Placebo Surgery?

May 09, 2008

A pal of mine, medical journalist Kent Steinriede of Outpatient Surgery Magazine, recently tipped me off to the strange phenomenon of sham or placebo surgery, in which medical researchers perform what essentially are fake operations on a portion of the patients in a clinical trial, in order to test the efficacy of a particular surgical procedure.

Here’s an example of how sham surgery works. A few years back, researchers from the U.S. Department of Veterans Affairs and Baylor College of Medicine wanted to find out whether arthroscopic surgery, then a common treatment for osteoarthritis of the knee, really did patients any good. A Baylor press release explains how they went about answering the question:

In the study, 180 patients with knee pain were randomized into three groups. One group received debridement, in which worn, torn, or loose cartilage is cut away and removed with the aid of a pencil-thin viewing tube called an arthroscope. The second group underwent arthroscopic lavage, in which the bad cartilage is flushed out. The third group underwent simulated arthroscopic surgery; small incisions were made, but no instruments were inserted and no cartilage removed.

It should be mentioned that when potential subjects for the study were informed beforehand that they might be receiving sham surgery that would have no effect on their condition instead of an actual arthroscopy, 56 percent — more than half — still agreed to participate. But the results were even more startling:

During two years of follow-up, patients in all three groups reported moderate improvements in pain and ability to function. However, neither of the intervention groups reported less pain or better function than the placebo group. Indeed, the placebo patients reported better outcomes than the debridement patients at certain points during follow-up. Throughout the two years, the patients were unaware of whether they had received real or placebo surgery.

This was particularly significant, because previous studies conducted without a sham group had reported that the majority of arthroscopy patients got relief from knee pain. The V.A.-Baylor study showed that it may not have been the surgery that caused their improvement, but rather the Subject Expectancy Effect  — i.e., if a patient thinks that a treatment will work, he or she has a better outcome than a patient who doesn’t really believe it will help.

The effect was even more startingly apparent in a University of Denver study published in 2004 on the effectiveness of transplantation of human embryonic dopamine neurons into the brains of persons with advanced Parkinson's disease. Half the patients were given the transplants, while the others received a phony operation in which small holes were drilled into their skulls for realism. Those who got the real operation experienced measurable improvements in movement, while those who got the sham surgery didn’t. Nevertheless, a year later, patients who believed that they had received a transplant reported a better quality of life than those who believed that they hadn’t gotten one, regardless of whether or not they actually had. Moreover, doctors treating the patients — who didn’t know which of them had the real transplants — reported more improvement in those who believed they’d received the treatment. As Science Daily reported:

One patient, for example, reported that she had not been physically active for several years before surgery, but in the year following surgery she resumed hiking and ice skating. When the double blind was lifted, she was surprised to find that she had received the sham surgery.

You may ask: How could that possibly be? How could patients experience results from a fake operation that doesn’t actually do anything? Are they simply being fooled into thinking that they feel better? Perhaps not. University of Michigan researchers have found that after patients were told that a fake medicine would alleviate their jaw discomfort,  it apparently caused their bodies to produce endorphins, a chemical that reduces pain. As this BBC News story details:

Their brain scans also showed that they had more endorphin activity after simply being told they were about to get the "medicine."

The most pronounced effects were seen in four parts of the brain known to be involved in processing and responding to pain, namely the left dorsolateral prefrontal cortex, the pregenual rostral right anterior cingulate, the right anterior insular cortex and the left nucleus accumbens.

Furthermore, activity in the dorsolateral prefrontal cortex was associated with the expectation of pain relief.

Activation of the other brain areas was associated with relief of the intensity of pain, how unpleasant it was and how the individuals felt emotionally during the pain.

This leads me to an extremely bizarre — but nevertheless intriguing — thought: If fake surgery actually helps study subjects, what about using it to treat ordinary patients, particularly ones for whom no other effective treatment seems to be available? To medical ethicists — some of whom object to the use of sham treatments even in clinical trials — this would be total heresy.  On the other hand, as I was surprised to learn, many doctors already occasionally engage in therapeutic deception. According to the American Medical Association AMedNews.com, a recent survey of 231 physicians revealed that nearly half had treated their patients with placebos, and 8 percent had used such fakery more than 10 times in the past year. (Only 4 percent of the doctors had bothered to inform patients that they might be receiving the proverbial sugar pill, despite a 2006 AMA report that condemned the use of placebos without patient consent as a breach of trust.)

