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Letter to the Editor / Reply

The International Journal of Artificial Organs / Vol. 27 / no. 8, 2004/ p. 733

Ozone therapy and clinical efficacy

N. DI PAOLO 1, V. BOCCI 2, E. GAGGIOTTI 1

1 Nephrology, Dialysis and Transplantation Department, University Hospital of Siena, Siena - Italy
2 Institute of General Physiology of the University of Siena, Siena - Italy

Dear Editor

In a recent letter, Dr. L Tylicki and Dr. B. Rutkowski expressed their appreciation of our review on ozone therapy. We, in turn, have been following the work of these enthusiastic Polish nephrologists with great interest, because ozone therapy, which is not sponsored by pharmaceutical industries or health authorities, can only progress with serious basic and clinical studies which depend on our initiative. It is unfortunate that ozone therapy has been discredited by quacks and is surrounded by scepticism and disinterest.
Tylicki and Rutkowski observe that ozone therapy seems to be safe but ask if it is clinically effective. Fifteen years of laboratory and clinical work by V. Bocci and 10 years of the work done together, conceiving and developing Extracorporeal Blood Oxygenation and Ozonation (EBOO), has never revealed any acute or chronic toxicity of ozone therapy, only positive and sometimes astonishing results. Needless to say, we are always careful to use ozone doses within a well established therapeutic range, bearing in mind that “the more the better” is NOT true with ozone. A judicious dose of ozone is necessary to trigger biological and therapeutic responses. The acute oxidative stress induced temporarily reduces the body’s antioxidant capacity to a limited extent.
We are critical of the use of ozone in cosmetic medicine, as there have been no serious studies and direct injection of ozone under the skin is associated with risk of embolism.
The efficacy of ozone therapy is not yet demonstrated as results of the first controlled studies are only now appearing. We are currently testing the efficacy of EBOO for peripheral vasculopathy in controlled studies with rigorous protocols. We agree with the Italian Health Ministry that results of controlled clinical studies are necessary before the validity of ozone therapy can be judged. However, our experience convinces us that ozone therapy can be a valid approach in certain diseases, and we can demonstrate that it is extremely valid in vascular diseases (caused by atherosclerosis, diabetes, uremia etc.) and for healing chronic wounds, such as bed sores and leg ulcers. The combination of parenteral therapy and topical treatment with ozonated oil will be a medical revolution. It is difficult to say when it will happen, because our research proceeds at a snail’s pace compared to official medicine. The same is true of our clinical studies compared to those recently published on statins and TNF inhibitors, which involve thousands of patients and experimenters supported by huge funding.
In any case, we are fortunate to be able to work in peace and in a scientifically correct manner within the public health system, by virtue of recent provisions by the Health Ministry and the Director of our university hospital. The latter has been particularly attentive to the problem and has sustained us and supported our aims over the years. Our answer to our Polish colleagues is therefore a definite YES. We are convinced of the efficacy and innocuousness of ozone therapy, though many methods still need to be investigated in depth, and those already in an advanced state and considered safe need to be tested in controlled clinical trials to obtain approval by government health authorities.

Address for correspondence:
Nicola Di Paolo, MD
Department of Nephrology
University Hospital
Viale Bracci
53100 Siena, Itay
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