Pang Hao-Yu, Chen Xu, Xi Ling-Yun, Jia Qian-Lin, Bai Yang, Cao Jing, Hong Xia
Department of Neurology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, 100091, China.
Graduate School, Beijing University of Chinese Medicine, Beijing, 100029, China.
Chin J Integr Med. 2025 Apr;31(4):291-298. doi: 10.1007/s11655-024-3923-1. Epub 2024 Dec 11.
To evaluate the therapeutic effect of Yu Melody relaxation training (YMRT) combined with Jianpi Jieyu Decoction (JJD) in treating patients with insomnia disorders (ID).
In this randomized controlled study, 94 ID patients were included from Xiyuan Hospital, China Academy of Chinese Medical Sciences from September 2022 to January 2024. They were randomly assigned to the YMRT group (47 cases, YMRT plus JJD) and the control group (47 cases, oral JJD) using a random number table. Both treatment administrations lasted for 4 weeks, with a 2-week follow-up. The primary outcome was change in Insomnia Severity Index (ISI) scores from baseline to 4 weeks of intervention. Secondary outcomes included ISI response at week 4, as well as ISI, Patient Health Questionnaire-9 (PHQ-9), and Generalized Anxiety Disorder 7-item (GAD-7) scores at baseline and weeks 1, 2, 3, 4, and 6. Additionally, Pittsburgh Sleep Quality Index (PSQI) scores were evaluated at baseline and weeks 4 and 6. Adverse events (AEs) were recorded and compared between groups.
Five patients in each group did not complete the protocol requirements. The overall dropout rate was 10.64%. The full analysis set included all 47 cases in each group. The ISI score decreased significantly at week 4 from baseline in the YMRT group compared with the control group, with a between-group difference of -3.2 points [95% confidence interval (CI): -5.08 to -1.34; P<0.05]. The ISI response at week 4 in the YMRT group was significantly higher than that in the control group (85.11% vs. 51.06%), with a between-group difference of 34.05% (95% CI: 13.77% to 50.97%; P<0.05). At week 6, the YMRT group demonstrated greater reductions from baseline than the control group, with between-group differences of -2.1 points (-95% CI: -3.49 to -0.64; P<0.05) for PHQ-9 scores, -3.5 points (95% CI: -5.21 to -1.85; P<0.05) for PSQI scores, and -1.9 points (95% CI: -3.47 to -0.28; P<0.05) for GAD-7 scores. Moreover, at weeks 4 and 6, the ISI and PSQI scores in the YMRT group were significantly lower than those in the control group (P<0.05); and at week 6, the PHQ-9 score in the YMRT group was significantly lower (P<0.05). There was no significant difference in the incidence rates of AEs between the two groups (8.51% vs. 4.26%, P>0.05).
YMRT combined with oral JJD could improve sleep quality and alleviate depressive and anxiety symptoms in patients with ID. This combined therapy was effective and safe, and its effect was superior to oral JJD alone. (Registration No. ChiCTR2200063884).
评价俞氏韵律放松训练（YMRT）联合健脾解郁汤（JJD）治疗失眠症（ID）患者的疗效。
在这项随机对照研究中，选取了2022年9月至2024年1月中国中医科学院西苑医院的94例ID患者。使用随机数字表将他们随机分为YMRT组（47例，YMRT加JJD）和对照组（47例，口服JJD）。两种治疗方案均持续4周，并进行2周的随访。主要结局是从基线到干预4周时失眠严重程度指数（ISI）评分的变化。次要结局包括第4周时的ISI反应，以及基线、第1、2、3、4和6周时的ISI、患者健康问卷-9（PHQ-9）和广泛性焦虑障碍7项（GAD-7）评分。此外，在基线、第4和6周时评估匹兹堡睡眠质量指数（PSQI）评分。记录并比较两组的不良事件（AE）。
每组各有5例患者未完成方案要求。总脱落率为10.64%。全分析集包括每组的所有47例病例。与对照组相比，YMRT组在第4周时ISI评分较基线显著降低，组间差异为-3.2分[95%置信区间（CI）：-5.08至-1.34；P<0.05]。YMRT组在第4周时的ISI反应显著高于对照组（85.11%对51.06%），组间差异为34.05%（95%CI：13.77%至50.97%；P<0.05）。在第6周时，YMRT组较对照组从基线的降低幅度更大，PHQ-9评分的组间差异为-2.1分（95%CI：-3.49至-0.64；P<0.05），PSQI评分的组间差异为-3.5分（95%CI：-5.21至-1.85；P<0.05），GAD-7评分的组间差异为-1.9分（95%CI：-3.47至-0.28；P<0.05）。此外，在第4和6周时，YMRT组的ISI和PSQI评分显著低于对照组（P<0.05）；在第6周时，YMRT组的PHQ-9评分显著更低（P<0.05）。两组AE的发生率无显著差异（8.51%对4.26%，P>0.05）。
YMRT联合口服JJD可改善ID患者的睡眠质量，减轻抑郁和焦虑症状。这种联合疗法有效且安全，其效果优于单纯口服JJD。（注册号：ChiCTR2200063884）
