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The wrist-worn Relief Band helps to calm nausea from morning sickness and chemotherapy.
By WES ALLISON
© St. Petersburg Times, published October 23, 2000
Seven weeks into her pregnancy, nausea virtually halted Kimberly Gallet's life. She vomited every morning, vomited throughout the day and vomited at night. She could keep down neither food nor water and became dehydrated. When her stomach was empty, her body was wracked by dry heaves.
She wasn't a good candidate for traditional anti-nausea drugs, and her doctor suggested Gallet try a new device that would send a small electrical charge to her wrist and, she hoped, calm her undulating stomach. Luckily for her, it did.
"For me, it was the difference between feeling like you had the flu and feeling like you were dead. It brought me back to life, so to speak," said Gallet, 34, whose baby is due in eight weeks. "I had a fever, and I was dehydrated, but it did keep me from continuosly vomiting."
The device, called the Relief Band, straps to the wrist like a watch and is gaining acceptance by some area doctors. Gallet's obstetrician, Dr. Madelyn Butler of the Woman's Group in Tampa, said it doesn't work for everyone, but it is very helpful for some women.
"That's the first thing we try," said Butler, who experimented with the band during her own pregnancy. "If it doesn't work, then we go to another option. The first three months are when the fetus is developing the organ system, and you want to avoid drugs when possible."
Another effective tool against nausea and vomiting would have a huge potential market. Doctors estimate more than 50 percent of pregnant women suffer from morning sickness, usually between the sixth and 14th weeks of pregnancy, and some need to be hospitalized. Woodside Biomedical, a private California firm that makes the band, figures some 50-million Americans get motion sick at one point or another.
Considering the scope of the problem, doctors acknowledge medicine has done a poor job of countering it. Over-the-counter standbys, such as Dramamine, help some people, and doctors can prescribe stronger anti-emetics if necessary. But often these drugs come with unsavory side effects, including drowsiness or even upset stomach, and they aren't effective for everyone.
When it comes to pregnant women, most of what doctors dispense is advice: Eat small meals frequently, including lots of proteins and carbohydrates. Stay away from sweets. Lean toward bland foods.
When that doesn't work, doctors may turn first to over-the-counter medications, then stronger prescription drugs. Some of them "work well to stop the nausea as long as you're using it every four hours, but it makes her drowsy," said Dr. Randy Armstrong, an obstetrician/gynecologist at Insignia Care for Women in Tampa.
"She can't drive, can't work, can't take care of other kids. It presents a major problem."
Dr. Elliott Cazes of Gentle Care Ob/Gyn in north Tampa said morning sickness accounts for the most unscheduled visits to his office. Although it's often viewed as a rite of passage, and women often are expected simply to tough it out, it can be a major problem for some.
"If you can take away the nausea, you can make a lot of pregnant patients happy," Cazes said. "In patients that have severe nausea, it takes over their life in the first part of pregnancy. It's miserable. It's all they can think about."
Cazes and Armstrong said they were skeptical about the Relief Band, because similar devices haven't worked that well. Armstrong tried it first on longtime patients whom he could count on to use the band properly and provide good feedback. He has been using it frequently for about six months.
"Probably 75 percent of the patients have had good response and have been very pleased with it," Armstrong said. "That's probably a better percentage than any of the things that we have."
The Relief Band, like the Seaband before it, is akin to acupuncture or pressure-point therapy. It sends a tiny electrical charge into the wrist at the median nerve, stimulating the nervous system to restore the natural rhythm of the stomach. The patient applies a thin layer of gel on her wrist to help conduct the charge.
Woodside Biomedical says it's not sure how the band works, but the company points to longstanding research that shows pressure or a small charge delivered to the wrist can ease nausea.
The U.S. Food and Drug Administration has approved the band for use by prescription only for nausea and vomiting related to morning sickness and chemotherapy and after surgery, when the lingering effects of anesthesia can cause nausea. It's also available for motion sickness without a prescription.
The FDA approval doesn't mean the agency endorses the product, but that Woodside submitted enough data to prove it's safe and effective for those uses. The band has no known side effects, but should not be used by anyone who has a pacemaker.
Dr. Lixing Lao, assistant professor of complementary medicine at the University of Maryland School of Medicine in Baltimore, has been conducting clinical trials of how well acupuncture stops the nausea and vomiting so common among chemotherapy patients.
His findings, which he presented this spring at an American Cancer Society conference in Tampa, show acupuncture at the wrist can help patients for whom anti-emetic drugs don't work, especially if it's accompanied with a slight electrical charge. The principle has been used for centuries in Chinese acupuncture.
Lao said he hasn't studied the Relief Band, but the principle is sound. It won't work for everyone, but his research shows acupuncture can help sick chemotherapy patients cut back on the doses of anti-emetic medications and ease the side effects from them.
As long as the signal is properly applied, there's no reason it won't work for other forms of nausea, too, he said.
The band first won FDA approval in 1998, but it has been slow to catch on, local doctors say, in part because it is an alternative concept. It's also expensive, costing between $50 and $150, depending how long the charge will last, and some doctors report less success with it than others, including Dr. Scott Riddell of West Coast Women's Care in Palm Harbor.
"To soak $150 into it, not knowing it's going to work, is pretty tough," said Riddell, who has used the band infrequently. "People are willing to spend their $10 co-pay (for a drug). Plus it's not a medicine, so it might not be covered under your pharmacy plan."
Woodside also is pitching the band to boaters, flyers and others for whom motion sickness ruins the fun. The company advertises heavily on the Internet and in specialty catalogs, and it sponsors an off-shore racing boat. According to the company, sales topped $1-million midway through this year.
"It's non-traditional, it's not what patients have come to expect . . . so sometimes it takes a little convincing," Cazes said.
He also prescribed it for patient who suffered from severe motion sickness. "She used this thing and was swearing by it," he said.
Gallet, a clinical researcher who lives in Tampa, needed a way to control the nausea enough to allow her to function. Morning sickness lasted a full 19 weeks, about five or six weeks longer than usual.
She wore the band around the clock, and except for some skin irritation if she didn't switch wrists, she has no complaints.
Purpose: Anti-nausea and vomiting.
Manufacturer: Woodside Biomedical of Carlsbad, Calif.
Availability: By prescription only for nausea and vomiting related to morning sickness, chemotherapy and as an adjunct to drugs for post-operative nausea. No prescription necessary for use in controlling motion sickness.
Cost: About $48 for a 48-hour disposable band to $75 for a 144-hour disposable to $150 for a 144-hour reusable band.
How it works: That's not exactly clear, the manufacturer says, but the electric signal from the band interrupts the nausea process.
Side effects: None known. Should not be used by anyone with a pacemaker.
- Source: Woodside Biomedical, Times research.