Hormone Replacement Therapy - Risks, Research and Relief

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Ever since the large government study called the Women’s Health Initiative found a number of risks associated with menopause hormones, millions of women who are in or near menopause have been weathering hot flashes and other symptoms on their own. But now, new research suggests that the benefits of short-term hormone treatment to control life-disrupting menopausal symptoms outweigh the risks — as long as the treatment is started at or near menopause.

There are also lots of products now available and different ways to use them that enhance the safety of hormone replacement. And there is even an app to help women and their doctors explore various options and choose the most suitable treatment.

To help women and their doctors assess H.R.T. options and select the best treatment for women 45 and older with menopausal symptoms, the North American Menopause Society has developed a mobile app, MenoPro, for iPhone/iPad and Android devices.

 

Women have long been worried of the risks of of cancer, blood clots or heart disease. Most professional medical societies concerned with women’s health now recommend treatment for menopausal symptoms for up to five years using therapy that combines estrogen and progesterone and even longer for those who take estrogen alone.

Every day, about 6,000 women in the United States — more than two million women a year — enter menopause. At an average age of 51, they stop having their periods because their ovaries no longer produce enough estrogen to stimulate growth of the uterine lining that is shed each menstrual cycle.

For months before and up to a decade or more after menopause begins, many women have symptoms that can seriously diminish the quality of their lives by disrupting their productivity, sleep, moods and ability to enjoy sexual intercourse.

The most common symptom — hot flashes — can leave some women dripping with sweat for minutes at a time several times a day and especially during the night. Menopause-related vaginal dryness and atrophy can result in severe sexual discomfort, pain and bleeding with exercise, vaginal and urinary infections and incontinence.

Until the early 2000s, many women with menopausal symptoms took hormone replacement therapy — H.R.T. — to counter them. Even some who did not have disturbing symptoms used H.R.T. because observational studies indicated it lowered the risk of cardiovascular diseases, and popular books and articles suggested it delayed signs of aging.

Then in 2002, the results of the largest randomized clinical trial of hormone replacement, the Women’s Health Initiative (W.H.I.), created a kind of menopausal panic, prompting millions of middle-age women to stop or not start hormone treatments and doctors to not prescribe them.

The study found that, among the women treated with the hormones, there was an increased risk of heart attacks, strokes, blood clots and, most frightening of all to many women, a slightly higher risk of breast cancer among those randomized to take the leading H.R.T. regimen of conjugated equine estrogens (Premarin) and a synthetic progesterone (Provera) recommended for women who still had a uterus. (Those without a uterus, who were randomized to take conjugated estrogens alone, had no increase in breast cancer; in fact, they had a slight decrease over all.)

However, according to Dr. JoAnn E. Manson, an endocrinologist and one of the principal investigators for the W.H.I., “The W.H.I. findings have been seriously misunderstood and misinterpreted,” and millions of women for whom the benefits clearly outweigh the risks are needlessly being denied treatment. “The pendulum has swung too far,” she said.

In the years after the W.H.I. findings, many new analyses and studies have prompted experts to rethink the wisdom of avoiding hormone replacement, especially for women within a few years of menopause whose personal and family history do not place them at high risk of breast cancer.

In an analysis in 2013 in the American Journal of Public Health, Dr. Philip M. Sarrel and his co-authors calculated that, based on reduced death rates among women taking only estrogen in the W.H.I. study, avoiding hormone replacement resulted in the premature deaths of 18,601 to 91,610 women in the decade after the study’s release.

Dr. Manson is distressed about the large number of women — about a third of those now on hormone replacement — who are relying on “custom-compounded” products that have not been reviewed for safety and effectiveness by the Food and Drug Administration. They come with no warnings in a package insert and could contain contaminants and inconsistent dosages, she said.

 

“There’s little or no reason to go the custom-compound route,” she said. “Women today have so many options — a wide array of doses, from low to traditional, and ways to use them.” In addition to pills, there are patches, gels and sprays applied to the skin. Vaginal and urinary symptoms can be treated with vaginal inserts containing very small amounts of estrogen that do not enter the bloodstream and thus are safe for women who have had breast cancer.