The following individuals were eligible if they met all the inclusion criteria: individuals with MCI, as defined by the criteria set out by the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5) [22 ], or probable/possible AD, AD with cerebrovascular disease, and mixed dementia as defined by the National Institute on Aging-Alzheimer’s Association criteria [23 ]. The main inclusion criteria were age ≥55 years, outpatients, Neuropsychiatric Inventory (NPI) subcategory scores for ‘anorexia’ ≥3 points, prefrailty or frailty defined as the Japanese version of the Cardiovascular Health Study (J-CHS) criteria, and a global Clinical Dementia Rating (CDR) score of 0.5 or 1.0.
Individuals were excluded if they had severe agitation/aggression, malignant tumor, or other life-threatening diseases, and had major depression, bipolar disorder, schizophrenia, alcoholism, or drug addiction (described in DSM-5) within the past two years. Individuals were also excluded if they had taken medicines containing Polygala Root, Citrus Unshiu Peel, or Kampo medicine, which had indications for anorexia, fatigue, weakness after illness, and upper gastrointestinal disorders such as gastritis, within the past 4 weeks. There were two categories of concomitant drugs administered during the study period. In category 1, continued stable use during the treatment period was allowed for therapeutic agents for dementia (cholinesterase inhibitors) started within the previous 24 weeks, and other effective agents for cognitive decline, frailty, and peptic ulcer started within the previous 4 weeks. For category 2, the use of hypnotics, psychotropic agents, anticonvulsants, effective agents for anorexia, and first-generation antihistamines as rescue drugs were allowed when complications worsened during the study period; however, the dose and frequency of use were kept to a minimum.
Individuals were excluded if they had severe agitation/aggression, malignant tumor, or other life-threatening diseases, and had major depression, bipolar disorder, schizophrenia, alcoholism, or drug addiction (described in DSM-5) within the past two years. Individuals were also excluded if they had taken medicines containing Polygala Root, Citrus Unshiu Peel, or Kampo medicine, which had indications for anorexia, fatigue, weakness after illness, and upper gastrointestinal disorders such as gastritis, within the past 4 weeks. There were two categories of concomitant drugs administered during the study period. In category 1, continued stable use during the treatment period was allowed for therapeutic agents for dementia (cholinesterase inhibitors) started within the previous 24 weeks, and other effective agents for cognitive decline, frailty, and peptic ulcer started within the previous 4 weeks. For category 2, the use of hypnotics, psychotropic agents, anticonvulsants, effective agents for anorexia, and first-generation antihistamines as rescue drugs were allowed when complications worsened during the study period; however, the dose and frequency of use were kept to a minimum.
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