Off Topic (sort of): Is the Placebo Effect Real?

In order to help people with my site and blog, I try to stay away from saying anything controversial — aside from my belief that eczema is eminently solvable and understandable, and that there is nothing really wrong with these kids absent these relatively new environmental influences.  I only wish what I have to say in this post weren’t controversial — I don’t know why it is, but it is.  Forgive the lack of photos, I’ll try to remedy that soon.  This post is excerpted from a letter I wrote many years ago, and it highlights the philosophy that led to the way I went about problem solving eczema for my son.  I have posted this opinion anonymously online since, but I may as well come out and say it.  There are critical (unnecessary) barriers to solving intractible health problems, and real people suffer while we all wait for those in ivory towers to break them down.  In the era of distributed knowledge and the Internet, that must change.

When people use the site to problem solve their own children’s eczema, the breakthrough is usually when they can see the eczema outbreaks are not random.  In my experience, when people accept they can solve the problem, they are more than halfway there.  When they see they are in control, they’re there — they may not yet have all the influences or rashes eliminated, but they know they can do it.  I believe the perspective discussed below could help solve other currently-deemed intractable diseases.  I hope the following is helpful to others:

—AJ Lumsdaine, SolveEczema.org

More than ten years ago, Danish researchers Hrobjartsson and Gøtzsche published the watershed study, “Is the placebo powerless?  An analysis of clinical trials comparing placebo with no treatment,” in the New England Journal of Medicine.  The two researchers looked through the history of placebo-controlled clinical trials and found over 100 studies that included three patient groups rather than two:  1) a group given treatment, 2) a group given a placebo intended to mimic treatment, and 3) a group given nothing at all.  The authors decided to compare the groups given nothing to the placebo groups, and found that there is no significant clinical effect associated with placebos.  In other words, the placebo effect – interpreted as improvement resulting from patients’ belief in a treatment – is more myth than reality.

As you might imagine, the study generated quite a firestorm in the medical community.  I remember reading a letter by the head of Harvard Med School, in which he scratched his head at the earth shattering results, but also said he wouldn’t want anyone to give him a placebo.

And after such earth-shattering results, then what happened?

Hrobjartsson and Gøtzsche followed up with another study in 2004:  “Is the placebo powerless?  Update of a systematic review with 52 new randomized trials comparing placebo with no treatment.”  Again they “found no evidence of a generally large effect of placebo interventions.  A possible small effect on patient-reported continuous outcomes, especially pain, could not be clearly distinguished from bias.”

Although these researchers were arguably the first to make a dent in ironclad beliefs about placebos, especially in the media, they are not the first to analyze and refute the concept.

In 1997, researchers Kienle and Kiene wrote, “In 1955, Henry K. Beecher published the classic work entitled “The Powerful Placebo.”  Since that time, 40 years ago, the placebo effect has been considered a scientific fact.  Beecher … claimed that in 15 trials with different diseases, 35% of 1082 patients were satisfactorily relieved by a placebo alone.  This publication is still the most frequently cited placebo reference.  Recently Beecher’s article was reanalyzed with surprising results:  In contrast to his claim, no evidence was found of any placebo effect in any of the studies cited by him.  There were many other factors that could account for the reported improvements in patients in these trials, but most likely there was no placebo effect whatsoever.  False impressions of placebo effects can be produced in various ways. … These factors are still prevalent in modern placebo literature.  The placebo topic seems to invite sloppy methodological thinking.  Therefore awareness of Beecher’s mistakes and misinterpretation is essential for an appropriate interpretation of current placebo literature.”

No one is claiming that placebo-controlled trials are unnecessary.  On the contrary, these studies further emphasize the importance of placebos in clinical trials to eliminate the junk drawer of biases and other effects that needs to be separated from the clinical effect of the drug or treatment under scrutiny.  But the studies also point out how sloppy definitions of the placebo effect have perpetuated false beliefs.

The popular lay understanding of the placebo effect — the myth — is of powerful physical changes that result from an expectation or hope, a belief that good will happen if one is taking a medication (or that bad will happen if one is expecting bad side effects).

On the other side of the spectrum, is the definition of placebo effects as what is attributable to everything else that is not a medication effect – including the natural course of the illness, other effects caused by a placebo, even reporting biases among researchers and patients.  When the definitions are confused, the placebo effect is falsely supported as resulting from belief in treatment.

