FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

Published at www.nejm.org March 17, 2003 (10.1056/NEJMoa030311)

	PDF Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background The Women's Health Initiative (WHI) and other clinical trials indicate that significant health risks are associated with combination hormone use. Less is known about the effect of hormone therapy on health-related quality of life.

Methods The WHI randomly assigned 16,608 postmenopausal women 50 to 79 years of age (mean, 63) with an intact uterus at base line to estrogen plus progestin (0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate, in 8506 women) or placebo (in 8102 women). Quality-of-life measures were collected at base line and at one year in all women and at three years in a subgroup of 1511 women.

Results Randomization to estrogen plus progestin resulted in no significant effects on general health, vitality, mental health, depressive symptoms, or sexual satisfaction. The use of estrogen plus progestin was associated with a statistically significant but small and not clinically meaningful benefit in terms of sleep disturbance, physical functioning, and bodily pain after one year (the mean benefit in terms of sleep disturbance was 0.4 point on a 20-point scale, in terms of physical functioning 0.8 point on a 100-point scale, and in terms of pain 1.9 points on a 100-point scale). At three years, there were no significant benefits in terms of any quality-of-life outcomes. Among women 50 to 54 years of age with moderate-to-severe vasomotor symptoms at base line, estrogen and progestin improved vasomotor symptoms and resulted in a small benefit in terms of sleep disturbance but no benefit in terms of the other quality-of-life outcomes.

Conclusions In this trial in postmenopausal women, estrogen plus progestin did not have a clinically meaningful effect on health-related quality of life.

Notice: Because of its potential therapeutic implications, this article was published at www.nejm.org on March 17, 2003. It will appear in the May 8, 2003, issue of the Journal.

Click on "PDF of this article" for the full text.

This article has been cited by other articles:

