Safety of Hormone Replacement Therapy

A Review

 

Raquel Lucas

Serviço de Higiene e Epidemiologia, Faculdade de Medicina da Universidade do Porto

 

Abstract

The recent publication of a number of large observational and experimental studies that assessed the safety of hormone replacement therapy (HRT) raised a generalised debate. These studies were conducted during a period of clear and rapid expansion of HRT in almost every country, and provided alarming associations between this therapy and several frequent chronic diseases. Subsequently to these findings, a substantial drop in the volume of prescriptions was observed internationally. However, many of the findings of these studies had already been suggested previously. Moreover, a number of methodological issues concerning the recent studies was raised and the validity of their associations questioned. The current absence of clear-cut guidelines on the use of HRT is probably a consequence of the conflicting evidence. In the Portuguese population this may partially account for the notorious lack of association between this therapy and hysterectomy or oophorectomy. Additionally, although sales data seemed to indicate an increasing trend in the prevalence of HRT up to 2002, the uptake of HRT was then a privilege of women in higher socioeconomic strata. Presently, the contribution of long-term hormone replacement therapy to women’s health remains unclear and this subject increasingly demands a multidisciplinary approach.

Key-words: hormone replacement therapy; medicine safety; research design; review.

 

Segurança da Terapêutica Hormonal de Substituição

Resumo

Nos últimos anos, a publicação dos resultados de estudos observacionais e experimentais que avaliaram a segurança da terapêutica hormonal de substituição (THS) ocasionou um debate generalizado. Estes estudos indicaram associações alarmantes entre esta terapêutica e algumas doenças de elevada frequência e foram realizados durante um período de grande expansão da THS na maioria dos países. Como consequência, observou-se uma descida pronunciada no volume de prescições de THS a nível internacional. No entanto, uma grande parte dos resultados destes estudos tinha já sido sugerida anteriormente. Adicionalmente, alguns dos seus aspectos metodológicos foram criticados, com as consequentes dúvidas respeitantes à validade das associações encontradas. A actual inexistência de orientações técnicas sobre o uso de THS é provavelmente uma consequência da evidência contraditória. Daí poderá também resultar a ausência de associação encontrada na população portuguesa entre esta terapêutica e a histerectomia ou a ooforectomia. Antes, a THS, cujo volume de vendas vinha aumentando até 2002, era um privilégio das mulheres de estratos socio-económicos elevados. Presentemente, o papel da terapêutica hormonal de substituição a longo prazo na saúde da mulher permanece incerto, constituindo um tema que cada vez mais exige uma abordagem multidisciplinar.

Palavras-chave: terapêutica hormonal de substituição; segurança de medicamentos; desenho de estudo; revisão.

 

 

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Correspondência:

Dr.ª Raquel Lucas

Serviço de Higiene e Epidemiologia

Faculdade de Medicina da Universidade do Porto

Alameda Prof. Hernâni Monteiro

4200-319 Porto

e-mail: rlucas@med.up.pt