A little over a month ago, I wrote about how proponents of “complementary and alternative medicine” (CAM), now more frequently called “integrative medicine,” go to great lengths to claim nonpharmacological treatments for, well, just about anything as somehow being CAM or “integrative.” The example I used was a systematic review article published by several of the bigwigs at that government font of pseudoscience, the National Center for Complementary and Integrative Health (NCCIH) about CAM approaches for the management of chronic pain. You can read my whole post for yourself if you want the details (and read Edzard Ernst and Steve Novella for more), but the CliffsNotes version consists of two main points. First, the review didn’t really show that any CAM approach worked, given how the authors included so many studies with no placebo or sham control and didn’t systematically assess the quality of the studies. Second, this study is the best publicized example of how NCCIH, looking for a reason to justify itself, has latched on to the opioid addiction crisis in this country and gone “all in” with CAM for chronic pain. Of course, the problem is that none of the real “alternative” treatments show any convincing evidence of efficacy; so NCCIH has to claim exercise (in the form of yoga and Tai Chi, for instance) and various other modalities that aren’t really “alternative” as being part of CAM. True, the authors did try to claim that acupuncture works for back pain and osteoarthritis of the knee, but the flaw of including mostly studies with no placebo/sham control completely undermined that claim. Basically, taken in its entirety, the NCCIH’s systematic review failed to find convincing evidence that any CAM therapy really works for chronic pain.
So I wrote my post, noting also how this review article and its framing of CAM as equivalent to any nonpharmacologic treatment were clearly in line with the last two NCCIH strategic plans, perused the comments our readers left, and pretty much forgot about the study, because fortunately, it didn’t seem to get much traction. (Releasing it right before the Labor Day weekend probably didn’t help NCCIH much.) However, there is one person who did not forget, and that person is John Weeks. Last week, he published a response to the criticisms of the NCCIH review in the Journal of Alternative and Complementary Medicine (JACM) entitled “Polarization-Based Medicine: Protests Against the Mayo-NCCIH Pain Guidance Evoke the Bigotry of the Political Season.”
As they say, it’s on.
Willow Curve is advertised as the “world’s first digital anti-inflammatory device”, “a laser smart device” designed to relieve joint 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 computer chips use that information to tailor a digital prescription on the fly. That 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? They say that the Willow Curve dilates blood vessels, slows nerve response time (is that a good thing?), releases endorphins, blocks specific pain receptors, and detoxifies by removing toxic debris from the joints.
They offer no evidence in support of these claims. I tried to get clarification from the company, but they didn’t answer my inquiries.
This cover picture is scientifically inaccurate. See explanation below.
José Jarimba believes that our bodies are physically molded into an asymmetric form by our mothers’ sleeping positions during pregnancy, that this has lifelong adverse impacts on health, and that shoe inserts can eliminate pain and other health problems by realigning the body. This is a silly untested hypothesis by a single individual. As such, it would be too minor to merit mention on SBM; but it is worth analyzing as a teaching opportunity. Jarimba attempts to bypass the scientific process; he provides a prime example of self-deception, confirmation bias, scientific ignorance, and the “Unpersuadables” I recently wrote about.
Much of alternative medicine originated with a “lone genius” who had an epiphany, thought he had discovered something no one had ever noticed before, extrapolated from a single observation to construct an elaborate theory that promised to explain all or most human ills, and began treating patients without any attempt to test his hypotheses using the scientific method. Some of them were uneducated laymen, others were scientifically trained medical doctors who should have known better. I wrote about one of them here, Dr. Batmanghelid, inventor of the Water Cure, who attributed a great variety of illnesses to dehydration after he thought he had cured a prisoner’s peptic ulcer disease by giving him a glass of water. Similar paths were followed by many others. Hahnemann invented homeopathy after he thought a malaria remedy gave him symptoms of malaria. Palmer invented chiropractic after he thought he had restored a man’s hearing by repositioning an out-of-place bone in his back. Nogier invented ear acupuncture after he imagined that the external ear looked sort of like a fetus. Shapiro invented EMDR after she noticed during a walk in a park that moving her eyes seemed to reduce the stress of disturbing memories. Bach invented Bach flower remedies after a walk in the country revealed his intuitive psychic connection to various plants. Jose Jarimba follows in their footsteps. (more…)
A while ago, I wrote about how the Cleveland Clinic had recently opened a clinic that dispensed herbal medicine according to traditional Chinese medicine (TCM) practice. As regular readers of the SBM blog might expect, I was not particularly impressed or approving of this particular bit of infiltration of quackademic medicine into a major academic medical center, particularly given some of the amazingly pseudoscientific treatments espoused by the naturopath who was running the clinic. I also pointed out that, although herbalism is the most plausible (or perhaps I should say the least implausible) of modalities commonly associated with “complementary and alternative medicine” (CAM) or “integrative medicine”, it still exhibits a number of problems, the biggest of which is what I like to call either the delivery problem or the bioavailability problem. In brief, herbs, when they work, are adulterated drugs. The active ingredient is usually a minor constituent, embedded in thousands of other constituents that make up herbs, and it’s almost impossible to control lot-to-lot consistency with respect to content or active ingredients given how location, weather, soil conditions, rainfall, and many other factors can affect how the plants from which the medicines are extracted grow and therefore their chemical composition. To demonstrate the concept, I pointed out that it’s much safer and more predictable to administer digoxin to a patient who needs its activity on the heart than it would be for the patient to chew on some foxglove leaves, given that the therapeutic window (the difference between the doses needed to produce therapeutic effects and the lowest dose that will cause significant toxicity) is narrow.