• Walf, A., Koonce, C., Frye, C. (2009). Adult female wildtype, but not oestrogen receptor {beta} knockout, mice have decreased depression-like behaviour during pro-oestrus and following administration of oestradiol or diarylpropionitrile. J Psychopharmacol 23: 442-450 [Abstract]  
• Gass, M. L. S., Bassuk, S. S., Manson, J. E. (2009). Reassessing Benefits and Risks of Hormone Therapy. AMERICAN JOURNAL OF LIFESTYLE MEDICINE 3: 29-43 [Abstract]  
• Brown, S. (2008). Lower risk of MI associated with cyclical and transdermal hormone replacement therapies. Menopause Int 14: 140-143 [Full Text]  
• Martin, K. A., Manson, J. E. (2008). Approach to the Patient with Menopausal Symptoms. J. Clin. Endocrinol. Metab. 93: 4567-4575 [Abstract] [Full Text]  
• Welton, A. J, Vickers, M. R, Kim, J., Ford, D., Lawton, B. A, MacLennan, A. H, Meredith, S. K, Martin, J., Meade, T. W, for the WISDOM team, (2008). Health related quality of life after combined hormone replacement therapy: randomised controlled trial. BMJ 337: a1190-a1190 [Abstract] [Full Text]  
• Hogue, C. W. Jr, Fucetola, R., Hershey, T., Nassief, A., Birge, S., Davila-Roman, V. G., Barzilai, B., Thomas, B., Schechtman, K. B., Freedland, K. (2008). The Role of Postoperative Neurocognitive Dysfunction on Quality of Life for Postmenopausal Women 6 Months After Cardiac Surgery. Anesth. Analg. 107: 21-28 [Abstract] [Full Text]  
• Schulkin, J. (2008). Hormone Therapy, Dilemmas, Medical Decisions.. J Law Med Ethics 36: 73-88  
• Vitale, C., Mercuro, G., Cerquetani, E., Marazzi, G., Patrizi, R., Pelliccia, F., Volterrani, M., Fini, M., Collins, P., Rosano, G. M.C. (2008). Time Since Menopause Influences the Acute and Chronic Effect of Estrogens on Endothelial Function. Arterioscler. Thromb. Vasc. Bio. 28: 348-352 [Abstract] [Full Text]  
• Decensi, A., Gandini, S., Serrano, D., Cazzaniga, M., Pizzamiglio, M., Maffini, F., Pelosi, G., Daldoss, C., Omodei, U., Johansson, H., Macis, D., Lazzeroni, M., Penotti, M., Sironi, L., Moroni, S., Bianco, V., Rondanina, G., Gjerde, J., Guerrieri-Gonzaga, A., Bonanni, B. (2007). Randomized Dose-Ranging Trial of Tamoxifen at Low Doses in Hormone Replacement Therapy Users. JCO 25: 4201-4209 [Abstract] [Full Text]  
• Schumacher, M., Guennoun, R., Ghoumari, A., Massaad, C., Robert, F., El-Etr, M., Akwa, Y., Rajkowski, K., Baulieu, E.-E. (2007). Novel Perspectives for Progesterone in Hormone Replacement Therapy, with Special Reference to the Nervous System. Endocr. Rev. 28: 387-439 [Abstract] [Full Text]  
• Veronesi, U., Maisonneuve, P., Rotmensz, N., Bonanni, B., Boyle, P., Viale, G., Costa, A., Sacchini, V., Travaglini, R., D'Aiuto, G., Oliviero, P., Lovison, F., Gucciardo, G., del Turco, M. R., Muraca, M. G., Pizzichetta, M. A., Conforti, S., Decensi, A. (2007). Tamoxifen for the Prevention of Breast Cancer: Late Results of the Italian Randomized Tamoxifen Prevention Trial Among Women With Hysterectomy. JNCI J Natl Cancer Inst 99: 727-737 [Abstract] [Full Text]  
• Potter, J. E. (2007). A 60-Year-Old Woman With Sexual Difficulties. JAMA 297: 620-633 [Abstract] [Full Text]  
• Cvoro, A., Paruthiyil, S., Jones, J. O., Tzagarakis-Foster, C., Clegg, N. J., Tatomer, D., Medina, R. T., Tagliaferri, M., Schaufele, F., Scanlan, T. S., Diamond, M. I., Cohen, I., Leitman, D. C. (2007). Selective Activation of Estrogen Receptor-{beta} Transcriptional Pathways by an Herbal Extract. Endocrinology 148: 538-547 [Abstract] [Full Text]  
• Dahlman-Wright, K., Cavailles, V., Fuqua, S. A., Jordan, V. C., Katzenellenbogen, J. A., Korach, K. S., Maggi, A., Muramatsu, M., Parker, M. G., Gustafsson, J.-A. (2006). International Union of Pharmacology. LXIV. Estrogen Receptors. Pharmacol. Rev. 58: 773-781 [Full Text]  
