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. 2025 May 7:16:1554841.
doi: 10.3389/fneur.2025.1554841. eCollection 2025.

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 #  1 , Qinying Ma #  1 , Moqing Zhou  1 , Lin Yang  1 , Wenyuan Wang  1 , Yanyong Wang  1
Affiliations

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 et al. Front Neurol. .

Abstract

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.

Keywords: efficacy; generalized anxiety disorder; mechanism; sleep disturbance; stellate ganglion block.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Comparison of anxiety and depression between the two groups. #p < 0.05 compared to the same group before treatment (1 day); *p < 0.05 compared to the control group at 1 month after treatment.
Figure 2
Figure 2
Comparison of sleep quality between the two groups. #p < 0.05 compared to the same group before treatment (1 day); *p < 0.05 compared to the control group at 1 month after treatment.
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