Background: Alzheimer's disease (AD) is the most common cause of dementia. Traditional Chinese formula Danggui Shaoyao San (DSS) has been considered a potential therapeutic approach for AD. However, no systemic review regarding its efficacy and safety has been conducted. Herein, we propose a protocol for the study that aims to evaluate the efficacy and safety of DSS in patients with AD.
Methods: Sixteen electronic databases including PubMed, EMBASE, Cochrane database, Web of science, Chinese National Knowledge Infrastructure, VIP, Wanfang database, China Biomedical Literature Database, Chinese Clinical Trial Registry System, Koreanstudies Information Service System, Oriental Medicine Advanced Searching Integrated System, Research Information Sharing Service, DBpia, Korean Traditional Knowledge Portal, Japanese CiNii databases and J-STAGE databases will be searched from the inception up to February 29, 2020. Randomized controlled trials (RCTs) that meet the pre-specified eligibility criteria will be included. RevMan software (V.5.3.5) will be used to perform data synthesis following data extraction and publication risk assessment. Subgroup and sensitivity analysis will be performed according to the condition of included RCTs. The primary outcomes include changes in the Mini-Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog), and Activities of Daily Living scale (ADL). Additional outcomes are clinical effective rate and adverse event rate. The Grading of Recommendations Assessment, Development and Evaluation system will be used to assess the strength of the evidence.
Results: This study will provide a well-reported and high-quality synthesis of RCTs on the efficacy and safety of DSS for the treatment of AD.
Conclusion: This systematic review protocol will be helpful for providing evidence of whether DSS is an effective and safe therapeutic approach for patients with AD.
Ethics and dissemination: Ethical approval is not necessary as this protocol is only for systematic review and does not involve privacy data or conduct an animal experiment. This protocol will be disseminated by a peer-review journal or conference presentation.
Systematic review registration: PROSPERO CRD42020150450.