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Herbal Products: Echinacea may be OK for pregnant women
Herb doesn't appear to cause major fetal malformations
By Terry Murray
TORONTO ? Echinacea appears not to cause major fetal malformations if it's taken during pregnancy. That was the finding of a small, prospective, controlled study thought to be the first investigation of the herb's fetal safety when used during gestation.
The study was conducted by researchers at the Hospital for Sick Children's Motherisk program (a teratogen information service and research program) and the Canadian College of Naturopathic Medicine here.
The study involved 206 women who contacted Motherisk between 1996 and 1998 about the safety of echinacea in pregnancy, and subsequently used echinacea products (112 used them during the first trimester). Their pregnancy outcomes were compared with those of 206 women who contacted the program about the herb's safety in pregnancy but did not use it.
Rates of malformations were not significantly different between the two groups, the researchers said in a report of their findings, published in the Archives of Internal Medicine. Perhaps more important was the finding that the children of women who use echinacea in the first trimester did not have a greater rate of malformations either.
For the women who took the herb, there were 195 live births (including three sets of twins), 13 spontaneous abortions and one therapeutic abortion.
For women in the control group (who were matched for several characteristics, including having had an upper respiratory infection during the pregnancy), there were 198 live births, seven spontaneous abortions and one therapeutic abortion.
Six babies in the echinacea group had major malformations including one chromosomal abnormality and six minor malformations. Four major malformations and two minor malformations were seen in babies who were exposed during the first trimester.
Infants in the control group showed comparable rates and types of malformations, with seven major and seven minor malformations reported in that group.
The findings are reassuring, although the numbers are small, said Dr. Gideon Koren, director of the Motherisk program and professor of pediatrics, pharmacology and medical genetics at the University of Toronto. "For some other drugs, even with 200 (patients) you can show them to be unsafe," he said in an interview.
The researchers concluded that the study "suggests that gestational use of echinacea during organogenesis is not associated with a detectable increased risk for major malformations."
But Dr. Koren cautioned that the numbers are too small to detect less than a twofold increased risk. "There's always a problem of (statistical) power. You can only say 'safe' to the degree of numbers that you have."
Another limiting factor is that the content of the echinacea preparations, formulations and dosages used were not standardized. As a result, the study is not strong enough for clinicians to tell their pregnant patients to go ahead and take echinacea if they are developing an upper respiratory tract infection (URTI), Dr. Koren said. "There is still debate about the efficacy. If a woman tells a physician that echinacea works for her and she is convinced that it helps her, our data can be interpreted cautiously as showing that it does not increase risk as long as the physician understands that the power of 200 or so patients is relatively limited."
But the findings may be useful in reassuring women who used the herb before they knew they were pregnant, he added. That could be a large group given that an estimated 50% of all pregnancies are unplanned, and because echinacea products are among the most popular phytomedicines in North America, are used for URTIs which are common and are perceived as being effective, he said.
Medications are usually used with caution in pregnancy, but many women in the study group perceived the risk of echinacea to be low because it's "natural." Some health-care providers they consulted also felt that using the herb in pregnancy was unlikely to be a concern, "with almost half of them suggesting that the product is safer, even though studies are not available," the report said."Without proper evidence-based information, health-care providers are often left with the difficult task of estimating the reproductive risk of such remedies."
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