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

IF 3.3 3区医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Complementary therapies in medicine 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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Abstract

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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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

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。

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来源期刊

Complementary therapies in medicine 医学-全科医学与补充医学

CiteScore

8.60

自引率

2.80%

发文量

101

审稿时长

112 days

期刊介绍： Complementary Therapies in Medicine is an international, peer-reviewed journal that has considerable appeal to anyone who seeks objective and critical information on complementary therapies or who wishes to deepen their understanding of these approaches. It will be of particular interest to healthcare practitioners including family practitioners, complementary therapists, nurses, and physiotherapists; to academics including social scientists and CAM researchers; to healthcare managers; and to patients. Complementary Therapies in Medicine aims to publish valid, relevant and rigorous research and serious discussion articles with the main purpose of improving healthcare.