A randomized cross-over study of a traditional Japanese medicine (kampo), yokukansan, in the treatment of the behavioural and psychological symptoms of dementia

Abstract

The effectiveness and safety of yokukansan (TJ-54), a traditional Japanese medicine (kampo) for the treatment of the behavioural and psychological symptoms of dementia (BPSD), were evaluated in 106 patients diagnosed as having Alzheimer's disease (AD) (including mixed-type dementia) or dementia with Lewy bodies. Patients were randomly assigned to group A (TJ-54 treatment in period I and no treatment in period II; each period lasting 4 wk) or group B (no treatment in period I and TJ-54 treatment in period II). BPSD and cognitive functions were evaluated using the Neuropsychiatric Inventory (NPI) and the Mini-Mental State Examination (MMSE), respectively. Activities of daily living (ADL) were evaluated using Instrumental Activities of Daily Living (IADL) in outpatients and the Barthel Index in in-patients. For the safety evaluation, adverse events were investigated. Significant improvements in mean total NPI score associated with TJ-54 treatment were observed in both periods (Wilcoxon test, p=0.040 in period I and p=0.048 in period II). The mean NPI scores significantly improved during TJ-54 treatment in groups A and B (p=0.002 and p=0.007, respectively) but not during periods of no treatment. Among the NPI subscales, significant improvements were observed in delusions, hallucinations, agitation/aggression, depression, anxiety, and irritability/lability. The effects of TJ-54 persisted for 1 month without any psychological withdrawal symptoms in group A. TJ-54 did not show any effect on either cognitive function or ADL. No serious adverse reactions were observed. The present study suggests that TJ-54 is an effective and well-tolerated treatment for patients with BPSD.

Improving the Quality of Postgraduate Education in Traditional Japanese Kampo Medicine for Junior Residents: An Exploratory Survey Conducted in Five Institutions in the Tohoku Area

“…On the other hand, YKS is prescribed for neurosis, insomnia, and irritability in frailty. Many clinical trials have shown that YKS improved the behavioral and psychological symptoms of dementia, such as hallucination, delusion, agitation, and aggression (Iwasaki et al 2005, Mizukami et al 2009, Matsuda et al 2013, Monji et al 2009, Okahara et al 2010. Subsequently, a meta-analysis was performed to examine the effect of YKS on these symptoms (Matsuda et al 2013).…”

Treatment of Dementia-related Symptoms with Japanese Traditional Medicine (Kampo): A Review of Clinical Studies

“…In fact, since 2010, YKS has been listed alongside modern conventional medicine in the Japanese Guidelines for the Management of Dementia by the Japanese Society of Neurology (http://www.neurology-jp.org/guidelinem/nintisyo.html). YKS has a different therapeutic mechanism from that of anti-psychotic agents and improves BPSD and activities of daily living (ADL) without impairing cognitive function or causing extrapyramidal symptoms, which is its greatest advantage in the treatment of elderly patients [5][6][7][8][9][10]. Interestingly, YKS used to be a TCM medicine for symptoms in children such as night cry and sleep terrors.…”

“…Interestingly, YKS used to be a TCM medicine for symptoms in children such as night cry and sleep terrors. Meanwhile, starting in 2005, 5 RCTs have provided support for YKS's efficacy in treating dementia-related symptoms [5,[7][8][9][10] and YKS is now used widely for various symptoms in elderly patients as well as in children in Japan.…”

Severe metabolic alkalosis, hypokalemia, and respiratory acidosis induced by the Chinese herbal medicine yokukansan in an elderly patient with muscle weakness and drowsiness

“…Several investigators have recently shown that the Chinese herbal medicine yokukansan can alleviate the behavioral and psychological symptoms of dementia (BPSD), such as hallucinations, delusions, agitation, aggression, and wandering, in patients with Alzheimer's disease, with few side effects [7][8][9]. The numbers of elderly people with Alzheimer's disease have been increasing, and drugs that can safely and effectively mitigate BPSD are, therefore, in demand.…”