence that the unconventional therapies might not be effective. The whole package is aggressively promoted as superior to conventional therapy, which is denigrated whenever possible. Here is an example:

About 40 years ago, President Nixon declared war on cancer. His goal was to find a cure for this horrible disease. Sadly, we are no closer to reaching that goal today than we
were 40 years ago. In most cases…we really haven’t done a better job of treating or curing cancer. While it is true that survival rates have increased, this is mainly due to early diagnosis. People and pets with Stage 3 or Stage4 metastatic cancer rarely survive.

The situation is no better for our pets. While treatment protocols have changed over the last 40 years, most pets with cancer are expected to only live 6 to 12 months following
diagnosis, and that’s ONLY if owners spend thousands of dollars treating the pet with surgery, radiation, and chemotherapy.

The good news is that using an integrative approach changes these sobering facts and statistics. Designing individualized treatment protocols for each person or pet with cancer,
incorporating a proper diet, nutritional supplements, and other natural therapies offers a much better prognosis for the cancer patient. We now have large volumes of research to show exactly how these natural therapies work in killing cancer and extending the lives of cancer patients.

In my own practice, the average pet with cancer, given a prognosis of 6 to 12 months of life
expectancy from conventional veterinarians, typically lives 12 to 24 months or even longer. Additionally, many pets with “incurable” cancers are cured from their cancers using an integrative approach to boost the pet’s immune system, kill cancer cells, reduce the spread of cancer, and detoxify the patient.

The world of integrative oncology offers much hope for the cancer patient. Integrative
doctors are helping people and pets with cancer live longer lives and in many cases curing cancers that are still considered incurable by conventional medicine.

…After surgery cuts out most of the cancer, and chemotherapy kills most of the cancer, and radiation burns most of the cancer, what’s left to do destroy any remaining
cancer cells? Absolutely nothing! Unless the patient continues therapy, using a combination of proper diet, mind-body medicine, and nutritional supplements, any cancer cells that have survived conventional therapy will, at some point, continue to grow, spread, and ultimately kill the patient.

The sad news is that so many cancer patients will ultimately die after surviving conventional therapies because nothing is done to prevent the recurrence of cancer…not one of these patients is doing anything “natural” to support her immune system or continue the fight against cancer once conventional therapies have finished. How sad and tragic to know that many people will needlessly die out of ignorance once their cancer returns.

…In my own veterinary practice, while I can never offer guarantees to my patients, I tell them that based upon my years of using natural therapies to help pets with cancer, I expect my patients to live one and a half to two times longer than their conventional doctors expect them to live IF they will use properly prescribed natural therapies.

So what are the general messages in this article?

1. Conventional medicine has made almost no meaningful progress in cancer treatment in the last 40 years.

2. Conventional therapy is icky (cutting, burning, and killing), expensive, and ultimately not very effective since most pets die of their cancer anyway after less than a year.

3. An “integrative” approach adding “natural” therapies to conventional treatment can
reliably help patients live up to twice as long as those treated conventionally, and can frequently cure cancers when mainstream medicine cannot.

Despite the reference to “large volumes of research” supporting these claims, none is provided in this article. The first claim is obviously and demonstrably untrue. The second consists of an attempt to derogate life-saving therapies by describing them in hostile
language combined with a falsehood. And the third claim is merely opinion with no reliable evidence supporting it.

Clearly, the burden of proving medical claims that are not generally accepted by the medical profession properly falls on the person making the claims. The absence of any effort to support these statements and implications with any evidence beyond personal opinion is a deliberate choice reflecting the author’s lack of interest in careful scientific
demonstration of the value of the therapies he recommends. While I do not intend to do the work of collecting and evaluating the research evidence for this author, I will point out some of the clear factual errors and (deliberate?) misstatements he makes.

1. We haven’t made any significant progress in cancer treatment in 40 years.

This is common claim on the part of those promoting alternative cancer therapies is patently false and has been debunked extensively elsewhere (e.g. A New Perspective on the War on Cancer, which reviews a book on the subject, the Emperor of All Maladies: A Biography of Cancer). Cancer has become a prominent cause of death as people have stopped dying as soon and often from infectious diseases, trauma, malnutrition and many of the other causes of mortality that science and science-based medicine has dramatically reduced. We have a long way to go in figuring out all the factors that contribute to the development of cancer and in preventing and treating cancer. But that is a far cry from saying that we have made no significant progress in the last four decades.

