A fascinating article from Wired magazine (http://www.wired.com/medtech/drugs/magazine/17-09/ff_placebo_effect) addresses the curious problem that the placebo effect seems to be increasing in clinical trials and has torpedoed the launch of several new medications. Any new drug coming to market needs to demonstrate significant efficacy compared to a "dummy" pill, or placebo. Recently new "blockbuster" medications ranging from anti-depressants, to Parkinson medications, to medications for Crohn's disease have been shown to be effective, but not as effective as placebo, so have had to be pulled. Even Prozac, the work horse of mood enhancers, has not shown effectiveness compared to placebo in recent clinical studies.
The NIH and Big Pharma alike are (finally) looking into the science of placebos, though Big Pharma is reluctant to pay for the studies (natch.)
"Ironically, Big Pharma's attempt to dominate the central nervous system has ended up revealing how powerful the brain really is. The placebo response doesn't care if the catalyst for healing is a triumph of pharmacology, a compassionate therapist, or a syringe of salt water. All it requires is a reasonable expectation of getting better. That's potent medicine."
I actually had the opportunity to speak to the author of this article on a recent radio call-in talk show to discuss how the keen attention paid to placebo effect in acupuncture research is glaringly absent from surgery research. Surgeries are often compared to other surgeries or conservative treatment, but rarely are "sham" surgeries performed. see posts http://ksparrowmd.blogspot.com/2009/08/another-popular-back-procedure-found-to.html and http://ksparrowmd.blogspot.com/2009/04/believing-in-treatments-that-dont-work.html
He reminded me of the open heart procedure called Mammary Artery Ligation which had finally been debunked. But that is one of very few surgical procedures that have been subjected to any sort of even handed scrutiny. I would add that open heart surgery has to be one of the most powerful, ritualistic procedures performed in medicine and must have extremely powerful placebo properties.
My interest in this topic is because of my involvement in acupuncture research, but I also am interested in therapies that don't fit the medical model and are therefore unexplained. The Western Medical Model is phenomenally valuable, but it does have its limits and there is a tyranny of the mechanistically rational when it comes to alternatives. I also think that the placebo effect is the ultimate testament to the power of "mind-body" medicine. I think it is high time that it should be studied and hopefully harnessed, not ridiculed.
I, personally, have no interest in handing out placebos for a living, but studying what is happening physiologically interests me no end.
P.S.
I happened on another article from Wired about the effectivenes of sham acupuncture for back pain. http://www.wired.com/wiredscience/2007/09/for-back-pain-e/ Even sham acupuncture worked better than physical therapy or medications, as the NHS in Britain is now acting on.
Showing posts with label sham surgery. Show all posts
Showing posts with label sham surgery. Show all posts
Tuesday, September 8, 2009
Monday, August 24, 2009
Another Popular Back Procedure found to be ineffective
The Mayo clinic has found that using medical cement to fix cracks in the brittle vertebrae of elderly people is no better than placebo. The reason that this article is of interest to me is that it fits in the category of things that make sense from a Western Medicine point of view, and so are enthusiastically performed even though there is no evidence for efficacy. Or as my blog post of 4.2.09 was titled, "Believing in Treatments that Don't Work." Given the rigorous standards for acupuncture research, the use of sham needles, sham placement or even (ridiculously) trying to control for the practitioner interaction, it is nice to see the Mayo clinic applying the same rigor to a "logical," popular, western medical procedure.
They go on to say at the end of article that the "miraculous" recoveries seen could be due to the anesthesia, placebo, or the fractures healed on their own. The anesthesia in this case was local anesthesia, so it is possible that the needling helped.
I am the first to admit that there are mysteries in the healing process and that placebo can play a large roll in any therapy, including acupuncture. But Western Medical procedures should be treated with the same level of skepticism as acupuncture is, if not more, since they are often more dangerous and almost always much more expensive. A quick search to determine how much the back cement treatment costs shows that it it runs $526-558 for the first level and then $236 for each level after that. That doesn't include the anesthesia or recovery room fees etc... In addition, particularly with the drama of surgical procedures the placebo effect has the potential to be quite powerful indeed.
http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2009/08/06/MNN9194H2O.DTL
Cement for backs ineffective from San Francisco Chronicle,
Stephanie Nano, Associated Press
Thursday, August 6, 2009
A common treatment that uses medical cement to fix cracks in the spinal bones of elderly people worked no better than a sham treatment, the first rigorous studies of the popular procedure reveal.
Pain and disability were virtually the same up to six months later, whether patients had a real treatment or a fake one.
Tens of thousands of Americans each year are treated with bone cement, especially older women with osteoporosis, some of them stooped and unable to stand up straight. The treatment is so widely believed to work that the researchers had a hard time getting patients to take part when it was explained that half of them would not get the real thing...
"All of us who do the procedure have seen apparently miraculous cures," said Dr. David F. Kallmes, a radiologist at the Mayo Clinic who led one of the studies. But he said there were also "miraculous cures" among those who got the fake treatments.
Bone cement has long been approved for many medical uses, but this particular use had not been tested.
The findings, published in today's New England Journal of Medicine, mean patients and doctors need to review the options together, wrote Dr. James N. Weinstein of Dartmouth Medical School in an accompanying editorial. "When best evidence suggests a tossup between treatment options and no benefit, informed patient choice is essential," he said.
The researchers do not know why people felt better, but suggest it could be due to the anesthesia, the placebo effect or that the fractures healed on their own over time.
They go on to say at the end of article that the "miraculous" recoveries seen could be due to the anesthesia, placebo, or the fractures healed on their own. The anesthesia in this case was local anesthesia, so it is possible that the needling helped.
I am the first to admit that there are mysteries in the healing process and that placebo can play a large roll in any therapy, including acupuncture. But Western Medical procedures should be treated with the same level of skepticism as acupuncture is, if not more, since they are often more dangerous and almost always much more expensive. A quick search to determine how much the back cement treatment costs shows that it it runs $526-558 for the first level and then $236 for each level after that. That doesn't include the anesthesia or recovery room fees etc... In addition, particularly with the drama of surgical procedures the placebo effect has the potential to be quite powerful indeed.
http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2009/08/06/MNN9194H2O.DTL
Cement for backs ineffective from San Francisco Chronicle,
Stephanie Nano, Associated Press
Thursday, August 6, 2009
A common treatment that uses medical cement to fix cracks in the spinal bones of elderly people worked no better than a sham treatment, the first rigorous studies of the popular procedure reveal.
Pain and disability were virtually the same up to six months later, whether patients had a real treatment or a fake one.
Tens of thousands of Americans each year are treated with bone cement, especially older women with osteoporosis, some of them stooped and unable to stand up straight. The treatment is so widely believed to work that the researchers had a hard time getting patients to take part when it was explained that half of them would not get the real thing...
"All of us who do the procedure have seen apparently miraculous cures," said Dr. David F. Kallmes, a radiologist at the Mayo Clinic who led one of the studies. But he said there were also "miraculous cures" among those who got the fake treatments.
Bone cement has long been approved for many medical uses, but this particular use had not been tested.
The findings, published in today's New England Journal of Medicine, mean patients and doctors need to review the options together, wrote Dr. James N. Weinstein of Dartmouth Medical School in an accompanying editorial. "When best evidence suggests a tossup between treatment options and no benefit, informed patient choice is essential," he said.
The researchers do not know why people felt better, but suggest it could be due to the anesthesia, the placebo effect or that the fractures healed on their own over time.
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