Yao Ping, Guo Xingyan, Guo Zhiguo, Lin Wuhong, Liu Min, Chen Min, Li Jie, Cui Long-Biao, Lv Dongsheng
Inner Mongolia Mental Health Center (The Third Hospital of Inner Mongolia Autonomous Region, Brain Hospital of Inner Mongolia Autonomous Region), Hohhot, China.
Department of Radiology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Front Psychiatry. 2025 Jul 24;16:1533652. doi: 10.3389/fpsyt.2025.1533652. eCollection 2025.
Traditional Chinese medicine is one of the important methods for treating chronic insomnia disorder (CID).
We aimed to observe the multi-dimensional clinical outcomes of modified suanzaoren decoction (SZRD) compared to esazolam tablets in the treatment of CID patients.
A total of 80 patients with CID were divided into two treatment groups, and were given modified SZRD and esazolam tablets treatment respectively for 6 weeks. The Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index, Hamilton Anxiety Scale, Hamilton Depression Scale, polysomnography (PSG), repeated battery for the assessment of neuropsychological status were performed to assess the changes of subjective and objective sleep, mood, and cognitive function.
Intra-group improvement: Compared to before treatment, both the modified SZRD and estazolam groups showed improvements in subjective sleep, depression, anxiety, immediate memory, and delayed memory scores (<0.05). Inter-group comparison: There was a significant difference between the modified SZRD and estazolam groups in subjective PSQI scores (=0.033). Based on PSG objective assessment results, both the estazolam and modified SZRD groups demonstrated a significant increase in N3 stage sleep (slow-wave sleep) duration compared to before treatment (=0.037). However, there was no statistically significant difference in the effect size between the two groups (>0.05), indicating that both interventions were equivalent in improving deep sleep. Nevertheless, residual variance analysis indicates that estazolam showed enhanced predictive stability in subjective sleep quality assessed by ISI (SSR=11.73 vs. 31.19; =13.39, <0.001), while modified SZRD exhibited enhanced predictive stability in objective slow-wave sleep maintenance, specifically in N3 stage duration (SSR=703.11 vs. 1761.08; =4.98, =0.029).
After the treatment of CID with the modified SZRD and esazolam, they have the comparable clinical efficacy. However, estazolam showed a more consistent treatment effect in subjective sleep quality assessment among the study population, whereas modified SZRD showed a more consistent treatment effect in objective slow-wave sleep maintenance, specifically in N3 stage duration. The registration number was NCT06452953.
中医是治疗慢性失眠障碍（CID）的重要方法之一。
我们旨在观察与艾司唑仑片相比，改良酸枣仁汤（SZRD）治疗CID患者的多维度临床疗效。
将80例CID患者分为两个治疗组，分别给予改良SZRD和艾司唑仑片治疗6周。采用匹兹堡睡眠质量指数（PSQI）、失眠严重程度指数、汉密尔顿焦虑量表、汉密尔顿抑郁量表、多导睡眠图（PSG）、重复神经心理状态评估量表来评估主观和客观睡眠、情绪及认知功能的变化。
组内改善情况：与治疗前相比，改良SZRD组和艾司唑仑组在主观睡眠、抑郁、焦虑、即刻记忆和延迟记忆评分方面均有改善（<0.05）。组间比较：改良SZRD组和艾司唑仑组在主观PSQI评分上存在显著差异（=0.033）。基于PSG客观评估结果，与治疗前相比，艾司唑仑组和改良SZRD组的N3期睡眠（慢波睡眠）时长均显著增加（=0.037）。然而，两组之间的效应量无统计学显著差异（>0.05），表明两种干预措施在改善深度睡眠方面等效。尽管如此，残差方差分析表明，在通过ISI评估的主观睡眠质量方面，艾司唑仑显示出更高的预测稳定性（SSR=11.73对31.19；=13.39，<0.001），而改良SZRD在客观慢波睡眠维持方面，特别是在N3期时长方面显示出更高的预测稳定性（SSR=703.11对1761.08；=4.98，=0.029）。
改良SZRD和艾司唑仑治疗CID后具有相当的临床疗效。然而，在研究人群的主观睡眠质量评估中，艾司唑仑显示出更一致的治疗效果，而改良SZRD在客观慢波睡眠维持方面，特别是在N3期时长方面显示出更一致的治疗效果。注册号为NCT06452953。
