The ozone treatment that two COVID-19 patients hospitalized in Spain have received, one in Vila-real (Castellón) and the other in Barcelona, has led to lawsuits and rejection by health professionals.
The General Council of Official Medical Associations (CGCOM) itself recently reported that the available studies do not have sufficient methodological rigor to conclude or support the medical benefits of this therapy against severe COVID.
Now, at the request of the Barcelona College of Physicians, experts from the Ibero-American Cochrane Center – part of the Clinical Epidemiology and Public Health Service of the Sant Pau Hospital (Barcelona) – have reviewed the scientific evidence on the efficacy and safety of ozone therapy against to COVID-19, and the results of your synthesis document match.
No clinical benefit of ozone treatment in patients with covid-19 can be concluded, nor can any claim about its safety be made.
“The important limitations observed in the set of studies identified in this review do not allow us to conclude any type of clinical benefit of ozone treatment in patients with COVID-19, nor to make any affirmation about its safety,” the authors point out.
“Consequently,” they emphasize, “its use in routine clinical practice is not recommended. Rather, its use should be restricted to the context of well-designed and rigorous clinical studies that help to establish both its potential benefits and potential risks. adequate “.
The review consisted of a quick review of the scientific literature as of August 27, 2021, identifying recommendations in the main international guidelines for the treatment of COVID-19 (such as those of the who or the National Institutes of Health from the United States), systematic reviews – one of which was highlighted by the Carlos III Health Institute – and health technology reports, in addition to the main clinical studies.
Currently, the results of two clinical trials are available, one in a center in India and the other in several in Italy, but these show different limitations in their design and execution. Furthermore, according to the authors, “they offer very inaccurate results about their clinical relevance and the possible damages derived from the therapy, reasons why the available evidence in this regard is very uncertain to support the use of this treatment “.
“Very low” quality of scientific evidence
The Cochrane critical review has also detected a “very low” quality of scientific evidence in the various studies analyzed when reporting on aspects such as viral conversion from positive to negative, indicators of progression and clinical improvement, mortality or occurrence of adverse events.
In the EU, ozone is not considered a health product, and in Spain ‘ozone therapy’ is not authorized by the Spanish Agency for Medicines and Health Products
The report concludes that, although there is a large literature on the biological effects of ozone, for example in viral and lung diseases, so far there are very few that directly evaluate how it affects clinical outcomes in patients with COVID-19.
As you remember the CGCOMIn the European Union, this gas (03, a molecule made up of three oxygen atoms) is not considered a medical device, and in Spain ‘ozone therapy’ is not authorized by the Spanish Agency for Medicines and Health Products (AEMPS).
In the case of our country, its use could only occur in the context of a marketing authorization or a clinical trial authorized by the AEMPS itself.