Evidence Mapping Analysis of Clinical Studies on Treatment of Alzheimer's Disease with Chinese Patent Medicines postprint

Abstract: Background　Alzheimer's disease（AD）is a complex neurodegenerative disease. The therapies of AD bring some heavy burdens to patients and their families at present. The clinical studies on Chinese patent medicines for AD has been increasing in recent years，but the study evidence is still unclear. Objective　To analyze the clinical researches evidence of Chinese patent medicines for Alzheimer's disease in recent 5 years. Methods　The relevant literatures published between January 2019 and December 2024 was systematically searched in 8 electronic databases. The data were presented by combining text descriptions and graphs to clearly reveal the distribution of evidence. Results　A total of 82 clinical trials，30 systematic reviews/Meta-analyses，9 network Meta-analyses，7 guidelines/consensus/clinical pathways，1 overview of systematic review，and 1 health technology assessment were included. The attention of Chinese patent medicines for AD has fluctuated and declined. The clinical study and assessment focused on 21 kinds of Chinese patent medicines，mainly focus including Compound Congrong Yizhi Capsule and Compound Haishe Capsule，and the injection was mainly Ginkgo biloba extract. Clinical studies were mainly single-center and small-sample RCTs，and the quality of literature was generally not high. On the selection of outcome indicators，it mainly focuses on cognitive function，alternative outcomes and quality of life indicators，which lack the characteristics of TCM syndrome differentiation and treatment，and the selection and measurement of outcomes were lack of standardization. The overall quality of systematic review/Meta-analysis were relatively lower，and the quality of methodology，the formulation and reporting standardization of clinical practice guidelines and consensus need to be further improved. Conclusion　Some single-center，small-sample clinical studies have been carried out on the Chinese patent medicines for AD. The multi-center，large-sample and high-quality clinical studies should be further carried out based on the characteristics of AD clinical diagnosis and treatment with Chinese patent medicines in the future，so as to produce high-quality clinical evidence and provide relevant reference for the treatment of AD with Chinese patent medicines.