RESEARCHERS EXPLORE THE AFTERMATH OF HORMONE REPLACEMENT THERAPY

Most women experience recurrence of symptoms; few resume hormone therapy

JULY 12, 2005

WORCESTER Mass. —Three years ago bombshell reports from the multi-site Women’s Health Initiative (WHI) indicated combination menopausal hormone therapy resulted in unexpectedly greater health risks than benefits, while failing to improve quality of life for postmenopausal women. Now, in a recent analysis, WHI researchers have found that women who had menopausal symptoms when joining the trial and discontinued hormone therapy when the trial stopped experienced a return of significant menopausal symptoms. Few of those women chose to return to hormone therapy and many sought alternative methods to deal with the symptoms.

In a new study, “Symptom Experience After Discontinuing Use of Estrogen Plus Progestin,” published July 13 in the Journal of the American Medical Association (JAMA),researchers led by Judith K. Ockene, PhD, the Barbara Helen Smith Chair in Preventive and Behavioral Medicine and Chief of the Division of Preventive and Behavioral Medicine at the University of Massachusetts Medical School and lead author of the study, examined the symptom and psychosocial consequences for women when they stop hormone therapy. The study surveyed 8,405 out of 9,351 women at the 40 WHI study centers who were still taking study pills when the estrogen plus progestin intervention was halted. These women averaged 69.1 years old and had been taking the study pills for an average of 5.7 years.

The subsequent analysis, which focused on symptoms such as hot flashes or night sweats, vaginal dryness and pain or stiffness, found that 55 percent of the women who were on active hormones during the trial and had experienced these symptoms at baseline had a recurrence of symptoms. “This study is a significant first step in the effort to understand the lasting effects of combination menopausal hormone therapy (MHT) and offers some important initial answers to questions about what happens when women stop MHT,” Dr. Ockene said, adding, “These findings of a recurrence of symptoms should be considered when women are deciding with their clinicians whether to use hormone therapy for menopausal symptoms. More research is needed about alternatives for women to treat their menopausal symptoms, such as exercise, increased fluid intake and herbal and natural hormones.”

Specifically, the study found that:

  • Women who had symptoms when they joined the WHI were more likely to have these symptoms after they stopped their study pills, regardless of their age.
  • After stopping their study pills, women who had received active hormones reported having more symptoms than women who received inactive placebo pills.
  • Younger women, 55 to 59 years when they stopped study pills, were more likely to experience symptoms than older women.
  • Women who had used hormones before they joined the WHI were more likely to have hot flashes or night sweats or pain or stiffness after stopping study pills, no matter which type of study pill they were taking.
  • Women try to manage their symptoms after stopping hormones in many different ways, including drinking more fluids, exercising and talking with a health care provider. Most women find these efforts helpful.
  • Fewer women who tried taking herbal or natural hormones for their symptoms found them helpful compared to women who tried most other kinds of strategies.
  • Very few women started using prescription hormone therapy after stopping their study pills.

The WHI involves over 161,000 women who are participating in a set of clinical trials or an observational study at more than 40 sites across the country. Clinical trials in Massachusetts are based at UMass Medical School in conjunction with Fallon Clinic, and at the Brigham and Women’s Hospital. The clinical trials are designed to test promising but unproven treatments for heart disease, breast and colorectal cancer and osteoporosis. WHI is sponsored by the National Heart, Lung and Blood Institute in collaboration with the National Cancer Institute; the National Institute of Arthritis and Musculoskeletal and Skin Diseases; the National Institute on Aging; and the Office of Research on Women’s Health.

Originally scheduled to run until 2005, the estrogen plus progestin trial of the WHI studies enrolled between 1993 and 1998 more than 16,600 menopausal women aged 50 to 79 who had not had a hysterectomy. An important objective of the trial was to examine the effect of estrogen plus progestin on the prevention of heart disease and hip fractures, and any associated change in risk for breast and colon cancer. The adverse effects of estrogen plus progestin applied to all women, irrespective of age, ethnicity or prior disease status. In response to these reports, standard guidelines were changed to say that treatment of moderate to severe menopausal symptoms, like hot flashes and night sweats, is the main reason for women to use hormone therapy and advised that it be used for the shortest time and in the lowest dose possible. Prompted by these findings, millions of women were moved to weigh the risks of hormone therapy against the improved quality of life the hormones were thought to provide and discontinued combination hormone therapy as a result.

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The University of Massachusetts Medical School, one of the fastest growing academic health centers in the country, has built a reputation as a world-class research institution, consistently producing noteworthy advances in clinical and basic research. The Medical School attracts more than $173 million in research funding annually, 80 percent of which comes from federal funding sources. UMMS is the academic partner of UMass Memorial Health Care, the largest health care provider in Central Massachusetts. For more information, visit www.umassmed.edu

Contact: Kelly Bishop, 508-856-2000