It can’t be said enough that we vets would be worthless without veterinary nurses/technicians, and most people will never understand how hard and important their job is. But this brilliant song from one of the technicians I’m lucky enough to work with comes close!
Examples of the victory of fear and misinformation over science and reason in public policy are easy to find, and I find myself writing about them often. But occasionally the pendulum swings in the right direction for a bit, and we gain a little ground in the never-ending conflict between rational, science-based governance and faith-based, anti-science politics. My own state of California has provided a welcome example this year.
In the spring, I worked to support the passage of SB 277, a bill eliminating non-medical exemptions from school vaccination requirements, and I was thrilled to see the bill pass the legislature and be signed into law by Governor Jerry Brown in June. IN his signing statement, the governor emphasized that “the science is clear that vaccines dramatically protect children” and that “the evidence shows that immunization powerfully benefits and protects the community.” Despite the hysteria and misinformation marshaled against the legislation, both the legislature and the governor made rational decisions in the best interests of public health.
Even more encouraging is the failure of the opposition to SB 277 to generate enough public support for a referendum overturning the measure. California’s referendum system too often makes public policy decisions a popularity contest, but in this case even the relatively low number of citizens needed for the referendum process could not be sufficiently misled to support this anti-vaccine measure.
Only a few days ago, the governor signed yet another important public health measure, SB 792, which requires childcare workers in daycare facilities and other settings to be appropriately vaccinated. The anti-science and anti-government hysteria associated with this bill was, if anything, even more strident and absurd than that regarding SB 277, yet the legislature and the governor did what was best for the public based on science, not fear.
Finally, Governor Brown recently took another tough stand on a science-based issue, this time vetoing a “right-to-try” law, AB 159. This well-intentioned but misguided legislation was intended to make it easier for people with terminal or untreatable illness to get access to experimental, unproven drugs with the notion that ”they have nothing to lose” and so should be allowed to use experimental therapies. Right-to-try laws sound like they are intended to benefit patients, but they are really part of an organized campaign to use these patients’ suffering as a toll to undermine FDA regulations and the drug approval process. The doctors at Science-based Medicine have written extensively about how these laws actually put patients at risk of greater suffering and earlier death, and how they undermine the science-based system of drug testing that protects all of us from harmful therapies. (1, 2, 3). In 24 states so far, desperate patients and their families and advocates have been used to force passage of such laws on purely emotional grounds despite the evidence that they do not help patients. These laws, like the “health freedom” movement have much more to do with a general distrust of government regulation and a libertarian political view than with evidence-based efforts to help patients.
It is refreshing, if still to uncommon, to see politicians making sound, science-based decisions about health policy and resisting the emotional, fear-based rhetoric of anti-science and anti-government activists. I’m not naïve, and I’ve seen enough change in the political winds over the decades to realize the pendulum will continue to swing, but it is worth celebrating each victory and hoping for gradual progress to a more rational, science-based culture.
I’ve written before about why the near magical status of antioxidant supplements, supposed to be miraculous in preventing or treating disease and aging, is inconsistent with science and not supported by good evidence. Antioxidants in general, and specific supplements like resveratrol (1, 2, 3) and Vitamins C and E (4, 5, 6), and even antioxidants in foods, have proven far less miraculous than hoped or claimed by alternative practitioners, and some have even proven harmful. Some studies intended to investigate whether antioxidant vitamins can prevent or treat cancer have actually found an increase in risk. A new laboratory study provides a bit more evidence concerning the potential risks of such chemicals.
LeGall K., et al. Antioxidants can increase melanoma metastasis in mice. Science Translational Medicine. 2015;7:308.
The article is behind a paywall, but a description of the results published elsewhere suggest that antioxidants can promote tumor growth and invasion under some circumstances. This is consistent with previous research, though the actual effects in patients with naturally occurring disease is not clear.
These results don’t mean antioxidants might not have value in prevention or treatment of some diseases. But like anything which affects the complex physiological processes of the body, they can have unintended consequences. This means they must be used rationally and with appropriate research evidence to support their use, not treated as magical and safe panceas.
Introduction
This lecture had surprisingly little information about acupuncture itself. It began with a review of the pathophysiology of spinal cord injury and the typical steps for evaluating and stabilizing patients presenting with acute spinal cord injury. Most of the treatments discussed were standard, conventional therapies (surgery, anti-inflammatory and analgesic medications, exercise and physical therapy, etc), and it was emphasized that acupuncture and the other alternative treatments recommended were not intended as substitutes for standard conventional care.
This reinforces the fact that unlike course offered by the Chi Institute and others promoting a TCM perspective, the instructors of this course are making a sincere effort to approach the subject of acupuncture from a science-based perspective. I have disagreed with a number of their conclusions about acupuncture so far, but I believe their claims and the evidence they present are worth evaluating seriously, unlike the obvious mythological nonsense of TCM. Just as I challenge the stereotypes and clichés put forward about conventional medicine and veterinarians who practice it, it is important that as skeptics we not stereotype or prejudge people who make claims that we find dubious or ultimately reject as untrue.
The emphasis of the lecture was on the relationship between the physiology of spinal cord injury and the goals of therapy- controlling pain, preventing secondary injury associated with inflammation, ischemia, and other factors following the initial trauma, and preserving and restoring neurologic function. In general, the claims made for specific therapies, including acupuncture, were based on the plausible mechanism identified in the pre-clinical and animal model literature I have already acknowledged exists for needling and, especially, electrical stimulation using acupuncture needles.
My main objection to some of these claims I that they trust the translation from experimental studies to clinical patients more than I think is justified. Just because preclinical studies find effects by which acupuncture and other therapies might work doesn’t mean they will work in real patients. It only means that some clinical research is justified. And to date, that research either hasn’t been done or has been limited and unconvincing for most of the methods described in this lecture.
Non-acupuncture Therapies Suggested for Spinal Cord Injury
I will briefly discuss the main non-acupuncture therapies suggested as possible adjuncts to standard care.
PEG, and the related compound P 188, are polymers that are hypothesized to protect and facilitate repair in damaged nerve tissue. Most of the research on the effects of PEG in spinal cord injury have been rodent model studies. A systematic review identified 5 studies involving systemic administration of PEG (as opposed to direct application to the spinal cord, which would not be practical in most veterinary patients), most in rodents and one in dogs:
The extensive body of literature from Dr. Borgens’ lab on the use of PEG in a guinea-pig model of SCI has arguably served as the basis for interest in PEG as a neurooprotective agent.
Of the five studies identified in this systematic review, three utilized Wistar or Sprague Dawley rats with either clip compression or contusion injuries, one utilized a guinea-pig model with a forcep crush injury, and one utilized canines who suffered paraplegia from intervertebral disc herniations…Subcutaneously injected PEG was reported to be effective with a delay in intervention of 6?h post injury (Borgens and Bohnert, 2001), and dogs treated with PEG within 72?h of injury were reported to recover better than historical controls. In a rat SCI model, a 1-h time window of efficacy was reported by Baptiste and colleagues (2009).
With respect to non-behavioral outcomes, PEG was reported to decrease NF200 degradation, reduce apopotosis, and improve tissue sparing at the lesion site (Baptiste et al., 2009). In contrast, Kwon and colleagues (2009) and Ditor and colleagues (2007) found no significant tissue neuroprotection with PEG alone. With respect to behavioral outcomes, Borgens and Bohnert (2001) reported improved electrophysiologic recordings and the return of the cutaneous truncal muscle reflex after PEG treatment, and reported improved hindlimb recovery in PEG-treated dogs as compared to historical controls. Baptiste and colleagues (2009) reported modest improvements in BBB scores in PEG-treated animals, but no improvement on inclined plane testing. Ditor and colleagues (2007) also reported very modest improvement in BBB scores and a reduction in allodynia with PEG treatment.
This research suggests there might be some beneficial effects, though the effect size and clinical relevance cannot be determined from such lab animal studies. The canine study is the most relevant to veterinary use of PEG:
Laverty PH, Leskovar A, Breur GJ, Coates JR, Bergman RL, Widmer WR, Toombs JP, Shapiro S, Borgens RB. A preliminary study of intravenous surfactants in paraplegic dogs: polymer therapy in canine clinical SCI. J Neurotrauma. 2004 Dec;21(12):1767-77.
