For many women, nausea and vomiting (aka, morning sickness) are a seemingly unavoidable part of a normal pregnancy. However, a new study reported in The New England Journal of Medicine suggests that these women may find relief in a drug commonly used to treat nausea and vomiting during pregnancy in Europe.
To summarize the study:
The rate of birth defects was the same among women who took the drug, metoclopramide (Reglan), and women who had taken other medications thought to be safe during pregnancy.
The study participants received care and were followed in Israeli, Italian, and Brazilian hospitals
The investigators compared 126 women who had taken 10 to 40 milligrams of metoclopramide during the first trimester of pregnancy and an equal number of women who took drugs that are not considered dangerous to the fetus.
"The rate of major malformations was within the normal range (1% to 5%) and was identical in the two groups," the researchers report.
"Our data suggest that the administration of metoclopramide during the first trimester of pregnancy is probably not associated with an increased risk of fetal malformations, spontaneous abortions, or decreased birth weight of the infants," Dr. Matitiahu Berkovitch of Assaf Harofeh Medical Center in Zerifin, Israel, and colleagues explained in their letter.
The New England Journal of Medicine August 10, 2000;343:445-446.
One of the most ludicrous aspects of this study was that there was no real control group. Instead of comparing the pregnant women taking the drug (Reglan) with women either taking no drug or a placebo, they compared them with women taking other medications.
You may also have noted that the author stated that the drug "is PROBABLY not associated with" adverse effects. Is PROBABLY good enough when it comes to our children? If you leave your child unattended in a public place for a short period of time, PROBABLY nothing bad will happen, but I doubt that most parents are willing to accept those odds.
I am not surprised that NEJM published this study though and I was expecting to see far more of these types of studies as their new editor begins to exert his influence. Their previous editor, Dr. Angell had some of the best articles ever published in NEJM (1, 2) regarding the connection between the drug companies and researchers, before she left NEJM earlier this year. The new editor has clear connections with the drug industry and I suspect we will see more of these types of articles in the future from NEJM.
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