(Philadelphia,
PA) - Researchers report that a combination of components
found in the oral contraceptive YasminÒ have
been found to ease the symptoms of premenstrual syndrome
(PMS) and premenstrual dysphoric disorder (PMDD), a
severe form of PMS distinguished by significant irritability
or depression and other mood problems.
According to Ellen Freeman, PhD, of the department of
Obstetrics and Gynecology in the University of Pennsylvania
School of Medicine and lead author of the study, the
oral contraceptive may offset the major symptoms of
PMS and PMDD by suppressing ovulation, reducing water
retention, and counteracting the effects of testosterone.
The results of the double-blind, multi-site study are
published in the current issue of the Journal of
Women's Health and Gender-Based Medicine.
"The majority of women experience some physical
and emotional changes as part of their menstrual cycle,
but for some - especially those diagnosed with PMDD
- it can be disabling," said Freeman, research
professor and co-director of Penn's Division of Human
Behavior and Reproduction. "The advantage of using
an oral contraceptive to treat PMDD is that it provides
contraception and a possible reduction of menstrually-related
symptoms."
Yasmin contains a combination of estrogen and a unique
progestin, drospirenone. Drospirenone, is chemically
similar to spironolactone, a diuretic that doctors prescribe
to treat water retention. Additionally, studies have
suggested that drospirenone may also be effective in
calming symptoms such as premenstrual irritability that
may be associated with high testosterone levels.
"This is the first report of the use of an oral
contraceptive that treats multiple symptoms of PMDD,"
said Freeman. "Our results suggest that Yasmin
has promise as a treatment for both the mood and physical
symptoms of premenstrual syndromes."
Freeman and colleagues from a number of sites across
the U.S. enlisted 82 women, aged 18-40, to take part
in the study to evaluate the efficacy of Yasmin in the
treatment of PMDD. Qualified volunteers with PMDD were
randomized and treated with either Yasmin or a placebo.
Neither the patients nor the clinicians knew which treatment
was administered.
The volunteers recorded their PMDD symptoms using the
Calendar of Premenstrual Experiences (COPE), a tool
standardized for use in PMS/PMDD studies. Each day of
the three month study, the participants reported the
severity of their symptoms on the COPE scale, via a
call to an automated telephone system.
Overall, the Yasmin users showed greater reduction in
the severity of symptoms than the placebo group for
all symptoms rated on the COPE scale. The researchers
noted statistically significant improvement with the
contraceptive in symptoms such as acne, increased appetite
and food cravings. In addition, Yasmin was well tolerated,
and reports of adverse events were typical of those
associated with oral contraceptive use.
Since diuretic medications may increase the potassium
level in some people, women should consult their physicians
before taking Yasmin. Women who have kidney, liver or
adrenal disease should not take the contraceptive, because
this activity could cause serious health problems.
Contributors to this research include Robin Kroll, MD,
of the North Seattle Women's Group in Seattle, Washington
and Andrea Rapkin, MD, of the University of California,
Los Angeles. This study was funded by Berlex Laboratories,
Inc., the makers of Yasmin.
The researchers agree that this study is a first step
in determining if Yasmin is an effective treatment for
PMDD, and recommend further studies to refute or confirm
these promising results.
"Women should realize that they do not have to
have their lives disrupted by the effects of PMS and
PMDD," said Freeman. "What we have to remember
is that the feelings of bloating, pain, and frustration
are physical and emotional manifestations of a real
cyclical disorder - one that can be treated."
# # #
Editor's Note: Dr. Freeman has no financial interest
in Berlex Laboratories, Inc.
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