Randomized controlled trial of Bushen Yinao pill combined with conventional therapy on intestinal flora and cognitive function in older patients with Alzheimer's disease

Objective This study evaluated the effects of the Bushen Yinao pill, combined with standard therapy, on gut flora, 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 at a hospital in China 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 Traditional Chinese Medicine (TCM) syndrome scores, gut microbiota composition, inflammatory markers, cognitive function, overall efficacy, and safety. Results After treatment, the intervention group (ITG) showed significant reductions in TCM syndrome scores compared to the control group (CTG) ( P < 0.05). The ITG also showed significant increases in beneficial bacterial flora in the gut 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 significantly more in the ITG ( P < 0.05). There were no significant differences in adverse reactions between the groups ( P > 0.05). Conclusion The Bushen Yinao pill, when combined with standard therapy, may help to regulate gut microbiota, reduce inflammatory markers, and enhance cognitive function in AD patients, while also showing a favorable safety profile. Further research is recommended to validate these findings in other populations.