Methodology for developing clinical practice guidelines of integrated traditional Chinese and Western medicine:principles and methods for selection of Chinese patent medicines
CAO Zumao
JIN Yinghui
WANG Yongbo
LIN Fengxia
ZENG Zhicong
TIAN Guoxiang
SHANG Hongcai
Abstract：A certain proportion of clinical practice guidelines for integrated traditional Chinese and Western medicine include recommendations for Chinese patent medicines(CPMs).Given the characteristics of CPMs-such as a large variety of formulations,overlapping indications,and widespread off-label use-their selection has become a critical methodological issue.Scientific screening of CPMs prior to evidence retrieval and evaluation is a prerequisite for ensuring the scientific rigor and clinical applicability of such guidelines.This paper analyzes the deficiencies in the selection process of existing CPM-related guidelines,including an incomplete retrieval scope,insufficient transparency in the screening process,and a lack of support from systematic clinical investigations.Based on these findings,five basic principles for CPM selection are proposed:legality and normative compliance of drugs,alignment with clinical indications,clinical investigation-based evidence,support from evidence-based medicine,and independent consideration of dosage forms.Taking CPMs for hypertension treatment as an example,a comprehensive screening process is outlined,encompassing multi-source evidence retrieval,dynamic supplementation,verification of legality and normative compliance,and clinical investigation combined with dynamic revision.Stringent screening ensures the standardization and targeting of CPM selection;clinical investigations reflect real-world clinical medication needs;evidence-based evaluation optimizes resource allocation;and independent consideration of dosage forms achieves a multi-dimensional balance.This approach is conducive to improving the scientific rigor,transparency and traceability of CPM-related guidelines,enabling drug selection criteria to reflect the latest evidence and clinical practice,and ultimately enhancing the credibility and practical value of the guidelines.
Keywords：Chinese patent medicinesclinical practice guidelinesmedicinal selectionmethodology
Publication Date：2026-02-20
Online Publishing Date：2026-03-19(First online date of this platform, not the publication date of the document)
Pages：6( 129-134 )