Nanette Santoro, MD

Most women who traverse menopause experience significant symptoms and many require at least temporary pharmacological treatment for maintenance of quality of life. Despite the controversy surrounding it, hormone therapy (HT) with either estrogen alone (E) or estrogen plus progestin (E+P) remains the most effective treatment for menopausal symptoms. This article provides a brief history of menopausal hormone therapy (HT) and discusses practical aspects of treatment and discontinuation.


	HT has had a cyclical history of high acceptance and uptake, followed by reduced use related to emergence of risk. Its efficacy for symptoms was recognized in the 1950s and 1960s.

 Shortly thereafter, increased risk of endometrial cancer associated with E preparations was followed by the addition of progestin to regimens for women with a uterus, and a transient reduction in enthusiasm for HT.

In the 1980s, the strong observational association between hormone use and reduced risk of coronary heart disease (CHD)

 led to exploration of systemic benefits of HT beyond symptom relief, which triggered another surge in use. However, when the effectiveness of HT as a preventive medication was tested in a randomized clinical trial, the 

(WHI), there was no observed reduction in CHD in women with or without a uterus, and a small signal for initial harm emerged, with differential risks depending upon whether a woman had a uterus and was randomized to E+P or had a hysterectomy and therefore took E Alone (Table 1).

 Differences in treatment with E+P compared to E alone reveal an elevated risk of CHD, venous thromboembolism (VTE), breast cancer in the E+P arm and no risk for breast cancer in the E-only arm (Table 1). The association between breast cancer in the E+P arm was further corroborated by an 11-year follow-up study among participants of the WHI study, which demonstrated a small increase in breast cancer incidence (HR, 1.25 [95%CI 1.07-1.46; 

 = 0.004]) and mortality (HR, 1.96 [95%CI: 1.00-4.04, 

 After publication of these findings, HT prescriptions dropped by 32% overall with a > 60% drop in prescriptions for conjugated equine estrogen (CEE)/medroxyprogesterone acetate (MPA).

Based upon these findings, HT is not recommended for preventive use by 

The American College of Obstetricians and Gynecologists

 Despite its rigor, the WHI was designed in the late 1980s and was constructed to test the hypothesis that CHD would be prevented by the then-commonly-used preparation of CEE plus MPA (in women with a uterus) or CEE alone in women without a uterus. Subclinical coronary disease was not considered in participant recruitment, and women were stratified into 10-year age bins that included many women who would otherwise not be taking HT for current indications (i.e., symptom relief). This makes some of the endpoints difficult to interpret when advising a current patient in her early 50s who requires symptom control.

Current evidence from WHI and other trials


	More recent follow-up of women who participated in the WHI, now 17 years after its original outcome publication, provide a very reassuring perspective on the long-term harms and benefits of exposure to HT for women in different age groups, and can be helpful for clinicians in guiding their recommendations.

 Studies subsequent to the WHI have examined a series of

intermediate endpoints to help explain the discrepancy between the WHI and observational studies, specifically the Nurses’ Health Study,

 with respect to the outcome of CHD. When the WHI data are limited to women in the youngest age group (50-59), there is no increased risk of CHD associated with HT. Follow-up studies such as the 

 (KEEPS) provided similar reassurance about the safety of “early initiation” of HT with respect to carotid intimal medical thickness (CIMT) and coronary calcium scores. The 

 (ELITE) study demonstrated reduced CIMT accrual with early initiation of HT following menopause and minimal cardiovascular effects with later treatment initiation compared to placebo.

 Taken together, these findings support the notion that use of HT in women who are in the early postmenopause does not confer CHD risk, and may be of some benefit. 


	Because of its unmatched effectiveness, HT is the treatment of choice for many symptomatic women, and more recent review of clinical guidelines indicates situations in which extended use for more than just a few years can be considered (as opposed to the “lowest possible dose for the shortest possible time”) after informed, shared decision-making.

While hot flashes and night sweats are the most prevalent symptoms of menopause, vaginal dryness or genitourinary syndrome of menopause (GSM), adverse mood (depression and/or anxiety), and poor sleep are additional clinical complaints that are attributable to menopause and likely to be relieved by HT.

 This is not an all-encompassing list of symptoms, however, and clinicians may consider a 3- to 6-month empiric trial of HT for atypical symptoms that appear strongly related to menopause. If HT is ineffective, it should be stopped, and other causes and treatments will need to be considered.