In addition to Acute Lymphocytic Leukemia, which the author acknowledges as an example of a cancer for which we have seen dramatic progress in treatment and patient outcomes, many other childhood cancers are now curable or can be very successfully treated (1). Overall cancer incidence and mortality are falling due to a combination of efforts aimed at prevention, early detection, and improvements in treatment (2). While some cancers have been resistant to the development of effective therapies, others
have seen dramatic increases in the length and quality of life granted by treatment. The National Cancer Institute regularly reports on trends in cancer diagnosis and treatment, and their data clearly shows significant progress since the passage of the National
Cancer Act in 1971.

There is no question the dramatic changes in cancer treatment in the early 20th century have largely been replaced by more incremental and less satisfying small improvements, and we all hope for much greater success in the future. But there clearly has been
significant progress in the last 40 years, and it should be noted that it has
all been due to improvements in science-based, conventional therapy, not so-called alternative medical approaches.

2. “People and pets with Stage 3 or Stage 4 metastatic cancer rarely survive.”

This is one of those statements that is trivially true and also deeply misleading. Of course the most advanced cancer has the shortest life expectancy. The whole point of cancer screening and early treatment is to prevent cancers from progressing to these advanced
stages. The implication for a statement like this is, of course, that by using the author’s methods we could do better. As usual, no evidence is provided to support this assertion.

Since I, like the author of this article, am a general practitioner, I asked a colleague, Dr. Gerald Post, who is a veterinary cancer specialist, to address some of the other specific factual claims made in the article. He was kind enough to share his expertise, and here
is what he has to say:

I usually don’t comment on or disparage my fellow veterinarians, but the claims made by this person were so egregious I could not stop my fingers from pounding on my
keyboard.

Claim A:  “most pets with cancer are expected to liver 6-12 months following diagnosis, and that’s ONLY if owners spend thousands of dollars treating the pet with surgery, radiation, and chemotherapy.” HOGWASH! As a veterinary oncologist, all is see, day in day out is cancer. Many of the cancers that I treat have median survival times of 12 months or longer. We recently published a paper documenting that the survival time for dogs with B cell lymphoma treated with our protocol was over 600 days!!!! Median means that 50% of these dogs lived OVER 600 days.

There are many cancers, such as mammary tumors and many skin tumors that don’t ever see an oncologist—not because they die, but because they are very adequately treated by general practice veterinarians. In many cases these tumors are cured by them and don’t even need an oncologist (and for a veterinary oncologist to say he is not needed is saying a lot).

Claim B: “ In my own practice, the average pet with cancer, given a prognosis of 6 to 12 months of life expectancy from conventional veterinarians, typically lives 12 to 24
months or even longer. Additionally, many pets with “incurable” cancers are cured from their cancers using an integrative approach to boost the pet’s immune system, kill cancer cells, reduce the spread of cancer, and detoxify the patient.”

At the risk of repeating myself HOGWASH!!

Where is the proof for any of these statements? As an ethical doctor, if I were to make any of these statements, I would need to have some evidence –aside from my own beliefs—that
the statements were true. After an exhaustive search of the veterinary medical literature, I was unable to find one reference to support any of the assertions made. Immunotherapy is a very valid treatment, don’t get me wrong. The use of IL-2 in dogs with metastatic cancer is documented. Feline interferon can be used to improve the immune response and increase survival in cats infected with feline leukemia.  These very reputable articles, however, make no claims on curing cancer.

Claim C: ”After surgery cuts out most of the cancer, and chemotherapy kills most of the cancer, and radiation burns most of the cancer, what’s left to do destroy any remaining
cancer cells? Absolutely nothing!”

I am assuming that the author just never heard of metronomic chemotherapy or small molecule inhibitors/tyrosine kinase inhibitors. To make the statement that absolutely
nothing can be done post-chemotherapy, radiation therapy, or surgically is
……you guessed it HOGWASH! Metronomic therapy—the use of very low dose cyclophosphamide, an NSAID, as well as doxycycline, has been shown to decrease
the recurrence rate for soft tissue sarcomas, hemangiosarcomas, and theoretically, because it works by inhibiting the in-growth of new blood vessels—something all tumors need to grow larger than 1-2 mm—it can work on any tumor type.

Please make a note that for the claims I am making, I give you the reader and my clients
information based upon documented and peer-reviewed studies. No one is saying that all studies are absolutely factual or that future studies will not refute some claims made by earlier studies. But I am saying that basing my recommendations and claims on evidence IS important. As a reader and as a client you deserve it. When you see a doctor you are relying not only on his or her expertise, but also on the combined knowledge of all the
clinician/scientists in the world!

