Efficacy and Safety of Acupuncture Combined with Yishen Granule in Elderly Adults with Mild Cognitive Impairment: A Multicenter, Randomized Controlled Trial.

Objective: Mild cognitive impairment (MCI) is a clinical disease that is prevalent in the elderly. Traditional Chinese herbs (TCHs) and acupuncture are valuable therapeutic options for MCI. This study aimed to assess the efficacy and safety of acupuncture and Yishen Granule (YSG) in restoring cognitive function in elderly patients with MCI. Methods: A multicenter, randomized, double-blind, parallel-group, controlled trial (8-week intervention) was conducted at two tertiary hospitals in Shanghai, China. A total of 120 participants were randomly divided into four groups (n = 30 per group): A, acupuncture with YSG; B, acupuncture with placebo herbal medicine; C, sham acupuncture with YSG; D, sham acupuncture with placebo herbal medicine. The primary outcome was a change in Montreal Cognitive Assessment (MoCA), while the secondary outcome was to evaluate improvement in the Mini-Mental State Examination (MMSE). Assessments were conducted at baseline and weeks 4 and 8. Results: Of the 120 patients (69.17 ± 6.57 years; 71 women [59.17%] and 49 men [40.83%]) included in the study, 106 (88.33%) completed the study. Two-way repeated measures ANOVA showed that the MoCA and MMSE scores in group A were significantly different from those in group D at week 4 (P < .05). At week 8, the MoCA and MMSE scores in groups A, B, and C were significantly improved compared with those in group D (P < .001 for all), and the delayed recall score in group A was significantly greater than those in groups B and C (P < .05). Acupuncture and YSG were well tolerated and safe, and no serious adverse events were reported. Conclusions: Acupuncture, YSG, and the combination of both improved cognitive function, with the combined therapy being the most effective, which can be beneficial in preventing dementia and improving the quality of life of the elderly.