Women's Health Initiative

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The US Women's Health Initiative ( Engl . Women's Health Initiative, abbreviated WHI) was established in 1991 by the National Institutes of Health launched. The aim of the initiative was to conduct medical research in the core areas of health problems affecting older women. For this purpose, three clinical test series for preventive measures and a large observational study were designed and financed. Research focused on cardiovascular diseases , cancer and osteoporosis . A total of $ 625 million was spent and 160,000 women were recruited to participate in the study. The Estrogen plus Progestin Study (E + P) was stopped prematurely in 2002 because the risks exceeded the benefits of postmenopausal therapy, in particular an increased risk of cardiovascular complications and breast cancer was shown.

Scientific background

Since the 1950s, medical research - especially in the USA - has used epidemiological surveys, i.e. large cohort studies, to discover connections between lifestyle factors and common diseases. The seven-country study , the Nurses' Health Study (NHS) and the Framingham Heart Study paved the way . Since these studies only examined men (seven-country study, Framingham study) or only women from a certain occupational group (NHS, nurses), there was hardly any meaningful data for women. In addition, ethnic minorities have hardly been represented in previous studies. The women's health initiative should fill these gaps.

Preliminary studies in the 1980s showed that women were threatened in terms of their survival prognosis and quality of life primarily from cardiovascular diseases, cancer and osteoporosis. Estrogen deficiency as a characteristic of menopause has been recognized as a risk factor, especially for osteoporosis. Smaller studies showed a benefit of hormone replacement therapy.

execution

From 1993, women between 50 and 79 years of age were recruited for the project in initially 16 and later a total of 40 study centers in the USA. 20% of the participants should come from ethnic minorities. The primary goal of recruiting was the three intervention studies; All interested women who were not suitable for these studies or who did not want to participate could at least take part in the observational study (cohort study).

93,676 women were participants in the cohort study, 48,835 participants were treated with dietary measures, 27,347 women received hormone replacement therapy and 36,282 women were examined to determine whether supplementation with calcium and vitamin D was useful.

Results

The cohort study identified numerous risk factors for breast cancer: hormone replacement therapy, active and passive smoking, excessive alcohol consumption. Cardiovascular diseases have been reported among others. a. Associated with sleep disorders, particulate matter and a lack of physical activity. Consumption of whole grain products was associated with a low risk of type 2 diabetes; multivitamin preparations did not show any protective effect against cancer, heart disease or premature death.

The intervention studies showed no benefit of hormone replacement treatment on cardiovascular risk, but an increased risk of breast cancer from estrogen-progesterone preparations. Estrogen supplements lowered the risk of breast cancer. Diet change to low-fat, plant-based food intake reduced cardiovascular risk factors, but did not affect the actual occurrence of cardiovascular diseases, breast or colon cancer. Preventive treatment with calcium and vitamin D did not reduce the risk of colon cancer or fractures.

Data from the Women's Health Initiative have been published in more than 2000 publications, making it one of the most important studies in medical history.

Follow-up projects

The study project was significantly expanded in the course of the study; participants from all study arms were invited again to investigations in three five-year supplementary stages (most recently 2015–2020). Additional study projects looked at factors affecting longevity or the effectiveness of certain dietary supplements.

criticism

The epidemiological study is subject to the usual limitations of cohort studies; Correlations do not necessarily provide an indication of causal relationships. This is reflected in the discrepancy between many of the results of the observational study and the intervention studies. In addition, for the women's health initiative there is the relatively low adherence to therapy and the high dropout rate of the participants. The average age of the women was also 63 years. Preventive treatments for menopausal symptoms would be started 10 to 15 years earlier. Another point of criticism is that an essential therapeutic incentive of the treatments, namely the alleviation of symptoms in menopausal symptoms, was not recorded.

