No increase in early deaths among woman who use hormone therapy

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Women can take hormone replacement therapy for the menopause without fear that it will cause early death, the first long-term study has concluded.

The landmark research, backed by the USA government, began in the early 1990s to rigorously test hormones' effects in older women randomly assigned to take the pills or dummy treatment. They were followed for 18 years and tracked for chronic diseases like cancer, as well as heart attack and deaths. The study was halted in 2002, after investigators found the hormone therapy appeared to put women at greater risk of invasive breast cancer, strokes and heart disease.

Dr. Joshua Roth, lead author of the HICOR analysis, said he does not believe that the new WHI study would change his findings.

However, an 18-year follow-up of 27,347 women who were part of the WHI study found that they were no more likely to die of any cause than women who took placebo pills. "Mortality rates are the ultimate "bottom line" when assessing the net effect of a medication on serious and life-threatening health outcomes".

The researchers found during the five to seven years of treatment, death rates were about 30 percent lower among women aged 50 to 59 when they received hormone therapy than when they received placebo. "We now think about an appropriate dose for the appropriate length of time for the appropriate woman dealing with the (menopause) symptoms that she has".

Most deaths occurred after women stopped taking hormones.

Among the youngest women, there were fewer overall deaths early on among hormone users than dummy-pill users, but the rates evened out after women stopped using the pills.

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After 18 years, which included 10 to 12 years of follow-up after stopping hormone therapy, the differences by age group diminished and were no longer statistically significant. But there is no evidence that hormone therapy should be used for prevention of cardiovascular diseases and other chronic illnesses, they say.

Experts said the hormone therapy is safe to use by women who are looking to relieve symptoms from menopause such as hot flashes.

"There was no increase in total mortality or in death rates from cardiovascular disease or cancer", Dr. Manson said.

"In clinical decision making, these considerations must be weighed against the impact of untreated menopausal symptoms that women experience, including impaired quality of life, disrupted sleep, reduced work productivity and increased health care expenditures", she added.

The WHI hormone therapy trials addressed the benefits and risks of the most common formulations of hormone therapy used at the start of the study.

Today, there are new formulations of hormone therapies, which include lower doses and novel administration methods, such as skin patches, gels, and sprays. "But that is the reason that all-cause mortality is such an important summary measure, since interventions like hormone therapy can have a complex pattern of benefits and risks".