Comparing the Effect of Acupuncture, Sham Acupuncture, and Waiting-List Control on Patients with Post-stroke Cognitive Impairment: A Randomized Clinical Trial.

Background: There remains no global consensus on the use of acupuncture therapy in post-stroke cognitive impairment (PSCI), particularly in large sample multi-center RCTs.

Aim: To determine whether acupuncture can enhance cognitive function in PSCI.

Design and methods: This RCT was conducted from December 2019 to February 2024. A total of 360 participants were recruited and randomly assigned to manual acupuncture (MA), sham acupuncture (SA), or waiting-list control (WC) groups in a 1:1:1 ratio. This study utilized centralized randomization with allocation concealment by Minimpy software and was executed in five hospitals located in Tianjin, Changchun, Changsha, Baotou, and Changzhi, China. The MA group underwent 36 acupuncture sessions for 12 weeks. Participants were observed for a further 24 weeks without any intervention. The primary outcome was measured by MoCA scale. Secondary outcomes were evaluated by MMSE, CDR, NPI, FAQ, WHOQOL-BREF, and Aβ-42. Statistical analysis was conducted by t-tests, the Kruskal-Wallis test, one-way ANOVA, and linear mixed-effects model.

Results and conclusion: 307 of the 360 patients were analyzed. The MA group showed significant improvement in MoCA scores compared to the SA and WC groups, with increases of 2.21 [95% CI, 1.28 to 3.13; P < 0.001] and 2.76 [95% CI, 1.74 to 3.77; P < 0.001] at week 36. The results derived from the MMSE, CDR, NPI, FAQ, and WHOQOL-BREF indicate that acupuncture therapy may enhance cognitive function and overall quality of life, although it does not appear to affect Aβ-42 levels when contrasting the MA group with the SA or WC groups. Acupuncture therapy could significantly improve cognitive function in adults with PSCI.

Trial registration: Chinese Clinical Trial Registry: ChiCTR2000033801.