Randomized double-blind placebo-controlled multicenter trial of Yokukansan for neuropsychiatric symptoms in Alzheimer's disease

被引：37

作者：

Furukawa, Katsutoshi ^{[1
]}

Tomita, Naoki ^{[1
]}

Uematsu, Daisuke ^{[2
]}

Okahara, Kazunori ^{[3
]}

Shimada, Hiroyuki ^{[4
]}

Ikeda, Masaki ^{[5
]}

Matsui, Toshifumi ^{[6
]}

Kozaki, Koichi ^{[7
]}

Fujii, Masahiko ^{[8
]}

Ogawa, Tatsuji ^{[9
]}

Umegaki, Hiroyuki ^{[10
]}

Urakami, Katsuya ^{[11
]}

Nomura, Hiroshi ^{[12
]}

Kobayashi, Naoto ^{[13
]}

Nakanishi, Aki ^{[14
]}

Washimi, Yukihiro ^{[15
]}

Yonezawa, Hisashi ^{[16
]}

Takahashi, Satoshi ^{[16
]}

Kubota, Masaharu ^{[17
]}

Wakutani, Yosuke ^{[18
]}

Ito, Daisuke ^{[19
]}

Sasaki, Takahiro ^{[20
]}

Matsubara, Etsuro ^{[21
,24
]}

Une, Kaori ^{[1
]}

Ishiki, Aiko ^{[1
]}

Yahagi, Yukie ^{[22
]}

Shoji, Mikio ^{[21
]}

Sato, Hiroyasu ^{[22
]}

Terayama, Yasuo ^{[16
]}

Kuzuya, Masafumi ^{[10
]}

Araki, Nobuo ^{[20
]}

Kodama, Manabu ^{[23
]}

Yamaguchi, Takuhiro ^{[22
]}

Arai, Hiroyuki ^{[1
]}

机构：

[1] Aging & Canc Tohoku Univ, Inst Dev, Div Brain Sci, Dept Geriatr & Gerontol, 4-1 Seiryo Cho Aobaku, Sendai, Miyagi 9808575, Japan

[2] Uematsu Neurol Clin, Saitama, Japan

[3] Keimei Mem Hosp, Kunitomi, Japan

[4] Osaka City Univ, Dept Geriatr & Neurol, Grad Sch Med, Osaka, Japan

[5] Gunma Univ, Dept Neurol, Grad Sch Med, Maebashi, Gunma, Japan

[6] Natl Hosp Org Kurihama Med & Addict Ctr, Yokosuka, Kanagawa, Japan

[7] Kyorin Univ, Dept Geriatr Med, Sch Med, Mitaka, Tokyo, Japan

[8] Yamagata Kousei Hosp, Yamagata, Japan

[9] Aoba Neurosurg Clin, Sendai, Miyagi, Japan

[10] Nagoya Univ, Dept Community Healthcare & Geriatr, Grad Sch Med, Nagoya, Aichi, Japan

[11] Tottori Univ, Fac Med, Sch Hlth Sci, Dept Biol Regulat, Yonago, Tottori, Japan

[12] Hiroshi Nomura Neurol Clin, Sendai, Miyagi, Japan

[13] Azuma St Clin, Fukushima, Japan

[14] Osaka City Kousaiin Hosp, Dept Neurol & Psychiat, Suita, Osaka, Japan

[15] Natl Ctr Geriatr & Gerontol, Dept Cognit Disorders, Obu, Japan

[16] Iwate Med Univ, Dept Neurol, Morioka, Iwate, Japan

[17] Kusakabe Mem Hosp, Yamanashi, Japan

[18] Kurashiki Heisei Hosp, Neurol, Kurashiki, Okayama, Japan

[19] Keio Univ, Dept Neurol, Sch Med, Tokyo, Japan

[20] Saitama Med Univ, Sch Med, Dept Neurol, Moroyama, Saitama, Japan

[21] Hirosaki Univ, Dept Neurol, Inst Brain Sci, Grad Sch Med, Yufu, Japan

[22] Tohoku Univ Hosp, Clin Res Innovat & Educ Ctr, Sendai, Miyagi, Japan

[23] Kodama Hosp, Ishinomaki, Japan

[24] Oita Univ, Dept Neurol, Fac Medicine, Oita, Japan

来源：

GERIATRICS & GERONTOLOGY INTERNATIONAL | 2017年 / 17卷 / 02期

关键词：

Alzheimer's disease; behavioral and psychological symptoms of dementia; Kampo medicine; Neuropsychiatric Inventory Brief Questionnaire Form; Yokukansan; PSYCHOLOGICAL SYMPTOMS; DEMENTIA; METAANALYSIS; IMPROVEMENT;

D O I：

10.1111/ggi.12696

中图分类号：

R592 [老年病学]; C [社会科学总论];

学科分类号：

03 ; 0303 ; 100203 ;

摘要：

AimYokukansan (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). MethodsA total of 22 sites consisting of clinics, hospitals and nursing homes participated. A total of 145 patients with AD were randomized. Active YKS (7.5g/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. ResultsFour-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. ConclusionsOur 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

引用

页码：211 / 218

页数：8

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