• Turgeon, J. L., Carr, M. C., Maki, P. M., Mendelsohn, M. E., Wise, P. M. (2006). Complex Actions of Sex Steroids in Adipose Tissue, the Cardiovascular System, and Brain: Insights from Basic Science and Clinical Studies. Endocr. Rev. 27: 575-605 [Abstract] [Full Text]  
• Sestak, I., Kealy, R., Edwards, R., Forbes, J., Cuzick, J. (2006). Influence of Hormone Replacement Therapy on Tamoxifen-Induced Vasomotor Symptoms. JCO 24: 3991-3996 [Abstract] [Full Text]  
• Ho, K. K Y (2006). Endocrinology: the next 60 years.. J Endocrinol 190: 3-6 [Abstract] [Full Text]  
• Yaffe, K., Vittinghoff, E., Ensrud, K. E., Johnson, K. C., Diem, S., Hanes, V., Grady, D. (2006). Effects of ultra-low-dose transdermal estradiol on cognition and health-related quality of life.. Arch Neurol 63: 945-950 [Abstract] [Full Text]  
• Miller, J. W. (2006). Using a Drug Before the Risks and Benefits Are Known From a Phase 3 Clinical Trial: Thoughts on Compassion. Arch Ophthalmol 124: 1029-1031 [Full Text]  
• Land, S. R., Wickerham, D. L., Costantino, J. P., Ritter, M. W., Vogel, V. G., Lee, M., Pajon, E. R., Wade, J. L. III, Dakhil, S., Lockhart, J. B. Jr, Wolmark, N., Ganz, P. A. (2006). Patient-Reported Symptoms and Quality of Life During Treatment With Tamoxifen or Raloxifene for Breast Cancer Prevention: The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 Trial. JAMA 295: 2742-2751 [Abstract] [Full Text]  
• Bardwell, W. A., Natarajan, L., Dimsdale, J. E., Rock, C. L., Mortimer, J. E., Hollenbach, K., Pierce, J. P. (2006). Objective Cancer-Related Variables Are Not Associated With Depressive Symptoms in Women Treated for Early-Stage Breast Cancer. JCO 24: 2420-2427 [Abstract] [Full Text]  
• Basson, R. (2006). Sexual Desire and Arousal Disorders in Women. NEJM 354: 1497-1506 [Full Text]  
• Wei, F., Miglioretti, D. L., Connelly, M. T., Andrade, S. E., Newton, K. M., Hartsfield, C. L., Chan, K. A., Buist, D. S. M. (2005). Changes in Women's Use of Hormones After the Women's Health Initiative Estrogen and Progestin Trial by Race, Education, and Income. J Natl Cancer Inst Monogr 2005: 106-112 [Abstract] [Full Text]  
• Whelan, T. J., Goss, P. E., Ingle, J. N., Pater, J. L., Tu, D., Pritchard, K., Liu, S., Shepherd, L. E., Palmer, M., Robert, N. J., Martino, S., Muss, H. B. (2005). Assessment of Quality of Life in MA.17: A Randomized, Placebo-Controlled Trial of Letrozole After 5 Years of Tamoxifen in Postmenopausal Women. JCO 23: 6931-6940 [Abstract] [Full Text]  
• Brunner, R. L., Gass, M., Aragaki, A., Hays, J., Granek, I., Woods, N., Mason, E., Brzyski, R., Ockene, J., Assaf, A., LaCroix, A., Matthews, K., Wallace, R., for the Women's Health Initiative Investigators, (2005). Effects of Conjugated Equine Estrogen on Health-Related Quality of Life in Postmenopausal Women With Hysterectomy: Results From the Women's Health Initiative Randomized Clinical Trial. Arch Intern Med 165: 1976-1986 [Abstract] [Full Text]  
• Ockene, J. K., Barad, D. H., Cochrane, B. B., Larson, J. C., Gass, M., Wassertheil-Smoller, S., Manson, J. E., Barnabei, V. M., Lane, D. S., Brzyski, R. G., Rosal, M. C., Wylie-Rosett, J., Hays, J. (2005). Symptom Experience After Discontinuing Use of Estrogen Plus Progestin. JAMA 294: 183-193 [Abstract] [Full Text]  
• Davis, S R, Dinatale, I, Rivera-Woll, L, Davison, S (2005). Postmenopausal hormone therapy: from monkey glands to transdermal patches. J Endocrinol 185: 207-222 [Abstract] [Full Text]  
• Wylie-Rosett, J. (2005). Menopause, micronutrients, and hormone therapy. Am. J. Clin. Nutr. 81: 1223S-1231S [Abstract] [Full Text]  
• Ness, J., Aronow, W. S., Newkirk, E., McDanel, D. (2005). Use of Hormone Replacement Therapy by Postmenopausal Women After Publication of the Women's Health Initiative Trial. Journals of Gerontology Series A: Biological Sciences and Medical Sciences 60: 460-462 [Abstract] [Full Text]  
