Should Patients Be Told They Are Taking A Placebo?
24 CommentsBy Ed Silverman // December 23rd, 2010 // 10:41 am
Who says silence is golden? A new study finds that the placebo effect works even when patients know the medicine they take is a fake. Remember that doctors are not actually telling patients the truth when doling out placebos, so the research suggests that doctors may no longer need to fib for patients to benefit from a placebo.
In the study, which was published in PLos One, 80 patients with irritable bowel syndrome were given an inactive pill or no treatment at all. And after 21 days, 59 percent of those given a placebo - and were made aware that they took a placebo - reported adequate relief of symptoms. By comparison, just 35 percent of those given no treatment reported feeling better.
“Our results challenge the conventional wisdom that placebo effects require ‘intentional ignorance,’ ” the researchers write. “Our study points to a potential novel strategy that might allow the ethical use of placebos consistent with evidence-based medicine. Minimally, open-label placebo may have potential as a ‘wait and watch’ strategy before prescriptions drugs are prescribed” and it “may be appropriate for clinicians to recommend that patients try an inexpensive and safe placebo accompanied by careful monitoring before and after prescribing medication.”
There were some limitations, however. For one, this was a small sample size and the study was not run for very long. Also, patients were told that placebos have previously demonstrated benefit despite lacking active ingredients, suggesting some patients may have expected a placebo would work. And both groups received medical attention, which may have also coaxed some into feeling improvements.
Nonetheless, this is a provocative notion. The researchers noted that a recent survey of internists and rheumatologists found that, while only small numbers of docs surreptitiously use inert placebos, about 50 percent prescribe meds they consider to have no specific effect on patients and are used solely as placebos (read the abstract). Informing patients might yield some interesting results. So what do you think? Vote and share your thoughts…
Should Patients Be Told They Are Being Given A Placebo?
- No (68%, 62 Votes)
- Yes (32%, 29 Votes)
Total Voters: 91
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I. Spatz
Was this study evidence of a placebo effect to the Hawthorne Effect? The latter is the well known effect of people changing their behavior (or in this case reported condition) in response to being studied. The article is quite clear that those in the placebo arm of the study were told that the study was based one the fact that placebo often had a benefit. What if they had been told the study was seeking to disprove any benefit or that placebo could not possibly have any benefit? And, of course, unlike a normal placebo-controlled study, those in each arm knew whether they were being treated or not.
I. Spatz
First line should read “Was this study evidence of a placebo effect OR the Hawthorne Effect?”
John English
This study result may may demonstrate another classic factor - the Hawthorne Effect. In that venerable study (non-GMP, I assure you) at the Western Electric plant in Hawthorne NY, it emerged that just the act of being studied resulted in improvements. Or to put it in a simpler fashion, people appreciate attention and will repond to it.
“…The study was originally commissioned to determine if increasing or decreasing the amount of light workers received increased or decreased worker productivity. The researchers found that productivity increased DUE TO attention from the research team and NOT because of changes to the experimental variable….” **
Even a ‘double-blind” design won’t block the possibility of this effect, although in my experience in the GxP industries, I can’t recall it being mentioned as a concern.
** Brief reference for your convenience:
http://psychology.about.com/od/hindex/g/def_hawthorn.htm
John English
I. Spatz it looks like ‘great minds think alike.’ Our comments crossed in the ‘net.
Michael S. Altus, PhD, ELS
Psychiatrist Walter A. Brown, MD, advocated the use of placebos with the patient’s consent in two articles:
Brown WA. Placebo as a treatment for depression. Neuropsychopharmacology. 1994
Jul;10(4):265-9; discussion 271-88. Review.
Brown WA. The Placebo Effect. Scientific American. 1998;278(Jan):90-95; letters 1998;278(May):10.
Justice in MI
Obviously, this in the context of treatment, not studies.
Partly related to the Hawthorn comments, being told “the placebo did it”–for those who already had improvement–would seemingly reinforce the effect. My sense is that most patients would take a kind of bodily pride in knowing that they, in effect, cured themselves. And that, in turn, should reinforce the effect.
So, related to outcomes, I think it probably is a good idea to let pts know once they’ve been on the placebo for a while. They might well feel even better!
Justice in MI
Curious to know the rationale of the “no” voters, particularly given my surmise that learning about placebo might actually increase health benefits.
Assuming it’s not about selling more drugs, is there an ethical issue or concern with pt-HCP trust that you are concerned about?
industry insider
IBS has significant psychiatric overlay, hence placebo0 responsive. Show me a malignant tumor that shrinks with placebo and maybe I’ll think about it.
PlaceboCancerStudies
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=40&abstractID=33999
Yes, I Know
There are some legal issues aka, problems, as to giving the patient a placebo without (first) telling them of the potential.
It would be okay if this were a well planned clinical trial AND, the patients (all of them) were told that some would get the placebo and others, not. I would suggest a double blind, so no one knows but the drug company.
