Abstract
BACKGROUND: Dementia is becoming a major public health problem worldwide with the aging of the world's population. Behavioral and psychological symptoms of dementia (BPSD), associated symptoms of dementia, not only predicts the poor prognosis of patients with dementia, but is also a major factor causing the care burden on caregivers, especially informal caregivers. For BPSD management, an alternative to existing psychotropic drugs is needed, given the benefit-harm ratio. Therefore, in this systematic review, we will evaluate the effectiveness and safety of herbal medicine for BPSD. METHODS AND ANALYSIS: Thirteen electronic databases will be comprehensively searched. Clinical studies reporting the efficacy (or effectiveness) and safety of herbal medicines in BSPD management published from their inception to December 2020 will be included. The primary outcome will be BPSD symptoms assessed by the validated tool. Moreover, total effective rate, daily living activities and quality of life of patients, burden and quality of life of caregiver, placement in a long-term care facility from home, and safety data will be regarded as the secondary outcome. Two independent researchers will perform the study selection, data extraction, and quality assessment process. To assess the methodological quality of the included studies, validated tools according to its design, such as the Cochrane Collaboration's risk of bias tool will be used. To perform meta-analysis, RevMan version 5.3 will be used, with mean differences for continuous outcomes and risk ratio for binary outcomes, and 95% confidence intervals. According to the heterogeneity and number of included studies, a fixed- or random-effects model will be used. REGISTRATION NUMBER: OSF (URL: https://osf.io/3u8ch), PROSPERO (CRD42020211000) (URL: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020211000).