Description

Pregnant women have historically used herbal remedies all throughout the world. However, the safety of using them throughout the first trimester of pregnancy is sometimes questioned. To find out if taking herbal remedies in the first trimester of pregnancy increases the chance of birth abnormalities. By connecting a population-based drug prescription database that covers all hospitals in Xiamen, China, the population-based retrospective cohort analysis included pregnancies registered in a population-based and long-term follow-up database with live births. The sequential administration of one or more prescriptions for herbal medications to prevent miscarriage during the first trimester was considered the exposure of interest. We looked at 23 distinct categories of birth defects by nationwide monitoring, as well as the total number of birth defects (not including chromosomal abnormalities). We added both active and blank (non-use) controls to make comparisons easier. To account for the confounders, Poisson Regression Model (PRM) based on Propensity Score Matching (PSM) was used. The robustness was examined using negative control analysis and multiple sensitivity studies. Of the 195,824 pregnancies in the final cohort, 29,063 (14.8%) had early-pregnancy herbal medicine prescriptions, 3,024 of which were herbal medication monotherapy. These herbal remedies peaked between weeks five and eight of pregnancy and were frequently used in conjunction with other medications, particularly pharmaceutical ones. 2,795 birth abnormalities in all were found. Herbal medicine monotherapy was not linked to an increased risk of general birth abnormalities when compared to progesterone monotherapy (i.e., active control). Pregnancy outcomes with herbal medication monotherapy had a comparable risk to those without drug usage (i.e., blank control). Sensitivity analyses revealed consistent results.

Safety of herbal remedies

Larger studies with broader pregnancy populations are required for additional confirmation, although the available data does not point to an increased risk of birth abnormalities while using herbal medications in the early stages of pregnancy. In many nations, herbal remedies-which can be made as herbal extracts, single herbs, or herbal formulas-are frequently used to support pregnancies or to treat early pregnancy symptoms including nausea and vomiting. In recent years, the use of herbal remedies during pregnancy has grown in popularity, ranging. In China, the use of herbal remedies is common in early gestation, 26.13% of pregnancies are prescribed with one or more herbal remedies, and 94.96% of herbal medicines are used in conjunction with pharmaceutical medications. However, the lack of strong clinical evidence has raised serious concerns about the safety of herbal medications used in the early stages of pregnancy, notably their effect on birth abnormalities. Pregnant women are typically excluded from Randomized Controlled Trials (RCTs) due to their special status, and the majority of the information on birth abnormalities that is currently accessible comes from spontaneous adverse event reporting that occurs after approval. The possible risk of birth abnormalities was examined in a few epidemiological studies, but the tiny sample sizes prevented them from producing conclusive results. Inadequate control for the effects of pregnant women's medical problems and concurrent medication use was another significant drawback. Large-scale population-based research would provide the best evidence regarding the impact of herbal remedies on birth abnormalities. The population-based study could ascertain the safety of herbal medicines on birth abnormalities if it had enough power, an unselected population, and suitable controls for bias and confounding.

Pregnancy outcomes

We performed a cohort analysis using a reputable big population-based database to see if using herbal remedies during the early stages of pregnancy was linked to an increased risk of birth abnormalities. Using the population-based prescription database, 519,525 pregnancies and live births were recorded for both inpatients and outpatients. 225,896 pregnancies with medication records and live deliveries were found. A total of 195,824 pregnancies were included in the analyses after ineligible pregnancies were eliminated. We obtained information on the exposure to herbal medications over the whole pregnancy by using a sizable population-based database. We analyzed almost 200,000 pregnancies and discovered that 14.8% of them utilized herbal medicines in the early stages of pregnancy, with two-thirds of those prescriptions being for pregnancy support and miscarriage prevention.

According to the results, which were derived using exacting statistical techniques, using herbal remedies in the first trimester of pregnancy was not linked to complications. According to our research, there is no evidence that using herbal remedies in the first trimester of pregnancy raises the risk of birth abnormalities. This study offers important new information on the safety of herbal remedies during pregnancy and is likely the first to examine this link with a population-based cohort.

However, due to the nature of observational research, care should be taken when interpreting these results. Further research, including larger studies with different. Unless otherwise noted, no data pertaining to any of the study's subjects has ever been published before. Although the datasets examined in this study are not publically accessible, the corresponding author can provide them upon reasonable request.