Naturopathic oncology is what I like to call a “pseudospecialty.” It sounds like a medical specialty, at least superficially, and certainly naturopaths try their damnedest make their pseusospecialty sound like a real medical specialty to the rubes. They talk all mediciney and sciencey, while throwing in appeals to nature and “natural cures” as the best way to heal cancer. Then, of course, there’s the fact that all naturopaths are trained in The One Quackery To Rule Them All (homeopathy), and many use homeopathy to treat patients, and you get the picture. “Naturopathic oncologists” shouldn’t be allowed anywhere near cancer patients—just as naturopaths shouldn’t be allowed anywhere near patients. There’s a reason why, when I see the abbreviation “FABNO” that naturopathic oncologists like Not-A-Doctor Dugald Seely have after their name, I say, “FAB? NO!” as I watch them cosplay real doctors.
As much as I detest the quackery in naturopathic oncology (and all naturopathy), it especially irks me to look at attempts by naturopaths to do research that will validate their field. It’s such a massive waste of money, time, patients, and space on PubMed to list the studies. Indeed, I was particularly annoyed when three years ago I learned that a Canadian naturopath, Dugald Seely, received first $4 million and then $3 million to carry out clinical research in naturopathic oncology, all within six months of each other. Dugald Seely, of course, is someone I’ve written about before, thanks to his heavy involvement in the Society for Integrative Oncology and his involvement in writing “integrative oncology” guidelines for breast cancer patients. He runs the Ottawa Integrative Cancer Centre and is a big name in “naturopathic oncology.”
I always wondered what Dugald Seely was doing with all that money. Thanks to Jann Bellamy, I know now. Although I did discuss the broad outlines of the studies, at the time the protocols for the studies themselves hadn’t been published anywhere. For instance, there is Thoracic Peri-Operative Integrative Surgical Care Evaluation (Thoracic POISE), which, or so it was said, was to consist of two parts: an observational study examining integrative care techniques to use on patients before and after surgery and a randomized controlled trial to evaluate the techniques and see if they reduce adverse events and improve survival. The second study is called the Canadian/US Integrative Oncology Study (CUSIOS), and its goal is to “observe and measure the overall survival of a cohort of late stage (III and IV) cancer patients who receive advanced integrative oncology (AIO) treatments and, to describe integrative therapies provided by naturopathic doctors across the cohort.”
I can’t believe it, but in the three intervening years since I initially noted these huge donations, I never thought to follow up to see just what it was that Seely was doing with that money. Jann sent me a link to the ClinicalTrials.gov entry for the CUSIOS trial, but I’m going to start with the Thoracic POISE trial (NCT02845479) first. Here’s its ClinicalTrial.gov entry. What surprised me immediately is that, more than three years later, this study is listed as not yet recruiting. It has an estimated start date of June 2018. Its sites are Ottawa General Hospital and the Ottawa Integrative Cancer Center. Now, clinical trials can take a long time to design and obtain regulatory approval for, but this appears to be only the first part of the study and doesn’t even include the randomized controlled clinical trial. It’s just a single-arm study of 40 patients. It’s described as follows:
Despite enormous advances in thoracic surgery and oncology, two critical issues concern patients undergoing curative-intent surgery for lung, gastric and esophageal cancer: first, a majority (~60%) of patients experience minor and major adverse events occurring during and in the days following surgery; second, patients worry about the significant risk of cancer recurrence and mortality months to years after surgery. These issues, combined with side effects of chemotherapy and radiation, have detrimental effects on health-related quality of life (HRQoL). On a deeper level, there is the problem of an ongoing failure to integrate and evaluate the best of what complementary medicine has to offer surgical oncology care.
I had to stop right here. So the rationale of this study is that because complication rates are high after surgery for lung, gastric, and esophageal cancer and there is a significant risk of cancer recurrence and chemotherapy causes serious side effects, all resulting in detrimental effects on the patient’s quality of life, Seely’s hypothesizing that these issues are due to an “ongoing failure to integrate and evaluate the best of what complementary medicine has to offer surgical oncology care”? As a surgical oncologist myself, I almost spit up my iced tea that I was drinking as I wrote this. So the problem behind all the complications from advanced surgery for these cancers, the resection of which involves big operations that can cause big complications, is a lack of quackery? It would seem that Dugald Seely believes this.
