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Sham surgery: an ethical analysis.

Franklin G Miller¹

¹National Institutes of Health.

The American Journal of Bioethics : AJOB

|January 28, 2004

Summary

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Sham surgery, or placebo surgery, is ethically permissible in surgical clinical trials. This analysis argues against absolute prohibitions, focusing on methodology, risk-benefit, and informed consent for ethical sham controls.

Area of Science:

Medical Ethics
Clinical Trial Design
Surgical Research

Background:

Surgical clinical trials rarely utilize sham surgery due to ethical concerns.
Recent ethical debates question the inherent or presumptive unethical nature of sham surgery.

Purpose of the Study:

To argue against the absolute ethical prohibition of sham surgery in clinical trials.
To provide an ethical analysis supporting the use of sham surgery as a control.

Main Methods:

Ethical analysis of sham surgery in clinical trials.
Review of three case studies involving sham surgery.
Examination of a sham-controlled trial for arthroscopic knee surgery.

Main Results:

Keywords:

Analytical Approach Biomedical and Behavioral Research

Related Experiment Videos

Arguments against sham surgery are deemed mistaken.

No sound ethical reasons exist for an absolute ban on sham surgery.

Methodological rationale, risk-benefit, and informed consent are key ethical considerations.

Conclusions:

Sham surgery can be ethically justified in specific clinical trial contexts.
Ethical considerations should focus on trial-specific assessments rather than absolute prohibitions.
Further ethical deliberation on sham-controlled trials is warranted.