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Hormone therapy with oestrogen or oestrogen plus progesterone does not reduce the risk of dementia or mild cognitive impairment in older postmenopausal women
ARTICLE IN PRESS Evidence-Based Healthcare & Public Health (2004) 8, 396–397
www.elsevier.com/locate/ebhph
EVIDENCE-BASED CLINICAL PRACTICE
Hormone therapy with oestrogen or oestrogen plus progesterone does not reduce the risk of dementia or mild cognitive impairment in older postmenopausal women$
KEYWORDS HRT; Postmenopausal women; Oestrogen; Progesterone; Dementia; Cognitive function; Alzheimer’s disease; Randomised controlled trial.
Summary Question What is the effect of hormone therapy with oestrogen or oestrogen plus progesterone on dementia and mild cognitive impairment in older postmenopausal women? Study design
Pooled results of two randomised controlled trials.
Main results Hormone therapy with oestrogen or oestrogen plus progesterone increased the risk of dementia compared with placebo (68% with hormone treatment v 40% with placebo; HR 1.76, 95% CI 1.19 to 2.60). Hormone therapy with oestrogen or oestrogen and progesterone did not significantly increase the risk of mild cognitive impairment compared with placebo (HR 1.25, 95% CI 0.97 to 1.60). Authors’ conclusions Oestrogen, or oestrogen plus progesterone, does not reduce the risk of dementia or mild cognitive impairment in postmenopausal women aged 65 or older. & 2004 Published by Elsevier Ltd.
Further details Question What is the effect of hormone therapy with oestrogen or oestrogen plus progesterone on dementia and mild cognitive impairment in older postmenopausal women?
Study design Pooled results from two randomised controlled trials. $ Abstracted from: Shumaker SA, Legault C, Kuller L et al. Conjugated equine oestrogens and incidence of probable dementia and mild cognitive impairment in postmenopausal women: Women’s Health Initiative Memory Study. JAMA 2004; 291: 2947–2958.
1744-2249/$ - see front matter & 2004 Published by Elsevier Ltd. doi:10.1016/j.ehbc.2004.09.032
ARTICLE IN PRESS EVIDENCE-BASED CLINICAL PRACTICE
397
Setting 39 Academic centers, USA. WHI trial from June 1995 to July 2002; WHIMS trial from June 1995 to February 2004.
Participants Women’s Health Initiative (WHI) study: 4532 Post menopausal women. Participants of the oestrogen-only trial were aged between 50 and 79 years old and had previously had a hysterectomy. Women’s Health Initiative Memory Study (WHIMS) study: 2947 post menopausal women aged between 65 and 79 years old, who had previously had a hysterectomy and who were free of dementia (as determined by the WHIMS protocol). Women who had mild cognitive impairment (MCI) at baseline were excluded.
Intervention WHI study: hormone therapy (0.625 mg conjugated equine oestrogen daily plus medroxyprogesterone acetate 2.5 mg daily), or placebo. WHIMS study: hormone therapy (0.625mg conjugated equine oestrogen daily) or placebo. The interventions involved 4 phases; in phase 1 cognitive function was measured with the Modified Mini-Mental state Examination (3MSE). Women scoring r72 (for those with r8 years of formal education) or r76 (for those with Z9 years of education) continued to phase 2. Phase 2 involved neurological tests (based on a modified Consortium to Establish a Registry for Alzheimer’s Disease [CERAD]) and interviews with a friend or family member. In phase 3 cognitive and behavioral impairments were assessed by a specialist with experience in diagnosing dementia. Women diagnosed as having probable dementia went forward to phase 4 which involved a non-contrast computed tomography brain scan and blood tests.
