Acupuncture plus wet cupping therapy for post stroke depression: a randomized controlled trial

Objective To explore the preliminary clinical efficacy and safety of acupuncture plus wet cupping on post-stroke depression (PSD) and to investigate its potential associations with changes in the hypothalamic-pituitary-adrenal (HPA) axis and inflammatory factors. Methods 130 mild-to-moderate PSD patients were randomized into two groups: an acupuncture plus wet cupping therapy group (AC group, n=65) and an acupuncture-only group (Acu group, n=65). The primary outcome was the change from baseline (pre-treatment) in the Hamilton Depression Scale-24 (HAMD-24) score at the end of week 4 (post-treatment). Secondary outcomes included the change from baseline in the HAMD-24 score at the 8 weeks after the 4-week treatment period (follow-up), the changes from baseline (pre-treatment) in the Self-rating Depression Scale (SDS), National Institute of Health Stroke Scale (NIHSS), and Montgomery-Asberg Depression Rating Scale (MADRS) at the end of week 4 (post-treatment) and 8 weeks after the 4-week treatment period (follow-up). Hematological indicator outcomes were measured at baseline and the end of week 4 (post-treatment), including cortisol (Cort), adrenocorticotropic hormone (ACTH), interleukin (IL-1β, IL-2, IL-6, IL-8, IL-10, IL-17), and tumor necrosis factor-α (TNF-α). Results 118 patients completed the trial. AC group showed greater reductions in HAMD-24, SDS, NIHSS, MADRS scores post-treatment and follow-up (all P<0.01), and more significant regulation of Cort, ACTH, pro-inflammatory cytokines (IL-1β, etc.) and anti-inflammatory IL-10 (all P<0.01). No serious adverse events occurred. Conclusion In this randomized controlled trial, acupuncture plus wet cupping might show comparative superiority over acupuncture monotherapy in improving PSD symptoms and neurological function, and was accompanied by favorable changes in HPA axis and inflammatory factors. The findings reflect incremental therapeutic benefits rather than definitive efficacy beyond placebo or standard care for PSD. Clinical trial registration https://www.chictr.org.cn/index.html , identifier ChiCTR2400084634.