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 antherapeutic 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.
2.3. Treatment
For the acupuncture combined with FEM (AFEM) group, the prescription of
acupuncture included 3 points, included Baihui (GV20), Shenting (GV24),
Yintang (GV29), with disposable, sterilized, filiform needles 0.30×25-mm real
needles (Huatuo Medical Device Co, Ltd). Fig. 1 shows the nomenclature and
location of main acupoints. Treatments were performed by licensed acupuncturists
with at least 5 years of clinical experience with a training session before
study initiation. Rotating manipulation was applied to achieve deqi sensation.
After depi, twirling for 30 s at the frequency of 200 times per minute,
reinforcing-reducing method was conducted. During the retaining period,
chinese traditional five-element music by the Audio and Video Publishing House
of the Chinese Medical Association was adopted. Patients in the treatment groups
received a 30-min treatment 5 times per week for 4 consecutive weeks.
Patients in the CBT arm were offered individual 40-min sessions scheduled
twice a week in the first two weeks, then weekly in the following 4 weeks.
Therapists followed the procedures outlined in the CBT Manual for
Depgression 26 developed by the authors.