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| Current status of outcome measures in randomized controlled trials of traditional Chinese medicine for recurrent spontaneous abortion：a systematic analysis |
| Hits 393 Download times 193 Received:March 01, 2025 |
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| DOI
10.11656/j.issn.1673-9043.2025.07.10 |
| Key Words
recurrent spontaneous abortion;traditional Chinese medicine;core outcome set;randomized controlled trial |
| Author Name | Affiliation | E-mail | | WANG Haoxian | Department of Obstetrics and Gynecology, First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, China
First Clinical Medical College, Henan University of Chinese Medicine, Zhengzhou 450000, China | | | LI Jiuxian | Department of Obstetrics and Gynecology, First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, China | lijiuxian1982@163.com | | LIU Yan | First Clinical Medical College, Henan University of Chinese Medicine, Zhengzhou 450000, China | | | SUN Shuo | First Clinical Medical College, Henan University of Chinese Medicine, Zhengzhou 450000, China | | | LI Xiangyu | First Clinical Medical College, Henan University of Chinese Medicine, Zhengzhou 450000, China | | | XU Guangli | Department of Reproductive Medicine, First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, China | |
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| Abstract
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| [Objective] To analyze the current application status of outcome measures in randomized controlled trials（RCTs） of traditional Chinese medicine（TCM） for recurrent spontaneous abortion（RSA），providing evidence for establishing a core outcome set（COS） in this field. [Methods] The article systematically searched CNKI，SinoMed，VIP，Wanfang，PubMed，Embase，Cochrane Library，and Web of Science for RCTs of TCM treating RSA. The Cochrane Risk of Bias tool was used for quality assessment，and outcome measures were statistically analyzed using Excel. [Results] Among 192 included studies，92 outcome measures were identified. The top 10 most frequently reported were：clinical effectiveness（9.0%），pregnancy success rate（7.3%），progesterone level（5.9%），human chorionic gonadotropin（5.2%），TCM syndrome score（4.3%），abortion rate（3.9%），adverse event incidence（3.6%），D-dimer level（3.2%），vaginal bleeding（2.9%），estradiol level（2.8%）. [Conclusion] Significant heterogeneity exists in both methodological quality and outcome selection among current RCTs of TCM for RSA. There is an urgent need to conduct high-quality RCTs and develop a standardized COS for TCM intervention in RSA. |
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