Reproductive Ethics and Menopause Research Paper

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The cessation of menstruation is a universal event for women who live long enough to reach their middle years. Menopause is the name given to this event, defined retrospectively as the last menstrual period. Discussion about menopause and its treatment raises a number of issues relevant to public health ethics. These include whether menopause is a disease, the role of exogenous estrogens alone or combined with progestogens in the treatment of menopausal symptoms (known as hormone replacement therapy, or HRT), and more recently, the role of HRT as preventative treatment for a range of disorders. In particular, there has been controversy over the relationship between HRT and cardiovascular disease in postmenopausal women. Specific ethical issues include the implications of defining menopause as a disease and its subsequent medicalization, the quality of information available for women to make informed decisions about HRT, the emphasis on decreasing individual risk factors through medication, and broader questions of research ethics.


As women age, there is a decrease in ovarian follicular activity, with a decline in estradiol and progesterone. This leads to a rise in follicle stimulating hormone (FSH) and luteinizing hormone (LH). Initially, women may experience irregular menstrual cycles with changes in the amount of blood loss. This menopausal transition is known as the perimenopause, which starts at a median age of 45.5–47.5 years in Western women. The average time to the last menstrual period from the start of the perimenopause is 4 years. During the perimenopause, there is increased frequency of anovulatory cycles, increased menstrual irregularities, and decreased fertility (O’Connor and Kovacs, 2003).

The symptoms experienced by women as they go through menopause vary considerably, with significant cultural and geographic differences in both the nature and intensity of symptoms. Many women have minimal symptoms. The classic symptoms of lowered levels of estrogen are vasomotor instability leading to hot flushes, palpitations, and night sweats; and genitourinary symptoms such as vaginal dryness and urinary frequency. Other symptoms that have been described include changes in general quality of life and psychological well-being associated with mood swings, anxiety, depression, memory and sleep disturbances, decreased energy and changes in libido, and a range of other symptoms such as muscle and joint aches, headaches, and sensory disturbances. These symptoms may last for several years, preceding and after the last menstrual period.

Following menopause, women have low levels of estradiol and progesterone, and declining levels of LH and FSH. This altered hormonal milieu is an inevitable part of aging; the relationship between these hormonal changes and diseases such as osteoporosis and cardiovascular disease that become more common with increasing age in women, remains the subject of some controversy.

Culture And Menopause

The symptoms that women experience at menopause and the meanings that they attach to menopause are profoundly affected by prevailing sociocultural influences such as attitudes toward aging and older women, and their status in society. Factors thought to play a role in women’s experiences of menopause include culturally influenced behaviors such as diet, smoking, and exercise; cultural attitudes toward and expectations of menopause, including the influence of medicalization; meanings assigned to menopause such as whether it is seen as normal, deviant, or an illness; previous health, including reproductive health; mother’s experience of menopause; relationship with and attitudes of husbands/partners; attitudes toward women and child rearing; social supports; socioeconomic status; education; career; and religious beliefs (Melby et al., 2005). Lifestyle choices influenced by culture, such as smoking and diet, can modify the underlying biology of menopause, with associated changes in symptomatology.

The reported frequency and importance of symptoms varies enormously. For example, women in rural India described loss of vision as their primary symptom of menopause (Singh and Arora, 2005), whereas women of low socioeconomic status in the United States described mood swings, sleeping and memory problems, and lower energy levels more frequently than hot flushes, but despite this, felt positive about menopause (Schnatz et al., 2005). Recent results from the Study of Women’s Health across the Nation (SWAN), which is the latest and largest of epidemiological studies of menopause, following on from the Massachusetts Women’s Health Study and the Healthy Women Study, show significant variations between American women. American Caucasian women reported significantly more symptoms than other menopausal U.S. women; African American women had the highest rates of vaso-motor symptoms; and Chinese American and Japanese American women reported significantly fewer symptoms than Caucasians, African Americans, or Hispanics.

Despite all these variations, research from many locations shows that the majority of women pass through menopause with relatively little discomfort (Melby et al., 2005).

Is Menopause A Disease?

Given the universal nature of menopause as part of women’s reproductive cycle, there are strong reasons to consider menopause to be a natural transition, similar to puberty. There have been various challenges to this view, however, most famously by Wilson (1966) in his publication Feminine Forever. Wilson put forward the argument that the lowered levels of estrogen experienced by postmenopausal women should be considered a deficiency disease and treated by administration of exogenous estrogen. This argument draws upon a quantitative conception of disease as a variation from a statistical norm. In this quantitative approach to disease, population measurements of various physiological parameters such as blood pressure, blood sugar levels, or hemoglobin are used to develop descriptive statistics. Cut-off levels for ‘normal’ are then defined, often using two standard deviations from the mean as the cut-off, with any values lying outside of these defined as abnormal. There are various diseases defined in this way, such as diabetes, hypertension, and anemia. Wilson argued that, like levels of blood sugar in diabetes or thyroxine in thyroid disease, postmenopausal levels of estrogen lie outside the norm and are therefore a sign of disease. Diseases defined in this way as deviations from the norm can be cured by treatment aimed at returning the abnormal parameter to normal. Wilson proposed that the ‘estrogen deficiency disease’ of menopause should be cured by treatment with exogenous estrogens.

