Investigational Diseases and Conditions

Hyperbaric Oxygen Therapy Approval Status

No Clearance by US Food and Drug Administration (FDA)

No Approval by the Undersea and Hyperbaric Medical Society (UHMS)

! Read the US Food and Drug Administration (FDA) position paper on off-label hyperbaric treatment:
Hyperbaric Oxygen Therapy: Don't Be Misled, published 22 August 2013.

About Clearance and Approval


HyperbaricLink Commentary
Regarding investigational diseases and conditions

Individual clinicians and the hyperbaric medical community are investigating the efficacy of hyperbaric oxygen therapy (HBOT) treatment for a number of diseases and conditions. In every case the weight of scientific evidence is currently insufficient for HBOT to be approved as a standard treatment.

The level of research activity for investigational diseases and conditions varies widely. In a number of cases there are no clinical trials under way. This in itself should be telling for patients and caregivers investigating the effectiveness of HBOT for off-label treatment. If there is no basis on which a clinician can form a hypothesis about how hyperbaric oxygen might improve a medical condition, there is a good chance that it cannot.

The size, type, and quality of the studies currently under way all vary. The most pursuasive research is controlled, double-blinded, enrolls a substantial number of patients, and is conducted at multiple medical centers. Before being fully accepted as valid the study must be replicated by other researchers in a separate clinical trial. None of the research into these conditions comes close to meeting these requirements.

Treatment of all these conditions with hyperbaric oxygen is considered “off-label”. Providers may not legally advertise a specific medical benefit as resulting from treating them with hyperbaric oxygen therapy.

We create individual condition pages for investigational diseases and conditions when:

  1. there is sufficient clinical or public interest in treatment of the condition with HBOT,
  2. multiple relevant studies have been published, and
  3. internet resources will provide sufficient supporting references.

Conditions not meeting those criteria are listed at right.

Current Conditions

The following are investigational diseases and conditions for which we have not published an individual summary.

  • Asphyxiation
  • Coma
  • Crohn’s disease
  • Diabetes
  • Drug/Alcohol detox
  • Encephalopathy
  • Envenomation (snake and spider bites)
  • Frostbite
  • Hearing loss
  • Inflammatory bowel disease (IBD)
  • Mitochondrial disease
  • Near drowning
  • Near hanging
  • Parkinson's disease
  • Physical rehabilitation
  • Poisoning
  • Post-traumatic stress disorder (PTSD)
  • Spinal cord injury
  • Sports injuries
  • Tinnitus
  • Vertigo

News about Investigational Conditions and Hyperbaric Oxygen Therapy

More news from O2.0 – the HyperbaricLink blog

Complete investigational conditions news archive from O2.0 — the HyperbaricLink blog.

Page Data
Updated: 04 Aug 2015 04:14 PM
Created: 13 Jun 2009 12:00 AM
By: About the authors »