ArticleDrugs - real world outcomes2024
Risk of Major Congenital Malformations Associated with the Use of Japanese Traditional (Kampo) Medicine Containing Ephedra During the First Trimester of Pregnancy.
Article in Drugs - real world outcomes, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed, 7 citations in OpenAlex.
- Kampo Medicines Modulate Angiogenic, Antioxidant, and Inflammatory Pathways in Human Preclinical Models: Implications for Preeclampsia.Antioxidants (Basel, Switzerland) · 2026Article
- Temporal trends in the prescription of traditional Japanese herbal (Kampo) medicines to pregnant women: analysis of an administrative hospital database in Japan.Journal of pharmaceutical health care and sciences · 2025Article
- Perinatal Outcomes After the Use of Kampo Medicines Containing Ephedra During Pregnancy.Pharmacoepidemiology and drug safety · 2025Article
- Suitability of Japanese Medical Databases for Studies on Infant Outcomes After Maternal Drug Exposure: An Evaluation Based on Core Data Elements.Pharmacoepidemiology and drug safety · 2025Article
Corrections and comments
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Authors and funding
19 authors at 1 institution in 1 country.
Funding
Abstract
backgroundJapanese traditional (Kampo) medicines containing ephedra may be used to treat colds during pregnancy. There are reports that ephedrine, a component of ephedra, has a risk of teratogenicity; however, the evidence remains equivocal.
objectiveThis study aimed to evaluate the risk of major congenital malformations (MCMs) associated with exposure to Kampo medicines containing ephedra during the first trimester of pregnancy using the Tohoku Medical Megabank Project Birth and Three-Generation Cohort Study (TMM BirThree Cohort Study).
methodsTo 23,730 mother-infant pairs who participated in the TMM BirThree Cohort Study from July 2013 to March 2017, questionnaires in early and middle pregnancy were distributed approximately at weeks 12 and 26 of pregnancy, respectively. Infants' risk of MCMs in women who used Kampo medicines containing ephedra or acetaminophen during the first trimester was assessed, and the odds ratios (ORs) were estimated with unadjusted and adjusted analyses.
resultsAmong 20,879 women, acetaminophen and Kampo medicines containing ephedra were used in 665 (3.19%) and 376 (1.80%) women, respectively, in the first trimester. Among the infants born to the mothers who used acetaminophen or Kampo medicine containing ephedra during the first trimester, 11 (1.65%) and 8 (2.13%), respectively, had overall MCMs. OR of overall MCMs was higher in women who used Kampo medicines containing ephedra than in those who used acetaminophen in the first trimester (adjusted OR, 1.45; 95% confidence interval (CIs), 0.57-3.71); however, the difference was not statistically significant.
conclusionsIn this study, there was no statistically significant association between the use of Kampo medicines containing ephedra during the first trimester of pregnancy and the risk of MCMs. Although some point estimates of ORs exceeded 1.00, the absolute magnitude of any increased risks would be low.
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