Patients with generalized anxiety disorder (GAD) frequently comorbid with insomnia symptoms, which complicates clinical management. Studies have shown that acupuncture can effectively alleviate anxiety and improve sleep architecture; however, its synergistic effect when combined with anxiolytic medication in GAD patients with insomnia symptoms remains to be investigated.
Evaluate the synergistic effect of acupuncture combined with anxiolytic medication in treating GAD patients with comorbid insomnia symptoms.
This multicenter randomized controlled study was conducted from January 2024 to October 2025 at Shanghai Jiao Tong University School of Medicine Affiliated Mental Health Center, Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital and Shanghai Research Institute of Acupuncture and Meridian. A total of 74 patients with GAD with insomnia symptoms were enrolled and randomly assigned to an experimental group (n=43, acupuncture plus anxiolytics) or a control group (n=31, anxiolytics alone), both receiving 8 weeks of treatment. Clinical assessments were performed at five time points: baseline (V1), 1 month into treatment (V2), end of treatment (V3), 1 month post-treatment (V4), and 3 months post-treatment (V5), using the Hamilton Anxiety Rating Scale (HAMA) and the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was the HAMA reduction rate. Generalized linear mixed models (GLMM) were used to analyze the effects of group, time, and their interaction on HAMA and PSQI scores. Non-parametric sensitivity analyses were conducted to verify result robustness. Acupuncture-related adverse events were also recorded.
In the end, 69 patients with valid data were included in the analysis, with 38 cases in the experimental group and 31 cases in the control group. The HAMA reduction rate was significantly higher in the experimental group than in the control group [89.5% (34/38) vs 61.3% (19/31), P<0.01]. GLMM results revealed significant main effects of time, group, and group×time interaction on both HAMA and PSQI scores (P<0.01). Sensitivity analyses were consistent with the GLMM results, demonstrating lower HAMA and PSQI scores in the experimental group at V3 (P<0.01). PSQI sub-dimension analysis at V3 also demonstrated that the experimental group achieved greater improvements in sleep quality, sleep duration, sleep efficiency and daytime dysfunction compared with the control group (P<0.05). No serious treatment-related adverse events occurred in either group.
Acupuncture combined with anxiolytic medication is significantly superior to anxiolytic medication alone in alleviating anxiety and improving sleep quality in GAD patients with insomnia symptoms, with robust efficacy and a favorable safety profile, thus providing a better therapeutic option for this population.
Insomnia disorder has become a global public health challenge, frequently comorbid with anxiety and depression, while existing monotherapies have their respective limitations. The combination of stellate ganglion block (SGB) and cognitive behavioral therapy for insomnia (CBT-I) shows promise, but the optimal treatment frequency of SGB within this combined regimen remains unclear.
This study aimed to directly compare the efficacy and safety of high-frequency (12 consecutive days) versus low-frequency (6 consecutive days) SGB combined with CBT-I in the treatment of insomnia disorder.
This study was a prospective randomized controlled trial. A total of 126 patients with insomnia disorder who attended the Anesthesia Sleep Clinic of the Third Affiliated Hospital of Guangzhou University of Chinese Medicine from February to August 2025 were enrolled and randomly divided into a high-frequency SGB group (HF-SGB group, n=63) and a low-frequency SGB group (LF-SGB group, n=63). All patients received standard CBT-I for 4 weeks. On this basis, the HF-SGB group underwent ultrasound-guided SGB treatment for 12 consecutive days, while the LF-SGB group received SGB for 6 consecutive days. Assessments were conducted using the Pittsburgh Sleep Quality Index (PSQI), the Generalized Anxiety Disorder scale (GAD-7), and the Patient Health Questionnaire (PHQ-9) at one day before treatment initiation (baseline, T1), one day after treatment completion (T2), 4 weeks after treatment completion (T3), and 12 weeks after treatment completion (T4). Adverse events during treatment were also recorded.
