Women's Health Research Newsletter
April 2005

Hot Flash Relief:  What are My Options?

There is a lot of confusing, seemingly contradictory information out there these days about the best way to manage hot flashes and also ensure long- term quality of life.  This month’s newsletter seeks to minimize some of this confusion, and present information about two studies currently underway in the Women’s Health Research Unit (WHRU) at Oregon Health and Sciences University.

To Take Hormones or Not to Take Hormones

In 2002, the FDA’s Data and Safety Monitoring Board announced that they were putting a halt on a study looking at the efficacy of hormone treatment to combat hot flashes due to an increase in the number of women who contracted breast cancer while they were on the study.  Naturally, this caused significant uproar, and many women discontinued their use of hormonal treatment for the prevention of hot flashes.

However, subsequent analysis of the data collected during the conduct of this research indicated that the findings could have been much different, and were, perhaps, inaccurate.  The age of the women in the treatment arm of the study, flaws in study design (the study suffered a very high drop out rate by subjects), and indeed the severity of the disease itself were all brought into question.

Additional concerns involved the “increase” in prevalence of breast cancer.  Sadly, the risk of breast cancer does increase with age, and the women involved in this study were 63 years old on average, putting them in a higher risk bracket from the start.  Additionally, questions were raised about the accuracy of this data from a diagnostic perspective:  the introduction of mammogram technology was followed by a steady increase in detected cancer, but this rate has remained steady since 1987, primarily due to the fact that mammogram screening is now standard of care for women over the age of 40.1

Where Are We Now?

Leon Speroff, MD, a renowned expert in this field and a faculty member at OHSU, sums this situation up well.  He writes,

The increasing incidence of breast cancer, together with earlier
detection and treatment, is producing a growing pool of patients
for whom the question of estrogen treatment is important and at
the same time difficult.  The problem is easy to articulate:  we
have no data.  There are absolutely no published clinical trials of
sufficient size and scope in which the impact of estrogen treatment
has been documented when given to women with previously
treated breast cancer.2

This has inspired a new generation of research in this area, and the Women’s Health Research Unit is excited to offer two studies looking at ensuring that this important subject is studied in order to provide the best possible, and safest, options to postmenopausal women in the future.

Study Opportunities:

The WHRU currently has two isolated studies ongoing looking at methods for relieving hot flashes.

The first is a non-hormonal study for the treatment of hot flashes.  This study is looking at the safety and efficacy of a new medication that is very similar to a particular type of anti-depressant.  In 2000, CNN Health reported findings related to the reduction in hot flashes for cancer patients with the use of certain anti- depressants.  Current research is examining whether this method would prove as effective in postmenopausal women.  Study participants would have a 67% chance of receiving the study drug on this study.

We are also conducting a study examining the safety and efficacy of a hormone therapy treatment.  This study is examining the safety and efficacy of a patch containing either estrogen alone or estrogen and progestin in the treatment of hot flashes.  This study is placebo controlled, and subjects on the study have a 67% chance of receiving study medication.

For more information about this, or any of our study opportunities, please call our confidential recruitment line at 503 494-3666, or visit our website at http://www.ohsuwomenshealth.com/research/current.html/

Insurance coverage is not required in order to participate on one of our studies.

Heidi P. Milliken, Ph.D.
Division Manager
Women’s Health Research Unit
Oregon Health & Sciences University

1. Lecture delivered by Leon Speroff entitled, “Postmenopausal Hormone Therapy and the Risk of Breast Cancer.

2. Speroff, “Postmenopausal Hormone Therapy and the Risk of Breast Cancer.”