Positive Results Published On Testosterone For Men With MS
- From: Ivan <ivan-irv-joe@xxxxxxxx>
- Date: Sat, 23 Jun 2007 13:41:15 -0700
Main Category: Multiple Sclerosis News
Article Date: 20 Jun 2007 - 1:00 PDT
Researchers from the University of California, Los Angeles have
published results from a small study, funded by the National MS
Society and others, suggesting that one year of treatment with a gel
containing the sex hormone testosterone (applied to the skin) in 10
men with relapsing-remitting multiple sclerosis resulted in
significant improvements in cognitive function and in slowing brain
tissue loss. Nancy Sicotte, MD, Rhonda Voskuhl, MD, and colleagues
report these positive findings in the May 2007 issue of Archives of
Neurology (2007;64:683-688 ).
Further research involving larger numbers of patients and controls
would help to confirm and expand these early results, and to ensure
the safety and effectiveness of testosterone treatment in MS.
Background: Sex hormones may contribute to MS susceptibility by
influencing the immune attack on brain and spinal cord tissues.
Laboratory studies have shown that the severity of EAE, an MS-like
disease, is decreased when testosterone, a male sex hormone, is
administered to male and female mice. Dr. Voskuhl was awarded funding
from the National MS Society's targeted research initiative on Gender
Differences in MS to undertake a small study of testosterone gel in
men with MS. Preliminary results of this study were originally
presented at the 58th Annual Meeting of the American Academy of
Neurology in April 2006.
Study: Ten men with relapsing-remitting MS, ranging from 29 to 61
years of age, were studied. Relapsing-remitting MS is the most common
form of the disease, involving clearly defined flare-ups followed by
partial or complete recovery periods. After a six-month observation
period, they were treated with testosterone gel applied to the skin
(10 grams daily, containing 100 mgs of testosterone) for one year.
None of the men were taking disease-modifying therapies. Clinical
assessments including blood tests, as well as clinical measures of
disease activity and cognitive function were completed every three
months. Magnetic resonance imaging scans were taken before treatment
and monthly to measure evidence of disease activity. The extent of
brain tissue loss (atrophy) was assessed by determining normalized
brain volumes using automated computer software.
Since all 10 of the men received treatment and none received inactive
placebo, the investigators compared measures taken before treatment
versus after treatment. Testosterone levels were in the lower range of
normal before treatment, and although they increased with treatment,
remained in the normal range.
After 12 months of testosterone treatment, measures of clinical
disease activity remained stable, blood tests were normal, and no
adverse events related to treatment were reported. The men showed
significant improvements in performance on a test of cognitive
function called the Paced Auditory Serial Addition Task (a test of
processing speed and memory) compared to the pre-treatment period. The
authors report that the improvement could not be accounted for by well-
known "practice effects," which had stabilized during the pre-
treatment period.
MRI scans showed no increases in disease activity or tissue damage
during treatment, although the authors note that the patients began
the study with relatively low levels of disease activity on MRI.
Significantly, the rates of brain atrophy, measured by normalized
brain volume, slowed by 67 percent during the last nine months of
treatment. Muscle mass increased significantly during the study;
testosterone is sometimes used for this purpose in other chronic
diseases.
This small study shows that testosterone treatment may have
therapeutic benefit in men with relapsing-remitting MS. Further study
involving larger numbers of patients and control groups is necessary
to confirm these early results, and to ensure the safety and
effectiveness of testosterone treatment for MS.
"We're gratified that these early, promising results stemmed from the
National MS Society's targeting of gender differences as an important
area of research in MS," said Dr. John R. Richert, the Society's
executive vice president of research. "It also demonstrates how basic
laboratory findings can quickly translate into possible new
therapeutic strategies."
Dr. Voskuhl and colleagues are already proceeding with a similar
effort involving the sex hormone estriol: Based on a small, early-
phase trial that showed decreases in disease activity in 12 women with
MS, she is now launching a multicenter, controlled clinical trial of
oral estriol (added to the approved MS therapy glatiramer acetate) in
130 women with relapsing-remitting MS.
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