A total of 116 patients completed the follow-up, with 58 in each group. Repeated-measures ANOVA showed that the main effects of time, the main effects of group, and the time×group interaction effects for PSQI, GAD-7, and PHQ-9 scores were all statistically significant (P<0.05). Except for the PHQ-9 score in the LF-SGB group at T4, which showed no statistically significant difference compared to baseline (P>0.05), all other scores in both groups improved from baseline at T2, T3, and T4 (P<0.05). At all follow-up time points, the PSQI, GAD-7, and PHQ-9 scores in the HF-SGB group were significantly lower than those in the LF-SGB group (P<0.05). At T2, the median PSQI score difference between the two groups was 3 points, reaching the minimal clinically important difference for this scale. There was no statistically significant difference in the incidence of adverse events between the two groups (P>0.05), and all adverse events were mild and transient.
High-frequency SGB combined with CBT-I is superior to the low-frequency regimen in improving sleep and emotional symptoms in patients with insomnia disorder, with comparable safety. The 12-day SGB protocol can be considered the preferred clinical option.
Coexisting obstructive sleep apnea (OSA) and insomnia, termed COMISA, is clinically prevalent but frequently underdiagnosed. Although non-invasive positive pressure ventilation (NPPV) is the first-line treatment for OSA, patients with COMISA often show poor adherence to NPPV due to difficulty falling asleep and intolerance to the mask or airflow. Eszopiclone improves insomnia and shortens sleep latency, thus potentially enhancing initial NPPV adherence. Telemedicine management overcomes geographical barriers, enables dynamic adjustment of ventilator parameters, and facilitates long-term follow-up.
To investigate the effect of telemedicine management combined with eszopiclone on NPPV adherence in patients with COMISA.
Patients who attended the Sleep Center and Physical Examination Center of Sichuan Provincial Fourth People's Hospital from January to October 2024 were enrolled. After completing questionnaire assessments and polysomnography, those who met the diagnostic criteria for COMISA and agreed to receive NPPV were randomly assigned to either an experimental group or a control group. The experimental group received telemedicine-supported NPPV pressure titration and treatment, plus oral eszopiclone for 4 weeks before bedtime. The control group received in-hospital manual NPPV pressure titration and routine outpatient card-reading follow-up. Both groups were followed for 3 months. The Pittsburgh Sleep Quality Index (PSQI), Self-Rating Scale of Sleep (SRSS), and Epworth Sleepiness Scale (ESS) were recorded at baseline and at 3 months. NPPV adherence parameters (nightly use hours, percentage of days of use relative to total days, percentage of days with ≥4 hours of use, 95th percentile pressure, residual AHI, and air leak) were automatically collected via the ventilator cloud platform at 1 week, 1 month, and 3 months. Repeated-measures analysis of variance (ANOVA) was used to compare changes over time between groups, and paired t-tests were used to compare pre- and post-treatment scores within groups.
A total of 83 patients with confirmed COMISA (43 in the experimental group, 40 in the control group) were included. During the 3-month treatment period, the experimental group showed significantly better outcomes than the control group in NPPV use hours, percentage of days of use (both total days and days with ≥4 hours), post-treatment AHI, and air leak (all adjusted P<0.017). Regarding sleep scales, at 3 months the experimental group had significant reductions from baseline in PSQI (P=0.022), SRSS (P<0.001) and ESS (P=0.041), whereas the control group showed a reduction only in PSQI (P=0.001) and SRSS (P=0.036). Between-group comparisons revealed lower PSQI (P<0.001) and ESS (P=0.016) scores in the experimental group than in the control group; no significant between-group difference was observed in SRSS scores (P>0.05). The incidence of eszopiclone-related adverse events in the experimental group was 25.6% (11/43), all events were mild to moderate, with no serious adverse events or signs of respiratory depression. All patients in the experimental group were successfully connected to the telemedicine platform, and a total of 3 280 automatic data uploads were completed.
Telemedicine management combined with eszopiclone effectively improves NPPV adherence, sleep quality in patients with COMISA. This integrated approach offers a novel strategy for the comprehensive management of this population.
