Safety of Japanese Herbal Kampo Medicines for the Treatment of Depression During Pregnancy.

OBJECTIVE: We aimed to clarify the fetal safety of herbal Kampo medicines, including Hange-koboku-to, Koso-san, Nyoshin-san, Yokukansan, Yokukansan-kachinpi-hange, Saiko-keishikankyo-to, Keishi-karyukotu-borei-to, and Kanbaku-taisou-to, when administered to pregnant women with depression using a large healthcare administrative database.

METHODS: We extracted data from the JMDC Claims Database (2005-2018) for this retrospective cohort study of pregnant women aged ≥19 years admitted to obstetric clinics or hospitals for delivery. Participants were classified into four groups: those without depression, those diagnosed with depression without medication, those administered Kampo medicines for depression, and those administered Western medicines for depression. Neonatal outcomes (congenital anomalies, low birthweight, and preterm birth) were considered the safety outcome measures.

RESULTS: We identified 179,707 eligible mothers. The adverse outcomes did not differ significantly between participants receiving Kampo medicine and those not diagnosed with depression during pregnancy. The proportion of low-birthweight babies did not differ significantly between the Kampo medicine and non-depression groups [adjusted odds ratio (aOR), 1.28; 95% confidence interval (CI), 0.86-1.91], but was significantly higher in the unmedicated-depression (aOR, 1.31; 95%CI, 1.07-1.61) and Western medicine groups (aOR, 1.47; 95%CI, 1.18-1.83).

CONCLUSION: Kampo medicines are safe for treating depression during pregnancy without increasing the incidence of congenital anomalies, low birthweight, or preterm birth.