In this study, 19 dogs were treated with surgery and steroids (which are now quite controversial and less frequently used) as well as PEG or P 188. The outcomes were compared against historical records of dogs with similar disease treated in the past. This sort of design introduces a lot of potential confounding factors, so the results must be viewed cautiously. In this case, the PEG-treated dogs recovered better than the historic controls, however those dogs generally did much worse than is typically reported for dogs receiving standard care.
No subsequent clinical trials have yet been published, although one funded by the Morris Animal Foundation is underway at the North Carolina State University veterinary college. PEG remains a potentially useful but as yet unproven adjunctive therapy for dogs with spinal cord injury. The studies so far have not identified any significant risks, though more research is needed to ensure safety as well as efficacy.
2. Oscillating electrical fields-
Various forms of electrical stimulation have been found, in in vitro or animal model studies, to have effects on damaged nerve tissue that might potentially be beneficial to patients. And as previously discussed, some of the most positive research on acupuncture involves so-called “electroacupuncture,” which arguably is just another method of providing electrical stimulus with little in common with historical acupuncture practices. There is some limited clinical research suggesting possible beneficial effects of oscillating electrical field stimulus. According to a recent review:
This oscillating field stimulator (OFS) has been tested in two studies in dogs with sub-acute spinal injuries, with beneficial outcomes.41,42 These studies led to a phase 1 trial with an OFS in humans with acute traumatic SCI.43 The stimulator was implanted within 3 weeks after injury, and remained in place for 15 weeks. The stimulation provided significant improvement in two measures of sensory sensitivity and in seven out of nine patients improved motor scores were observed, compared to historical data for untreated patients. Although an erratum was later published concerning some discrepancies in functional scoring, the fundamental conclusions of the trial are still compelling.
Borgens RB., Toombs JP., Blight AR., McGinnis ME., Bauer MS., Widmer WR., and Cook JR., Jr.: Effects of applied electric fields on clinical cases of complete paraplegia in dogs. Restor Neurol Neurosci 1993; 5:305.
Borgens RB., Toombs JP., Breur G., Widmer WR., Waters D., Harbath AM., March P., and Adams LG.: An imposed oscillating electrical field improves the recovery of function in neurologically complete paraplegic dogs. J Neurotrauma 1999; 16:639.
Shapiro S., Borgens R., Pascuzzi R., Roos K., Groff M., Purvines S., Rodgers RB., Hagy S., and Nelson P.: Oscillating field stimulation for complete spinal cord injury in humans: a phase 1 trial. J Neurosurg Spine 2005; 2:3.
3. Hyperbaric Oxygen (HBOT)-
I have summarized the evidence for hyperbaric oxygen therapy in detail before. My overall conclusion was:
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….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.
A systematic review of HBOT for spinal cord injury has been published:
Ninety-three studies were identified in the database Pubmed. Among these, through a set of inclusion/exclusion criteria, 11 articles published between 1963 and 2009 were selected. In the nine experimental studies, different ways to apply the treatment were observed. The measured outcomes were: functional, histological, biochemical and electrophysiological.
In most of the studies, the results show recovery of locomotor function, histology and/or biochemical features. Regarding the two studies in clinical samples, the results are controversial. The samples are heterogeneous and the application of hyperbaric oxygen therapy is not the same for all patients in each study. Considering the results of this review, further studies are necessary to define the role of hyperbaric oxygen therapy in acute spinal cord injury.
This does not amount to very strong evidence to recommend HBOT for dogs and cats with spinal cord injury.
4. Antioxidants-
This is, of course, a pretty broad and vague category. Oxidative damage has been identified as a component to secondary injury in cases of spinal cord trauma, so it is reasonable to hypothesize antioxidants might have some clinical value. However, similar reasonable hypotheses regarding the role of antioxidants in aging, cancer, and other health conditions have not held up well to rigorous investigation, so a reasonable hypothesis alone is not sufficient. A couple of examples will illustrate the complex and inconsistent research results in this area:
Yao M, Yang L, Wang J, Sun YL, Dun RL, Wang YJ, Cui XJ. Neurological recovery and antioxidant effects of curcumin for spinal cord injury in the rat: a network meta-analysis and systematic review. J Neurotrauma. 2015 Mar 15;32(6):381-91. doi: 10.1089/neu.2014.3520. Epub 2015 Jan 9.
Eight studies with adequate randomization were selected and included in the systematic review. Two studies had a higher methodological quality. Overall, curcumin appears to significantly improve neurological function, as assessed using the Basso, Beattie, Bresnahan (BBB) locomotor rating scale (four studies, n=132; pooled mean difference [MD]=3.09; 95% confidence interval [CI], 3.40-4.45; p=0.04), in a random-effects model and decrease malondialdehyde (MDA) using a fixed-effects model (four studies, n=56; pooled MD=-1.00; 95% CI=-1.59 to -0.42; p=0.00008). Effect size, assessed using the BBB scale, increased gradually with increasing curcumin dosage. The difference between low- and high-dose curcumin using the BBB scale was statistically significant. Neurological recovery and antioxidant effects of curcumin were observed in rats with SCI despite poor study methodological quality.
Cristante AF1, Barros Filho TE, Oliveira RP, Marcon RM, Rocha ID, Hanania FR, Daci K. Antioxidative therapy in contusion spinal cord injury. Spinal Cord. 2009 Jun;47(6):458-63. doi: 10.1038/sc.2008.155. Epub 2008 Dec 9.
Forty male Wistar rats were used, divided into four groups of 10 animals each. Group 3 received vitamin C 100 mg kg(-1) day(-1) intraperitoneally; Group 2 received vitamin E 100 mg kg(-1) day(-1) orally; Group 1 received vitamins C and E, at the same dosages; and Group 4 was the control. The vitamin therapy was administered for 1 month and then the animals were killed. A direct contusional injury was caused and functional evaluation was performed using the Basso, Beattie and Bresnahan rating scale. The rats were evaluated on the second postoperative day and weekly thereafter, until the end of the experiment.
The results were evaluated by means of the one-tailed, non-paired and non-parametric Mann-Whitney test, comparing the groups two by two. No significant difference in functional performance was observed between the groups.
The use of vitamins C and E in these rats did not improve their neurological performance. However, histopathological examination showed that the inflammatory response was less intense following administration of the combination of vitamins C and E.
The general idea that antioxidants must be good for spinal cord injury is not supportable. However, it is possible that some specific agents might provide some clinical benefit in some situations. Unfortunately, there hasn’t yet been much clinical research to identify these.
5. Stem Cells-
I have also written about stem cell therapies often, and again the conclusion has bene that there is promising preclinical research but very little in the way of clinical evidence for efficacy in specific conditions. This is certainly true for veterinary patients, and with regard to spinal cord injury specifically, the evidence is very preliminary:
Antonic A, Sena ES, Lees JS, Wills TE, Skeers P, Batchelor PE, Macleod MR, Howells DW. Stem cell transplantation in traumatic spinal cord injury: a systematic review and meta-analysis of animal studies. Stem Cells- PLoS Biol. 2013 Dec;11(12):e1001738. doi: 10.1371/journal.pbio.1001738. Epub 2013 Dec 17.
One hundred and fifty-six publications using 45 different stem cell preparations met our prespecified inclusion criteria. Only one publication used autologous stem cells. Overall, allogeneic stem cell treatment appears to improve both motor (effect size, 27.2%; 95% Confidence Interval [CI], 25.0%-29.4%; 312 comparisons in 5,628 animals) and sensory (effect size, 26.3%; 95% CI, 7.9%-44.7%; 23 comparisons in 473 animals) outcome. For sensory outcome, most heterogeneity between experiments was accounted for by facets of stem cell biology. Differentiation before implantation and intravenous route of delivery favoured better outcome. Stem cell implantation did not appear to improve sensory outcome in female animals and appeared to be enhanced by isoflurane anaesthesia. Biological plausibility was supported by the presence of a dose-response relationship. For motor outcome, facets of stem cell biology had little detectable effect. Instead most heterogeneity could be explained by the experimental modelling and the outcome measure used. The location of injury, method of injury induction, and presence of immunosuppression all had an impact. Reporting of measures to reduce bias was higher than has been seen in other neuroscience domains but were still suboptimal. Motor outcomes studies that did not report the blinded assessment of outcome gave inflated estimates of efficacy. Extensive recent preclinical literature suggests that stem-cell-based therapies may offer promise, however the impact of compromised internal validity and publication bias mean that efficacy is likely to be somewhat lower than reported here.
