The Pharmaceutical Journal
Vol 269 No 7218 p474
5 October 2002

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Phase I trial shows oral estriol may offer hope to women with multiple sclerosis

A drug currently used as hormone replacement therapy (HRT) could improve outcomes in women with relapsing-remitting multiple sclerosis (MS), the results of a phase I clinical trial suggest.

American researchers found that, after giving six women with the disease 8mg oral estriol daily for six months, the size and number of lesions in their brains decreased compared with baseline measurements (Annals of Neurology 2002;52:1). The median total lesion volume decreased by 82 per cent (P=0.01) and the number decreased by 82 per cent (P=0.02). In addition, the women developed an increased protective immune response compared with measurements made before treatment.

Once estriol treatment had stopped, magnetic resonance imaging measurements showed the brain lesions returned to pre-treatment levels. Four women with the secondary progressive form of the disease were also treated with 8mg estriol daily, but no improvements were seen in this group. According to the researchers, animal models of MS have already demonstrated that estriol, which is only present in appreciable amounts during pregnancy and is used for short-term HRT at a maximum daily dose of 3mg, can ameliorate disease and alter immune response. They also say relapse rates have been shown to reduce markedly in pregnant women with MS during the last trimester of pregnancy.

Despite the small numbers involved in the trial, the authors believe their findings are clinically important for women with relapsing-remitting MS, because the only currently available treatments are injectable anti-inflammatory drugs. They also say the research could have implications for the treatment of other autoimmune diseases that improve during pregnancy.

Study lead Dr Rhonda Voskuhl, an associate professor at the University of California Los Angeles, commented: "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 daily or weekly [injections]. Based on these results, a larger placebo-controlled trial of estriol is warranted in women with relapsing-remitting MS."