Effects of Acupuncture Combined with Five-element music for People with mild/moderate Post-Stroke Depression: A Randomized Controlled Trial.

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 (11) 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.