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Herbal Medicines Used During the First Trimester and Major Congenital Malformations

An Analysis of Data from a Pregnancy Cohort Study

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Abstract

Background: Major congenital malformations place a considerable burden on the affected child, the family and society. Any kind of medicine used during pregnancy might have a harmful impact; therefore, such practice has raised concerns. The objective of the current study was to explore the relationship between the use of herbal medicines by pregnant women during the first trimester of pregnancy and the risk of major congenital malformation in their live born infants.

Methods: This was a cross-sectional analysis of data from a prospective pregnancy cohort, which was established between 1984 and 1987. To assemble the cohort, pregnant women of ≥26 weeks of gestation who came to the Taipei Municipal Maternal and Child Hospital in Taiwan for prenatal care were enrolled in the study and interviewed using a structured questionnaire. Detailed information, including herbal medicine use during different periods of pregnancy, was obtained during the interview. Past medical history, current obstetric data and details on conventional medicines used during pregnancy were abstracted from medical records. Data on birth weight, gestational duration and characteristics of live born infants were gathered from the Taiwan national birth register. Congenital malformation information was obtained from multiple sources: the newborn examination record (1984–7); the national death register (1984–2003); and Taiwan National Health Insurance data (1996–2000). Multiple logistic regression was used to estimate the odds ratio [OR] of major congenital malformation by herbal medicines used during the first trimester.

Results: A total of 14 551 live births were analysed. After adjustment for confounding factors, taking huanglian during the first trimester of pregnancy was found to be associated with increased risk of congenital malformations of the nervous system (adjusted OR 8.62, 95% CI 2.54, 29.24). An-Tai-Yin was associated with an increased risk of congenital malformations of the musculoskeletal and connective tissues (adjusted OR 1.61, 95% CI 1.10, 2.36) and the eye (adjusted OR 7.30, 95% CI 1.47, 36.18).

Conclusion: We found evidence for a possible link between the use of specific herbal medicines during the first trimester of pregnancy and increased risks of specific groups of congenital malformations. We could not investigate whether the adverse effects were related to direct toxicity from the herbal medicines, or were from misuse, contamination or uncontrolled confounding. Nonetheless, we would advise caution regarding use of herbal medicines during pregnancy, and we suggest that further investigation of these findings is warranted.

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Acknowledgements

This study was supported by grants (BHP-PHRC-92-4 and D0H93-HP-1702) from the Bureau of Health Promotion, Department of Health, Taiwan.

The authors have no conflicts of interest that are directly relevant to the content of this study.

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Authors and Affiliations

  1. Institute of Occupational Medicine and Industrial Hygiene, National Taiwan University College of Public Health, 17 Syujhou Road, Taipei 100, Taiwan

    Chao-Hua Chuang, Jung-Der Wang, Jung-Nien Lai &  Pau-Chung Chen

  2. Department of Nursing, Fooyin University, Kaohsiung County, Taiwan

    Chao-Hua Chuang

  3. Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK

    Pat Doyle

  4. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

    Jung-Der Wang

  5. Department of Nursing, National Taipei College of Nursing, Taipei, Taiwan

    Pei-Jen Chang

  6. Division of Gynecology, Traditional Chinese Medicine, Taipei City Hospital, Taipei, Taiwan

    Jung-Nien Lai

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  1. Chao-Hua Chuang
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  2. Pat Doyle
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Correspondence to Pau-Chung Chen.

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Chuang, CH., Doyle, P., Wang, JD. et al. Herbal Medicines Used During the First Trimester and Major Congenital Malformations. Drug-Safety 29, 537–548 (2006). https://doi.org/10.2165/00002018-200629060-00006

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