LAUSR

Abstract Background: This systematic review protocol describes the methods proposed to evaluate the efficacy and safety of Jihwangeumja in patients with Alzheimer disease. Methods: The following databases, PubMed, EMBASE, CENTRAL, Cumulative Index to Nursing and Allied Health Literature, China National Knowledge Infrastructure, National Digital Science Library, Korean Information Service System, and Korean Medical Database will be searched for relevant publications without language or publication status restrictions. Search terms will be based on “Alzheimer” for participants and “Jihwangeumja” or “Dihuang Yinzi” for interventions. Two researchers will independently extract the study data from the included studies and only randomized controlled trials will be included. The risk of bias will also be assessed independently by 2 researchers using the Cochrane risk of bias tool. We will use RevMan software random-effects and fixed-effect models for the assessment of heterogeneity and data synthesis. Any changes in the plan for documenting significant protocol amendments will require the researchers to have a revision agreement and register the international prospective register of systematic review modification. Results: The treatment effect and safety will be measured by meta-analysis and the quality of the included studies will be reviewed. Conclusion: This systematic review will provide evidence regarding the efficacy and safety of Jihwangeumja. Ethics and dissemination: Ethical approval is not required because individual patient data will not be included in this paper. The study findings will be disseminated through conference presentations. OSF Registration DOI: 10.17605/OSF.IO/HXA58.