Tara Haelle

October 27, 2017

PHILADELPHIA — Misperceptions about data from the Women's Health Initiative and the use of hormone therapy in menopausal women continue to perplex clinicians, results from a new study show.

Despite the publication of 18-year follow-up data, which confirmed the 2007 findings on the safety and effectiveness of hormone therapy in younger women, clinicians still have knowledge gaps that require education, said lead researcher JoAnn Pinkerton, MD, from the Midlife Health Center at the University of Virginia in Charlottesville, who is executive director of the North American Menopause Society (NAMS).

"When the initial Women's Health Initiative study came out in 2002, the message was so negative and so strong that it affected both clinicians and women and instilled fears of heart disease, dementia, breast cancer, stroke, and heart attacks," Dr Pinkerton told Medscape Medical News.

Over the next 15 years, subsequent data clearly revealed how small the risks are for healthy menopausal women, but it's harder to get that message out, she said.

It's easier to get out a message of fear than of hope.

"It's easier to get out a message of fear than of hope," Dr Pinkerton explained. But the good news is that "this is safe, it's effective, women can use it, and we have newer options for women."

During a continuing medical education program conducted by Dr Pinkerton and her colleagues from July 2016 to March 2017, clinicians watched a 30-minute interview in which an expert explained the published Women's Health Initiative data.

Of the 34,501 program participants, 1087 completed pre- and post-tests to assess their understanding of the data and the appropriate use of hormone therapy for postmenopausal women.

Dr Pinkerton presented results for just obstetricians and gynecologists, and nurse practitioners and physician assistants who work in an ob/gyn setting here at the NAMS 2017 Annual Meeting.

Table. Average Scores of Professionals Working in an Ob/Gyn Setting

Healthcare Professional Pretest, % Post-test, %
Overall score
Physicians 57 70
Nurse practitioners 49 68
Physician assistants 52 70
Questions about new menopausal medications
Physicians 39 58
Nurse practitioners 36 62
Physician assistants 50 77
Questions about appropriate application of clinical guidelines
Physicians 81 92
Nurse practitioners 84 88
Physician assistants 70 97

 

"When we did our educational program, we thought that everyone knows these data anyway, so I was very surprised to see in the pretest how many wrong perceptions clinicians had," Dr Pinkerton told Medscape Medical News.

"And we are very pleased that we were able to improve that," she added.

The researchers identified misconceptions about the primary objectives of the Women's Health Initiative trials and the difference in outcomes between estrogen alone and estrogen plus progestin.

Understanding Estrogen and Progestin

After the program, participants understood that the initial results had not been stratified by age or time since menopause, and that significant differences became evident in later analyses that looked at when women began hormone therapy.

"It was very frustrating to realize that people didn't understand there's a difference between estrogen only or estrogen with the synthetic progestin, or that age matters, or that there were new formulations out there," said Dr Pinkerton.

"We came away from the educational program realizing that we have a lot of education yet to do, not only for women, but also for clinicians who take care of women," she explained.

"We had a 10-year period in which many women were not interested in hormone therapy. They were frightened of it and providers were frightened to prescribe it," she told Medscape Medical News. "During that time, a lot of educational opportunities were lost. It's really like we're starting over."

The researchers were particularly surprised that pre- and post-test results were not higher among the physicians.

"Improvements were seen in some key areas, but our data suggest that there remains uncertainty about HT risks, differences between findings for estrogen alone or with progestin, the interpretation of follow-up studies and the benefits and risks of newer menopausal medications," the researchers conclude. "Future educational interventions are warranted to reinforce the appropriate treatment of symptomatic menopausal women according to the 2017 NAMS hormone therapy position statement."

The negative ramifications of so many years of misinformation have been substantial, said Mache Seibel, MD, a menopause expert and resident trainer at the Beth Israel Deaconess Medical Center in Boston.

There is a generation of women from 2002 to 2017 who have purposely avoided hormone therapy as a result of misinformation.

"There is a generation of women from 2002 to 2017 who have purposely avoided hormone therapy as a result of misinformation," Dr Seibel told Medscape Medical News.

"That's deprived them of the most effective treatment available for the alleviation of menopause symptoms and for reduced risk from chronic diseases, including heart disease, osteoporosis, and type 2 diabetes," he explained. "It's affected women's ability to work, it's affected their relationships with intimate partners because of loss of libido, and it's subjected them to an increased risk of chronic illness — all because of misinformation and fear of estrogen."

Media Perpetuated Fear

The media played a substantial role in perpetuating that fear, said James Simon, MD, from Women's Health & Research Consultants and the George Washington University School of Medicine in Washington, DC.

The "ammunition" needed to break down the barriers of misunderstanding about hormone therapy has been available since the study's publication in 2002, he told Medscape Medical News.

However, he pointed out, because of the presentation of the results and negative amplification in the press, "the ammunition was not readily available to practitioners, particularly those who take care of younger women, the women most likely to use hormone therapy for the symptomatic relief of hot flashes and sleep disturbances and vaginal symptomatology."

Dr Simon said he hopes the 18-year follow-up data will lead to "a more evidence-based use of hormones, which are clearly safe and beneficial in younger women, and clearly detrimental and not safe in women who take them 10 or more years since their menopause."

The hard thing about this is that the data keep evolving, so what we think we know is not always what's really true.

Part of the challenge is recognizing that scientific information is always incomplete, said Karen Adams, MD, from Oregon Health & Sciences University in Portland.

"We all have to be advocates for our patients. The hard thing about this is that the data keep evolving, so what we think we know is not always what's really true," she told Medscape Medical News. "We have to have some humility about this and not assume that we have every answer."

People are suffering who could be helped with hormone therapy. "We have to communicate the science to women in a way that helps us decide together what's best, and not discount their suffering," she noted.

Dr Pinkerton said she hopes that a better understanding of the Women's Health Initiative data will put a dent in the non-evidence-based belief that compounded formulations not approved by the US Food and Drug Administration (FDA) are safe, particularly because those compounded therapies often contain hormones, but are unregulated.

"Every woman who gets an estrogen product receives a boxed warning based on the Women's Health Initiative, but if you get a compounded product, there is no label that gives you the potential risks," she said. "Women mistakenly think they are safe, but there are some unique risks."

Women have many more options today for FDA-approved hormone therapy than they did 2 decades ago, including products with lower doses, she said.

"Much less synthetic estrogen is used today, and micronized progesterone is available as an approved product," Dr Pinkerton told Medscape Medical News.

"And there are many transdermal estradiol products that are now FDA-approved and available, so women interested in bioidentical estrogen can get it as a patch, a spray, a ring, and so on," she added.

This research was funded by Pfizer. Dr Pinkerton reports receiving research funds through the University of Virginia from TherapeuticsMD for clinical research. Dr Seibel and Dr Adams have disclosed no relevant financial relationships. Dr Simon reports received consulting, advising, speaking, and research funds from a wide range of pharmaceutical and industry sources, and owns stock in Sermonix Pharmaceuticals.

North American Menopause Society (NAMS) 2017 Annual Meeting: Abstract P-52. Presented October 11, 2017.

Follow Medscape Ob/Gyn on Twitter @MedscapeObGyn and Tara Haelle @tarahaelle

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