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INTERNATIONAL MENOPAUSE SOCIETY

HRT in the early menopause:
Scientific evidence and common perceptions

Summary of the First IMS Global Summit on menopause-related issues
March 29–30, 2008

A. Pines, D. W. Sturdee, M. H. Birkhäuser, T. de Villiers, F. Naftolin, A. Gompel, R. Farmer, D. Barlow, D. Tan, P. Maki, R. Lobo and H. Hodis, et al. on behalf of the International Menopause Society

INTRODUCTION
Hormone replacement therapy (HRT) remains the first-line and most effective treatment for menopausal symptoms. But, despite massive, good-quality clinical outcome data on efficacy and safety when HRT is begun for symptoms in the early postmenopause, many physicians and lay people believe that hormones are risky and undesired even in the most appropriate case scenarios. Many misconceptions and misperceptions play roles in this complicated situation: some are purely scientific, others are cultural or social. The importance of the media and internet as effective, but unmonitored, means for dissemination of information, interpretation and recommendations cannot be ignored. Actual scientific facts and data have become trivialized in the mass media, often receiving less editorial scrutiny than normal journalism. Furthermore, many HRT prescribers and users do not attempt to broaden their knowledge on menopause and its treatment beyond capturing headlines or short commentaries, often produced by unqualified or prejudiced sources or unprofessional people. As a result, a gap has formed between the actual clinical evidence and the way it is perceived by all concerned.

The results of the Women’s Health Initiative (WHI), a very large, government-sponsored study of hormone treatment regardless of indications (in contradistinction to normal practice that is based on clinical symptoms and signs), were prematurely released before the study was completed and before the results could be properly evaluated. As a result, the results were over-interpreted and negatively slanted. It was viewed as a negative study by its investigators and failed to emphasize the data, which pointed at the vast importance of age and time since menopause as major determinants of the benefit–risk equilibrium of HRT and the many benefits from timely employment of HRT. This was a catalyst for negative sentiments toward HRT. By the time that more detailed analyses from the WHI study could be published in the past 2 years, much ground was lost for all concerned and much remains to be set right for patients and caregivers, alike. At present, it is clear that the WHI showed that properly timed HRT is safe for healthy women in their early postmenopause and has major preventative effects against fractures. It reduces mortality and this may be, in large part, due to prevention of heart disease.

The premature evaluation of the WHI includes statements and warnings from many health authorities, such as the US Preventive Services Task Force (USPSTF) and the European Agency for the Evaluation of Medicinal Products (EMEA) that sent a message that still prevails: the use of HRT is dangerous and therefore should be avoided, unless there is a substantial reduction in quality of life because of menopausal symptoms, in which case treatment should be given for the shortest possible duration. This seems untenable in light of the presently available data, the opinion of skilled and experienced health professionals, and even some of the WHI investigators themselves. The aim of the International Menopause Society (IMS) in developing the Zürich Summit was to openly discuss and better understand the current situation in various areas of the globe.

The knowledge and perspectives of scientists, consumers and the media were sought to recommend ways to narrow the gap between the evidence and its perception by health professionals and the lay public. The forum, which included experts from the various fields of menopause medicine and representatives of 40 national and regional menopause societies, agreed that the following summary of the scientific data will be addressed as the ‘Evidence’.

Each statement will quote its scientific level of evidence, and a list of the corresponding references is attached at the end of the document. Level A evidence refers to data from randomized controlled trials, whereas Level B evidence comes from case– control/observational studies. As pointed out in the Summit’s title, the focus of discussions was the effects of HRT first administered during the early postmenopausal period.

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