Common indications for initiating hormonal therapy in women include vasomotor symptoms (VMS) and genitourinary dysfunction. While the mechanism for VMS is not fully understood and is likely multifactorial, symptoms can be severe and affect quality of life. Average duration of vasomotor symptoms is 7.4 years but durations up to 10 years have been reported.

 HT has been shown to reduce hot flash frequency and severity by about 75%.

 Genitourinary symptoms include vaginal or vulvar dryness, discharge, itching, and dyspareunia as a result of vaginal atrophy from hypoestrogenism-GSM. These symptoms can cause sexual dysfunction and detrimental effects on quality of life, self-esteem, and sexual intimacy. With local therapy for atrophic vaginitis, the addition of progesterone is usually not indicated due to no evidence of increased risk of endometrial cancer although very-long-term data are lacking.

 HT has also been shown to reduce the rate of postmenopausal osteoporotic fractures, with some studies showing a reduction in hip fracture of as much as 33%.

 While prevention of osteoporosis is not usually an indication for HT, it is an additional benefit that will accrue to women who take it for symptom control. Some studies have shown HT to be effective in postmenopausal women with chronic insomnia although it should not be used as a first-line agent for chronic insomnia, and should only be considered in the presence of other comorbid conditions and if the benefits outweigh the risks of HT.

 The benefit of HT for reducing joint pain is controversial with preclinical studies showing positive effects that have not been consistently seen with follow-up clinical studies.

 In the WHI, women randomized to HT were less likely to have joint stiffness compared to placebo.

Estrogen therapy, when combined with exercise, has shown efficacy in maintaining and increasing muscle mass, strength, and performance.


	There are many options when it comes to HT, so the best treatment regimen for each patient can be optimized given the patient’s specific goals and risk factors. Women who have a uterus should take a progestin or a selective estrogen receptor modulator (SERM) in combination with estrogen to avoid the effects of unopposed E on the endometrial lining. For women with prior hysterectomy, if hormone therapy is indicated, E alone should be used as there is no benefit and potential harm to adding P.

 (FDA)-approved formulations of E are available (Table 3). E can be delivered orally, transdermally, or vaginally. Retrospective studies and meta-analyses have shown that the transdermal mode of delivery carries less risk of VTE, presumably due to bypass of the liver.

 However, there are no RCTs that have compared oral and transdermal routes directly. A recent observational study of oral estradiol use indicated that its VTE risks were similar to transdermal and less than oral CEE.

Application of transdermal estrogen can be done via patches, gels or sprays. Although there is high acceptability of transdermal routes, complaints from patients with patches include skin irritation and lack of adhesion. There are many blogs and reviews of patches online that may discourage women from trying this effective option. It may be useful to give patients a set of steps to troubleshoot issues with patches when initiating therapy (Table 4). CEE has similar efficacy for vasomotor and genitourinary symptoms when compared to transdermal estradiol.

If GSM is a patient’s primary concern, then vaginal E can be provided in a low dose that improves local symptoms without having systemic effects. It can take the form of a low-dose vaginal ring, cream, tablet or insert. Note that high-dose vaginal creams and rings have systemic effects and may require P for endometrial protection. Table 3 lists vaginal E formulations.

The treatment goal for HT is symptom relief using the lowest effective dose. For this reason, it is most often appropriate to start with lower doses of E and titrate up on a biweekly to monthly basis until symptom relief is optimally balanced against side effects. Starting dose varies by compound and route: oral CEE can be started at 0.45 mg/daily, oral estradiol 0.5 mg/daily, and transdermal estradiol 0.025 mg/daily. Patients with surgical menopause may require higher doses for symptomatic relief. Common side effects of E include breast tenderness, vaginal bleeding, bloating, and headaches, which occur less frequently at lower doses. Higher starting doses may be needed for women with severe vasomotor symptoms and significant distress.

Progestins have the same routes of administration as E, as well as delivery via an intrauterine device. However, progesterone is not available in a transdermal formulation. Progestins can be combined with E in a pill or a patch or given separately. Whether treatment is E only or E+P, continuous (daily) use is advised. Exceptions in which cycling E+P is indicated may be for women in their first years of menopause, as they are more prone to breakthrough bleeding, and women with premature menopause who want to have a monthly bleed. For women who do not tolerate E therapy, P can be given alone for treatment of vasomotor symptoms. Oral synthetic progestins and micronized progesterone have been shown to be effective in the treatment of hot flashes.

 However, micronized progesterone has a less negative effect on serum lipoproteins compared to MPA, reduces postprandial increases in glucose,

 and can also induce a soporific effect when taken at bedtime. For these reasons, it may be the preferred progestin by many women.

