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Naturopathy vs. Science: Diabetes Edition

Diabetes Mellitus
Does naturopathy offer something special or uniquely effective for the treatment of diabetes? Naturopaths are alternative medicine practitioners who claim to provide primary care, like medical doctors. Among naturopaths and their supporters, it’s regularly claimed that naturopathy offers something that “conventional” medicine does not: Naturopaths are described as “doctors plus”, using unconventional approaches to coax the body to “heal itself” with methods that are claimed to be safer and more effective than conventional drugs and medical interventions. The superiority of naturopathy over conventional medicine is an argument that showed up in the comments to my last post, when I pointed out that this year’s Nobel Prize in Physiology or Medicine failed to validate either naturopathy or herbalism. Here’s one example:

Someone diagnosed with pre-Type 2 diabetes could visit a Naturopathic Doctor and stop the disease in its tracks. The doctor would recommended a simple diet change to a high-fat, low-carb, zero refined sugar diet, maybe some supplements, and exercise. Bye, bye, Type 2 diabetes. The same person could visit an MD, and before you know it would be taking insulin and Metformin (and other horrible drugs) for the rest of his or her life. An added bonus with the insulin is weight gain. Notice that the diabetes commercials feature overweight actors and actresses? Yes, there are natural cures. Is this is a site promoting good health, or is it a front for the pharmaceutical companies?

You can follow the comment thread for the discussion that followed. The same commenter continued in Mark Crislip’s post on Friday about the difference between naturopathy and conventional medicine:

Allopath – you will be taking insulin, Metformin and other drugs for the rest of your life. Your diabetes will be managed, but there will be a slow deterioration in the quality of your life.

Naturopath – we can reverse this with a change in your diet, along with exercise.

Naturopath wins.

Now this individual never claimed to be a naturopath – but testimonials like these are not surprising. I’ve written several posts in the past about the claims made by naturopaths, and how they stack up against the scientific evidence. Naturopaths offer an array of disparate health practices like homeopathy, acupuncture and herbalism that are linked by the (now discarded) belief in vitalism – the idea we have a “life force”. From this philosophy can sometimes emerge sensible health advice, but not because naturopaths are following the evidence. As long as a treatment is viewed as being congruent with the naturopathic belief system, it’s acceptably “naturopathic”. In past posts I’ve looked at the naturopathic perspectives on fake diseases, infertility, autism, prenatal vitamins, vaccinations, allergies, and even scientific facts themselves. Britt Hermes is a former naturopath and has written extensively about naturopathy from the perspective of an insider, and her evaluation is scathing: There are no naturopathic standards of care, naturopathic training is much different than what naturopaths purport, and the accreditation of naturopathic schools is questionable. Now, diabetes is a widely prevalent chronic disease. It causes a huge burden of illness on society. And while we have a fair understanding of its causes and how to treat it, there are still far too many people suffering from complications of the disease. Diabetes already requires care from multiple medical professionals, including physicians, nurses, dietitians, and pharmacists. Should naturopathy be included? Is there any evidence that demonstrates that naturopathy can “stop” diabetes? And how does advice from a naturopath differ from “conventional” medical advice? (more…)

Posted in: Naturopathy, Science and Medicine

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The American Cancer Society’s new mammography guidelines: Déjà vu all over again

The American Cancer Society’s new mammography guidelines: <em>Déjà vu</em> all over again

One of the things that feels the weirdest about having done the same job, having been in the same specialty, for a longer and longer time is that you frequently feel, as the late, great Yogi Berra would have put it, déjà vu all over again. This is particularly true in science and medicine, where the same issues come up again and again and again, often with the same arguments on either side. Sometimes the same players are even involved. So it is with mammography recommendations. Indeed, I’m feeling déjà vu all over again right now, as I read headlines like “Women advised to get mammograms later, less often“, “American Cancer Society, in a Shift, Recommends Fewer Mammograms“, and “ACS: Breast cancer screening should begin at age 45“. What provoked these headlines was a major revision in the American Cancer Society’s recommendation for mammographic screening for breast cancer in women at average risk of the disease. In a seeming replay from 2009, when the United States Preventative Services Taskforce (USPSTF) sent shockwaves through the breast cancer world by recommending that most women not start mammography until age 50 and then only to have it done every two years instead of every year, the American Cancer Society (ACS) has now just similarly ratcheted back its recommendations for screening mammography, just not as much as the USPSTF did. The new recommendations were communicated in a special communication published by JAMA on Tuesday.

