College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.
Department of Oriental Neuropsychiatry, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.
Medicine (Baltimore). 2021 May 14;100(19):e25592. doi: 10.1097/MD.0000000000025592.
This systematic review protocol describes the methods proposed to evaluate the efficacy and safety of Jihwangeumja in patients with Alzheimer disease.
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.
The treatment effect and safety will be measured by meta-analysis and the quality of the included studies will be reviewed.
This systematic review will provide evidence regarding the efficacy and safety of Jihwangeumja.
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.
DOI: 10.17605/OSF.IO/HXA58.
本系统评价方案描述了评估 Jihwangeumja 治疗阿尔茨海默病患者的疗效和安全性的方法。
我们将无语言或发表状态限制地检索以下数据库的相关文献:PubMed、EMBASE、CENTRAL、Cumulative Index to Nursing and Allied Health Literature、中国国家知识基础设施、国家数字科学图书馆、韩国信息服务系统和韩国医学数据库。检索词将基于参与者的“阿尔茨海默病”和干预措施的“Jihwangeumja”或“Dihuang Yinzi”。两名研究人员将独立地从纳入研究中提取研究数据,仅纳入随机对照试验。两名研究人员将使用 Cochrane 偏倚风险工具独立评估偏倚风险。我们将使用 RevMan 软件随机效应和固定效应模型评估异质性和数据综合。对方案进行有意义的记录的任何更改都需要研究人员达成修订协议,并在国际系统评价修改前瞻性注册中进行登记。
将通过荟萃分析来衡量治疗效果和安全性,并对纳入研究的质量进行评价。
本系统评价将提供关于 Jihwangeumja 疗效和安全性的证据。
由于本文不会纳入个体患者数据,因此不需要伦理批准。研究结果将通过会议报告进行传播。
OSF 注册:DOI:10.17605/OSF.IO/HXA58.