For a classic example of confusing changes from belief in treatment with other effects caused by a placebo, look no further than a watershed arthroscopic surgery trial from a few years ago, meant to test whether placebo-controlled surgeries are necessary and oft-cited as demonstrating that placebos are powerful.  Unfortunately, the many who wrote about this study as proving the power of placebos, meant placebos-as-causing-physical-effects-from-expectation.  But that’s not how the researchers of the study were using the term.  (This is one reason, especially in this day and age, full medical articles really must be made available to everyone online, not just abstracts.)

Patients were divided into three groups — patients to receive one of two popular arthroscopic surgeries, and a patient group to receive a sham surgery in which they were operated on and closed up without any actual surgical intervention.

Patients in all three groups improved, and this was taken as proof the placebo effect is powerful, and equated to mean the belief in treatment produces powerful effects.

But in fact, if people read the full article, they could see the placebo in this study wasn’t just the surgery.  Patients in all three groups – those given one of two different kinds of common knee surgeries and those in the placebo surgery group – all patients followed a comprehensive regimen of rest, walking aids, gradual exercise, and analgesics, in addition to their surgeries.  So, the placebo in this study was not just a sham surgery, the placebo was a sham surgery AND a comprehensive regimen of rest, walking aids, gradual exercise, and analgesics.  Unfortunately, there was neither a group that got the same regimen of rest and rehabilitation but did not get surgery at all, nor was there a control group that got nothing, to determine whether the observed improvements were from an independent effect of the placebo (i.e., improvements from just the rest and rehabilitation) or the natural course of the disease.

The study authors merely examined whether two common knee surgeries produced better outcomes than a placebo surgery (they did not), the study design in no way supported the existence of real clinical changes stemming from patients’ belief in treatment.  In fact, the study authors made oblique reference to the Hrobjartsson results and suggested themselves that the effects they observed could be the result of the natural course of the disease or related to an independent influence (but not the result of a belief in the treatment).

Despite such serious research supporting the need for a revolution in how we think about the placebo effect, nothing has really changed in over a decade.

Too few studies bother to delve into how the natural course of a disease plays into the picture.   If we know now from definitive research that improvements aren’t from belief in the treatment, but the result of something else, shouldn’t we be acting on this?

I’m sorry to burst one of the happiest bubbles in popular medical mythology, but there is just no good evidence that belief in a treatment alone produces a significant clinical change down the road, only wishful interpretations that it does.

Now, I’m not suggesting there is no mind-body connection, far from it.  I’m only saying that just because we see some obvious mind-body connections, does not mean that the conscious brain has unfettered control of all physiological processes.  Just because you can jump over a box, does not mean you can leap tall buildings in a single bound.

I’m also not saying, believe it or not, that there will never be a role for harnessing hope in medical treatment.  I’m just skeptical that sham treatments are the right vehicle.  If a passenger tries to catch a moving train, for example, a sudden surge of hope might make all the difference in whether she catches it and reaches her destination.  The surge in hope won’t allow her to keep outrunning a train forever, though.  In other words, a short-term belief could affect the long-term outcome in a significant way – but only if the train is real, not a mirage (or a sugar pill).

There is a much more serious issue at stake here than whether we can harness the power (however minor it has proven to be) of belief in treatment.  The popular concept of the placebo effect—as resulting from belief—undermined the crucial role of empiricism in medical practice, which has in turn seriously degraded the scientific authority of clinicians (even within the medical profession, very rigorous and scientific observations by good clinicians of individual patients are typically deemed “anecdotal” by definition).  This has in turn led to an over-reliance on statistical studies in medicine to problem solve for individuals (leading naturally to “one-size-fits-all treatments”), rather than to PROVE solutions found through empirical means.

In the decades since the concept of the placebo effect was first embraced, how many millions of times have doctors come across clinically significant improvements in their patients, even cures, but dismissed what they saw as the probable result of their patients’ beliefs in treatment, the irreproducible products of their patients’ minds?  How many times have clues to cures been left uninvestigated because of how beliefs about placebos lead to handwaving about the “vagaries of the human body”? 

We know now, we have solid proof now, that significant clinical changes are not the result of beliefs but of something else.  Something else — like the rigorous plan of rest and rehabilitation in the arthroscopic surgery study — that could, through empirical problem solving, be discerned and tested and turned into a solution or many solutions.

Every day, the belief that clinically significant improvements in individuals may merely be the result of the placebo effect costs our world opportunities to solve or cure tough diseases.

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