What changed regarding mammography recommendations

Before we get to the issues, how, specifically, did the ACS change its mammography recommendations? Before this change, the ACS basically recommended the same thing that most other American professional societies dealing with breast cancer did: yearly mammography starting at age 40 for the rest of a woman’s life. The new guidelines now recommend that women with an average risk of breast cancer should undergo regular screening mammography starting at age 45 years and continuing annually until age 54. From age 55 and older, the ACS recommends that women transition to every two years. (More details below.) As I Tweeted when I saw these recommendations, basically it appears that the ACS has more or less split the difference between the old recommendations and the USPSTF recommendations.

So why is the ACS changing its recommendations? And what does this say about the science and our values regarding cancer screening? If you’ve been reading this blog, you know that over the last several years there has been a steady drip, drip, drip of studies that range from highlighting the downside of widespread mammographic screening to downright questioning the value of mammography. That’s why I’ve been discussing rethinking screening for breast cancer since at least 2008. Basically, you can go back and read my old posts and, if you have a lot of time and are enough of a glutton for punishment to read them all, watch the evolution of my thinking about breast cancer screening over the last seven years.

Back in the day, I used to fully support breast cancer screening beginning at age 40 and proceeding yearly throughout. As I examined more and more of the evidence, I became less enthusiastic about screening so intensely and started to believe that starting at 40 was too young for most women. Indeed, I was probably the only breast cancer doctor at my cancer center in 2009 who supported the USPSTF recommendations when they were announced, which led to some—shall we say?—interesting discussions about what should be said to the press and what a press release our cancer center wanted to release ASAP should actually say. I also got myself into a little…trouble…for criticizing colleagues in radiology—not from my institution, I hasten to add!—for some rather blatant turf protection. Let’s just say that a prominent radiologist, one who’s achieved far more renown in his field than I ever have in mine, was most displeased with some of my commentary and let me know about it. I found this displeasure odd, given that I am most definitely not a nihilist with respect to mammography screening (and, make no mistake, there are quite a few of those out there these days). I’m just a lot more balanced and aware of its limitations than I used to be. On the other hand, I did call him out for some of his more obnoxious comments that implied that those who question mammography are cackling gleefully at the thought of more women dying of breast cancer. Interestingly, I don’t seem to get asked to contribute to such press releases that much anymore, but in fairness neither do most of the other breast cancer clinicians I work with; so I probably can’t blame it on my previous outspokenness.

What brought me to this point is an increasing understanding of the concepts of overdiagnosis and lead time bias, coupled with a string of studies that show more modest benefits (and, in one case, no benefit) from screening mammography. To be honest, the attack dog reaction by some mammography supporters to some of these negative studies also set my skeptical antennae a’twitchin’ as well.

Posted in: Cancer, Public Health

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Are Placebos Getting Stronger?

placebo1A new study looked at clinical trials for neuropathic pain over the last 23 years and found that the response of subjects in the placebo group has been increasing over time, but only in the United States. The cause of this increase is unknown, and has provoked a fascinating discussion about the nature of placebos and their role in medical research.

What is the placebo effect?

We have discussed the placebo response at length here at SBM because the concept is critical to understanding clinical science, and it is largely misunderstood. Most often it is presented as a mind-over-matter response to the expectation of benefit. Proponents of worthless treatments often hype the placebo response as if it can have real healing power, when the evidence shows it does not.

In reality, there are a large number of placebo effects and the phenomenon is quite complex. In clinical trials “the placebo effect” is whatever happens in the placebo group of the study, the group receiving an inactive treatment. This is not one effect, however, but a complex combination of many effects.


Posted in: Clinical Trials

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Willow Curve Device for Pain: Strong Claims, Weak Evidence

willow curveWillow Curve is advertised as the “world’s first digital anti-inflammatory device,” “a laser smart device” designed to relieve pain with thermal and photonic energy. It contains over 150 bio-sensory and bio-therapeutic components that continuously monitor the body’s thermal and electrical response to the device, and internal computer chips use that information to determine a tailored digital prescription on the fly. The digital prescription consists of “multiple energies” that change thousands of times a second.

It’s not clear exactly what the sensors sense, or how they work. It’s not clear how the device responds to information from the sensors to alter the output of heat and light, and it’s not clear how it chooses the appropriate dose for that patient. They don’t divulge information like intensity and wavelength for the various treatment protocols. They claim that the treatment “stimulates 15 bio-physiological processes for treating the joint and surrounding tissues,” [which 15 are those, exactly?] dilates blood vessels, slows nerve response time, releases endorphins, blocks specific pain receptors, and detoxifies by removing toxic debris from the joints. They offer no evidence in support of those claims. I tried to get clarification from the company, but they didn’t answer my inquiries. (more…)

Posted in: Medical devices

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Choosing Wisely: Changing medical practice is hard

OK, so Choosing Wisely isn't quite like this, but it's still very important.

OK, so Choosing Wisely isn’t quite like this, but it’s still very important.

