Objective: To determine the effectiveness of Japanese Kampo medicines on the overall live birth rate among patients with recurrent pregnancy loss (RPL) in a real-world setting.
Methods: In the current retrospective cohort study, we used the JMDC Claims Database to extract information on women diagnosed with RPL between January 1, 2005 and August 31, 2018. Eligible women were divided into two groups according to Kampo medicines administered as treatments for RPL. The primary outcome was the live birth rate during the study period. Propensity score matching, Kaplan-Meier cumulative incidence plots, log-rank test, and Cox proportional-hazards regression model were used to compare the primary outcome between patients with and without Japanese herbal Kampo medicines.
Results: Among 5517 eligible patients, 1652 used Kampo medicines and 3865 did not. After propensity score matching, the live birth rate at 2.0 years was 15.7% in the Kampo group and 11.2% in the non-Kampo group. At 4.0 years, the difference between the two groups had slightly increased. The overall live birth rate differed significantly between the two groups (hazard ratio 1.32, 95% confidence interval 1.13-1.53; P < 0.001).
Conclusion: Japanese herbal Kampo medicines may improve the live birth rate in patients with RPL.
Keywords: Cohort study; Japanese herbal Kampo medicine; Live birth rate; Propensity score matching; Recurrent pregnancy loss.
© 2020 International Federation of Gynecology and Obstetrics.