Web links

literature

Individual evidence

  1. ↑ G. Heiss, R. Wallace, GL Anderson, A. Aragaki, SA Beresford, R. Brzyski, RT Chlebowski, M. Gass, A. LaCroix, JE Manson, RL Prentice, J. Rossouw, ML Stefanick: Health risks and benefits 3 years after stopping randomized treatment with estrogen and progestin. In: JAMA: the journal of the American Medical Association Volume 299, Number 9, March 2008, pp. 1036-1045, ISSN  1538-3598 . doi : 10.1001 / jama.299.9.1036 . PMID 18319414 .
  2. ↑ Black Dm, Cummings Sr, Genant Hk, Nevitt Mc, Palermo L: Axial and Appendicular Bone Density Predict Fractures in Older Women. June 1992, accessed on May 11, 2020 .
  3. ↑ Effects of Estrogen or Estrogen / Progestin Regimens on Heart Disease Risk Factors in Postmenopausal Women. The Postmenopausal Estrogen / Progestin Interventions (PEPI) Trial. The Writing Group for the PEPI Trial. January 18, 1995, accessed May 11, 2020 .
  4. ^ Johnson S, Mebane-Sims I, Hogan Pe, Stoy Db: Recruitment of Postmenopausal Women in the PEPI Trial. Postmenopausal estrogen / progestin interventions. August 1995, accessed on May 11, 2020 .
  5. ↑ Barrett-Connor E, Slone S, Greendale G, Kritz-Silverstein D, Espeland M: The Postmenopausal Estrogen / Progestin Interventions Study: Primary Outcomes in Adherent Women. July 1997, accessed May 11, 2020 .
  6. Jump up ↑ Hays J, Hunt Jr, Hubbell Fa, Anderson Gl, Limacher M: The Women's Health Initiative Recruitment Methods and Results. October 2003, accessed on May 11, 2020 .
  7. ↑ Prentice R, Anderson Eq: The Women's Health Initiative: Lessons Learned. 2008, accessed on May 11, 2020 .
  8. ↑ Stampfer MJ, Colditz Ga: Estrogen Replacement Therapy and Coronary Heart Disease: A Quantitative Assessment of the Epidemiologic Evidence. January 1991, accessed May 11, 2020 .
  9. ^ Dupont Wd, Page Dl: Menopausal Estrogen Replacement Therapy and Breast Cancer. January 1991, accessed May 11, 2020 .
  10. ↑ Steinberg Kk, Thacker Sb, Smith Sj, Stroup Df, Zack Mm: A Meta-Analysis of the Effect of Estrogen Replacement Therapy on the Risk of Breast Cancer. April 17, 1991, accessed May 11, 2020 .
  11. ↑ Oh K, Hu Fb, Manson Je, Stampfer Mj, Willett Wc: Dietary Fat Intake and Risk of Coronary Heart Disease in Women: 20 Years of Follow-Up of the Nurses' Health Study. April 1, 2005, accessed May 11, 2020 .
  12. ↑ Liu S, Stampfer Mj, Hu Fb, Giovannucci E, Rimm E: Whole-grain Consumption and Risk of Coronary Heart Disease: Results From the Nurses' Health Study. September 1999, accessed on May 11, 2020 .
  13. ↑ Fung TT, Stampfer MJ, Manson Je, Rexrode Km, Willett WC: Prospective Study of Major Dietary Patterns and Stroke Risk in Women. September 2004, accessed on May 11, 2020 .
  14. ↑ Liu S, Manson Je, Lee Im, Cole Sr, Hennekens Ch: Fruit and Vegetable Intake and Risk of Cardiovascular Disease: The Women's Health Study. October 2000, accessed on May 11, 2020 .
  15. ↑ Chevalley T, Rizzoli R, Nydegger V, Slosman D, Rapin Ch: Effects of Calcium Supplements on Femoral Bone Mineral Density and Vertebral Fracture Rate in vitamin-D-replete Elderly Patients. September 1994, accessed on May 11, 2020 .
  16. ^ Bischoff-Ferrari Ha, Willett Wc, Wong Jb, Giovannucci E, Dietrich T: Fracture Prevention With Vitamin D Supplementation: A Meta-Analysis of Randomized Controlled Trials. May 11, 2005, accessed May 11, 2020 .
  17. ↑ McCullough Ml, Robertson As, Rodriguez C, Jacobs Ej, Chao A: Calcium, Vitamin D, Dairy Products, and Risk of Colorectal Cancer in the Cancer Prevention Study II Nutrition Cohort (United States). February 2003, accessed May 11, 2020 .
  18. ^ Bibliography - Publications and Paper Proposals (Excel). Retrieved May 11, 2020 .
  19. ↑ WHI - Cocoa supplement and multivitamin Outcomes Study (COSMOS) trial. Retrieved May 11, 2020 .
  20. ↑ Prentice Rl, Manson Je, Langer Rd, Anderson Gl, Pettinger M: Benefits and Risks of Postmenopausal Hormone Therapy When It Is Initiated Soon After Menopause. July 1, 2009, accessed May 11, 2020 .
  21. ↑ Banks E, Canfell K: Invited Commentary: Hormone Therapy Risks and benefits - The Women's Health Initiative Findings and the Postmenopausal Estrogen Timing Hypothesis. July 1, 2009, accessed May 11, 2020 .