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
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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引用次数: 0

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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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.

Registration

This study registered with the ClinicalTrials.gov Identifier: ChiCTR1900023741.
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CiteScore
7.20
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