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Randomized double-blind placebo-controlled multicenter trial of Yokukansan for neuropsychiatric symptoms in Alzheimer's disease.
Geriatr Gerontol Int. 2017 Feb; 17(2):211-218.GG

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 (7.5 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.

Authors+Show Affiliations

Department of Geriatrics and Gerontology, Division of Brain Sciences, Institute of Development, Aging and Cancer Tohoku University, Sendai, Japan.Department of Geriatrics and Gerontology, Division of Brain Sciences, Institute of Development, Aging and Cancer Tohoku University, Sendai, Japan.Uematsu Neurological Clinic, Saitama, Japan.Keimei Memorial Hospital, Kunitomi, Japan.Department of Geriatrics and Neurology, Osaka City University Graduate School of Medicine, Osaka, Japan.Department of Neurology, Gunma University Graduate School of Medicine, Maebashi, Japan.National Hospital Organization Kurihama Medical and Addiction Center, Yokosuka, Japan.Department of Geriatric Medicine, Kyorin University School of Medicine, Mitaka, Japan.Yamagata Kousei Hospital, Yamagata, Japan.Aoba Neurosurgical Clinic, Sendai, Japan.Department of Community Healthcare & Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University, Yonago, Japan.Hiroshi Nomura Neurology Clinic, Sendai, Japan.Azuma Street Clinic, Fukushima, Japan.Department of Neurology and Psychiatry, Osaka City Kousaiin Hospital, Suita, Japan.Department of Cognitive Disorders, National Center for Geriatrics and Gerontology, Obu, Japan.Department of Neurology, Iwate Medical University, Morioka, Japan.Department of Neurology, Iwate Medical University, Morioka, Japan.Kusakabe Memorial Hospital, Yamanashi, Japan.Neurology, Kurashiki Heisei Hospital, Kurashiki, Japan.Department of Neurology, School of Medicine, Keio University, Tokyo, Japan.Department of Neurology, School of Medicine, Saitama Medical University, Moroyama, Japan.Department of Neurology, Institute of Brain Science, Hirosaki University Graduate School of Medicine, Yufu, Japan.Department of Geriatrics and Gerontology, Division of Brain Sciences, Institute of Development, Aging and Cancer Tohoku University, Sendai, Japan.Department of Geriatrics and Gerontology, Division of Brain Sciences, Institute of Development, Aging and Cancer Tohoku University, Sendai, Japan.Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai, Japan.Department of Neurology, Institute of Brain Science, Hirosaki University Graduate School of Medicine, Yufu, Japan.Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai, Japan.Department of Neurology, Iwate Medical University, Morioka, Japan.Department of Community Healthcare & Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.Department of Neurology, School of Medicine, Saitama Medical University, Moroyama, Japan.Kodama Hospital, Ishinomaki, Japan.Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai, Japan.Department of Geriatrics and Gerontology, Division of Brain Sciences, Institute of Development, Aging and Cancer Tohoku University, Sendai, Japan.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

26711658

Citation

Furukawa, Katsutoshi, et al. "Randomized Double-blind Placebo-controlled Multicenter Trial of Yokukansan for Neuropsychiatric Symptoms in Alzheimer's Disease." Geriatrics & Gerontology International, vol. 17, no. 2, 2017, pp. 211-218.
Furukawa K, Tomita N, Uematsu D, et al. Randomized double-blind placebo-controlled multicenter trial of Yokukansan for neuropsychiatric symptoms in Alzheimer's disease. Geriatr Gerontol Int. 2017;17(2):211-218.
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. (2017). Randomized double-blind placebo-controlled multicenter trial of Yokukansan for neuropsychiatric symptoms in Alzheimer's disease. Geriatrics & Gerontology International, 17(2), 211-218. https://doi.org/10.1111/ggi.12696
Furukawa K, et al. Randomized Double-blind Placebo-controlled Multicenter Trial of Yokukansan for Neuropsychiatric Symptoms in Alzheimer's Disease. Geriatr Gerontol Int. 2017;17(2):211-218. PubMed PMID: 26711658.
* Article titles in AMA citation format should be in sentence-case
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, Y1 - 2015/12/29/ PY - 2015/10/26/accepted PY - 2015/12/30/pubmed PY - 2017/12/27/medline PY - 2015/12/30/entrez KW - Alzheimer's disease KW - Kampo medicine KW - Neuropsychiatric Inventory Brief Questionnaire Form KW - Yokukansan KW - behavioral and psychological symptoms of dementia SP - 211 EP - 218 JF - Geriatrics & gerontology international JO - Geriatr Gerontol Int VL - 17 IS - 2 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. SN - 1447-0594 UR - https://www.unboundmedicine.com/medline/citation/26711658/Randomized_double_blind_placebo_controlled_multicenter_trial_of_Yokukansan_for_neuropsychiatric_symptoms_in_Alzheimer's_disease_ L2 - https://doi.org/10.1111/ggi.12696 DB - PRIME DP - Unbound Medicine ER -