High-Dose Ozonated Major Autohemotherapy ("Ten-Pass Therapy"): A Critical Appraisal

Emma Borrelli MD, PhD Public Outpatient Clinic for Ozone Therapy, Neurosurgical Unit, University Hospital Le Scotte, Siena, Italy Adjunct Professor, Postgraduate Courses on Oxygen Ozone Therapy, University of Siena, Italy

      The present editorial aims to raise serious concern regarding the increasing diffusion, within the field of ozone therapy, of a practice that currently lacks both experimental and clinical evidence: high dose ozonated major autohemotherapy, commonly referred to as "ten-pass therapy."

      In recent years, Dr. Rowen, a practitioner based in the United States, has promoted the aforementioned "ten-pass," or high-dose major autohemotherapy technique. This approach rests upon a single published hypothesis advanced by Dr. Lahodny, which postulated a therapeutic effect of over-range ozone concentrations on mitochondrial activity after an “in vitro” study.

       This method—for which no peer-reviewed data demonstrating either safety or clinical efficacy have been published to date—raises substantial concern on both grounds. The cumulative ozone dose administered in a single session is exceedingly high, 140,000 μg of ozone in total, a quantity approximately ten times greater than that employed in evidence-based major ozonated autohemotherapy protocols. This dosing regimen finds no justification within the current, well characterized framework of ozone pharmacology. The proponents of this technique rely solely on observations of mitochondrial activity in six subjects undergoing the procedure, from which they infer a possible improvement in mitochondrial function. Critically, however, no mechanistic explanation is offered regarding other essential safety parameters (e.g., effects on hematological indices and cellular integrity) or efficacy endpoints (e.g., effects on inflammatory, immunological, and antioxidant biomarkers).

     Further cause for concern lies in the response of certain manufacturers of ozone therapy devices, several of whom have rapidly embraced this unsubstantiated methodology and introduced equipment specifically engineered to perform ten-pass treatments. This commercialization appears to have proceeded despite explicit cautionary statements issued by members of the scientific community at international conferences and professional meetings.

     From a toxicological perspective, the ozone concentrations employed in the ten-pass method fall within a range associated with cytotoxic and potentially genotoxic effects, the consequences of which may manifest not only acutely but also following cumulative long-term exposure. Relying upon a transient subjective sense of well-being—sometimes reported by patients following treatment—as a surrogate measure of evidence-based therapeutic benefit is methodologically untenable and, in a clinical context, ethically unacceptable.

   It is imperative to specify that scientific knowledge may be subject to revision over time, and no claim to definitive truth is advanced here. However, any substantive revision of established clinical practice must be grounded in rigorous experimental and clinical evidence, rather than in speculative inference. The ozone therapy community is therefore strongly urged to exercise caution with respect to non validated methodologies and to adhere to practices supported by a robust and extensive body of peer reviewed literature—at minimum, until compelling and reproducible scientific data emerge that would justify a revision of current ozone therapy protocols.