A pill routinely prescribed for morning sickness, can be an effective nausea remedy, researchers say – although not all doctors agree.
The warning comes from researchers who conducted a new analysis of a previously published study that was used to win marketing approval for the drug
A pill routinely prescribed for morning sickness, can be an effective nausea remedy, researchers say – although not all doctors agree.
The warning comes from researchers who conducted a new analysis of a previously published study that was used to win marketing approval for the drug in the U.S. and Canada.
The drug pyridoxine-doxylamine is sold as Diclegis in US and Diclectin in Canada. This is made by millions of pregnant women, because it was developed in the 1970s, researchers note in PLOS One. An older version of the drug with an extra ingredient has been used as far back in the 1950’s.
For the current study, the researchers looked at data from a decades-old trial, and found little evidence that the drug is effective, said study co-author Dr. Navindra Persaud, a researcher at St. Michael’s Hospital and the University of Toronto in Canada.
“This medication is recommended as first-line treatment for nausea and vomiting during pregnancy,” Persaud said by e-mail. “We now have more information about this 1970’s research that should make us question whether the medication should have been approved, and whether it has ever been proven to be effective.”
The original research in the 1970s was designed to determine if the drug can relieve morning sickness in the first trimester of pregnancy.
To see whether these results have shown that the drug is effective, Persaud and co-author Dr. Rujun Zhang of the University of Toronto examined 36,000 pages of documents from the U.S. Food and Drug Administration, including the original report of the study, the protocol and the summary of the results, and other documents from Health Canada.
About 2,300 pregnant women have participated in the original trial in 14 clinics in the U.S., the researchers found. All of the women suffer from nausea and vomiting in the first 12 weeks of pregnancy.
The women were randomly assigned to eight treatment groups, including one that received a placebo or a dummy pill, and seven that received a variety of medications, including the combination which is now sold as Diclectin.
Each participant was asked to take two tablets per day at bedtime and an additional pill in the afternoon if needed for a week.
On the basis of data of 1,599 women who completed the study, participants were 14 percent more likely to report treatment was good or excellent with Diclectin than with placebo, the new analysis found.
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