Wolfram Tetzlaff. A Systematic Review of Cellular Transplantation Therapies for Spinal Cord Injury. J Neurotrauma. 2011 Aug; 28(8): 1611–1682.
Cell transplantation therapies have become a major focus in pre-clinical research as a promising strategy for the treatment of spinal cord injury (SCI). In this article, we systematically review the available pre-clinical literature on the most commonly used cell types in order to assess the body of evidence that may support their translation to human SCI patients….162 studies were identified and reviewed in detail, emphasizing their behavioral effects (although not limiting the scope of the discussion to behavioral effects alone). Significant differences between cells of the same “type” exist based on the species and age of donor, as well as culture conditions and mode of delivery. Many of these studies used cell transplantations in combination with other strategies. The systematic review makes it very apparent that cells derived from rodent sources have been the most extensively studied, while only 19 studies reported the transplantation of human cells, nine of which utilized bone-marrow stromal cells. Similarly, the vast majority of studies have been conducted in rodent models of injury, and few studies have investigated cell transplantation in larger mammals or primates. With respect to the timing of intervention, nearly all of the studies reviewed were conducted with transplantations occurring subacutely and acutely, while chronic treatments were rare and often failed to yield functional benefits.
6. Laser-
This is yet another plausible, promising, and unproven therapy I have written about at length. (Here, here, and most recently here). The little bit of clinical research specifically on treatment of spinal cord injury in dogs is mixed and inconclusive. Rodent model studies have provided some suggestion of possible benefits, but again there is no convincing clinical trial evidence that laser really helps actual clinical patients.
Ando T, Sato S, Kobayashi H, Nawashiro H, Ashida H, Hamblin MR, Obara M. Low-level laser therapy for spinal cord injury in rats: effects of polarization. J Biomed Opt. 2013 Sep;18(9):098002. doi: 10.1117/1.JBO.18.9.098002.
The effects of laser polarization on the efficacy of near-infrared low-level laser therapy for spinal cord injury (SCI) are presented. Rat spinal cords were injured with a weight-drop device, and the lesion sites were directly irradiated with a linearly polarized 808-nm diode laser positioned either perpendicular or parallel to the spine immediately after the injury and daily for five consecutive days. Functional recovery was assessed daily by an open-field test. Regardless of the polarization direction, functional scores of SCI rats that were treated with the 808-nm laser irradiation were significantly higher than those of SCI alone group (Group 1) from day 5 after injury. The locomotive function of SCI rats irradiated parallel to the spinal column (Group 3) was significantly improved from day 10 after injury, compared to SCI rats treated with the linear polarization perpendicular to the spinal column (Group 2). There were no significant differences in ATP contents in the injured tissue among the three groups. We speculate that the higher efficacy with parallel irradiation is attributable to the deeper light penetration into tissue with anisotropic scattering.
Paula AA, Nicolau RA, Lima Mde O, Salgado MA, Cogo JC. Low-intensity laser therapy effect on the recovery of traumatic spinal cord injury. Lasers Med Sci. 2014 Nov;29(6):1849-59.
The objective of this study was to investigate the effect of the LILT (GaAlAs laser-780 nm) on the locomotor functional recovery, histomorphometric, and histopathological changes of the spinal cord after moderate traumatic injury in rats (spinal cord injury at T9 and T10). Thirty-one adult Wistar rats were used, which were divided into seven groups: control without surgery (n?=?3), control surgery (n?=?3), laser 6 h after surgery (n?=?5), laser 48 h after surgery (n?=?5), medullar lesion (n?=?5) without phototherapy, medullar lesion?+?laser 6 h after surgery (n?=?5), and medullar lesion?+?laser 48 h after surgery (n?=?5). The assessment of the motor function was performed using Basso, Beattie, and Bresnahan (BBB) scale and adapted Sciatic Functional Index (aSFI). The assessment of urinary dysfunction was clinically performed. After 21 days postoperative, the animals were euthanized for histological and histomorphometric analysis of the spinal cord. The results showed faster motor evolution in rats with spinal contusion treated with LILT, maintenance of the effectiveness of the urinary system, and preservation of nerve tissue in the lesion area, with a notorious inflammation control and increased number of nerve cells and connections. In conclusion, positive effects on spinal cord recovery after moderate traumatic spinal cord injury were shown after LILT.
Acupuncture for Spinal Cord Injury
The clinical trial evidence for acupuncture in dogs with spinal cord injury is limited, at high risk of bias, and confounded by the use of electrical stimulation through acupuncture needles (e.g. Here). There is, however some clinical trial evidence in humans suggesting possible benefits:
Heo I, Shin BC, Kim YD, Hwang EH, Han CW, Heo KH. Acupuncture for spinal cord injury and its complications: a systematic review and meta-analysis of randomized controlled trials. Evidence-Based Complementary and Alternative Medicine 2013; 2013: 364216.
To evaluate the evidence supporting the effectiveness of acupuncture treatment for SCI and its complications, we conducted search across 19 electronic databases to find all of the randomized controlled trials (RCTs) that used acupuncture as a treatment for SCI and its complications. The methodological quality of each RCT was assessed using the Cochrane risk of bias tool and the PEDro scale. Sixteen RCTs, including 2 high-quality RCTs, met our inclusion criteria (8 for functional recovery from SCI, 6 for bladder dysfunction, and 2 for pain control).
The meta-analysis showed positive results for the use of acupuncture combined with conventional treatments for the functional recovery in terms of motor ASIA scores and total FIM scores when compared to conventional treatments alone. Positive results were also obtained for the treatment of bladder dysfunction, in terms of the total efficacy rate, when comparing acupuncture to conventional treatments. However, 2 RCTs for pain control reported conflicting results.
Our systematic review found encouraging albeit limited evidence for functional recovery, bladder dysfunction, and pain in SCI. However, to obtain stronger evidence without the drawbacks of trial design and the quality of studies, we recommend sham-controlled RCTs or comparative effectiveness research for each condition to test the effectiveness of acupuncture.
Ma Ruijie, Liu Xin, Clark Justin, Williams Gail M., and Doi Suhail A.. The Impact of Acupuncture on Neurological Recovery in Spinal Cord Injury: A Systematic Review and Meta-Analysis. Journal of Neurotrauma. 2015. epub ahead of print. doi:10.1089/neu.2014.3866.
The effect of acupuncture on neurological recovery in individuals with SCI remains inconclusive despite previous studies and meta-analyses. The aim of the current study was to perform a more rigorous systematic review and bias-adjusted meta-analysis of studies so that the overall impact of acupuncture on neurological recovery in SCI can be determined. Randomized controlled trials (RCTs) only were included and were searched for in seven databases through to August 2014. Four key outcomes were assessed: neurological recovery, motor function, sensory function, and functional recovery. Several statistical approaches were compared, models were tested for robustness using sensitivity analysis, and results are presented as weighted mean difference (WMD) or standardized mean difference (SMD) for continuous outcomes and relative risk (RR) for binary outcomes. The included studies’ susceptibility to bias was also assessed. A total of 12 studies were included after exclusions were applied. Heterogeneity was evident among the studies included.
Pooled analyses showed that acupuncture may have a beneficial effect on neurological recovery (RRs: 1.28, 95% confidence interval [CI]: 1.12–1.50), motor function (WMD: 6.86, 95% CI: 0.41–13.31), and functional recovery (SMD: 0.88, 95% CI: 0.56–1.21) and all statistical approaches concurred. Sensitivity analyses suggested that the smaller studies (sample size <30), those with acute disease, and studies that used varying acupuncture sessions demonstrated a larger magnitude of effect. However, studies were generally of poor quality and publication bias favoring positive studies was evident. Therefore, the benefit of acupuncture we report is by no means definitive and well-designed future studies are recommended to confirm this.
Even this relatively weak positive evidence must be viewed in context, however. I have discussed the issue of publication bias in the acupuncture literature before. Systematic reviews often originate from China or Chinese researchers, and there is evidence that there is a particularly large problem with publication bias in this area. One study from 1998 found absolutely no negative acupuncture studies had ever been published in China to that point. Subsequent reviews have identified significant risk of bias in the acupuncture literature:
Bin Ma, Guo-qing Qi, Xiao-ting Lin, Ting Wang, Zhi-min Chen, and Ke-hu Yang. Epidemiology, Quality, and Reporting Characteristics of Systematic Reviews of Acupuncture Interventions Published in Chinese Journals. The Journal of Alternative and Complementary Medicine. September 2012, 18(9): 813-817.
