Male vs. Female Differences in Responding to Oxygen–Ozone Autohemotherapy (O2-O3-AHT) in Patients with ME/CFS, 2021, Chirumbolo et al

[Sly Saint]

Male vs. Female Differences in Responding to Oxygen–Ozone Autohemotherapy (O2-O3-AHT) in Patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Abstract
(1) Background: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a syndrome that has fatigue as its major symptom. Evidence suggests that ozone is able to relieve ME/CFS-related fatigue in affected patients.

(2) Objective: To evaluate whether differences exist between males and females in ozone therapy outputs in ME/CFS.

(3) Methods: In total, 200 patients previously diagnosed with ME/CFS (mean age 33 ± 13 SD years) underwent treatment with oxygen–ozone autohemotherapy (O2-O3-AHT). Fatigue was investigated via an FSS 7-scoring questionnaire before and following 1 month after treatment.

(4) Results: The Mann-Whitney test (MW test) assessed the significance of this difference (H = 13.8041, p = 0.0002), and female patients showed better outcomes than males. This difference was particularly striking in the youngest age cohort (14–29 years), and a KW test resulted in H = 7.1609, p = 0.007 for the Δ = 28.3% (males = 3.8, females = 5.3).

(5) Conclusions: When treated with O2-O3-AHT, females respond better than males.

https://www.mdpi.com/2077-0383/11/1/173

 

[Creekside]

Did they compare this to any other pain reduction techniques? Maybe females are simply more likely to check 'improved' rather than 'no change' on these sorts of questionnaires.

 

[hibiscuswahine]

They are keen to build up their published results, this has most of the same text as their previous paper (where they noted the difference) but now gets it’s own paper.
https://www.s4me.info/threads/patie...one-autohemotherapy-2021-tirelli-et-al.23966/

Still not a RCT.

 

[Milo]

The diagnosis of ME/CFS therefore almost entirely based on fatigue-related symptoms [24,25].

oh, really?

The burdensome task to achieve a proper and sound diagnosis affects the therapeutic approach [26], despite some commendable attempts [5,7,11]; however, ME/CFS remains a considerable concern for clinics

oh, really?

Promising attempts in treating ME/CFS fatigue with oxygen–ozone autohemotherapy (O2-O3-AHT) were successfully performed by our group and others

oh, really?

O2-O3-AHT may affect many complex issues in terms of immunity, most of which characterize the pathogenetic mechanisms causing ME/CFS

oh you’re saying?

2.1. Patient Recruitment
In total, 224 outpatients (mean age from the clinical centers of Pordenone and Gorle (Bergamo) were enrolled, having met the eligibility criteria agreed for the present study

So, basically open label, recruited among patients who willingly came to their alternative clinic for treatment (Risk of bias: high)

it is unclear how much these patients paid for the treatments

Each patient was asked to respond to 7 questions pertaining to fatigue, the Fatigue Severity Scale (FSS) by Chalder et al. before undergoing therapy and one month following therapy

That’s it. Are you tired a lot, a little bit a little less or not at all? Before therapy and after 1 month.

No detail about the participants’s functioning before and after. No activity tracker data.

Discussion
Our results suggest that O2-O3-AHT is able to relieve fatigue in almost half of the whole cohort of ME/CFS patients

Well, that came out of left field because nowhere on this paper do we get results or data to verify this. All that is presented is a male vs female change in score.

Thus far, no sound explanation can be attained to explain why female patients show better outcomes with O2-O3-AHT. This fact might be explained by the different endocrine endowment in males compared to females, at least in terms of ER receptors and their effect on T cell activation and NK cell functional activity [11]. The modulation of immunity may be a sound solution to counter ME/CFS fatigue, and ozone may be a possible approach [5,6,27]. We are therefore unable to fully elucidate how ozone can restore wellness in patients suffering from ME/CFS-related fatigue

This would be quite comical if it was not published in a peer-reviewed scientific journal. Basically they are saying ‘we have no clue why it works and why women respond better to ozone treatments, but anywho, come on up, we take credit cards. We also take your blood but we give it right back into ya.’

Conflicts of Interest: The authors declare no conflict of interest.

interesting.

Edit to add: there is an open review, which does not enlighten much i am afraid. https://www.mdpi.com/2077-0383/11/1/173/review_report

Edit to add #2:

Informed Consent Statement: Informed consent was obtained from all subjects involved in the study. All subjects were outpatients of our healthcare institution, and made their own decisions and were aware of the purpose of undergoing treatment with oxygen–ozone, which is not an experimental therapy. Therefore, patients were simply asked to agree and sign a consent form to use their data for research purposes. All subjects gave their informed consent for optional inclusion in the research before they participated in the study, which was conducted in accordance with the Declaration of Helsinki

So basically they were enrolling their own patients coming for ozone anyways, made them sign a consent and given the treatment and questionnaire. It sounds like the rules are different in Italy, in regards to ethics review board. They used their in-house ethics review board and followed the declaration of Helsinki. There would be a few ethical questions in regards to the process from my point of view.

 

[dratalanta]

What about male vs. female differences in response to placebo in an open label trial based on self-reporting of subjective data? Since such trials are anyway useless, it’s perhaps to be expected that there seems to be a relative lack of research into the influence of agreeableness (in the technical sense) on the results of this kind of pseudo-trial. But since we do know that women score higher for agreeableness, and since the participant’s willingness to go along with things is a major issue in this kind of trial, the failure to consider this explanation does make me wonder if anyone before us actually read the paper with any seriousness.