A multicenter, randomized, double-blind clinical trial on the efficacy and safety of Gongxuening Capsule in reducing postoperative bleeding after induced abortion
10.3760/cma.j.cn101441-20240924-00355
- VernacularTitle:宫血宁胶囊减少人工流产术后出血的有效性与安全性的多中心随机双盲研究
- Author:
Lirong TENG
1
;
Chunying LI
;
Ping PENG
;
Shuping ZHAO
;
Xiangying GU
;
Xiaoxia ZHENG
;
Jing JIANG
;
Yali NI
;
Min WANG
;
Banglan WANG
;
Chenchen REN
;
Li SHAN
;
Qing LIN
;
Xinyan LIU
Author Information
1. 中国医学科学院北京协和医院妇产科学系产科中心，北京 100730
- Publication Type:Journal Article
- Keywords:
Abortion, induced;
Multicenter study;
Randomized controlled trial;
Gongxuening Capsules;
Double-blind
- From:
Chinese Journal of Reproduction and Contraception
2025;45(1):39-44
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To assess the efficacy and safety of Gongxuening Capsules in reducing post-abortion bleeding following artificial abortion.Methods:A multicenter, randomized, double-blind study was conducted. From May 31, 2022 to March 31, 2023, 484 women who underwent vacuum aspiration abortion for early intrauterine pregnancy were enrolled in 11 centers and randomly assigned to control group and the study group at a 1∶1 ratio using a center-block randomization method. Control group were administered a placebo of Gongxuening Capsules for 9 d, while the study group received the actual Gongxuening Capsules for the same duration. The outcomes measured included vaginal bleeding volume, duration of vaginal bleeding, endometrial thickness, time to menstrual recovery, and complications.Results:1) A total of 484 subjects were enrolled, and 472 completed the study. Totally 450 subjects were included in the efficacy analysis set, with 224 in control group and 226 in the study group; 468 subjects were included in the safety analysis set, with 236 in control group and 232 in the study group. The baseline characteristics of the two groups were comparable (all P>0.05). 2) The vaginal bleeding volume was lower in the study group [(13.30±12.14) mL] than in control group [(19.00±17.67) mL, P<0.001]. The proportion of subjects in the study group with bleeding days less than 4 d [29.65% (67/226)] was higher than that in control group [19.20% (43/224), P=0.010]. 3) No significant differences were observed between the two groups in terms of time to menstrual recovery and endometrial thickness (all P>0.05). 4) In the study group, 3 subjects experienced non-therapeutic-related complications, while 11 subjects in control group. The incidence of complications was lower in the study group [1.29% (3/232)] than in control group [4.66% (11/236), P=0.033]. Conclusion:The administration of Gongxuening Capsules to women following artificial abortion significantly reduced vaginal bleeding volume and was associated with good safety, with the treatment being well-tolerated by the subjects.
