A study contributes to the deceptive rebranding of naturopathy as "lifestyle counseling"

That naturopathy is a veritable cornucopia of quackery mixed with the odd sensible, science-based suggestion here and there is not in doubt, at least not to supporters of science-based medicine (SBM). However, what naturopaths are very good at doing is representing their pseudoscience as somehow being scientific and thus on par with actual SBM. So how do they accomplish this? Certainly, it's not through the validation of any of the cornucopia of pseudoscience and quackery that naturopaths apply to their patients as though picking "one from column A and one from column B" from a proverbial Chinese menu of woo. Naturopaths' favored modalities include homeopathy (which remains to this day an integral part of naturopathy that all naturopaths are taught), acupuncture and traditional Chinese medicine (TCM), "detoxification" practices (a key precept of a lot of naturopathy) such as juicing, enemas, and chelation therapy, and the various other quack modalities that make up the practice of naturopathy. Treatments like these (especially homeopathy, whose precepts would require a massive rewriting of the laws of physics and chemistry for it to work) have not been and almost certainly cannot ever be scientifically validated with an evidence base of the quality and quantity supporting SBM.

So, instead naturopaths play a very clever game. In all fairness, naturopaths are not the only practitioners of so-called "complementary and alternative medicine" (CAM) or "integrative medicine" who play this game, but from my observations they appear to be the most talented at it. Their skill at obfuscating the line between SBM and naturopathy is evidenced by the success they have had in state legislatures in expanding their scope of practice, most recently in Colorado, where, if there is not a groundswell of support urging the Governor to veto SB-215 (or, as Jann Bellamy aptly called it, the quack full employment act), consumer protections against quackery in Colorado will be laid waste. At the same time, there is a naturopath licensing act (HB-1111) sitting on the Governor's desk as well that would license naturopaths and give them the path to mandatory reimbursement from insurance companies. Instructions to write to the Governor opposing both bills can be found here and here; they would be disastrous for efforts to keep full vaccination in Colorado. A direct link to write the Governor can be found here.

So how do naturopaths succeed? They rebrand certain elements of SBM as being "alternative," as being part and parcel of naturopathy. No, they go further than that, rebranding such science-based modalities as being somehow unique to naturopathy. Dietary interventions become "alternative" and "naturopathy." Of course, never mind that the dietary recommendations given by naturopaths and science-based nutrition recommendations are all too often related only by coincidence. Naturopaths also appropriate exercise, lifestyle interventions, and counseling as somehow "alternative." I was reminded of this by a study published two weeks ago in CMAJ by Seely et al., entitled Naturopathic medicine for the prevention of cardiovascular disease: a randomized clinical trial. The study purports to demonstrate that the addition of naturopathic care to standard medical care for patients with cardiovascular disease can result in improved Framingham risk scores and is being touted throughout the CAM blogosphere as strong evidence that naturopathy adds something positive to SBM.

Before I get to the study itself, let's see how pro-quackery propagandists are promoting it, starting (where else?) on that continuingly wretched hive of scum and quackery, The Huffington Post. There, our old friend John Weeks touts the study thusly, while objecting to an editorial that suggested looking at the individual supplements recommended by the naturopaths in the trial:

Yet there was a much better recommendation Stanbrook might have made, given the importance of cardiovascular disease in the high costs of health care.

But why not start by noting that optimal care of most individuals with cardiovascular risk involves multiple etiologies? Care is complex. Of necessity, it demands the kind of individualization of treatment and whole person approaches such as the naturopathic doctors and their integrative medicine brethren practice. A good clinician doesn't treat patients with lifestyle risks who are at differing levels of readiness for change with the same prescriptions.

Why not, then, Stanbrook might have recommend, [sic] a follow-up in which the naturopathic doctors are working in a primary care capacity, rather than adjunctively, with these individuals. This would not only be money saving. This is in fact typically the way these naturopathic doctors practice their brand of integrative medicine, in Ontario and elsewhere.

Yes, you read it right. Weeks is using this study to argue that naturopaths should function as primary care physicians, despite how well documented it is that they are completely unsuited to such a role, as well demonstrated by Peter Lipson in his primary care challenge (also here and here and here). The study, of course, provides support for nothing of the sort, although unfortunately even physicians seem to be taken in by it, as evidenced by the very editorial that Weeks touts, with the cringe-inducing title, Can naturopaths administer complementary preventative care? More on that later. Let's start with the study by Dugald Seely et al., for which most of the authors were from the Canadian College of Naturopathic Medicine. A finer example of the strategy of naturopaths to try to represent diet and lifestyle counseling as being somehow unique to naturopaths I have not seen in a long time.

