Trial Report Stellate Ganglion Block reduces symptoms of SARS-CoV-2-induced ME/CFS: A prospective cohort pilot study, 2024, Duricka & Liu

Discussion in 'ME/CFS research' started by Dolphin, Feb 7, 2025.

  1. Dolphin

    Dolphin Senior Member (Voting Rights)

    Messages:
    6,230
    https://www.tandfonline.com/doi/full/10.1080/21641846.2025.2455876

    Research Article
    Stellate Ganglion Block reduces symptoms of SARS-CoV-2-induced ME/CFS: A prospective cohort pilot study
    Deborah L. Duricka
    &
    Luke D. Liu
    Received 16 Nov 2024, Accepted 16 Jan 2025, Published online: 06 Feb 2025
    ABSTRACT

    Background
    Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a debilitating condition characterized by fatigue, orthostatic intolerance (OI), post-exertional malaise (PEM) and unrefreshing sleep. Our previous work has shown that modulating the autonomic nervous system can alleviate symptoms of Long COVID, which shares striking similarities with ME/CFS.

    Objective
    Determine the effect of stellate ganglion block (SGB) on symptoms of ME/CFS.

    Methods
    Subjects who met the WHO criteria for Long COVID and the Institute of Medicine criteria for ME/CFS were treated with sequential bilateral SGBs separated by 18–24 hours for three consecutive weeks (n = 10). At baseline, and at 2-weeks and 2-months post-treatment, we collected subjective assessments (SF-36 and DSQ2) of symptoms, objective assessments of orthostatic intolerance and cognitive performance, and saliva to measure morning cortisol. During the entire study period, a wearable device collected physiological data several nights a week to measure sleep parameters.

    Results
    DSQ2 measures of PEM, Unrefreshing Sleep, Cognitive Impairment, and OI improved significantly following treatment. SF-36 measures of Vitality, Physical Function, and Social Function improved significantly following treatment. Objective symptoms of POTS associated with infectious onset resolved following treatment. Objective measures of cognitive impairment were reduced following treatment, most notably in the areas of Immediate and Delayed Recognition. Morning cortisol and measures of sleep architecture did not change significantly following treatment.

    Conclusions
    Symptoms of ME/CFS were reduced after treatment with SGBs in this small prospective cohort pilot study. Given the lack of FDA-approved treatments for ME/CFS, replication of results in a large clinical trial is warranted.

     
    Binkie4, Deanne NZ, Murph and 6 others like this.
  2. Yann04

    Yann04 Senior Member (Voting Rights)

    Messages:
    1,710
    Location:
    Romandie (Switzerland)
    Interesting… Could this still be due to placebo? Ie. I’m trying harder and risking more PEM for the tests because I believe I’ve been treated?

    Also noting this is a non-controlled long COVID (disease duration >5 years) cohort, without controls it’s unknown if the improvements could simply be noise from natural recoveries.
     
    Murph, Peter Trewhitt, Hutan and 3 others like this.
  3. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

    Messages:
    16,365
    Location:
    London, UK
    Yes to both.
    Almost as barbaric as trepanning or blood letting.
     
  4. forestglip

    forestglip Senior Member (Voting Rights)

    Messages:
    1,802
    Screenshot_20250207-084606.png

    I haven't read the whole study, but a lot of these charts show quite large effects.
    rftg_a_2455876_f0001_oc.jpg

    rftg_a_2455876_f0002_oc.jpg

    All nine of the participants from the first few figures (SF-36, PEM, cognitive impairment, OI, sleep) improved from baseline (except one person for OI).

    Still want to see a larger placebo controlled trial, but the consistency is intriguing. And the POTS metric is probably more robust than most measures against placebo effect. Though it's not out of the realm of possibility that it's also placebo.

    Edit: And natural recovery is a possibility.
     
    Murph, Peter Trewhitt, Hutan and 5 others like this.
  5. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

    Messages:
    16,365
    Location:
    London, UK
    Except that they are not effects, merely observed changes. Nobody knows what caused them.

    I wouldn't want to see any more of this without (a) a basic theoretical justification (b) some usable data, rather than these.

    You cannot just say you think X is due to a bad autonomic system so let's block the system a bit more with some injections. It doesn't even make sense.
     
  6. Utsikt

    Utsikt Senior Member (Voting Rights)

    Messages:
    1,202
    Location:
    Norway
    Rituximab showed large placebo effects with blinding. This was unblinded and without controls.

    SGB is already hyped in some communities. I worry this will make it worse.
     
  7. Kitty

    Kitty Senior Member (Voting Rights)

    Messages:
    7,633
    Location:
    UK
    In any case, weak opioid painkillers would be enough to mask some ME/CFS symptoms quite nicely in someone who hadn't had them before.

    I know because I made that mistake myself, and ended up in a nice crash.
     
