Centre for the Philosophy of Natural; and Social Science Contingency and Dissent in Science Technical Report 03/08 Double-Blinding: The Benefits and Risks of Being in the Dark

The feature of being “double blind”, where neither patients nor physicians are aware of who receives the experimental treatment, is almost universally trumpeted as being a virtue of clinical trials. Hence, trials that fail to remain successfully double blind are regarded as providing inferior evidential support. The rationale for this view is unobjectionable: double blinding rules out the potential confounding influences of patient and physician beliefs. Nonetheless, viewing double blind trial as necessarily superior is problematic. For one, it leads to the paradox that very effective experimental treatments will not be supportable by best evidence. If a new drug were to make even the most severe symptoms of the common cold disappear within seconds, most participants and investigators would correctly identify it as the latest wonder drug and not the control (i.e. placebo) treatment. Any trial testing the effectiveness of this wonder drug will therefore fail to remain double blind. Similar problems arise for treatments, such as exercise and most surgical techniques, whose nature makes them resistant to being tested in double blind conditions. It seems strange that an account of evidence should make a priori judgments that certain claims can never be supported by ‘best evidence’. It would be different if the claims at issue were pseudoscientific – untestable. But so far as treatments with large effects go, the claim that they are effective is highly testable and intuitively they should receive greater support from the evidence than do claims about treatments with moderate effects. In this paper I argue that the two potential confounders ruled out by double blinding are not actual confounders outside placebo controlled trials of treatments with mild effects and that have subjective outcome measures. The patient, treated on the fashionable theory, sometimes gets well in spite of the medicine. The medicine therefore restored him, and the young doctor received new courage to proceed in his bold experiments on the lives of his fellow creatures” Thomas Jefferson, letter to Dr. Caspar Wistar many investigators and readers delineate a randomized trial as high quality if it is “double-blind,” as if double-blinding is the sine qua non of a randomized controlled trial. ... A randomized trial, however, can be methodologically sound ... and not be double-blind or, conversely, double-blind and not methodologically sound. Schulz, Chalmers, and Altman (2002) ∗ Department of Public Health and Primary Care, University of Oxford