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Placebo by Conditioning

power-of-placebo-effectTruly understanding placebo effects (note the plural) is critical to science-based medicine. Misconceptions about placebo effects are perhaps the common problem I encounter among otherwise-scientific professionals and science communicators.

The persistence of these misconceptions is due partly to the fact that false beliefs about placebos, namely that “the” placebo effect is mainly an expectation mind-over-matter effect, is deeply embedded in the culture. It is further exacerbated by recent attempts by CAM proponents to promote placebo-medicine, as their preferred treatments are increasingly being demonstrated to be nothing but placebos.

One idea that proponents of placebo medicine have tried to put forth is that you can have a placebo effect without deception. The study most often pointed to in order to support this claim is Ted Kaptchuk’s irritable bowel syndrome study. However, this study was flawed in that it told participants that placebos can heal, so it wasn’t exactly without deception. (more…)

Posted in: Medical Ethics, Science and Medicine

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Should placebos be used in randomized controlled trials of surgical interventions?

Randomized controlled trial

Alone of all the regular contributors to this blog, I am a surgeon. Specifically, I’m a surgical oncologist specializing in breast cancer surgery, which makes me one of those hyper-specialized docs that are sometimes mocked as not being “real” doctors. Of course, the road to my current practice and research focus was long and involved quite a few years doing general surgery, so it is not as though I am unfamiliar with a wide variety of surgical procedures. Heck, I’m sure I could do an old-fashioned appendectomy, bowel resection, or cholecystectomy if I had to. Just don’t ask me to use the da Vinci robot or, with the exception of the case of a cholecystectomy, a laparoscope, although, given the popularity of robotic surgery, I sometimes joke that I really, really need to figure out how to do breast surgery with the robot. After all, if plastic surgeons are using it for breast reconstruction, surely the cancer surgeon should get in on the action.

I keed. I keed.

Clinical trials of surgical procedures and placebo controls

I have, however, from time to time addressed the issue of science-based surgery, and this weekend seems like as good a time to do so again, given that I just came across an article in the BMJ reporting a systematic review of the use of placebos in surgical trials. It’s a year old, but worth discussing. Before I get to discussing the nitty-gritty of this particular trial, let me just note that the evaluation of surgical procedures for efficacy and safety tends to be more difficult to accomplish than it is for medications, mainly because it’s much harder to do the gold standard clinical trial for surgical procedures, the double-blind, placebo-controlled randomized clinical trial. The two most problematic aspects of designing such an RCT in surgery, as you might imagine, are the blinding, particularly if it’s a trial of a surgical procedure versus no surgical procedure, and persuading patients to agree. I’ll deal with the latter first, because I have direct personal experience with it. (more…)

Posted in: Clinical Trials, Surgical Procedures

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Mediocre Expectations

Pictured: Relevant.  Oh yeah, it's going to get weird. Image courtesy of the Wellcome Trust Image Library via the Wikimedia Commons.

Pictured: Relevant. Oh yeah, it’s going to get weird.

I had a dickens of a time writing this entry. The last week has been spent in New York for NECSS. It is safe to say that New York has plenty of distractions for us Dug the Dog types. Reality may be a honey badger, but New York is a squirrel. I say that when I travel I usually do not come across food better than I can find in Portland. Nope. Not true of New York. It joins Paris and New Orleans in the holy trinity of good eats, although I will stick with Pacific Northwest beer. And the rule is that for every day you are gone, three days’ worth of work piles up. I really need to stop taking time off.

I spoke at NECSS on a favorite topic of mine, how acupuncture works. It doesn’t. But I discussed a few studies that I found interesting. Like all studies, no single paper is definitive. The third law of the medical literature states that for every study, there is an equal and opposite study. A bit of an exaggeration perhaps but I do find the direction that the following studies point interesting both as to acupuncture’s mechanism of inaction and how the mind functions, making them worth collecting in an essay. (more…)

Posted in: Science and Medicine

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Placebo, Are You There?

