A Proposed Road Map for the Ethical Evaluation of Sham (Placebo) Surgery

Abstract

The use of a placebo and of double-blind control groups in surgery CTs would improves the quality of results, providing that an accurate ethical assessment procedure is in place, firstly to ensure patient safety and secondly to prevent abuses/procedural biases. Future testing of the proposed flowchart is outlined.

Sham controls in device trials for chronic pain – tricky in practice-a review article

“…Various frameworks have been developed to help guide researchers through salient ethical issues [ 53 , 64 ]. The consensus shared by the ethical literature surrounding the conduct of sham-controlled trials is not whether it is ethical to conduct a sham but rather consider whether conditions that make it ethical have been met.…”