In this edition of Riding in Cars with Researchers, we are discussing the use of placebos. Why do we use placebos in clinical research trials? If I should be treating you with something else, it is unethical and malpractice not to. That is where the misconception stems. People think that they should be on something, then it’s really scary if they are randomized to a placebo, and it sounds unethical.
The first way placebos are used is in a double-blind or double dummy. The standard in research today is double-blind, meaning you don’t know what you got randomized to, nor do I. That is so we are not able to introduce bias into the study. If I know what you got randomized to, I may actually treat you a little different, even subconsciously. If I treat you differently, that actually bleeds into the data and becomes an influence on what the data looks like. We want to minimize that as much as possible, so we do a double-blind.
For example, let’s make up a study where we are using two antibiotic pills. One antibiotic is a small white pill and one is a large blue pill. In order to maintain the blind, we do what is called a double dummy. There are actually two placebos. There is a small white antibiotic pill and a placebo small white antibiotic pill. Similarly, there is an active large blue antibiotic pill and a placebo large blue antibiotic pill. If you are randomized to the active white antibiotic pill, you will also receive a placebo blue antibiotic pill. And vice versa. So in a study with two placebos, everybody gets what is believed to be an active therapy, not just a placebo. Nobody is ever randomized to only a placebo because with antibiotics it would be unethical for you to have an infection and for us to not treat you. So reason #1 that you would receive a placebo is only to protect the blind, but you don’t only receive the placebo.
The second way placebos are used is when there is no comparative. If I invent the cure for cancer today, there is no existing cure, so there is nothing to compare it to. For instance, one example is non-alcoholic steatohepatitis. This is an active area of research today and there is nothing to compare it to. So in those trials, patients can be randomized into placebo because there is no ability to have a comparative – nothing else exists. So reason #2 that you end up with a placebo is if there is nothing to compare it to.
The 3rd and final reason we use placebo is when the standard of care is not to treat. For example, most patients with mild acne don’t receive therapy. Most simply wash their face, don’t touch their face and that is the area of care standard. So if we designed an acne trial where everyone in it is guaranteed to be on an antibiotic, we would actually be over-treating some patients by treating them with an antibiotic that normal standard of care would not prescribe. So those patients can be randomized to the normal standard of care, which is to do nothing. So the 3rd reason for placebos is when there is no existing treatment or therapy.
The fundamental point is if we should be treating you with something, we will. It is unethical and malpractice not to do so. If something changes in the middle of the trial, we will let you know and change our course of treatment.
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