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Do physicians really believe in placebos?

ResearchBlogging.orgIn a previous post, I argued that placebo is an artifact of certain clinical interactions, rather than a treatment that we can exploit. Apparently, there are a whole lot of doctors out there who don’t agree with me. Or are there?

A recent study published in the British Medical Journal is getting
a lot of enk (e-ink) in the blogosphere. As a practicing internist, I have some pretty strong opinions (based in fact, of course) about both this study and placebos in general.

The Study

The current BMJ study defines placebo as “positive clinical outcomes caused by a treatment that is not attributable to its known physical properties or mechanism of action.”  I’ve got a lot of problems with this definition, but we’ll get to that later.  It also allowed physiologically active medications to “count” as placebos.  Oops.

The study surveyed internists and rheumatologists practicing in the U.S. They tried to control negative responses to the term “placebo” thusly (from the Methods section):

Because the term “placebo” and behaviours surrounding its use can be contentious, we devised a series of non-judgmental questions beginning with broad questions that avoided the term “placebo” and then gradually gained more specificity, culminating in items whose responses used a clear definition of a “placebo treatment.” By constructing a series of items in this manner we allowed respondents to describe their attitudes and experiences as accurately as possible.

The first set of three items began with a hypothetical scenario in which a dextrose tablet was shown in clinical trials to be superior to a no treatment control group (thus establishing its efficacy as a placebo treatment). To avoid biasing responses these three questions did not use the term “placebo,” “placebo treatment,” or “placebo effect.”

I know a lot of doctors.  They tend to be fairly bright.  I don’t think any of them would be deceived by this scenario.  When you read “dextrose pill”, you think “placebo”.  It might as well be the same word.

Respondents were then asked to indicate which of several treatments they had used within the past year primarily as a placebo treatment, defined as a treatment whose benefits derive from positive patient expectations and not from the physiological mechanism of the treatment itself; and how they typically described placebo treatments to patients. By asking these five questions both without the term “placebo” and then using the term, we aimed to assess physicians’ practices as accurately as possible.

All docs would recognize this as a placebo scenario.  However, the definition above is rather problematic.   Is a placebo “a treatment whose benefits derive from positive patient expectations and not from the physiologic mechanism of the treatment itself”?

The validity of this study hinges on the answer to this question.

Placebo—I do not think it means what you think it means

The concept of placebo, and the way it is used in this study are both problematic.  First, we have an elephant in the exam room.  When we observe a so-called placebo effect, we are very susceptible to the post hoc ergo propter hoc fallacy.  Just because the patient’s condition changes doesn’t mean we have done anything to cause that change.  In fact, due to the remarkably inexact human pattern-recognition software, we are likely to attribute a change in a patient’s condition to something, and if we don’t know what that something is, we may label it “placebo”.  So the very concept of placebo may be an artifact of our way of thinking, a label to place on a co-incidence, rather than a “thing”.  We may have wrongly reified a rather fuzzy concept.

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Placebos in the news again

ResearchBlogging.orgTowards the end of last week, I was contemplating what I would be writing about for Monday. No topic had quite floated my boat, but I hated to dip into the archive of topics I’ve written about before to update a post. After all, I like to be topical whenever possible. Then what to my wondering eyes should appear (yes, I know Christmas is still two months away) but a study in the British Medical Journal by a group lead by Jon C. Tiburt at the Department of Bioethics at the National Institutes of Health in collaboration with investigators at the Osler Institute at Harvard University and the McClean Center for Clinical Medical Ethics at the University of Chicago entitled Prescribing “placebo treatments”: results of national survey of US internists and rheumatologists.

Serendipity? Who cares? The study addresses a very important aspect of science-based medicine.
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Posted in: Herbs & Supplements, Science and Medicine, Science and the Media

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Is There a Placebo Effect for Animals?

One of the occasional arguments used in support of “alternative” approaches to human medicine is the observation that since “alternative” medicine is used (with anecdotal success) in animals, and animals don’t know anything about the treatment that they’re getting, then they must work a priori.  Of course, the fallacy of such an observation is pretty obvious to anyone with a logical/skeptical frame of mind, because it assumes that the therapies do work (even though there’s little evidence of that).

