RT Journal
A1 Dowrick, Adam S.
A1 Bhandari, Mohit
T1 Ethical Issues in the Design of Randomized Trials: To Sham or Not to Sham
JF The Journal of Bone & Joint Surgery
JO The Journal of Bone & Joint Surgery
YR 2012
FD July 18
VO 94
IS Suppl 1(E)
SP 7
OP 10
DO 10.2106/JBJS.L.00298
UL http://dx.doi.org/10.2106/JBJS.L.00298
AB Abstract: 
  The placebo effect is based on the expectations of the patient regarding the effectiveness of the treatment. The high levels of stress and rituals involved with surgery can lead to a strong placebo effect. However, the ethical principles of performing sham surgery to measure any placebo effect have been questioned, and sham-controlled surgical trials are rarely conducted. While there are a number of ethical principles that must be considered to justify the implementation of a sham-controlled surgical clinical trial, four areas deserve particular attention: equipoise, risk minimization, informed consent, and deception. Particularly in orthopaedics, where equipoise is common, sham-controlled trials may be important to ensure that inferior or ineffective treatments do not become standard practice.