Researchers question results of drug trial as anti-nausea medication, approved for use by pregnant women, appears to be ineffective

“Previously unpublished information” about one of the most commonly prescribed medicine for nausea in pregnancy implies that the drug is actually ineffective.

Thousands of pages of documents retrieved from Health Canada about a randomized clinical trial reported in 2010 suggests that pyridoxine-doxylamine was effective in reducing nausea and vomiting during pregnancy. The documents were acquired by researchers from St. Michael’s Hospital.

In the trial, pregnant women who received the drug called Diclectin (Canada) or Diclegis (U.S.) disclosed that their symptoms were reduced by “0.7 greater than women who took a placebo” based on a 13-point scale.

However, according to Dr. Nav Persaud, a researcher and family physician at St. Michael’s, the manufacturer’s comprehensive 9,000-page “clinical study report” noted that the findings are only clinically relevant after a three-point reduction in symptoms is applied. The doctor adds that this information remained unknown until recently.

Dr. Persaud comments that while the findings reported in 2010 could be statistically meaningful, they were not significant enough to be noticed by the women who took the medication. At the end of the two-week trial, the women who received a placebo only had “little or no symptoms.” (Related: Morning Sickness: 10 Natural and Simple Tips to Avoid the Nausea.)

Dr. Persaud is concerned that there could have been “selective reporting” about the secondary outcomes in the 2010 publication to make Diclectin seem effective. Based on the 2010 paper, the drugs had “apparent benefits” like a decrease in time off from work caused by nausea and vomiting. However, the 2010 publication did not mention outcomes that showed no remarkable difference between the two groups like “time lost from household tasks” or the “number of visits to health-care providers.”

Duchesnay Inc., the manufacturer of the drug, sponsored the 2010 clinical trial. It was conducted at six university medical centers in the U.S.

Based on the documents, 101 female participants took pyridoxine-doxylamine while a control group was made up of 86 women. Even though the original enrollment was higher, it appears that many women dropped out during the trial.

Dr. Persaud shares that Duchesnay contacted the Food and Drug Administration (FDA) early in the 2000s for the approval of pyridoxine-doxylamine. The FDA then told the manufacturer that this required evidence from a clinical trial.

In 2013, the FDA approved the drug following the conclusion of the trial. The drug was soon prescribed to 33 million women around the world, per Duchesnay. At least one prescription was filled for every two births in Canada.

Back in the 1980s, the drug was “voluntarily withdrawn from the American market in the midst of legal claims about birth defects that were eventually rejected by courts.” In recent news, celebrity Kim Kardashian was admonished by the FDA when she “inappropriately” endorsed the drug on social media.

Dr. Persaud concludes that the FDA, Health Canada, and regions offering the drug must revisit their decision to do so via publicly funded prescription drug plans. He advised that pregnant women can also try more efficient treatments instead of taking the drug. Dr. Persaud also urged clinicians to stop prescribing pyridoxine-doxylamine.

Natural remedies for morning sickness

Instead of taking drugs that aren’t always effective, try some of these natural remedies for morning sickness:

• Acupressure or acupuncture – These techniques, which use gentle pressure or tiny needles to target specific nerve centers in the body, can help ease nausea.
• Change your eating patterns – Make sure that your stomach is never empty by eating small and frequent meals the whole day.
• Exercise – If you have a queasy stomach, going for a “gentle walk” might help. Take a 20-minute walk every day to release endorphins that will counteract nausea.
• Ginger – Ginger can help settle an upset stomach. You can drink it as a soda or tea if you’re having stomach problems.
• Mint – Eat or smell anything minty to combat nausea.

You can read more articles about natural cures for pregnancy-related health concerns at WomensHealth.news.

Sources include:

ScienceDaily.com

Parents.com