TITLE:
The Efficacy and Safety of Yokukansankachimpihange for Treating Behavioral and Psychological Symptoms of Dementia in Patients with Alzheimer’s Disease: An Open-Label Pilot Study
AUTHORS:
Ryutaro Arita, Tetsuhiro Yoshino, Miwako Ohgishi, Takuya Hamaguchi, Yuko Horiba, Kaori Sawai, Kei Funaki, Hajime Tabuchi, Mizuki Oka, Takahito Yoshizaki, Kenji Watanabe, Masaru Mimura
KEYWORDS:
Alzheimer’s Disease, Behavioral and Psychological Symptoms of Dementia, Yokukansankachimpihange, Kampo Medicine, Apathy, Neuropsychiatric Inventory
JOURNAL NAME:
Advances in Alzheimer's Disease,
Vol.7 No.4,
December
10,
2018
ABSTRACT: Previous
clinical trials have demonstrated the efficacy of yokukansan, a traditional
Japanese medicine, for the treatment of behavioral and psychological symptoms
of dementia (BPSD). However, less evidence is available for the treatment of
BPSD with yokukansankachimpihange (YKSCH), which consists of yokukansan and two
additional herbal ingredients. The present study was conducted to investigate
the efficacy and safety of YKSCH for treating BPSD in patients with Alzheimer’s
disease (AD). We enrolled
outpatients with mild-to-moderate AD who exhibited BPSD and obtained a
Neuropsychiatric Inventory (NPI) score of >3 including subscale scores for “agitation”, “anxiety”, “irritability”, and “sleep and night-time behavior change”. A daily YKSCH dose of 7.5 g was administered for 12 weeks with
concomitant administration of anti-dementia medication. BPSD was evaluated using the NPI at baseline and every 4 weeks during the
intervention. We also examined apathy using the Japanese translation of the Apathy Scale, the short version of the
Japanese version of the Zarit Caregiver Burden Interview, and the Modified
Crichton Rating Scale for Predicting Activities of Daily Living. Cognitive
dysfunction was evaluated using the Mini Mental State Examination and the AD
Assessment Scale-Cognitive (Japanese version). Five participants were enrolled. The NPI total score tended to decrease
between the baseline and 8-week evaluations during the YKSCH intervention
(Wilcoxon signed rank test, P = 0.063). In terms of the NPI subscale scores,
“apathy”, “agitation”, “delusions”, and “sleep and night-time behavior change”
decreased after the intervention in those who exhibited each symptom at
baseline. There were no significant differences in the other scores examined.
No serious adverse events were observed. YKSCH could ameliorate BPSD in
patients with mild-to-moderate AD with agitation, anxiety, irritability, and
sleep and night-time behavior change, and it
was well-tolerated.