A total of 88 SRs were identified; none of the reviews had been updated. Less than one third (27.3%) were written by clinicians and one third (35.2%) were reported in specialty journals. The impact factor of 53.4% of the journals published was 0. Information retrieval was not comprehensive in more than half (59.1%) of the reviews. Less than half (36.4%) reported assessing for publication bias. Though 97.7% of the reviews used the term “systematic review” or “meta-analysis” in the title, no reviews reported a protocol and none were updated even after they had been published after 2 or more years….Although many SRs of acupuncture interventions have been published in Chinese journals, the reporting quality is troubling.
Yuyi Wang, Liqiong Wang, Qianyun Chai, Jianping Liu. Positive results in randomized controlled trials on acupuncture published in chinese journals: a systematic literature review. J Altern Complement Med 2014 May;20(5):A129
This review found 847 reported randomized clinical trials of acupuncture in Chinese journals. 99.8% of these reported positive results. Of those that compared acupuncture to conventional therapies, 88.3% found acupuncture superior, and 11.7% found it as good as conventional treatments. Very few of the studies properly reported important markers of quality and control for bias such as blinding, allocation concealment, and losses to follow-up.
So while there is some positive research suggesting acupuncture may have beneficial effects in spinal cord injury, it is generally weak and subject to a significant risk of bias.
Bottom Line
This lecture was generally science-based and focused on the physiology of spinal cord injury and many standard conventional treatments. A number of non-standard therapies were also suggested. All of these, including acupuncture, have reasonable pre-clinical research evidence suggesting effects which might be clinically beneficial. However, for most of these therapies, there is very little clinical research and it is limited and not robust. For acupuncture specifically, there is weak clinical trial evidence suggesting possible benefits for this condition. However, there is a well-known problem with adequately controlling for placebo effects in acupuncture trials, and there is a significant problem with publication bias in the acupuncture literature, so these results have to be viewed with significant skepticism.
In 2010, I reported on the evidence-based guidelines for treatment of allergies in dogs put out by the International Task Force on Canine Atopic Dermatitis. This extremely useful document reviewed the evidence concerning many different treatments for allergies in dogs, from topical shampoos and medications to oral medications and dietary supplements. While the lack of evidence for particular therapies does not always mean these treatments don’t work (though this can indicate a lack of efficacy under certain circumstances), it makes sense to focus our efforts on those treatments that have the best chance of helping our itchy canine companions, and these are the treatments that have built up a strong foundation of scientific evidence, from basic lab testing through clinical trials. The task force report helps us to know which treatments those are.
Olivry, T. et al. Treatment of canine atopic dermatitis: 2015 updated guidelines from the International Committee on Allergic Diseases of Animals (ICADA). BMC Veterinary Research. 2015;11:210.
The updates to the original guidelines are fairly minor. New research has led to some new treatments, including oral medications topical treatments such as shampoos. Research evidence has also clarified the role of some existing therapies. Some antihistamines, for example, which did not previously have evidence for benefits in itchy dogs now look like they might have some small benefit in mildly effected dogs, especially if given continuously and before a symptom flareup.
The evidence has also grown stronger that “allergy testing” cannot be used to diagnose allergies since positive tests can often be seen in dogs who are itchy for reasons other than allergies. These tests may still be helpful in guiding therapy, though this is not completely clear. There is also still no evidence to support using allergy tests to identify food allergies, though this is still recommended by some vets.
As for dietary supplements, essential fatty acids such as in fish oil are the only one that has any evidence of clinical benefits. What dose, source, or formulation is most effective isn’t known, and there is no clinical evidence for benefit from any other oral supplement.
I have mentioned Dr. Deva Khalsa before, hawking magic water, making unsubstantiated claims about the health value of garlic, and so on. However, I recently ran across an article written by her in the pseudo-journal Integrative Veterinary Care (IVC) which surpasses anything I’ve seen from her before. I would be tempted to put this post in the “Humor” category if it weren’t for the real risk that such nonsense can pose to veterinary patients when their owners believe it.
Khalsa, D. NAET- A cure for the allergy epidemic. Integrative Veterinary Care. 2015;5(4);42-45.
She begins by blaming allergies, which are, of course, a real and serious health problem, on all the usual bogeymen of alternative vets, “over-vaccination, GMO foods, and environmental chemicals and toxins.” This is the sort of claim so deeply rooted in the faith of alternative medicine that it seems self-evident, so naturally no evidence is provided. As it happens, there isn’t any good evidence to support these claims, which are at best unproven hypotheses. If these notions actually turn out to have some validity at some point, of course, it still won’t have anything to do with the dramatic claim that forms the centerpiece of Dr. Khalsa’s article; that allergies can be cured by the simple methods she describes. It seems odd that such simple and effective therapies exist and yet allergies, unlike infectious diseases for which there are simple and effective vaccinations, don’t seem to be going away….
The method she discusses is called NAET- Nambudripad’s Allergy Elimination Technique, after the acupuncturist and chiropractor whom made it up, “while searching for solutions to her lifelong allergies, and surviving on the two foods she could safely eat-white rice and broccoli.” NAET is claimed to “reprogram” the immune system to not respond inappropriately to allergens, thus curing the allergy.
The origin myth for this practice is itself both hysterical and reason to doubt the miraculous claims made for it:
One day, after eating a carrot (a known antigen for [Dr. Nambudripad]), she developed an immediate and severe allergic reaction. She quickly needled some of her own acupuncture points, but passed out while still holding onto the carrot. Upon awakening, she reported a great feeling of peace, and discovered she was no longer allergic to carrots.
Somehow, this bizarre epiphany led to a revolutionary method of curing allergies. Once again, we are taught that despite the dramatic and unprecedented improvements in health and longevity that followed the advent of the scientific method, we apparently could achieve greater success if we eschewed scientific research and relied on individual intuition and random revelations of this sort.
The first step in employing the NAET cure is to identify the allergy triggers through applied kinesiology, a form of diagnostic quackery often favored by chiropractors. In humans, this usually involves some variation of asking a patient to resist downward pressure on an extended arm with and without the nearby presence of a suspected allergen. Supposedly, the patient becomes detectably weaker in the mere presence of the offending substance. This, of course, is voodoo which ignores the complex and well-established physiology of allergies, and it is ultimately a kind of “energy medicine” or faith healing practice.
In veterinary medicine, applied kinesiology becomes one step more ridiculous. Since the patient cannot be instructed to resist pressure and fooled into feeling weaker when a potential allergen is nearby, the method often involves bringing the potential allergen near the patient while asking the owner to touch the patient with one hand and resist the pressure on their other arm, acting as a proxy for their pet’s reaction. That anyone with a medical degree could believe that it is possible to diagnose allergies in a dog by waving a jar of wheat over the dog and pushing on their owner’s arm is at once mind boggling and sad.
Once the offending substances are identified, the cure can commence. This simply requires bringing the allergen close to the patient, always held in a glass container, and then applying acupressure to specific points on the back. Even more amazing, this method can be used to cure even life-threatening autoimmune diseases. “As an example, a dog with autoimmune hemolytic anemia can be treated with his own blood in a glass vial.”
It is probably unnecessary to point out that there is no scientific evidence to support the theory or methods of NAET. No controlled research has been conducted on the treatment (nor should it be, since it would be unethical abuse of patients and waste of resources to perform a clinical trial on such voodoo), and numerous groups of allergy treatment specialists warn against the use of applied kinesiology and other bogus allergy diagnostic and treatment methods.
According to Dr. Khalsa, this magical restoration of normal energy flow in the patient, “moves the treatment of allergies out of the world of biology and into the world of physics.” I would be inclined to say instead that this approach moves the treatment of allergies out of the world of medicine and into the world of fantasy.
I’ve written a lot about homeopathy over the years. I have investigated and summarized the scientific evidence, looked into the history and philosophy behind the practice, and even taken an online introductory course in this type of witchcraft so that I could fully understand the claims and the truth behind the practice. As a relatively minor therapy (less than 2% of adults in the U.S. use it in any given year and less than 4% have ever tried it) which usually involves giving only water or sugar pills to patients, one might wonder why this bit of nonsense is worth the trouble of debunking. Unfortunately, the fact is that the practice, and the irrational beliefs associated with it, can still harm and even kill patients.
