TY - JOUR
T1 - Randomized double-blind placebo-controlled multicenter trial of Yokukansan for neuropsychiatric symptoms in Alzheimer's disease
AU - Furukawa, Katsutoshi
AU - Tomita, Naoki
AU - Uematsu, Daisuke
AU - Okahara, Kazunori
AU - Shimada, Hiroyuki
AU - Ikeda, Masaki
AU - Matsui, Toshifumi
AU - Kozaki, Koichi
AU - Fujii, Masahiko
AU - Ogawa, Tatsuji
AU - Umegaki, Hiroyuki
AU - Urakami, Katsuya
AU - Nomura, Hiroshi
AU - Kobayashi, Naoto
AU - Nakanishi, Aki
AU - Washimi, Yukihiro
AU - Yonezawa, Hisashi
AU - Takahashi, Satoshi
AU - Kubota, Masaharu
AU - Wakutani, Yosuke
AU - Ito, Daisuke
AU - Sasaki, Takahiro
AU - Matsubara, Etsuro
AU - Une, Kaori
AU - Ishiki, Aiko
AU - Yahagi, Yukie
AU - Shoji, Mikio
AU - Sato, Hiroyasu
AU - Terayama, Yasuo
AU - Kuzuya, Masafumi
AU - Araki, Nobuo
AU - Kodama, Manabu
AU - Yamaguchi, Takuhiro
AU - Arai, Hiroyuki
N1 - Publisher Copyright:
© 2015 Japan Geriatrics Society
PY - 2017/2/1
Y1 - 2017/2/1
N2 - Aim: 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). Methods: 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. Results: 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. Conclusions: 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.
AB - Aim: 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). Methods: 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. Results: 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. Conclusions: 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.
KW - Alzheimer's disease
KW - Kampo medicine
KW - Neuropsychiatric Inventory Brief Questionnaire Form
KW - Yokukansan
KW - behavioral and psychological symptoms of dementia
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U2 - 10.1111/ggi.12696
DO - 10.1111/ggi.12696
M3 - Article
C2 - 26711658
AN - SCOPUS:84952690888
SN - 1447-0594
VL - 17
SP - 211
EP - 218
JO - Geriatrics and Gerontology International
JF - Geriatrics and Gerontology International
IS - 2
ER -