Way back in the 1970s and 80s, when I was in practice, women of a certain age were more or less routinely given some combination of estrogen and progesterone to reduce the ravages of menopause. In fact, such treatment, known as hormone replacement therapy (HRT) was sometimes given without any concern for menopausal distress, but rather to protect women from heart disease. It seemed logical that, since men developed heart and other vascular diseases a decade or more earlier than do women, enhancing women’s female hormone levels pharmaceutically would likely render them extra protection.
Mind you, there was no evidence from studies to support this approach, but until a large federal trial was released in 2002, it was standard practice to treat menopausal symptoms like sweats, hot flashes, and mood swings with HRT. Often treatment was continued for years after menopause-related problems had ceased — again, with the idea that women were being protected against heart disease with hormone therapy. Further, it was well known that such treatment helped maintain bone strength and delay osteoporosis, thin bones that can lead to fractures.
This picture changed dramatically in 2002, when the Women’s Health Initiative (WHI) study was released.
This NIH trial evaluated various outcomes among over 16,000 older women, half of whom got HRT as compared to the control group who got a placebo, over an average of 5 years. Unexpectedly, not only was there no reduction in heart problems, a slight increase was seen. And there was also a slight increase in breast cancer and vein problems in women on HRT. A decrease in bowel cancer and hip fractures was noted, on the plus side.
Women everywhere, on their own and on the advice of their doctors, stopped taking HRT: the number of prescriptions dropped by about one-half over the next few years. Since HRT was (and remains) the most effective way to reduce menopausal symptoms, many women suffered its travails with minimal relief, out of fear of HRT.
Over the course of the next 8 years of the decade, however, re-evaluation of the WHI database revealed that the initial announcements were based on inadequate information and incomplete analysis.
The main adverse outcomes — increases in heart events and breast cancer — were confined to the oldest subset of women, who had been on HRT for the longest time. Analysis of the women in the study who were actually peri-menopausal, in the age group from 50 to 55, slight reductions in those disturbing events were found.
As these new data gradually reached the medical community and the population at large, a new message became the standard of care: HRT is the most valuable method to relieve menopausal symptoms, and as long as it’s used early in menopause and for the fewest number of years needed, it’s quite safe.
Recently, two new studies have been published to add ammunition to this recommendation. In March, a group of 7,500 women, who had also been in the WHI group, was assessed at the Fred Hutchinson Cancer Center in Seattle. They were studied six years after they had been on estrogen-only HRT — only women who have had a hysterectomy can take this type of treatment, since without progesterone, estrogen can cause cancer of the uterus — and a major reduction in breast cancer incidence of 23% was found. And only 2 weeks ago, a Danish research group studied cardiovascular outcomes among over 1,000 women, half of whom had received HRT for about 11 years, as compared to the half who were given only placebo. Again, a reduction in heart problems of 50% was revealed.
There are two important lessons to be learned from the widespread misinterpretations of the WHI data: first, evaluations of such important studies should be done patiently and carefully, and not by press release or wishful thinking; and, women who suffer from moderate to severe menopausal distress need no longer fear HRT — it should be requested or prescribed based upon individual patient criteria and for the briefest period required.