PDF(Pubmed)
Abstract：
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.
摘要：
痴呆症的行为和心理症状是造成护理负担和医疗费用负担的主要因素。常规的药物治疗对益处与风险没有明显的影响。草药woohwangchungsimwon经常用于治疗神经精神疾病。以前曾报道过woohwangchungsimwon对痴呆症的行为和心理症状的影响；然而，尚未进行任何临床研究。我们旨在评估woohwangchungsimwon联合多奈哌齐缓解可能的阿尔茨海默病中这些症状的疗效和安全性。在这个随机的，评估者盲化，平行组临床试验，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woohwangchungsimwon多奈哌齐组合组（n=37）或多奈哌齐单组（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24周的研究。神经精神病量表子量表得分将是主要结果。次要结果将包括认知功能，痴呆严重程度，物理功能，生活质量,抑郁症,焦虑,和失眠。对于安全评估，我们将评估不良反应，测量生命体征,并进行实验室测试。这是第一个旨在证实woohwangchungsimwon联合多奈哌齐缓解痴呆行为和心理症状的有效性和安全性的试验。其发现可以为他们共同管理以控制可能的阿尔茨海默病的这些症状提供基础。