So what does Seely want to do to study his hypothesis (if you can call it that)? Well, he wants to start out with this:
The Thoracic-POISE Project has the overarching goal of improving care for thoracic cancer patients by impacting HRQoL, reducing surgical adverse events, prolonging overall survival and pioneering integrative care delivery. This multi-stage project aims to design, pilot-test and evaluate a broad-based, multi-agent, evidence-based integrative care program to be delivered by naturopathic doctors (ND) in conjunction with standard surgical and oncologic care. It is hypothesized that this integrative care program will improve HRQoL as well as reduce surgical adverse events and improve cancer survival. Stage I of the project will pilot-test the intervention and outcomes collection in a single-arm, feasibility study.
You want to know how you really improve impacting HRQoL, reduce surgical adverse events, and prolong overall survival? You do it with science-based medicine. You do it by testing new treatments that aren’t based on the vitalistic nonsense that naturopaths practice. And you don’t waste $4 million on a study like this and the followup study that quacks like Dugald Seely concoct after this pilot study to test some naturopathic quackery or other that they identify.
So the first primary outcome is the feasibility of the study protocol, which will be assessed by the percentage of participants who complete all assessments and integrative care appointments. That’s it? But what are the other outcome measures? Here are the secondary outcomes:
- Compliance: supplemental intervention [Time Frame: Enrollment – 1 year post surgery] Count of missed doses assessed by patient diary.
- Compliance: nutritional intervention [Time Frame: Enrollment – 1 year post surgery] Mediterranean diet score calculated by food frequency questionnaire administered at enrollment and 1 year post surgery
- Compliance: physical intervention [Time Frame: Enrollment – 1 year post surgery] Extent of adherence to physical activity recommendations assessed using a patient diary.
- Compliance: mental/emotional domain [Time Frame: Enrollment – 1 year post surgery] Number of days audio-recordings were used assessed by patient diary.
- Communication between practitioners [Time Frame: Enrollment – 1 year post surgery] Number of communications (phone, consult note, etc.) between integrative and standard care practitioners per participant
- Qualitative experience of care and study protocol [Time Frame: Enrollment – 1 year post surgery] Semi-structured interviews with thematic analysis
- Feasibility of recruitment [Time Frame: Enrollment] Percentage of participants recruited out of potentially eligible patients invited.
Here are other outcome measures:
- Adverse events [Time Frame: Enrollment – 1 year post surgery] Health Related Quality of Life [Time Frame: Enrollment – 1 year post surgery] Functional Assessment of Cancer Therapy-General Score
- Cancer-related symptoms [Time Frame: Enrollment – 1 year post surgery] Edmonton Symptom Assessment Scale
- Anxiety and Depression [Time Frame: Enrollment – 1 year post surgery] Hospital Anxiety and Depression Scale
- Fatigue [Time Frame: Enrollment – 1 year post surgery] Multidimensional Fatigue Inventory
- Functional exercise capacity [Time Frame: Enrollment – 1 year post surgery] 6 minute walk test
- Change in body mass index [Time Frame: Enrollment – 1 year post surgery]
- Inflammation: Multi-analyte cytokine array. [Time Frame: Enrollment – 1 year post surgery] Plasma concentrations of a panel of cytokines (IL2, IL10, TGF-beta, TNF-alpha, IFN-alpha, and IFN-gamma) will be measured in blood samples collected 4 weeks before surgery, 2-3 days before surgery, on post-operative day (POD) 1, POD 5 (+/-2), 3-4 weeks, 6 months and 1 year post-surgery
- Natural kill cell activation [Time Frame: Enrollment – 1 year post surgery] NK cell activity will be measured by NKVue™ in blood samples collected 4 weeks before surgery, 2-3 days before surgery, on post-operative day (POD) 1, POD 5 (+/-2), 3-4 weeks, 6 months and 1 year post-surgery
So what we have here is a whole lot of outcomes examined in a small number of patients. It’s basically a fishing expedition. Now, there’s nothing inherently wrong with a fishing expedition in science, as long as it’s clear that that’s what it is and the outcomes researchers are “fishing” in are chosen carefully based on science. This just looks like a shotgun approach. Unfortunately, the protocol isn’t very revealing about what sorts of “integrative medicine” Seely will be testing. Elsewhere, I could find that the interventions are supposed to relate to targeted natural health products; nutritional approaches; fitness improvements (particularly pulmonary fitness); and mind and body medicine and psychological well-being. Whatever that all means. They’re also wasting millions of dollars doing it.
