Is Hormone Replacement Therapy Unsafe?

The evidence is stacking up …

It’s official. Synthetic, not-natural-to-the-body hormone replacement therapy (HRT) is no longer considered ‘safe’ when used long term, and perhaps increases the risk of cancer and heart disease. Links of HRT to breast cancer, stroke and other diseases has caused widespread panic to women on some form of HRT.

The Women’s Health Initiative (WHI) revealed in July 2002 that women taking combined estrogen and progestin hormone therapy were at increased risk of breast cancer and stroke. 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.

This US study on the risks of combined estrogen-progestin was called off because of fears for its participants. The trial was cut short after five years because it was found one in 100 women taking the HRT combination suffered health consequences, including breast cancer and heart disease.

There is no question that an increased number of HRT-supplemented women in the study experienced coronary heart disease, strokes, pulmonary embolism, and breast cancer. Additional studies such as the Heart and Estrogen / Progestin Replacement Study Follow-up (HERS II) corroborate these findings, demonstrating that cardiovascular risk occurs primarily in the first year
of treatment.

After years of promotional messages about the benefits of HRT, the results from the WHI came as a surprise to patients and health care providers alike. The conclusions of this study were disconcerting, and left women with a decision that feels no more certain than a roll of the dice.

Certainly, we had good reason to feel like we’d been treated like guinea pigs because HRT had been widely promoted as a safe panacea to the uncomfortable symptoms of menopause. We discovered (though many of us already had the physical evidence to prove) that sometimes it is not safe at all.

Why weren’t these products tested more thoroughly before they were prescribed so broadly and why weren’t we told of the possible risks earlier?

And the evidence started to stack up…

In October of that same year, the Women’s International Study of Long Duration Oestrogen after Menopause (WISDOM), a British trial evaluating hormone therapy, was also stopped after finding elevated risks of breast cancer.

This was followed, twelve months later, by the results of the Million Women Study that indicated for the first time that the increased risk started between one and two years of HRT use (estrogen-plus-progestin & estrogen-alone). The risks grew larger the longer the HRT treatment continued.

The Million Women Study – an unprecedented study of the medical histories of nearly 1.1m British women who were cancer-free as they entered the national screening programme – revealed that those on some types of HRT were twice as likely to develop breast cancer as those who had not used it.

The results of the Million Women Study disagreed with the fact that the Women�s Health Initiative reported an increase in breast cancer not observed in the estrogen only arm of the clinical trial (an average follow-up has now reached about 7 years).

Swedish researchers, in early 2004, stopped yet another study examining the impact of hormone replacement therapy (HRT) in women with a history of breast cancer because of an unacceptably high risk of recurrence of the disease.

These studies DID NOT include bioidentical progesterone.

Is BHRT any safer?

The 1995 PEPI trials clearly demonstrated that natural progesterone actually works better than synthetic progestin in terms of protecting the heart, and that natural progesterone can protect against uterine cancer as well as synthetic progestin. Yet drug companies continue to convince us otherwise!

A study from researchers at the College of Nursing and Health Sciences at The University of Texas at Tyler, led by Kenna Stephenson, M.D., clearly showed that 30 women using 20 mg of progesterone daily, in a cream, had relief of their menopausal symptoms and didn’t have the side effects associated with the progestins such as Provera. The study was published in the November issue of Blood: The Journal of The American Society of Hematology.

“We are gratified that such a highly recognized, authoritative journal has published our abstract,” said Dr. Kenna Stephenson, visiting associate professor and scholar in residence, “and we are confident that women can consider bio-identical hormones, such as natural progesterone cream, to be a viable option for relief of menopausal symptoms”. With natural progesterone cream, we found no markers for inflammation or clotting-indicators for most of the serious diseases related to use of traditional hormone replacement therapy, like Provera and Prempro.”

The results of a large cohort study in 2005 suggest that, when combined with synthetic progestins, even short-term use of estrogens may increase breast cancer risk. Micronized progesterone may be preferred to synthetic progestins in short-term HRT.

In one of the few ‘head to head’ comparisons of bioidentical vs. synthetic hormones, the effects of substituting a synthetic oral progestin, with a bioidentical progesterone cream were studied in 26 healthy menopausal women with an average age of 57. The aim was to determine patients� acceptance of transdermal progesterone cream and its effects upon the endometrium (uterine lining) compared to standard hormone therapy.

Dr. Helene Leonetti’s study shows promise for using a bioidentical progesterone cream instead of a synthetic progestin (medroxyprogesterone acetate or MPA) to protect the uterus in women using hormone replacement therapy. The demonstration of effectiveness here might warrant a study with a larger cohort of women over a longer period of time to confirm the effectiveness of progesterone cream. At the end of the study, 77% of the 26 women stated they preferred the bioidentical progesterone cream over the MPA.

Women in Balance recently had the opportunity to talk with several presenting officials, including Dr. Jacques Rossouw, one of the original designers of the WHI study, and the Project Officer of the WHI National Heart, Lung and Blood Institute, a division within NIH. They asked Dr. Rossouw for his comments regarding the future of hormone research, and what in particular, he thought might be explored, designed, or funded.

“We are interested in the role that progesterone plays in women�s health and its protective attributes,” he said. “There are currently two studies that might yield information about the role of bioidentical hormones: the KEEPS (Kronos Early Estrogen Prevention Study) and the ELITE (Early versus Late Intervention Trial with Estradiol), both using a bioidentical estrogen and progesterone.” Dr. Rossouw revealed that NIH agencies are already providing funding to the ELITE study.

Dispensing a little less poision

Dr. Randolph, trained pharmacist and Board Certified practicing gynecologist, and co-author of From Hormone Hell to Hormone Well dispenses some advice for his peers: “If doctors want to do the right thing and keep their patients’ loyalty, they need to get their heads out of the pharmaceutical companies’ pockets. They need to return to their role as patient advocates. They need to take the initiative to read all the medical evidence; e.g. the studies that incriminate synthetic HRT as well as the ones that support bio-identical HRT. More women will be better off once more doctors find their brains, review the literature and, then, decide for themselves what type of HRT they feel is best for their patients”.