Tuesday, January 3, 2017

A True Placebo has No Effects

Do clinical studies lie? A true placebo has no effect. Is the Gold Standard of medicine, the double blind placebo controlled trial, scientific nonsense, based on "fools gold"?

A placebo effect, is defined by Webster's dictionary as: "improvement in the condition of a patient that occurs in response to treatment but cannot be considered due to the specific treatment used".

In other words, a placebo is not caused by a placebo. If it is a true placebo, then it did not cause the placebo effect. Only false placebos can cause placebo effect.

How can this be? Aren't placebos a gold standard tool of modern medicine? Actually no. Placebos are scientific nonsense.

The best known, perhaps first, serious medical consideration of placebo effect, was written by Henry K. Beecher, M.D. with the title "The Powerful Placebo". Beecher documented many situations where a placebo, given to a patient in a clinical study, had a powerful effect. But the placebo given, by definition, could not cause the effect.

But Webster's says the effect "cannot be considered due to the specific treatment used". How can a placebo have a powerful effect, if placebo effects are not caused by the placebo?

The Oxford Dictionary attempts to provide an answer with their definition: “A beneficial effect produced by a placebo drug or treatment, which cannot be attributed to the properties of the placebo itself, and must therefore be due to the patient's belief in that treatment

This answer that has been used to support many medical research studies.

But, it's nonsense.

If placebo effect is "due to the patient's belief in the treatment",

then... if we treat the patient by modifying their belief and we successfully change the beliefs of the patient,

then...changing the patient's belief is a treatment. It's the that treatment caused "the beneficial effect" on the patient.

But, by definition, it's a real treatment, causing a real effect, not placebo treatment.

A placebo treatment cannot cause placebo effect. When a treatment causes an effect, it's not a placebo treatment. 

How can this paradox be resolved?  It's easy actually. We need to rewrite the definitions of placebo and placebo effect, with definitions that make sense.

Placebo Effect: a beneficial effect on a patient's illness, where we do not understand the cause. 

 - when we understand the cause, it is not a placebo effect.
 - when we don't understand the cause, it is placebo effect.
 - when we figure out the cause of a placebo effect, it becomes a real, known cause, and the placebo effect disappears. It's converted in to a real effect.

Placebo effects are like shadows, illusions, unknowns, caused by misunderstanding. As soon as we understand, they disappear.  They become real effects.

But... If a placebo effect is an effect where we do not understand the cause, then, what is a placebo?

Placebo: a treatment followed by a beneficial effect on the patients illness, where we do not understand the cause of the benefit.

We're not saying the placebo caused the effect.  Maybe it did.  Maybe it didn't. We don't understand.

What does this mean for the Gold Standard of medicine, the double blind, placebo controlled, clinical trial?

A double blind placebo controlled clinical trial pits a placebo against a new medicine or treatment. Sometimes, the medicine wins. Often, it's a statistical, technical draw. Once in a while, the placebo wins.

Let's look at all six cases.

Six cases? Aren't there only three possible results?  Actually no. There are six possible results for any treatment, depending on whether the treatment cures, or only makes the patient (or the doctor) feel better. When a treatment cures, the results have a different meaning.

When the Treatments cure:

1. If the cure is only produced in the medical treatment group, and never produced in the placebo treatment group, the medicine is clearly the best treatment.

2. If the cure is sometimes produced in the medical group, and sometimes in the placebo group, then - we really don't know what happened.

3. If the only the placebo treatment group produced cures, then we need to study the placebo treatment, and abandon the medical treatment.

NONE of the above situations occurs in today's clinical studies. Today's clinical studies don't cure. Almost never.  If the treatment cures, it is not necessary to test against a placebo.  Why not? There are two main reasons:

a. A cure is a cure. If we know how to cure, there is no need for a clinical study. We diagnose the disease - and prescribe the cure. The illness is cured.

b. Cured is not defined for most diseases. Cured is almost NEVER defined for clinical studies. There is no need to define 'cured' for a double blind placebo controlled clinical study. In the vast majority of clinical studies, if a cure is encountered, it is ignored. Cures are not defined for the purposes of the study, and it is assumed that any cure is not a result of the medicine being tested.

When the Treatments Don't Cure:

The clinical study might produce a beneficial effect on the patient's illness, or their symptoms of illness, (or not), but it cannot produce a cure for the illness. Most clinical studies have no intention to cure.

4. If the treatment group gained more benefit, than the placebo group, the treatment wins.

5. If a benefit results from the treatment group, and the placebo group also sees a benefit, then we really don't know what happened. This is the result of many, perhaps most, double blind, placebo controlled clinical studies.

6. If the placebo group benefits more than the treatment group - we should to pursue the placebo treatment, and discard the medical treatment.  But that never happens.  What actually happens? We dismiss the placebo treatment, and pursue a different medical treatment.

And the Winner is? 

Most, almost all placebo controlled double blind clinical studies today result in 5. The treatment group sees some benefits. The placebo group sees some benefits. We're not really sure what happened.

If the treatment group wins, the treatment heads to market.  If the placebo group wins, the results are discarded.

How can this happen? It happens because the goal of double blind placebo controlled study is to find a medicine that "does not cure" better than the placebo treatment "does not cure".

Double blind placebo controlled studies measure which treatment "does not cure better".  The result is predictably, nonsense, failure to understand.

We know that we don't know why the placebo treatment worked some of the time. But nobody cares, because they forget that a true placebo treatment has no effects.

The next time someone says "It's probably just placebo effect.", ask: 
"Was it caused by a real placebo, or a false placebo?"

to your health, tracy