The study itself was fairly straightforward as randomized trials go. The subjects were all members of the Canadian Union of Postal Workers aged 25 to 65 years who were under the care of a primary care physician who could speak English and were competent to provide informed consent. The only exclusions were women who were pregnant or breast feeding or who wanted to become pregnant in the the following year. Also excluded were people with a history of myocardial infarction in the last six months, with chronic kidney or liver disease, or with lower relative ratios of total cholesterol to HDL. The study took place at multiple sites, for a total of 246 subjects, 207 of whom completed the study. These subjects were randomized either to either "usual care" by their existing family physician alone or to "usual care" plus naturopathic care. Obviously, the study was not blinded, of course. Rather it was a "pragmatic" trial, which means that pretty much anything goes for both arms. The idea is to compare "usual care" in the community to "usual care" plus naturopathy. One notes that CAM and "integrative medicine" practitioners (particularly fans of acupuncture) love pragmatic trials because they are less rigorous than a true randomized clinical trial.

What's of interest, before we get to the results, is what "naturopathic care" consisted of:

Participants in the naturopathic group received naturopathic care at 7 preset times over a 1-year period, at a frequency that was somewhat typical of routine naturopathic care in the community. The initial visit was 1 hour, with subsequent 30-minute follow-up visits. For consistency with naturopathic practice, treatment recommendations were individualized from a predetermined menu of interventions based on which risk factors were present and patient preferences (Appendix 1, available at www.cmaj.ca/lookup/suppl/doi:10.1503/cmaj.120567/-/DC1). Therapies included specific diet and lifestyle recommendations and the prescription of selected natural health products. Because a range of interventions were recommended to participants in the naturopathic group, the frequency and composition of each recommendation as well as participant adherence are not reported. We did not have direct control over the care given to the control group; thus, we did not track or report recommendations made by the participants’ family physicians.

The menu of therapies was guided by an expert advisory process, during which 4 naturopathic doctors (P.R., R.B., D.L., T.G.) provided guidance to trial clinicians based on existing peer-reviewed published evidence and clinical experience. This process resulted in a trial manual of therapies provided to each of the 3 clinicians (O.S., S.A., C.H.) to guide their practice. The recommended interventions included weight loss of about 2.3–4.6 kg through a combination of caloric restriction and regular physical activity.5,12 Dietary recommendations were based on components of the Mediterranean and Portfolio dietary regimes.13,14 Examples of prescriptions for natural health products included omega-3 fatty acids eicosapentaenoic acid and docosahexaenoic acid,12,15 soluble fibre,16 coenzyme Q1017 and plant sterols5 (Appendix 1).

It's telling to look at the menu of interventions. Listed there are lifestyle interventions, which include a weight loss of 5-10 lbs; aerobic and anaerobic exercise, 30 min./d five times a week and two to three times a week, respectively; and 10 min/d of diagphragmatic breathing. The dietary interventions all focused on caloric restriction and decreased fat and red meat intake similar to the Mediterranean and Portfolio diets. In this, there is nothing that isn't part of SBM. The two links I included went to the Mayo Clinic website and the other is to a WebMD article. Real primary care doctors and cardiologists have been recommending diets rich in vegetables, fruits, and nuts for a long time as a strategy to decrease cardiovascular risk. As for the supplements included on the menu of potential interventions that the naturopath could choose include fish oil, plant sterols, cinnamon, CoQ10, ALA (alpha lipoic acid), lutein, and fiber. So in reality, I wasn't quite correct to say earlier that "anything goes" in the naturopathic care arm of the trial. In fact, the range of interventions were highly constrained from what naturopaths usually offer, which include not just lifestyle and diet advice, but lots of supplements that go beyond the limited suite of supplements the naturopaths in this study recommended. True, the evidence base for these supplements doing anything for cardiovascular disease is sparse, but they are also probably, as Douglas Adams would say, "mostly harmless."

Be that as it may, it must also be remembered that "in the real world" naturopaths frequently prescribe acupuncture, traditional Chinese medicine, homeopathy, and all range of woo for treatment of just about everything, the "individualization" of treatment being basically what I like to call "making it up as you go along" or whatever the particular naturopath tends to prefer. So, right from the beginning, it should be clear that what we are looking at is not naturopathic practice but a small subset of what naturopaths do and offer. It's the Trojan horse, as I like to call it, where the quackery (like homeopathy, chelation therapy, etc.) is hidden in a horse made of seemingly reasonable, science-based recommendations and modalities. Once the horse enters the realm of SBM (ahem, is "integrated" with SBM), then the quackery jumps out of the trapdoor in the bottom and takes over. Even Seely himself works at a clinic that offers reiki, naturopathy, traditional Chinese medicine, hydrotherapy, lymphatic drainage, and more. Indeed, if you want to get an idea of the approach of this clinic, the Ottawa Integrative Cancer Center, you should take a look at this post, in which Seely himself recommends a book by a breast cancer survivor who was treated by a naturopath who gave her intravenous vitamin C (along with other non-evidence-based interventions) between rounds of chemotherapy, endorsing the book as a "profound testament to the possibility of a truly integrative model of care that includes the voices of her dedicated team of healers."