At the end of the day, the reason why evidence is important is respect! Respect for my clients, respect for my patients and respect for my profession. I truly believe that
those people who seek out cancer treatment for their pets love their pets dearly and are intelligent people, who deserve the best information possible. This empowers them so that they can ultimately make the wisest decision for themselves.

3. Adding “natural remedies” to conventional cancer treatment can prolong life and even cure cancers conventional treatment alone cannot.

This is the core advertising message in the article, and there is not a speck of evidence to show it is true. Substituting alternative medicine for conventional cancer treatment is almost always harmful, as the sad outcome of the NCCAM-funded study of the Gonzalez cancer therapy for pancreatic cancer and many individual anecdotes illustrate. As for adding unproven therapies to conventional treatment, there have been numerous pre-clinical studies and small, low-quality clinical trials published investigating specific alternative therapies used in this way. A few positive results have been reported here and there,, but there is certainly no clear and persuasive body of evidence to show that such an
approach improves quality of life, survival, or any other meaningful, measurable outcome of cancer treatment. This claim is pure ideology and advertising unsupported by solid science. As such, it is at least deeply unethical and at worst false advertising.

Bottom Line

The claims made in this article disparaging scientific cancer therapy and lauding the benefits of adding unproven alternative methods to conventional treatment are unsupported by reliable scientific evidence. Science has made significant progress in
preventing, detecting, and treating cancer and undoubtedly will continue to do
so. This progress has been, and will continue to be due to rigorous, systematic
scientific research. A reliance on tradition, anecdote, personal clinical
experience, and low-quality scientific evidence to justify cancer therapies is
not in the best interest on cancer patients. The good news is that scientific medicine offers real hope for continued improvement in the length and quality of life for cancer patients. The bad news is that some of these patients will be denied the full benefits of scientific medicine and subjected to unnecessary, unhelpful, and sometimes even harmful alternatives if they are misled by sweeping and confident claims unsupported by real evidence. It is our responsibility as doctors to ensure our patients and clients have the full and true facts about their options so they can choose the best possible care for
themselves and their pets.

An abstract presented at this year’s American College of Veterinary Internal Medicine reports on a study hypothesizing that low level laser therapy would shorten recovery times in dogs having back surgery for ruptured intervertebral disks and hind limb paralysis.

C.C. Williams; G. Barone. Is Low Level Laser Therapy an Effective Adjunctive Treatment to Hemilaminectomy in Dogs with Acute Onset Parapleglia Secondary to Intervertebral Disc Disease? Proceedings, American College of Veterinary Internal Medicine Forum, Denver, CO. June, 2010.

I’ve reviewed the evidence for cold laser therapy before, and it is generally of low quality and mixed. Overall, it is possible this therapy could have beneficial effects, but it is far from convincingly demonstrated at this point.

I would have expected this small study to find positive results. Of course most studies do regardless of the truth of the underlying hypothesis, which is why preclinical evidence and replication are so critical to effective evaluation of medical interventions. And unfortunately, many investigators and journal editors are reluctant to publish negative results, even though these are the most useful results. So I give these authors great credit for having the intellectual integrity to publish results that do not support their original hypothesis. That is how good science should be done. (Of course, they conclude by suggesting that the negative results were merely an artifact of the small size of the study not truly evidence that their hypothesis was incorrect. Such attempts to put the most positive possible spin on negative results are ubiquitous and probable unavoidable, so that shouldn’t be held against them).

The study involved 17 dogs with naturally occurring disease, ruptured intervertebral disks leading to partial or complete hind limb paralysis. All dogs had surgery (hemilaminectomy). They were divided into a group that also received 4 days of laser therapy following surgery and a group that did not. It is not clear if this allocation was random, or if there were any significant differences in the composition of the two groups. These are very important factors in evaluating the meaning of the results.

There is also no mention of any blinding, placebo control, or other attempt to control for possible bias beyond utilizing the same pain medication protocol for both groups. This significantly raises the risk of bias in the study. Such bias would almost certainly favor a positive result.

In any case, the investigators found no difference in recovery time between the two groups. Given the limited bias controls in the study, this is a bit surprising. Certainly, this small study cannot be taken as definitive regardless of the results. But it is one more bit of evidence to consider in the overall evaluation of the possible uses of cold laser therapy, and a bit which shifts the balance slightly in the negative direction.

Update: After this post was published, I became aware of a second, very similar study with different results:

W.E. Draper; T.A. Schubert. Low Level Laser Therapy as an Adjunctive Therapy to Thoracolumbar Decompression for Canine Intervertebral Disk Disease.

