Morning Sickness, New Treatment and Old--Update
The only drug approved for morning sickness by the Food and Drug Administration (FDA) in more than 30 years will soon be available for women in the United States. The drug, called Diclegis, is a new version of a drug named Bendectin, which was pulled from the market in 1983. Introduction of Diclegis provides women with another treatment option for the nausea and vomiting associated with morning sickness.
Most pregnant women experience morning sickness
More than six million women in the United States and more than one hundred million in the world get pregnant each year. It is estimated that 85 percent of women who get pregnant experience some degree of morning sickness, which can range from mild nausea and/or vomiting to debilitating episodes of both symptoms, resulting in a condition known as hyperemesis gravidarum.
Approval of Diclegis allows women in the United States to have access to a formula that has been available for women in Canada for years. Diclegis is a combination of vitamin B6 (10 mg pyridoxine hydrochloride) and the antihistamine doxylamine succinate (10 mg).
This is the same ingredient combination available in the Canadian prescription drug, Diclectin, which was recently the subject of a study to determine its effectiveness in treating hyperemesis gravidarum. Diclegis has not been approved for this use.
Hyperemesis gravidarum can be harmful to both the mother and the fetus if the woman is unable to keep food down and also loses electrolytes, nutrients, and fluids. Fortunately, for most women with morning sickness, the symptoms are not this severe, although they can still be life-altering.
At the recent annual meeting of the Society for Maternal-Fetal Medicine, the results of a new study concerning a treatment for severe morning sickness was discussed. The new treatment approach was tested in pregnant women who had had severe morning sickness or hyperemesis gravidarum during a previous pregnancy.
Half the women were told to take the medication Diclectin® (delayed-release formula of 10 mg doxylamine and 10 mg pyridoxine [vitamin B6]) before experiencing nausea and vomiting, while the other half were told to take the medication at the first symptoms of morning sickness.
Women who took the preventive/pre-emptive doses of the medication experienced significantly reduced symptoms of severe morning sickness compared with women who waited for symptoms to begin before starting treatment. In fact, the number of cases of moderate to severe morning sickness symptoms was 70% lower among women who started treatment early compared with the other group during the first three weeks of morning sickness. Another benefit of starting treatment early was a reduction in the recurrence of hyperemesis gravidarum in women with a history of severe morning sickness.
Diclegis is scheduled to reach the US market by the end of May 2013. Although it has been approved for use in pregnant women, there are a number of precautions women should observe.
For example, women who have any of the following conditions should use this drug with caution: asthma, elevated intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, bladder neck obstruction, or pyloroduodenal obstruction. Pregnant women should tell their doctor about any other medications they are using before they take Diclegis.
Other morning sickness treatments
Use of any other types of medications during pregnancy is done with caution because of possible harm to the fetus.
However, there are safe natural treatments women can try to manage nausea and vomiting. For example:
- Acupressure. A study appearing in Complementary Therapies in Clinical Practice reported on the effectiveness of acupressure applied to the wrist in women with morning sickness. Twenty-five women received acupressure treatment while another 24 received sham treatments over nine days. The authors reported that acupressure appeared to be effective in controlling symptoms of morning sickness. Women can purchase acupressure wrist bands or learn to treat themselves using acupressure points.
- Ginger. Anecdotal reports and a limited number of studies have noted that pregnant women who use ginger have enjoyed some relief from nausea and vomiting. In one study, 123 pregnant women with morning sickness were randomly assigned to receive either 650 mg of ginger or 25 mg of vitamin B6 three times a day for four days. Both treatments resulted in a significant reduction in nausea and vomiting, although ginger was rated better. Approximately 25% of women experienced some minor side effects associated with ginger, including heartburn, sedation, and arrhythmia. Some women find that eating crystallized ginger or drinking ginger tea or ginger ale (that contains real ginger) is helpful.
- Vitamin B6. Also known as pyridoxine, this B vitamin is frequently taken alone (versus combined with doxylamine in Diclectin) to treat morning sickness. As the previous study showed, vitamin B6 proved to be somewhat effective in reducing nausea and vomiting. The most recent Cochrane Database of Systematic Reviews noted that there was “only limited evidence from trials to support the use of pharmacological agents including vitamin B6” in treatment of morning sickness. A suggested dose is 10 to 25 mg three to four times daily. Doctors also may prescribe a vitamin combination called PremesisRx that consists of pyridoxine, vitamin B12, folic acid, and calcium.
- Electrical stimulation. A study from the University of Texas Health Science Center at Houston School of Nursing evaluated 14 trials that involved the explored the use of acupressure, acupuncture, and/or electrical stimulation (using an acustimulation device, which is worn on the wrist) on women with morning sickness. More than 1,600 women were involved in the trials. The reviewers reported that compared with controls, the use of all three treatment approaches reduced nausea and vomiting, and that acupressure alone and electrical stimulation alone also were effective. Acupuncture, however, did not provide good results, although the authors pointed out there are limited trials involving pregnant women and acupuncture.
In addition to these treatment options, women can make lifestyle changes to help prevent and manage nausea and vomiting. For example:
- Eat small, frequent meals and snacks
- Avoid spicy, fatty, acidic, or fried foods
- Nibble on plain crackers, rice cakes, or low-salt pretzels. Keep these foods next to the bed to help manage nausea during the night
- Sip cold fluids throughout the day
- Avoid odors from foods and other sources that trigger nausea
Forty percent of pregnant women experience morning sickness symptoms that disrupt their lifestyle, and more than half experience daily vomiting. Available treatments and management tips, the knowledge that it’s only temporary, and support of family and friends can help women get through morning sickness.
(Updated April 9, 2013)
Can Gurkan O, Arslan H. Effect of acupressure on nausea and vomiting during pregnancy. Complementary Therapies in Clinical Practice 2008 Feb; 14(1): 46-52
Centers for Disease Control and Prevention
Chittumma P et al. Comparison of the effectiveness of ginger and vitamin B6 for treatment of nausea and vomiting in early pregnancy: a randomized double-blind controlled trial. Journal of the Medical Association of Thailand 2007 Jan; 90(1): 15-20
Food and Drug Administration/Diclegis news release
Helmreich RJ et al. Meta-analysis of acustimulation effects on nausea and vomiting in pregnant women. Explore (NY) 2006 Sep-Oct; 2(5): 412-21
Koren G, Maltepe C. Preemptive Diclectin therapy for the management of nausea and vomiting of pregnancy and hyperemesis gravidarum. AJOG 2013; 208:1 (Suppl): 20
Matthews A et al. Interventions for nausea and vomiting in early pregnancy. Cochrane Database of Systematic Reviews 2010 Sep 8; (9):CD007575