Oxygen-Ozone Therapy is an Effective Therapy in Chronic Fatigue Syndrome: Results in 100 Patients

Background

Chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME/CFS), is a long-term condition marked by persistent, disabling fatigue that is not relieved by rest and is often accompanied by unrefreshing sleep, cognitive difficulties and worsening of symptoms after exertion. Its causes are not fully understood, and conventional treatments – including glucocorticoids, antidepressants, immunotherapy and metabolic drugs – frequently bring little benefit. The authors of this paper set out to document their clinical experience of using oxygen-ozone therapy, delivered as ozonated autohaemotherapy, in people with the condition.

Study design

This was an uncontrolled observational study of 100 patients with chronic fatigue syndrome (80 women and 20 men, aged 13 to 60, with symptom duration ranging from 1 to 15 years). Each patient received ozonated autohaemotherapy, a procedure in which a quantity of the patient's own blood is withdrawn, mixed with an oxygen-ozone gas mixture and reinfused. Treatment was given twice weekly for one month, followed by a maintenance schedule of twice monthly. There was no control or comparison group, and treatment was not randomised or blinded.

Findings

The authors reported that 70 of the 100 patients – a 70% response rate – experienced an improvement in fatigue and general wellbeing following treatment. They described these improvements as consistent with results previously observed when ozone therapy has been used in other conditions, and noted that no serious adverse effects were attributed to the oxygen-ozone therapy. Response was assessed clinically rather than with a validated, standardised fatigue-rating instrument.

What the authors concluded

Tirelli and colleagues concluded that the 70% response rate suggested oxygen-ozone therapy could be a useful option for chronic fatigue syndrome, positioned as an integrative or complementary approach alongside standard care. They described their series as, to their knowledge, the largest reported group of CFS patients treated with ozone therapy at the time of publication, and called for further, more rigorous investigation.

Limitations of this study

This was an uncontrolled, single-arm observational study with no comparison group, no randomisation and no blinding, so it is not possible to separate any effect of the treatment from placebo response, the natural fluctuation of symptoms or other influences. Response was judged clinically rather than with validated fatigue-rating instruments, and the follow-up and reporting were limited. The paper appeared in a lower-tier journal (Biomedical Journal of Scientific & Technical Research) whose peer review is considered light. The findings should therefore be read as preliminary and hypothesis-generating rather than as firm evidence of effectiveness, and larger randomised controlled trials would be needed to confirm any benefit.