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Ethical issues in the design of randomized trials: to sham or not to sham

, : Ethical issues in the design of randomized trials: to sham or not to sham. Journal of Bone and Joint Surgery. American Volume 94 Suppl 1: 7-10

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.


PMID: 22810439

DOI: 10.2106/JBJS.L.00298

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