I recently ran across a prime example of lousy science done solely for the purpose of propping up alternative-medicine beliefs or practices. Good science aims to discover what is true, not simply buttress one’s existing beliefs or provide marketing material for them. And good medical research requires that there be a reasonable chance the treatment being tested will solve an important clinical problem in a way that improves the welfare of patients. This study fails on those basic criteria, as well as on more technical but still important methodological grounds.
Shin Jin Cheol; Kim SangHun; Park HyungJin; Seo KyoungWon; Song KunHo. Effect of aromatherapy and apipuncture on Malassezia-related otitis externa in dogs. Journal of Veterinary Clinics, 2012, 29, 6, pp 470-473.
Malessezia is a form of yeast normally found in the ears of dogs. In some individuals, these yeast can be present in excessive numbers, and this is usually associated with inflammation and associated discomfort. The fundamental problem is typically not the yeast itself, but the factors that lead to inflammation and overgrowth of yeast. These are often underlying allergies (to dietary proteins or environmental allergens), the conformation of the individual patient’s ear (dogs with long, hairy ear canals and floppy ears are often at greater risk of otitis or inflammation in the ear), and the past history of the patient (recurrent otitis damages the ear canal in a way the increases the risk of future episodes).
Medication to reduce the number of yeast present is often included in treatment of otitis, but it is important to realize the yeast themselves are almost never the problem. Inflammation, bacterial overgrowth, and predisposing factors must also be addressed, or treatment will only provide partial or temporary relief. Most commonly, dogs with yeast otitis are given topical medications with steroids and medications that reduce bacterial and yeast populations. Ideally, if the problem is severe or recurrent, underlying causes are investigated and addressed.
Oral medications are sometimes used, though there is no compelling evidence for their efficacy in yeast otitis. In fact, I found this paper while I was looking for studies that might show whether or not the oral antifungal drug ketoconazole alone was effective in treating yeast otitis. I suspect it rarely is since it addresses only part of the problem, and likely not the most important part in many dogs. In any case, I did not find any such studies, so whether or not this drug is helpful is an open question.
However, in this study ketoconazole is used as a positive control, so the design begins with an unfounded assumption that this treatment should be effective. The comparison is then a combination of essential oils poured into the ear and, for the most ridiculous part, the injection of bee venom into a purported acupuncture point, Small Intestine 19, located next to the opening of the ear canal. So we have a comparison between an unproven oral drug and a variety of other untested chemicals (calling them “essential oils” doesn’t change their status as untested or as chemicals) combined with an insect toxin injected near the ear. Add in the fact that subjects weren’t randomized, investigators weren’t blinded, and the outcome measures evaluated were subjective, and you have the perfect recipe for crappy science:
- Start with an implausible but deeply held belief as your hypothesis
- Choose an unproven or lousy conventional treatment to compare with your alternative medicine
- Make sure the outcome is a judgment call and that you do little or nothing to control for the effects of chance or bias
- Toss in some questionable statistical analysis and voilá, you have BOGUS SCIENCE!
In terms of plausibility, a number of essential oils have been shown to have anti-microbial properties in test tubes. Of course, so does bleach and boiling water, so this by itself does little to support their use in actual patients. Bee venom has, not surprisingly, a lot of interesting chemicals in it. However, there is little good quality research, and it has not yet been shown to be a truly effective for any condition, though there might be some potential for medical use in the future. As for injecting it into acupuncture points, which arguably don’t exist anyway, that’s nonsense. There are a couple of interesting small studies suggesting acupuncture could have some impact on otitis in dogs generally, but these are preliminary, and overall the evidence is too limited to draw a conclusion.
Not surprisingly, given the lack of control for bias, the study showed no difference between the dogs given oral anti-fungal medication and those given essential oil and “apipuncture” treatment. Both groups appeared to improve significantly by 2 weeks, though not at the 1-week assessment. Given the design of the study, there is no way to determine if this had anything to do with the treatments given, or how either would compare with standard therapy, usually consisting of topical medication containing a steroid, antibiotic, and anti-fungal combination.
The group receiving the antifungal medication did show some slight changes in a couple of liver enzymes. This is not unusual with the oral antifungal, and it is not clear this had any clinical significance. Nevertheless, the authors use this as an argument to prefer their alternative therapy.
So we have a comparison between an unproven and not typically used “conventional” treatment and an implausible and unproven alternative with no effort to control for bias or other sources of error. We find no difference between the groups except a bloodwork change of uncertain significance. And the whole focus of the study is treating an aspect of the problem that isn’t generally the cause. What we have is less an argument for the alternative therapy presented than it is a fine example of the misuse of scientific research in alternative medicine.