Editorials - Placebo
VIEWPOINT: Randomised controlled trials using invasive ‘placebo’ controls are unethical and should be excluded from Cochrane Reviews
- By: Allan M Cyna, David Costi & Philippa Middleton
- On: June 14, 2011, 16:37
Keywords:
Placebo controls are frequently used to ‘blind’ participants, trial personnel and outcome assessors to intervention and control in clinical trials. Effective blinding of treatment reduces the risk of performance bias (differences between groups in the care provided apart from the intervention being evaluated) and detection bias (differences between groups in how outcomes are ascertained, diagnosed or verified). A placebo has traditionally been defined as an “inert or innocuous substance”, such as a ‘sugar pill’. However, some randomised controlled trials (RCTs) have been shown to erroneously use the term ‘placebo’ to describe an invasive intervention that exposes participants, allocated to a control group, to risks of serious harm. In this context therefore, the term ‘placebo’ describes an invasive intervention which is neither inert nor innocuous ...
VIEWPOINT: Randomised controlled trials using invasive control interventions should be included in Cochrane Reviews
- By: David F Kallmes, Rachelle Buchbinder and Franklin G Miller
- On: July 05, 2011, 13:12
Keywords:
We find it fascinating that both Cyna et al. and ourselves begin at the exact same point – that is, patient protection is paramount – yet we end up at diametrically opposing views regarding the use of invasive ‘placebos’ in randomised controlled trials (RCTs). Protection of patients in clinical practice requires that we determine whether treatments are effective and offer a favourable risk-benefit ratio. This determination requires research to evaluate treatments. In doing research, we need to be concerned about two, potentially competing, considerations: (1) protection of patient-participants, and (2) scientifically sound methodology to answer clinically important research questions. We believe that, in certain circumstances, the use of an invasive procedure strictly as a control intervention in the setting of an RCT for pain palliation is not only ethical but also essential for patient protection ...
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