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1991.04.24 :  Study -- Premenstrual Syndrome (PMS)

Contact:  Lee Hoffman (301) 443-4536
April 24, 1991

       Contrary to popular belief, a new study suggests that
premenstrual syndrome (PMS) is not simply related to changes in
the levels of reproductive hormones that occur during the
premenstrual phase of a woman's cycle.
       Instead, PMS may be triggered by reproductive hormonal
events, as yet unidentified, occurring before the premenstrual
phase, or it may be the result of a cyclic mood disorder that is
synchronized with (but not caused by) the menstrual cycle.      
       An estimated 5 percent of American women are affected by
PMS and experience behavioral, emotional and physical symptoms
severe enough to impair their social or occupational functioning. 
Symptoms include sadness, irritability, anger, tension, loss of
energy and changes in appetite and sleeping patterns.  
       The study, which appears in the April 25 issue of The New
England Journal of Medicine,* was conducted by researchers at the
National Institute of Mental Health and the National Institute of
Child Health and Human Development, Bethesda, Md.  NIMH
scientists Peter J. Schmidt, M.D., and David R. Rubinow, M.D.,
headed the investigation.  The study helps explain why hormone
therapy attempting to correct a presumed abnormality during the
premenstrual phase is not effective in treating PMS.  The
findings are consistent with results from previous studies
showing the inefficacy of therapy with the hormone progesterone. 

       "There appears to be no physiologic rationale for the use
of progesterone therapy in PMS," said Dr. Rubinow.  Although
progesterone is not approved by the Food and Drug Administration
for the treatment of this disorder, many physicians prescribe it
to correct a possible abnormality in the premenstrual phase.
       In the study, investigators altered the timing of
menstrual cycles in women with PMS but found that symptoms
continued to occur at the same regular monthly intervals, despite
elimination of usual hormone changes in the premenstrual (or late
luteal) phase of the cycle.  These results demonstrate that the
onset of behavioral symptoms is not simply related to
reproductive hormonal changes that occur during the premenstrual
phase.  The study, however, does not rule out that previous
cyclical changes in reproductive hormones may have contributed in
some way to the continuation of PMS symptoms in these women.
       "This important study dramatically alters our
understanding of and treatment approaches for PMS.  It provides
valuable new information about the disorder and will stimulate
further research to help the millions of women suffering from
PMS," said Alan I. Leshner, Ph.D., NIMH acting director. 
"Scientifically, the fact that the hormone-PMS relationship is
not as simple as previously believed makes PMS a useful model for
understanding the very complex relationship between biology and  

       Investigators administered the drug mifepristone (RU486)
alone or in combination with the hormone human chorionic
gonadotrophin (hCG) to women with severe PMS to alter the timing
of their menstrual cycles.  Pregnancy tests were given to
potential participants to insure that pregnant women were not
admitted to the study.  All study participants rated the severity
of their PMS symptoms over a five-month period.   

       Seven women received mifepristone alone to end their
premenstrual phase prematurely and induce menstruation. 
Mifepristone causes menstruation by blocking the action of
progesterone.  Seven women with PMS received mifepristone and
hCG.  Mifepristone induced menstruation in two to three days,
while hCG preserved the premenstrual phase.  Seven women, who
served as controls, were given an inactive substance (placebo). 
Participants did not know whether they were receiving medications
or placebo, so the women did not know whether they were in the
premenstrual or postmenstrual (follicular) phase of their
menstrual cycles.   

       Other authors of the study are Gay N. Grover, M.S.N., and
Kari L. Muller, B.S., of NIMH, and Lynnette K. Nieman, M.D., and
George R. Merriam, M.D., of NICHD.

       The National Institute of Mental Health is part of the
Alcohol, Drug Abuse, and Mental Health Administration.  The
National Institute of Child Health and Human Development is part
of the National Institutes of Health.  These institutes and the
Food and Drug Administration are among the components of the
Public Health Service family of health agencies within the
Department of Health and Human Services.

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