Sunday, March 6, 2016

Managing Menopause: Is it time to take a second look at the Women's Health Initiative (WHI) study results?



Menopause is an important life event for a woman that signifies the end of her reproductive era and transitioning into a period of increasing health risk from cardiovascular disease, osteoporosis, and other chronic diseases.

According to a census in 1998, there were more than 477 million postmenopausal women in the world, and the number is going to rise to approximately 1.1 billion by 2015. Life expectancy for women worldwide was 65 years in 1998 which has currently increased to 73.2 years (81 years in developed countries).  With increasing life expectancy women spend one third of life in this phase of life.  

In the year 2000, there were an estimated 45.6 million postmenopausal women in the United States, out of which about 40 million were older than age 51, the average age of natural menopause in the Western world.                                    

According to a book chapter by Dr.  JoAnn E. Manson, MD, DrPH professor of medicine at Harvard Medical School and Brigham and Women's Hospital “Aging of the female reproductive system begins at 20 weeks gestation with regard to follicle atresia and proceeds as a continuum. It consists of a steady loss of oocytes from atresia or ovulation, and does not necessarily occur at a constant rate. Because of the relatively wide age range (40-58 y) for natural menopause, chronologic age is a poor indicator of the beginning or the end of the menopause transition.

This article is based on a perspective by JoAnn E. Manson, M.D., Dr.P.H., and Andrew M. Kaunitz, M.D. in March 03, 2016 edition of  The New England Journal of Medicine( NEJM).

Menopausal symptoms are well tolerated by some women, but may be very troublesome to other women. Often there is underreporting of menopausal symptoms due to cultural taboos. The attitude towards menopause varies according to culture and ethnicity, with 80% African women reporting symptoms versus very few Asian women reporting symptoms.

There has been an ongoing confusion regarding the findings of WHI study and prescription of hormonal therapy to relieve the symptoms of menopause.

The Women's Health Initiative (WHI) was launched in 1991 and consisted of a set of clinical trials and an observational study, which together involved 161,808 generally healthy postmenopausal women.
The clinical trials were designed to test the effects of postmenopausal hormone therapy, diet modification, and calcium and vitamin D supplements on heart disease, fractures, and breast and colorectal cancer. The trials were specifically designed to address questions about effect of initiating menopausal hormone therapy for the prevention of chronic disease in postmenopausal women across a broad range of ages, including many women in their 60s and 70s?

In 2002, the study results ripped the widely held belief that hormone replacement therapy protected women from heart disease and other chronic illnesses.  Instead, the Women's Health Initiative study found concluded that taking estrogen plus progestin hormone replacement therapy — HRT — actually increased a woman's risk of heart disease and breast cancer.

Within months of the results, number of women using HRT dropped by half. 

The results of the study were extrapolated to women in 40s and 50s who had severe vasomotor symptoms disrupting quality of life. In-fact, these women had trouble finding clinician who could prescribe them with HRT.  

But, studies conducted during Extended Poststopping Phases of the Women’s Health Initiative Randomized Trials when broken down according to age groups showed entirely different outcomes. Subgroup analysis stratified according to age and time since menopause onset modified the effect of HRT on some of the outcomes. The study concluded that HRT is a reasonable option for the management of moderate to severe menopausal symptoms among generally healthy women during early menopause.

In-fact, the USPSTF in its recommendation made a specific mention that “This recommendation applies only to postmenopausal women who are considering hormone therapy for the primary prevention of chronic medical conditions. This is not a recommendation about the use of hormone therapy to treat menopausal symptoms, such as hot flashes or vaginal dryness; the USPSTF did not review the evidence related to this possible indication because it falls outside of the mission and scope of the USPSTF. This recommendation also does not apply to women younger than 50 years who have had surgical menopause”.

The North American Menopause Society (NAMS), the Endocrine Society, the American College of Obstetricians and Gynecologists (ACOG) endorse the use of HRT in younger women for treating postmenopausal symptoms, who do not have specific contraindication for the therapy.

This will definitely improve the quality of life and it is quite likely that the benefit would outweigh the risks.

These organizations have many resources that help clinicians in decision making, the NAMS have a MenoPro Mobile App, which helps in personalization of treatment to individual patient and help patient in shared decision making.

The MenoPro app has several unique features, including the ability to calculate your 10-year risk of heart disease and stroke, which is important in deciding whether a treatment option is safe for you. It also has links to online tools that assess your risk of breast cancer and osteoporosis and fracture.


Photo courtesy: NAMS

Finally Dr. JoAnn E. Manson emphasized the need of training young healthcare providers to keep up with the variety of options in treating postmenopausal women. This will certainly help in improving the quality of life of a growing population.





References:

Manson JE, Kaunitz A. Menopause management: getting clinical care back on track. N Engl J Med. 2016;374:803-806.





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