BUFFALO, N.Y. -- Good news may be on the horizon for Kate
Middleton, Duchess of Cambridge, and other women stricken with
severe nausea and vomiting during pregnancy, thanks to the work of
a University at Buffalo professor who is conducting research on a
drug that is showing success treating pregnant women with this
Thomas Guttuso Jr., MD, assistant professor of neurology in the
UB School of Medicine and Biomedical Sciences, has been studying
the drug gabapentin, an anti-seizure and anti-pain drug that he
previously had studied in cancer patients receiving
"I became interested in this drug for hyperemesis gravidarum (an
extreme form of morning sickness) because I saw how effective it
appeared to be in treating chemotherapy-induced nausea and vomiting
in patients who had failed treatment with conventional
anti-emetics," says Guttuso. Anti-emetics are drugs currently
approved for treating nausea and vomiting.
In 2010, he published in the journal Early Human Development the
results of an open-label pilot study that enrolled seven women from
Western New York examining the drug's safety, tolerability and
effectiveness in treating hyperemesis gravidarum.
"It was really exciting to see how quickly the women responded,"
None of the women had seen any improvement on any other
anti-emetic medications they had tried.
"But when they started with gabapentin, all of them showed a
dramatic improvement," he says. "Within two hours of taking the
first pill, most of the patients were feeling much better and
several were able to start eating and drinking again. It was a
pretty amazing thing to see.
"The study showed that after two weeks of gabapentin therapy,
the seven women experienced an average 80 percent reduction in
their nausea and a 94 percent reduction in their vomiting and near
normal levels of eating and drinking," Guttuso says. After this
study was published, Guttuso knows of five more women with
hyperemesis gravidarum that tried gabapentin and all experienced
The women needed to take gabapentin on average until about half
way through their pregnancies before they could stop it without
recurrent nausea and vomiting.
One of the potential concerns with gabapentin was that two of
the babies born to patients in the UB study were found to have
congenital defects. As a result, the Food and Drug Administration
placed the study on clinical hold in April 2011 until further
safety data was available on the use of gabapentin during
By May 2012 several pregnancy registries and other studies had
reported that the rate of congenital defects among a total of 258
infants born to women taking gabapentin early in their pregnancies
was about the same as the rate of congenital defects in the general
population. After reviewing these findings, the FDA removed the
clinical hold allowing Guttuso to resume his research on the
effects of gabapentin on hyperemesis gravidarum.
Although the results of the small pilot study were very
encouraging, Guttuso emphasizes that a placebo-controlled study
among many more patients needs to be conducted in order to know if
gabapentin truly is effective for hyperemesis gravidarum. "The
evidence right now is still very preliminary," he states.
Early next year, Guttuso plans to submit a new grant proposal to
the National Institutes of Health in order to support such a study
with enrolling sites both at UB and at the University of Rochester.
Guttuso is hopeful that the study will be funded.
"This is a study that really needs to be done because currently
there are no effective treatments for hyperemesis gravidarum,"
Guttuso says. "Women end up having to keep going back to the
hospital for intravenous fluids because of dehydration from their
persistent nausea and vomiting."
Guttuso is a Western New York neurologist and UB professor whose
practice focuses primarily on patients with movement disorders such
as Parkinson's disease. He originally became interested in
gabapentin when he accidentally discovered that it appeared to be
effective in treating hot flashes in postmenopausal women. Soon
thereafter, another patient with breast cancer undergoing
chemotherapy informed him that gabapentin appeared to fully resolve
her chemotherapy-induced nausea and vomiting.
After observing the marked improvements in nausea and vomiting
that many cancer patients experienced from gabapentin, he thought
that it should be tried with patients suffering from hyperemesis
gravidarum. He then teamed up with several Buffalo obstetricians to
do the pilot study on pregnant women.
"I think a lot of people don't appreciate just how sick and
disabled these women can be," Guttuso says. He notes that 15
percent of women with this condition end up having abortions even
though they really want to have children.
"Some of the most severely affected end up having abortions
because they have no hope of getting better," he says. "Ending the
pregnancy is currently the only effective treatment for hyperemesis
gravidarum. These women are so sick. They often retch every 15 to
30 minutes and it can go on all day and often at night as
Two of the women in Guttuso's small pilot study were planning to
have abortions. One of them was scheduled for one the next day out
of desperation. Once she went on gabapentin, her symptoms abated
and she was able to continue with her pregnancy to term. Since
then, she has had a second healthy child while taking gabapentin
throughout her pregnancy, during which she had only mild and rare
nausea and vomiting.
"I think this research has great potential to provide relief to
many women suffering with hyperemesis gravidarum," says