The Necessity of Sham Controls

A fundamental issue in biomedical research is how we prove a therapy is effective. When considering medications intended to improve objective endpoints such as mortality, the randomized, blinded, placebo control trial is the standard. There is less agreement when it comes to procedural interventions intended to improve subjective endpoints such as pain, dyspnea, or angina. Recent trials evaluating the efficacy of 2 widely accepted practices make the case that the comparison of procedural interventions with sham controls is not only ethically permissible, but should be the expected standard prior to widespread uptake.