I have pointed out before how some veterinary homeopaths make recommendations for homeopathy or against scientific medicine that can cause great harm to patients, (1, 2, 3, 4, 5). However, I still feel it is important that people see how consistently delusional and dangerous these vets can be, since they manage to appear reasonable, and even supportive of science, when they are marketing their practices to pet owner sand conventional veterinarians. Talking amongst themselves, however, they freely make claims that are so obviously untrue and ridiculous that it should be clear to most people that their advice is best rejected. I recently came across yet another example in the faux veterinary journal Integrative Veterinary Care (IVC).
Cooney, T. Homeopathic treatment for epidemic diseases: Focus on parvo and distemper. Integrative Veterinary Care. 2015;5(4);54-58.
Given the overwhelming evidence that homeopathic remedies cannot prevent or treat diseases, recommending their use for any condition is irrational. However, recommending the use of homeopathy for serious, life-threatening disease is dangerous and unethical. Even the World Health Organization (WHO), which for political reasons is often quite reluctant to criticize alternative therapies regardless of the evidence, has issued a warning that homeopathy should not be used in preference to science-based medicine for serious illnesses. And the National Center for Complementary and Alternative Medicine (NCCAM), another political agency very friendly to CAM, also warns that there is no evidence homeopathy can prevent of treat any disease.
Dr. Conney begins by citing a very old lie from the homeopathy marketing kit, that homeopathic treatment has been proven effective in epidemics of infectious disease by its use against influenza in the pandemics of the early 20th century. The specifics of these sorts of studies and claims have been discussed by others (Cuba 2007, Cuba 2007, 1918 Flu Epidemic), but there are several obvious problems with them. For one thing, they are often based on uncontrolled reporting and case selection by proponents of homeopathy. Undoubtedly, homeopaths in 1918 claimed a very low mortality from the flu, without objective statistics (which are, shockingly, not available from 100years ago), there is no way to verify these claims.
Additionally, conventional medicine in the early 20th century was itself not science-based, and the early apparent successes of homeopathy were simply a reflection of the fact that an inactive treatment that did nothing was less likely to harm the patient than bloodletting, purgatives, and other pseudoscientific mainstream therapies of the time. Conventional medicine, however, has moved on and learned to use science to weed out ineffective therapies or those that do more harm than good, while homeopathy is still true to its unscientific 19th century superstitions.
Dr. Cooney continues making things up through the rest of the article. He claims, for example, to have collected “clinical data” showing that puppies who get parvovirus infections after having been vaccinated are less likely to survive than infected puppies who have never been vaccinated, and that puppies receiving homeopathic nosodes (a type of fake vaccine) had the highest survival rate. By “clinical data,” of course, Dr. Cooney means his own uncontrolled observations, which shockingly turn out to support exactly what he believed in the first place. One wonders why science is needed at all if we can prove ourselves right just by looking at our patients and seeing what we want and expect to see.
The clinical evidence of controlled research, of course, has proven the tremendous efficacy of parvovirus vaccines. Properly vaccinated puppies are so unlikely to get the infection that the companies making the vaccine ware willing to pay all medical costs for any pup who has been vaccinated on schedule and gets parvo. This, of course, virtually never happens, which is why they are willing to make this sort of guarantee. Nosodes, on the other hand, have been demonstrated not to be effective for parvovirus or other serious infectious diseases.*
Dr. Cooney provides no scientific evidence for his dramatic claims, he merely repeats some anecdotes from his own practice, which prove nothing other than his ability to see what he expects to see. For more on the unreliability of anecdotes and testimonials like these, see these articles:
The Role of Anecdotes in Science-Based Medicine
Why We Need Science: “I saw it with my own eyes” Is Not Enough
Don’t Believe your Eyes (or Your Brain)
Medical Miracles: Should We Believe?
Alternative medicine and placebo effects in pets
Dr. Cooney makes the same sort of unsupportable claims about canine distemper, another deadly viral infection. He admits it is quite rare and that he hardly ever sees a case, though he neglects to mention that this is because of widespread vaccination. However, he brazenly claims that when the infection does occur, “yields the only hopeful outcome in most cases.” He supports assertion, of course, only with a testimonial from another veterinary homeopath and his own personal experiences.
Dr. Cooney derides conventional treatment as “’anti’ drugs like anti-emetics, anti-diarrheals, anti-nausea meds, antibiotics” and so on because in the twisted logic of homeopathy, treating the life-threating clinical effects of disease and the suffering they cause is a mistake. The body should be allowed to “vent the disease,” apparently even if it torments or kills the patient in doing so.
Undoubtedly, many of the patients Dr. Conney treats for parvo and distemper survive. This is likely due in part to misdiagnosis, since distemper is rare and difficult to diagnose, and he claims to see parvo regularly in vaccinated puppies despite the 99% effectiveness of the vaccine in preventing the disease. It is always easier to cure a life-threatening disease with fake medicine when the patient doesn’t actually have the disease in the first place.
It is also the case that Dr. Cooney apparently provides at least some of the standard supportive care, including intravenous fluids. With appropriate supportive care, about 50% of distemper cases survive, and about 80-95% of parvo cases survive. It would take an objective, controlled scientific study to prove what seems very likely to be the case, that Dr. Cooney’s use of fake medicines and avoidance of science-based treatments probably leads to a higher mortality rate among those true parvo and distemper cases he sees than those treated appropriately. However, even without such a study it seems obvious that for a licensed veterinarian to promote such pseudoscience and discourage accepted medical treatment for life-threating, and completely preventable, infectious diseases is dangerous unethical.
* Holmes MA, Cockcroft PD, Booth CE, Heath MF. Controlled clinical trial of the effect of a homoeopathic nosode on the somatic cell counts in the milk of clinically normal dairy cows. Vet Rec 2005; 156:565-567.
Larson L., Wynn S., and Schultz R.D. A Canine Parvovirus Nosode Study. Proceedings of the Second Annual Midwest Holistic Veterinary Conference 1996.
Acupuncture and the Evidence
I have spent several hours, now, listening to lectures discussing scientific evidence and acupuncture. I have also made an effort to find and read many of the specific papers discussed so that I can evaluate their strengths and weaknesses for myself. The instructors for this course have taken a varied and somewhat scattered approach to discussing the scientific evidence, but their presentations seem to fall into three broad categories: discussions of animal model studies investigating the physiologic effects of needling and electrical stimulation of tissues with needles; discussions of the nature of placebo effects; and discussion of the epistemology of science and evidence-based medicine.
The framework for the discussion, of course, begins with the assumption that acupuncture, in some form for at least some conditions, is an effective therapy. This appears to be based predominantly on personal clinical experience. Science is then seen as a means for validating this fact and understanding the mechanisms and application of acupuncture in more detail. The appropriate null hypothesis, that acupuncture has no clinically meaningful beneficial effects, seems to be off the table, which undermines somewhat the instructors’ claims to be approaching this therapy in a truly scientific and evidence-based way. Nevertheless, bias does not itself prove a belief is wrong, only that it may not be based entirely on a rational assessment of the evidence. So I have tried to evaluate the evidence and arguments presented on their own merits.
Pre-clinical Acupuncture Research
This has always been the strongest element in the arguments for acupuncture. There is abundant research evidence that there are physiologic responses to the stimuli generally employed by acupuncturists: dry needling and electrical stimulation via acupuncture needles. And there are plausible mechanisms by which some of these responses could result in clinically meaningful benefits for a number of symptoms. While it remains unclear that any particular needling locations have more or better effects than any other (1, 2), there are undeniably effects to needling and so-called electroacupuncture.
The instructors cite a number of research studies to illustrate specific effects of acupuncture and to at least imply that these represent mechanisms for clinical benefits. Up to this point in the course, these studies are mostly rat models for pain or gastrointestinal motility, and they often focus on the activity or expression of particular neurotransmitters or other neuroactive compounds, ion channels, or other signaling mechanisms within the nervous system. I think the evidence is convincing insofar as needling and electrical stimulation have measurable physiological effects.
