PLACEBO OR NOT PLACEBO?

Key words: Evidence Based Medicine, Placebo, Statistical significance

Every day we read about the efficacy, both pharmacological and non, of a given treatment. The Evidence Based Medicine has taught us to appreciate the methodologic value of the studies we read, and we have learned it. However, an aspect which should not be neglected is the clinical relevance of any result. The statistical significance of a result is clearly a fundamental factor in choosing a new treatment. But it is not enough. The difference must be not only statistically significant, but also clinically relevant: the treatment must lead to consistent benefices, perceivable by the doctor and the patient, and visible every day or almost. The benefices of a new treatment must be evaluated through an adequate confrontation. That is with placebo, if for a given disease there is no accepted treatment. But, if for a given disease a codified and accepted treatment (the “Gold Standard”) exists, the confrontation must be conducted with the codified treatment. The question we have to answer is in fact what are the advantages of the new treatment, if compared to the traditional one? The Author quotes two examples of this problem, related to the use of antileukotriens in asthma and of tacrolimus in atopic dermatitis.