What about the CUSIOS trial (NCT02494037)? This one’s at least as bad and costing $3 million. What is Seely doing for that much money? CUSIOS is doing a multicenter observational study of patients with breast, colorectal, pancreatic, and ovarian cancers. Seely starts out with an appeal to popularity:
It is estimated that between 50 and 80% of cancer patients in the United States (US) supplement their conventional oncology treatment regimen with some form of complementary or alternative medicine therapy or practice. A smaller percentage of these patients receive medical treatment from naturopathic doctors (NDs) who are board certified in naturopathic oncology (Fellows of the American Board of Naturopathic Oncology, FABNO) or have equivalent experience in caring for cancer patients and from traditional Chinese medicine (TCM) providers with advanced training in oncology (DAOM or physicians with training in TCM). This level of care is being defined here as advanced integrative oncology (AIO). AIO clinics provide comprehensive science- and experience-based naturopathic and Chinese medical oncology integrated with each patient’s conventional medical treatment.
Science-based naturopathic oncology? There’s no such thing! Ditto traditional Chinese medicine! As for the “FABNO” designation, it’s akin to graduating from the Hogwart’s School of Witchcraft and Wizardry, with the exception that the magic of J.K. Rowling’s fictional world worked. FAB? NO!
So here’s the study:
Although there have been some studies of complementary and alternative medicine use by cancer patients, little is known about the effectiveness of the naturopathic medicine and TCM provided to people with cancer in an integrative setting. While there is scientific evidence supporting specific treatments that are commonly used, systematic study of their effectiveness (especially when used in combination as commonly recommended) is virtually non-existent. An early step in the evaluation of clinical outcomes associated with AIO is to take a health service approach and seek to answer the question: “Does exposure to AIO services improve the clinical outcomes of patients with advanced stage cancer?”
The survival outcome of consecutively recruited advanced stage breast, colorectal, pancreatic, and ovarian cancer patients treated at multiple naturopathic oncology clinics in North America will be tracked and compared to outcomes published in the current medical literature and by SEER (Surveillance, Epidemiology and End Results) in order to address the fundamentally important question of whether or not AIO has a beneficial impact on survival. Involvement of a total of seven active AIO clinics from Canada and the US will allow the recruitment of a sufficient sample size to address this question as well as provide outcomes that are generalizable for AIO across North America.
So let me get this straight. Seely is going to recruit 400 patients with advanced stage cancer, treat them with quackery in addition to their conventional therapy, and then follow their survival, comparing it with the SEER database? This is what’s known as a trial with a historical control. It can sometimes be valid to compare a single-arm study results to historical controls, but it’s really not very useful. Comparison to historical data is always fraught with difficulty, and large differences between what is observed in a trial compared to historical controls are necessary to be even suggestive of a benefit or detriment. How will they know what to expect anyway? And let’s say they do find something? How will they know if naturopathic oncology has anything to do with improved survival if they observe good results? Will they wonder if naturopathic oncology is harmful if they observe worse than expected outcomes? They might as well throw the $3 million into a shredder. At least then they wouldn’t be using it to produce dubious data that will be used as propaganda to support “integrative oncology” and “naturopathic oncology.”
After all, look at the secondary outcomes. One is nothing more than looking at AIO treatment recommendations for cancer and the conventional oncology treatment data to describe the cancer treatments. Seriously. There is no standardization. Basically, patients will likely get conventional therapy plus whatever magic snake oil naturopaths want to give them. The other secondary outcome will basically be quality of life data.
So what will Seely have at the end of these two studies? What he almost certainly won’t have are data that tell us whether any of the interventions his fellow quack naturopaths (but I repeat myself) have any impact on survival, recurrence, or even quality of life in cancer patients, even if he manages to pull off a randomized trial in the Thoracic POISE project, because he won’t be testing individual interventions. He will, however, have spent $7 million between the two studies. That’s a lot of money, at least three or four R01-level projects or around 10-15 R21 preliminary grants. Indeed, this much money is on the order of a Stand Up 2 Cancer “Dream Team” grant, or various large team science grants offered by the NIH. I weep for what the money could have done for cancer patients if applied to testing science-based treatments instead of fairy dust. In the end, naturopaths like Dugald Seely are cosplaying real doctors and clinical trials are their props.