The Discrepancy between Observational Studies and Randomized Trials of Menopausal Hormone Therapy: Did Expectations Shape Experience?

Annals of Internal Medicine

Volumn 139, Issue 11, 2003, Pages 923-929

  Col, Nananda F ^a   Pauker, Stephen G ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ESTROGEN; GESTAGEN; SEX HORMONE;

CARDIOVASCULAR RISK; CAUSE OF DEATH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY DISEASE; CORRELATION ANALYSIS; DEATH CERTIFICATE; DISEASE ASSOCIATION; FEMALE; HEART INFARCTION; HORMONAL THERAPY; HUMAN; LUNG EMBOLISM; MATHEMATICAL MODEL; MENOPAUSAL SYNDROME; META ANALYSIS; OUTCOMES RESEARCH; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; RISK FACTOR; SOCIOECONOMICS; STROKE;

EID: 1642576185     PISSN: 00034819     EISSN: None     Source Type: Journal    
DOI: 10.7326/0003-4819-139-11-200312020-00011     Document Type: Review

References (65)

1. Grady D, Rubin SM, Petitti DB, Fox CS, Black D, Ettinger B, et al. Hormone therapy, to prevent disease and prolong life in postmenopausal women. Ann Intern Med. 1992; 117:1016-37. [PMID: 1443971]
2. Grodstein F, Stampfer MJ, Manson JE, Colditz GA, Willett WC, Rosner B, et al. Postmenopausal estrogen and progestin use and the risk of cardiovascular disease. N Engl J Med. 1996;335:453-61. [PMID: 8672166]
3. Grodstein F, Stampfer M. The epidemiology of coronary heart disease and estrogen replacement in postmenopausal women. Prog Cardiovasc Dis. 1995;38: 199-210. [PMID: 7494882]
4. Hulley S, Grady D, Bush T, Furberg C, Herrington D, Riggs B, et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group. JAMA. 1998;280:605-13. [PMID: 9718051]
5. Petitti DB. Hormone replacement therapy and heart disease prevention: experimentation trumps observation [Editorial]. JAMA. 1998;280:650-2. [PMID: 9718060]
6. Sturgeon SR, Schairer C, Brinton LA, Pearson T, Hoover RN. Evidence of a healthy estrogen user survivor effect. Epidemiology. 1995;6:227-31. [PMID: 7619927]
7. Posthuma WF, Westendorp RG, Vandenbroucke JP. Cardioprotective effect of hormone replacement therapy in postmenopausal women: is the evidence biased? BMJ. 1994;308:1268-9. [PMID: 8205018]
8. Grodstein F. Invited commentary: can selection bias explain the cardiovascular benefits of estrogen replacement therapy? Am J Epidemiol. 1996; 143:979-82; discussion 983-4. [PMID: 8629616]
9. Matthews KA, Kuller LH, Wing RR, Meilahn EN, Plantinga P. Prior to use of estrogen replacement therapy, are users healthier than nonusers? Am J Epidemiol. 1996;143:971-8. [PMID: 8629615]
10. Barrett-Connor E. Postmenopausal estrogen and prevention bias. Ann Intern Med. 1991;115:455-6. [PMID: 1872493]
11. Cauley JA, Cummings SR, Black DM, Mascioli SR, Seeley DG. Prevalence and determinants of estrogen replacement therapy in elderly women. Am J Obstet Gynecol. 1990;163:1438-44. [PMID: 2240084]
12. Adler NE, Boyce WT, Chesney MA, Folkman S, Syme SL. Socioeconomic inequalities in health. No easy solution. JAMA. 1993;269:3140-5. [PMID: 8505817]
13. Humphrey LL, Chan BK, Sox HC. Postmenopausal hormone replacement therapy and the primary prevention of cardiovascular disease. Ann Intern Med. 2002;137:273-84. [PMID: 12186518]
14. Influence of adherence to treatment and response of cholesterol on mortality in the coronary drug project. N Engl J Med. 1980;303:1038-41. [PMID: 6999345]
15. Horwitz RI, Viscoli CM, Berkman L, Donaldson RM, Horwitz SM, Murray CJ, et al. Treatment adherence and risk of death after a myocardial infarction. Lancet. 1990;336:542-5. [PMID: 1975045]
16. Grodstein F, Manson JE, Colditz GA, Willett WC, Speizer FE, Stampfer MJ. A prospective, observational study of postmenopausal hormone therapy and primary prevention of cardiovascular disease. Ann Intern Med. 2000;133:933-41. [PMID: 11119394]
17. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288:321-33. [PMID: 12117397]
18. Wassertheil-Smoller S, Hendrix SL, Limacher M, Heiss G, Kooperberg C, Baird A, et al. Effect of estrogen plus progestin on stroke in postmenopausal women: the Women's Health Initiative: a randomized trial. JAMA. 2003;289: 2673-84. [PMID: 12771114]
19. Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991;121:293-8. [PMID: 1985385]
