Although hyperbaric oxygen therapy (HBO2T) is the primary or adjunctive treatment for a limited number of clinical conditions, off-label use is increasing as a result of public demand. Because of unusual research problems and limited regulatory mechanisms to ensure patient safety, physicians question whether it is ethical to provide HBO2T for an unproven indication. An ethical approach to the off-label use of HBO2T is proposed. This approach requires combining a physician's clinical judgment with guidelines written by recognized organizations in hyperbaric medicine and patient informed consent. Scientific guidelines can identify which off-label uses of HBO2T are not therapeutic, which are potentially therapeutic, and to what degree. Registries or a central repository for the systematic collection of data can promote research. Ethical guidelines should require patient informed consent for approved indications, for potentially therapeutic off-label indications, and for registry or research participation. The creation of a consortium of hyperbaric clinics may improve the validity of information disseminated to the general public and promote the ethical practice of HBO2T.
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