We here at Science-Based Medicine like to point out that arguably the most striking difference between science-based medicine (and the evidence-based medicine from which we distinguish it) and alternative medicine, “complementary and alternative medicine” (CAM), or (as it’s called now) “integrative medicine” is a concerted effort to change for the better. In other words, in SBM, we are continually doing studies to improve practice. These studies take on two general forms: Comparing new treatments with old to determine if the new treatments work better and, as has become an imperative over the last several years supported by more research dollars, comparing existing treatments in order to determine which ones work better. In the case of the former, we are trying to add to our knowledge and thereby add more effective treatments, while in the case of the latter we are trying to weed out treatments that are less effective and/or less safe or that cost more money to produce the same results. Indeed, the rise of an explicit framework, evidence-based medicine, is a result of the desire of medicine as a profession to improve what it is doing. (Yes, I know this blog frequently criticizes EBM, but in the case of treatments that have science behind them EBM and SBM should be—and usually are—synonymous.) This is in marked contrast to CAM, where treatments based on prescientific vitalism never, ever go away, no matter how many clinical trials show them to be no better than placebo and basic science shows them to be ludicrously disconnected from reality.

An example of this imperative to make things better is Choosing Wisely. This is an initiative launched in 2012 in which the American Board of Internal Medicine (ABIM) Foundation challenged specialty societies to produce lists of tests and interventions that doctors in their specialty routinely use but that are not supported by evidence. The explicit goal of Choosing Wisely was to identify and promote care that is (1) supported by evidence; (2) not duplicative of other tests or procedures already received; (3) free from harm; and (4) truly necessary. In response to this challenge, medical specialty societies asked their members to “choose wisely” by identifying tests or procedures commonly used in their field whose necessity should be questioned and discussed. The resulting lists of “Things Providers and Patients Should Question” was designed to spark discussion about the need—or lack thereof—for many frequently ordered tests or treatments.

Posted in: Clinical Trials, Politics and Regulation

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“Safe” dietary supplements can land you in the emergency room

Dietary supplements
If there’s one thing I’ve been consistent about, it’s that, however ridiculous all the other woo I routinely discuss here is—homeopathy, reiki, reflexology, I’m talking to you and your friends—herbal medicine and supplements might have value because they might have a physiological effect that is beneficial in treating or preventing disease. Of course, if that’s the case, it’s because the herb or supplement contains chemicals that act as drugs. They’re “dirty” drugs in that they are mixed with all sorts of other substances in the herb or supplement that might or might not have effects, which means that different lots of the herbs or supplements often have different activity, but they are drugs nonetheless. That’s why, for instance, doctors don’t tell patients to chew on foxglove leaves when they want a patient to get digoxin. Digoxin is a powerful drug with a relatively narrow “therapeutic window,” meaning that the difference between the levels of the drug in the blood needed for therapeutic effect are not very far from toxic levels; so predictable, reliable drug content is essential. I just learned a while ago that within the living memory of some older physicians digoxin actually was prescribed as crude extracts, which was very difficult and dangerous, hence the necessity of purification. In other cases, (such as Artemisinin, for which Youyou Tu was recently awarded the Nobel Prize in Physiology or Medicine), crude plant extracts do not contain sufficient quantities of the active component, necessitating its isolation, purification, and, in some cases, chemical modification to increase its absorption, stability, or activity.

One thing that proponents of herbal medicine and supplements often forget, though, is that if herbs or supplements can have potentially beneficial effects (albeit difficult to regulate effects due to the crude, impure nature of the extracts often used) because they contain drugs, then herbs and supplements can also produce adverse events, again, because they contain drugs. You can overdose on herbs and supplements. This point was recently reinforced by a new study by Geller et al. published last week in the New England Journal of Medicine (NEJM), entitled “Emergency Department Visits for Adverse Events Related to Dietary Supplements.” It was carried out by investigators from the Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, and Chenega Government Consulting; and the Center for Food Safety and Applied Nutrition and the Division of Public Health Informatics and Analytics and the Division of Dietary Supplement Programs, Food and Drug Administration. The title pretty much tells you what the study is about, and what the study is about is that dietary supplements cause a lot of visits to the emergency room every year; 23,005 (95% confidence interval [CI], 18,611 to 27,398) emergency department visits per year can be attributed to adverse events related to dietary supplements.

Posted in: Herbs & Supplements, Politics and Regulation

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A liquid that was almost, but not quite, entirely unlike tea.

A coffee enema - almost, but not quite, totally unlike tea.

A coffee enema – almost, but not quite, totally unlike tea…and some sort of complex analogy involving naturopathy and science.

Those of you in the know recognize the title from the Hitchhikers Guide to the Galaxy, among the funniest and most quotable books of all time. If you have not read the five books in the trilogy, get to work. Consider it a homework assignment.

