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Testosterone replacement improves muscle
strength, function in HIV-infected women
BOSTON - April 26, 2004 - Researchers from Massachusetts
General Hospital (MGH) have found that restoring normal levels of
testosterone can improve muscle strength and function in HIV-infected
women with low levels of the male hormone. The report in the April
26 Archives of Internal Medicine is the first long-term,
randomized, placebo-controlled study of testosterone treatment in
women with HIV.
"There has been very little research in the use of androgens
[male hormones] to treat HIV-infected women," says Steven Grinspoon,
MD, of the MGH Neuroendocrine Unit and Program in Nutritional Metabolism,
the report's senior author. "We found that giving natural testosterone
at levels that are normal for women produces significant improvement
for patients with few other treatment options."
Earlier
studies from the same group had shown that testosterone injections
can improve the quality of life in men with the extreme muscle loss
called AIDS-wasting syndrome. However, there is little information
about gender-specific effects and treatments for HIV infection in
women, who now represent almost one-third of diagnosed AIDS patients
in the U.S. A 1998 study by the MGH researchers found that short-term
use of skin patches that deliver normal levels of testosterone had
no adverse effects on a group of women with HIV, and the investigators
followed that finding with the current study.
A group of 57 HIV-infected women with lower-than-normal body weight
and testosterone levels was enrolled in the trial. Half of them
received skin patches designed to deliver testosterone at levels
normal for women and the others received identical-appearing placebo
patches. Upon entering the double-blinded study, all participants
had extensive measurements taken of body weight and composition;
of upper- and lower-body muscle strength, and of muscle function
based on the distance walked in 6 minutes. Overall, study participants
were found to have significant reductions in both muscle strength
and function, an observation not previously documented in any study
of HIV-infected women.
After the 6-month study period, which 52 participants completed,
those who received testosterone patches were found to have significantly
higher levels of the hormone, most returning to normal levels. Testosterone
levels for the placebo group remained below normal or at the low
end of the normal range. Although there were no significant changes
in weight in either group the groups, the testosterone group had
somewhat increased muscle mass.
In the tests of muscle strength and function, the group receiving
testosterone showed significant improvement compared with measurements
taken before the study. Placebo groups members, in contrast, lost
both strength and muscle function during the study period. None
of the study participants reported such potential side effects of
testosterone treatment as alterations in their hair, skin or voice
or any related metabolic changes.
"Although natural testosterone delivery products like the patches
used in this study are not currently being marketed, they are in
development at several pharmaceutical companies. When they do become
available, it may be reasonable for physicians treating HIV-infected
women to test patients' testosterone levels and attempt to restore
levels that are reduced, says Grinspoon, an associate professor
of Medicine at Harvard Medical School.
Grinspoon stresses that this therapy would only be appropriate for
patients with documented low testosterone, who should be closely
monitored during treatment. He and his colleagues are looking into
longer-terms effects of testosterone replacement on muscles and
bones. They also note that testosterone-replacement treatment should
be studied for other groups of women with weight loss associated
with serious illness.
The study's co-authors are first author Sara Dolan, NP, Stephanie
Wilkie, NP, Negar Aliabadi and Meghan P. Sullivan, all of the MGH
Program in Nutritional Metabolism; and Nesli Basgoz, MD, and Benjamin
Davis, MD, of the MGH Infectious Disease Unit. The study was supported
by grants from the National Institutes of Health and the Mary Fisher
Clinical AIDS Research and Education Fund.
Massachusetts General Hospital, established in 1811, is the original
and largest teaching hospital of Harvard Medical School. The MGH
conducts the largest hospital-based research program in the United
States, with an annual research budget of more than $400 million
and major research centers in AIDS, cardiovascular research, cancer,
cutaneous biology, medical imaging, neurodegenerative disorders,
transplantation biology and photomedicine. In 1994, MGH and Brigham
and Women's Hospital joined to form Partners HealthCare System,
an integrated health care delivery system comprising the two academic
medical centers, specialty and community hospitals, a network of
physician groups, and nonacute and home health services.
Media Contact: Sue
McGreevey, MGH Public Affairs
Physician Referral Service: 1-800-388-4644
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