Farmacoriflessioni
Ti piace vincere facile? Ovvero, del placebo non ne posso più
Impariamo a pretendere un confronto adeguato
PLACEBO OR NOT PLACEBO?
STEFANO MICELI SOPO
Dipartimento di Scienze Pediatriche, Policlinico A. Gemelli, Università Cattolica del Sacro Cuore, Roma
Giugno 2006 - pagg. 372 -376
Abstract
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.
Classificazione MeSH
Bibliografia
1. Miceli Sopo S. L’immunoterapia specifica per
via sublinguale (SLIT) può essere d’aiuto nei
bambini con asma persistente mal controllato
dalla terapia farmacologica di fondo? Area Pediatrica
2006;3:41-4.
2. Simons FE, Villa JR, Lee BW, et al. Montelukast added to budesonide in children with persistent asthma: A randomized, double-blind, crossover study. J Pediatr 2001;138:694-8.
3. Phipatanakul W, Greene C, Downes SJ, et al. Montelukast improves asthma control in asthmatic children maintained on inhaled corticosteroids. Ann Allergy Asthma Immunol. 2003; 91:49-54.
4. Reitamo S, Van Leent EJ, Ho V, et al. and European/ Canadian Tacrolimus Ointment Study Group. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone acetate ointment in children with atopic dermatitis. J Allergy Clin Immunol 2002;109:539- 46.
5. Reitamo S, Harper J, Bos JD, et al. and European Tacrolimus Ointment Group. 0.03% Tacrolimus ointment applied once or twice daily is more efficacious than 1% hydrocortisone acetate in children with moderate to severe atopic dermatitis: results of a randomized doubleblind controlled trial. Br J Dermatol 2004;150: 554-62.
6. Friedlander SF, Hebert AA, Allen DB and Fluticasone Pediatrics Safety Study Group. Safety of fluticasone propionate cream 0.05% for the treatment of severe and extensive atopic dermatitis in children as young as 3 months. J Am Acad Dermatol 2002;46:387-93.
7. Calvani M, Cardinale F, Martelli A, Muraro A, Pucci N, Savino F. Dermatite atopica e allergia alimentare. Rivista di Immunologia e Allergologia Pediatrica (RIAP) 2006;2;7-22.
8. Darsow U, Lubbe J, Taieb A, et al. and European Task Force on Atopic Dermatitis. Position paper on diagnosis and treatment of atopic dermatitis. J Eur Acad Dermatol Vener 2005;19: 286-95.
9. Leung DYM, Nicklas RA, Li JT, et al. Disease management of atopic dermatitis: an updated practice parameter. Ann Allergy Asthma Immunol 2004;93 (3 Suppl 2):S1-21.
10. FDA Issues Public Health Advisory Informing Health Care Providers of Safety Concerns Associated with the Use of Two Eczema Drugs, Elidel and Protopic. http://www.fda. gov/bbs/topics/ANSWERS/2005/ANS01343. html.
2. Simons FE, Villa JR, Lee BW, et al. Montelukast added to budesonide in children with persistent asthma: A randomized, double-blind, crossover study. J Pediatr 2001;138:694-8.
3. Phipatanakul W, Greene C, Downes SJ, et al. Montelukast improves asthma control in asthmatic children maintained on inhaled corticosteroids. Ann Allergy Asthma Immunol. 2003; 91:49-54.
4. Reitamo S, Van Leent EJ, Ho V, et al. and European/ Canadian Tacrolimus Ointment Study Group. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone acetate ointment in children with atopic dermatitis. J Allergy Clin Immunol 2002;109:539- 46.
5. Reitamo S, Harper J, Bos JD, et al. and European Tacrolimus Ointment Group. 0.03% Tacrolimus ointment applied once or twice daily is more efficacious than 1% hydrocortisone acetate in children with moderate to severe atopic dermatitis: results of a randomized doubleblind controlled trial. Br J Dermatol 2004;150: 554-62.
6. Friedlander SF, Hebert AA, Allen DB and Fluticasone Pediatrics Safety Study Group. Safety of fluticasone propionate cream 0.05% for the treatment of severe and extensive atopic dermatitis in children as young as 3 months. J Am Acad Dermatol 2002;46:387-93.
7. Calvani M, Cardinale F, Martelli A, Muraro A, Pucci N, Savino F. Dermatite atopica e allergia alimentare. Rivista di Immunologia e Allergologia Pediatrica (RIAP) 2006;2;7-22.
8. Darsow U, Lubbe J, Taieb A, et al. and European Task Force on Atopic Dermatitis. Position paper on diagnosis and treatment of atopic dermatitis. J Eur Acad Dermatol Vener 2005;19: 286-95.
9. Leung DYM, Nicklas RA, Li JT, et al. Disease management of atopic dermatitis: an updated practice parameter. Ann Allergy Asthma Immunol 2004;93 (3 Suppl 2):S1-21.
10. FDA Issues Public Health Advisory Informing Health Care Providers of Safety Concerns Associated with the Use of Two Eczema Drugs, Elidel and Protopic. http://www.fda. gov/bbs/topics/ANSWERS/2005/ANS01343. html.
Corrispondenza: stefano.micelisopo@poste.it