So, what do you think? Should doctors use fake operations to tap into the placebo effect and try to help consenting patients who might not see improvement through conventional treatment? Or would sham surgery for therapeutic purposes be utterly wrong? Express your opinion below.

Comments

[Dr. McDreamy]

It may sound crazy, but the theraputic use of placebos and sham surgery is an idea that some doctors and ethicists are actually pondering. Check out this article...
http://www.csmonitor.com/2005/0407/p13s01-stss.html

[Joey]

Deliberately performing operations that do nothing seems like the definition of malpractice. I can't imagine that this would even be legal.

[Mothra]

I think in order to give someone hope about something, it's dfinitely worth investigating. But if someone found out, there could be a lot of anger about it.

[Alternative healer]

What we really are talking about here is the mind-body connection. Doctors are calling this by a different name (the placebo effect) but increasingly, they're trying to tap into it

A January 2008 study of doctors in the Chicago area (http://www.medicalnewstoday.com/articles/93003.php) yielded some surprising results.

50 per cent of the 466 invited participants responded (231 out of 466).

45 per cent of respondents reported using a placebo in clinical practice.

Of these, 34 per cent introduced the placebo to the patient as "a substance that may help and will not hurt", 19 per cent said "it is medication", and 9 per cent said "it is medicine with no specific effect".

Only 4 per cent of those who used placebo told the patient "it is a placebo".

The most common reasons for using a placebo were to calm the patient and to supplement another treatment.

There was much disagreement on the definition of placebo and how it works.

96 per cent of respondents believed placebos have therapeutic effects.

40 per cent of respondents said placebos can have physiological benefits for certain health problems.

12 per cent of respondents said placebos should be categorically prohibited in routine medical care.

48 per cent of respondents reported giving at least one type of placebo-like treatment where there was no clinical evidence to support it.

[Wavy Gravy]

Instead of fake surgery, why not try an alternative medicine cure instead? There are treatments that focus on the mind-body link without deception.

[Alexander]

I really don't think it's right for a doctor to perform a fake operation and lie to the patient about it.

[Caffeine Driven Stress Magnet]

Dispensing placebo medications is one thing, but doing fake operations increases the risk for the patient, since surgery always has some risks. I'm not convinced this is a real phenomenon. Is there any evidence that doctors actually are performing fake operations?

[Dr. McDreamy]

The first use of placebo surgery for research was back in the 1950s, when cardiologist Dr. Leonard Cobb used it to demonstrate that the relief that patients seemingly got from a common surgical procedure for angina was actually caused by the placebo effect. Placebo surgery isn't necessarily that much more risky than other things to which research subjects are exposed. Here's a Google book that explains this in more detail:
(http://books.google.com/books?id=0xORQJJ5sHMC&pg=PA78&lpg=PA78&dq=using+fake+surgery+to+treat+patients&source=web&ots=NjD2_C7RxP&sig=za0LUpqTcZIE2-uQbhvZVgKuIKE&hl=en#PPA77,M1)

[Prozac Nation]

http://www.guardian.co.uk/society/2008/feb/26/mentalhealth.medicalresearch
Prozac, used by 40m people, does not work say scientists

Analysis of unseen trials and other data concludes it is no better than placebo

Full text: the PLoS paperhttp://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050045

Sarah Boseley, health editor The Guardian, Tuesday February 26 2008
This article appeared in the Guardian on Tuesday February 26 2008 on p1 of the Top stories section. It was last updated at 09:56 on February 26 2008.
A single Prozac capsule. Photograph: Alamy

Prozac, the bestselling antidepressant taken by 40 million people worldwide, does not work and nor do similar drugs in the same class, according to a major review released today.

The study examined all available data on the drugs, including results from clinical trials that the manufacturers chose not to publish at the time. The trials compared the effect on patients taking the drugs with those given a placebo or sugar pill.

When all the data was pulled together, it appeared that patients had improved - but those on placebo improved just as much as those on the drugs.

The only exception is in the most severely depressed patients, according to the authors - Prof Irving Kirsch from the department of psychology at Hull University and colleagues in the US and Canada. But that is probably because the placebo stopped working so well, they say, rather than the drugs having worked better.

