A medication commonly prescribed for morning sickness during pregnancy appears to be ineffective, based on results from a previously unpublished clinical trial paid for by its Canadian manufacturer and submitted as part of the approval process to both Health Canada and the FDA, a new report suggests.
Nav Persaud, a family physician and researcher at St. Michael?s Hospital in Toronto, obtained thousands of pages of documents from Health Canada related to the 2010 clinical study, which suggested Diclectin (pyridoxine-doxylamine) was effective in reducing nausea and vomiting in pregnant women.
The trial sponsored by drug-maker Duchesnay Inc. of Quebec was conducted at six U.S. medical centres and compared symptom reduction in 101 women put on the medication versus 86 women given a placebo, or dummy pill. At the end of the two-week study, there was little difference in symptoms between the two groups; on a 13-point scale, women who took the drug reported symptom reduction only 0.7 points higher than that for women who got a placebo, the documents show.
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5 ways to cope with morning sicknessThe study specified that the findings would be clinically important only if there were a three-point reduction in symptoms, Persaud said Wednesday in an interview. ...