Randomized controlled trial of bushen yinao pill combined with conventional therapy on intestinal flora imbalance and cognitive function improvement in older patients with Alzheimer's disease.

Objective: This study aimed to evaluate the effects of the Bushen Yinao Pill, combined with standard therapy, on gut flora imbalances, inflammatory markers, and cognitive function in older patients with Alzheimer's disease (AD).

Methods: A total of 136 AD patients treated at the Department of Neurology from August 2022 to September 2023 were randomly assigned to two groups: 68 patients received standard treatment (control group, CTG), and 68 patients received the Bushen Yinao Pill plus standard treatment (intervention group, ITG). Outcomes included TCM syndrome scores, gut microbiota composition, inflammatory markers, cognitive function, overall efficacy, and safety.

Results: ITG showed significant reductions in syndrome scores as compared to CTG after treatment (P < 0.05). The ITG also showed significant increases in beneficial bacteria and decreases in harmful bacteria compared to the CTG (P < 0.05). Inflammatory markers (Aβ, IL-6, TNF-α) were reduced, and cognitive function improved more significantly in the ITG (P < 0.05). The effective rate was higher in the ITG, with no significant difference in adverse reactions between the groups (P > 0.05).

Conclusion: The Bushen Yinao Pill, when combined with standard therapy, effectively regulates gut microbiota, reduces inflammatory markers, and enhances cognitive function in AD patients, showing a favorable safety profile. Further research is recommended to validate these findings in diverse populations.