I bit off more than I can chew for this entry. I usually plan on about 8–10 hours over 4 –5 days to write these entries. So I had this idea. Now that naturopaths have been declared primary care providers by the Oregon legislature I thought it would be good to look over all the websites in Portland to see, in their own words, what naturopaths were offering. I figured there would not be that many sites to review. How many naturopaths could be in Portland?

So I went to the Oregon Board of Naturopathic Medicine Licensee Directory and entered Portland into the search box. And?

578 hits.

There is not enough beer time in the world

Holy Cannoli. I thought there would be 30, which is the number infesting Eugene, the second most naturopathed city in Oregon. There is no way that I could do a comprehensive review of that many websites in the limited time I have to devote to the blog. But my brain is not unlike an oil tanker with blog entries, it takes a long time to change direction and I had nothing else mentally lined up to write about. (more…)

Posted in: Naturopathy

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The Amarin case: off-label promotion and a double standard for prescription drugs vs. dietary supplements

Screenshot 2015-10-14 23.04.19

A recent court decision enjoined the FDA from threatening prosecution against a drug manufacturer for off-label promotion of a prescription drug. Based on this and an earlier decision by an appellate court, it appears that the FDA can no longer prosecute a pharmaceutical manufacturer for a truthful and non-misleading off-label promotion to health care professionals, at least within the jurisdiction of the United States Court of Appeal for the Second Circuit, which covers Connecticut, New York and Vermont.

For this reason, the case, Amarin Pharma, Inc. v. FDA (Amarin), received a good deal of attention in the world of drug regulation. (Here is an excellent analysis by two attorneys who practice in the area of drug regulation.) First, we’ll take a look at the issue of off-label promotion. Then we’ll look at an issue that really didn’t engender much comment, but that I find fascinating: how the same substance can be subject to very different regulatory treatment, depending on whether it is sold as a dietary supplement or prescription drug.

Background: Initial approval of Vascepa and subsequent research

In 2012, the pharmaceutical manufacturer Amarin received FDA approval for a new drug, Vascepa, as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (triglycerides ≥ 500mg/dL). Approval was based on a single phase 3 clinical trial.

Following that approval, Amarin designed a second single phase 3 clinical trial to look at the effect of Vascepa on triglyceride levels among statin-treated patients with persistently high triglycerides (≥ 200 and ≤ 500 mg/dL). Pursuant to an agreement with the FDA that, if it met certain conditions, Vascepa would obtain approval for this use, Amarin proceeded with an FDA-approved protocol. As a further condition of the agreement, it also began enrolling patients in a third trial to see if Vascepa actually reduced major cardiac events. (more…)

Posted in: Clinical Trials, Herbs & Supplements, Legal, Nutrition, Pharmaceuticals, Politics and Regulation

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Whole Body Vibration Therapy

WBVTWhen skeptics hear the term “vibration” a red flag goes up, because that is a common term used in pseudoscientific jargon. Vibrations are often used to refer vaguely to energy or some physical or even spiritual property that cannot be detected, and is used in a hand-waving manner to explain extraordinary claims.

Vibrations, however, are also a real thing, referring to physical oscillations. Whole body vibration therapy (WBVT) refers to these legitimate physical vibrations. It is being offered as a treatment for balance, back pain, neurological disorders, and also simple fitness. Does it actually work, however, for the indications claimed?

What is WBVT?

WBVT is considered a passive exercise modality, in which something is being done to the person, rather than the person actively engaging in an activity, such as walking, weight lifting, or swimming. With WBVT users lay, sit, or stand on a platform that vibrates rapidly in one or more directions. The idea is that the rapid vibrations force the muscles of the body to contract in reaction, providing a form of exercise.


Posted in: Neuroscience/Mental Health

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Weston Price’s Appalling Legacy

Weston A. Price Foundation: Not recommended

Weston A. Price Foundation: Not recommended

One of our readers requested a post about the Weston A. Price Foundation (WAPF). I knew it was not a trustworthy source of medical information, but I had not imagined just how atrocious it really was. After spending some time on the website, I realized that it is not just a cornucopia of false information about dentistry and nutrition, but is full of anti-vaccine propaganda and bizarre and dangerous health advice that could result in serious harm to patients.

The purpose of the Weston A. Price Foundation

It is a non-profit, tax-exempt charity founded in 1999 to disseminate the research of Weston A. Price, who “established the parameters of human health and determined the optimum characteristics of human diets.” (He did no such thing!) It publishes a journal “dedicated to exploring the scientific validation of dietary, agricultural and medical traditions through the world.” That statement reveals how poorly they understand science. The purpose of science is not to “validate” traditions and beliefs; it is to ask “if” those traditions offer any demonstrable benefits, and if the beliefs correspond to reality. (more…)

Posted in: Dentistry, Nutrition, Vaccines

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