What are the clinical benefits of ozone therapy?

Clinical Benefits of Ozone Therapy

Ozone therapy is not recommended for therapeutic purposes due to significant safety concerns and lack of proven clinical efficacy. 1

Evidence Against Ozone Therapy

The International Working Group on Diabetic Foot (IWGDF) explicitly recommends against using ozone therapy for diabetic foot ulcers, as high-quality systematic reviews found no difference between ozone therapy and standard care for wound healing outcomes 1. This strong recommendation is based on high-quality evidence showing minimal benefit while exposing patients to potential risks.

Safety Concerns

Ozone presents significant safety issues that limit its clinical application:

• Highly toxic when inhaled with dose-dependent effects:

  • At 0.1 ppm: Stimulation of upper respiratory and urinary tracts
  • At 1.0-2.0 ppm: Rhinitis, cough, nausea, and asthma
  • At 2-5 ppm: Breathing difficulties and retrosternal pain after 10-20 minutes
  • At 10 ppm: Can be fatal after 4 hours
  • At 50 ppm: Can cause death within minutes 1

• Regulatory agencies have established strict exposure limits:

  • U.S. Environmental Protection Agency: 0.08 ppm for 8 hours
  • Occupational Safety and Health Administration: 0.10 ppm for 8 hours
  • Food and Drug Administration: 0.05 ppm for 8 hours 1

Limited Evidence for Specific Applications

While some research suggests potential benefits, the evidence remains limited and inconsistent:

Potential Applications with Limited Evidence

1. Disinfection purposes: Ozone may be effective for disinfection of surfaces and personal protective equipment when used in unoccupied settings with proper ventilation 2. Low ozone exposures (0.1–0.4 mg L-1 min) can achieve about 4 log10 of inactivation in aerosols, while exposures between 1-4 mg L-1 min may inactivate viruses on surfaces 2.

2. Wound treatment: Some small studies suggest potential benefits for infected wounds, but the IWGDF explicitly recommends against its use for diabetic foot ulcers 1, 3.

3. Inflammatory conditions: Limited evidence suggests possible anti-inflammatory effects, but high-quality clinical trials are lacking 4.

Methodological Issues in Available Research

Many studies supporting ozone therapy suffer from significant methodological limitations:

• Small sample sizes
• Short follow-up periods
• Lack of proper control groups
• Inconsistent application methods and dosing
• Inadequate blinding 1, 3

Clinical Decision Making

When considering treatments for conditions where ozone therapy has been proposed:

1. For diabetic foot ulcers: Follow standard wound care protocols as recommended by IWGDF 1

2. For chronic wounds: Consider evidence-based approaches like hyperbaric oxygen therapy for non-healing ischemic ulcers 1

3. For respiratory conditions: Use supplementary oxygen only when indicated by evidence-based guidelines 1

Practical Considerations

If ozone is used for non-medical disinfection purposes:

• Ensure no humans are present during application
• Allow sufficient time for ozone levels to decrease
• Use ozone decomposition devices
• Ensure proper ventilation after use 2, 1

Conclusion

Based on current evidence, patients should be directed toward evidence-based treatments with established safety and efficacy profiles rather than ozone therapy. The significant safety concerns and lack of proven efficacy make ozone therapy an unsuitable option for clinical use in most therapeutic contexts 1.