This post is by Adam Clemans.
Marco Arruda, an MD and PhD in the Department of Pediatric Neurology at the Glia Institute (São Paulo, Brazil) is the author of a recent editorial in JAMA Pediatrics about the use of Triptan for headaches in children. There’s a lot of controversy because placebos work very well for headache — so much so that they often have to use some tricky methods to actually show a treatment effect with the real drugs.
In a recent article on Medscape, Dr. Arruda is quoted as saying: “Although placebo is the enemy of great clinical trials, it is likely the best friend of good clinicians.”
This makes me wonder what he thinks makes a good clinician. If Triptan and a placebo are equally effective, it is curious that anyone would skip the placebo and prescribe the drug, which has listed as side effects:
Anaphylactic shock, angina, angioedema, breast pain, colitis, coronary artery vasospasm, hemiplegia, hypertension, myocardial ischemia, MI, neuropathy, rash, seizure, syncope, tachycardia, ventricular fibrillation, ventricular tachycardia
Why does putting patients in harm’s way make one a good clinician?
Has anyone studied the side effects of placebos?
placebos have definite side effects for drug companies
To the post itself, I’m not quite sure what Adam is getting at with his last question.
“Although placebo is the enemy of great clinical trials, it is likely the best friend of good clinicians.”
implies a good clinician would make use of some sugar pills (placebos)…
“This makes me wonder what he thinks makes a good clinician.”
It would seem he thinks it is one that uses sugar pills sometimes
“Why does putting patients in harm’s way make one a good clinician?”
His idea is that the clinician *didn’t*, by using sugar pills.
Am I missing/misreading something here?
I wonder what the malpractice status is for a doctor that gives a placebo – for it to work, he must tell the patient it is actually a drug. The lawyers could have a field day with that one…
Apparently placebos often work even when the patient is told, “This is a sugar pill with no active ingredients, but it has helped some people with your condition.”
Paul, I was a little unsure of what he meant at 1st too, but if you read the linked article, it is clear he is advocating using Triptans:
“… when possible, treat within label by giving preference to approved drugs; and when no evidence is available, or when first-line therapies have failed, select a drug based on plausibility, proved efficacy in studies with adults, and proved safety of the drug in children.”
The problem is, there is no proof that these drugs are safe in children. It is obvious that Placebos are safer and, apparently, equally effective.
A placebo is a tricky thing for a clinician and for patients. Personally, I would feel a little disappointed if I made the effort to come to a doctor and they told me to take a sugar pill, even if it was shown to be equally effective, and even if my logical brain believed that. Also, people dramatically underestimate ‘no treatment’ and in doing so over-estimate the placebo effect. Just doing nothing cures many problems and ‘no treatment’ is rarely run as a 2nd control.
Maybe in children you can get away with prescribing pure placebos, but I’m not surprised that it just doesn’t catch on with doctors and their adult patients.
So… what if, instead of pure placebos, we had a movement towards ‘low dose’ medicines. Why not give someone low-dose aspirin at 1/5th or 1/10th of the normal dose? It will have very minimal side effects and would be something that both practitioners and patients can feel like is ‘at least something’. It could get some real-world momentum, and would really reduce over treatment and side effects if it did.
“Arruda […] points out that these studies “force us to remember that ‘no evidence of efficacy does not mean the evidence of no efficacy’.””
sigh…
Seth: It’s one of the Consolations of Pseudo-Science, that you can say things like that.
Have the aforementioned side-effects also been compared to the side-effects of placebos?
In Triptan trials, the placebo groups usually have few side effects because they believe (or are told?) that Triptans have few side effects as well.
In one trial patients were told they might be receiving an antidepressant but received placebo; side effects included dry mouth, drowsiness, constipation, and sexual problems.
In another trial patients were told they might get an anticonvulsant but received placebo; they experienced more drowsiness & sleepiness.
These are not at all comparable to heart attack, anaphylaxis, seizures, etc.
In some cases, “placebo effect” is confused with the effect of time passing. For example, if a patient gets better after getting a placebo, this is called a placebo effect even though it isn’t clear that the placebo was responsible. The improvement might have happened if nothing was done.