Of course, I am telling you this from a retired medical malpractice investigator.
industry insider
We already have a large single blind study of the effects of placebo in cancer chemotherapy. It is the case of Robert Courtney, the Missouri pharmacist who diluted the IV cancer chemotherapy of thousands of patients, causing at least one death. He was basically giving them placebos. Courtney is now serving time in a Federal Penitentiary in Rochester, MN, with earliest projected release date in 2027.
http://www.lawyersweekly.com/reprints/dbj11.htm
JaT
The day doctors start treating with snake oil is the day they have outlived their usefulness. Mine would not only be fired but I would seek an investigation. I suspect fraud and neglect wouldn’t be big leaps - disclosed or not. No incentive to be a diagnostician. Did (s)he exhaust every possibility? Did I get worse or die?
That will be $150.00 - come back if things persist.
That will be $150.00 - come back if things persist.
That will be $150.00 - come back if things persist.
Racketeering comes to mind.
Disclosure of the information in a time when people have access to the interweb is the obvious choice. It doen’t excuse the act even so.
Mark p.s.2
If there is no medical ingredients, is this placebo effect better to be called a religious effect? A certain amount of people believe they will get better, so get better because of their faith-trust-hope of a better future.
In church what you put in the donation plate is voluntary though.
Yes, I Know
Insider,
I remember that case. The druggist had no bad feelings about diluting the drugs and charging the same as if a full order. In his own way, he was a greedy, cold blooded sociopath. At the trial he felt bad but that could have been just an act.
Justice in MI
Without diluting (so to speak) the ethical issues involved, we know the efficacy of most medical treatments depend, to some degree, on the expectation of success, trust and confidence in between patient and HCP, and the existence of a treatment plan that makes sense to a patient.
We all know (yes?) about the success of feigned knee surgeries?
The discussion here strikes me as a somewhat homeopathic take on placebo; i.e,known active ingredients are highly diluted or largely missing.
PB
Let’s not bring ‘God’ into this. Placebos don’t have a place in medical practice to replace active ingredient medications/substances. We should know that the mind is powerful and takes an active role on our health. So this information is not surprising. What is surprising is that anyone would contemplate giving a patient a non therapy and making them think it is therapeutic. What about informed consent?
JaT
What puzzles me is that FDA can promote (through approvals) the use of ineffective medications while they tell drug makers they cannot promote drugs for off-label uses or make claims of efficacy where none exists.
Hypocritical at the very least.
JaT
I am assuming placebos are FDA approved. Yes?
industry insider
FDA has approved “active placebos” when it likes a new class of meds, i.e. buspirone as an anxiolytic alternative to benzodiazepines.
JaT
So I had to do some looking because I was starting to feel all sheepish and apologetic about my FDA comment - not knowing for sure. A search led to this 2003 article:
http://www.theonion.com/articles/fda-approves-sale-of-prescription-placebo,1606/
“As industry analysts predict the drug’s sales will top $25 billion in the first year, the approval of placebo is expected to unleash one of the pharmaceutical industry’s biggest marketing battles to date.”
The ones listed in the article (by AZ, GSK, and Lilly) do not appear on the company product pages however. There wasn’t a flood of information about FDA approved placebos under my search criteria at all.
Industry Insider, would those not-benzodiazepines be labeled as diazapam or alprazolam? Not a silly question where duping is concerned or where not-really-dilantin has come about. I’m just not interested in blindly participating further in post-marketing experiments of newly approved or restructured products of any kind.
These are questions we should not have to ask.
PB nailed it:
“What about informed consent?”
Merry Christmas Everyone
Justice in MI
Whoa, Nelly! No one is advocating giving pts placebos. The study reported was one in which pts knew that they might receive either placebo or drug. And the only thing at issue was informing pts, after the fact, which one they got.
The most “radical” suggestion raised was starting pts with the same two possibilities, seeing how they did, and then informing them at some appropriate time (21 days in the study reported).
If, indeed, pts improved on placebo–and perhaps more often than on drut–this would spare them ehaving to go through the latter. “All drugs have dangers”–that’s what we hear here all the time. Placebos, relatively speaking, don’t.
If one favors informed consent, this would seem to be an approach entirely in keeping.
Could it be abused by insurance and similar? No question. As far as I know, however, no pt. has been forced to go through such a trial before being rx’d a drug. Given the often marginal benefit of drug over placebo (with SSRIs, for example, for anything other than the most severe depression), the benefits might well outweigh the risks.
Josh
JaT,
I hope you are not serious quoting The Onion….a well known satirical newspaper.
JaT
I don’t know a thing about The Onion. I did find the names of the placebos to be ridiculous. That would explain it and thx for the heads up.
The point was to find if FDA approves placebos which could be prescribed by doctors in leiu of medications. Gonna go wipe the egg off of my face now. Ugh.
Josh
The Onion is a good read though….