Developments from the WHI Therapy Trials

What are the WHI Therapy Trials?

The Women's Health Initiative (WHI) was a major 15-year research program to address the most common causes of death, disability and poor quality of life in postmenopausal women— cardiovascular disease, cancer, and osteoporosis.

From the WHI home page (last updated Jan 2010):
The WHI was launched in 1991 and consisted of a set of clinical trials and an observational study, which together involved 161,808 generally healthy postmenopausal women. The clinical trials were designed to test the effects of postmenopausal hormone therapy, diet modification, and calcium and vitamin D supplements on heart disease, fractures, and breast and colorectal cancer.

The hormone trial had two studies: the estrogen-plus-progestin study of women with a uterus and the estrogen-alone study of women without a uterus. (Women with a uterus were given progestin in combination with estrogen, a practice known to prevent endometrial cancer.) In both hormone therapy studies, women were randomly assigned to either the hormone medication being studied or to placebo. Those studies have now ended. The women in these studies are now participating in a follow-up phase, which will last until 2010.

Estrogen-Alone Arm of Study Stopped

On March 2, 2004, the National Institutes of Health (NIH) announced that it had stopped the estrogen-alone arm of the WHI study after careful consideration of preliminary data and an average follow-up of nearly 7 years. Premarin was the form of estrogen used in the trials. While Premarin alone did not increase the risk of breast cancer or other cancers, it did slightly increase the risk of stroke and did not reduce risk of heart disease as previously thought.

There were two WHI postmenopausal hormone therapy trials:

•  the estrogen plus progestin study (stopped in 2002) of women with a uterus
•  the estrogen-alone study of women without a uterus (stopped March 2, 2004)

(Women with a uterus were given progestin in combination with estrogen, a practice known to prevent endometrial cancer.) In both hormone therapy trials, women were randomly assigned to either the hormone medication being studied or to placebo. Women in both trials have been asked to stop taking their study medication and to stay in the follow-up phase of the trial.

statements and findings from the NIH

	NHLBI Statement, March 2, 2004: NIH Asks Participants in Women's Health Initiative Estrogen-Alone Study to Stop Study Pills, Begin Follow-up Phase
	Sample letter to Estrogen-Alone Participants
	NHLBI Advisory for Physicians on the WHI trial of Conjugated Equine Estrogens versus Placebo
	Questions and Answers About the WHI Postmenopausal Hormone Therapy Trials
	The Estrogen-Alone Study
	The Estrogen-Plus-Progestin Study
	Oral Contraceptives and Cardiovascular Disease

Project AWARE's Comments

We feel concern that the discontinuation of this study will send the message "all HRT and all estrogen supplementation is bad for women."

The estrogen used in the discontinued study was Premarin. No other type of estrogen was used. Premarin is synthesized from the urine of pregnant mares, and is not bio-identical to human estrogen.

There are transdermal and other non-oral forms of bio-identical estrogen available to women, and there is much evidence that shows these other forms are safer, providing a more "natural" effect on the body than any oral formulation, including bio-identical oral estrogens.

We encourage you to investigate the resources regarding HRT in this website. Learn which transdermal and other non-oral forms of bio-identical estrogen you might consider. Read about alternatives to the kind of HRT used in WHI trials so that you can consult your physician armed with information, and to find the right solution for you. For further guidance and more specific information, you can contact any compounding pharmacy.

The estrogen plus progestin arm of the WHI trials was stopped in 2002 when data showed that after 5 years the balance of benefits from combined hormone replacement therapy did not compensate for an increased risk of cardiovascular events.

We believe it is important to note that the progestin used was a molecularly altered synthetic, not natural, or bio-identical progesterone. An alternative to total rejection of HRT would be the initiation of HRT trials involving "natural", or bio-identical hormones.

We invite you to explore our website for more comprehensive information on bio-identical hormones.

Page uploaded March 2004, Updated August 2010

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Updated 09/29/2010