However, this is a long way from demonstrating these techniques are effective clinical therapies. Those the effects identified might be mechanisms for clinical benefits, this has to be demonstrated at all levels, from the animal model to the clinical trial, and this has generally not been done. And it is clear that many other stimuli have similar effects. Pinching the skin or needling without penetration or even hitting your thumb with a hammer have measurable effects that could conceivably modify pain, blood pressure, or other variables affected by the nervous system. An effective therapy is not simply any intervention that does something, but an intervention than consistently and reliable does something specific and desirable in a particular patient population. This cannot be proven in lab animal studies, for acupuncture or any other potential therapy.
The studies cited, like all research, have plenty of limitations that have to be acknowledged. Often, there is a lack of blinding or control stimulation, and again the vast majority seem to involve electro-acupuncture, which begs the question of whether needling in predetermined locations traditionally sued by acupuncturists is itself the source of the observed effects, or if electrical stimulation is the treatment actually being studied.
So far, these lectures have added some depth to my understanding of the specific, and quite varied, effects of needling and electrical stimulation, but this is low-level evidence that only supports the claim that acupuncture might be a useful clinical therapy, not the claim that it actually is. That has to be demonstrated by clinical trials.
Clinical Trial Evidence
So what does the clinical trial evidence say about acupuncture. Well, it is a bit tricky. It is difficult to do a well-controlled acupuncture study because it is difficult to effectively employ some of the best methods to control for bias and placebo effects; a placebo control and blinding of patients and therapists to whether placebo of real acupuncture is being used. Patients, especially those with previous experience of acupuncture, can often tell if they are in the treatment or control group, and acupuncturists always know. This makes the results of most trials somewhat unreliable.
There are many, many studies of acupuncture, most of pretty poor quality or high risk for bias. When these are aggregated and assessed for quality in systematic reviews, generally there is no consistent difference between real and sham acupuncture, though both do better in terms of subjective outcomes like pain than no treatment at all or less dramatic ineffective therapies. This evidence is most consistent with acupuncture being mostly a placebo therapy, with perhaps some small effects on pain and other symptoms via non-specific mechanisms.
To their credit, the instructors in this course acknowledge that from an evidence-based perspective, the clinical trial literature does not support much efficacy for acupuncture.
[Acupuncture] activates the brain in areas that are activated when patients take a placebo, thinking it may be a real treatment.
Non-specific effects of needling ANYWHERE activate similar brain regions, but many studies use “non-verum” points as the placebo.
Unsurprisingly, in the vast majority of RCTs studying acupuncture, the treatment is superior to non-treatment, but not superior to placebo.
The most appropriate conclusion to draw from this, using a science-based perspective, would be that acupuncture is likely merely a placebo and does not have predictable, meaningful clinical effects beyond placebo. However, you can imagine the cognitive dissonance accepting such a conclusion would induce in folks not only practicing but teaching acupuncture, and of course the instructors do not come to this conclusion. They appear genuinely committed on some level to the science-based view. However, they also clearly believe acupuncture is effective based on their personal clinical experiences. When the science supports this, they are happy to rely on it. But when the science does not support their experiences, they begin looking for ways to explain the results that do not require giving up their beliefs. Most of the rest of the lectures on evidence for acupuncture consist of this sort of salvage operation, attempting to explain why an effective therapy consistently fails to be validated in clinical trials. This involves redefining placebo effects, challenging the methods of clinical trials, and a lot of goalpost moving.
Placebos
These lectures spend a lot of time discussing the nature of placebo effects, and they make a number of troubling claims about placebos that suggest a fundamental misunderstanding of the nature of controlled scientific research. This understanding is most often and articulately represented by the work of Ted Kaptchuk, a proponent of Chinese medicine and a researcher into the nature of placebo effects. Dr. Kaptchuk’s research is interesting, but the conclusions and claims he makes are quite controversial, though they are presented in this course as established science.
One idea that the instructors try to suggest is that placebo effects may not be simply the false perception of improvement in one’s symptoms but real healing.
The meanings and expectations created by the interaction of doctors and patients matter physically, not just subjectively.
This is an idea Ted Kaptchuk has suggested as well, and it is really a rationalization to preserve belief in a therapy that does not outperform placebos in clinical trials. The reason placebos are used, and part of the reason clinical trials have proven so much more effective than individual experience in evaluating medical therapies is that placebos represent a collection of errors that create the impression of improvement without a real, objective change in health.
One of the best explanations for what goes into the placebo effects seen in clinical trials comes from Science-based Medicine in a translation of a French article. This graphic illustrates the relationship between research placebos and actual healing.
Many different kinds of error feed into the apparent improvement experienced by patients getting placebos in clinical trials, but these do not represent actual , objective healing caused by the placebo therapy. A number of studies have looked at the question of whether or not placebos have meaningful clinical benefits, as opposed to simply creating the perception of improvement in subjective symptoms while leaving objective measures of health unchanged, and the conclusions do not support the “powerful placebo” idea.
Asbjørn Hróbjartsson, M.D., and Peter C. Gøtzsche, M.D., Is the Placebo Powerless? — An Analysis of Clinical Trials Comparing Placebo with No Treatment. Engl J Med 2001; 344:1594-1602.
Conclusions
We found little evidence in general that placebos had powerful clinical effects. Although placebos had no significant effects on objective or binary outcomes, they had possible small benefits in studies with continuous subjective outcomes and for the treatment of pain. Outside the setting of clinical trials, there is no justification for the use of placebos.
Hróbjartsson A, Gøtzsche PC. Placebo interventions for all clinical conditions. Cochrane Database Syst Rev.2010 Jan 20;(1):CD003974. doi: 10.1002/14651858.CD003974.pub3.
Authors’ conclusions:
We did not find that placebo interventions have important clinical effects in general. However, in certain settings placebo interventions can influence patient-reported outcomes, especially pain and nausea, though it is difficult to distinguish patient-reported effects of placebo from biased reporting. The effect on pain varied, even among trials with low risk of bias, from negligible to clinically important. Variations in the effect of placebo were partly explained by variations in how trials were conducted and how patients were informed.
Meta-regression analyses showed that larger effects of placebo interventions were associated with physical placebo interventions (e.g. sham acupuncture), patient-involved outcomes (patient-reported outcomes and observer-reported outcomes involving patient cooperation), small trials, and trials with the explicit purpose of studying placebo. Larger effects of placebo were also found in trials that did not inform patients about the possible placebo intervention.
The literature best supports the traditional idea that placebos fool patients (or, in the case of veterinary medicine, clients and vets) into thinking their condition is improved when it is not by objective measures. Some acupuncture studies illustrate this patter, including one I’ve written about before involving sham acupuncture as a treatment for acute asthma attacks.
Wechsler, ME. Kelley, JM. Ph.D. Boyd, IOE. Dutile,S. Marigowda, G. Kirsch, I. Israel, E. Kaptchuk, TJ. Active albuterol or placebo, sham acupuncture, or no intervention in asthma. N Engl J Med 2011; 365:119-126
In addition to asking the patients how they felt after each treatment, the investigators also measured their lung function, using an instrument that records, among other data, how much air the patients could force out of their lungs in a given period of time. It turns out that this objective measure showed a 20% improvement with the bronchodilator inhaler, but a significantly lower 7% improvement with the inert therapies or no treatment at all. So while the patients couldn’t tell the difference between real and fake therapies, their lungs certainly could.
As David Gorski from Science-based Medicine put it,
[This finding] indicated how dangerous it could be to rely on placebo effects to treat asthma in that it could easily result in the death of your patients by lulling them into a false sense of security of not feeling short of breath when, from a physiologic standpoint, they are on the knife’s edge of respiratory failure.
The instructors refer to this study, but they draw a very different lesson from it than I do. To them, it illustrates the second idea concerning placebos which they suggest might justify acupuncture even if it has no more than a placebo effect, which is that the outcomes of interest ultimately should be the patient experience, not necessarily objective measures of health and disease. As one put it,
A patient centered approach requires that patient-preferred outcomes trump the judgment of the physician.
This strikes me as a dangerous approach to medicine. It is true, of course, that the ultimate goal of medical treatment is the total well-being of the patient. And for humans, at least, the values and goals of the patient are a major determinant of what constitutes well-being. However, there is a reason patients seek the advice and guidance of doctors. Our training and experience gives us a perspective that is different from the patient’s and useful to them. And part of this perspective is an understanding that subjective symptoms are influenced by many factors besides the true trajectory of a disease or overall health. Something can make you feel better without making you truly physically better, and if doctors have methods of assessing this that patients do not have, it is our duty to put this knowledge to the service of the patient’s overall well-being, even if it may sometimes conflict with their short-term perceptions of their symptoms.
