Placebo Effect in Clinical Trial Design for Irritable Bowel Syndrome
Journal of Neurogastroenterology and Motility
;
: 163-170, 2014.
Artigo
em Inglês
| WPRIM
| ID: wpr-87489
ABSTRACT
Ongoing efforts to improve clinical trial design in irritable bowel syndrome have been hindered by high placebo response rates and ineffective outcome measures. We assessed established strategies to minimize placebo effect as well as the various approaches to placebo effect which can affect trial design. These include genetic markers such as catechol-O-methyltransferase, opioidergic and dopaminergic neurobiologic theory, pre-cebo effect centered on expectancy theory, and side effect unblinding grounded on conditioning theory. We reviewed endpoints used in the study of IBS over the past decade including adequate relief and subjective global relief, emphasizing their weaknesses in fully evaluating the IBS condition, specifically their motility effects based on functional net value and relative benefit-harm based on dropouts due to adverse events. The focus of this review is to highlight ongoing efforts to improve clinical trial design which can lead to better outcomes in a real-world setting.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Pacientes Desistentes do Tratamento
/
Placebos
/
Catecol O-Metiltransferase
/
Marcadores Genéticos
/
Efeito Placebo
/
Avaliação de Resultados em Cuidados de Saúde
/
Síndrome do Intestino Irritável
Tipo de estudo:
Ensaio Clínico Controlado
Limite:
Humanos
Idioma:
Inglês
Revista:
Journal of Neurogastroenterology and Motility
Ano de publicação:
2014
Tipo de documento:
Artigo
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