Difference between placebo and control

It's about creating a stronger connection between the brain and body and how they work together," says Professor Ted Kaptchuk of Harvard-affiliated Beth Israel Deaconess Medical Center, whose research focuses on the placebo effect.

Placebos won't lower your cholesterol or shrink a tumor. Instead, placebos work on symptoms modulated by the brain, like the perception of pain. For years, a placebo effect was considered a sign of failure. A placebo is used in clinical trials to test the effectiveness of treatments and is most often used in drug studies. For instance, people in one group get the actual drug, while the others receive an inactive drug, or placebo.

This way, the researchers can measure if the drug works by comparing how both groups react. If they both have the same reaction — improvement or not — the drug is deemed not to work. More recently, however, experts have concluded that reacting to a placebo is not proof that a certain treatment doesn't work, but rather that another, non-pharmacological mechanism may be present.

How placebos work is still not quite understood, but it involves a complex neurobiological reaction that includes everything from increases in feel-good neurotransmitters, like endorphins and dopamine , to greater activity in certain brain regions linked to moods, emotional reactions, and self-awareness.

All of it can have therapeutic benefit. But placebos are not all about releasing brainpower. You also need the ritual of treatment. You receive all kinds of exotic pills and undergo strange procedures. In a double-blind trial, neither the researchers nor the research participants know who is getting active medication and who is getting placebo. A monitoring group not involved in the study randomly assigns patients to one group or the other, and keeps track of the group assignments during the trial.

In contrast, in an open-label trial, both researchers and patients know the patient is receiving an active treatment. The placebo effect refers to the tendency all of us have to feel better for a while when we think we are receiving a treatment that will help us. The placebo effect can occur when the treatment is actually helping, or when it is doing nothing, or when it is actually harming us. So, why use placebos in a trial for a disease as serious as ALS?

This is true for several important reasons: Because no one knows if they are receiving active treatment, the chances are reduced that any benefit seen will be due to the placebo effect. People with ALS are a diverse group. One important way in which they differ is in the speed of progression of their illness: some people progress slowly, while others, unfortunately, progress more quickly.

By randomly assigning subjects to active treatment and placebo groups, that diversity is spread equally between the groups. This increases the chances that any benefit seen will be due to differences in treatment, rather than differences in the patients in each group. The fastest way to develop new treatments for all people with ALS, is to test new drugs in studies designed to give the answer quickly and without doubt. Currently, this is only possible by comparing the active treatment new therapy with a placebo.

Two recent ALS clinical trials show how important double-blind, placebo-controlled trials are in weeding out ineffective treatments. An open-label trial of lithium in a small number of patients suggested this drug helped slow the disease. But a larger, placebo-controlled, double-blind trial found no effect. Without that trial, many ALS patients may have gone on to take a useless medication.

Animal studies and open-label human trials suggested the antibiotic minocycline was beneficial. But a larger, placebo-controlled trial showed it was not, and may even have been harmful. Without that larger trial, patients may have continued taking minocycline, causing harmful effects without helping their disease. Only with placebo-controlled trials could these two treatments be ruled out as ineffective in ALS, saving patients from taking medicines that offer no benefit and that could even be dangerous.

An important point to remember is that experimental drugs are indeed experimental. That means that the drug can have a positive effect, no effect at all, or be detrimental. It is sometimes difficult to keep in mind that a patient on a placebo may actually be getting better treatment than someone on the active medication. A trial with a negative result is very disappointing to both participants and study organizers.

But every trial teaches us something valuable and makes subsequent trials more likely to succeed. The disappointment of negative trial results such as these only strengthens our commitment to finding truly beneficial treatments for ALS.

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