Premium
Randomized double‐blind placebo‐controlled multicenter trial of Y okukansan for neuropsychiatric symptoms in A lzheimer's disease
Author(s) -
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
Publication year - 2017
Publication title -
geriatrics and gerontology international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.823
H-Index - 57
eISSN - 1447-0594
pISSN - 1444-1586
DOI - 10.1111/ggi.12696
Subject(s) - medicine , placebo , randomized controlled trial , adverse effect , dementia , psychiatry , physical therapy , disease , alternative medicine , pathology
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 A lzheimer'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