In the case of entirely subjective symptoms, of course, the experience of relief is relief, and it cannot reasonably be declared “unreal” without wading into the philosophical morass of qualia, which I try to avoid. However, the experience of symptomatic relief, valuable as it may be in itself, should not be confused with true amelioration of disease or restoration of health. If asthmatics feel temporarily better with placebo therapy, that doesn’t mean we have restored their well-being. Placebo effects, remember, tend to be mild, short-term, and not associated with significant, sustained improvement in health condition.
What the instructors also fail to acknowledge is that placebo effects which lead to subjective experience of relief occur with truly, objectively effective therapies as well as with placebos. We can have both effective treatment and symptomatic relief, and there is no need to settle for only perceived improvement. In fact, I would argue that it is unethical to rely on a placebo therapy to make patients feel better when there are objectively effective therapies available. And when there are not, we are obliged to inform patients of this even if it diminishes our ability to use placebos to relieve their symptoms by fooling them into thinking we have improved their physical health.
Finally, the issue of placebo effects is complicated in veterinary medicine by the fact that some of the effects in the diagram above, those based on belief and expectation, don’t apply to veterinary patients. We can’t fool our pets into feeling better with placebos. However, we can fool their owners and ourselves into believing we have made them feel better when we haven’t. This makes the use of placebos doubly dangerous and unethical in veterinary medicine.
Imperfect Science
The instructors spend some time discussing flaws and sources of bias and error in clinical trials of acupuncture and in the methodology of systematic reviews and meta-analyses used to summarize clinical trial research. The majority of these criticisms are quite valid. There is no question that medical science is, like all human endeavors, deeply flawed and subject to bias and error. I have written about the problematic nature of much research evidence myself, and I actually just completed a master’s thesis specifically looking at some quality measures of veterinary clinical trials, which are far, far from ideal in many ways (hopefully something from this will be published reasonably soon). So questioning the reliability of the scientific literature is fair game, and it is not inconceivable that the benefits of acupuncture could be greater than they appear due to methodological problems with how it is studied.
That said, this begs the question of how else we evaluate therapies like acupuncture. Science is imperfect, but it is far, far superior to any other method we have ever used. The dramatic and unprecedented improvements in human health and longevity that have been brought about by the application of controlled scientific research to health, nutrition, and other related areas, are undeniable. If we must make judgments, and we must make them on the basis of the evidence we have rather than the ideal evidence we would like to have, then what can we rely on that is better than clinical research? While they might not admit it, I suspect deep down the instructors of this course believe their personal experiences are compelling proof that acupuncture is effective, and they find the inability of clinical science to confirm this to be more likely a failing of the research than of acupuncture. The potential bias in this view is obvious. My own view is that we are more likely to come to the right answer more often if we rely on scientific research, flawed as it is, than if we trust out personal experiences.
Bottom Line
The instructors present reasonably good evidence that acupuncture (dry needling and electrical stimulation) have wide-ranging physiologic effects that could plausibly have local and distant clinical benefits. They acknowledge, however, that clinical trials have not tended to support a meaningful, consistent benefit above placebo for acupuncture. Unfortunately, despite their ostensible commitment to evidence-based medicine, they appear to have a strong belief in the efficacy of acupuncture based on their personal experiences, and this has led the to respond to the absence of good clinical trial evidence for the practice by questioning the appropriateness of the methods and outcomes used to obtain this evidence rather than their belief in acupuncture.
The reinterpretation of placebo effects suggested in the course materials, as either true measures of real healing or as sufficient endpoints for therapy in themselves, seem misguided. While symptomatic relief is an important goal for patients, it is not sufficient in itself if it leaves the underlying disease unimproved. And such placebo effects can be obtained as easily by therapies with measurable objective benefits as by placebos. Offering placebos alone is ethically questionable, particularly if patients are misled into believing they are truly effective treatments, and it can harm patients if it creates a false impression of improvement.
The critiques offered of clinical trials and higher level scientific evidence are often valid. But they beg the question of what should be used instead to evaluate therapies such as acupuncture. The implication, that personal experience of success is sufficient reason to utilize a therapy despite an inability to validate its effects through clinical research, seems to suggest that such experiences are as or more reliable than controlled research. The history of science and medicine, and the state of human health, argue strongly against this view.
I have reviewed the overall evidence concerning homeopathy, from basic science through clinical trial research in great detail previously. Despite more than 150 years of effort by advocates for this practice, virtually no reliable evidence has been developed to show it can work or does work.
The same conclusion has been reached by many others, from the systematic reviews of homeopathic trials and systematic reviews of these systematic reviews, to the formal investigations of governmental agencies such as the British House of Commons Science and Technology Committee and the Australian National Health and Medical research Council. While homeopaths have had more than a century to try, they have not been able to produce a body of scientific evidence to convince anyone but themselves that homeopathy works.
However, homeopaths crave the legitimacy (and boost to their business) that comes from the appearance of scientific validation, so they continue to produce publications intended to create this appearance. A series of publications have been produced by a group of homeopaths employed by a homeopathic organization specifically to produce pro-homeopathic literature. This includes a number of systematic reviews. I have discussed one of these in detail previously. The study reviewed placebo-controlled randomized clinical trials of homeopathy. Despite grand claims of a robust evidence base, even these dedicated advocates could find almost no suggestion of an effect.
So the best that two committed supporters of homeopathy could find when attempting an objective evaluation of the veterinary homeopathy literature were two studies that were probably pretty reliably conducted, one of which found an effect and one of which didn’t. Once again, in the face of the inherent implausibility of the practice (despite the nonsense about “nanoparticles” which these authors themselves reference as if it solved the plausibility problem), and a century and a half of dedicated effort, such a glaring lack of positive evidence is far more consistent with homeopathy being a placebo than with it being the dramatically effective therapy its proponents claim.
However, for propaganda purposes, simply being able to cite studies and reviews creates the impression there is some reason to think homeopathy might work, so the authors have gone on to produce another review, this time of studies using something other than a placebo control.
Mathie, RT. Clausen, J. Veterinary homeopathy: Systematic review of medical conditions studied by randomised trials controlled by other than placebo. BMC Veterinary Research 2015, 11:236.
Like their other reviews, this one found no high-quality research evidence to support a beneficial effect for homeopathy. The studies reviewed were of generally poor quality and did not effectively control for bias and other sources of error. This is routine for homeopathy research and so not surprising. Given the implausibility of the premises behind homeopathy and the failure to find clear, meaningful effects in good quality research for over a century, once again the only rational conclusion is that homeopathy doesn’t work and that it is time to give up on it.
As I’ve argued before, science and evidence-based medicine are worthless if we can never reach a conclusion or reject any therapy no matter how many failed attempts we have made to find evidence it is effective. The absence of evidence absolutely can be evidence of absence and a reason to stop wasting resources on an idea once adequate efforts have been made. If this is not true, than science will never be able to reject any idea no matter how implausible, and we effectively surrender the most effective tool ever discovered for finding out the truth about nature.
However, belief counts for more than evidence with homeopaths, and science is merely a marketing tool, not a means to discover the truth about the practice. So these authors portray the absence of evidence in this study not as still more evidence of the absence of an effect but as a reason for yet more research:
Due to their extremely poor quality, OTP-controlled trials are incapable of providing useful additional insight into the effectiveness of homeopathic treatment or prophylaxis in animals. To clarify the matter, new and substantially improved OTP-controlled research in both individualised and non-individualised veterinary homeopathy is strongly indicated.
The opposite is actually true. Further research is strongly contraindicated. There is a tremendous shortage of good-quality research evidence in veterinary medicine, and more and better evidence is desperately needed to support effective clinical practice. Wasting precious and scarce resources on hare-brained ideas that have failed to prove their worth hundreds of times over for decades is not a rational, appropriate or ethical choice.
I’ve often written about the problem of confusing religion with medicine. In religion, one is allowed to make any claims one likes, and the only evidence required is faith. In medicine, one is required to provide evidence to support claims about health and disease, and that evidence must come from science, not simply belief or opinion. This distinction is part of the reason for the unprecedented and dramatic success of medicine at improving health and lengthening life in the last couple of centuries, something thousands of years of faith-based healing was unable to accomplish.