No, science-based is not what I would call the practice of naturopathy. If anything, the account confirms to me my belief that "integrative oncology" in general and naturopathic oncology in particular are in reality the "integrating" of nonsense with science. Even the naturopathy school where Seely is faculty is steeped in prescientific vitalism (of course it is, it's a naturopathy school), such as exploring "the manifestation of prana or energetic life force as related to disease in the five sheaths of the body" and, of course, homeopathy.

So what were the results of the study? It wasn't powered to look at "hard" outcomes like death or myocardial infarctions; instead its a priori defined primary outcomes included changes in the prevalence of metabolic syndrome and changes in the Framingham 10-year cardiovascular risk score. For those not familiar with metabolic syndrome, the Adult Treatment Panel III defines it as the presence of three of five risk factors: abdominal obesity; "triglycerides ≥ 1.70 mmol/L or taking medication for elevated triglyceride; HDL cholesterol < 1.03 mmol/L for men or < 1.3 mmol/L for women; systolic blood pressure ≥ 130mmHg or diastolic blood pressure ≥ 85 mm Hg or taking antihypertensive medication; or fasting blood glucose ≥ 5.6mmol/L or taking medication for diabetes." The Framingham risk score produces an estimate of risk for major cardiovascular events. Secondary outcomes included changes in individual risk factors, changes in quality of life (estimated by the use of the Short Form Health Survey and the Measure Yourself Medical Outcomes Profile questionnaire). Naturopathic doctors "collected all biometric and validated questionnaire measures at baseline, 26 weeks and 52 weeks for both groups."

The findings were as follows:

Of 246 participants randomly assigned to a study group, 207 completed the study. The characteristics of participants in both groups were similar at baseline. Compared with participants in the control group, at 52 weeks those in the naturopathic group had a reduced adjusted 10-year cardiovascular risk (control: 10.81%; naturopathic group: 7.74%; risk reduction –3.07% [95% confidence interval (CI) –4.35% to –1.78%], p < 0.001) and a lower adjusted frequency of metabolic syndrome (control group: 48.48%; naturopathic care: 31.58%; risk reduction –16.90% [95% CI –29.55% to –4.25%], p = 0.002).

Of note, also:

Although the treatment group improved more than the control group for almost all secondary outcomes, most were not statistically significant (Table 2 and Appendix 2, available at www.cmaj.ca /lookup/suppl/doi:10.1503/cmaj.120567/-/DC1). Notable significant results were reductions in waist circumference, ratio of total cholesterol to HDL, and scores for symptoms 1 and 2 (self-identified as important symptoms of concern) on the Measure Yourself Medical Outcomes Profile questionnaire, general wellbeing and reduction in medication (number of medications and/or dosage).

Looking at the table, I note that there were 25 measures, each sampled twice after baseline (once at 26 weeks and once at 52 weeks), for a total of 50 measurements. I didn't see a correction for multiple comparisons; so it's hard for me to tell whether the number of "statistically significant" improvements are really significant or due to multiple comparisons.

These results lead the investigators to conclude:

According to the American Heart Association, the “prime emphasis in management of the metabolic syndrome per se is to mitigate the modifiable, underlying risk factors (obesity, physical inactivity, and atherogenic diet) through lifestyle changes…Then, if absolute risk is high enough, consideration can be given to incorporating drug therapy to the regimen.”5 Primary health care that provides in-depth counselling around diet and lifestyle is uniquely poised to help comanage metabolic risk factors. We have shown that naturopathic care is a feasible and potentially effective adjunct to usual medical care in reducing the incidence of metabolic syndrome and cardiovascular risk.

