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

[Dolphin]

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

• Cite this article
  
• https://doi.org/10.1080/21641846.2025.2455876
  

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.

https://twitter.com/user/status/1887857019534622970

 

[Yann04]

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.

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.

 

[Jonathan Edwards]

Could this still be due to placebo? without controls it’s unknown if the improvements could simply be noise from natural recoveries.

Yes to both.
Almost as barbaric as trepanning or blood letting.

 

[forestglip]

Orthostatic tolerance testing at baseline and at post-treatment time points (a) revealed four subjects who met the diagnostic criteria for POTS (change in HR >30bpm) at baseline. At both post-treatment time points (2 weeks and 2 months post-treatment), POTS was resolved in three subjects. The fourth subject had a history of POTS prior to COVID infection and ME/CFS diagnosis. The response of subjects with new-onset POTS (b) was significant at both time points (p = 0.02 and 0.03). Neither orthostatic hypotension nor narrow pulse pressure was observed in any subjects.

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




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.

 

[Jonathan Edwards]

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

Except that they are not effects, merely observed changes. Nobody knows what caused them.

Still want to see a larger placebo controlled trial

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.

 

[Utsikt]

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.

 

[Kitty]

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.

 

[Utsikt]

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/

 

[Trish]

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.

 

[forestglip]

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

What kind of usable data do you mean?

 

[Jonathan Edwards]

What kind of usable data do you mean?

No idea really but not this sort of self-fulfilling open trial.

 

[Yann04]

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”.

 

[Utsikt]

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”.

You’d need to properly justify running it in the first place.

 

[Yann04]

You’d need to properly justify running it in the first place.

Yes but my question is assuming that this trial was going to happen, what would be the most rigorous methodology.

 

[Utsikt]

Yes but my question is assuming that this trial was going to happen, what would be the most rigorous methodology.

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.

 

[Jonathan Edwards]

Yes but my question is assuming that this trial was going to happen, what would be the most rigorous methodology.

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.

 

[Braganca]

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!

 

[Hutan]

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

 

[Hutan]

Here's the supposed mechanism (paragraphs added):

In 80% of the population, the first thoracic and inferior cervical ganglion are fused, comprising a structure called the stellate ganglion. Injecting local anesthetic near this site, a stellate ganglion block (SGB), can inhibit the entire cervical sympathetic chain and produces temporary physiological changes (e.g. increased regional blood flow) hypothesized to ‘reset’ the sympathetic/parasympathetic balance of the autonomic nervous system [Citation35].

A successful SGB is evidenced by predictable and observable physiological signs including Horner’s Syndrome, which typically reflects blockade of the superior cervical ganglion. Symptoms of Horner’s syndrome include ipsilateral ptosis, meiosis, anhidrosis, and facial flushing [Citation36]. While clinically useful for confirming a successful block, Horner’s syndrome complicates blinded studies with sham treatment controls.

SGB has been shown to alter lymphocyte subsets and natural killer cell activity in healthy volunteers [Citation37], reduce systemic inflammatory response in severe trauma [Citation38], TBI [Citation39], and subarachnoid hemorrhage [Citation40], reduce markers of inflammation in chronic ulcerative colitis [Citation41], and increase cerebral blood flow in healthy volunteers [Citation42] and stroke patients [Citation43].

I think they meant miosis (constriction of the pupil) rather than meiosis.

 

[Hutan]

Participants were identified from patients presenting to the Neuroversion clinic for treatment of Long COVID symptoms, by referral from physicians in the surrounding community or by word of mouth. Patients underwent a standard medical evaluation to assess general health, confirm Long COVID diagnosis according to WHO criteria, evaluate pre-consent inclusion/exclusion criteria, and introduce the study. Patients who showed interest then met with the study coordinator and informed consent was obtained.

Forty consecutive patients were screened on presentation for Long COVID at the Neuroversion Clinic. Ten patients met criteria and were enrolled in the study.

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.

One subject (S4M-048) was removed from the study after contracting a respiratory infection that prevented her from completing the treatment protocol.