Evidence map›Paper›PMID 41331836›Full record

ReviewChinese medicine2025

Technical guidelines for non-clinical pharmacological research of traditional Chinese medicine (TCM) formulae.

Weijie Li, Fangbo Zhang, Ping Wang, Yanqiong Zhang, Peng Cao, Zhijie Ma, Hailan Yao, Jiabo Wang, Hongjun Yang, Haiyu Xu

Abstract readReview
In one paragraph

Review in Chinese medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Weijie LiState Key Laboratory for Quality Ensurance and Sustainable Use of Dao-di Herbs, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
Fangbo ZhangState Key Laboratory for Quality Ensurance and Sustainable Use of Dao-di Herbs, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
Ping WangState Key Laboratory for Quality Ensurance and Sustainable Use of Dao-di Herbs, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
Yanqiong ZhangState Key Laboratory for Quality Ensurance and Sustainable Use of Dao-di Herbs, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
Peng CaoState Key Laboratory of Technologies for Chinese Medicine Pharmaceutical Process Control and Intelligent Manufacture, Nanjing University of Chinese Medicine, Nanjing, 210023, China.
Zhijie MaBeijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.
Hailan YaoDepartment of Biochemistry and Immunology, Capital Institute of Pediatrics, Beijing, 100020, China.
Jiabo WangSchool of Traditional Chinese Medicine, Capital Medical University, Beijing, 100069, China.
Hongjun YangState Key Laboratory for Quality Ensurance and Sustainable Use of Dao-di Herbs, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, 100700, China. hongjun0420@vip.sina.com.
Haiyu XuState Key Laboratory for Quality Ensurance and Sustainable Use of Dao-di Herbs, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, 100700, China. hyxu@icmm.ac.cn.

Funding

National Key R&D Program of China 2023YFC2308200National Key R&D Program of China 2023YFC3502900National Natural Science Foundation of China 82304830
6 · The paper itself

Abstract

Non-clinical pharmacology of traditional Chinese medicine (TCM) formulae plays a crucial role in elucidating their therapeutic mechanisms. With the integration of cutting-edge disciplines such as systems biology, big data, and artificial intelligence, the research depth and breadth in this field continue to expand. However, technical standards for non-clinical pharmacology research on TCM formulae have not yet been established. To address this, technical guidelines for non-clinical pharmacology research of TCM formulae were formed, aiming to scientifically standardize research content, elevate research quality, and facilitate the mutual translation between clinical and basic research. Guided by integrative pharmacology of TCM and driven by clinical value, these guidelines employ multi-dimensional qualitative pharmacokinetics (PK) and pharmacodynamics (PD) studies alongside quantitative "PK-PD" studies of key components. This approach enables the transition from panoramic description to precise mechanistic research, establishing a complete evidence chain system for the effectiveness of TCM formulae and demonstrating their holistic action characteristics of "multi-component, multi-pathway, multi-target". Meanwhile, the guidelines emphasize that animal models for TCM research should ensure stability and reproducibility. Additionally, pharmacodynamic evaluation is characterized by its measurability and quantifiability. The mechanisms of action at the molecular level should be in-depth and interpretable. These aspects collectively provide guidance for basic non-clinical pharmacology research on TCM formulae and the development of new TCM drugs. The formulation of these guidelines leveraged the research strengths of the drafting units' teams, incorporated literature review findings, and achieved consensus through extensive discussions among multidisciplinary experts. Broad expert opinions from universities, research institutes, and enterprises engaged in new drug development were solicited, ensuring the guidelines' practicality, standardization, scientific rigor, and feasibility.

Indexed as

Animal model of TCMIntegrative pharmacology of TCMMolecular regulationNew drug developmentNon-clinical pharmacologyPharmacodynamic evaluationTraditional Chinese medicine (TCM) formulae

Identifiers

PMID41331836
PMCPMC12673726

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.