Despite being prescribed for pregnant women for over 40 years, a new study that looked at the trial on which the effectiveness of the drug, Diclectin, found the original trial’s outcome was based on flawed research.
According to a worrying new study published by PLOS One by researchers in Toronto, Canada, the combination of two of this medication’s key elements – ingredients pyridoxine and doxylamine that women have been reportedly using to ward off morning sickness for more than 40 years – is being called into question.
This shocking scientific revelation centres around the true effectiveness of the medication – one that has been long recommended by obstetricians – and if in fact it may be associated with birth defects.
One of the lead authors of this study, family GP and researcher at St. Michael’s Hospital Dr Nav Persaud, says he decided to look more into the clinical research behind this drug after recommending it to a pregnant patient.
What he found was an old, incomplete body of research that determined the drug was a success, but provided limited detail as to why.
Not only that, but after digging and digging for more research, he attempted to contact the initial study’s authors – most of whom he discovered had passed away.
Plus, during the testing of the study’s test subjects – women pregnant up to the 12-week mark who were experiencing nausea and periods of vomiting – Dr Persaud uncovered that the researchers had failed to consistently report their findings, leaving critical flaws in the study.
“Everything related to this medication should be revisited,” he says.
“Until there is clear evidence this medication is effective, clinicians should stop prescribing it and the implications are that patients should stop taking it.”
Agencies/Canadajournal