"Given these results, there seems little reason to prescribe antidepressant medication to any but the most severely depressed patients, unless alternative treatments have failed," says Kirsch. "This study raises serious issues that need to be addressed surrounding drug licensing and how drug trial data is reported."

The paper, published today in the journal PLoS (Public Library of Science) Medicine, is likely to have a significant impact on the prescribing of the drugs. The National Institute for Health and Clinical Excellence (Nice) already recommends that counselling should be tried before doctors prescribe antidepressants. Kirsch, who was one of the consultants for the guidelines, says the new analysis "would suggest that the prescription of antidepressant medications might be restricted even more".

The review breaks new ground because Kirsch and his colleagues have obtained for the first time what they believe is a full set of trial data for four antidepressants.

They requested the full data under freedom of information rules from the Food and Drug Administration, which licenses medicines in the US and requires all data when it makes a decision.

The pattern they saw from the trial results of fluoxetine (Prozac), paroxetine (Seroxat), venlafaxine (Effexor) and nefazodone (Serzone) was consistent. "Using complete data sets (including unpublished data) and a substantially larger data set of this type than has been previously reported, we find the overall effect of new-generation antidepressant medication is below recommended criteria for clinical significance," they write.

Two more frequently prescribed antidepressants were omitted from the study because scientists were unable to obtain all the data.

Concerns have been raised in recent years about the side-effects of this class of antidepressant. Evidence that they could prompt some young people to consider suicide led to a warning to doctors not to prescribe them for the under-18s - with the exception of Prozac, which was considered more effective than the rest.

In adults, however, the depression-beating benefits were thought to outweigh the risks. Since its launch in the US in 1988, some 40 million people have taken Prozac, earning tens of billions of dollars for the manufacturer, Eli Lilly. Although the patent lapsed in 2001, fluoxetine continues to make the company money - it is now the active ingredient in Sarafem, a pill sold by Lilly for premenstrual syndrome.

Eli Lilly was defiant last night. "Extensive scientific and medical experience has demonstrated that fluoxetine is an effective antidepressant," it said in a statement. "Since its discovery in 1972, fluoxetine has become one of the world's most-studied medicines. Lilly is proud of the difference fluoxetine has made to millions of people living with depression."

A spokesman for GlaxoSmithKline, which makes Seroxat, said the authors had failed to acknowledge the "very positive" benefits of the treatment and their conclusions were "at odds with what has been seen in actual clinical practice".

He added: "This analysis has only examined a small subset of the total data available while regulatory bodies around the world have conducted extensive reviews and evaluations of all the data available, and this one study should not be used to cause unnecessary alarm and concern for patients."

[Therapist]

Other experts have cited numerous problems with the Prozac vs. Placebo study, which you can read at http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050045 . (A detailed critique is available at http://medicine.plosjournals.org/perlserv/?request=read-response&doi=10.1371/journal.pmed.0050045&ct=1#r2209)

It's also important to note that the description of the findings in first paragraph of the newspaper article is not accurate. Though the study questioned the efficacy of prozac for patients with moderate depression, it found that patients with severe depression showed a statistically significant improvement vs. counterparts who took the sugar pill, and recommended the continued use of the medication by those patients. Beyond that, the inclusion of other "similar drugs in the same class" is misleading, because the study did not deal with sertraline (Zoloft), which is now the most commonly prescribed SSRI for depression.

The most important comparison to be made is between SSRIs and the previous generation of tricyclic antidepressants, which for years were the best available treatment for moderate to severe depression. SSRIs achieve results that are comparable to the earlier drugs, but without the troubling side effects and health risks of the earlier medications.

[Chico]

i think this idea is completely ridiculous!!!!

[Astroboy]

This topic just isn't weird enough for me.

[Manda]

Wow, an amazing story. I can go both ways with it. I believe if nothing else has worked for the patient that placebos should be an option, though it should be provided for free or little cost. Doctors and other medical centers should not be able to pretend to do something and charge for the real thing.

[Regulatory Consulting]

Thank you very much for this informative post.......

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[Rob]

Such approach may be verry difficult in regular clinical trials. Ethical considerations for approval of such trials are easy to predict. So it's possible they will be accepted as a very unique exploratory studies in relation to "general" discovery and knowlegde, however reglar trials may be less probable.

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