Trial Report Ten sessions of hyperbaric oxygen versus sham treatment in patients with long covid HOT-LoCO…, 2025, Kjellberg et al.

The difference with the patient community is that we accept that treatments don't work, and leave them behind. At the time it started being suggested, there were lots of posts on the LC sub-reddit. I maybe remember 1-2 in the last 2 years. Because we have all the stakes, we are eager to abandon things that don't work, have no investment in them.
That might be true here. But my experience is that not insignificant amount of people very much hold onto their pet treatments in LC groups.
 
That might be true here. But my experience is that not insignificant amount of people very much hold onto their pet treatments in LC groups.
Oh, yes, subsets are common. There is also the occasional "brain retraining" post on the LC sub-reddit. Comments vary, there usually are a few who really vouch for it. Sometimes the posts get deleted because most of the early responses aren't positive. It varies. There are also still the occasional posts on supplement stacks. Some for exercise. Here and there. But like with HBOT, whereas there was a moment where it was talked about a lot, being a main topic of discussion, it all fell out of fashion and most people just ignore it now.
 
Great to see a good quality trial, even if it has a null result.
Karolinska University, Sweden.
Adequately sized trial

I guess it is always possible to say 'ah, but the treatment should have been slightly different' - given for longer, given at a higher dose, given by better trained therapists... But still, this is useful.

The present randomised, placebo-controlled, double-blind clinical trial was conducted in compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use-Good Clinical Practice, the protocol was published at the start of the trial, and we report ben- efits and harms.
That's an interesting organisation - International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use-Good Clinical Practice - website here: https://www.ich.org/
 
Patient representatives from the post-COVID association in Sweden (Svenska Covidföreningen) were involved and approved the trial design.
Great to see this. I'm assuming this is a good association?

The following is a lot, but it looks as though they have really tried hard to reduce bias and do things well. They also paid a lot of attention to blinding.
The protocol was approved by the Swedish ethical review board (2021-02634, amendment 2021-04572, approval date 25 May 2021 and 22 September 2021) and the Swedish medical products agency (5.1-2020-36673, approval date 06 July 2021). The trial was registered on ClinicalTrial.gov (NCT04842448), 13 April 2021, and on EudraCT (2021-000764-30), 21 May 2021, before the start of the trial.

Patient representatives from the post-COVID association in Sweden (Svenska Covidföreningen) were involved and approved the trial design.

The protocol includes a detailed description and rationale for the primary and main secondary endpoints, including patient reported outcomes (PRO) in line with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) SPIRIT-PRO Extension guidelines.21 The full protocol is published and available with open access.22

The trial was conducted in accordance with The Declara- tion of Helsinki, ICH-GCP, local and national regulations and is reported according to Consolidated Standards of Reporting Trials (CONSORT) Harms 2022 guidelines.23

The trial was monitored by an independent monitoring organisation, Karolinska Trial Alliance (KTA), before, during and after the trial according to the monitoring plan.

An independent data safety monitoring board (DSMB) reviewed the data three times during the trial. A charter delineating their operating guidelines and stop- ping rules for terminating individual subjects, a portion or all the trial prematurely, was drawn up and agreed on before the trial started. The DSMB is composed of three experts in their respective disciplines of medicine, clin- ical trial methodology and conduct. The members of the DSMB, meeting plan and responsibilities are specified in the original protocol (p6 and 44).

Inclusion criteria are basically healthy and working/studying prior to Covid-19 infection, persisting symptoms post-Covid-19 infection for at least 12 weeks and ongoing, diagnosed with a post-covid-19 condition. The people included were mostly fairly young, healthy BMI.
 
Change in SF-36 Physical Function
(note, SF-36 Physical Function is the 10 questions about things like whether you can walk a block or a mile, or climb a flight of stairs or 3, or have trouble bathing and dressing. RP is Role Physical - 4 questions asking things like 'were you limited in the work or activities you could do due to your physical health?'.

very few of our subjects could tolerate more than three treatments per week due to severe PEM. There were no subjects in the highest interval of base- line disease severity, the mean of the Rand-36 physical domains PF and RP above 50, due to the high severity of the disease. Most subjects (66) were in the 0–30 interval, and 14 subjects were in the medium interval of 30–50.

Primary endpoint, mean change from baseline at 13 weeks in RAND-36 domain, PF was 9 (18.68) in HBOT (n=40) versus 8.59 (16.02) in placebo (n=39), least square mean difference between groups (LSD), 0.63 (95% CI (−7.04 to 8.29)), p=0.87.

I wanted to highlight this. Higher scores mean better physical health. These people were scoring in the 0 to 50 range, which is low compared to the general population, but, I think, in line with what people with an ME/CFS-type illness participating in a trial would report.

The mean improvement was an increase of around 9 on the 0-100 scale from a baseline score of about 38. That's a pretty substantial improvement in percentage terms, nearly 25%. And that is from both a convincing placebo and from a treatment that turned out to be no better than a placebo that I expect most of the participants would have been very hopeful about. The treatment did not involve instruction in the benefits of ignoring symptoms, thinking positively or reframing symptoms as benign, nor did it specifically encourage people to increase their physical activity.
 
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Great to see this. I'm assuming this is a good association?
I have not followed them closely, but the general impression in Norways is positive. They got up and running very soon into the pandemic and I believe they have been able to employ someone. They collaborate with their Scandinavian counterparts as well.
 
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