Sham surgery: justified but practical? A systematic review of sham surgery trials in orthopaedics

Sham Surgery in Orthopedics: A Systematic Review of the Literature.

Objective To evaluate the evidence for the effectiveness of sham surgery in orthopedics by conducting a systematic review of literature. Methods Systematic searches were conducted on Biomed Central, BMJ.com, CINAHL, the Cochrane Library, NLM Central Gateway, OVID, ProQuest (Digital Dissertations), PsycInfo, PubMed/Medline, ScienceDirect and Web of Science. Secondary searching (PEARLing) was u...

Critical review of sham surgery clinical trials: Confounding factors analysis

OBJECTIVE Sham surgery (placebo surgery) is an intervention that omits the step thought to be therapeutically necessary. In surgical clinical trials, sham surgery serves an analogous purpose to placebo drugs, neutralizing biases such as the placebo effect. A critical review was performed to study the statistical relevance of the clinical trials about sham surgery in the light of potential confo...

Sham surgery controls are

Debate continues about the ethics of sham surgery controls. The most powerful argument for sham surgery controls is that rigorous experiments are needed to demonstrate safety and efficacy of surgical procedures. Without such experiments, there is danger of adopting worthless procedures in clinical practice. Opponents of sham surgery controls argue that sham surgery constitutes unacceptable viol...

Placebos that harm: sham surgery controls in clinical trials.

Recent debates over the use of sham surgery as a control for studies of fetal tissue transplantation for Parkinson's disease have focused primarily on rival interpretations of the US federal regulations governing human-subjects research. Using the core ethical and methodological considerations that underwrite the equipoise requirement, we find strong prima facie reasons against using sham surge...

Sham Surgery and Reasonable Risk