Pregnancy hormone helps multiple sclerosis patients avoid relapses, study finds

Taking the pregnancy hormone estriol along with their conventional medications helps patients with relapsing-remitting multiple sclerosis (RRMS) avoid relapses, according to results of a Phase II randomised, placebo-controlled study.

University of California Los Angeles (UCLA) researchers believed that increased estriol in the blood might play a role in suppressing a woman's immune system so that the fetus is not rejected as being foreign. After discovering that treatment with estriol was also protective in the MS model, the team conducted a successful pilot clinical trial in 2002 at UCLA.

In 2007, the researchers launched the Phase II trial at UCLA and 15 other sites across the US.

“The beauty of estriol is that it is not a shot and can be taken in pill form, and also that it's not a new drug. It has decades of safety behind it," said the study's lead author Dr Rhonda Voskuhl, professor in the UCLA Department of Neurology and director of UCLA's Multiple Sclerosis Program.

Current MS treatments are very complex to manufacture, she notes. With their findings, they hope to pave the way for oral, safe treatments that are more widely accessible since estriol is simple and naturally occurring, Voskuhl said.

In the lab, Voskuhl and her team discovered that estriol potentially provides a one-two punch against the disease, both reducing the ability of immune cells to attack the brain, while also making brain cells more resistant to damage if any immune cells do make it through. Specifically, they showed that estriol treatment improved cognition and prevented atrophy of the cognitive region of the brain.

After a successful first phase, the researchers continued with the study’s phase II where they enrolled 164 patients. Among the participants, 83 allocated to the estriol group and 81 to the placebo group. Both arms continued their conventional medication, injectable glatiramer acetate.

The team found that the patients taking estriol had a third to a half as many relapses compared to those taking the placebo, with this improvement occurring over and above that provided by their conventional treatment. In addition, when estriol levels were the highest, there was improved cognitive function and less atrophy of the brain area related to cognition. The treatment was well tolerated during the two years the volunteers took estriol and the only significant side effect was irregular menstruation.

MS is an incurable disease of the central nervous system that can affect the brain, spinal cord and optic nerves, according to Better Health Channel. The effects of MS are varied and unpredictable, and no two people with MS will have the same symptoms.

To date, there is no FDA approved treatment for MS that improves disabilities. The principal aims of medications for MS are to shorten attacks, manage specific symptoms and slow the progression of disease by reducing the relapse rate.

Among MS patients, 85 per cent start with RRMS, wherein there are clear episodes of inflammatory activity, or relapses. During a relapse, there are new or worsening symptoms, accompanied by inflammatory lesions in the brain.

Going forward, Voskuhl hopes to see a Phase III trial conducted to replicate these findings, since this is necessary for FDA approval of estriol for MS. She continues to seek support to advance this as well as other MS research projects.

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