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Study: Safe hormone therapy after hysterectomy

Rating

2 Star

Study: Safe hormone therapy after hysterectomy

Our Review Summary

This story provides a brief overview of the results of the Estrogen-Alone study, which was a large, randomized, blinded trial and part of the Women’s Health Initiative study of hormone replacement therapy (HRT). The story accurately notes that estrogen-alone therapy is only for postmenopausal women who have had a hysterectomy.

The story provides some balance on the risks and benefits of taking estrogen alone to relieve symptoms of menopause, and there is caution that it is not right for certain women. There is discussion of some of the established benefits of HRT, such as relieving hot flashes and helping to prevent osteoporosis. However, there is no quantitative data from the study on how great a benefit HRT would provide. For example, in the estrogen alone study, there were only 6 fewer hip fractures (11 cases in estrogen alone and 17 cases in placebo group) out of tens of thousands of women enrolled. There is no discussion of other medications which are effectively used to prevent osteoporosis and have fewer health risks.

The most erroneous portion of the story is the claim that “women can take this form of HRT with worrying about breast cancer.” It is true that there were fewer cases of breast cancer in the estrogen alone group: 28 per 10,000 in the estrogen group vs. 34 per 10,000 in the placebo group, and the difference was not statistically significant. However, there were more abnormal mammograms that required follow-up and 33% more breast biopsies in the estrogen alone group (747 vs. 549), which does not necessarily mean more breast cancer, but can signal changes in breast cells and tissue. Also, women at a higher risk of developing breast cancer in the estrogen-alone group had larger tumors that spread to the lymph nodes, which can mean a poorer prognosis and more breast cancer treatment.

Lastly, there is no discussion that menopause is a natural part of aging and not a condition which necessitates medical intervention. Unless symptoms are very bothersome, many women do not need to take hormone therapy medications to ease symptoms common in menopause such as hot flashes, cold sweats and vaginal dryness and discomfort. The report does not talk about less invasive alternative treatments for relieving symptoms of menopause such as exercise, vaginal creams, and wearing loose, cool clothing to prevent discomfort from hot flashes and cold sweats.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story doesn’t mention the cost of taking estrogen alone. There is also no discussion of the additional cost of screening for breast cancer via mammograms and breast biopsies, or follow-up visits that might be required for women at higher risk of developing breast cancer from taking estrogen-alone HRT.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The story mentions some of the established benefits of HRT, such as relieving hot flashes and helping to prevent osteoporosis. However, there is no quantitative data from the study on how great a benefit. There is also no comparison between the two groups regarding the relative or absolute risk reduction of experiencing hot flashes or developing osteoporosis due to taking estrogen alone. In the estrogen alone study there were only 6 fewer hip fractures (11 cases in those on estrogen alone and 17 cases in those on placebo). For a woman considering this therapy, these are important distinctions.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

Mentions some harms of treatment such as an increased risk of blood clots and strokes, but the interpretation of increased breast cancer risk for a subgroup of the study in omitted and misinterpreted. Also, there is no mention that the study found a slight increased risk of dementia in the estrogen-alone group. There were about 12 extra cases of dementia in every 10,000 women using estrogen alone each year. This increased risk was not statistically significant. Estrogen therapy is also associated with an increased risk of symptomatic gallstones.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

No quantitative evidence presented from estrogen-alone study of the Women’s Health Initiative. The claim that “women can take this form of HRT with worrying about breast cancer is not correct. Breast cancer was diagnosed in 28 per 10,000 in the estrogen group and 34 per 10,000 in the placebo group; however, this was not statistically significant. Additionally, there were more abnormal mammograms and breast biopsies in the estrogen group than in the placebo group. Women at a higher risk of developing breast cancer in the estrogen therapy group had larger tumors that spread to the lymph nodes. This is critically important information for women and their physicians as they consider estrogen therapy.

Does the story commit disease-mongering?

Not Satisfactory

There is no discussion here that menopause is a natural part of aging and not a condition which necessitates medical intervention. Unless symptoms are very bothersome, many women do not need to take hormone therapy medications to ease symptoms common in menopause such as hot flashes, cold sweats and vaginal dryness and discomfort.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

No attempt to interview other sources, but we realize this is a TV story providing a brief overview of the results of the estrogen-alone portion of the Women’s Health Initiative HRT trial. There is discussion of the risks and benefits of taking estrogen alone and that it should be tailored to an individual woman’s health and familial risks. There is some caution about taking estrogen-alone hormone therapy.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story does not talk about alternative treatments for relieving symptoms of menopause such as exercise, vaginal creams, and wearing loose, cool clothing to prevent discomfort from hot flashes and cold sweats. Also, there is no talk of other (less risky) medications which are used to prevent osteoporosis.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

It is fairly clear from this story that this is not a new therapy – this treatment is available to women from a primary care provider or gynecologist.

Does the story establish the true novelty of the approach?

Satisfactory

Mentions hormone replacement therapy (HRT) as part Women’s Health Initiative estrogen-alone study for women who have had hysterectomies. The story does not present HRT as a new treatment for bothersome menopausal symptoms such as hot flashes and vaginal discomfort. It is clear that HRT is not proven to prevent heart disease or cancer.

Does the story appear to rely solely or largely on a news release?

Satisfactory

There is no attempt to discuss the finding of the WHI with researchers in women’s health not affiliated with the study. However, this is a time-limited science report on the evening news. There is an explanation of the results of the WHI and caution about taking estrogen-alone hormone therapy. This appears to be a somewhat balanced report and not taken from press release.

Total Score: 4 of 10 Satisfactory

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