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

Katsutoshi Furukawa, Naoki Tomita, Daisuke Uematsu, Kazunori Okahara, Hiroyuki Shimada, Masaki Ikeda, Toshifumi Matsui, Koichi Kozaki, Masahiko Fujii, Tatsuji Ogawa, Hiroyuki Umegaki, Katsuya Urakami, Hiroshi Nomura, Naoto Kobayashi, Aki Nakanishi, Yukihiro Washimi, Hisashi Yonezawa, Satoshi Takahashi, Masaharu Kubota, Yosuke WakutaniDaisuke Ito, Takahiro Sasaki, Etsuro Matsubara, Kaori Une, Aiko Ishiki, Yukie Yahagi, Mikio Shoji, Hiroyasu Sato, Yasuo Terayama, Masafumi Kuzuya, Nobuo Araki, Manabu Kodama, Takuhiro Yamaguchi, Hiroyuki Arai

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16 Citations (Scopus)

Abstract

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 (7.5g/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. 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.

Original languageEnglish
JournalGeriatrics and Gerontology International
DOIs
Publication statusAccepted/In press - 2015

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Keywords

  • Alzheimer's disease
  • Behavioral and psychological symptoms of dementia
  • Kampo medicine
  • Neuropsychiatric Inventory Brief Questionnaire Form
  • Yokukansan

ASJC Scopus subject areas

  • Geriatrics and Gerontology
  • Gerontology
  • Health(social science)

Cite this

Furukawa, K., Tomita, N., Uematsu, D., Okahara, K., Shimada, H., Ikeda, M., Matsui, T., Kozaki, K., Fujii, M., Ogawa, T., Umegaki, H., Urakami, K., Nomura, H., Kobayashi, N., Nakanishi, A., Washimi, Y., Yonezawa, H., Takahashi, S., Kubota, M., ... Arai, H. (Accepted/In press). Randomized double-blind placebo-controlled multicenter trial of Yokukansan for neuropsychiatric symptoms in Alzheimer's disease. Geriatrics and Gerontology International. https://doi.org/10.1111/ggi.12696