> For a drug to be approved by the Food and Drug Administration, it must prove itself better than a placebo, or fake drug.
False, the FDA doesn't actually have any requirement to prove that a treatment is better than placebo. Many trials don't even include a placebo arm, they only compare themselves against existing drugs that were grandfathered into the system without any efficacy testing. Or they compare themselves to inert placebos rather than active ones, even if they are psychoactive drugs. Or they only compare themselves against placebos for a few weeks, even if they are meant to be used for long periods of time.
This is how we have drugs like antidepressants and ADHD drugs on the market even the though research shows they are actually worse than taking no drug at all.
While there is a good amount of controversy around the efficacy of antidepressants, first-line ADHD medications (the stimulants) work in roughly 70% of cases, which is much superior to placebo. For those with ADHD, treatment can make a large quality of life improvement.
Source - memory from having written a book on adult ADHD
I'm not sure I understand the first scenario. If they are tested against drugs which have already been shown to be better than a placebo, doesn't basic logic show they would be, as well?
Or is there a case where one could "pass" this test, but still "lose" against a placebo?
For the rest, I didn't realize there was a difference between inert and active placebos.
It strikes me that for something like knee surgery, at least, the recovery routine might be what provides the benefit. What if you took a group and did not pretend to give them surgery but made them rest and go through physical therapy as if you had?
"Less than a year ago, many were shocked when arthroscopic surgery for meniscal tears performed no better than sham surgery. This procedure was the most common orthopedic procedure performed in the United States."
Earlier this year I re-injured the meniscus in my knee and was about to undergo surgery when a radiologist in the family mentioned this study. I cancelled the surgery and followed the alternative recovery method of ice, ibuprofen and rest. It took a long three weeks for me knee to feel normal again, but it would've been much longer had I undergone the surgery.
Perhaps we could create a placebo bureaucracy, say an FDA like agency which just approved anything that came through it. And then we could compare the end results of that agency with the FDA to see which one approved the most 'actually useful' medicines and the one which had the most 'later found to be harmful' medicines.
Very old news. Surgery for "Gastroesophageal reflux disease" was an famous example: http://en.wikipedia.org/wiki/Placebo#cite_note-198 . If I remember correctly in one study symptoms dissipated in 50% of patients, who got sham surgery - just skin incisions.
A friend of mine who repairs PCs occasionally finds nothing wrong with them and does the usual "I'll run some maintenance on it" and the client is always happier afterwards. He doesn't charge for stuff unless anything needs to be done.
> We did not find that placebo interventions have important clinical effects in general. However, in certain settings placebo interventions can influence patient-reported outcomes, especially pain and nausea, though it is difficult to distinguish patient-reported effects of placebo from biased reporting. The effect on pain varied, even among trials with low risk of bias, from negligible to clinically important. Variations in the effect of placebo were partly explained by variations in how trials were conducted and how patients were informed.
Jokes about homeopathy aside, if you can answer your own question, there's probably a Nobel prize in it for you. Mind/body interactions are incredibly complex and as yet pretty poorly understood.
There are some known ways to take advantage of similar effects--for instance, helping patients find ways to lower stress as a means of mitigating risk factors like high blood pressure.
Right now they don't have a clue. In my world, the effect
is the only existence of God--until proven differently. So
believing strongly in something isn't as foolish as some
"Intellectuals" would berate?
> They had an incision, and a procedure was faked so that they didn’t know that they actually had nothing done.
Is it just me, or does this seem ethically dubious? A sugar pill placebo does no harm, but when you are cutting people open to "fake" surgery...just doesn't sit right.
> The ethical issues aren’t easily dismissed. Theoretically, a sugar pill carries no risk, and a sham procedure does. This is especially true if the procedure requires anesthesia. The surgeon must go out of his or her way to fool the patient. Many would have difficulty doing that.
> But we continue to ignore the real potential that many of our surgical procedures and medical devices aren’t doing much good — and might even be doing harm, since real surgery has been shown to pose more risks than sham surgery.
The Placebo Effect should be taught in grade school. We shouldn't have to wait until college to realize just how
many products, drugs, professions, etc. are an absolute
sham.
The prevalence of the Placebo Effect across many medicinal domains seems like evidence that there is an underlying cause. Perhaps emotional well being has an impact on health?
