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Efficacy and Safety of Huanglian Wendan Decoction Combined with Donepezil in Patients with Mile Alzheimer?s disease: A Randomized Controlled Trial
Lin Lin, Yang QiHan, Li TingTing, Hou JiXin, Hou JiXin, Duan Ran, Wen Quan
Background and Objective: Currently, drugs for Alzheimer's disease (AD) are unable to slow or prevent neuronal damage. Clinical studies have shown that a Traditional Chinese Medicine (TCM) decoction combined with conventional Western medicine has a synergistic effect in the treatment of AD. This study aimed to investigate the clinical efficacy and safety of the Huanglian Wendan Decoction (HLWD) combined with donepezil in patients with AD.
Methods: Fifty-two eligible patients were randomly and equally assigned into two groups: one receiving HLWD and donepezil and one control group receiving donepezil alone for 12 weeks. The primary endpoints were measured by the Mini-Mental State Examination (MMSE) and serum levels of Interleukin-1β (IL-1β) and Interleukin-6 (IL-6). Secondary outcomes were evaluated using the Wechsler Memory Scale (WMS), the activity of daily living (Barthel index), and the TCM Symptom Grading Quantitative Scale Score (TCMS).
Results: After 12 weeks of treatment, the MMSE, WMS, and Barthel index scores in the patients of both the groups were higher than those before treatment (P<0.05). TCMS was lower than before treatment in both the groups (P<0.05), whereas the MMSE, WMS, and Barthel index scores of the HLWD group were significantly higher than those of the control group (P<0.05). After treatment, the TCMS score of the HLWD group was significantly lower than that of the control group (P<0.05). Additionally, IL-1β and IL-6 levels in both the groups decreased (P<0.05), while they were significantly lower in the HLWD group than those in the control group (P<0. 05).
Conclusion: HLWD combined with donepezil has significant clinical efficacy in the treatment of patients with mild AD, improving their cognition, memory function, self-care ability, TCM symptoms, and reducing the levels of IL-1β and IL-6.