RESUMEN
Colchicine is a treatment for gout that has been used for more than a millennium. It is the treatment of choice for familial Mediterranean fever and its associated complication, amyloidosis. The 2009 U.S. Food and Drug Administration approval of colchicine as a new drug had research consequences. Recent investigations with large cohorts of patients with gout who have been taking colchicine for years have demonstrated novel applications within oncology, immunology, cardiology and dermatology. Some emerging dermatological uses include the treatment of epidermolysis bullosa acquisita, leucocytoclastic vasculitis, aphthous stomatitis and others. In this work we relate the history and the new horizon of this ancient medicine.
Asunto(s)
Colchicina/uso terapéutico , Fármacos Dermatológicos/uso terapéutico , Supresores de la Gota/uso terapéutico , Moduladores de Tubulina/uso terapéutico , Colchicina/historia , Colchicina/farmacología , Fiebre Mediterránea Familiar/tratamiento farmacológico , Gota/tratamiento farmacológico , Gota/historia , Supresores de la Gota/historia , Supresores de la Gota/farmacología , Historia del Siglo XIX , Historia del Siglo XXI , Historia Antigua , Humanos , Enfermedades Reumáticas/tratamiento farmacológico , Enfermedades de la Piel/tratamiento farmacológico , Estomatitis Aftosa/tratamiento farmacológico , Moduladores de Tubulina/farmacologíaAsunto(s)
Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Artefactos , Medicina Clínica/estadística & datos numéricos , Humanos , Selección de Paciente , Fisiología/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Investigación/estadística & datos numéricos , Tamaño de la MuestraRESUMEN
PURPOSE: To identify methodological features that affect the validity of conclusions drawn from active-control equivalence trials and to apply these criteria to recently published trials comparing antihypertensive agents from different classes. METHODS: Standard methodological criteria for randomized clinical trials and six additional methodological features that affect the validity of active-control equivalence trials were applied to four recently published large trials that compared different antihypertensive classes and that concluded that their results showed equivalence. RESULTS: All four of these trials fulfilled standard criteria for randomized trials. However, none fulfilled all of the six additional methodological criteria that affect the validity of active-control equivalence trials, one fulfilled five criteria, two fulfilled two criteria, and one failed to fulfill any of the criteria. CONCLUSION: Standard methodological criteria for evaluating superiority trials are inadequate for the interpretation of active-control equivalence trials. The methodological criteria outlined in this article for judging the validity of active-control equivalence trials are not specific to antihypertensive trials and may be applied to trials that test a wide variety of interventions.