What is a Placebo and Why They are Used in Clinical Trials

placebo effect in clinical trials

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The placebo effect

A placebo can be defined as harmless pill, medicine, treatment, or procedure that is given to a patient or a subject for more of a psychological benefit than for a physical effect. The placebo effect is generally used as a control substance so that the researchers can test outcomes of a therapeutic effect versus no therapeutic effect.

A subject is given a pill or a treatment and they are not told if it contains the active treatment or not. This way the clinical trial can determine if it was the real treatment that worked or if it was simply the placebo effect and the psychological aspect of taking something that made the subject think it worked.

How is the placebo effect used in clinical trials

Once a participant has been informed of all aspects of the study, and they have signed an informed consent form agreeing to participate in the study, the best studies blindly place them into one of two groups. The first group is a control group and the second group is the experimentation group.

If a study is a randomized clinical trial, and it is looking at the effectiveness of a medication, the control group will be given a “sugar pill” or a capsule with no active ingredient in it. The experimental group will get the pill with the active ingredients they are trying to test.

This way, if the experimental treatment that was being studied in the one group demonstrated great results, but the group that did not get the treatment (or the control group) did not get great results, it can be concluded that the experimental treatment may be the cause for the positive outcomes.

Sometimes, none of the participants in the study know whether they are taking the active or inactive (placebo) treatment. On occasion, not even the people running the study know (this is called a double-blind test). 

Why is a placebo necessary

It is still not completely understood how placebos work, but there are several theories as to why they work and why they are necessary. Most of the theories center around the psychological aspect of the effects.

One of the theories as to why placebos work is self-limiting disorders. Many conditions like a headache or a common cold will resolve themselves eventually with or without medication or a placebo. The end of the symptoms is merely a coincidence.

Remission is another theory, where the symptoms of some disorders, such as lupus or Multiple Sclerosis just come and go. A remission is a period of time when the symptoms go away, but during a course of placebos it may be coincidence, and not due to the placebos at all.

Change in behavior could be the cause as well. The placebo could increase a person’s drive and desire to take better care of themselves. Improving one’s diet, exercise, and way of life may be the cause for improvement in results.

A subject’s altered perception could be the reason for positive outcomes too. The person’s interpretation of their symptoms might improve with the expectation of feeling better after having taken a placebo pill. For example, the subject might interpret a sharp pain as now simply an uncomfortable tingling instead due to being given a treatment.

Taking the placebo may also reduce one’s anxiety. A subject may expect to feel better, and taking the treatment may be soothing and reduce the levels of chemicals in the body associated with stress.

Whatever the reason that these placebos work, the mere thought that they may produce positive outcomes is the main reason placebo treatment is needed. Every subject in the study must believe the treatment they are receiving will work.

Summary

In summary placebos have been used in clinical trials for quite some time. Placebos are used to help test the effectiveness of treatments in healthcare.

For moral and ethical reasons, subjects participating in these clinical trials are made aware that they may be given a ‘dummy’ or ‘false’ treatment.

For more information on aspects of clinical trials like the placebo effect, check out the blog at Stan’s Gigs Blog.

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