20. Sacco RL, Wolf PA, Gorelick PB. Risk factors and their management for stroke prevention: outlook for 1999 and beyond. Neurology. 1999;53: S15-24. [PMID: 10532644]
21. Cholesterol, diastolic blood pressure, and stroke: 13,000 strokes in 450,000 people in 45 prospective cohorts. Prospective studies collaboration. Lancet. 1995; 346:1647-53. [PMID: 8551820]
22. Prandoni P, Bilora F, Marchiori A, Bernardi E, Petrobelli F, Lensing AW, et al. An association between atherosclerosis and venous thrombosis. N Engl J Med. 2003;348:1435-41. [PMID: 12686699]
23. Wagner KR, Elmore JG, Horwitz RI. Diagnostic bias in clinical decision making: an example of L-tryptophan and the diagnosis of eosinophilia-myalgia syndrome. J Rheumatol. 1996;23:2079-85. [PMID: 8970044]
24. Sartwell PE, Masi AT, Arthes FG, Greene GR, Smith HE. Thromboembolism and oral contraceptives: an epidemiologic case-control study. Am J Epidemiol. 1969;90:365-80. [PMID 5395236]
25. Schlesselman JJ, Stadel BV, Korper M, Yu W, Wingo PA. Breast cancer detection in relation to oral contraception. J Clin Epidemiol. 1992;45:449-59. [PMID: 1588351]
26. Tunstall-Pedoe H. Uses of coronary heart attack registers. Br Heart J. 1978; 40:510-5. [PMID: 656216]
27. Tunstall-Pedoe H. Perspectives on trends in mortality and case fatality from coronary heart attacks: the need for abetter definition ofacute myocardial infarction [Editorial]. Heart. 1998;80:112-3. [PMID: 9813552]
28. Kannel WB, Cupples LA, Gagnon DR. Incidence, precursors and prognosis of unrecognized myocardial infarction. Adv Cardiol. 1990;37:202-14. [PMID: 2220449]
29. Lindberg HA, Berkson DM, Stamler J, Poindexter A. Totally asymptomatic myocardial infarction: an estimate of its incidence in the living population. Arch Intern Med. 1960;106:628-33. [PMID: 13762265]
30. Sheifer SE, Manolio TA, Gersh BJ. Unrecognized myocardial infarction. Aun Intern Med. 2001;135:801-11. [PMID: 11694105]
31. Goldberg RJ, O'Donnell C, Yarzebski J, Bigelow C, Savageau J, Gore JM. Sex differences in symptom presentation associated with acute myocardial infarction: a population-based perspective. Am Heart J. 1998;136:189-95. [PMID: 9704678]
32. Wenger NK. Gender, coronary artery disease, and coronary bypass surgery [Editorial]. Ann Intern Med. 1990;112:557-8. [PMID: 2327674]
33. Peterson ED, Alexander KP. Learning to suspect the unexpected: evaluating women with cardiac syndromes [Editorial]. Am Heart J. 1998;136:186-8. [PMID: 9704677]
34. Kannel WB, Sorlie P, McNamara PM. Prognosis after initial myocardial infarction: the Framingham study. Am J Cardiol. 1979;44:53-9. [PMID: 453046]
35. Gender disparities in clinical decision making. Council on Ethical and Judicial Affairs, American Medical Association. JAMA. 1991;266:559-62. [PMID: 1843800]
36. Healy B. The Yentl syndrome [Editorial]. N Engl J Med. 1991;325:274-6. [PMID: 2057027]
37. Wilson PW, Garrison RJ, Castelli WP. Postmenopausal estrogen use, cigarette smoking, and cardiovascular morbidity in women over 50. The Framingham Study. N Engl J Med. 1985;313:1038-43. [PMID: 2995808]
38. Tunstall-Pedoe H, Morrison C, Woodward M, Fitzpatrick B, Watt G. Sex differences in myocardial infarction and coronary deaths in the Scottish MONICA population of Glasgow 1985 to 1991. Presentation; diagnosis, treatment, and 28-day case fatality of 3991 events in men and 1551 events in women. Circulation. 1996;93:1981-92. [PMID: 8640972]
39. Stampfer MJ, Willett WC, Colditz GA, Rosner B, Speizer FE, Hennekens CH. A prospective study of postmenopausal estrogen therapy and coronary heart disease. N Engl J Med. 1985;313:1044-9. [PMID: 4047106]
40. The coronary drug project. Design, methods, and vaseline results. Circulation. 1973;47(3 Suppl):I1-50. [PMID: 4570454]
41. The Coronary Drug Project. Findings leading to discontinuation of the 2.5-mg day estrogen group. The coronary Drug Project Research Group. JAMA. 1973;226:652-7. [PMID: 4356847]
42. Campisi R, Nathan L, Pampaloni MH, Schoder H, Sayre JW, Chaudhuri G, Schelbert HR. Noninvasive assessment of coronary microcirculatory function in postmenopausal women and effects of short-term and long-term estrogen administration. Circulation. 2002;105:425-30. [PMID: 11815423]
