\Doxylamine-pyridoxine (Diclegis), recommended to treat nausea and vomiting in pregnancy, may not be as effective as previously reported, according to a reanalysis published in PLOS One.
Briefly, roughly 250 women at 7 to 14 weeks’ gestation reporting pregnancy-related nausea and vomiting were randomized to receive Diclegis or placebo for 2 weeks. The treatment group had a statistically significant improvement of 0.73 points on the 13-point PUZE symptom scale, researchers reported in 2010. However, in this reanalysis, a separate group of researchers point out that a 3-point difference is required to be considered clinically significant. In addition, another analysis of the data found no statistical difference between the two groups.
The authors conclude: “Clinical practice and guidelines should be updated. This reanalysis underscores the importance of public access to individual participant level data from clinical trials and verification of the findings.
How did this study pass peer review in 2010 to be published? Once published several medical journals, including the Journal of the American Medical Association (JAMA) cited this study, endorsing the use of this drug for morning sickness. The articles spanning the past seven years announce “a new day for pregnant women”, listing the drug as “one of the best studied drugs of all time.”
After a drug is approved and use with the public begins, post-release reports of side effects are gradually compiled. Some of the side effects associated with Diclegis are: dyspnea, palpitation, tachycardia, vertigo, visual disturbances, abdominal pain, constipation, diarrhea, fatigue, irritability, malaise, headaches, migraines, anxiety, insomnia, nightmares, itching and rash. During clinical trials side effects were reported in greater than 5% of subjects.
Diclegis is 10mg of vitamin B6 and Doxylamine, an antihistamine. The inactive ingredients include: ammonia, butyl alcohol, silicon dioxide, isopropyl alcohol, polyethylene glycol, polysorbate and talc. Some of these additives are used to achieve delayed release of the active ingredients.
Studies of the active ingredients over the course of 30 years, beginning in the 1960’s, show no increase in teratogenicity. A teratogen is a substance that can halt pregnancy or increase fetal malformation. I’m guessing that is how Diclegis earned the title of best studied drug.
Morning sickness readily responses to ginger. Ginger may increase the absorption of pharmaceutical drugs and can thin the blood at high doses. However, no adverse side effects are reported at therapeutic doses. Historical use of ginger as a general tonic goes back over 5,000 years in both India and China. As a spice, it was originally considered a luxury.
I also use vitamin B6 frequently, although I have never had occasion to use it in the treatment of morning sickness. Vitamin B6 is intimately involved in the sulfur amino acid pathways that liberate sulfur for use in phase II liver detoxification (among other things). I can readily see how improved phase II liver detox could reduce or eliminate morning sickness. This is the pathway through which spent hormones are rendered harmless and eliminated from the body.
The Bottom Line:
If you suffer from morning sickness please try ginger rather than Diclegis. Your baby doesn’t need to be exposed to all those chemicals. Make sure you use a high quality ginger. I obtain mine from Australia, where herbs must adhere to pharmaceutical standards. You might even try adding vitamin B6, but make sure you use the bioavailable form – pyridoxal 5’-phosphate – as a third of us have genetic impairment of the conversion pathway from the food form.
Source: New England Journal of Medicine January 18, 2018
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