The irrationality of a non-specific immunomodulation therapy used in cardiovascular diseases deserves a critical comment

American Journal Cardiovascular Drugs

Zanardi

Travagli

2011

Self Cite

In this article, we scientifically evaluate the bio-oxidative procedure known as oxygen-ozone therapy. Research over a decade has established a comprehensive framework for understanding and recommending this type of autohemotherapy in vascular diseases. In contrast, a non-specific immunomodulation therapy, using heavily oxidized and denatured blood, has been recently used in studies involving a total of approximately 3000 patients and has led to 'disappointing' results. Such a treatment appears to be an inappropriate example of the so-called minor autohemotherapy, and its poor outcomes may discourage any further studies. Therefore it appears necessary to clarify that the use of only a minimal ozone dose and a valid experimental protocol is likely to produce beneficial results. Millions of people suffer from chronic limb, brain, and heart ischemia, and such patients may benefit if appropriate ozone therapy could be implemented. Accordingly, we propose the need for a well designed, multicenter, clinical trial to be conducted.

Section: Studies That May Have Compromised the Future Of Ozone Therapymentioning

confidence: 99%

Ozone: A New Therapeutic Agent in Vascular Diseases

American Journal Cardiovascular Drugs

Zanardi

Travagli

2011

Self Cite

“…It has proved to be useless in two multicenter, randomized, double-blind, placebo-controlled studies (SIMPADICO and ACCLAIM trial) enrolling about 3000 patients with critical vascular pathologies. [52] These trials have proved two things: the excessive dose of ozone is useless and the value of a wealthy sponsor.…”

Section: Current State-of-the-art Results Achieved In Clinical Trialsmentioning

confidence: 99%

“…This procedure was designed to establish a non‐specific immunomodulation therapy in the hope of reducing the inflammatory process and the chronic oxidative stress present in vascular diseases. It has proved to be useless in two multicenter, randomized, double‐blind, placebo‐controlled studies (SIMPADICO and ACCLAIM trial) enrolling about 3000 patients with critical vascular pathologies [52] . These trials have proved two things: the excessive dose of ozone is useless and the value of a wealthy sponsor.…”

Section: Current State‐of‐the‐artmentioning

confidence: 99%

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

Journal of Pharmacy and Pharmacology

Zanardi

Borrelli

et al. 2011

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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.

“…Sliwa and Ansari ( 2008 ) pointed out several potential problems but did not comment the wrong oxidative technology. On the other hand, I had made specific criticisms regarding the irrational technology and deeply dissented with Vasogen’s hypothesis (Bocci, 2008a , b ; Bocci et al, 2010a ).…”

Section: Ischaemic Diseases (Hind-limb Ischaemia Cerebral and Heart mentioning

confidence: 99%

The Clinical Application of Ozonetherapy

2010

Ozone

Self Cite

The reader may be eager to examine in which diseases ozonetherapy can be proficiently used and she/he will be amazed by the versatility of this complementary approach (Table 9 1). The fact that the medical applications are numerous exposes the ozonetherapist to medical derision because superficial observers or sarcastic sceptics consider ozonetherapy as the modern panacea. This seems so because ozone, like oxygen, is a molecule able to act simultaneously on several blood components with different functions but, as we shall discuss, ozonetherapy is not a panacea. The ozone messengers ROS and LOPs can act either locally or systemically in practically all cells of an organism. In contrast to the dogma that “ozone is always toxic”, three decades of clinical experience , although mostly acquired in private clinics in millions of patients, have shown that ozone can act as a disinfectant, an oxygen donor, an immunomodulator, a paradoxical inducer of antioxidant enzymes, a metabolic enhancer, an inducer of endothelial nitric oxide synthase and possibly an activator of stem cells with consequent neovascularization and tissue reconstruction .