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Clinical Trial Reports

By Stanton R. Mehr
Published: Tuesday, Jun 15, 2010
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â–º PHASE IV

Cancer Risks and Postmenopausal Hormone Link Confirmed

Overall health risks, including breast cancer, heart attacks, and related problems that outweighed the benefits of treatment with estrogen and progestin after menopause caused Women’s Health Initiative (WHI) researchers to abandon the trial six years ago, after a mean follow-up of 5.6 years. This landmark study changed how hormone-replacement therapy was prescribed, and researchers from the University of North Carolina, School of Public Health, Chapel Hill, reported some interesting findings based on their follow-up of the women who participated in that trial.

In the initial double-blind, placebo-controlled, randomized WHI study, 16,608 women aged 50 through 79 years received conjugated equine estrogens 0.625 mg/day plus medroxyprogesterone acetate 2.5 mg/day. The latest report, a postintervention follow-up that included 15,730 women, began in July 2002 and concluded in March 2005.

This follow-up to the WHI study found that the annualized risk of cardiovascular problems was 1.97% (343 events) in patients who received hormone-replacement therapy, compared with 1.91% (323 events) in the placebo group. Patients in the WHI’s active treatment group experienced approximately one-quarter greater risk of malignancies (and breast cancer risk) (Table). The researchers revealed a slight trend toward a lower hazard ratio for breast cancer during the follow-up period. Postmenopausal patients receiving hormonereplacment therapy also had a “somewhat” higher level of all-cause mortality than the placebo group. They noted that overall, there was no change in the risks or benefits than that seen in the original WHI study. The global risk for the women receiving hormone- replacement therapy was still 12% higher than for women in the placebo group.

Outcomes follow-up of women's health initiative (WHI)

 

  Risk Category
 

WHI Intervention Group
 

Placebo Group
 

Hazard Ratio
 

  Any Malignancy*
 

  1.56%
 

  1.26%
 

  1.24
 

  Breast Cancer*
 

  0.42%
 

  0.33%
 

  1.27
 

  All-Cause Mortality
 

  1.20%
 

  1.06%
 

  1.15
 * Annualized Incidence


Heiss G, Wallace R, Anderson GL, et al: Health risks and benefits 3 years after stopping randomized treatment with estrogen and progestin. JAMA 2008;299:1036-1045.






â–º PHASE III

Do Vitamins Protect Against Lung Cancer?

In the United States, lung cancer remains the leading cause of cancer-related deaths. Approximately one-half of the population takes supplemental multivitamins in order to help prevent chronic diseases or cancer. However, researchers from the University of Washington, Seattle, found that taking vitamin supplements, especially vitamins C, E, and folate, do not lower the risk of lung cancer; long-term use of high-dose vitamin E may in fact increase the risk.


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