Kim Man Gi, Hyun Mi-Suk, Park Sang Gu, Cho Eun, Kim Jinsik, Choi Hyung-Kyoon, Son Kyung-Lak, Lim Chi-Yeon, Kim Kwang Ki, Koo Byung Soo
Department of Oriental Neuropsychiatry, Dongguk University Ilsan Oriental Hospital, Goyang 10326, Republic of Korea.
Department of Oriental Neuropsychiatry, Graduate School of Dongguk University, Seoul 04620, Republic of Korea.
Healthcare (Basel). 2023 Jul 16;11(14):2036. doi: 10.3390/healthcare11142036.
Behavioral and psychological symptoms of dementia are a major factor in the burden of care and medical expenses. Conventional pharmacological treatments do not exert a distinct effect on the benefits versus the risks. The herbal medicine woohwangchungsimwon is frequently prescribed for neuropsychiatric disorders. An effect of woohwangchungsimwon on behavioral and psychological symptoms of dementia has been previously reported; however, no clinical studies have been conducted. We aim to evaluate the efficacy and safety of woohwangchungsimwon combined with donepezil for alleviating these symptoms in probable Alzheimer's disease. In this randomized, assessor-blinded, parallel-group clinical trial, 74 participants with probable Alzheimer's disease will be divided via block randomization into a woohwangchungsimwon + donepezil combination group (n = 37) or a donepezil single group (n = 37). Participants will include patients under donepezil treatment for at least a month. We will perform the study for 24 weeks. The Neuro-Psychiatric Inventory subscale scores will be the primary outcome. Secondary outcomes will include cognitive function, dementia severity, physical function, quality of life, depression, anxiety, and insomnia. For safety evaluation, we will assess adverse reactions, measure vital signs, and conduct laboratory tests. This is the first trial aiming to confirm the efficacy and safety of woohwangchungsimwon combined with donepezil for alleviating behavioral and psychological symptoms of dementia. Its findings could provide a basis for their co-administration to control these symptoms in probable Alzheimer's disease.
痴呆的行为和心理症状是护理负担和医疗费用的主要因素。传统的药物治疗在利弊方面没有显著效果。草药五加茸芝丸常用于治疗神经精神疾病。此前已有报道五加茸芝丸对痴呆的行为和心理症状有作用；然而，尚未进行临床研究。我们旨在评估五加茸芝丸联合多奈哌齐在缓解可能的阿尔茨海默病患者这些症状方面的疗效和安全性。在这项随机、评估者盲法、平行组临床试验中，74名可能患有阿尔茨海默病的参与者将通过区组随机化分为五加茸芝丸 + 多奈哌齐联合组（n = 37）或多奈哌齐单药组（n = 37）。参与者将包括接受多奈哌齐治疗至少一个月的患者。我们将进行为期24周的研究。神经精神科问卷分量表得分将作为主要结局。次要结局将包括认知功能、痴呆严重程度、身体功能、生活质量、抑郁、焦虑和失眠。为进行安全性评估，我们将评估不良反应、测量生命体征并进行实验室检查。这是第一项旨在证实五加茸芝丸联合多奈哌齐缓解痴呆行为和心理症状的疗效和安全性的试验。其研究结果可为在可能的阿尔茨海默病中联合使用它们来控制这些症状提供依据。
