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Transdermal and oral hormone replacement therapy and the risk of stroke: a nested case-control study

BMJ 2010; 340 doi: (Published 04 June 2010) Cite this as: BMJ 2010;340:c2519

Generalization of data is wrong

The preliminary results of the Women's Health Initiative (WHI) back
in July 2002 warned of severe adverse events which were associated with
postmenopausal hormone therapy (HT)(1). As a consequence, the prescription
policies of HT changed dramatically, and the number of women using HT was
more than halved. The new paradigm was "use HT only if there are severe
menopausal symptoms, for the shortest duration". However, with more data
coming from the WHI trial in the past 8 years, as well as data from other
studies, it became clear that generalization of the WHI study conclusions
to all hormone users was wrong. HT cannot be regarded as a single entity:
the age at initiation of therapy, the dosage, the route of administration
and the exact type of estrogen and progestogen are all important factors
in determining its benefits and risks. It is time to realize that the WHI
study was not designed to investigate the effects of HT in recently
menopausal women, the typical hormone consumers. WHI participants were
relatively old and used a specific oral hormonal product at a standard
dose, but different results were obtained with other populations or
hormonal protocols. The study of Renoux et al (2) is a very good example
since it demonstrated that unlike oral preparations, transdermal HT was
not associated with an increased risk for stroke. Therefore, the
perception that HT is unsafe and should be avoided seems wrong.
Symptomatic women should not be denied of this treatment when needed, and
clinical decisions on HT should be based on individual assessment. Current
guidelines and statements on HT point at the high efficacy and a good
safety profile of HT, especially in healthy, first time users, young
postmenopausal women (3,4).

Amos Pines, MD
The International Menopause Society

1. Rossouw JE, Anderson GL, Prentice RL, 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
2. Renoux C, Dell’Aniello S, Garbe E, Suissa S. Transdermal and oral
hormone replacement therapy and the risk of stroke: a nested case-control
study. BMJ 2010; 340: c2519
3. Pines A, Sturdee DW, Birkhäuser MH, et al. IMS updated recommendations
on postmenopausal hormone therapy. Climacteric 2007;10:181-94
4. North American Menopause Society. Estrogen and progestogen use in
postmenopausal women: 2010 position statement of The North American
Menopause Society.
Menopause 2010;17:242-55.

Competing interests:
None declared

Competing interests: No competing interests

06 June 2010
Amos Pines
menopause specialist
Dept. Med