Efficacy and safety of acupoint application for gastrointestinal function in treating post-stroke depression: Protocol for a randomized controlled trial
- Author:
Xuan Zhang
1
;
Shuhui Li
1
;
Juntao Wang
1
;
Chung Tai Lau
1
;
Jacky C.P. Chan
2
Author Information
- Publication Type:Journal Article
- Keywords: Acupoint application; Gut microbiota; Post-stroke depression; Protocol; Randomized controlled trial
- From: Journal of Traditional Chinese Medical Sciences 2025;2025(4):552-558
- CountryChina
- Language:English
- Abstract: ObjectiveTo evaluate the efficacy and safety of acupoint application for post-stroke depression (PSD) by regulating gastrointestinal function. A secondary objective is to explore the potential mechanism underlying this approach from the perspective of gut microbiota.MethodsThis multicenter, randomized, double-blind (patients and assessors), placebo-controlled trial will enroll 80 patients with PSD, and include a 1-week run-in period, a 4-week treatment phase, and a 12-week follow-up. Eligible participants will randomly be assigned in a 1:1 ratio to either the acupoint application or placebo (non-acupoint) groups. Treatments will be administered thrice weekly for 4 weeks. The primary outcome is change in the Hamilton Rating Scale for Depression (HAMD) score. Secondary outcomes include the Beck Depression Inventory (BDI), 36-Item Short-Form Health Survey (SF-36), Barthel Index of Activities of Daily Living, Social Adaptation Self–Evaluation Scale (SASS), and gut microbiota profiling. All outcomes will be assessed at baseline (prior to treatment), during treatment (weeks 2 and 4), and during follow-up (weeks 8, 12, and 16). The Treatment Emergent Symptom Scale (TESS) will be used for evaluation throughout the 4-week treatment phase.DiscussionThe results of this study will provide important evidence supporting a novel treatment strategy for PSD that targets gastrointestinal regulation, potentially informing future clinical practice.
