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Morning Sickness Drug May Not Be Effective

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A pill that doctors commonly prescribe for morning sickness may not be effective, researchers say, though not all medical experts agree with the findings.

The conclusion was made by researchers who had conducted an analysis of a previously unpublished trial that was used to pave the way for approval of the drug in the USA and Canada.

The drug, called pyridoxine-doxylamine, is known as Diclegis in the U.S. and Diclectin in Canada. Since its development in the 1970s, it has been used by millions of pregnant women to combat nausea. An older version of the drug that contains an additional ingredient has been used since the 1950s, Fox News reports.

Researchers took a look at data from a trial that is almost forty years old, and found little evidence that the drug is effective. Dr. Navindra Persaud, a researcher at St. Michael’s Hospital and the University of Toronto, and co-author on the study, said,

This medication is recommended as the first-line treatment for nausea and vomiting during pregnancy. We now have more information about this 1970s study that should make us question whether this medication should have been approved and whether it was ever proven to be effective.

The trial was supposed to determine if the medicine was effective in alleviating morning sickness in the first trimester of pregnancy. Persaud and co-author Dr. Rujun Zhang of the University of Toronto reviewed 36,000 pages of documents from the US Food and Drug Administration, along with the original study reports.

Some 2,300 pregnant women participated in the 1970s study across 14 clinics in the USA. All of the women had been experiencing nausea and vomiting in their first 12 weeks of pregnancy. Women were randomly assigned to treatment groups, and received either placebos or various medicines, including Diclectin.

Of the 1,599 women who completed the study, 14% were more likely to report that treatment was moderate or excellent with the drug compared to the placebo. But the findings may be unreliable, the researchers state, because the final results are unavailable and 37% of participants in the placebo group dropped out of the study.

In addition, there was no way to tell how the doctors scored symptoms. Data regarding patient visits for 30 of the participants were missing, as well. Persaud recommended that women stop taking the drug and ask their doctors about alternatives.

But some doctors disagree. Dr. Siripanth Nippita, a researcher at Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, said, “Studies that have been done since this trial was completed in the 1970s show that doxylamine and pyridoxine are an effective treatment for nausea and vomiting in pregnancy.” Nippita was not involved in the study.

The study was published in PLOS One.

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