Morning Sickness Drug May Not Be Effective: Canadian Researchers

Diclectin is prescribed 300,000 times each year by Canadian doctors.

It's common for expectant parents to experience morning sickness, especially during their first trimester. That's why it's good to know that medication exists to help combat the nausea and/or vomiting that can occur at any time of the day.

But according to Canadian researchers, Diclectin (pyridoxine-doxylamine), the drug most commonly prescribed for morning sickness, may not be effective.

Dr. Nav Persaud, a researcher and family physician at Toronto's St. Michael's Hospital, re-analyzed data from a 2010 paid clinical trial and found that the drug failed to meet effectiveness standards.

The two-week study compared 101 women, who were prescribed the drug, to 86 women who were given a placebo. It was found that women who took the drug only experienced reduced symptoms 0.7 points — on a 13-point scale — more than those who took the placebo.

Persaud noted on Wednesday that there needed to be at least a three-point reduction in symptoms for Diclectin to be proven effective, the National Post reports.

"There was a very small difference between the women who got a placebo and the women who got this medicine," Persaud said, according to HealthDay.

"I think medications should only be approved and prescribed if they're proved to be effective," he added. "If the medication is not effective, it doesn't matter if it's safe or not."

CBC News reports that Diclectin is prescribed 300,000 times each year by Canadian doctors. The drug is recommended so often that Persaud even admitted to the news outlet that he "had been routinely prescribing the medication without thinking about it."

It wasn't until one of his patients asked if Diclectin would actually help with morning sickness that the Toronto physician began looking into the data.

Persaud and four other researchers obtained 9,000 pages of Health Canada documents about Diclectin and published their analysis in the journal PLOS ONE on Wednesday. In the journal, they conclude that Diclectin has no "clinically important benefit" when it comes to relieving expectant women's symptoms of nausea and vomiting.

"It is quite likely that the women who took this medication when it was prescribed to them ... were getting better because of the natural course of nausea and vomiting, and their improvement likely had nothing to do with the medication," Persaud said.

According to Baby Center Canada, morning sickness usually starts around week five to six of pregnancy and continues until around week 14. However, it's possible for some women continue to experiencing symptoms beyond that timeframe.

Diclectin is the only prescription drug authorized by Health Canada to treat morning sickness, CTV News reports. As a result, Persaud says he believes the government agency needs to rethink its stance on the drug.

In a statement to CTV News, however, Health Canada said: "The available evidence continues to support Diclectin in the treatment of nausea and vomiting during pregnancy."

The last time the agency reviewed data on Diclectin was in 2016. "No new safety or efficacy issues were identified as part of the review," a spokesperson said.

Regardless, Persaud told CBC News, "I have completely stopped prescribing this medication. I don't think it should be prescribed. I don't think patients should take it."

Medication isn't the only way to alleviate nausea and vomiting in the first trimester. In December, the Society of Obstetricians and Gynaecologists noted that home remedies such as ginger, vitamin B6, and acupuncture could help ease symptoms.

Ginger, specifically, is thought to be effective, since the superfood is known to ease upset stomachs and nausea. In fact, it was revealed last year that the Duchess of Cambridge eats ginger biscuits to combat hyperemesis gravidarum (HG), which is a severe form of morning sickness.

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