This article brings up a very important point, and I'm grateful that it was submitted here. The professor of pediatrics who wrote the article is onto some important issues, and I was especially glad he cited some of the research literature with direct links. Reading a review he cited,[1] I see that one of the problems here is the vagueness of what he calls "improvement" in many medical studies. Is the treatment endpoint of a knee operation patients moving better than they used to, as measured by trained observers watching the patients do standardized movements? Or is "improvement" a patient self-report of less pain? Several of the examples the author writes about are examples of treatments indicated to relieve pain (angina, which is chest pain, or lower back pain, and it looks like most of the knee surgery he mainly focuses on was also done to relieve patient-reported pain). Patient self-reported pain is a symptom, a matter important to the patient, but it is not a diagnostic sign that can be objectively observed by anyone else (as, for example, blood pressure or white cell count can be objectively observed).
Too many medical studies, and almost all "alternative medicine" testimonials, are based on soft endpoints (patient self-reports of improvement) rather than on "hard endpoints" (longer healthier life after reduction in all-cause mortality, or resuming walking after being paralyzed, or something observable objectively and lastingly important).
Pretty much all studies by all authors of whatever researcher background that appear to show a "placebo effect" show that only for patient-reported subjective symptoms that are usually temporary anyway like pain and nausea. Nobody asks for a placebo treatment for a broken leg or a life-threatening infection. The medical researchers who look at the issue with proper study designs and statistical controls know that placebos are essentially useless, as they at most have influence just on self-reported subjective symptoms, not on any sign that affects the progression of a disease or maintenance of good health.[2]
Findings on placebo effects by researchers who have considered the issue carefully include
"Despite the spin of the authors – these results put placebo medicine into crystal clear perspective, and I think they are generalizable and consistent with other placebo studies. For objective physiological outcomes, there is no significant placebo effect. Placebos are no better than no treatment at all."[3]
"We did not find that placebo interventions have important clinical effects in general. However, in certain settings placebo interventions can influence patient-reported outcomes, especially pain and nausea, though it is difficult to distinguish patient-reported effects of placebo from biased reporting. The effect on pain varied, even among trials with low risk of bias, from negligible to clinically important. Variations in the effect of placebo were partly explained by variations in how trials were conducted and how patients were informed."[4]
So, yes, let's make sure that studies of surgical techniques include studies of sham surgery. (Studies of acupuncture had better always have sham acupuncture arms in which "real" acupuncture points are disregarded or other aspects of supposedly ancient Chinese technique are intentionally omitted without the patient knowing that.) This will improve the evaluation of safety and effectiveness of new surgical techniques. Just don't assume that ANY placebo is ever good for ANYTHING that you couldn't achieve just by giving yourself a good pep talk.
"- Administration of placebos should be considered when a patient is refractory to standard treatment, suffers from its side effects, or is in a situation where standard treatment does not exist."
[+] [-] Alex3917|11 years ago|reply
False, the FDA doesn't actually have any requirement to prove that a treatment is better than placebo. Many trials don't even include a placebo arm, they only compare themselves against existing drugs that were grandfathered into the system without any efficacy testing. Or they compare themselves to inert placebos rather than active ones, even if they are psychoactive drugs. Or they only compare themselves against placebos for a few weeks, even if they are meant to be used for long periods of time.
This is how we have drugs like antidepressants and ADHD drugs on the market even the though research shows they are actually worse than taking no drug at all.
[+] [-] harvestmoon|11 years ago|reply
Source - memory from having written a book on adult ADHD
[+] [-] lisper|11 years ago|reply
Isn't "active placebo" a contradiction in terms?
[+] [-] taeric|11 years ago|reply
Or is there a case where one could "pass" this test, but still "lose" against a placebo?
For the rest, I didn't realize there was a difference between inert and active placebos.
[+] [-] viewer5|11 years ago|reply
What do you mean?
[+] [-] agarden|11 years ago|reply
[+] [-] jobu|11 years ago|reply
Earlier this year I re-injured the meniscus in my knee and was about to undergo surgery when a radiologist in the family mentioned this study. I cancelled the surgery and followed the alternative recovery method of ice, ibuprofen and rest. It took a long three weeks for me knee to feel normal again, but it would've been much longer had I undergone the surgery.
[+] [-] sniderlane|11 years ago|reply
[+] [-] Procrastes|11 years ago|reply
[+] [-] unknown|11 years ago|reply
[deleted]
[+] [-] ChuckMcM|11 years ago|reply
[+] [-] tokenadult|11 years ago|reply
[1] "Dietary supplement industry says 'no' to more information for consumers (again)" http://www.sciencebasedmedicine.org/big-supp-resists-giving-...
[+] [-] ucho|11 years ago|reply
[+] [-] ToastyMallows|11 years ago|reply
http://www.stuffyoushouldknow.com/podcasts/how-the-placebo-e...
[+] [-] sudowhodoido|11 years ago|reply
A friend of mine who repairs PCs occasionally finds nothing wrong with them and does the usual "I'll run some maintenance on it" and the client is always happier afterwards. He doesn't charge for stuff unless anything needs to be done.
