"Taking the pregnancy hormone estriol along with their conventional medications helped patients with relapsingremitting multiple sclerosis RRMS avoid relapses according to results of a Phase II randomized placebocontrolled study led by UCLA researchers. The study published online in Lancet Neurology was truly translational. The UCLA team took observations from the bedside tested them in the laboratory and took those findings back again to patients in clinical trials said the studys lead author Dr. Rhonda Voskuhl professor in the UCLA Department of Neurology and director of UCLAs Multiple Sclerosis Program. Its long been observed that during the second half of pregnancy women with RRMS have reduced relapses but the reason was unclear. It is also during this period that the fetal placenta produces estriol increasing the hormone levels in the blood. This protection during pregnancy occurs not only in MS but also in other autoimmune diseases such as psoriasis and rheumatoid arthritis. Voskuhl took this information to the lab. She hypothesized that increased estriol in the blood might play a role in suppressing a womans immune system so that the fetus is not rejected as being foreign having half of the fathers proteins. This temporary suppression of the immune system would be good for pregnant mothers with autoimmune diseases. Her team found that treatment with estriol was protective in the MS model. That led to a successful pilot clinical trial in  at UCLA and then the Phase II trial launched in  at UCLA and  other sites across the United States. The beauty of estriol is that it is not a shot and can be taken in pill form and also that its not a new drug. It has decades of safety behind it said Voskuhl who holds the Jack H. Skirball Chair for Multiple Sclerosis in the UCLA Department of Neurology. Also current MS treatments are very complex to manufacture. These findings hopefully will pave the way for oral safe treatments that are more widely accessible since estriol is simple and naturally occurring. Multiple sclerosis is an autoimmune disease of the central nervous system where immune cells from the blood attack the tissue surrounding the brains nerve fibers. Called myelin this tissue is like the insulation wrapped around an electrical wire. When the myelin is damaged it interferes with the ability of the nerves to send signals to and from the brain resulting in symptoms including cognitive problems difficulty with walking poor vision and other disabilities. In RRMS 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. A relapse can continue anywhere from several days to months. Relapses are usually followed by remission or improvement. However some residual symptoms may remain and after many years people with RRMS often transition to a progressive form of the disease. During the progressive phase there are no longer relapses but instead gradual worsening of permanent disabilities and loss of brain volume or atrophy. In the lab Voskuhl and her team discovered that estriol potentially provides a onetwo 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. It seems that during pregnancy estriol can both suppress the immune system and protect the brain for not only is it important to avoid rejection of the fetus as foreign it is also critical to protect the developing fetal brain. While these two effects may be designed to protect the fetus they may also be exactly what the doctor ordered for women with MS. In  Voskuhl completed the pilot study in which  nonpregnant women with MS were given estriol yielding a greater than  percent drop in inflammatory lesions in the brain within only six months of treatment. In the Phase II study researchers enrolled  patients with  allocated to the estriol group and  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. To date there is no FDA approved treatment for MS that improves disabilities. These two trials are very unique in that neither were funded by a pharmaceutical company. Rather they were funded by the National Institutes of Health NIH and the National Multiple Sclerosis Society consistent with the new NIH policy that more research should focus on sex differences in disease. Additional major funding was from the Conrad N. Hilton Foundation whose mission it is to improve the lives of disadvantaged people throughout the world. Synthetic Biologics Inc. provided estriol and placebo for the multicenter trial and has licensed certain rights from UCLA. 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. It is estimated that more than . million people are affected by MS worldwide. Approximately  percent of patients are diagnosed at onset with RRMS the most common form of MS.   Story Source Materials https provided by University of California  Los Angeles Health Sciences http Note Content may be edited for style and length.   Journal Reference . Rhonda R Voskuhl HeJing Wang T C Jackson Wu Nancy L Sicotte Kunio Nakamura Florian Kurth Noriko Itoh Jenny Bardens Jacqueline T Bernard John R Corboy Anne H Cross Suhayl DhibJalbut Corey C Ford Elliot M Frohman Barbara Giesser Dina Jacobs Lloyd H Kasper Sharon Lynch Gareth Parry Michael K Racke Anthony T Reder John Rose Dean M Wingerchuk Allan J MacKenzieGraham Douglas L Arnold Chi Hong Tseng Robert Elashoff. Estriol combined with glatiramer acetate for women with relapsingremitting multiple sclerosis a randomised placebocontrolled phase  trial. The Lancet Neurology  DOI .S httpdx.doi.org.S"