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Clinical Trials and Drug Approval: Why Placebos are Essential

Placebos play an important role in clinical trials.

When I was doing my training to become a psychotherapist, we were taught that the expectation of change is a very powerful thing.  In fact, sometimes when people call to make an appointment with a psychotherapist, they feel better - before they even step into the therapist's office.  Just the expectation and the hope of feeling better can actually make us feel better.  Now there is evidence to suggest that this effect actually changes the brain's activity.   Studies show that the brain's neurochemical activity actually changes when there is a belief or expectation of treatment (Meissner et al. 2011; Beauregard, 2009).

This is why placebo double-blind studies are so important when conducting clinical trials.  Clinical trials are studies on drugs not yet approved by the FDA.  There are four phases to clinical trials, and  in phase 3, placebo double-blind studies are conducted in various clinics and hospitals.  We are looking at the safety and efficacy of the study drug.  Do the drug's benefits outweigh its side effects, and does it show effectiveness beyond that of a placebo?

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In placebo double-blind studies, both the researchers and the subject do not know if the subject is taking study medication or placebo.  (If there is a medical emergency, the researcher can receive permission to "unblind' the study subject.  That is, find out if the subject was taking medication or placebo.) (In clinical trials, participants are referred to as "subjects", and the drug we are researching is not called "medication", because it has not yet been approved by the FDA.)

Study subjects are informed at the beginning of the study what the odds are of receiving a placebo instead of the study drug.  They are also informed that the assignment of study drug or placebo is random.  Subjects are also informed that participation in the study is voluntary, and that there are other treatments available if they do not wish to participate in the study.

I'm a rater for clinical trials, and in a placebo double-blind study I have no idea if the subject is on the study drug or placebo.  This helps ensure that when I interview a study subject about their symptoms, the assessment scale results are unbiased.  Just the fact that a researcher knows someone is on the study drug may unintentionally skew the testing results one way or the other.  That's just how humans work.  The "cleaner" the study methodology, the better.  This means that the less extra stuff (or "confounding variables" that can interfere with accurate test results, the better.

While it may take a while for drugs to get approved by the FDA, there is a good reason for this.  The U.S. has one of the toughest food and drug safety administrations in the world.  And part of that is the four-phase clinical trial system, including placebo double-blind studies. 

For more information on clinical trials, see www.centerwatch.gov.

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Copyright 2012 Sarkis Media LLC



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Stephanie Sarkis, Ph.D., N.C.C., L.M.H.C., is the author of Making the Grade with ADD and ADD and Your Money. 

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