What is a Placebo? At the Heart of Randomized Controlled Clinical Trials
As a prospective clinical trial participant, we at TrialX.com always recommend you to get informed of all the technical jargon commonly used to describe a clinical trial or research study. “Placebo” is one such term that you MUST be aware of; hence, through this post (a part of the clinical trial primer series), “what is a placebo?” we attempt at demystifying this term for you.
A placebo is basically a dummy medication which may be defined as an inactive sweetener based pill, syrup, or powder that has no pharmacological treatment value (meaning it is not intended to have any effect on any aspect of the body’s functions).
So if a Placebo has “No treatment value,” you may be wondering, why is it then used in a clinical trial? In certain types of clinical research studies (called randomized clinical trials), the researchers divide the participants into 2 (or more ) groups called a control group and an experimental group. The experimental group is administered the study treatment or medication, whereas the control group is administered with a placebo that is designed to look as similar to the “real medication” as possible. This is done because the researchers dont want the participants in the experimental group to know which group they belong to by just looking at the medication (this is called blinding the participants to the treatment group). This is done because knowing which group you belong to can bias one into thinking that they are actually benefiting (or not benefiting) from the study treatment. At times, just the perception of receiving a better treatment can result in improvement in the medical condition of the patient (it is speculated that this perception could be because of the release of certain hormones called as endorphins). By having a placebo or control group, the researchers aim at nullifying this effect. Additionally, the researchers by using the placebo, can get good comparative data of the effectiveness of the medication per-se when everything else is kept similar between the two groups.
What if I receive a placebo and my condition worsens due to lack of treatment: Firstly, there are strict rules that disallow placebos to be used in life threatening conditions like cancer, AIDS, etc.; placebos are always used in clinical trials studying conditions with less serious implications. Even in these research studies, to safeguard the well being of the participants, the clinicians have to be ready with a treatment protocol called as “rescue medication.” In case, at any point of time during the clinical trial, the doctors find that the condition of a participant is worsening, then the person is immediately withdrawn from the clinical trial and started off on a course of rescue medication – the standard form of treatment presently available for the said condition. This treatment is always provided free of cost and neither you nor your insurance company is charged for any of these expenses.
However, be assured that such extreme situations rarely occur and several placebo controlled studies have been successfully conducted wherein the patients receiving placebo never realized that they did not get the real drug and their condition was not adversely affected either.
Thus, placebos, though just a dummy, play an important in ascertaining the effectiveness of the experimental treatment.