针灸结合五行音乐对轻度/中度卒中后抑郁症患者的疗效：随机对照试验

IF 4.3 3区材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC ACS Applied Electronic Materials Pub Date : 2024-09-25 DOI:10.1016/j.ctim.2024.103088

Jinglong Sun , Xia Zhou , Binbin Ren , Youhua Guo , Qifeng Xu , Qin Wang , Ziyun Feng , Qingqing Jia , Wenwen Li , Li Li , Shouqiang Chen

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摘要

目的评估针灸结合五行音乐（FEM）作为中风后抑郁症患者身心状态治疗策略的有效性和安全性：2019年6月至2021年4月期间，在中国3家医院开展多中心随机临床试验，共招募237名PSD患者。轻度/中度PSD患者（17项GRID汉密尔顿抑郁量表（HAMD）评分7-24分）被随机分配（1:1）至针灸联合FEM（AFEM）组或认知行为疗法（CBT）组：主要结果：HAMD-17从基线到第12周的变化和组间差异为主要结果。次要结果包括Fugl-Meyer评估量表评分和卒中生活质量量表（SS-QOL）评分：在这项意向治疗分析中，237 名患者被随机分配到 AFEM 组（119 人）或认知行为疗法 (CBT) 组（118 人）。在这237名参与者中，有225人（94.9%）在第12周时完成了所有结果测量。从基线到第 12 周，AFEM 组和 CBT 组的 HAMD-17 均有显著改善。在第8周时，AFEM组患者的HAMD-17得分明显降低，为-3.56（95% CI，-4.59至-2.53；P 结论：结果表明，针灸和五行疗法能有效改善患者的HAMD-17得分：结果表明，针灸和五行音乐能明显改善中国PSD患者的抑郁症状，其毒性反应与CBP组相似：本研究已在ClinicalTrials.gov注册：ChiCTR1900023741。

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Effects of acupuncture combined with five-element music for people with mild/moderate post-stroke depression: A randomized controlled trial

Objectives

To evaluate the efficacy and safety of acupuncture combined with five-element music (FEM) as an therapeutic strategy for the physical and mental state of Post-stroke depression patients.

Design and setting

Multicenter, randomized clinical trial conducted at 3 hospitals in China and enrolling 237 patients with PSD between June 2019 and April 2021. Participants mild/moderate PSD (17-item GRID Hamilton Depression Scale (HAMD) score 7–24) were randomly assigned (1:1) to acupuncture combined with FEM (AFEM) group or cognitive behavioral therapy (CBT) group.

Main outcome measures

The primary outcome was change and differences between the groups in HAMD-17 from baseline to week 12. Secondary outcomes included Fugl-Meyer Assessment Scale score and Stroke-Specific Quality of Life Scale (SS-QOL) score.

Results

The 237 patients in this intention-to-treat analysis were randomized into either the AFEM group (n=119) or the cognitive behavioral therapy (CBT) group (n=118). Of these 237 participants, 225 (94.9 %) completed all outcome measurements at week 12. The AFEM and CBT groups both showed significant improvement in HAMD-17 from baseline to week 12. Patients in the AFEM group had significantly lower HAMD-17 scores of −3.56 at week 8 (95 % CI,-4.59 to −2.53; p <.001) and −3.50 at week 12 (95 % CI,-4.53 to −2.46; p<.001) than patients in the CBT group. The SS-QOL score improved significantly at week 12. The Fugl-Meyer score was significantly lower in the AFEM group than in the CBT group at week 4, but this difference was not statistically significant upon follow-up at weeks 8 and 12. The incidence of treatment-related adverse events was 2.1 % in the AFEM group, with no serious adverse events reported.

Conclusions

The results suggest that acupuncture and five-element music significantly improve the depressive symptoms in this cohort of Chinese PSD patients, and the toxicities were similar with CBP group.