Reliable and effective oxygen-ozone therapy at a crossroads with ozonated saline infusion and ozone rectal insufflation.

JPP – Journal of Pharmacy and Pharmacology – November 9, 2011

Objectives This review aims to highlight the advantages and safety of oxygen-ozone therapy (OOT) and to suggest ways to enhance its acceptance. Key findings The treatment of a herniated disk by injecting a gaseous oxygen-ozone mixture inside the nucleus pulposus is a great clinical success. However, the use of OOT lags for a number of reasons, including lack of standardization, the need for numerous treatments, lack of knowledge and even denial. Anecdotally, several million treatments by OOT have been performed worldwide indicating its usefulness, mainly in peripheral arterial diseases and age-related macular degeneration.

The scepticism that accompanies the systemic use of ozone can only be overcome by demonstrating the validity of OOT in controlled and randomized clinical trials. Cheaper and quicker methods, such as ozonating physiological saline with successive infusion as well as ozone rectal insufflations, are becoming popular, however, such alternative procedures are erratic, unstable and liable to be toxic, with deleterious consequences, and are likely to discredit the beneficial use of ozone. Summary The approval of ozone in terms of both therapeutic efficacy and safety will depend on the results achieved by authoritative clinical trials.

During the last decade, oxygen-ozone therapy (OOT) has slowly come of age and today it is used in many countries. This has come about as scientific studies have clarified the mechanism of action of ozone when it comes in contact with human blood and biological fluids. With the exception of pathologies such as decompression sickness, CO and smoke poisoning, severe blood-loss anaemia and gas gangrene, where hyperbaric oxygen therapy is extremely useful, OOT appears to be more beneficial than hyperbaric oxygen therapy in peripheral arterial diseases complicated by chronic ulcers,

[1] osteoradionecrosis, refractory osteomyelitis

[2] and necrotizing fasciitis.

[3] OOT originated in Germany in around 1970 but for many years was performed in an empirical fashion with out knowing how ozone acted.

[4] As ozone is one of the most reactive oxidants(E° =+2.076V), it seemed difficult to understand how it could be therapeutically useful. However, in recent years, the concepts of paradoxical pharmacology,

[5] hormesis,

[6] and systems biology

[7] have become accepted. The ozone paradox has been clarified and all the
elicited biochemical reactions and pharmacokinetics of the generated compounds appear well within the realms of standard biochemistry, molecular biology and pharmacology.

[8,9] Indeed, among alternative approaches, OOT is well qualified to be accepted as a conventional medicine. In Russia, Ukraine and Cuba, treatment with ozone is already a reality in public hospitals, but they have adopted doubtful administration modalities such as the infusion of ozonated saline or oxygen-ozone rectal insufflations of excessive amounts of gaseous ozone.

These surrogates have been developed because they are in expensive, rapid and applicable to thousands of patients every day. Owing to the uncertainty in both concentration and stability of crucial compounds, no regulatory agency will accept these procedures and this discredits OOT. The aims of this review were:

(1) to pharmacologically evaluate both reliable and doubtful methods of ozone administration;

(2) to establish precise rules for performing this therapeutic treatment; and

(3) to briefly summarize the state of the art medical use of ozone.

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