Bioidentical hormones refer to plant-based hormones such as phytoestrogens that share the same chemical or structural composition as hormones produced by the body. In addition, the idea of bioidentical hormones has often been conflated with a product that is more “natural” and therefore safer than conventional pharmaceuticals.

 Although there are FDA-approved bioidentical hormones such as micronized progesterone and estradiol in numerous forms including the pill, patch, gel, and ring, compounded formulations are readily available but are not under the scrutiny of the FDA approval process. Due to concerns regarding reliability of dosage, purity, lack of evidence regarding superior effectiveness over FDA-approved hormonal formulations and lack of FDA oversight, use of compounded hormonal therapy is not recommended.

Innovations in menopause symptom treatment have led to creation of symptom-specific medications (Table 4).

Patients on HT should be monitored every 1 to 3 months when starting the treatment, then every 1 to 2 years once treatment is optimized. Age-appropriate breast cancer screening should be maintained. Any vaginal bleeding that arises after the first 6 months of HT should be investigated further for endometrial hyperplasia and cancer, unless the patient is clearly not yet menopausal.

Dr. Santoro is on the Scientific Advisory Boards of Astellas/Ogeda and Menogenix, Inc., and holds stock options in Menogenix, Inc. The other authors have nothing to disclose.

Wilson RA. Feminine Forever: M. Evans and Company, Inc.; 1966.

Weiss NS, Szekely DR, English DR, Schweid AI. Endometrial cancer in relation to patterns of menopausal estrogen use. 

Stampfer MJ, Colditz GA, Willett WC, Manson JE, Rosner B, Speizer FE, et al. Postmenopausal estrogen therapy and cardiovascular disease. Ten-year follow-up from the nurses’ health study. 

Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women’s Health Initiative randomized controlled trial. 

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Articles

Hormonal therapy is not without controversy but it is still one of the most effective treatments for patients with symptoms.

Practical approach to managing menopause

"Facts” about women’s health that are simply untrue can wreak havoc with the doctor/patient relationship but ob/gyns can help protect women from taking clickbait.

The term “fake news” has dominated our political landscape for the past 3 years, but it has a long and infamous history. The “yellow journalism” that infested the coastal cities in New York and California at the turn of the 20th century was 

 to have led to the US entry into the Spanish-American War.

 The remnants of this type of sensational print reporting can still be seen in supermarket tabloids, with ludicrous headlines about alien abductions and other nonsense. 

The new normal for many of us is that we get our daily information about the world around us from our personal computers, those devices that are always, always attached to us and that can also make phone calls. The sites from which we seek information often require minimal to no verification. To continue to exist, they must maximize their “hits” to generate advertising revenue. The site and the advertisers, depending upon exactly how we have logged in, next use our pattern of clicks to feed us more and more information geared to our apparent personal tastes, as deciphered by a machine-learning algorithm. The eventual result is a barrage of information that contains variable and unknown amounts of disinformation-”fake news”-that we either sift through and try to verify (very rarely), accept and await verification from a second source (hazardous when your content is being curated by a computer that is trying to give you what it thinks you want see), or sink into a funk of cynicism and disbelief of everything and disengage (common response). 

Our inherent belief in our rational ability to sort information, especially when it is now vast and readily accessible, is not well founded.

 We are, therefore, all vulnerable to defective processing and acquisition of “facts” that are simply untrue. As we become further and further insulated within our Internet-curated bubble of beliefs, we may also choose to call unwanted information feeds “fake news” even when they are true, because they don’t appear representative of all else we have been reading. Clearly, the hazards of these patterns of behavior are evident in many walks of life and are considered responsible for our current deeply divided political atmosphere.  

Obstetrics and gynecology is a very personal and powerful field. We are privy to the most private details of our patients’ lives and have the ability to influence future generations with actions that we take today. The trust relationship that we have with our patients is essential to our effectiveness. The ability of fake news to wreak havoc with this trust relationship is a threat to our life’s work that can be, at times, simply annoying, but can take some very negative turns. What follows are a few examples that illustrate “fake news” in its various forms. 

1. Women no longer have to endure the ravages of menopause! (Part 1) 

 touting a new medical procedure that “could delay menopause by 20 years”.

 Two smiling, jogging midlife women are shown. The procedure promises to improve women’s lives by “delaying the onset of more common symptoms of the menopause, which range from low mood, anxiety and difficulty sleeping, to hot flushes, night sweats and a reduced sex drive.” But that’s not all! “Doctors claim the operation could benefit thousands of women who experience serious health problems, such as heart conditions and bone-weakening osteoporosis, that are brought on by the menopause.”