• Carel, J.-C., Ecosse, E., Bastie-Sigeac, I., Cabrol, S., Tauber, M., Leger, J., Nicolino, M., Brauner, R., Chaussain, J.-L., Coste, J. (2005). Quality of Life Determinants in Young Women with Turner's Syndrome after Growth Hormone Treatment: Results of the StaTur Population-Based Cohort Study. J. Clin. Endocrinol. Metab. 90: 1992-1997 [Abstract] [Full Text]  
• Dodin, S., Lemay, A., Jacques, H., Legare, F., Forest, J.-C., Masse, B. (2005). The Effects of Flaxseed Dietary Supplement on Lipid Profile, Bone Mineral Density, and Symptoms in Menopausal Women: A Randomized, Double-Blind, Wheat Germ Placebo-Controlled Clinical Trial. J. Clin. Endocrinol. Metab. 90: 1390-1397 [Abstract] [Full Text]  
• DuBeau, C. E. (2005). Estrogen Treatment for Urinary Incontinence: Never, Now, or in the Future?. JAMA 293: 998-1001 [Full Text]  
• Levine, D. W., Dailey, M. E., Rockhill, B., Tipping, D., Naughton, M. J., Shumaker, S. A. (2005). Validation of the Women's Health Initiative Insomnia Rating Scale in a Multicenter Controlled Clinical Trial. Psychosom. Med. 67: 98-104 [Abstract] [Full Text]  
• Pardee, K., Reinking, J., Krause, H. (2004). Nuclear Hormone Receptors, Metabolism, and Aging: What Goes Around Comes Around. Sci Aging Knowl Environ 2004: re8-re8 [Abstract] [Full Text]  
• Peterson, H. B., Thacker, S. B., Corso, P. S., Marchbanks, P. A., Koplan, J. P. (2004). Hormone Therapy: Making Decisions in the Face of Uncertainty. Arch Intern Med 164: 2308-2312 [Full Text]  
• McClung, M. R., Wasnich, R. D., Hosking, D. J., Christiansen, C., Ravn, P., Wu, M., Mantz, A. M., Yates, J., Ross, P. D., Santora, A. C. II, on behalf of the Early Postmenopausal Intervention, (2004). Prevention of Postmenopausal Bone Loss: Six-Year Results from the Early Postmenopausal Intervention Cohort Study. J. Clin. Endocrinol. Metab. 89: 4879-4885 [Abstract] [Full Text]  
• Flemming, K. D., Brown, R. D. Jr (2004). Secondary Prevention Strategies in Ischemic Stroke: Identification and Optimal Management of Modifiable Risk Factors. Mayo Clin Proc. 79: 1330-1340 [Abstract]  
• Roumie, C. L., Grogan, E. L., Falbe, W., Awad, J., Speroff, T., Dittus, R. S., Elasy, T. A. (2004). A Three-Part Intervention To Change the Use of Hormone Replacement Therapy in Response to New Evidence. ANN INTERN MED 141: 118-125 [Abstract] [Full Text]  
• Oken, B. S., Kishiyama, S., Zajdel, D., Bourdette, D., Carlsen, J., Haas, M., Hugos, C., Kraemer, D. F., Lawrence, J., Mass, M. (2004). Randomized controlled trial of yoga and exercise in multiple sclerosis. Neurology 62: 2058-2064 [Abstract] [Full Text]  
• Chiuve, S. E., Martin, L. A., Campos, H., Sacks, F. M. (2004). Effect of the Combination of Methyltestosterone and Esterified Estrogens Compared with Esterified Estrogens Alone on Apolipoprotein CIII and Other Apolipoproteins in Very Low Density, Low Density, and High Density Lipoproteins in Surgically Postmenopausal Women. J. Clin. Endocrinol. Metab. 89: 2207-2213 [Abstract] [Full Text]  
• Morley, J. E. (2004). Is the Hormonal Fountain of Youth Drying Up?. Journals of Gerontology Series A: Biological Sciences and Medical Sciences 59: M458-M460 [Full Text]  
• Nelson, H. D. (2004). Postmenopausal Estrogen for Treatment of Hot Flashes: Clinical Applications. JAMA 291: 1621-1625 [Abstract] [Full Text]  
• Carnes, M., Mahoney, J. E. (2004). Update in Women's Health. ANN INTERN MED 140: 538-544 [Full Text]  
• Ke, H. Z., Foley, G. L., Simmons, H. A., Shen, V., Thompson, D. D. (2004). Long-Term Treatment of Lasofoxifene Preserves Bone Mass and Bone Strength and Does Not Adversely Affect the Uterus in Ovariectomized Rats. Endocrinology 145: 1996-2005 [Abstract] [Full Text]  
