Ten years after the WHI, the IMS calls for NIH to revise recommendations on hormone replacement therapy (HRT)

10 years since the first press conference from the Women’s Health Initiative (WHI) study, a large randomised controlled trial on HRT, funded by the National Institutes of Health (NIH) in the USA. The presentation of these initial results caused a dramatic drop in the use of HRT throughout the world.

The presentation and interpretation of the WHI data was heavily criticised by many in the menopause community. Over the last 10 years, this data has continued to be re-evaluated, and the negative interpretation of several of the initial conclusions are now open to question. The International Menopause Society (IMS) believes that the NIH has been guilty of unbalanced reporting in failing to inform women about the latest information. The IMS calls on the WHI and the NIH to revise its advice to reflect current consensus – not just the initial WHI results.

The IMS points out that all drugs have risks and benefits. The NIH and WHI were very prominent in calling attention to the risks of HRT when the first results came out. However, as the WHI has continued to re-evaluate the results, some of their interpretations of the data have changed.

· For example, in 2002 the initial WHI findings failed to point out that HRT initiated near menopause or before the age of 60 years, pose very little risk compared to HRT initiated later in life. This is very relevant as the majority of women initiating HRT will do so in this window of opportunity before the age of 60 years. Many WHI researchers now accept that there are age-related effects.

· The WHI has also failed to emphasise the later findings that estrogen alone therapy, as given to women who have had a hysterectomy, actually decreases the risk of breast cancer.

These are just two examples of the how opinions have changed over the last 10 years.

IMS President Dr Tobie de Villiers said:

“Of course there are still differences between what the WHI thinks and what the menopause community thinks, but I think it is fair to say that in many ways the WHI has moved more towards our position over the last 10 years. In spite of this, they have not been particularly even-handed in presenting results. For example, the main NIH patient brochure on HRT has not been updated in the last 7 years*, in spite of a wealth of new information. The WHI was a billion dollar project, and the NIH has an obligation to present a balanced opinion of the results. The least that they can do is to agree that HRT is a good option for symptom relief for most women going through the menopause. The IMS and in fact the whole menopause community, will be very happy to work with the NIH to provide a balanced review of the evidence”.