This study followed 36 dogs with acute hind limb weakness or paralysis due to intervertebral disk rupture. These dogs were assigned by alternating allocation to receive standard surgical therapy and post-operative laser therapy or standard treatment only. There was, again, no blinding or placebo control. The outcome measure assessed was the average time until the dogs in each group could walk. Those dogs receiving laser therapy were ambulatory after an average of about 6 days, compared to about 12 days for those not in the laser treatment group.

These positive results conflict with those of the other study. Again, positive results are what I would expect from an unblinded and uncontrolled trial, so they must be interpreted cautiously. Though the outcome measure itself is appropriate, it can involve some subjective judgments, and without randomization, blinding, and placebo controls, it is impossible to be certain that the treatment and control groups did not differ in some relevant way other than the treatment under investigation.

So from the point of view of an evidence-based analysis of the preponderance of the data, these two studies do little to settle the question of what if any value cold laser therapy might have in intervertebral disk disease. Their different results may be due to differences in patient population, laser treatment technique, or some other factor that obscures the true benefit of laser therapy in the first study. Or, they may differ because the second study was subject to some uncontrolled bias that did not operate in the first. I any case, the question is still an open one, and hopefully as more evidence accumulates we will be able to answer it more clearly.

I initially wrote about Evolution Diet, and its promoter Eric Weisman, in 2009. In my first article, I primarily addressed the  irresponsible and false advertising for the product, and I only touched briefly on Mr. Weisman’s bogus academic credentials and anti-scientific philosophy. Then a few months ago, thanks to information from a reader, I wrote an update which specifically addressed Mr. Weisman’s long history of violating the laws governing his work as a chiropractor as well as those regulating the practice of veterinary medicine. Beyond simply having a unscientific and utterly false set of beliefs about pet health and nutrition, and an egregiously misleading and inappropriate approach to marketing his products, Mr. Weisman was also clearly a scam artist with no regard for the reasonable and appropriate laws governing veterinary and human medicine.

Fortunately, it now appears that finally, almost 30 years after the first action taken against Mr. Weisman in 1982 by the Minnesota Board of Chiropractic, Mr. Weisman will face criminal charges for his actions. According to news reports, he will face 58 counts, including practicing human and veterinary medicine without a license and animal cruelty. I have argued before that the legal system does not effectively control even dramatic cases of quackery and medical fraud, and it is disappointing the Mr. Weisman has been able to continue to profit from taking advantage of sick people and the owners of sick animals for so many decades. But it is encouraging to see him face at least some consequences at last.

The news reports contain some quite horrific examples of Mr. Weisman’s conduct. He allegedly prescribed nutritional and supplement “treatments’ for people with cancer, diagnosed and treated animals with cancer (including some who did not actually have cancer), and consistently falsely represented himself as trained and qualified to diagnose and treat both human and animal illness.

Perhaps the most disturbing story for me as a veterinarian was of a cat Mr. Weisman brought to the veterinary hospital at the University of Minnesota.

Weisman brought in a cat he suspected had kidney failure and cancerous lesions, the complaint said. According to the U’s veterinarian, the cat had neither – it died of pneumonia, was unable to absorb nutrients from the food it ate and had broken bones in each of its front legs. The suspected cancerous lesions, the veterinarian said, were actually scabs caused by the cat walking on its joints instead of its broken feet, the complaint said.

That someone capable of such cruelty could present himself as a public benefactor and a martyr seems inconceivable, but Mr. Weisman’s delusions include just such a perception of himself.

[I am] being attacked because I try to help make a better, more just society. I try to help those that do not have help or are not getting good assistance.

This case illustrates quite starkly the real harm and suffering that can result from irrational and unscientific beliefs about health and disease, and from the actions of individuals who are so blindly committed to such beliefs that they are capable of inflicting terrible harm on those who come to them for help while still seeing themselves as heroes and victims of government and the conventional medical profession.

As promised, here is the first tidbit out of Massimo Pigliucci’s Nonsense on Stilts that I want to share. (Technically, it’s not Dr. Pigliucci’s tidbit since he is summarizing part of another book, John Casti’s Paradigms Lost. But Piglucci’s book is where I found it.) These red flags make a nice addition to the various signs of medical nonsense I’ve discussed before (1, 2, 3). Since I have not read the original source for these qualities of pseudoscience, and they were listed but not discussed in detail by Dr. Pigliucci, I may not be interpreting them in precisely the same way as Dr. Casti intended, but they do resonate with my own experiences dealing with proponents of pseudoscience.

