The preliminary results of a small US study of patients with relapsing remitting multiple sclerosis suggest a combination of the estrogen hormone estriol and Copaxone, a drug used to treat relapsing forms of the disease, may improve symptoms. The researchers say a larger study should now be done before any recommendations are to be made.
Lead author Dr. Rhonda Voskuhl, of the University of California, Los Angeles, presented the findings at a scientific session of the American Academy of Neurology Meeting 2014 in Philadelphia, PA.
Multiple sclerosis (MS) is a disease where the body's own immune system attacks the myelin sheath that insulates the nerve fibers in the brain and spinal cord and stops the electrical signals they convey from leaking out.
As the disease progresses, symptoms develop, ranging from mild numbness in the arms and legs, to pain, movement and balance problems, as well as changes in cognitive ability, and eventually paralysis and blindness.
Although MS can be difficult to diagnose, estimates suggest it affects around 2.3 million people worldwide, 400,000 of them in the US, where, with the exception of trauma, it is thought to be the most frequent cause of neurological disability that starts before old age.
Relapsing remitting multiple sclerosis (RRMS) is the most common form of the disorder, where patients experience symptom flare-ups interspersed with periods of recovery.
Trial tested whether estriol further reduced the number of relapses
At the meeting, Dr. Voskuhl reported how she and her colleagues conducted a small 2-year, phase II clinical trial in 158 patients with RRMS. The main goal of the trial was to test whether estriol further reduced the number of relapses in patients who were already receiving Copaxone, an FDA-approved drug indicated for reducing the frequency of relapses in patients with RRMS.
Copaxone (glatiramer acetate) is a synthetic protein that simulates myelin basic protein, a component of the myelin. Estriol is a type of estrogen that is only produced in the body during pregnancy.
Lab studies have suggested that estrogen may help decrease inflammation that occurs in MS and protect the nerve fibers from myelin destruction.
There have also been reports that women with MS experience symptom reduction during pregnancy, when estrogen levels are higher. But studies investigating the effect of estrogen therapy in women have shown mixed results.
The patients were given Copaxone plus 8 milligrams per day of estriol or placebo pills.
Bigger reduction in relapses in combined therapy group
The results showed that, at 12 months, patients who received estriol as well as Copaxone experienced a greater reduction in relapse rates than those who only received Copaxone. However, the differences were not as great at 24 months.
Dr. Walter Koroshetz, deputy director of the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health, and which - along with the National Multiple Sclerosis Society - funded the study, says despite the encouraging results from the small phase II study, a larger study is now needed to establish whether the benefits of the combination therapy outweigh the risks for patients with MS, and adds:
"At present, we cannot recommend estrogen as part of standard therapy for MS. We encourage patients to talk with their doctors before making any changes to their treatment plans."
Meanwhile, Medical News Today recently reported on an Australian study published in the Multiple Sclerosis Journal that showed promising results for an immune treatment for MS. The treatment, which boosts immunity to Epstein-Barr virus, helped a patient with advanced MS experience noticeable clinical improvement after 6 weeks.