Shankar Vedantam did a thought provoking “Hidden Brain” podcast on the placebo effect.
Franz Mesmer is the godfather of the placebo effect. He created a lot of “atmosphere” around his sugar pills and since then, the public perception is that the placebo effect is a “New Age” phenomenon and it involves deception. But there is a lot of science behind the placebo effect.
Placebo controlled drug trials are the norm. Placebo has a strong effect, esp. in trials involving obesity, GERD and pain. There is a higher placebo effect in percutaneous and endoscopic procedures compared to classic surgical procedures.
Hróbjartsson makes a strong counterpoint to the placebo effect in the New England Journal : “We did not detect a significant effect of placebo as compared with no treatment in pooled data from trials with subjective or objective binary or continuous objective outcomes. We did, however, find a significant difference between placebo and no treatment in trials with continuous subjective outcomes and in trials involving the treatment of pain”
Surgical placebo trials or “sham surgery” is more difficult and controversial to perform.
Sham surgery or invasive procedures have to contend with the 1947 Nuremberg Code that states : “all research should avoid any unnecessary physical or mental suffering, and the degree of risk to be taken should never exceed the humanitarian importance of the problem to be solved by the experiment.” The 1964 Helsinki declaration goes further to state that the “concern for the interests of the subject must always prevail over the interests of society and science.”
Surgery with sham controls that showed no benefit: Moseley published a groundbreaking study in the New England Journal re. arthroscopic knee surgery for osteoarthritis.
Surgery with sham control that showed benefit in the study arm: Freed’s study in the New England Journal re. transplantation of embryonic dopamine neurons for severe Parkinson’s disease.
But the above 2 examples presuppose that placebo is worthless and similar to no treatment. Is this truly the case?
Open label placebo trials blow this concept out of the water.
Open label placebo is where the patient is fully aware that they are taking a placebo. Here are 2 trials of open label placebo involving irritable bowel syndrome and cancer related pain.
Now the controversial part re. AFIB ablation. I am an electrophysiologist. I perform ablations for a living. I am on my way to San Francisco for the Heart Rhythm Society 2019 Annual Scientific Sessions. At this meeting I will listen to experts argue why their “secret sauce” ablation is better than the next person’s secret sauce. I believe that atrial fibrillation ablation works and I have several hundred patients who have had excellent response to ablation and swear by it. But science is not the same as belief, anecdote and experience. John Mandrola, MD wrote an article regarding this very issue in Medscape in 2016. He asked whether the success of AFIB ablation is a Pygmalion effect on part of the doctors and the patients. He was skewered by the electrophysiology community because of this article. But Mandrola is correct in that while AFIB ablation has been compared to drugs or no treatment, it has never been compared to sham ablation.
I am not prepared to take sides. But I do believe that a randomized controlled trial comparing AFIB ablation to sham ablation is necessary.
There are others in the EP community like Brian Olshansky who support this notion.