Wait, what?!? Something has gone wrong in the worldwide race for clicks if we are talking about creating a world where menopause occurs at age 70+.  Prolonged lifetime exposure to estradiol and progesterone is associated with increased risks of breast and endometrial cancer-risks that have been appreciated for many decades.

 Cardioprotection from extended ovarian function is far from proven. How can a responsible news source overstate the benefits of such a procedure? How many women would-seriously-want to undergo ovarian transplantation, which includes two surgical procedures, to delay menopause? What if the ovaries are replaced in a position where they might result in pregnancy? And decades more of menstrual periods? Ahem, no thank you.

2. Women no longer have to endure the ravages of menopause! (Part 2) 


	The Wonderful World of “Bioidentical Hormones” is another area where “fake news” abounds unfettered by any reality. Due to the lack of regulation and oversight for compounded hormones (which were exempted from being considered pharmaceuticals but rather are considered dietary supplements, thanks to the 

Dietary Supplement Health and Education Act of 1994

-thank you, Senator Orrin Hatch), there is almost no need whatsoever to provide any proof of claim, and penalties for false advertising are rarely imposed. Here are some claims made by various websites:

Synthetic hormones have a variety of negative side effects, but our approach to bioidentical hormone therapy, also known as BHRT, can help you avoid these.

Many women begin to feel the negative effects of hormone imbalances years before menopause…Our goal is to relieve the unwanted symptoms of aging caused when hormone levels are unbalanced.

Wait, what??!!?? The “bioidentical hormone” (BHRT) industry is arguably the first and one of the most effective “fake news” enterprises in medicine. Capitalizing on the wake of the 

 (WHI), which debunked the myth that estrogen and progesterone were powerful anti-aging drugs and would prevent disease, a proliferation of alternatives were born, reinventing the myth by claiming that the hormones used in the WHI were simply the wrong hormones, and the alternative products being sold had no such side effects and would, indeed, prevent aging. This marketing has been so effective that it is estimated that BHRT is currently one-third to half of the national use of menopausal hormone therapy.

3. HPV vaccines are bad for you…and the medical establishment is covering up! 

 is one of the most effective weapons in the medical armamentarium against cervical cancer, and has already demonstrated unanticipated benefits in reducing anal and oral cancers. The perfect storm of “anti-vaxxers” and religious conservative forces, who fear that vaccinating a young woman against HPV will encourage sexual promiscuity, has impeded the effective implementation and widespread use of this life-saving strategy, aided and abetted by “fake news”-some of which is promulgated by politicians.

The digital era has made the rapid propagation of “fake news” more efficient than ever. By offering up emotionally charged campaigns, based on powerful anecdotes that are repeated over and over again, fake news gets our attention.  Logic and facts are, well, boring when pitted against sensational clickbait. Truth gets replaced with “truthiness”: something that seems or feels like it is true (thank you, Stephen Colbert), so we just go with it. 

How can we and our patients protect ourselves from the clickbait?

. Direct your patients to reputable sources of information at the outset of a web search. Rather than reading the first item that comes up, assuming it is the most important one, it helps to bookmark reputable websites. The American College of Obstetricians and Gynecologists, of course, is an outstanding resource, as are the Centers for Disease Control and National Institutes of Health. Many academic medical centers have readily accessible web posts on a broad range of topics in women’s health. For specialty information, the 

American Society for Reproductive Medicine

American Society for Gynecologic Oncology

 provide excellent, fact-based information.

Reiterate the principles of critical thinking

. Educate your patients on how to tell if a source is reliable. Are the data referenced and peer reviewed?  Are clinical studies described? If they are described, were the studies registered under 

? Are the authors in the bibliography of a scientific piece all the same, small group of authors? This suggests an internally concatenating alternative reality may be behind the thinking. 

. I like to provide my patients with specific information sources on sensitive topics prone to disinformation campaigns.  I anticipate that they will be consulting “Dr. Google” as soon as they leave my office. If you have an electronic medical record, you can create dot phrases for commonly asked questions and avoid rewriting this for every similar patient scenario. Having patient education materials available in your office waiting room can also be an effective way to direct your patients to reliable sources of information.

. Highlight for your patients some of the more outrageous examples of viral information that were subsequently proven to be untrue (e.g., the Hillary Pizzagate Conspiracy), and alert them to be critical of stories that elicit a strong emotional response. Give them tools to sort out the real from the fake (

 is an excellent website for this purpose).

