Approximate Entropy of the Placebo Effect in Clinical Trials with New Generation Antidepressants

Recent research concluded that antidepressant drugs are ineffective in treating moderate or severe depression. Statistically, there are no differences between the results with active drugs or placebo. Some authors have attributed this fail to variability or irregularity of the placebo effect in depr...

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Autores principales: Cuestas, María Eloisa, Cuestas, Eduardo
Formato: Artículo revista
Lenguaje:Español
Publicado: Universidad Nacional Córdoba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología 2010
Materias:
depresión
antidepresivo
placebo
entropía aproximada
Acceso en línea:https://revistas.unc.edu.ar/index.php/med/article/view/22566
Aporte de:
Revista de la Facultad de Ciencias Médicas de Córdoba de Universidad Nacional de Córdoba
id I10-R327-article-22566
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institution Universidad Nacional de Córdoba
institution_str I-10
repository_str R-327
container_title_str Revista de la Facultad de Ciencias Médicas de Córdoba
language Español
format Artículo revista
topic depresión
antidepresivo
placebo
entropía aproximada
spellingShingle depresión
antidepresivo
placebo
entropía aproximada
Cuestas, María Eloisa
Cuestas, Eduardo
Approximate Entropy of the Placebo Effect in Clinical Trials with New Generation Antidepressants
topic_facet depresión
antidepresivo
placebo
entropía aproximada
author Cuestas, María Eloisa
Cuestas, Eduardo
author_facet Cuestas, María Eloisa
Cuestas, Eduardo
author_sort Cuestas, María Eloisa
title Approximate Entropy of the Placebo Effect in Clinical Trials with New Generation Antidepressants
title_short Approximate Entropy of the Placebo Effect in Clinical Trials with New Generation Antidepressants
title_full Approximate Entropy of the Placebo Effect in Clinical Trials with New Generation Antidepressants
title_fullStr Approximate Entropy of the Placebo Effect in Clinical Trials with New Generation Antidepressants
title_full_unstemmed Approximate Entropy of the Placebo Effect in Clinical Trials with New Generation Antidepressants
title_sort approximate entropy of the placebo effect in clinical trials with new generation antidepressants
description Recent research concluded that antidepressant drugs are ineffective in treating moderate or severe depression. Statistically, there are no differences between the results with active drugs or placebo. Some authors have attributed this fail to variability or irregularity of the placebo effect in depressed patients or artifacts induced by meta-analysis.This fact highlights the difficulties faced by the research of psychoactive drugs in depression and revives the debate about the usefulness of the employ of placebo in these studies. This study aimed to determine the variability of the placebo effect in antidepressant clinical trials in simple linear and nonlinear complex models. We performed a secondary analysis of data from 35 trials presented as evidence to the Food and Drug Administration (FDA) for approval of new generation antidepressants, all double-blind controlled with placebo in patients with unipolar mild or moderate depressive disorder, according to the criteria of "Diagnostic and Statistical Manual of Mental Disorders (DSM).Articles reviewed included 5133 patients . We have calculated the coefficient of variability, autocorrelation and approximate entropy of the placebo and treatment effects to determine whether the variability or regularity between different studies should be attributed to meta-analytical methods, placebo effect or ineffective treatment itself. The coefficient of variability in the placebo group was 26.49% and 18.81% in the treatment group. The placebo effect autocorrelation was within the confidential limits while the treatment group was outside showed cyclical variation. The approximate entropy value (ApEn N=35,m=2,R=2) in the placebo group was 0.5579 and 0.5744 in treatment group, leading to the conclusion that placebo effect is highly consistent and regular in complex non-linear models. The apparent variability of the placebo effect in depressed patients slould be due to artifacts induced by simple linear models analysis.
publisher Universidad Nacional Córdoba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología
publishDate 2010
url https://revistas.unc.edu.ar/index.php/med/article/view/22566