No, that's not what Seely et al. have shown at all. As a cardiologist I know said (and I paraphrase), "If I had four extra hours over seven visits to counsel each patient on lifestyle changes and diet, I bet I could get my patients' Framingham risk scores and incidence of metabolic syndrome down too." Indeed, David Winchester, who wrote a response to the study published in the CMAJ, nailed it, pointing out that the authors have not, in fact, demonstrated that the addition of naturopathic care to usual care produces better outcomes, but rather that they have shown this:

While the authors have demonstrated that a generous investment in counseling is effective at reducing calculated CHD risk, they have not demonstrated any effect specifically attributable to naturopathic care. Dietary counseling, for example, appears to be effective regardless of the provider (reference originally published in 2005). (2) As a practicing cardiologist, I routinely "deliver diet and health promotion advice" to my patients and "emphasize this form of self- directed care". As noted in the accompanying editorial, (3) I would welcome the opportunity to spend an additional four hours in consultation with my high CHD risk patients and I suggest such an intervention would have been the appropriate control comparator.

To these observations, I reiterate what I said above. The suite of interventions from which the naturopaths could choose were not anything unusual outside the realm of SBM. As Dr. Winchester and I agree, the suite included nothing unique to naturopathy, and, as I pointed out, it also left out a lot of outright quackery that naturopaths routinely use, such as chelation therapy. Dr. Winchester also points out something that was eating at me as I read the study. Specifically, he wondered on what evidence the naturopaths based their recommendations. For instance, he questioned the recommendation to cut down on coffee use, given that the available literature before the trial started supported an association between moderate coffee drinking and a reduced risk of diabetes and no increased risk of cardiovascular disease. He also questioned the evidence base for the supplements used, an evidence base that is at best thin.

Perhaps the most disturbing aspect of this trial is how thoroughly CMAJ has bought into the spin that naturopaths are putting on it. Instead of insisting that it be reported to show what it really showed, namely that intense counseling on losing weight and exercising more can potentially decrease cardiovascular risk, its editors significantly bought into the idea that there is something unique about naturopathy. True, Matthew Stanbrook, the deputy editor of CMAJ, did concede my point in his editorial that none of the interventions in the naturopathic medicine arm of this study are, in fact, unique to naturopathy, he flew by that objection to say something even more disturbing:

One might similarly argue that physicians could achieve the same results if they spent an equivalent of 4 hours per year dedicated to cardiovascular prevention with each patient. But that’s the point: this doesn’t seem feasible, given a family physician’s responsibility for overseeing all of a patient’s health issues, and the inability of many Canadians to obtain their own primary care physician based on current physician supply and distribution. In response, physicians already delegate many important aspects of medical care, such as diabetes education, smoking cessation counselling and asthma education, with good effect and in a manner that enhances rather than threatens their therapeutic relationship with patients. The results of Seely and colleagues provide proof of principle that some aspects of cardiovascular prevention could feasibly and effectively be delegated to naturopaths.

No, no, no, no, no! Note that the tasks mentioned by Stanbrook that have been delegated to non-physicians have in general been delegated to specialists who receive science-based training. Dietitians and nurses specializing in diabetes management counsel diabetic patients on diet and insulin use. Nurse practitioners, physician's assistants, and other mid-level providers are often primarily responsible for lifestyle counseling, asthma education, and routine follow-up visits. Here, the message seems to be that naturopaths are just like these mid-level providers, nurses, or other specialists. The problem is, they aren't. They're nothing like them because unlike nurses (except, I must concede, in those nursing schools where therapeutic touch is popular), PAs, NPs, dietitians and the like, their training is steeped in pseudoscience mixed with science, not science-based medicine. For example, as I've pointed out before, every single naturopath is required to be trained in homeopathy. Every. Single. One. Of. Them. They're even tested on homeopathy as part of their board examination. That is not science, and any specialty that thinks that homeopathy can be the least bit science-based is rooted far more in pseudoscience and quackery than science.

The idea that is being promoted by naturopaths is that, if physicians must delegate lifestyle and diet counseling, then naturopaths are somehow uniquely "qualified" to take on the role and fill in the gap. Some, like John Weeks, even argue that this means that naturopaths are capable of filling in for projected shortages in primary care physicians. It's a common talking point for not just naturopaths, but all manner of CAM practitioners. The hubris is staggering. If we as physicians are, because of the ever more constrained financial imperatives of medicine, no longer able to spend this sort of extra time with patients, then why on earth would we delegate diet and lifestyle counseling to naturopaths? The answer is that we shouldn't. If delegate we must, then we should delegate to practitioners who are actually trained in science-based interventions, not to practitioners of what is mostly prescientific, vitalistic quackery.

Unfortunately, because of the power of the Trojan horse message, this is a fight we might lose. Shruggies don't realize this, and politicians don't understand how much quackery is a feature, not a bug, in naturopathy. I fear that our efforts to educate will not be the equal of the quacks' efforts to legislate.