Like it or not, the information highway of the Internet can be a “disinformation highway” that is not under our control, but it is here to stay. Alerting patients to the pitfalls inherent in information access in this era of plentiful information may make them better at sorting it out. And like it or not, that task has now become part of our daily work if we are to promote the health of our patients. I’m off to check my Facebook feed for the week, and I hope I won’t be accosted by too many trolls! 

The author reports no potential conflicts of interest with regard to this article.

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Ludolph R, Allam A, Schultz PJ. Manipulating Google’s knowledge graph box to counter biased information processing during an online search on vaccination: application of a technological debiasing strategy. 

https://www.theguardian.com/science/2019/aug/04/medical-procedure-delay-menopause

Ketcham AS, Sindelar WF.  Risk factors in breast cancer. 

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https://www.biotemedical.com/bioidentical-hormone-replacement-pellet-therapy/?gclid=EAIaIQobChMIxOzulJ-K5AIVmSCtBh3dVgMZEAAYASAAEgK3u_D_BwE

https://www.royalmedicalcenters.com/non-menopausal-women-menopause-menopause-age-early-menopause/

Pinkerton JV, Santoro N. Compounded bioidentical hormone therapy: identifying use trends and knowledge gaps among US women. 

Teoh D. The power of social media for HPV vaccination--not fake news! 

As patients are exposed to more and more misinformation, ob/gyns have a responsibility to not just treat but also educate.

Fake news in ob/gyn

GSM can be clinically detected in up to 90% of postmenopausal women undergoing evaluation. However, only about one-third of menopausal women report vulvovaginal symptoms when surveyed.

 According to the 2010 United States census, there are approximately 50 million women over age 51, the average age of menopause.

 That means approximately 17 million women experience GSM symptoms, a number that is likely increasing due to population demographics. Studies have shown that many of these women rate their symptoms as either moderate or severe. Affected women perceive declines in quality of life similar to those of patients with chronic conditions such as arthritis, chronic obstructive pulmonary disease (COPD) and irritable bowel syndrome.

 GMS symptoms also negatively impact sexual satisfaction in over half of patients and strain personal relationships.

Palacios S, Nappi RE, Bruyniks N, Particco M, Panay N, Investigators ES. The European Vulvovaginal Epidemiological Survey (EVES): prevalence, symptoms and impact of vulvovaginal atrophy of menopause. Climacteric. 2018;21(3):286-291.

Howden LM, Julia. Age and Sex Composition: 2010. In. Commerce USDo, trans. United States Census Bureau: U.S. Census Bureau; 2010.

Avis NE, McKinlay SM. The Massachusetts Women’s Health Study: an epidemiologic investigation of the menopause. J Am Med Womens Assoc (1972). 1995;50(2):45-49, 63.

DiBonaventura M, Luo X, Moffatt M, Bushmakin AG, Kumar M, Bobula J. The Association Between Vulvovaginal Atrophy Symptoms and Quality of Life Among Postmenopausal Women in the United States and Western Europe. J Womens Health(Larchmt). 2015;24(9):713-722.

Kingsberg SA, Wysocki S, Magnus L, Krychman ML. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women’s VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013;10(7):1790-1799.

GSM can be clinically detected in up to 90% of postmenopausal women undergoing evaluation but only one-third report vulvovaginal symptoms when surveyed.

Common signs and symptoms of GSM

Children or adolescents with BMI > 85th centile or with additional risk factors

TGs > 250 ml/dL or HDL cholesterol < 35 mg/dL

Inactivity, severe obesity (BMI > 35 kg/m2), acanthosis nigricans

BMI = body mass index; CVD = cardiovascular disease; GDM = gestational diabetes; HDL = high-density lipoprotein; IGT = impaired glucose tolerance; IFG = impaired fasting glucose; PCOS = polycystic ovary syndrome; TG = triglycerides; T2DM = type 2 diabetes mellitus

recommends diabetes screening as part of a cardiovascular risk assessment in asymptomatic adults who are overweight or obese and aged between 40 and 70. Individuals with a history of PCOS< GDM, and those of higher-risk racial and ethnic groups should be considered for screening at younger ages and lower body mass indexes.

Type 2 diabetes in the non-pregnant patient

The USPSTF recommends diabetes screening as part of a cardiovascular risk assessment in asymptomatic adults who are overweight or obese and aged between 40 and 70.

Author | Nanette Santoro, MD

Articles

Practical approach to managing menopause

Fake news in ob/gyn

Common signs and symptoms of GSM

Populations appropriate for diabetes screening with retesting every 3 years