43. Kessler KM. Postmenopausal hormone therapy and cardiovascular disease. Ann Intern Med. 2001;135:1092-3; author reply 1093-4. [PMID: 11747398]
44. 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. JAMA. 1995;273: 199-208. [PMID: 7807658]
45. Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. N Engl J Med. 2000;342:1878-86. [PMID: 10861324]
46. Grodstein F. Invited commentary: can selection bias explain the cardiovascular benefits of estrogen replacement therapy? Am J Epidemiol. 1996;143:979-82; discussion 983-4. [PMID: 8629616]
47. Kaptchuk TJ. The placebo effect in alternative medicine: can the performance of a healing ritual have clinical significance? Ann Intern Med. 2002;136: 817-25. [PMID: 12044130]
48. Luparello TJ, Leist N, Lourie CH, Sweet P. The interaction of psychologic stimuli and pharmacologic agents on airway reactivity in asthmatic subjects. Psychosom Med. 1970;32:509-13. [PMID: 4097491]
49. Butler C, Steptoe A. Placebo responses: an experimental study of psychophysiological processes in asthmatic volunteers. Br J Clin Psychol. 1986;25 (Pt 3):173-83. [PMID: 3768575]
50. Sternbach RA. The effects of instructional sets on autonomic responsivity. Psychophysiology. 1964;62:67-72. [PMID: 14201846]
51. Flaten MA, Simonsen T, Olsen H. Drug-related information generates placebo and nocebo responses that modify the drug response. Psychosom Med. 1999;61:250-5. [PMID: 10204979]
52. Campbell S, Whitehead M. Oestrogen therapy and the menopausal syndrome. Clin Obstet Gynaecol. 1977;4:31-47. [PMID: 322905]
53. Girdler SS, O'Briant C, Steege J, Grewen K, Light KC. A comparison of the effect of estrogen with or without progesterone on mood and physical symptoms in postmenopausal women. J Womens Health Gend Based Med. 1999;8:637-46. [PMID: 10839650]
54. Simon JA, Stevens RE, Ayres SA, Phelps KV. Perimenopausal women in estrogen vasomotor trials: contribution to placebo effect and efficacy outcome. Climacteric. 2001;4:19-27. [PMID: 11379374]
55. Hróbjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med. 2001;344: 1594-602. [PMID: 11372012]
56. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273:408-12. [PMID: 7823387]
57. Jónsdóttir LS, Sigfusson N, Sigvaldason H, Thorgeirsson G. Incidence and prevalence of recognised and unrecognised myocardial infarction in women. The Reykjavik Study. Eur Heart J. 1998; 19:1011-8. [PMID: 9717035]
58. Sheifer SE, Gersh BJ, Yanez ND 3rd, Ades PA, Burke GL, Manolío TA. Prevalence, predisposing factors, and prognosis of clinically unrecognized myocardial infarction in the elderly. J Am Coll Cardiol. 2000;35:119-26. [PMID: 10636269]
59. Nadelmann J, Frishman WH, Ooi WL, Tepper D, Greenberg S, Guzik H, et al. Prevalence, incidence and prognosis of recognized and unrecognized myocardial infarction in persons aged 75 years or older: The Bronx Aging Study. Am J Cardiol. 1990;66:533-7. [PMID: 2392974]
60. Yano K, MacLean CJ. The incidence and prognosis of unrecognized myocardial infarction in the Honolulu, Hawaii, Heart Program. Arch Intern Med. 1989;149:1528-32. [PMID: 2742427]
61. Grimm RH Jr, Tillinghast S, Daniels K, Neaton JD, Mascioli S, Crow R, et al. Unrecognized myocardial infarction: experience in the Multiple Risk Factor Intervention Trial (MRFIT). Circulation. 1987;75:116-8. [PMID: 3815790]
62. Rosenman RH, Friedman M, Jenkins CD, Straus R, Wurm M, Kositchek R. Clinically unrecognized myocardial infarction in the Western Collaborative Group Study. Am J Cardiol. 1967; 19:776-82. [PMID: 6026145]
63. Sourander L, Rajala T, Räihä I, Mäkinen J, Erkkola R, Helènius H. Cardiovascular and cancer morbidity and mortality and sudden cardiac death in postmenopausal women on oestrogen replacement therapy (ERT). Lancet. 1998; 352:1965-9. [PMID: 9872245]
64. Sidney S, Petitti DB, Quesenberry CP Jr. Myocardial infarction and the use of estrogen and estrogen-progestogen in postmenopausal women. Ann Intern Med. 1997;127:501-8. [PMID: 9313017]
65. Rosenberg L, Palmer JR, Shapiro S. A case-control study of myocardial infarction in relation to use of estrogen supplements. Am J Epidemiol. 1993;137: 54-63. [PMID: 8434573]