By Jean Brissonnet, translation by Harriet Hall

Note: This was originally published as “Placebo, es-tu là?” in Science et pseudo-sciences 294, p. 38-48. January 2011. It came to my attention in the course of an e-mail correspondence with the editors of that magazine, where one of my own articles was published in French translation in January 2015. I thought this was the best explanation of placebo that I had ever read. It covers the same points my colleagues and I have addressed and more. It describes the pertinent research and uses particularly effective graphs to illustrate the principles (a picture is worth a thousand words). The author, Jean Brissonnet, kindly gave his permission for me to translate it and share it with our readers.


In fact, you don’t need to give a placebo to get a placebo effect and therefore we can now think about how we can maximize the placebo component of routine care.

~ Damien Finniss, 2010

The scene takes place in a surgical suite where they are preparing to do a cataract operation. The patient is lying on the operating table. A few minutes earlier the anesthetic gel was applied to the cornea to permit an operation under simple local anesthesia. The surgeon arrives in the company of the anesthetist. They are engaged in a spirited discussion and don’t seem to be agreeing.

“It has been proven,” says the surgeon, “that 30% of the action of a medical treatment is due to the placebo effect.”

“I doubt that,” retorts his interlocutor, “I think that placebo story is one of those medical myths on a par with the idea that we only use 10% of our brain, that nails and hair grow after death, or that cellphones create interference in hospitals.”[1]

“No,” insists the surgeon with a superior tone, “the fact is established and has been proven by numerous studies.”

The anesthetist shakes his head with a slight smile, but he doesn’t reply. As for the patient, who might have much to say on the subject, he keeps quiet, because it would not be prudent to argue with someone who is about to suck the lens out of your eye.

This true anecdote would not be of interest if it didn’t concern two members of the medical profession. Why such uncertainty? Why such lack of knowledge about such a fundamental subject? This faith in an all-powerful, magical, and mysterious placebo is common among the general public and it serves as justification for resorting to unconventional medicines that have never been able to show solid proof of efficacy; but we see that it still persists among the medical profession.

To know whether the placebo effect is real or should be relegated to the same category as poltergeists, it will help to go back in history.

cartoon

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Posted in: Clinical Trials, Science and Medicine

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Using the fear of Ebola to promote the placebo legislation that is “right to try”

rick-snyder

Perhaps the most pervasive medical conspiracy theory of all involves stories that there exist out there all sorts of fantastic cures for cancer and other deadly diseases but you can’t have them because (1) “they” don’t want you to know about them (as I like to call it, the Kevin Trudeau approach) and/or (2) the evil jackbooted thugs of the FDA are so close-minded and blinded by science that they crush any attempt to market such drugs and, under the most charitable assessment under this myth, dramatically slow down the approval of such cures. The first version usually involves “natural” cures or various other alternative medicine cures that are being “suppressed” by the FDA, FTC, state medical boards, and various other entities, usually at the behest of their pharma overlords. The second version is less extreme but no less fantasy-based. It tends to be tightly associated with libertarian and small government fantasists and a loose movement in medicine with similar beliefs known as the “health freedom” movement, whose members posit that, if only the heavy hand of government were removed and the jack-booted thugs of the FDA reined in, free market innovation would flourish, and the cures so long suppressed by an overweening and oppressive regulatory apparatus would burst the floodgates. Under this views, these cures, long held back by the dam of the FDA, would flow immediately to the people, and there would be much rejoicing. (Funny how it didn’t work out that way before the Pure Food and Drug Act of 1906.) Of course, I can’t help but note that in general, in this latter idea, these fantastical benefits seem to be reserved only for those who have the cash, because, well, the free market fixes everything. At least, that seems to be the belief system at the heart of many of these conspiracy theories.