Clearly, however, some people perceive that the therapies work, including veterinarians – there are veterinary acupuncturists, chiropractors, homeopaths, etc., etc.  Since there’s very little scientific support for the idea that the therapies actually have any clinically significant effect on biological processes, including the processes that result in disease, questions arise as to whether there are other effects of “alternative” treatments on animals. Specifically, people may wonder whether or not animals can benefit from placebo effects.
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Posted in: Acupuncture, Science and Medicine, Veterinary medicine

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When Further Research Is NOT Warranted: The “Wisdom of Crowds” Fallacy

Most scientific research studies have at least one thing in common: the conclusion section ends with, “further research is warranted.” I’d say it’s about as common as the “talk to your doctor” disclaimer in TV ads for pharmaceutical products. And in a way, they both serve the same purpose. They’re a “CYA” move.

What does “further research is warranted” mean in plain English? I think it can be roughly translated: “My research study is not of the size or scope to fully explain all the phenomena described in this article. Therefore, draw conclusions beyond the data and study methods at your own risk. And yeah, my work is important and cool – so people should study it further.”

Of course, the first two sentences are reasonable – we should always remember not to draw conclusions beyond the information provided by the data we’ve collected (even though that’s about as challenging as getting a beagle not to eat a table scrap in an empty room). The real problem is the third sentence. Is the research promising enough to require further investment? How are we to know if further research is indeed warranted? I would argue that it should not be based solely on the subjective opinions of the researchers nor the popularity of the research topic to the general public. (more…)

Posted in: Clinical Trials, Science and Medicine

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Interpreting the Medical Literature

The science in science-based medicine includes all of science, but relies most heavily on the biomedical literature – published studies that collectively represent our scientific medical knowledge. The scientific basis of medicine is only as good as this body of knowledge and the manner in which it is interpreted and put into practice.

We often discuss on this blog how to evaluate individual studies- the need for blinding, randomization, the importance of study size to meaningful statistical analysis, and other features that distinguish a reliable study from a worthless one. This is important, but only half of the equation. We also at times discuss the medical literature as it relates to a specific medical question or set of related questions – does homeopathy work or are statins beneficial for cholesterol reduction, for example. This requires not only the ability to judge individual studies, but a higher order analysis of the overall pattern of evidence among all relevant studies. Failure to do this, by focusing only on individual studies, results in the failure to see the forest for the trees.

It is this higher order analysis that I wish to discuss in this entry.

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Posted in: Clinical Trials, Science and Medicine

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A New Twist for Autism: A Bogus “Biomedical” Board

Here’s a short addition to the topic of Pseudomedical Pseudoprofessional Organizations (PPOs).† New pseudo-board-certification schemes pop up like mushrooms after a spring rain, but just last week there was an announcement of one with a difference:

The American Medical Autism Board

AMAB offers the first of its kind board/diplomate certification program for medical doctors specializing in biomedical treatment of autism and related disorders. These disorders are known collectively as the Autism Spectrum Disorders (ASD). Thus, medical doctors who become certified by the American Medical Autism Board show that they specialize in biomedical treatment of ASD, and will have met the Board’s high levels of criteria for training and experience, and will have passed its rigorous certification examination.

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Posted in: Health Fraud, Politics and Regulation, Science and Medicine

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The Pseudomedical Pseudoprofessional Organization (PPO*)

(*Not to be confused with “Preferred Provider Organization,” which shares the acronym)

This is part of an ongoing series† discussing pitfalls of regulating physicians, but I’ve decided, in the interest of flexibility, to vary the title. A couple of weeks ago I gave some examples of how individual physicians practicing substandard, implausible medicine manage to avoid or delay being disciplined by state medical boards. I observed that the boards themselves seem reluctant or slow to act against such practices, even those that are illegal, and that this stands in contrast to their prompt actions against other types of malfeasance: those of the “low-hanging fruit” variety. In a comment, David Gorski reminded me that he had previously offered a few reasons for that discrepancy, with which I agree. Nevertheless, it seems odd that state boards don’t do better.

In an attempt to find more explanations, this week we’ll look at another tactic of practitioners of pseudomedicine: banding together to create pseudomedical pseudoprofessional organizations (PPOs), complete with pseudo-legitimate names, pseudo-legitimate conferences, pseudo-legitimate appearing websites, pseudo-”board certifications,” protocols for pseudo-therapies, patient brochures hyping pseudo-therapies, pseudo-consent forms for pseudo-therapies, pseudo-Institutional Review Boards to approve pseudo-research, pseudo-journals to publish reports of pseudo-research, very real financial contributions from pseudoscientific corporations to help pay for very real advertising, very real lobbying, very real legal representation, and more.