The problem with faith-based claims is that one has complete freedom to claim absolutely anything, and there is no way any claim can be disproven. Everything must be allowed to be true if one believes it, in which case the distinction between truth and falsehood become meaningless. Clients and patients are totally at the mercy of individual practitioner’s personal beliefs and practices, since there is no objective basis on which to judge their claims or actions. This total reliance on the whims and beliefs of one individual, presented as universal truth, has been a tremendous impediment to real knowledge and progress in the history of medicine.
I have no objection to people practicing whatever religion they like, or none at all. However, when they present their religious beliefs as medicine, they are deceiving the public and endangering patients. Sometimes, this takes subtle forms, such as claiming that Chinese Medicine is a rational system of diagnostic and therapeutic practices, when it is really a hodgepodge of philosophical, religious, and traditional practices almost entirely incompatible with science. However, in some cases the conflation of religion and medicine, belief and evidence, takes such a blatant form that it seems transparently fraudulent to call one’s practices anything other than faith healing.
It requires tremendous arrogance, always hidden behind a mask of humility of course, to market oneself as having special insight denied to other doctors which lets you lead people and their pets to “real” health despite the deep and dangerous misunderstanding of the universe that cripples the rest of the medical profession and most of society. I recently found a stunning example of this phenomenon, which I think illustrates the danger hidden behind the benign tone and marketing of religion pretending to be medicine.
Dr. Dennis Thomas, like many self-identified “holistic vets” puts his mainstream medical credentials front and center when promoting himself and his services while simultaneously denigrating scientific medicine (mislabeled as “Western Medicine,” of course, as if no one outside of Europe or North America relied on science-based medicine as their primary form of healthcare, when in fact this is the predominant form of healthcare everywhere in the world to the whatever extent local resources allow). He clearly wants to share the legitimacy that is attached to science while simultaneously rejecting its fundamental principles and its conclusions.
…the physical body exists simultaneously as both a material body and an energetic body. It also includes the awareness that the material body’s function, both in health and disease, follows specific science and logic, and that the energetic body’s function, in both health and disease, follows a different science and logic.***
This implies that the system he believes in for optimizing the patient’s spiritual energy is somehow equivalent to the system of developing knowledge about the physical world we call science, despite the fact that this system rejecting entirely the methods sciences uses.
Traditional medicine… specifically focuses on the material body and uses evidence based on the science and laws of the material world. This has proven to be very effective in handling health care from that perspective. However, traditional, allopathic medicine, completely ignores the existence of an energetic body and the energetic influences that have great affects on the manifestation of health in the material body. Using the science of quantum physics, we absolutely know that the energetic body not only influences the material body, but is also the major influence providing direction for the body’s functioning. Research indicates that the energetic influences are 100 times greater than the material or physical influences on cellular function. It seems logical that if we were to ignore the most important factors (energetic) that influence the body’s health, we would be severely limiting our ability to direct health and healing.”
Here Dr. Thomas claims that science-based medicine misses entirely the most important factor that influences health and disease, despite the abundant evidence to the contrary, and yet claims it is science itself which proves this to be true. Of course, the invocation of “quantum physics” to justify a fundamentally spiritual claim is a classic sign of quackery. Because quantum physics is a complex, fundamentally mathematical field, those of us not specializing in it understand it only shallowly through imprecise metaphors. It is easy to generalize these inappropriately to phenomena to which they don’t properly apply, and it is difficult to explain why this is inappropriate without utilizing mathematics most of us don’t understand. Ultimately, this is just another way of appealing to faith but calling it science.
Dr. Thomas, blithely dismisses the success of science-based medicine as “merely” addressing the physical body and then claims better results, without evidence, based on vague spiritual notions that he mislabels as science. This in itself is disingenuous and misleading. But it become much worse when he expands on his beliefs to make claims about the causes and effective treatments for disease that are completely made up and reflect only his beliefs and desires, not the nature of reality.
Bad, or distorted energy, might come from things in the environment, such as EMFs coming from nearby power lines.
Unhealthy energy can also come from computers or cell phones, microwaves, or many other sources.
The environment we and our pets live in is full of pollutants, toxins, and harmful microorganisms. Our food supplies are laden with preservatives, GMOs, hormones, and additive fillers. No material body, including our pets’ bodies, can maintain health, and repair damage when it is compromised with over-vaccination, low quality nutrition, and less than optimal environmental conditions.
This is the usual sort of fear-mongering that alternative practitioners must engage in to build business. Telling people that even when they and their pets appear to be well, they are actually besieged by unseen dangerous eating away at their well-being is necessary if you want to sell unproven and unnecessary interventions. And claiming that scientific medicine ignores disease prevention, which is obviously untrue, seems more reasonable if you also claim a whole host of deadly threats science doesn’t recognize (because you made them up), or that science-based medicine actually promotes as beneficial. The absence of real evidence for these claims is not a problem, of course, because this style of “medicine” is really all about faith.
Dr. Thomas, however, goes beyond even most “holistic” vets who practice the same kinds of treatments he uses (Chinese medicine, alternative nutrition, “energy medicine,” and so on). He identifies the main cause of illness as not in the physical universe at all, but in the negative attitudes of the pet owner. That’s right, if you’re not serene and happy all the time, you are probably making your pets sick!
By far the most influential energy that your pet is exposed to is your overall energetic state. Yes, the major influence that directs your pets health and well being is your perceived state of being…. what my years of observation have taught me is that when our pet develops a chronic or fatal disease, the form of that disease often reflects our perspective on life…. the emotions we are experiencing, when we think about our pet’s health condition, are likely the emotions that participated in the development of the problem in the first place. It is as though the sick pet is a microcosm of the larger macrocosm of the caretaker’s perceived reality about life itself. If I am frustrated with life and this perception persists long enough, the energy that is created will influence my reality.
When I see a person who is chronically frustrated with their job, or relationships, it does not surprise me when their pet develops a chronic illness. And when someone views life as painful and fearful, the way their pet passes on may be influenced by that attitude.
Of course, these claims are not only unproven but highly unlikely to be true. Such “create your own reality” notions are a form of magical thinking which has been around for millennia without any measurable effect on health and well-being, compared the clearly beneficial effect of science in these areas. Or as Tim Minchin has put it, “ Throughout history, every mystery ever solved has turned out to be—NOT magic!”
But beyond being nonsense, these claims are a particularly cruel and self-serving form of the usual alternative medicine fear-mongering. Ultimately, anything bad that happens to your pets happened because you weren’t in the “right” state of mind. The state you should be in is simply Dr. Thomas vague personal syncretism, incorporating elements of various spiritual and philosophical traditions. In other words, the cure is as made-up as the cause.
While Dr. Thomas may very believe this stuff, the function of these claims is pretty convenient for his business. Create fear of dangers that science can’t detect or address, add a touch of guilt to the fear, and then offer the pet owner a way out that is, coincidentally, just the set of services you are selling. There is even a built-in excuse for any undeniable treatment failure:
The Healing Room is a one-room facility that is designed to promote and direct healing for you and your pet. Please be aware that any energy you bring into the room will affect the energetic balance of the entire room. Your pet’s natural state is one of calm attention. However, animals are sponge-like in their ability to absorb and take on the emotional states of their human companions. This can contribute to, or block the healing of an energetic imbalance.
That’s right. If your pet doesn’t get better, it’s probably because you messed up the “healing vibrations” with bad thoughts. It has nothing to do with the completely bogus nature of the causes of disease and treatments Dr. Thomas is selling.
Understand, I have nothing against taking spiritual comfort wherever you find it. I meditate and find some elements of Buddhist practice appealing and useful in my own life. But history makes an ironclad case for separating our spiritual beliefs from the causes and treatments for disease. Religion has never made effective medicine, and the emphasis in science on material, physical reality that folks like Dr. Thomas disdain has led to tremendous improvements in our health and well-being.
Belief and faith may fairly remain unchallenged when they address purely human constructs, such as art and morality and the meaning of life. But they are actively harmful and misleading when they encroach on domain of the natural world. Successful medicine throughout the world is based on science and scientific knowledge for the simple reason that is works better than any other approach, including the timeless musings of philosophers and spiritual leaders.
Dr. Thomas is entitled to evangelize for his spiritual beliefs as much as he wants. But it is misleading and wrong to confuse these with veterinary medicine, which is properly a science-based pursuit.
***All quotes come from these two sites: 1, 2
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