The idea that the FDA is keeping cures from desperate terminally ill people, either intentionally or unintentionally, through its insistence on a rigorous, science-based approval process in which drugs are taken through preclinical work, phase 1, phase 2, and phase 3 testing before approval is one of the major driving beliefs commonly used to justify so-called “right-to-try” laws. These bills have been infiltrating state houses like so much kudzu, and the Ebola outbreak has only added fuel to the fire based on the accelerated use of ZMapp, a humanized monoclonal antibody against the Ebola virus, in some patients even though it hadn’t been tested in humans yet (more on that later). Already four of these laws have been passed (in Colorado, Missouri, Louisiana, and now Michigan) with a referendum in Arizona almost certain to pass next week to bring the total to five states with such laws. Basically, these laws, as I’ve described, claim to allow access to experimental drugs to terminally ill patients with a couple of major conditions: First, that the drug has passed phase I clinical trials and second that the patient has exhausted all approved therapies. As I’ve explained before more than once, first when the law hit the news big time in Arizona and then when a right-to-try bill was introduced into the legislature here in Michigan, they do nothing of the sort and are being promoted based on a huge amount of misinformation detailed in the links earlier. First, having passed phase 1 does not mean a drug is safe, but right-to-try advocates, particularly the main group spearheading these laws, the Goldwater Institute, make that claim incessantly. Second, they vastly overstate the likelihood that a given experimental drug will help a given patient. The list goes on.
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Posted in: Cancer, Clinical Trials, Pharmaceuticals, Politics and Regulation

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Chiropractic: A Summary of Concerns

ChiroAdj

Although obscured by controversy, there is evidence to indicate that spinal manipulation can be as effective as conventional treatment methods in relieving low-back pain.1,2,3,4 This grain of truth mixed with chiropractic vertebral subluxation theory that encompasses a broad scope of ailments makes it difficult for the average person to distinguish between appropriate and inappropriate use of manipulation by chiropractors. A person who is satisfied with chiropractic manipulative treatment for back pain might be led to believe that the same treatment can be used to treat a variety of organic ailments by correcting “vertebral subluxations.” Such treatment is usually described as a “chiropractic adjustment.”

A manual chiropractic adjustment

Although chiropractic care based on subluxation theory has been rejected by the scientific community, spinal manipulation used in the treatment of mechanical-type back pain has a plausible basis that makes it acceptable in mainstream healthcare. A good back-cracking back rub provided by a chiropractor or some other manual therapist can be a pleasurable, pain-relieving experience, and this can be a preferred method of treatment for some types of back pain. But you should be well-informed enough to know where to draw the line in separating subluxation-based chiropractic adjustments from appropriate use of generic spinal manipulation if you should consider treatment by a chiropractor. Otherwise, you might become the victim of the bait-and-switch tactics of chiropractors who offer you treatment for back pain and then attempt to indoctrinate you in subluxation theory.

Much of what follows in this article has been said before in other articles of mine posted on this site. An up-to-date summary of basic concerns about chiropractic care, however, might be useful for new readers and others, including professionals, who want a brief overview for quick reference in seeking answers to questions about the problematic aspects of chiropractic use of spinal manipulation.
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Posted in: Chiropractic

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Cancer Treatment Centers of America: Revisiting the epitome of “integrative” cancer care

Three weeks ago, I mentioned in a post that the week of October 7 to 14 was declared by our very own United States Senate to be Naturopathic Medicine Week, which I declared unilaterally through my power as managing editor of Science-Based Medicine (for what that’s worth) to be Quackery Week. One wonders where the Senate found the time to consider and vote for S.Res.221, which reads:

S.Res.221 – A resolution designating the week of October 7 through October 13, 2013, as “Naturopathic Medicine Week” to recognize the value of naturopathic medicine in providing safe, effective, and affordable health care.

