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Study clarifies health benefits, risks of hormone therapy

...Another 11,000 women who had undergone hysterectomies were randomized to receive Premarin (estrogen alone) or dummy pills.

Women with intact wombs generally do not take estrogen alone, because it increases the risk of uterine cancer.

The estrogen-and-progestin trial was halted in 2002, when the WHI researchers found that hormones caused a few extra heart attacks, strokes and breast cancers (although they prevented some hip fractures and colon cancers).

The estrogen-only trial was stopped two years later when researchers discovered that women taking Premarin had a slightly higher risk of stroke.

There was no difference in their risk of heart disease, and their breast cancer risk was actually lower.

Many researchers have questioned whether the findings of the WHI are applicable to the majority of menopausal women.

The average age of menopause is 51.

The average woman in the WHI was 63 and 12 years past menopause.

Monday’s findings help explain the discrepancy between the WHI and the many previous studies that found hormone therapy good for the heart.

"Earlier studies involved mostly women who started hormone therapy within two or three years of menopause," said Manson.

"The randomized controlled trials (which are considered the gold standard for medical research) were done mostly in women in their 60s and 70s who were more than a decade past menopause." Manson said the new WHI analysis found that women t...

Calcium Plus Vitamin Da Bust for Fractures and Colon Cancer

...Both were found to increase the risk of deep vein thrombosis and breast cancer, while offering no protection against heart disease.

But the hormones demonstrated efficacy for reducing hot flushes and other symptoms of menopause and for protecting bones.

A week ago, the WHI reported that low-fat diets did not reduce risk of breast or colon cancer and was equally ineffective in reducing the risk of cardiovascular disease.

The calcium-vitamin D study recruited 36,282 postmenopausal women ages 50 to 79 who were already enrolled in the WHI.

Of those, 18,176 were randomized to 1,000 mg of elemental calcium as calcium carbonate and 400 IU of vitamin D3 daily and 18,106 were randomized to placebo.

The women were followed for an average of seven years.

The mean age of the women was 62 and the mean body-mass index was 29.

In addition to the study medications, the women were permitted to use calcium supplements up to 1,000 mg a day and vitamin D up to 600 IU daily.

The women were also permitted the use of bisphosphonates and calcitonin during the trial, and half of the women were taking hormone therapy-all factors that critics said could obscure any potential benefit of the study supplements.

During the trial, the rate of hip fractures in the supplement group was 14 per 10,000 persons per year versus 16 per 10,000 persons per year in the control arm, for a 12% observed reducti...

Women's Health Initiative Study Data Show No Increased Risk of ...

...Wyeth provided the medications used in the HT portion of the WHI study, but did not have a role in the analysis or reporting of study findings.

The HT portion of the WHI study enrolled approximately 27,000 women between 1993 and 1998.

The estrogen-plus-progestin sub-study began with more than 16,000 women randomized to estrogen-plus-progestin or placebo.

The estrogen-alone sub-study enrolled more than 10,700 hysterectomized women.

The primary efficacy endpoint of WHI was the prevention of CHD, and the primary safety endpoint was the risk of breast cancer.

The secondary endpoints included hip fracture, colorectal cancer, stroke, pulmonary embolism and death from other causes.

The WHI was not designed to assess the relief of menopausal symptoms, such as hot flashes, night sweats and dryness from vaginal atrophy - the primary reasons women initiate therapy.

The estrogen-plus-progestin study arm of the WHI concluded in July 2002; the estrogen-alone arm concluded in March 2004.

Sub-study participants were then asked to enter into a follow-up phase.

It is important to note that the estrogen-alone sub-study of WHI evaluated the 0.625 mg strength of Premarin; today, a number of lower doses of the Premarin Family of Products are widely available, including Premarin 0.3 mg and 0.45 mg and About Estrogen-Alone Therapy Both estrogen-alone and estrogen-plus-progestin therapy ...

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