[+] [-] Toddarooski|11 years ago|reply
[+] [-] unknown|11 years ago|reply
[deleted]
[+] [-] matkam|11 years ago|reply
[+] [-] DanBC|11 years ago|reply
> We did not find that placebo interventions have important clinical effects in general. However, in certain settings placebo interventions can influence patient-reported outcomes, especially pain and nausea, though it is difficult to distinguish patient-reported effects of placebo from biased reporting. The effect on pain varied, even among trials with low risk of bias, from negligible to clinically important. Variations in the effect of placebo were partly explained by variations in how trials were conducted and how patients were informed.
[+] [-] kazinator|11 years ago|reply
http://en.wikipedia.org/wiki/Confirmation_bias
[+] [-] snowwrestler|11 years ago|reply
There are some known ways to take advantage of similar effects--for instance, helping patients find ways to lower stress as a means of mitigating risk factors like high blood pressure.
[+] [-] JacobJans|11 years ago|reply
[+] [-] marincounty|11 years ago|reply
[+] [-] 83457|11 years ago|reply
[+] [-] wdr1|11 years ago|reply
https://www.youtube.com/user/thehealthcaretriage
He does a great job covering a variety of subjects & explaining research to the layman.
[+] [-] smegel|11 years ago|reply
Is it just me, or does this seem ethically dubious? A sugar pill placebo does no harm, but when you are cutting people open to "fake" surgery...just doesn't sit right.
[+] [-] jonchang|11 years ago|reply
> The ethical issues aren’t easily dismissed. Theoretically, a sugar pill carries no risk, and a sham procedure does. This is especially true if the procedure requires anesthesia. The surgeon must go out of his or her way to fool the patient. Many would have difficulty doing that.
> But we continue to ignore the real potential that many of our surgical procedures and medical devices aren’t doing much good — and might even be doing harm, since real surgery has been shown to pose more risks than sham surgery.
[+] [-] msolujic|11 years ago|reply
[+] [-] marincounty|11 years ago|reply
[+] [-] unknown|11 years ago|reply
[deleted]
[+] [-] kylelibra|11 years ago|reply
[+] [-] briantakita|11 years ago|reply
[+] [-] tokenadult|11 years ago|reply
Too many medical studies, and almost all "alternative medicine" testimonials, are based on soft endpoints (patient self-reports of improvement) rather than on "hard endpoints" (longer healthier life after reduction in all-cause mortality, or resuming walking after being paralyzed, or something observable objectively and lastingly important).
Pretty much all studies by all authors of whatever researcher background that appear to show a "placebo effect" show that only for patient-reported subjective symptoms that are usually temporary anyway like pain and nausea. Nobody asks for a placebo treatment for a broken leg or a life-threatening infection. The medical researchers who look at the issue with proper study designs and statistical controls know that placebos are essentially useless, as they at most have influence just on self-reported subjective symptoms, not on any sign that affects the progression of a disease or maintenance of good health.[2]
Findings on placebo effects by researchers who have considered the issue carefully include
"Despite the spin of the authors – these results put placebo medicine into crystal clear perspective, and I think they are generalizable and consistent with other placebo studies. For objective physiological outcomes, there is no significant placebo effect. Placebos are no better than no treatment at all."[3]
"We did not find that placebo interventions have important clinical effects in general. However, in certain settings placebo interventions can influence patient-reported outcomes, especially pain and nausea, though it is difficult to distinguish patient-reported effects of placebo from biased reporting. The effect on pain varied, even among trials with low risk of bias, from negligible to clinically important. Variations in the effect of placebo were partly explained by variations in how trials were conducted and how patients were informed."[4]
So, yes, let's make sure that studies of surgical techniques include studies of sham surgery. (Studies of acupuncture had better always have sham acupuncture arms in which "real" acupuncture points are disregarded or other aspects of supposedly ancient Chinese technique are intentionally omitted without the patient knowing that.) This will improve the evaluation of safety and effectiveness of new surgical techniques. Just don't assume that ANY placebo is ever good for ANYTHING that you couldn't achieve just by giving yourself a good pep talk.
[1] http://www.bmj.com/content/348/bmj.g3253
[2] http://www.sciencebasedmedicine.org/michael-specter-on-the-p...
http://www.sciencebasedmedicine.org/ted-kaptchuk-versus-plac...
[3] http://theness.com/neurologicablog/index.php/the-rise-and-fa...
[4] http://www.ncbi.nlm.nih.gov/pubmed/20091554
[+] [-] pella|11 years ago|reply
from: http://jme.bmj.com/content/40/4/219.full
"The moral case for the clinical placebo"