Queries on the article "Maternal traditional Chinese medicine exposure and risk of congenital malformations" and suggestions for teratogenicity research

Abstract

Traditional Chinese Medicine (TCM) has a rich history spanning thousands of years, with its applications ranging from treating female infertility and recurrent pregnancy loss to managing nausea and vomiting of pregnancy. Yet the safety of pregnant women consuming Chinese herbal medicine (CHM) still lacks sufficient modern clinical research data. On April 19, the journal Acta Obstetricia et Gynecologica Scandinavica published a research article titled "Maternal traditional Chinese medicine exposure and risk of congenital malformations: a multi-center prospective cohort study." The study claimed that "Periconceptional TCM exposure is associated with an increased risk of congenital malformation," drawing attention from both English and Chinese media outlets, which extensively reported and commented on the findings.In response, various TCM organizations contested the research, asserting that it failed to adhere to fundamental standards of academic rigor, statistical analysis, and necessary methodologies to draw conclusions. International TCM practitioners and scholars thoroughly examined the article, uncovering multiple errors and arguing that these misleading conclusions significantly undermined the reputation of CHM. These scholars communicated their doubts directly to the corresponding author and the journal's chief editor, emphasizing that the article's conclusion was derived from secondary data analysis of another clinical research project and funding sources, therefore, called for withdrawal of the article. Eventually, the article was retracted due to flaws with the study design in collecting data on exposure to TCM in pregnant women, which affects the validity of the data to support the conclusions of the study.This article conducts a comprehensive academic inquiry into the article, meticulously outlining the identified errors, discusses the reproductive toxicity of CHM, and provides suggestions for future research to evaluate the safety of pregnant women using CHM rigorously, emphasizing evaluation on teratogenicity research of CHM should not only be based on study using healthy animals, but also incorporate clinical epidemiological research and disease-syndrome-based toxicology.