Patients with (ME/CFS) Greatly Improved Fatigue Symptoms When Treated with Oxygen-Ozone Autohemotherapy 2021, Tirelli et al

Patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Greatly Improved Fatigue Symptoms When Treated with Oxygen-Ozone Autohemotherapy

Abstract
(1) Background: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a chronic syndrome characterized by fatigue as its major and most outstanding symptom. Previous evidence has supported the ability of ozone to relief ME/CFS related fatigue in affected patients (2) Methods: A number of 200 ME/CFS previously diagnosed patients, (mean age 33 ± 13 SD years) were consecutively treated with oxygen-ozone autohemotherapy (O2-O3-AHT). Fatigue was evaluated via an FSS 7-scoring questionnaire before and following 30 days after treatment. (3) Results: Almost half (43.5%) of the treated patients evolved their FSS scale from the worst (7) to the best (1) score, assessing the highest improvement from being treated with O2-O3-AHT. Furthermore 77.5% of patients experienced significant ameliorations of fatigue, of 4–6 delta score. No patient showed side effects, yet experienced long lasting fatigue disappearance, by three months follow up
(4) Conclusions: Treatment with O2-O3-AHT greatly improves ME/CFS related fatigue, aside from sex and age distribution.

https://www.mdpi.com/2077-0383/11/1/29

 

Is this saying none of the patients had maintained the improvement at the 3 month point?

Edit: From the main text
"No patient reported adverse manifestation upon O2-O3-AHT and following the next 3 months from the treatment."

It looks like the patients DID maintain the improvement at the 3 month point and also did not have any side effects.
But did any of the patients who DIDN'T experience long lasting fatigue disappearance suffer side effects?

 

Interesting, but didn't see a case definition in the criteria.

If the inclusion criteria was only fatigue as the "major and most outstanding symptom", and not PEM and other highlighted symptoms, such as OI and cognitive difficulty, then it's unclear as to whether this research was actually looking at pwME.

 

I have read through their previous trials, they run a ME/CFS clinic in Italy. They make a reference to diagnostic criteria from the 2007 NICE guidelines. I am surprised they don’t use the IOM criteria as most researchers are. They did a 40-60 min interview and could’ve easily done this and stated what criteria they used. They say they used a physical fatigue scale as this was most prevalent and stable symptom. But there is a SF for mental fatigue as well and would have been good to have that too.

This is impressive result published in a international peer reviewed journal.

They did a study some years ago that were published in Ozone Therapy showing results but this was not picked up by the scientific community.
2006 https://www.pagepressjournals.org/index.php/ozone/article/view/7812
And 2018 https://www.pagepressjournals.org/index.php/ozone/article/download/7812/7433/

Just don’t understand why if they had positive results in a group of 65 back then to not expand their current 200 clients into a blinded randomised control trial this time. Which would have really helped understand if this is an effective treatment (even if requires monthly treatments etc as discussed in some of their earlier work).

 

I don't know if this therapy is substantially different, but the Wikipedia page on the general subject of "Ozone Therapy" is not very encouraging, to say the least.

https://en.wikipedia.org/wiki/Ozone_therapy

 

No controls. ME selection criteria unclear. Single outcome of self-reported fatigue, last follow-up at 3 months. Funded by SIOOT, Gorle (BG) which appears to be the Scientific Society of Oxygen-Ozone Therapy

I think I'll wait for something a little more rigorous before getting excited.