Yokukansankachimpihange Is Useful to Treat Behavioral/Psychological Symptoms of Dementia.

Eiichi Katsumoto,Toshio Yokouchi,Miho Shimizu,Toru Ishida,Toshihito Tsutsumi,Kenji Kinoshita,Yoko Nagai,Yasushi Yoshida,Masakazu Nishimura

doi:10.3389/fnut.2020.529390

Abstract

Yokukansankachimpihange is a Japanese herbal medicine reported to benefit anxiety and sleep disorders, and it has recently been introduced to treat behavioral and psychological symptoms of dementia. There are no multicenter studies of its effectiveness regarding dementia in Japan, and this study's main objective was to clarify the effects of Yokukansankachimpihange on behavioral and psychological symptoms of dementia in a sample of patients from multiple healthcare centers. Nine facilities affiliated with Osaka Association of Psychiatric Clinics participated in November 2013 through April 2015 and provided 32 Alzheimer's disease patients to whom Yokukansankachimpihange was orally administered for 8 weeks. During the study, the patients continued their regular medication regimens. Behavioral and psychological symptoms of dementia (Behavioral Pathology in Alzheimer's Disease Rating Scale [Behave-AD]), core symptoms [Mini-Mental State Examination (MMSE)], activities of daily living [Nishimura Activity of Daily Living Scale (N-ADL)], and gastrointestinal symptoms (nausea/vomiting, loss of appetite, gastric discomfort, constipation, and diarrhea) were measured at baseline, after 4 weeks of treatment and after 8 weeks of treatment. Yokukansankachimpihange was orally administered at a dosage of 7.5 g twice daily before or between meals for 8 weeks. The Behave-AD mean score significantly improved after 8 weeks of treatment. There were no significant changes in MMSE, N-ADL, or gastrointestinal symptoms; however, decreased gastrointestinal scores were observed after 8 weeks. There were no side effects related to Yokukansankachinpihange. Pharmaceutical treatments are important for treating behavioral and psychological symptoms of dementia, and this study confirmed Yokukansankachimpihange's efficacy for treating Alzheimer's disease. Because the aggressiveness and sleep disorder components of the Behave-AD construct were the symptoms most improved and those symptoms are known to significantly burden dementia patients' caregivers, Yokukansankachimpihange's efficacy might indirectly relieve these caregivers' burden of care.

Highlights

Antipsychotics used to treat behavioral and psychological symptoms of dementia (BPSD) require careful administration because of their potential side effects
This study aimed to clarify the effects of YKSCH on BPSD in a nine-center joint clinical study under conditions similar to those in which Alzheimer’s disease (AD) medications are used in real-world settings without specifying the type and route of cholinesterase inhibitor (ChEI) administration
The 12 protocol violations were two cases of memantine use, six cases of concomitant use of a ChEI initiated at the start of the study, six cases of concomitant use of non-ChEI medications started within 1 month of the study, and three cases of additional use of concomitant medications during the study period

Summary

Introduction

Antipsychotics used to treat behavioral and psychological symptoms of dementia (BPSD) require careful administration because of their potential side effects. Their main side effects are extrapyramidal symptoms, oversedation, cognitive decline, increased cerebrovascular disorders, and increased risk of mortality. A risk of increased blood sugar levels needs to be considered in the use of atypical antipsychotics. Yokukansan (YKS) (2), a Japanese herbal medicine, has been used to treat BPSD. Yokukansankachimpihange (YKSCH) is a Japanese herbal medicine made up of Citrus unshiu peel and Pinellia tuber combined with YKS. Citrus unshiu peel and Pinellia tuber were formulated to improve gastrointestinal symptoms (GIS), such as loss of appetite, nausea, and vomiting (3). The blend is expected to favorably influence anxiety and sleep disorders because of the influence that Citrus unshiu peel has on serotoninergic neural pathways (4)

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