Trial Report Efficacy and [...] potential mechanisms of stellate ganglion block in alleviating sleep disturbance in generalized anxiety disorder: [...], 2025, Liu+

[forestglip]

Efficacy and exploratory analysis of potential mechanisms of stellate ganglion block in alleviating sleep disturbance in generalized anxiety disorder: a randomized controlled trial excluding comorbid depression

Na Liu, Qinying Ma, Moqing Zhou, Lin Yang, Wenyuan Wang, Yanyong Wang

[Line breaks added]

Objective
To investigate the efficacy and mechanisms of stellate ganglion block (SGB) in treating generalized anxiety disorder (GAD) with sleep disturbance, excluding patients with comorbid depression.

Methods
This double-blind randomized controlled trial (RCT) enrolled 128 patients with GAD (Hamilton Anxiety Scale [HAMA] > 14, Generalized Anxiety Disorder 7-item Scale [GAD-7] ≥ 5) and sleep disturbance (Pittsburgh Sleep Quality Index [PSQI] ≥ 15), randomized to receive SGB (n = 64, 4 ultrasound-guided 1% lidocaine injections) or conventional treatment (n = 64, cognitive behavioral therapy [CBT] + estazolam 1–2 mg/day). Outcomes included anxiety (HAMA), depression (Hamilton Depression Scale [HAMD]), sleep quality (PSQI), polysomnography (PSG), and neurotransmitter levels (norepinephrine [NE], serotonin [5-HT], neuropeptide Y [NPY]).

Results
After 4 weeks, SGB demonstrated higher efficacy (98.4% vs. 89.1%, p = 0.028) and greater reductions in HAMA (9.36 ± 2.34 vs. 11.87 ± 2.71, p < 0.001) and HAMD scores (6.87 ± 2.01 vs. 8.09 ± 2.04, p < 0.001). PSQI improved significantly in the SGB group (5.74 ± 1.64 vs. 8.03 ± 1.86, p < 0.001), with increased total sleep time (TST) (429.76 ± 33.22 vs. 391.13 ± 30.76 min, p < 0.001) and efficiency (90.23 ± 13.29% vs. 86.34 ± 12.84%, p < 0.001).

Neurotransmitter analysis showed reduced NE (289.43 ± 51.68 vs. 253.78 ± 57.12 pg./mL, p < 0.05) and increased 5-HT (138.56 ± 19.73 vs. 124.93 ± 18.44 ng/mL, p < 0.05) and NPY (453.21 ± 73.41 vs. 402.34 ± 68.12 pg./mL, p < 0.05). Adverse events were comparable (6.25% vs. 3.13%, p = 0.403).

Conclusion
SGB effectively improves GAD symptoms and sleep quality in patients without comorbid depression, potentially via modulation of NE, 5-HT, and NPY pathways. The exclusion of psychiatric comorbidities enhances the specificity of these findings.

Link | PDF (Frontiers in Neurology) [Open Access]

 

[forestglip]

I'm confused about whether there was blinding. There's a paragraph talking about how everyone was blinded:

2.4 Blinding method

This study adhered to a double-blind design. Throughout the trial, patients, their families, surgeons, nurses, laboratory technicians, and data analysts were blinded to group assignments. All parties involved strictly maintained independence and avoided communication regarding treatment allocation to ensure unbiased implementation and evaluation. Blinding was achieved through the following measures:

• Anesthetic agents and placebo solutions were prepared in identical syringes by an independent pharmacist.

• Treatment codes were sealed in opaque envelopes and only unblinded after final data analysis.

But it seems like the control group 'received psychological intervention combined with estazolam tablets' and the study group received the stellate ganglion block. There's no further mention of placebo, and it's not clear that the study group received the psychological intervention and medication as well.

 

[Utsikt]

I'm confused about whether there was blinding. There's a paragraph talking about how everyone was blinded:


But it seems like the control group 'received psychological intervention combined with estazolam tablets' and the study group received the stellate ganglion block. There's no further mention of placebo, and it's not clear that the study group received the psychological intervention and medication as well.

The abstract says this:

randomized to receive SGB (n = 64, 4 ultrasound-guided 1% lidocaine injections) or conventional treatment (n = 64, cognitive behavioral therapy [CBT] + estazolam 1–2 mg/day).

It’s almost as if they have put in the bit about double blinding just to be able to say that it was double blinded in the title, and hope that no-one notices.

 

[forestglip]

Oh I think "on the basis of" means the study group received the control group intervention plus SGB:

On the basis of the intervention in the control group, patients in the study group underwent SGB treatment.

Edit: Maybe. I'm having trouble finding other papers that use that phrase. And that's not an official definition of that phrase. And the quote @Utsikt posted seems to say they got one or the other.

 

[jnmaciuch]

I’m not sure blinding with placebo injections would even be effective. The treatment was lidocaine, you could tell whether you received the treatment by whether you feel numbness.

Unless they happened to completely omit that detail in the participant consent process, which they shouldn’t have if they were adequately disclosing potential side effects.

And they didn’t mention what the “placebo” was.

 

[Jonathan Edwards]

I’m not sure blinding with placebo injections would even be effective. The treatment was lidocaine, you could tell whether you received the treatment by whether you feel numbness.

I agree that you can probably tell if you have had stellate ganglion block but I am not sure you get any numbness - the target is a sympathetic ganglion rather than a segmental sensory nerve.

It sounds to me like they have thrown in 'double blind' without any basis. Maybe the patients did not know which treatment was 'being tested'. Ethics requirements may not have been as they are in the UK or US?