Which brings me to medical marijuana, a.k.a. medical cannabis.
For many years I have been using Continuing Medical Education (CME) programs offered by the American Academy of Family Physicians (AAFP). The FP Essentials program consists of a monthly monograph with a post-test that can be submitted electronically for 5 hours of CME credit. Over a 9-year cycle, a complete family medicine curriculum is covered to prepare participants for the re-certification board exams. Some examples of typical subjects are skin cancer, hand and wrist injuries, valvular heart disease, and care of the newborn. I rely on these programs to learn, review, and keep up-to-date in my specialty. Imagine my dismay when I opened the latest package to find a monograph on Integrative Medicine.
First it was called various names like folk medicine, quackery, and unproven/untested treatments, then all of those (the less rational right along with the more rational) were lumped together under the umbrella term “Alternative Medicine,” then it became “Complementary and Alternative Medicine” (CAM), and now it has been re-branded as “Integrative Medicine.” The term is designed to make unscientific treatments seem more acceptable to science-based doctors. “Integrative Medicine” is a marketing term, not a meaningful scientific category. It is a euphemism for combining Complementary and Alternative Medicine (CAM) with mainstream medical practice, unproven with proven, magic with science. It has been critiqued many times on this blog. We have stressed that there is only one medicine, and that when a treatment is proven to work by good evidence, it is just “medicine.” When the evidence for a CAM treatment is not good, it essentially amounts to experimental treatments and/or comfort measures. Worse, sometimes CAM even persists in using treatments that have been proven not to work or that are totally implausible, like therapeutic touch or homeopathy. (more…)
In the three and a half years that the Science-Based Medicine blog has existed, we contributors have come in for our share of criticism. Sometimes, the criticism is relatively mild; often it’s based on a misunderstanding of what SBM is; but sometimes it’s quite nasty. I can’t speak for the rest of the SBM crew on this, but I’ve gotten used to it. It comes with the territory, and there’s little to do about it other than to skim each criticism as it comes in to see if the author makes any valid points and, if he doesn’t, to ignore it and move on. Indeed, there’s enough criticism being flung our way that I rarely respond directly anymore. Exceptions tend to be egregious examples, incidents that spark real problems, such as when Age of Autism blogger and anti-vaccine activist Jake Crosby tried to paint me as being hopelessly in the thrall of big pharma, which resulted in the anti-vaccine horde who read that blog to try to get me fired by sending complaints to the Board of Governors at my university and the dean of my medical school. Other examples tend to be what I call “teachable moments,” in which the mistakes made in the criticism provide fodder for making a point about SBM versus alternative medicine, “complementary and alternative medicine” (CAM), or “integrative medicine” (IM)—or whatever the nom du jour is.
File this next one under the “teachable moment” variety of criticism directed at SBM.
Believers in acupuncture claim it is supported by plenty of published scientific evidence. Critics disagree. Thousands of acupuncture studies have been done over the last several decades, with conflicting results. Even systematic reviews have disagreed with each other. The time had come to re-visit the entire body of acupuncture research and try to make sense out of it all. The indefatigable CAM researcher Edzard Ernst stepped up to the plate. He and his colleagues in Korea and Exeter did an exhaustive study that was published in the April 2011 issue of the medical journal Pain: “Acupuncture: Does it alleviate pain and are there serious risks? A review of reviews.” It is accompanied by an editorial commentary written by yours truly: “Acupuncture’s claims punctured: Not proven effective for pain, not harmless.” (The editorial is reproduced in full below.)
