WANG Wenya,JING Chengyang,SHI Lanjun,et al.Application and Production of Systematic Review and Meta-Analyses of Preclinical Studies in the Field of Traditional Chinese Medicine[J].Journal of Traditional Chinese Medicine,2025,66(13):1333-1339.
WANG Wenya,JING Chengyang,SHI Lanjun,et al.Application and Production of Systematic Review and Meta-Analyses of Preclinical Studies in the Field of Traditional Chinese Medicine[J].Journal of Traditional Chinese Medicine,2025,66(13):1333-1339.DOI: 10.13288/j.11-2166/r.2025.13.006.
Application and Production of Systematic Review and Meta-Analyses of Preclinical Studies in the Field of Traditional Chinese Medicine
Preclinical studies include pharmacology, toxicology, pharmacokinetics research of animal experiments and in vitro experiments, which are crucial steps in the pre-marketing drugs and medical products, and are essential for exploring the mechanisms of traditional Chinese Medicine (TCM) therapeutic mechanism and promoting clinical translation. Systematic reviews and meta-analyses of preclinical studies in the field of TCM can comprehensively integrate preclinical evidence, consolidate research findings, assess the quality and risk of bias of included studies, enhance the utilization of research results, reduce resource waste, and promote the iterative optimization of TCM research models and evaluation indicators. This article introduced the process and methodology of conducting systematic review and meta-analyses of preclinical studies in TCM from nine steps, defining the research question, forming a research team, writing and registering a study protocol, conducting a comprehensive search, screening literature, evaluating included studies, extracting data, synthesizing data (meta-analysis), and reporting systematic reviews. It aims to provide methodological references for conducting systematic reviews and meta-analyses of preclinical studies in TCM and to promote the establishment and improvement of the evidence system in the field of TCM.
关键词
Keywords
references
COLERANGLE JB . Chapter 25-Preclinical development of nononcogenic drugs (small and large molecules) [M]//FAQI AS. A comprehensive guide to toxicology in nonclinical drug development (second edition) . Boston : Academic Press , 2017 : 659 - 683 .
ZHAO B , HU K , ZENG X , et al . Development of a reporting guideline for systematic reviews of animal experiments in the field of traditional Chinese medicine [J]. J Evid Based Med , 2022 , 15 ( 2 ): 152 - 167 .
MENON J , VAN DER NAALDM , CHAMULEAU S , et al . Preclinicaltrials.eu: prospective registration of animal studies [J]. Eur Heart J , 2023 , 44 ( 44 ): 4617 - 4619 .
HUANG W , PERCIE DSN , VOLLERT J , et al . General principles of preclinical study design [J]. Handb Exp Pharmacol , 2020 , 257 : 55 - 69 . doi: 10.1007/164_2019_277 http://dx.doi.org/10.1007/164_2019_277 .
MURAD MH , ASI N , ALSAWAS M , et al . New evidence pyramid [J]. Evid Based Med , 2016 , 21 ( 4 ): 125 - 127 .
INEICHEN BV , HELD U , SALANTI G , et al . Systematic review and meta-analysis of preclinical studies [J]. Nat Rev Methods Primers , 2024 , 4 ( 1 ): 72 .
HUNNIFORD VT , MONTROY J , FERGUSSON DA , et al . Epidemiology and reporting characteristics of preclinical systematic reviews [J]. Plos Biol , 2021 , 19 ( 5 ): e3001177 .
HOOIJMANS CR , RITSKES-HOITINGA M . Progress in using systematic reviews of animal studies to improve translational research [J]. PLoS Med , 2013 , 10 ( 7 ): e1001482 .
DA SE , TOSCANO AE , SILVA P , et al . Effects of deficiency or supplementation of riboflavin on energy metabolism: a systematic review with preclinical studies [J]. Nutr Rev , 2025 , 83 ( 2 ): e332 - e342 .
SIDERI S , PAPAGEORGIOU SN , ELIADES T . Registration in the international prospective register of syste-matic reviews (PROSPERO) of systematic review protocols was associated with increased review quality [J]. J Clin Epidemiol , 2018 , 100 : 103 - 110 . doi: 10.1016/j.jclinepi. 2018.01.003 http://dx.doi.org/10.1016/j.jclinepi.2018.01.003 .
BANNACH-BROWN A , RACKOLL T , KAYNAK N , et al . Navigating PROSPERO4animals: 10 top tips for efficient pre-registration of your animal systematic review protocol [J]. Bmc Med Res Methodol , 2024 , 24 ( 1 ): 20 .
