Clinical efficacy and safety of compound Congrong Yizhi Capsules on Alzheimer's disease in mainland China: A systematic review with trial sequential analysis and GRADE assessment

Yefei Wang; Ningqun Wang; Zhenmin Xu; Shaojiao Liu; Xiao Liang; Yunling Zhang; Xianglan Jin

doi:10.1016/j.jep.2023.116208

Clinical efficacy and safety of compound Congrong Yizhi Capsules on Alzheimer's disease in mainland China: A systematic review with trial sequential analysis and GRADE assessment

J Ethnopharmacol. 2023 Jun 12:309:116208. doi: 10.1016/j.jep.2023.116208. Epub 2023 Jan 31.

Authors

Yefei Wang¹, Ningqun Wang², Zhenmin Xu³, Shaojiao Liu⁴, Xiao Liang⁵, Yunling Zhang⁶, Xianglan Jin⁷

Affiliations

¹ Graduate School, Beijing University of Chinese Medicine, Beijing, 100029, China. Electronic address: Yefei_WANG@bucm.edu.cn.
² Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, 100053, China. Electronic address: wangningqun@126.com.
³ Graduate School, Beijing University of Chinese Medicine, Beijing, 100029, China. Electronic address: zhenminxu@bucm.edu.cn.
⁴ Graduate School, Beijing University of Chinese Medicine, Beijing, 100029, China. Electronic address: shaojiaoliu2020@163.com.
⁵ Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. Electronic address: liangxiao022@126.com.
⁶ Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. Electronic address: yunlingzhang2004@163.com.
⁷ Department of Neurology, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, 100078, China. Electronic address: jxlan2001@126.com.

PMID: 36731808
DOI: 10.1016/j.jep.2023.116208

Abstract

Ethnopharmacological relevance: Alzheimer's disease (AD) is a degenerative disease of the central nervous system (CNS) with insidious onset. AD is also the most common cause of dementia. Compound Congrong Yizhi Capsules (CCYC), a traditional Chinese medicine compound developed by the team of Beijing University of Chinese Medicine, has been widely used to treat AD.

Aim of this study: To systematically evaluate the clinical efficacy and safety of CCYC for AD by meta-analysis, Trial Sequential Analysis (TSA) and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.

Methods: This study was registered at PROSPERO (CRD42022295496). Randomized controlled trials (RCTs) of CCYC as the treatment for AD published before December 1, 2021 were retrieved from 4 Chinses databases, 4 English databases and 2 clinical trials registration systems. RevMan 5.4 and STATA 17.0 was used to conduct the meta-analysis of the included studies, the quality of outcomes was rated by the GRADE system, the TSA was conducted by TSA 0.9.5.10 software.

Results: Seven studies were included, and the total sample size was 746. Meta-analysis showed that 6 months of treatment with CCYC plus conventional western medicine treatments (CTs) improved MMSE scores compared with CTs alone (WMD: 4.32, 95% CI: 3.23, 5.42), and TSA confirmed that more trials in the future will not reverse the result. Among which, CCYC combined with donepezil can significantly improve MMSE scores (WMD: 3.54, 95% CI: 2.86, 4.22). CCYC combined with olanzapine also showed good effect on both MMSE (WMD: 6.49, 95% CI: 5.54, 7.44) and ADL scores (WMD: 5.23, 95% CI: 4.63, 5.83). No serious adverse events were reported. The strengths of the evidences above are MODERATE.

Conclusion: CCYC combined with cognition-modifying western medicine can improve cognitive function, mental behavioural symptoms, and activities of daily living in AD patients with good safety.

Keywords: Alzheimer's disease; Compound Congrong Yizhi Capsules; GRADE; Systematic review; TSA.

Publication types

Meta-Analysis
Systematic Review

MeSH terms

Alzheimer Disease* / drug therapy
GRADE Approach
Humans
Plant Extracts / therapeutic use
Treatment Outcome

Substances

Alpinia oxyphylla fruit extract
Plant Extracts