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spelling I10-R327-article-225662024-08-27T18:24:04Z Approximate Entropy of the Placebo Effect in Clinical Trials with New Generation Antidepressants Entropía aproximada del efecto placebo en ensayos clínicos con antidepresivos de nueva generación Cuestas, María Eloisa Cuestas, Eduardo depresión antidepresivo placebo entropía aproximada Recent research concluded that antidepressant drugs are ineffective in treating moderate or severe depression. Statistically, there are no differences between the results with active drugs or placebo. Some authors have attributed this fail to variability or irregularity of the placebo effect in depressed patients or artifacts induced by meta-analysis.This fact highlights the difficulties faced by the research of psychoactive drugs in depression and revives the debate about the usefulness of the employ of placebo in these studies. This study aimed to determine the variability of the placebo effect in antidepressant clinical trials in simple linear and nonlinear complex models. We performed a secondary analysis of data from 35 trials presented as evidence to the Food and Drug Administration (FDA) for approval of new generation antidepressants, all double-blind controlled with placebo in patients with unipolar mild or moderate depressive disorder, according to the criteria of "Diagnostic and Statistical Manual of Mental Disorders (DSM).Articles reviewed included 5133 patients . We have calculated the coefficient of variability, autocorrelation and approximate entropy of the placebo and treatment effects to determine whether the variability or regularity between different studies should be attributed to meta-analytical methods, placebo effect or ineffective treatment itself. The coefficient of variability in the placebo group was 26.49% and 18.81% in the treatment group. The placebo effect autocorrelation was within the confidential limits while the treatment group was outside showed cyclical variation. The approximate entropy value (ApEn N=35,m=2,R=2) in the placebo group was 0.5579 and 0.5744 in treatment group, leading to the conclusion that placebo effect is highly consistent and regular in complex non-linear models. The apparent variability of the placebo effect in depressed patients slould be due to artifacts induced by simple linear models analysis. Investigaciones recientes concluyeron que los antidepresivos son ineficaces para tratar las depresiones moderadas o severas. Estadísticamente, no sería diferente la mejoría que experimentan los pacientes tratados con medicamentos activos o con placebo. Algunos autores han atribuido este fracaso a la variabilidad o falta de regularidad del efecto placebo en pacientes deprimidos o a artificios inducidos por los meta-análisis. Este hecho pone de manifiesto las dificultades que enfrenta la investigación de psicofármacos en la depresión y reaviva la polémica respecto de la utilidad del empleo de placebo en esos estudios. Este trabajo tuvo por objetivo determinar la variabilidad del efecto placebo en ensayos clínicos con antidepresivos. Se realizó un análisis secundario de los datos de 35 trabajos, presentados como evidencia a la Food and Drug Administration (FDA) para la aprobación de antidepresivos de nueva generación, todos ellos a doble ciego controlados con placebo, en pacientes con trastorno depresivo unipolar leve o moderado , de acuerdo a los criterios del "Diagnostic and Statistical Manual of Mental Disorders (DSM). Los artículos revisados incluyeron 5133 pacientes. Se realizó el cálculo del coeficiente de variabilidad, autocorrelación y la entropía aproximada de los efectos placebo y tratamiento para determinar si la varibilidad o regularidad de los mismos entre los diferentes estudios debe ser imputada a los métodos meta-analíticos, al efecto placebo o a la ineficacia del tratamiento en sí. El coeficiente de variabilidad en el grupo placebo fue de 26,49% y en el tratamiento 18,81%. La autocorrelación del efecto placebo se encontró dentro de los límites confidenciales, mientras que en el grupo tratamiento presentaba variación cíclica. El valor de la entropía aproximada (EnAp N =35, m =2 , r =2) en el grupo placebo fue de 0,5579 y en el grupo tratamiento de 0,5744, lo que permite concluir que el efecto placebo es altamente constante y regular en los modelos complejos no lineales. La aparente variabilidad del efecto placebo en pacientes deprimidos se debería entonces a artificios inducidos por los análisis realizados en modelos lineales simples. Universidad Nacional Córdoba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología 2010-12-07 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion application/pdf https://revistas.unc.edu.ar/index.php/med/article/view/22566 10.31053/1853.0605.v67.n4.22566 Revista de la Facultad de Ciencias Médicas de Córdoba.; Vol. 67 No. 4 (2010); 141-149 Revista de la Facultad de Ciencias Médicas de Córdoba; Vol. 67 Núm. 4 (2010); 141-149 Revista da Faculdade de Ciências Médicas de Córdoba; v. 67 n. 4 (2010); 141-149 1853-0605 0014-6722 10.31053/1853.0605.v67.n4 spa https://revistas.unc.edu.ar/index.php/med/article/view/22566/22186 Derechos de autor 2010 Universidad Nacional de Córdoba https://creativecommons.org/licenses/by-nc/4.0

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