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Hormone replacement therapy
1. Prof. Shad Salim Akhtar
MBBS, MD, MRCP(UK), FRCP(Edin), FACP(USA)
Consultant Medical Oncologist & Director
Hakim Sanaullah Cancer Centre
Sopore, Kashmir, J & K
2. Women value different health outcomes
differently
The decision to use HRT should be taken
jointly
All possible benefits and risks mentioned
Assess the women’s health history
Outline the possible goals
Accommodate the personal point of view
Greendale GA et al. The Menopause. Lancet 1999;353:571
5. Beneficial effects
Cardio protection
Osteoporosis prevention
Improved general quality of life
Risks
Cancer
GB disease
Thromboembolism
!!!HRT!!!!!!HRT!!!
6. Does HRT prevent osteoporosis??
Observational studies—yes
One clinical trial—yes
30%-50% decrease in fracture risk
Useful in pts prone to osteoporosis
Must be continued indefinitely
Fitzpatrick LA et al. Mayo Clin Proced 2000;75:559
7. Meta-analysis of Randomized Trials
Decreased incidence of
Non vertebral fractures—27%
Overall fractures in younger women—33%
No significant effect in older (>60 yrs)
FDA has removed osteoporosis as an indication for treatment
by conjugated equine oestrogen
Fitzpatrick LA et al. Mayo Clin Proced 2000;75:559
8. Other FDA approved agents are more
effective
10 yrs therapy is reqd to decrease risk of
fracture substantially
ERT has risks
Treatment other than ERT should be the first
chioce for osteoporsois
Grady D et al. JAMA 2001;285:2909
Grant from Organaon dgrady@itsa.ucsf.edu
10. Randomized, controlled, blinded trial
2763 women with CHD <80 yrs
1383 placebo and 1380 CHRT
Average follow up 4 yrs
Outcome
Non fatal MI
CHD death
Secondary outcomes
11. Results
No significant difference between 2 gps
More CHD events during Ist yr in HRT gp
<CHD events in yrs 4-5 in HRT gp
>Thromboembolic and GB disease in HRT gp.
Hulley S et al. JAMA 1998;280:605
12. ERA study (Estrogen replacement and
atherosclerosis trial)
Randomized double blind controlled trial
309 women
Coronary artery diameter measurement
No difference in three gps (ERT, CHRT,
Placebo)
Conclusion:
HRT should not be used with an expectation of
cardiovascular benefit
Harrington DM et al. NEJM 2000;343:522
13. Breast Cancer
Collaborative group study
52705 women with breast cancer
108411 controls
51 studies in 21 countries
53865 postmenopausal women
17830 on HRT
Median age at first use 48yrs
14. Incidence in 50-70 yrs age
Never users-----45/1000
5 yr users--------47/1000
10 yr users-------51/1000
15 yr users-------57/1000
Collaborative Group. Lancet 1997;350:1047-59
15. 46355 post menopausal women
Cohort study
2082 cases of Breast Ca diagnosed
Risk increased by
1% with each yr of use of estrogen
8% with each yr of use of CHRT
Schraiar C et al. JAMA 2000;283:485
16. 1897 Post menopausal women on HRT
1637 controls
HRT associated with 10 % increase in breast
cancer risk for each 5 year use
CHRT higher risk than ERT
Ross RK et al. J Natl Cancer Inst 2000;92:328-32
17. 211581 post menopausal women form Am
Cancer Society Cancer Prevention Study
944 Ovarian cancer deaths
Users 1.55 RR
Former users 1.16 RR
>10 yrs use 2.20 RR
Breast ca risk declines after stoppage of HRT
Increased mortality due to ovarian ca
persists even after29 yrs of use.
18. WE DO NOT KNOW
WISDOM trial
WHI trial
??? Early results positive against the useagainst the use??
19. “The idea of an anti-ageing pill in the form of ERT is
certainly attractive, but it is unlikely to be the
solution to healthy ageing in women. The huge
international variations and secular trends in
chronic disease indicate that many of these
conditions are potentially preventable and not due
to menopause per se. Japanese women who have
lowest endogenous estrogen levels, also have
greatest longevity, the lowest rates of CHD and a
low prevalence of menopausal symptoms. We
already have a good understanding of some existing
dietary and other measures we can take to improve
health. The valuable clinical uses of estrogens
should not divert attention form identifying and
acting on the major determinants of health in
women.”
BMJ editorial 1998;316:1842