Furukawa Katsutoshi, Tomita Naoki, Uematsu Daisuke, Okahara Kazunori, Shimada Hiroyuki, Ikeda Masaki, Matsui Toshifumi, Kozaki Koichi, Fujii Masahiko, Ogawa Tatsuji, Umegaki Hiroyuki, Urakami Katsuya, Nomura Hiroshi, Kobayashi Naoto, Nakanishi Aki, Washimi Yukihiro, Yonezawa Hisashi, Takahashi Satoshi, Kubota Masaharu, Wakutani Yosuke, Ito Daisuke, Sasaki Takahiro, Matsubara Etsuro, Une Kaori, Ishiki Aiko, Yahagi Yukie, Shoji Mikio, Sato Hiroyasu, Terayama Yasuo, Kuzuya Masafumi, Araki Nobuo, Kodama Manabu, Yamaguchi Takuhiro, Arai Hiroyuki
Department of Geriatrics and Gerontology, Division of Brain Sciences, Institute of Development, Aging and Cancer Tohoku University, Sendai, Japan.
Uematsu Neurological Clinic, Saitama, Japan.
Geriatr Gerontol Int. 2017 Feb;17(2):211-218. doi: 10.1111/ggi.12696. Epub 2015 Dec 29.
Yokukansan (YKS), a traditional herbal medicine, has been used to treat behavioral and psychological symptoms of dementia (BPSD). The present study is the first double-blind, randomized, placebo-controlled trial to determine the efficacy and safety of YKS for the treatment of BPSD in Alzheimer's disease (AD).
A total of 22 sites consisting of clinics, hospitals and nursing homes participated. A total of 145 patients with AD were randomized. Active YKS (7.5 g/day) and placebo were supplied to 75 and 70 participants, respectively. The primary outcome measure was the 4-week change in total score of the Neuropsychiatric Inventory Brief Questionnaire Form (NPI-Q), an instrument that evaluates BPSD. Secondary outcome measures included 12-week changes in NPI-Q scores, changes in NPI-Q subcategory scores and total scores of the Mini-Mental-State Examination.
Four-week changes in NPI-Q total scores did not differ significantly between the treatment and placebo groups. There were also no significant differences between groups in 12-week changes in total NPI-Q scores, NPI-Q subcategory scores or total Mini-Mental-State Examination scores. However, a subgroup with fewer than 20 points on the Mini-Mental-State Examination at baseline showed a greater decrease in "agitation/aggression" score in the YKS group than in the placebo group (P = 0.007). No serious adverse effects were observed during the study.
Our data did not reach statistical significance regarding the efficacy of YKS against BPSD; however, YKS improves some symptoms including "agitation/aggression" and "hallucinations" with low frequencies of adverse events. Geriatr Gerontol Int 2017; 17: 211-218.
yokukansan（YKS），一种传统草药，已被用于治疗痴呆的行为和心理症状（BPSD）。本研究是首个双盲、随机、安慰剂对照试验，以确定YKS治疗阿尔茨海默病（AD）中BPSD的疗效和安全性。
共有22个由诊所、医院和疗养院组成的地点参与。共有145例AD患者被随机分组。分别向75名和70名参与者提供活性YKS（7.5克/天）和安慰剂。主要结局指标是神经精神科问卷简表（NPI-Q）总分的4周变化，NPI-Q是一种评估BPSD的工具。次要结局指标包括NPI-Q评分的12周变化、NPI-Q子类别评分的变化以及简易精神状态检查的总分。
治疗组和安慰剂组之间NPI-Q总分的4周变化无显著差异。两组在NPI-Q总分、NPI-Q子类别评分或简易精神状态检查总分的12周变化方面也无显著差异。然而，基线时简易精神状态检查得分低于20分的亚组中，YKS组的“激越/攻击行为”评分比安慰剂组下降得更多（P = 0.007）。研究期间未观察到严重不良反应。
我们的数据在YKS治疗BPSD的疗效方面未达到统计学显著性；然而，YKS改善了一些症状，包括“激越/攻击行为”和“幻觉”，且不良事件发生率较低。《老年医学与老年病学国际杂志》2017年；17：211 - 218。
