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

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: Stellate ganglion block, generalized anxiety disorder, Sleep disturbance, efficacy, Mechanis