Assessing the risk of a necessary harm

Abstract

Within the past two decades, there has been renewed interest in novel surgical approaches for the treatment of Parkinson disease (PD). A fundamental question is then to define how to evaluate these techniques before incorporating them into medical practice. Randomized controlled trials (RCTs) remain the accepted standard for testing treatment efficacy and are routinely used to evaluate novel medical therapies. Using placebo in RCTs controls for the placebo effect and investigator bias. However, the ethical aspects of the use of placebo controls are a matter of debate.1,2 This is particularly true for surgery because sham surgery uses an invasive procedure as a placebo control, insulting the integrity of the human body and posing substantial risks to subjects assigned to the control group. Placebo surgery is thus considered by many surgeons and bioethicists to be inherently or presumptively unethical, violating the fundamental principles of beneficence and nonmaleficence. Consequently, novel surgical procedures are frequently introduced into clinical practice without reliable objective evaluation, with the risk of becoming part of standard medical practice to be subsequently abandoned after better evaluation. A recent illustration is arthroscopic surgery, having been widely used to relieve pain from arthritis of the knee despite lacking …