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.
Highlights
Behavioral and psychological symptoms of dementia (BPSD) constitute the major symptoms of dementia, in addition to cognitive impairment
Less evidence is available for the treatment of behavioral and psychological symptoms of dementia (BPSD) with yokukansankachimpihange (YKSCH), which consists of yokukansan and two additional herbal ingredients
The results of the present study demonstrated that YKSCH has the tendency to alleviate BPSD as assessed using the Neuropsychiatric Inventory (NPI) in patients with Alzheimer’s disease (AD) after 8-week administration, and that YKSCH is a well-tolerated treatment option
Summary
Behavioral and psychological symptoms of dementia (BPSD) constitute the major symptoms of dementia, in addition to cognitive impairment. BPSD become a mental and physical burden for caregivers and is a major reason for early institutionalization of patients with dementia, and thereby increases the cost of clinical care [2] [3] [4]. Yokukansan, a traditional Japanese medicine (Kampo medicine), has been reported to ameliorate BPSD, as assessed using the Neuropsychiatric Inventory (NPI) in four randomized control trials (RCTs) [5] [6] [7] [8]. A meta-analysis including these trials demonstrated the efficacy of yokukansan for treating BPSD, for treating delusions, hallucinations, and agitation [9]. A subsequent randomized double-blind placebo-controlled trial of yokukansan for treating BPSD in AD indicated no significant efficacy. Yokukansan is currently listed in the practice guidelines for the treatment of dementia in Japan [11]
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