Pregnancy Hormone Eases MS Symptoms in First Human Tests

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Pregnancy Hormone Eases MS Symptoms in First Human Tests

September 23, 2002

A hormone common in pregnant women shows promise as an easily administered

treatment for people with early-stage multiple sclerosis (MS). A new study

by neuroscientists at UCLA shows for the first time in humans that estriol

in oral tablet form can decrease the size and number of brain lesions, and

increase protective immune responses in patients with relapsing remitting

MS.

The results of the Phase I clinical trial led by Dr. Rhonda Voskuhl, an

associate professor of neurology at the School of Medicine at UCLA and the

study's principal investigator, appear in the October edition of the journal

ls of Neurology. Previous research has found similar results in pregnant

women and animals with early-stage MS. " I am excited by the prospect of

finding an easily administered treatment for MS based on a naturally

occurring phenomenon in pregnancy. At present the only approved treatments

are anti-inflammatory drugs administered with injections, " said Voskuhl,

also a research scientist at UCLA's Brain Research and Neuropsychiatric

institutes. " Our findings also hold promise for finding new treatments for a

host of other autoimmune disorders that improve during pregnancy, such as

rheumatoid arthritis. "

MS is a chronic disabling disease that affects one in 10,000 people.

Symptoms typically appear between age 20 and 30. The progressive

neurological disorder is most common among individuals of northern European

ancestry and occurs two to three times as often in women than in men.

Symptoms range from numbness in the limbs to paralysis to blindness.

Researchers believe the cause is polygenetic, with individuals who contract

the disease inheriting a specific combination of genes from both mother and

father. Symptoms develop when the immune system becomes overactive and

attacks neurons, or brain cells, by stripping away a conductive coating.

Once the coating is stripped away, the neurons don't conduct the brain's

electrical signals as well.

The early phase of the disease, or relapsing remitting MS, is characterized

by inflammation in the brain with milder neurological symptoms that come and

go. After about 10 years, the disease typically moves into the secondary

progressive phase, with chronic, disabling symptoms increasing and taking

hold as the brain atrophies. Anti-inflammatory injections are effective for

only relapsing remitting MS. " MS doesn't cut life short, it kills the

quality of life, " Voskuhl said. " Early treatment is crucial to preventing

disabling symptoms. Finding an easily administered oral treatment is

important, in part, because patients are less likely to delay treatment if

it involves a pill rather than weekly or daily shots. "

Estriol is a weak form of estrogen made by the fetal placental unit and

appearing in appreciable amounts only in pregnant women. The hormone is used

widely throughout Europe and Asia to treat symptoms of menopause but is not

approved in the United States for hormone replacement therapy because it

does not prevent osteoporosis.

The clinical trial involved 12 women, six with relapsing remitting MS and

six with secondary progressive. Ten of the patients completed the trial,

including all six with relapsing remitting MS. Periodic magnetic resonance

imaging (MRI), immune system tests, and cognitive tests were conducted for

each patient during a six-month pretreatment period, a six-month estriol

treatment period, a six-month post-treatment period and a four-month

treatment extension.

Among relapsing remitting patients treated with estriol, researchers found a

significant decrease in the number and size of inflammatory brain lesions,

an increase in protective immune response and an improvement in cognitive

test scores. When estriol treatment ended, the lesions increased to

pretreatment levels. When treatment was reinstated, the lesions again

significantly decreased. Researchers found no significant improvement in

lesions or immune response among the four secondary progressive MS patients

who completed the clinical trial.

" Based on these results, a larger, placebo controlled trial of estriol is

warranted in women with relapsing remitting multiple sclerosis, " Voskuhl

said. " If larger studies confirm the benefits of estriol treatment, further

studies for longer periods of time will be needed to determine whether

estriol can decrease relapse rates and disabling symptoms. "