Efficacy and safety of traditional Chinese herbal medicine in the treatment of threatened abortion A protocol for systematic review and meta-analysis

Background: Threatened abortion (TA) is the commonest complication that occurs in early pregnancy, especially in 8-12 gestational weeks when the secretion of estrogen and progesterone shifts from corpus luteum to placental. Conventional therapies are little evidence of their value. In China, traditional Chinese herbal medicine has been widely used for the treatment of TA for a long time. The lack of strong scientific evidences make this a priority area for research. We aim to evaluate the efficacy and safety of traditional Chinese herbal medicine in the treatment of TA, provide medical staffs with more useful information, and provide patients with better advises. Methods: We will search 8 databases and additional sources, including the Web of Science, PubMed, Cochrane Library, Embase, CBM, Wanfang, VIP, CNKI, and WHO ICTRP, ChiCTR, Clinical Trials, Grey Literature Database, for potentially eligible studies. Literature search, screening and retrieval are performed independently by two researchers. In the event of a dispute, a third party will be consulted to support the judgment. We will use RevmanV.5.3 to perform a fixed-effect meta-analysis for clinical homogeneity study data, and the level of evidence will be assessed using the GRADE method. Results: This systematic review and meta-analysis will put a high-quality synthesis of the efficacy and safety of traditional Chinese herbal medicine in the treatment of TA. Conclusion: The conclusion of this systematic review will provide evidence to assess traditional Chinese herbal medicine therapy whether is an efficacy and safe intervention to treat TA. Ethics and dissemination: Since this article does not contain patient personal information, ethical approval is not required. The contract is distributed by a peer-reviewed journal or conference report. Registration number: 10.17605/OSF.IO/DG3T8

Automated summary

This study aims to evaluate the efficacy and safety of traditional Chinese herbal medicine in treating threatened abortion, providing medical staff and patients with valuable information. The method includes searching multiple databases and sources, independently screening and retrieving literature, and performing meta-analysis and evidence level assessment. The conclusion will offer evidence on the effectiveness and safety of traditional Chinese herbal medicine therapy for threatened abortion.