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Study tries to resuscitate hormone therapy for menopause

Ever since the stunning 2002 findings from the massive, randomized, double-blinded Women’s Health Initiative study, hormone therapy as a “treatment” for menopause has been on life support.

Ever since the stunning 2002 findings from the massive, randomized, double-blinded Women’s Health Initiative study, hormone therapy as a “treatment” for menopause has been on life support.

Women have walked away from HT in droves, deciding instead to move through their menopausal years as their grandmothers did, with a shrug, a sense of humor and layered clothing.

But drug companies and many members of the medical community refuse to let go of the idea that menopause is an illness in need of treatment. They continue to try to convince women that hormones are just what the doctor ordered for a whole host of menopausal “complaints.”

The latest attempt to resuscitate HT (also sometimes referred to as hormone replacement therapy, or HRT) occurred last Friday in a study published in the British Medical Journal. A team of researchers from Britain, Australia and New Zealand reported that HT improved postmenopausal women’s “health related quality of life.”

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As a result, said the study’s authors, new “consideration should be given to revisiting HRT guidelines.” (Current guidelines recommend hormone therapy only as a short-term treatment for severe menopause-related hot flashes or night sweats; it’s no longer prescribed to prevent chronic diseases — even osteoporosis, for which safer treatments are available.)

Headlines about the study have been predictably positive: “Some Redemption for Hormone Therapy,” “Good Tidings for Women on HRT,”  “A Win-Win for Women?” and “HRT May Be Worth Cancer Risk, Study Suggests.”

Just a minute. Worth the risk of cancer? Is that really what the study’s findings suggest?

No, according to Amy Allina, program director of the Washington, D.C.-based National Women’s Health Network, an organization that has warned women about supplemental menopausal hormones for three decades. “My first thought on reading the study was that there is nothing new here,” she said. 

“This is a classic Women’s Health Initiative backlash article,” she added, noting that the study’s conclusion — that HT can improve health related quality of life — is not justified by the study’s own findings.

“It makes me question whether they have an agenda in terms of rehabilitating HRT,” she said.

First, a bit of history
As all women “of a certain age” by now know, the WHI study found that postmenopausal women given an estrogen-plus-progesterone combo increased their risk of heart attack, stroke, blood clots, breast cancer and colon cancer. Women given only estrogen faired a bit better, “just” increasing their risk of stroke, blood clots, colon cancer and, maybe, breast cancer. (Women taking estrogen alone are also at greater risk of uterine cancer, which is why this form of HT is recommended only for women who have had a hysterectomy.) Both groups had fewer fractures, but neither experienced any benefit in warding off Alzheimer’s disease or other types of dementia.

So striking (and unexpected) were the WHI findings, scientists brought the study to a screeching halt before its scheduled end — a highly unusual action. (Almost everybody involved in WHI thought the study was going to prove, at the very minimum, that HT helped prevent heart disease.) Sales of menopausal hormones — at the time, a reported $1 billion a year — plummeted.

But despite having the wind knocked out of them, HT’s boosters quickly regrouped. They parsed the WHI data, threw in findings from other, less authoritative studies and began make revisionist claims: The health risks from HT are minimal. They don’t pertain if you start taking the drugs early in your menopausal years and/or if you take them in lower doses. Hormone patches are safer than pills. “Natural” hormones are safer than synthetic ones.

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Proving these claims, however, would require another large double-blinded randomized trial like the WHI. Given the huge cost, such a study is unlikely.

Still, the aggressive attempts at HT CPR continue.

Contradictory WISDOM
The new study is based on data from the Women’s International Study of Long Duration Oestrogen After Menopause, or WISDOM, which, like its American cousin, the WHI, randomly assigned postmenopausal women to different treatment groups (in this case, estrogen-plus-progesterone or placebo). Recruitment began in 2001, but stopped abruptly a year later when the WHI results became known. 

Researchers analyzed data from health questionnaires filled out by 2,130 WISDOM participants who had had one year of treatment. They found a small, but statistically significant improvement in three of nine measurements of women’s health: hot flashes, sleep problems and sexual functioning. They found no improvement in the other measurements, which included memory, depression, anxiety and self-esteem.

In fact, they found no improvement in the women’s overall quality of life.

Yet, the researchers still concluded that “combined HRT started many years after the menopause can improve health related quality of life.”

How do the study’s authors explain that contradiction?

They claim their condition-specific questionnaire is more sensitive to factors that affect women’s quality of life than other, generic questionnaires.

Of course, there may be another explanation: The WISDOM women may not have considered the hot flashes, sleep problems and subdued sexual functioning they reported that big a deal — certainly not serious enough to stop them from enjoying life.

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“As bothersome as hot flashes may be,” said Allina, “when you talk to a woman about her overall quality of life, she’s considering so many other things.”

A not-so-delicate balance?
In a press release, physician Alastair MacLennan, one of the authors of the British Medical Journal study, stated that these latest findings “enable the risks of HRT to be reduced and its benefits maximized when the treatment is individualized to each woman.”

OK. Let’s balance those risks and benefits. On the benefits side: less troublesome hot flashes and a small but measurable improvement in sleep and sex.

On the risks side: a greater chance of developing heart attack, stroke, blood clots, breast cancer and colon cancer.

Some other factors to toss on the scale: Each of the three problems helped by HT in the WISDOM study can be ameliorated with less risky solutions, some as simple as changing your diet. (For the National Women’s Health Network’s discussion of non-hormonal therapies for hot flashes, go here.)

And, as the WISDOM study found, HT causes its own quality of life issues — vaginal bleeding and breast tenderness. In fact, 28 percent of the women on HT (compared with 13 percent of the women in the placebo group) discontinued treatment before a year was up and thus weren’t part of the final WISDOM analysis. The study’s authors concede that this dropout rate may have skewed their results.

So, despite the hyped headlines, the latest study doesn’t really change what we already know about supplemental menopausal hormones. 

“Women need to be making their decision [about HT] based on a full understanding of what the risks and benefits are,” said Allina. “This study doesn’t show us any new benefits. The equation is still the same.”