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Summaries for Patients are a service provided by Annals to help patients better understand the complicated and often mystifying language of modern medicine.
SUMMARIES FOR PATIENTS
Hormone Replacement Therapy in Postmenopausal Women with Heart Disease and Risk for Gallstones That Require Surgery
2 October 2001 | Volume 135 Issue 7 | Page S44
Summaries for Patients are presented for informational purposes only. These summaries are not a substitute for advice from your own medical provider. If you have questions about this material, or need medical advice about your own health or situation, please contact your physician. The summaries may be reproduced for not-for-profit educational purposes only. Any other uses must be approved by the American College of Physicians-American Society of Internal Medicine.
The summary below is from the full report titled "Effect of Estrogen plus Progestin on Risk for Biliary Tract Surgery in Postmenopausal Women with Coronary Artery Disease. The Heart and Estrogen/progestin Replacement Study." It is in the 2 October 2001 issue of Annals of Internal Medicine (volume 135, pages 493-501). The authors are JA Simon, DB Hunninghake, SK Agarwal, F Lin, JA Cauley, CC Ireland, and JH Pickar, for the Heart and Estrogen/progestin Replacement Study (HERS) Research Group.
What is the problem and what is known about it so far?
Two types of hormones, estrogens and progestins, are useful in treating the symptoms of menopause. These hormones may prevent some of the unwanted health problems in postmenopausal women, such as thinning of the bones (osteoporosis). It is unclear whether these hormones also prevent other undesired health problems, such as heart disease, colon cancer, and Alzheimer disease. Estrogens and progestins also have side effects. For example, estrogen increases the risk for gallstones. Gallstones are hard deposits ("stones") that form in the gallbladder, a small organ that makes substances that help the body digest food. Gallstones can, in some cases, lead to such problems as abdominal pain. When these problems occur, treatment usually involves surgery to remove the gallbladder. It is unknown whether using estrogen and progestin in combination increases the development of gallstones.
Why did the researchers do this particular study?
To find out whether women who take estrogen and progestin are more likely to need gallbladder surgery than are women who do not take these hormones.
Who was studied?
2253 postmenopausal women 44 to 79 years of age who had a gallbladder and were participating in a large study of hormone replacement to prevent heart attacks. All of the women had heart disease.
How was the study done?
The study randomly assigned women to take either a combination of estrogen and progestin or placebo. Placebo was a substance that looked like the hormone pills but contained no active ingredients. The participants and researchers did not know which women were assigned to the active treatment group and which were receiving placebo. The researchers compared the number of women in each group who were hospitalized for gallbladder surgery over the 5 years of the study.
What did the researchers find?
Of the 2253 women, 147 had gallbladder surgery. Women taking the hormones were slightly more likely than women taking placebo to require gallbladder surgery. The researchers estimated that for every 185 women who take estrogen and progestin, one additional case of gallbladder surgery would occur each year, as compared with women who were not taking hormones. Other factors that increased the risk for gallbladder surgery were being overweight, using fibric acid medications to treat high cholesterol levels, and having gallstones. Taking statin medications to treat high cholesterol levels decreased the chances that a woman would need gallbladder surgery.
What were the limitations of the study?
The study included only women with heart disease; therefore, the results might not apply to women without heart disease.
What are the implications of the study?
Women with heart disease who take estrogen plus progestin may increase their chances of needing gallbladder surgery.
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  B. Liu, V. Beral, A. Balkwill, J. Green, S. Sweetland, G. Reeves, and for the Million Women Study Collaborators Gallbladder disease and use of transdermal versus oral hormone replacement therapy in postmenopausal women: prospective cohort study BMJ, July 10, 2008; 337(jul10_2): a386 - a386. [Abstract] [Full Text] [PDF]
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 H. H. Wang, N. H. Afdhal, and D. Q-H. Wang Overexpression of estrogen receptor {alpha} increases hepatic cholesterogenesis, leading to biliary hypersecretion in mice J. Lipid Res., April 1, 2006; 47(4): 778 - 786. [Abstract] [Full Text] [PDF]
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 U.S. Preventive Services Task Force* Hormone Therapy for the Prevention of Chronic Conditions in Postmenopausal Women: Recommendations from the U.S. Preventive Services Task Force Ann Intern Med, May 17, 2005; 142(10): 855 - 860. [Abstract] [Full Text] [PDF]
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 D. J. Cirillo, R. B. Wallace, R. J. Rodabough, P. Greenland, A. Z. LaCroix, M. C. Limacher, and J. C. Larson Effect of Estrogen Therapy on Gallbladder Disease JAMA, January 19, 2005; 293(3): 330 - 339. [Abstract] [Full Text] [PDF]
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Cholecystitis, Biliary Tract Surgery, and Pancreatitis Obstet. Gynecol., October 1, 2004; 104(4_suppl): 17S - 24S. [Full Text] [PDF]
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H. D. Nelson Postmenopausal Estrogen for Treatment of Hot Flashes: Clinical Applications JAMA, April 7, 2004; 291(13): 1621 - 1625. [Abstract] [Full Text] [PDF]
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C. Minelli, K. R Abrams, A. J Sutton, and N. J Cooper Benefits and harms associated with hormone replacement therapy: clinical decision analysis BMJ, February 14, 2004; 328(7436): 371. [Abstract] [Full Text] [PDF]
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U.S. Preventive Services Task Force* Postmenopausal Hormone Replacement Therapy for Primary Prevention of Chronic Conditions: Recommendations and Rationale Ann Intern Med, November 19, 2002; 137(10): 834 - 839. [Abstract] [Full Text] [PDF]
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S. Hulley, C. Furberg, E. Barrett-Connor, J. Cauley, D. Grady, W. Haskell, R. Knopp, M. Lowery, S. Satterfield, H. Schrott, et al. Noncardiovascular Disease Outcomes During 6.8 Years of Hormone Therapy: Heart and Estrogen/Progestin Replacement Study Follow-up (HERS II) JAMA, July 3, 2002; 288(1): 58 - 64. [Abstract] [Full Text] [PDF]
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D. B. Petitti Hormone Replacement Therapy for Prevention: More Evidence, More Pessimism JAMA, July 3, 2002; 288(1): 99 - 101. [Full Text] [PDF]
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D. Grady A 60-Year-Old Woman Trying to Discontinue Hormone Replacement Therapy JAMA, April 24, 2002; 287(16): 2130 - 2137. [Full Text] [PDF]
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M. A. Hlatky, D. Boothroyd, E. Vittinghoff, P. Sharp, M. A. Whooley, and for the HERS Research Group Quality-of-Life and Depressive Symptoms in Postmenopausal Women After Receiving Hormone Therapy: Results From the Heart and Estrogen/Progestin Replacement Study (HERS) Trial JAMA, February 6, 2002; 287(5): 591 - 597. [Abstract] [Full Text] [PDF]
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K. M. Rexrode and J. E. Manson Postmenopausal Hormone Therapy and Quality of Life: No Cause for Celebration JAMA, February 6, 2002; 287(5): 641 - 642. [Full Text] [PDF]
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