Ernst et al. systematically reviewed all the systematic reviews of acupuncture published in the last 10 years: 57 systematic reviews met the criteria they set for inclusion in their analysis. They found a mix of negative, positive, and inconclusive results. There were only four conditions for which more than one systematic review reached the same conclusions, and only one of the four was positive (neck pain). They explain how inconsistencies, biases, conflicting conclusions, and recent high quality studies throw doubt on even the most positive reviews.
They also demolished the “acupuncture is harmless” myth by reporting 95 published cases of serious adverse effects including infection, pneumothorax, and 5 deaths. Some but not all of these might have been avoided by better training in anatomy and infection control. (more…)
It has long been recognized that there are substantial multifactorial placebo effects that create real and illusory improvements in response to even an inactive treatment. There is a tendency, however (especially in popular discussion), to oversimplify placebo effects – to treat them as one mind-over-matter effect for all outcomes. Meanwhile researchers are elucidating the many mechanisms that go into measured placebo effects, and the differing magnitude of placebo effects for different outcomes.
For example, placebo effects for pain appear to be maximal, while placebo effects for outcomes like cancer survival appear to be minimal.
A recent study sheds additional light on the expectation placebo effect for pain. The effect is, not surprisingly, substantial. However it does not extrapolate to placebo effects for outcomes other than pain, and the results of this very study give some indication why. From the abstract:
The effect of a fixed concentration of the μ-opioid agonist remifentanil on constant heat pain was assessed under three experimental conditions using a within-subject design: with no expectation of analgesia, with expectancy of a positive analgesic effect, and with negative expectancy of analgesia (that is, expectation of hyperalgesia or exacerbation of pain).
What they found was that the positive expectation group reported twice the analgesic effect as the no expectation group, and the negative expectation group reported no analgesic effect. This is a dramatic effect, but not surprising.
Is unmedicated natural childbirth a good idea? The American College of Obstetrics and Gynecology (ACOG) points out that
There is no other circumstance in which it is considered acceptable for a person to experience untreated severe pain, amenable to safe intervention, while under a physician’s care.
It is curious when an effective science-based treatment is rejected. Vaccine rejecters have been extensively discussed on this blog, but I am intrigued by another category of rejecters: those who reject pain relief in childbirth. They seem to fall into 3 general categories:
- Religious beliefs
- Objections based on safety
1. “In pain you will bring forth children” may be a mistranslation, and it certainly is not a justification for rejecting pain relief. Nothing in the Bible or any other religious text says “Thou shalt not accept medical interventions to relieve pain.” Even the Christian Science church takes no official stand on childbirth and its members are free to accept medical intervention if they choose.
2. The natural childbirth movement seems to view childbirth as an extreme sport or a rite of passage that is empowering and somehow enhances women’s worth. Women who “fail” and require pain relief or C-section are often looked down upon and made to feel guilty or at least somehow less worthy.
3. I’m not impressed by religious or heroic arguments, although I support the right of women to reject pain relief on the autonomy principle. What inquiring science-based minds want to know is what the evidence shows. Does avoiding medical treatment for pain produce better outcomes for mother and/or baby? It seems increasingly clear that it doesn’t. A new book, Epidural Without Guilt: Childbirth Without Pain, by Gilbert J. Grant, MD, helps clarify these issues.
As much as I support vaccines, I see the short term consequences. Vaccines can be painful. Kids don’t like them, and parents don’t like seeing their children suffer. That this transient pain is the most common consequence of gaining protection from fatal illnesses seems like a fair trade-off to me. But that’s not the case for every parent.
Today’s post isn’t going to focus on the extremes of the anti-vaccination movement. Rather, it’s going to look at ways to make vaccines less painful and more acceptable to children. The pain of vaccines can lead to anxiety, fear, and even nonadherence with vaccination schedules. Fear of needles and injections is not uncommon, it’s estimated that 10% of the population avoids vaccinations for this reason.
The vaccine schedules are intense. Where I live, the public vaccination schedule specifies seventeen injections of six different products over six visits in the first 18 months of life, plus influenza vaccinations and one-offs like H1N1. That’s a lot of visits, and a lot of tears if a child doesn’t handle them well.
In light of what’s known about the prevalence of needle fears, their potential effect on vaccination adherence (that could persist through adult life), and the possible impact on public health because of unvaccinated individuals, it makes sense to do whatever we can to minimize the pain and discomfort of vaccines, increasing their acceptance to children and their parents. But what works? I’ve personally found Smarties (the real ones) and Dora the Explorer stickers are effective distractions and bribes. But I’m not about to call my n=2 trial good science. Nicely, there’s much more evidence to guide our recommendations.