• Kuppermann, M., Varner, R. E., Summitt, R. L. Jr, Learman, L. A., Ireland, C., Vittinghoff, E., Stewart, A. L., Lin, F., Richter, H. E., Showstack, J., Hulley, S. B., Washington, A. E. (2004). Effect of Hysterectomy vs Medical Treatment on Health-Related Quality of Life and Sexual Functioning: The Medicine or Surgery (Ms) Randomized Trial. JAMA 291: 1447-1455 [Abstract] [Full Text]  
• Armstrong, K., Schwartz, J. S., Randall, T., Rubin, S. C., Weber, B. (2004). Hormone Replacement Therapy and Life Expectancy After Prophylactic Oophorectomy in Women With BRCA1/2 Mutations: A Decision Analysis. JCO 22: 1045-1054 [Abstract] [Full Text]  
• Minelli, C., Abrams, K. R, Sutton, A. J, Cooper, N. J (2004). Benefits and harms associated with hormone replacement therapy: clinical decision analysis. BMJ 328: 371- [Abstract] [Full Text]  
• Hsia, J., Criqui, M. H., Rodabough, R. J., Langer, R. D., Resnick, H. E., Phillips, L. S., Allison, M., Bonds, D. E., Masaki, K., Caralis, P., Kotchen, J. M., for the Women's Health Initiative Investigators, (2004). Estrogen Plus Progestin and the Risk of Peripheral Arterial Disease: The Women's Health Initiative. Circulation 109: 620-626 [Abstract] [Full Text]  
• Lopes, A. A., Latado, A., Lopes, G. B., Watts, N. B. (2004). Effects of Estrogen plus Progestin on Health-Related Quality of Life. NEJM 350: 622-622 [Full Text]  
• (2003). ADDITIONAL ARTICLES ABSTRACTED IN ACP JOURNAL CLUB. Evid. Based Med. 8: 163-163 [Full Text]  
• Ena, G., Rozenberg, S. (2003). Issues to debate on the Women's Health Initiative (WHI) study. Prescription attitudes among Belgian gynaecologists after premature discontinuation of the WHI study. Hum Reprod 18: 2245-2248 [Abstract] [Full Text]  
• Rock, E., DeMichele, A. (2003). Nutritional Approaches to Late Toxicities of Adjuvant Chemotherapy in Breast Cancer Survivors. J. Nutr. 133: 3785S-3793 [Abstract] [Full Text]  
• (2003). OTHER ARTICLES NOTED (25 Apr 2003 to 18 Jul 2003). Evid. Based Nurs. 6: e1-12 [Full Text]  
• Cauley, J. A., Robbins, J., Chen, Z., Cummings, S. R., Jackson, R. D., LaCroix, A. Z., LeBoff, M., Lewis, C. E., McGowan, J., Neuner, J., Pettinger, M., Stefanick, M. L., Wactawski-Wende, J., Watts, N. B. (2003). Effects of Estrogen Plus Progestin on Risk of Fracture and Bone Mineral Density: The Women's Health Initiative Randomized Trial. JAMA 290: 1729-1738 [Abstract] [Full Text]  
• Prestwood, K. M. (2003). The Search for Alternative Therapies for Menopausal Women: Estrogenic Effects of Herbs. J. Clin. Endocrinol. Metab. 88: 4075-4076 [Full Text]  
• Sheffield, J. V.L., Larson, E. B. (2003). Update in General Internal Medicine. ANN INTERN MED 139: 285-293 [Full Text]  
• Doren, M., Nilsson, J.-A., Johnell, O. (2003). Effects of specific post-menopausal hormone therapies on bone mineral density in post-menopausal women: a meta-analysis. Hum Reprod 18: 1737-1746 [Abstract] [Full Text]  
• (2003). Combination HRT Continues to Come Up Empty. Journal Watch Cardiology 2003: 1-1 [Full Text]  
• Chlebowski, R. T., Hendrix, S. L., Langer, R. D., Stefanick, M. L., Gass, M., Lane, D., Rodabough, R. J., Gilligan, M. A., Cyr, M. G., Thomson, C. A., Khandekar, J., Petrovitch, H., McTiernan, A. (2003). Influence of Estrogen Plus Progestin on Breast Cancer and Mammography in Healthy Postmenopausal Women: The Women's Health Initiative Randomized Trial. JAMA 289: 3243-3253 [Abstract] [Full Text]  
• (2003). Does Estrogen/Progestin Therapy Improve Quality of Life?. Journal Watch Dermatology 2003: 12-12 [Full Text]  
• Yaffe, K. (2003). Hormone Therapy and the Brain: Deja Vu All Over Again?. JAMA 289: 2717-2719 [Full Text]  
• (2003). WOMEN'S HEALTH INITIATIVE UPDATE: Health-Related Quality of Life. JWatch Women's Health 2003: 1-1 [Full Text]  
• (2003). Does Estrogen/Progestin Therapy Improve Quality of Life?. JWatch General 2003: 1-1 [Full Text]