1. Anachronistic Thinking: I take this to mean both an inappropriate reverence for the supposed historical longevity of an idea as well as ways of looking at health and disease that come from historical eras before a scientific understanding was possible and that are essentially mythological. Claiming that Traditional Chinese Medicine or acupuncture or some other therapy are thousands of years old (which often isn’t true anyway), and implying that this says something positive about the effectiveness of the approach is an example of anachronistic thinking. So is employing mystical, pre-scientific models of health and disease, such as referring to unmeasurable “energies” as the source of health or illness and the like.

2. Glorification of Mysteries: A mystical perspective often requires that the core truth about something be ultimately unknowable. While science accepts that there is much we do not know, and that there may be things we cannot know, it is fundamentally based on the premise that we can and should try to understand the natural world. If someone tells you health and disease are dependent on mysterious spiritual essences that can never be rationally understood or empirically examined, then you are dealing with pseudoscience.

3. Appeal to Myths: Myths are central to the justification of many pseudoscientific ideas. Fables and other narratives that are unproven or manifestly untrue lie behind non-medical pseudoscience, such as the study of UFOs and cryptozoology, as well as many pseudoscientific theories in medicine. The stories told about toxins in our environment, the mythology about how the natural history of dogs and cats requires them to eat raw diets, the stories about how vaccines and conventional medicines damage the immune system or otherwise do more harm than good, are all examples of myths that are used to justify pseudoscientific approaches to medicine.

4. A Cavalier Approach to Evidence: It is becoming more popular for advocates of pseudoscientific theories, such as homeopathy and homotoxicology for example, to pretend that they are approaching their ideas in an evidence-based manner. However, a closer inspection of their arguments finds an excessive and inappropriate reliance on testimonials, traditions, and other low-quality narrative forms of evidence along with a disdain for clinical trials and pre-clinical evidence. This is not surprising since testimonial narratives are far more likely to appear to validate such approaches than are higher quality forms of evidence.

This goes along with two other characteristics cited by Dr. Pigliucci which seem closely related, “explanation by scenario” and “‘literary’ rather than empirically based interpretations of facts. Pseudoscience is very much an enterprise which tells compelling stories and dresses them up to look like science but which fails to adhere to the methodological core of science, which is objective and systematic collection and analysis of empirical data intended to validate or invalidate the specific predictions of coherent theories about the natural world.

5. Extreme Resistance to Revising One’s Position: Cognitive dissonance is a powerful force in all of us. But pseudoscience as a collaborative social activity is often deliberately focused on maintaining and buttressing beliefs, whereas science is specifically intended to continuously updated and, when necessary, replace its own theories. Science may often be wrong, but as Pigliucci points out, it is always scientists who discover and reveal the errors of other scientists, not those who criticize the scientific enterprise from outside. This emphasis on disproving gives science, unfortunately, an aura of negativity which hampers its public relations. But this is to some extent a function of the very nature of the activity, which is to disprove rather than validate ideas. Negative results are more reliable because our cognitive biases are designed to support and maintain our beliefs. So if a particular medical approach is designed to be self-sustaining and criticism of it is viewed with great hostility (which can so easily and often be seen in the comments posted on this blog), then that approach is likely to be pseudoscience.

6. A Tendency to Shift the Burden of Proof: It is axiomatic in scientific discourse that those who make extraordinary claims bear the burden of providing evidence for these claims. Since pseudoscientific approaches to medicine often lack the support of compelling empirical evidence, advocates for them frequently attempt to shift this burden to critics. It makes no sense, however, to demand that critics prove an implausible idea untrue. If I claim to be the President of the United States, should that claim be automatically accepted unless a skeptic collects sufficient evidence to disprove it, or should I be expected to be the one to prove such an unlikely assertion before it is accepted?

7. Sympathy for a Theory Just Because It’s New or Daring: Pseudoscience is often centered on supposedly new ideas (though these often turn out to be recycled) which lone geniuses claim to have discovered and which mainstream science has somehow overlooked. Often these ideas are dramatic departures from conventional understanding which, if true, would replace the dominant paradigm. It is natural to see such unexpected and dramatic claims as appealing. In America in particular, I think, we have a sympathy for the rebel and the outsider. However, the less exciting reality is that most new ideas, conventional or unconventional, turn out to be wrong. And dramatic revolutions in scientific thinking are uncommon. We simply forget all the new and daring ideas that turned out to be wrong, and remember those few that were eventually validated. This gives us an inaccurate sense of how likely such paradigm shifts are. A hallmark of pseudoscience, then, is what I have elsewhere called the Galileo Complex, in which ideas are viewed positively because they seem new and dramatic.