Oxygen-Ozone Autohaemotherapy and Fatigue in ME/CFS: A 200-Patient Study
Background: few effective options for the fatigue of ME/CFS
Myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS) is a long-term condition whose central feature is profound, persistent fatigue that does not ease with rest and is made worse by activity. Effective treatments are limited, which has driven interest in other approaches. This study looked at oxygen-ozone autohaemotherapy - a procedure in which a small amount of the patient's blood is drawn, mixed with an oxygen-ozone gas mixture, and then returned to the bloodstream - as a way of reducing ME/CFS fatigue.
Study design: 200 ME/CFS patients treated and followed, no control group
This was a prospective observational study of 200 consecutive patients with ME/CFS (mean age 33). Each received oxygen-ozone autohaemotherapy, with at least two sessions a week. Fatigue was measured using the Fatigue Severity Scale (FSS), where a high score reflects severe fatigue and a low score reflects little or none. Importantly, there was no comparison or placebo group - everyone received the treatment and outcomes were tracked before and after.
Findings: large reported reductions in fatigue scores, sustained at three months
The authors reported that almost half of the patients (43.5%) moved all the way from the worst fatigue score (7) to the best (1) on the FSS, and that 77.5% experienced a substantial improvement of 4 to 6 points. Only about 5% showed negligible change. The improvements were maintained at three-month follow-up, and no adverse effects were reported. Because the study had no control group, these are before-and-after observations rather than proof that ozone alone produced the change.
What the authors concluded
The authors concluded that oxygen-ozone autohaemotherapy greatly improved ME/CFS-related fatigue in this group of patients, and that the benefit appeared regardless of age or sex. They presented it as a promising option worth further study, while noting that the mechanisms behind the improvement are not yet understood.
Limitations of this study
The key limitation is the absence of a control group: with no comparison arm, the results cannot rule out the placebo effect, natural fluctuation of symptoms, or other factors, and cannot establish that ozone caused the improvement. Fatigue was self-reported on a rating scale, the follow-up was relatively short at three months, and the work came from a single group of investigators. Randomised, controlled and independently replicated trials would be needed to confirm whether oxygen-ozone autohaemotherapy genuinely helps ME/CFS fatigue.
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