I know, I know, it probably took all of five minutes to consider and vote for this, thanks to Sen. Barbara Mikulski (D-MD), who sponsored it. In any case, as October 7 approached, I thought about how I could keep my promise to blog about naturopathy this week, and I came up with a way to do it. It’s a bit roundabout, but I think it fits. The idea derives from a discussion I was having a while back about one of my “favorite” hospitals, namely the Cancer Treatment Centers of America, in which a colleague of mine questioned why there were so many CTCA ads on NPR and why CTCA is sponsoring shows on PBS such as the upcoming The Emperor of All Maladies by Ken Burns. Although I can’t wait to see this particular series, I am a bit worried that the infiltration of quackademic medicine will make an appearance, given that CTCA is a major sponsor. (more…)

Posted in: Cancer, Homeopathy, Naturopathy

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The Placebo Narrative

Science journalist Sharon Begley wrote a recent piece in The Saturday Evening Post about Placebo Power. The piece, while generally better than the typical popular writing on placebos, still falls into the standard placebo narrative that is ubiquitous in the mainstream media. The article is virtually identical to a dozen other articles I have read on placebo effects in the popular press, and most significantly fails to even question that narrative.

Begley is generally one of the better science journalists, although I have had my disagreements with her – specifically over her attitude toward the relationship between skeptics and the media. She seems to have a distorted and negative view of skeptics and does not think that the media can or should help us in our “debunking crusade.” (The term itself speaks of a fundamental misunderstanding of the modern skeptical movement.)

I have also parted ways with Begley over her view of the relationship between science and medicine. She seems to have a fairly negative view of doctors, fueled in part by her imperfect grasp of medical science. This is the risk with even the best lay science journalists – science is often complex and it is difficult to master the nuances if you are not an expert and steeped in the evidence and the community. Further there is a tendency for people in general (including journalists) to go along with an appealing and available narrative. (For journalists those narratives that are appealing are the ones that make good headlines.) These shortcomings are present throughout her recent article on placebos.

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Posted in: Science and Medicine, Science and the Media

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The Placebo Gene?

A study recently published in PLOS one (Catechol-O-Methyltransferase val158met Polymorphism Predicts Placebo Effect in Irritable Bowel Syndrome) purports to have found a gene variant that correlates strongly with a placebo response in irritable bowel syndrome (IBS). The study is small and preliminary, but the results are interesting and do raise important questions about placebo responses.

Researchers are increasingly trying to tease apart the various components of “the placebo effect.” In reality we should use the term “placebo effects” as it is demonstrably multifactorial. “The placebo effect” really refers to whatever is measured in the placebo arm of a clinical trial – everything other than a physiological response to an active intervention. Within that measured response there are many potential factors that would cause an outcome from a fake treatment to be different from no treatment at all. These include statistical effects like regression to the mean and the natural course of symptoms and illness, reporting bias on the part of the subject, and a non-specific response to the therapeutic interaction with the practitioner.

It is also critical to realize that placebo responses vary greatly depending on the disease or symptom that is being treated and the outcome that is being measured. Placebo response is greatest for subjective symptoms of conditions that are known to be modified by things like mood and attention, while it is virtually non-existent for objective outcomes in pathological conditions. So there is a substantial placebo response for pain and nausea, but nothing significant for cancer survival.

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Posted in: Clinical Trials

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Can we finally just say that acupuncture is nothing more than an elaborate placebo?

I realize that Steve blogged about this study earlier in the week, but since I also commented on this particular study as my not-so-super-secret alter ego, I figured it rated a place on SBM as well. I emphasized different aspects of the study and tried to quantify exactly why, under even the most charitable interpretation of the study possible, the effects are not clinically significant. Besides, if the level of comments and e-mails is any indication, there is sufficient interest in this particular study to rate a second post.

Not suprisingly, this study is about about acupuncture. Well, it’s not exactly a study, it’s a meta-analysis that aggregates a whole lot of acupuncture studies in which this most popular of woos is administered to patients with chronic pain from a variety of causes. It’s also being promoted all over the place with painfully credulous headlines like:
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Posted in: Acupuncture

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