The morning sickness pill endorsed by Kim Kardashian is no more effective than a dummy pill, according to new research.
As many as 90 percent of women suffer from morning sickness during the early stages of pregnancy. Diclegis, which prescribed to 33 million worldwide, is the only FDA-approved drug on the market.
The pill became more popular when the 37-year-old reality star promoted the drug three times on Instagram in August 2015, April 2017, and July 2017.
Researchers of the new study also published a landmark medical report in 2017 that concluded Doclegis is ineffective, and a waste of money.
Kim Kardashian endorsed the controversial pill as helping her with her morning sickness while she was pregnant with her son, Saint West
A 2010 clinical trial that the FDA used to approve Diclegis in 2013 has missing data that, if utilized differently, would show that the difference between the drug and placebo’s effectiveness was not ‘statistically significant’, according to new research.
Kardashian was originally slammed by the FDA after her original post about Diclegis without mentioning the medication’s array of potential side effects.
The study, published in PLOS One, analzed results from a 2010 clinical two-week trial that found Diclegis led to a greater improvement in nausea and vomiting during pregnancy compared with placebo.
Results of the clinical trial were based on the PUQE score –pregnancy-unique quantification of vomiting/nausea, with a score of three meaning no symptoms and a score of 15 being extremely severe.
In the trial, pregnant mothers in the placebo group saw a 3.9 drop in their PUQE score from 8.8, while those on the morning pill saw a 4.8 point drop down from 9.0. There was only a 0.9 difference in PUQE score.
Although this seems like a significant difference, researcher Dr Navindra Persaud, of the Department of Family and Community Medicine at St. Michael’s Hospital, said missing data shows that there was supposed to be a three-point difference in PUQE score between the drug and placebo groups.
‘I was … surprised that important information about the trial was hidden until now,’ Dr Persaud told Medical News Today. ‘Although some results were published in 2010, the earlier reports did not mention the fact that a difference of three points on the 15-point symptom scale was prespecified as the … smallest difference that a patient would deem as important.’
The FDA approved the Diclegis following this trial, even though it did not meet the expected 3-point difference.
OMG. Have you guys heard about this? As you know my #morningsickness has been pretty bad.
Kim Kardashian, August 2015
In the trial, the placebo appeared to be just as effective as the drug.
‘In this trial, women given a placebo had large improvements in symptoms over two weeks,’ Dr Persaud said. ‘By the end of the two-week trial, women given a placebo had symptom scores around four and the lowest possible score on the symptom scale is three.’
WHY DICLEGIS IS CONTROVERSIAL
- An early version of the drug with an additional ingredient was first introduced in the 1950s
- In the 1970s, Benedictin became an FDA-approved drug to treat morning sickness
- It was voluntarily taken off the market in 1983 after several lawsuits claiming it was associated with birth defects
- In 2013, Diclegin became approved by the FDA to treat morning sickness
- The controversy surrounds the combination of the ingredients doxylamine and pyridoxine – said to increase the risk of birth defects
- The original 1970s study was also incomplete with participants dropping out and unincluded dat
Dr Persuad also spearheaded a study published in 2017 that revealed that the original 1970s clinical trial that the FDA and the federal department used to approve the drug found little evidence that the drug was effective.
Known as Diclegis in the U.S. and Diclectin in Canada, millions of women have taken the drug since it was developed in the 1970s.
An older version of the medicine with an additional ingredient has been used as far back as the 1950s.
In the mid-1950s, the combination of the ingredients doxylamine and pyridoxine was approved by the FDA for the treatment of morning sickness.
Sold under the name Bendectin, a series of lawsuits followed 20 years later claiming the drug was associated with birth defects.
The medication was voluntarily withdrawn from the American market in 1983.
Then, ‘this company Duchesnay applied to start selling the same two active ingredients under the name Diclegis,’ Dr Persaud said.
Not every doctor agrees believes Diclegis is ineffective.
Dr Siripanth Nippita, a researcher at Harvard Medical School and Beth Israel Deaconess Medical Center in Boston said: ‘Studies that have been done since this trial was completed in the 1970s show that doxylamine and pyridoxine are an effective treatment for nausea and vomiting in pregnancy.
‘Based on research involving over 200,000 women, we can say that doxylamine and pyridoxine are safe to take during pregnancy,’ Nippita, who was not involved in the new study, added. ‘They can be an important part of treatment for nausea and vomiting.’
Kim Kardashian (left) suffered morning sickness. The Duchess of Cambridge was famously hospitalized with a severe form of morning sickness called hyperemesis gravidarum
Despite his findings, Dr Persaud doesn’t think the FDA will withdraw Diclegis from the market anytime soon.
‘It is very unusual for medications to be removed from the market because of ineffectiveness,’ said Dr Persaud. ‘Medications are withdrawn when they are found to be harmful after approval but even this is quite rare. So it is unlikely that this medication will be withdrawn.’
A spokesman for Duchesnay, Inc. previously said: ‘Duchesnay is committed to providing pregnant women suffering from nausea and vomiting of pregnancy with a safe and effective treatment option when diet and lifestyle changes fail to adequately control their symptoms.
‘Diclectin is the only prescription medication indicated for the treatment of nausea and vomiting of pregnancy approved by Health Canada. It has been prescribed for over 40 years in Canada and has been proven safe and efficacious for use throughout pregnancy.’
She added: ‘We have complete confidence in the safety and efficacy of Diclectin and are very proud to provide it as a safe and effective treatment option for women suffering from nausea and vomiting of pregnancy.’