PAGE MJ , MCKENZIE JE , BOSSUYT PM , et al . The PRISMA 2020 statement: an updated guideline for reporting systematic reviews [J]. BMJ , 2021 , 372 : n71 . doi: org/10.1016/j.ijsu.2021.105906 http://dx.doi.org/org/10.1016/j.ijsu.2021.105906 .
SHETH VH , SHAH NP , JAIN R , et al . Development and validation of a risk-of-bias tool for assessing in vitro studies conducted in dentistry: The QUIN [J]. J Prosthet Dent , 2024 , 131 ( 6 ): 1038 - 1042 .
FERMIANO TH , PEREZ DSJ , Murase LS , et al . Antimicrobial activity of carvacrol and its derivatives on Mycobacterium spp.: systematic review of preclinical studies [J]. Future Med Chem , 2024 , 16 ( 7 ): 679 - 688 .
FAGGION CJ . Guidelines for reporting pre-clinical in vitro studies on dental materials [J]. J Evid Based Dent Pract , 2012 , 12 ( 4 ): 182 - 189 .
HOOIJMANS CR , ROVERS MM , DE VRIES RB , et al . SYRCLE's risk of bias tool for animal studies [J]. BMC Med Res Methodol , 2014 , 14 : 43 . doi: 10.1186/1471-2288-14-43 http://dx.doi.org/10.1186/1471-2288-14-43 .
PERCIE DSN , HURST V , AHLUWALIA A , et al . The ARRIVE guidelines 2.0: updated guidelines for reporting animal research [J]. PLoS Biol , 2020 , 18 ( 7 ): e3000410 .
CAMPBELL M , MCKENZIE JE , SOWDEN A , et al . Synthesis without meta-analysis (SWiM) in systematic reviews: reporting guideline [J]. BMJ , 2020 , 368 : l6890 . doi: 10.1136/bmj.l6890 http://dx.doi.org/10.1136/bmj.l6890 .
VOELKL B , VOGT L , SENA ES , et al . Reproducibility of preclinical animal research improves with heterogeneity of study samples [J]. PLoS Biol , 2018 , 16 ( 2 ): e2003693 .
YANG Y , MACLEOD M , PAN J , et al . Advanced methods and implementations for the meta-analyses of animal models: current practices and future recommendations [J]. Neurosci Biobehav Rev , 2023 , 146 : 105016 . doi: org/10.1016/j.neubiorev.2022.105016 http://dx.doi.org/org/10.1016/j.neubiorev.2022.105016 .
STERNE J A , GAVAGHAN D , EGGER M . Publication and related bias in meta-analysis: power of statistical tests and prevalence in the literature [J]. J Clin Epidemiol , 2000 , 53 ( 11 ): 1119 - 1129 .
STERNE JA , SUTTON AJ , IOANNIDIS JP , et al . Recommendations for examining and interpreting funnel plot asymmetry in meta-analyses of randomised controlled trials [J]. BMJ , 2011 , 343 : d4002 . doi: 10.1136/bmj.d4002 http://dx.doi.org/10.1136/bmj.d4002 .
Evaluation of the Methodological and Reporting Quality of Systematic Reviews/Meta-analysis on Traditional Chinese Medicine for Chronic Heart Failure
The Effectiveness and Safety of Fufang Xueshuantong Capsules (复方血栓通胶囊) in the Treatment of Glaucoma: A Systematic Review with Meta-analysis
Xijiao Dihuang Decoction(犀角地黄汤) as Adjuvant Therapy for Intracerebral Hemorrhage: a Systematic Review and Meta-analysis of Randomized Clinical Trials
Efficacy and Safety of Breviscapine Injection in the Treatment of Acute Cerebral Infarction: Systematic Review and Meta-analysis of Randomized Controlled Trials
Systematic Review of Animal Experiment Study on Chinese Medicine Intervention for Autoimmune Myasthenia Gravis
Related Author
LAI Xiaolei
HUANG Mingyue
LIU Hongxu
SHANG Juju
XING Wenlong
LI Xiang
Wenli CHEN
Lixia ZHANG
Related Institution
Beijing Hospital of Traditional Chinese Medicine,Capital Medical University
Beijing University of Chinese Medicine
Eye Hospital, Chinese Academy of Chinese Medical Sciences
Hospital Management Office, Chinese Academy of Chinese Medical Sciences
School of Medicine and Life Sciences,Nanjing University of Chinese Medicine