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.

广泛性焦虑障碍（GAD）患者常共病失眠症状，给临床治疗带来更多困难。有研究表明，针刺可有效改善焦虑症状，优化睡眠结构，但其联合抗焦虑药物对GAD患者伴发失眠症状的增效作用尚有待研究。

探讨针刺联合抗焦虑药物治疗GAD伴发失眠症状患者的增效作用。

本研究为多中心、随机对照试验，于2024年1月—2025年10月纳入上海交通大学医学院附属精神卫生中心、上海中医药大学附属龙华医院、上海市针灸经络研究所确诊的74例GAD伴失眠症状的患者，随机分为试验组（n=43）与对照组（n=31）。对照组接受抗焦虑药物治疗，试验组接受针刺联合抗焦虑药物治疗，两组均连续治疗8周。设置5个时间点（V1-基线期、V2-干预1个月、V3-干预结束期、V4-干预结束后1个月、V5-干预结束后3个月）进行临床评估，评估工具为汉密尔顿焦虑量表（HAMA）和匹兹堡睡眠质量指数（PSQI），主要临床评价指标为HAMA减分率。采用广义线性混合模型（GLMM）分析随访过程中组别、时间及交互作用对HAMA得分和PSQI得分的影响，同时进行非参数敏感性分析验证结果稳健性。针刺相关不良事件也均如实记录。

最终纳入数据有效的患者69例，其中试验组38例，对照组31例。试验组HAMA减分率高于对照组[89.5%（34/38）比61.3%（19/31），P<0.01]。GLMM分析结果显示，HAMA得分和PSQI得分的时间主效应、组别主效应、组别与时间的交互效应均具有统计学意义（P<0.01）。事后比较结果显示，试验组V3和V4时间点的HAMA得分低于对照组（P<0.05），试验组V3时间点的PSQI得分低于对照组（P<0.05）。补充性分析结果与GLMM分析结果一致，试验组干预结束期（V3）HAMA得分和PSQI得分低于对照组（P<0.01）。对PSQI子维度的分析结果也显示，试验组干预结束期（V3）的睡眠质量、睡眠时间、睡眠效率、日间功能障碍子维度得分低于对照组（P<0.05）。两组均未出现与治疗方案相关的严重不良事件。

针刺联合抗焦虑药物治疗GAD伴发失眠症状，在缓解焦虑和改善睡眠质量方面均明显优于单用抗焦虑药物，且疗效稳健、安全性良好，为此类患者提供了更优治疗方案。