Main outcomes Probable dementia: classified according to DSM-IV criteria. Mild cognitive impairment: measured with the Modified Mini-Mental state Examination (3MSE) score range 0-100, where higher scores reflect better cognitive function. Sources of funding: Wyeth Pharmaceuticals and Wake Forest University Health Sciences supported the WHIMS study. The National Heart, Lung and Blood Institute of the National Institutes of Health, US Department of Health and Human Services, funded the WHI study. Abstract provided by Bazian Ltd, London
www.elsevier.com/locate/ebhph
EVIDENCE-BASED CLINICAL PRACTICE
Hormone therapy with oestrogen or oestrogen plus progesterone does not reduce the risk of dementia or mild cognitive impairment in older postmenopausal women$
KEYWORDS HRT; Postmenopausal women; Oestrogen; Progesterone; Dementia; Cognitive function; Alzheimer’s disease; Randomised controlled trial.
Summary Question What is the effect of hormone therapy with oestrogen or oestrogen plus progesterone on dementia and mild cognitive impairment in older postmenopausal women? Study design
Pooled results of two randomised controlled trials.
Main results Hormone therapy with oestrogen or oestrogen plus progesterone increased the risk of dementia compared with placebo (68% with hormone treatment v 40% with placebo; HR 1.76, 95% CI 1.19 to 2.60). Hormone therapy with oestrogen or oestrogen and progesterone did not significantly increase the risk of mild cognitive impairment compared with placebo (HR 1.25, 95% CI 0.97 to 1.60). Authors’ conclusions Oestrogen, or oestrogen plus progesterone, does not reduce the risk of dementia or mild cognitive impairment in postmenopausal women aged 65 or older. & 2004 Published by Elsevier Ltd.
Further details Question What is the effect of hormone therapy with oestrogen or oestrogen plus progesterone on dementia and mild cognitive impairment in older postmenopausal women?
Study design Pooled results from two randomised controlled trials. $ Abstracted from: Shumaker SA, Legault C, Kuller L et al. Conjugated equine oestrogens and incidence of probable dementia and mild cognitive impairment in postmenopausal women: Women’s Health Initiative Memory Study. JAMA 2004; 291: 2947–2958.
1744-2249/$ - see front matter & 2004 Published by Elsevier Ltd. doi:10.1016/j.ehbc.2004.09.032
ARTICLE IN PRESS EVIDENCE-BASED CLINICAL PRACTICE
397
Setting 39 Academic centers, USA. WHI trial from June 1995 to July 2002; WHIMS trial from June 1995 to February 2004.
Participants Women’s Health Initiative (WHI) study: 4532 Post menopausal women. Participants of the oestrogen-only trial were aged between 50 and 79 years old and had previously had a hysterectomy. Women’s Health Initiative Memory Study (WHIMS) study: 2947 post menopausal women aged between 65 and 79 years old, who had previously had a hysterectomy and who were free of dementia (as determined by the WHIMS protocol). Women who had mild cognitive impairment (MCI) at baseline were excluded.
Intervention WHI study: hormone therapy (0.625 mg conjugated equine oestrogen daily plus medroxyprogesterone acetate 2.5 mg daily), or placebo. WHIMS study: hormone therapy (0.625mg conjugated equine oestrogen daily) or placebo. The interventions involved 4 phases; in phase 1 cognitive function was measured with the Modified Mini-Mental state Examination (3MSE). Women scoring r72 (for those with r8 years of formal education) or r76 (for those with Z9 years of education) continued to phase 2. Phase 2 involved neurological tests (based on a modified Consortium to Establish a Registry for Alzheimer’s Disease [CERAD]) and interviews with a friend or family member. In phase 3 cognitive and behavioral impairments were assessed by a specialist with experience in diagnosing dementia. Women diagnosed as having probable dementia went forward to phase 4 which involved a non-contrast computed tomography brain scan and blood tests.
Main outcomes Probable dementia: classified according to DSM-IV criteria. Mild cognitive impairment: measured with the Modified Mini-Mental state Examination (3MSE) score range 0-100, where higher scores reflect better cognitive function. Sources of funding: Wyeth Pharmaceuticals and Wake Forest University Health Sciences supported the WHIMS study. The National Heart, Lung and Blood Institute of the National Institutes of Health, US Department of Health and Human Services, funded the WHI study. Abstract provided by Bazian Ltd, London