Quality analysis and suggestions on the literature on clinical comprehensive evaluation of Chinese patent medicines
- VernacularTitle:中成药临床综合评价类文献质量分析及建议
- Author:
Xueyuan LI
1
;
Qianfei ZHANG
1
;
Baihe HE
2
;
Wei YANG
3
Author Information
1. School of TCM，Changchun University of Chinese Medicine，Changchun 130021，China;School of Integrated Traditional Chinese and Western Medicine，Changchun University of Chinese Medicine，Changchun 130117，China
2. School of TCM，Changchun University of Chinese Medicine，Changchun 130021，China
3. GCP Office，Affiliated Hospital of Changchun University of Chinese Medicine，Changchun 130021，China
- Publication Type:Journal Article
- Keywords:
Chinese patent medicine;
clinical comprehensive evaluation;
reporting standards;
Quality control;
standardized reporting
- From:
China Pharmacy
2026;37(18):2456-2461
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To analyze the current quality status and existing problems of literature on clinical comprehensive evaluation studies of Chinese patent medicines （CPMs）， and to provide a reference for optimizing the research design and improving the reporting quality.METHODS Articles on clinical comprehensive evaluation of CPMs published from January 1， 2020 to December 31， 2025 were systematically searched in CNKI， Wanfang Data， VIP and Chinese Medical Journal Full-text Database. An evaluation framework was constructed based on reporting completeness， content standardization and research transparency. The basic characteristics of the literature and the reporting information of each evaluation item were extracted item by item， and descriptive statistical analysis was performed.RESULTS A total of 107 articles were included， involving 146 CPMs. The number of articles showed an increasing trend year by year， and the research field mainly focused on cardiovascular and cerebrovascular diseases （33 articles ， 30.8%）. There were 99 articles evaluating a single drug and 8 articles conducting horizontal comparison among multiple drugs. The reporting of abstract sections and evaluation result items such as safety and effectiveness were relatively sufficient， with reporting rates mostly above 98%. However， the reporting rates of items such as guideline recommendations （59.8%）， the dimension of traditional Chinese medicine characteristics （64.5%） and conflict of interest statements （39.3%） were relatively low， and the reporting of process items such as evidence collection， evidence synthesis and quality control was also insufficient （69.2%-76.6%）.CONCLUSIONS The existing literature on clinical comprehensive evaluation of CPMs have initially formed a framework centered on the “6+1” dimensions， and the reporting of core evaluation contents is relatively complete. However， deficiencies remain in the presentation of guideline evidence and the disclosure of conflicts of interest， and the structured expression of the traditional Chinese medicine characteristic dimension also needs to be improved. In the future， reporting transparency， methodological reproducibility should be further strengthened， and the scope of application should be clearly defined， so as to enhance the value of evaluation results in informing clinical and policy decision-making.
