TY - JOUR
T1 - Safety of Japanese herbal Kampo medicines for the treatment of depression during pregnancy
AU - Michihata, Nobuaki
AU - Shigemi, Daisuke
AU - Yamana, Hayato
AU - Matsui, Hiroki
AU - Jo, Taisuke
AU - Yasunaga, Hideo
N1 - Funding Information:
The Department of Health Services Research of the Graduate School of Medicine (University of Tokyo) is supported by Tsumura & Co.
Funding Information:
This study was supported by grants from the Ministry of Health, Labor and Welfare, Japan, and the Ministry of Education, Culture, Sports, Science, and Technology, Japan.
Publisher Copyright:
© 2022 International Federation of Gynecology and Obstetrics.
PY - 2022
Y1 - 2022
N2 - Objective: 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 or older admitted to obstetric clinics or hospitals for delivery. Participants were classified into four groups: those without depression, those diagnosed with depression without medication, those given Kampo medicines for depression, and those given western medicines for depression. Neonatal outcomes (congenital anomalies, low birth weight, and preterm birth) were considered as 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-birth-weight neonates 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 group (aOR 1.31; 95% CI 1.07–1.61) and western medicine group (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 birth weight, or preterm birth.
AB - Objective: 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 or older admitted to obstetric clinics or hospitals for delivery. Participants were classified into four groups: those without depression, those diagnosed with depression without medication, those given Kampo medicines for depression, and those given western medicines for depression. Neonatal outcomes (congenital anomalies, low birth weight, and preterm birth) were considered as 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-birth-weight neonates 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 group (aOR 1.31; 95% CI 1.07–1.61) and western medicine group (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 birth weight, or preterm birth.
KW - Congenital anomaly
KW - Depression during pregnancy
KW - Hange-koboku-to
KW - Japanese herbal Kampo medicine
KW - Kanbaku-taisou-to
KW - Yokukansan
KW - Yokukansan-kachinpi-hange
UR - http://www.scopus.com/inward/record.url?scp=85130608441&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85130608441&partnerID=8YFLogxK
U2 - 10.1002/ijgo.14237
DO - 10.1002/ijgo.14237
M3 - Article
C2 - 35490369
AN - SCOPUS:85130608441
JO - International Journal of Gynecology and Obstetrics
JF - International Journal of Gynecology and Obstetrics
SN - 0020-7292
ER -