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Veronica Ravnikar, M.D.
Chair, Department of Obstetrics and Gynecology
 Prior to my arrival to Saint Barnabas as the new Chair of
the Department of Obstetrics and Gynecology, I served as co-principal
investigator and ob/gyn on the Women’s Health Initiative
study in Massachusetts. As I transferred here, I was still
eager to stay in touch with the findings since I was one of
the early investigators in the project.
The stoppage of the first arm of the study, mainly in women
with a uterus who were given combination estrogen-progesterone
therapy, has been analyzed. New reports about the stoppage
were released in the summer of 2002, when the study was abruptly
discontinued.
At the time, the general conclusions from the study were
that combination estrogen-progesterone therapy was not to
be used for primary prevention of heart disease. Women in
the study had more cardiac events in the first few years and
overall there was no protective benefit against heart disease.
In fact, there were also accompanying increases in breast
cancer (slight risk), thromboembolism (blocking of a blood
vessel by a particle from a blood clot) and stroke. Aside
from that, there were noted decreases in osteoporotic-related
fractures, endometrial cancer and colon cancer.
Now, the estrogen-only arm of the study has been discontinued.
Curiously, the findings are somewhat different. There was
no overall benefit against heart disease in the women in
the study but also no evidence of the early harm seen in
the estrogen and progesterone arm of the study. There was
no increase in breast cancer and no increase in thromboembolism.
There was an increase in stroke.
With both arms of the study the question remains whether or
not these patients represent the regular menopausal patient
in her late 40s early 50s who comes to a physician’s
office for menopausal complaints. The patients in the WHI
were at a mean age of 63 at the start of the study and 68
at the end of the study.
The other question is whether or not oral progesterone given
daily has a deleterious effect, had more cardiac events, breast
cancer and more thromboembolic phenomenon in the estrogen-progesterone
arm of the study. It clearly speaks for a different way of
giving progesterone. Skin crèmes with progesterone
are ineffective; progesterone given on an intermittent basis
orally or through a vaginal/intrauterine route may be the
way to go.
Needless to say, hormone therapy is still the best way to
treat early peri-post-menopausal symptoms. The new FDA guidelines
are to treat this endpoint for the shortest duration. Hormone
therapy for the prevention of heart disease has been disproved,
at least in the 60-year-old patient. Ironically, hormone therapy
protects bone very effectively even in this cohort of women
who did not enter the study for the prevention or treatment
of osteoporosis.
In conclusion, there are more and more facets of the study
that will be published in the near future. As a specialist
in this area and as chair of the department, I make sure that
we as a department discuss these issues for the benefit of
the patients who are caught in this confusion. At Saint Barnabas,
we have had many programs to highlight this information to
the community.
As part of our continuing medical education activities for
the attending ob/gyns in the department, I have highlighted
lectures on topics such as osteoporosis and sexuality. On
May 11, we were pleased to welcome visiting lecturer Dr. Wulf
Utian, M.D., Ph.D., who is the Arthur H. Bill Professor Emeritus
of Reproductive Biology and Obstetrics and Gynecology, Case
Western Reserve University. Dr. Utian is the Executive Director
of The North American Menopause Society (NAMS) and its founder.
He is editor of both Menopause: The Journal of The North American
Menopause Society and Menopause Management.
Both arms of the Women’s Health Initiative study have
been discontinued and they each tell us something a little
different. I am sure we will be debating this subject for
the next decade. The Department of OB/GYN at Saint Barnabas
promises to stay ahead of this discussion in order to provide
the highest quality of care to its female patients.
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