Nausea Free Pregnancy?

Main Category: Public Health
Article Date: 08 Jul 2003 - 0:00 PDT


Safe, Drug-Free Device Relieves Mild Morning Sickness, Study Finds

New research indicates such a product appears effective, and has the potential to curb the nausea that plagues 70 percent of pregnant women in their first trimester, reports a study conducted at Morristown Memorial Hospital in Morristown, N.J. The study, funded by the maker of the wristwatch-like device, was published today in Obstetrics & Gynecology journal.

The ReliefBand, manufactured by Woodside Biomedical, Inc. in Carlsbad, Calif., works based on an acupuncture-like principle.

It emits an electrical impulse that stimulates the median nerve in the arm, explains Dave Swenson, chief operating officer at Woodside Biomedical. The stimulation interferes with the signals sent to the brain associated with feelings of nausea.

As a result, it causes the nausea to subside, he explained. And, added Swenson, the product is unique in that it can reverse nausea once it has already started, which he adds that other methods do not.

The study concluded ReliefBand did reduce nausea and vomiting, based on self-reporting, instances of medication use, and weight gain, says lead author of the study, Dr. Todd Rosen from the department of obstetrics and gynecology at Morristown Memorial Hospital.

The device also allowed additional weight gain of up to three pounds in study subjects, and there were less incidents of dehydration.

The study also found the device was completely safe for the baby.

The research was the first large-scale trial of the device's effectiveness, says Rosen. ReliefBand was first approved by the FDA for motion sickness in 1997. A small study done four years ago was the basis for FDA approval of the over-the-counter device for pregnancy related nausea in 2002.

The new study involved 187 pregnant women, seven times the number involved in the earlier research.

Rosen noted that studies involving pregnant women are more difficult because moms are naturally reluctant to participate in any medical study that might harm their unborn children and possibly cause birth defects.

'As far as I am aware, this is the largest and best designed study of the use of a nerve stimulator for hyperemesis [morning-sickness] treatment in pregnancy,' noted Dr. Manuel Porto, professor and co-chair of obstetrics and gynecology at the University of California at Irvine.

An Alternative Approach?

For years, doctors have had few options for helping pregnant women with nausea.

Bendectin, a drug that was shown to be effective, was removed from the market in 1983 after accusations it caused birth defects. Since then, ob-gyns say there have been very few choices of effective treatment.

For nausea relief, says, Rosen, 'We usually recommend a modified diet.' Vitamin B6 and ginger tea also appear to be effective in fighting morning sickness in newly pregnant women. Steroids are used for more severe cases.

Yet while the risk of birth defects from medication is 'probably extremely small if not non-existent,' it's not something easily studied, explains Dr. Lauren Streicher, department of obstetrics and gynecology at Northwestern Memorial Hospital in Chicago.

Agreeing is Dr. Mary Jo O'Sullivan, professor and vice-chair of the department of obstetrics and gynecology at the University of Miami, Fla., who notes that many women don't want to take anything to treat morning sickness since some medications cause side-effects like sleepiness and impaired judgement, or they are simply anxious about taking pills.

A device like ReliefBand would eliminate that anxiety, added O'Sullivan. 'Other than things like antiemetics [delivered] either intermittently or continuously via a subcutaneous pump, ginger, and frequent small feedings, this is the newest non-invasive simple tool.'

Doctors agree. 'Basically, pregnant women do not have a lot of options when it come to dealing with nausea and pregnancy,' says Streicher. 'For mild to moderate nausea, this could mean the difference between [being] functional and non-functional.'

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