Exploring the use of the sham design for interventional trials: implications for endoscopic research
2007; Elsevier BV; Volume: 67; Issue: 1 Linguagem: Inglês
10.1016/j.gie.2007.09.003
ISSN1097-6779
Autores Tópico(s)Pain Management and Placebo Effect
ResumoRandomized controlled trials (RCTs) have become the gold standard for quality. Drug trials typically evaluate efficacy by comparison of the new drug with an inert agent or less frequently an “active” placebo. In these situations, it is important that the placebo look and taste similar to the comparator and have no side effects such that blinding is not compromised. In contrast to these study designs, how do you design a trial evaluating the efficacy of interventions such as surgery or endoscopy? How can you blind here? What group(s) do you use to compare with those receiving the real intervention? The comparator group in such studies may be even more important than with medication trials given the possibility of an enhanced “placebo” effect from any intervention. Indeed, a recent study showed that placebo analgesia was associated with reduction in brain activation as measured by functional magnetic resonance imaging (MRI). 1 Price D.D. Craggs J. Verne G.N. et al. Placebo analgesia is accompanied by large reductions in pain-related brain activity in irritable bowel syndrome patients. Pain. 2007; 127: 63-72 Abstract Full Text Full Text PDF PubMed Scopus (228) Google Scholar
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