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.