Individualization; Double-blind controlled studies

Double-blind controlled studies

Placebo-controlled studies are limited in value.

What’s up with the gold standard of “evidence-based” medicine’s insistence on double-blind controlled studies? Well, the origin of this method came from difficulties of doing science when there are too many variables. The concept is that if all variables can be cancelled out statistically except one, then the outcome measures only the effect of that one variable. Also, in medicine we always have to consider placebo effect, which can often be very effective. So methodology was developed in which neither the investigator nor the experimental subject know what is in the pill that is given. Half of them get nothing in an identical-appearing pill. Then, results are studied statistically to see if there is difference between the experimental group and the placebo group.

An interesting fact is that over the decades that such studies have been done, placebo reactions have risen from around 15% to now around 40%. To my knowledge, we don’t know why this is. But it does pose a problem for interpreting results.

Another interesting fact in science at large is that reproducibility of results changes over time. Reproducibility is important in case there is hidden bias in a study. Science insists that other laboratories follow detailed instructions in the original paper to see if results can be duplicated. Typically, at first this seems to work. But a major puzzle these days is why attempts to duplicate results become unreliable over time. I cannot explain this either, but it is a concern for “evidence-based” science.

For me, the most important problem with such studies happens when I am face-to-face with a patient. Almost never would my patient even qualify to be included in one of these studies because they have multiple complaints. One individual may have diabetes and high blood pressure and anxiety arising out of bullying in elementary school. How does controlling one parameter inform us of what would be true of this individual?

Moreover, even if we were to decide on a particular drug for our patient, there is a great deal of individual variation in sensitivity. One person does fine; the next has an adverse reaction.

It is true that medicine is creeping slowly toward individualization. Genomic testing helps to sort out unique tendencies to medications and illnesses. This is a positive direction, but still is not truly looking at the whole individual in terms of personality, background, attitudes, etc.

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