I have had the pleasure of chatting to Teresa Isabel Dias, a Canadian pharmacist, who is doing a fabulous job educating and informing about the menopause over there, where it sounds like they are even more reluctant to talk about it than over here in the UK, if you can believe that! She recently wrote this short, concise blog post that I wanted to share with you. It explains very clearly the pitfalls of the Women’s Health Initiative trial in 2002 which caused all the problems with the prescribing of HRT that still remains a problem with some clinicians today.
Note : the odd bit of terminology is different – Canadians refer to Hormone Replacement Therapy as just Hormone Therapy and Hot flushes are hot flashes over there!
Hormone Therapy: Women’s Health Initiative (WHI) Revisited
Written by Teresa Isabel Dias, BSc Pharm, RPh, NCMP
Menopause is not a disease; it is a normal and natural physiologic event. It is the end of fertility and ovarian function and it is confirmed in retrospect—12 months after the last menstrual period (LMP). The average age of menopause in North America is 52 years old.
Hormonal fluctuations and decline start in perimenopause, the years leading up to menopause, and contribute to physical, psychological, and emotional changes.
About 80 per cent of women report vasomotor symptoms (VMS) such as hot flashes and night sweats, and other symptoms. Menopause not only impacts women, but also their partners, children, family, friends and co-workers. Hormone therapy (HT) is the most effective treatment for menopausal symptoms such as hot flashes, night sweats and vaginal dryness, so why are there so few women on HT?
The Women’s Health Initiative (WHI) Trial aimed at supporting observational data that demonstrated that estrogen alone or estrogen plus a progestin may have a preventative effect on heart disease, hip fracture and colon cancer among other conditions. The trial of the estrogen plus progestin arm was stopped early due to an increase risk of heart disease, stroke, blood clots, and breast cancer. The way the results were announced in July 2002, and the media, helped to propagate the fear that HT increased the risk of breast cancer and heart attacks without explanation of the magnitude of the risks. This was a big disservice for menopausal women. Women and healthcare providers weren’t advised properly on how to interpret the results of the trial and abandoned HT altogether.
One of my customers literally dumped her estrogen tablets in the toilet and came to see me in the pharmacy three days later with severe menopause symptoms. If I knew then what I know now, and if my scope of practice at the time had permitted, I would have renewed her prescription!
With all the emphasis on the risks of HT, the benefits of HT for the relief of VMS and the treatment of vaginal atrophy were largely ignored. The positive effects of HT on the prevention of certain diseases like osteoporosis and osteoporotic fractures, diabetes, and, in women on the estrogen plus progestin arm, colon cancer, were insufficiently acknowledged.
Not surprisingly, women’s decisions regarding HT are surrounded by anxiety and confusion and new medical graduates lack appropriate training in the management of menopausal symptoms and HT. Many menopausal women are untreated, some are undertreated, and too many suffer needlessly.
Lessons learned from the WHI trials:
- Women in the WHI Trials ranged in age from 50-79 years old, with only 33 per cent being between the ages of 50 and 59— the decade when most women experience and need relief for menopause symptoms. It is easy to understand that the body and health of a 50-year-old woman is different from that of a 79-year-old woman, as older persons have a higher risk for age-related conditions like cardiovascular disease (CVD).
- The WHI was designed to assess the effect of HT for prevention of CVD, not to study outcomes in menopausal women. Nowadays HT is recommended for the treatment of menopause symptoms like VMS, Genitourinary Syndrome of Menopause (GSM), and to prevent bone loss and fracture in women under 60 years old who are within ten years of menopause onset.
- It’s important to understand increased risk and to put it into perspective: the estrogen-alone arm of the WHI reported an overall reduction of breast cancer incidence; the estrogen plus progestin arm reported an increased risk of breast cancer after five or more years of continuous therapy and in less than one woman per 1000. This is a lower risk than obesity or drinking more than two alcoholic drinks per day.
- In the WHI, women were taking 0.625 mg/day of conjugated equine estrogens combined with 2.5 mg/day of medroxyprogesterone acetate orally. There are other routes of administration (topical, vaginal, transdermal) and other hormones (estradiol and progesterone which are identical in structure to hormones produced within the body), which may have a better safety profile, but lack of trials prevents us from assuming so.
In summary, hormone therapy is an acceptable option for women younger than 60 years of age, who are healthy, within ten years of their last menstrual period and who experience bothersome menopausal symptoms. A woman’s quality of life, priorities, personal health risks (blood clots, stroke, heart disease, breast cancer), preferences and values should be taken into consideration. Therapy individualization and monitoring are paramount.
HRT : the benefits out way the risks
BMS summary of WHI 2002 : https://thebms.org.uk/2006/04/hrt-womens-health-initiative-the-final-outcome/