  8. Utsikt

    Utsikt Senior Member (Voting Rights)

    Messages:
    1,202
    Location:
    Norway
    SGB can be risky as well:
    Out of a total of 1909 articles, 67 articles met our inclusion criteria, yielding 260 cases with adverse events. In 134 of the 260 (51.5%) cases, SGNB was performed with image guidance. Sixty-four (24.6%) and 70 (26.9%) of the complication cases reported the use of ultrasound and fluoroscopy guidance, respectively. One hundred and seventy-eight (68.4%) patients had medication-related or systemic side effects, and 82 (31.5%) had procedure-related or local side effects. There was one report of death due to massive hematoma leading to airway obstruction. There was one case report of quadriplegia secondary to pyogenic cervical epidural abscess and discitis following an SGNB.

    https://pmc.ncbi.nlm.nih.gov/articles/PMC9034660/
     
  9. Trish

    Trish Moderator Staff Member

    Messages:
    58,012
    Location:
    UK
    It's a very short timescale for an ME/CFS treatment study. 2 weeks of treatment and 2 months followup.

    I reckon you could get the same set of subjective outcomes over 2 months from LP with true believers as participants. It can be surprising how much one can persuade oneself something has worked and push on with the help of coffee and adrenaline for a couple of months, including atributing crashes to infections or something else.
     
  10. forestglip

    forestglip Senior Member (Voting Rights)

    Messages:
    1,802
    What kind of usable data do you mean?
     
    Murph, Peter Trewhitt and Kitty like this.
  11. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

    Messages:
    16,365
    Location:
    London, UK
    No idea really but not this sort of self-fulfilling open trial.
     
  12. Yann04

    Yann04 Senior Member (Voting Rights)

    Messages:
    1,710
    Location:
    Romandie (Switzerland)
    Assuming there was only funding for 10 patients, as this trial was done, what would be the most rigorous way to run a trial of “SGB”.
     
    Peter Trewhitt and Kitty like this.
  13. Utsikt

    Utsikt Senior Member (Voting Rights)

    Messages:
    1,202
    Location:
    Norway
    You’d need to properly justify running it in the first place.
     
    Peter Trewhitt, alktipping and Kitty like this.
  14. Yann04

    Yann04 Senior Member (Voting Rights)

    Messages:
    1,710
    Location:
    Romandie (Switzerland)
    Yes but my question is assuming that this trial was going to happen, what would be the most rigorous methodology.
     
    Peter Trewhitt, alktipping and Kitty like this.
  15. Utsikt

    Utsikt Senior Member (Voting Rights)

    Messages:
    1,202
    Location:
    Norway
    To test the non-existent biomarkers related to SGB or ME/CFS or both.

    It ties into the reason for doing the trial in the first place.
     
    Peter Trewhitt, alktipping and Kitty like this.
  16. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

    Messages:
    16,365
    Location:
    London, UK
    The best thing I can think of is a dose response study, with 3 or 4 doses (9-12 cases). The lowest dose effectively acts as a control. You would also want to ask patients if they guessed whether they had a big or small dose. You might get a clear cut answer, but you might well not.

    The real issue is that the treatment makes about as much sense as taking vinegar baths once a week. And is likely to be 1000 times more dangerous.
     
  17. Braganca

    Braganca Senior Member (Voting Rights)

    Messages:
    388
    SGB is quite an ordeal to go through for a person with ME, requiring day surgery procedure with sedation. The sedation and the SGB itself leave you super groggy and uncomfortable. Carer needs to be with you. Can’t imagine all these people having this twice a week for 3 weeks!

    Also, yes it seems super hyped. I had it done once bc I had a specific neurological problem (itch and burn on arms). It did nothing for either the itch or my ME symptoms. In the SGB Facebook group for long Covid and ME, there are very few people claiming it helped, yet lots of people being offered it. Obviously it’s a nice little earner for hospitals!
     
  18. Hutan

    Hutan Moderator Staff Member

    Messages:
    31,404
    Location:
    Aotearoa New Zealand
    It will be interesting to see if Garner leaps to write a dismissal of this treatment (as he did for the microclot filtering treatment). While this treatment gives every appearance of deserving to be dismissed, the problems with the trial design are the same as for the particular treatments that Garner likes.

    Here's our treatment discussion thread:
    Stellate Ganglion Block treatment
     
  19. Hutan

    Hutan Moderator Staff Member

    Messages:
    31,404
    Location:
    Aotearoa New Zealand
    Here's the supposed mechanism (paragraphs added):
    I think they meant miosis (constriction of the pupil) rather than meiosis.
     
    Kitty and Peter Trewhitt like this.
  20. Hutan

    Hutan Moderator Staff Member

    Messages:
    31,404
    Location:
    Aotearoa New Zealand
    Selection bias - participants were inclined to believe that the treatment would be useful.

    Because the two authors have a vested interest in showing the treatment that they sell to be useful, the sort of loose approach to selection could lead to all sorts of biases. For example, maybe people who felt worse after the first few treatments gave up, and aren't recorded as trial participants. Maybe results were cherry picked.

     
    Last edited: Feb 8, 2025

Share This Page