There are many more PPOs than we’ll be able to examine, but they have common features. We’ll also look at how some Institutions That Should Know Better respond to PPOs, which can be frightening. (more…)

Posted in: Health Fraud, Politics and Regulation, Science and Medicine

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Getting It On with Homeopathy

I have more thoughts on the homeopathy matter than fit in follow-up notes, so here goes.

First, David Gorski recalls the 1994 Pediatrics report on childhood diarrhea treated with tailored homeopathic remedies for each patient. There is more to the story than has been written. I am certain much of this will get back to the authors, but others may benefit from knowing how this group of homeopaths operate.

I recall the paper well, because it was the first journal report that I deconstructed and published (Pediatrics, Oct 1995) as a regular article. I think it was the first time the journal had published a formal rebuttal outside the Letters section. The head of pediatric pharmacy at Valley Medical Center, San Jose, brought the paper to me and asked what I thought if it. Bill London of National Council against Health Fraud and I spent six months discussing it and working over the details.

The paper had so many flaws, that one letter could not contain them. It had five or six end points, several arithmetical errors, graphs with missing data, only one end point reached consensus signficance (barely.)

Each case received a remedy tailored to the age, condition, duration of symptoms, appearance and odor of the stool, the recall of the parent or relative about stool frequency (which depended on how often the child’s diapers were changed, and a number of other qualities, typical of a homeopathic approach to diagnosis. The remedies given were not based on etiology, but based on personal observations, We saw that the remedy was chosen at a snapshot in time, depending on all those factors which varied from hour to hour. So the remedies depended on the time at which the child was brought in for examination and were unchanged throughout the duration of illness. That made no sense at all. Besides, the specific remedies had no data behind them for proof of efficacy, and were chosen on basis of charts and computer references.

One could hardly find anything about the paper that would lend credibility to its conclusion that suggested homeopathy “worked“ better than placebo. The results in our opinion demonstrated nothing more than the variations in the clinical trial system (noise.)
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Posted in: Clinical Trials, Homeopathy, Science and Medicine

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Disintegrating Integrative Medicine: Lessons From Baking

Suppose I were to bake you a cake and my ingredient list included the following:

  • Eggs
  • Milk
  • Butter
  • Sand
  • Flour
  • Baking Powder
  • Vanilla
  • Melamine
  • Sugar
  • Chocolate icing

What is the problem with the ingredient list? It has integrated inedible and poisonous items into the very fine basic ingredients that make a good cake. This is the exact same problem that the medical profession faces with the “integrative medicine” movement. Insofar as it espouses and promotes well-vetted, healthy ingredients, it is a boon to patients. But when inordinate emphasis is placed on placebos (“sand”) or when dangerous practices (“melamine”) are inserted into the prescription for our patients’ “health and wellness,” that attractive-appearing cake becomes a recipe for disaster.

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A natural product of his environment

I’m delighted to have the opportunity to join this outstanding group of medical professional bloggers in adding my natural products angle to the application of science-based medicine.  With the exception of Dr. Gorski, who holds MD and PhD degrees, I believe I am the first “only a PhD” to be invited to SBM.  However, I have spent much of my career training, and training with, physician-scientists; so enthusiastic am I about the special qualities of the physician-scientist that I married one (or, rather, she chose to marry me, truth be told.).  Conversely, I view the invitation to write here as a responsibility in representing what my fellow basic scientists bring to bear on discussions of the scientific arguments for and against modalities classified broadly as complementary and alternative medicine or integrative medicine.

Why write about herbal medicines and natural products?

I have long been interested in bringing objective scientific information to the public, perhaps as early as my college years in bars while visiting my working-class hometown of Wallington, NJ, or while shooting darts with Philadelphia cops across from my undergrad apartment.  Any chat I’d have with an old buddy or bartender about drugs, cancer, or drugs and cancer would invariably draw some interest from fellow patrons overhearing my discussions.  These were usually followed by, “Hey, aren’t you Frankie Kroll’s boy?,” or “I’ve heard the government is hiding the cure for cancer – do you have any inside dope on that?”
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Posted in: Herbs & Supplements, Medical Academia, Pharmaceuticals, Science and Medicine, Science and the Media

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