This conception of menopause as a statistically defined deficiency disease has been challenged on the grounds that physiological parameters should not be interpreted in isolation as the sole criterion for diagnosing disease. The context is important in determining whether a particular measurement is pathological. A low hemoglobin level, for example, might be due to pregnancy rather than anemia, or a systolic blood pressure of 90 mmHg might be normal for a 75-year-old but pathological for a 20-yearold. The postmenopausal state is characterized by lower estrogen levels than during women’s reproductive years, but the levels are normal for age, just as pre-pubertal girls also have ‘low’ estrogen levels that are normal for their age. According to this line of reasoning, it is wrong to declare menopause the start of an estrogen deficiency disease as hormone levels are normal for age; what is wrong is expecting a 60-year-old woman to have the same estrogen levels as a 30-year-old (Rogers, 1999).

Diseases can also be defined qualitatively, according to the way that physiological events or symptoms are experienced, with unpleasant states classified as diseases. This conception of disease can place the individual and her experiences at the center of the diagnostic process. As already discussed, however, symptoms attributed to menopause vary by culture, thus making it difficult to make a claim for menopause as a disease based upon a universal set of symptoms. In addition, when symptoms, events, or practices that are culturally unwelcome are redefined as diseases, this intertwines the medical with the moral and can bring under medical control areas of life that were previously taken for granted. This happened in nineteenth-century responses to menopause, which was said to be associated with moral insanity demonstrated by peevishness and fits of temper or self-absorption and exacerbated by reading novels, dancing, or going to the theater. The treatment involved rest and avoiding excitement, effectively excluding women from those activities which society deemed inappropriate for ‘good’ women. Cultural norms have changed, but it is possible to see the pressure to treat menopause with HRT as part of a wider cultural approach to women, most noted in wealthier countries, that values them primarily for youthful attributes, which can be potentially sustained by long-term ingestion of exogenous estrogens (Rogers, 1999).

There are significant implications for public health and for health-care provision if an inevitable physiological change such as menopause is defined as a disease. These implications range from reinforcing cultural stereotypes about the attractiveness of youth to creating expectations about unpleasant symptoms at menopause to creating demand for medical treatments. Many studies have found that naturally occurring menopause (as opposed to menopause caused by premature failure or removal of the ovaries) appears to have no major impact on women’s health and behavior and can be self-managed. Conversely, there appears to be a positive association between believing menopause to be a problem and then experiencing those problems (Rogers, 1999).

Making Informed Decisions About Treatment For Menopause

Whatever view we take about whether or not menopause should be defined as a disease, a proportion of women experience significant symptoms which are severe enough to lead them to seek medical care. The ethical concept that is relevant in this situation is that of informed consent. There is a need for accurate information so that women can make informed decisions about treatment. At a minimum, this information should include:

  • the nature of the treatment on offer (what it involves, time course, evidence about efficacy, etc.)
  • the likely benefits
  • the potential harms or side effects and
  • other options, including no treatment.

This ethical requirement to provide information is complicated by the current uncertainty surrounding hormone replacement therapy. It is well accepted that treatment with HRT is effective in decreasing the frequency and severity of vaso-motor symptoms and in relieving vaginal dryness and urinary symptoms. There is less agreement about the long-term benefits and safety of HRT, although most authorities agree that there is an increased risk of breast cancer associated with use of HRT (Greiser et al., 2005). Health-care professionals have an obligation to be familiar with the latest research evidence so that they are able to provide women with accurate and relevant information.

There has been considerable interest in the processes for making decisions about treatment for menopause, in part because it has been recognized that menopausal treatment is largely symptomatic, rather than aimed at preventing long-term disability or disease. This has led to research into and the creation of decision support aids to assist women in identifying the values that are important to them in making a decision about accepting medical treatment (Fortin et al., 2003).

Hormone Replacement Therapy And Disease Prevention

One of the major ethical issues raised by menopause concerns the promotion and use of HRT as a preventative health-care measure, particularly in relation to osteoporosis and cardiovascular disease. With regard to osteoporosis, women lose approximately 30% of their bone mass in the 20 years following menopause, and have two to three times the risk of fractures compared with men of the same age. The association between osteoporosis and postmenopausal led to the widespread promotion of HRT as a preventative treatment for osteoporosis. This promotion supported the view of menopause as an estrogen deficiency disease and the desirability of taking HRT both to treat the ‘disease’ and to decrease the risk of fractures. The former benefits the individual patient, but the latter has the potential to be a significant public health intervention, given the morbidity and mortality associated with fractures in elderly women. Research in this area indicates that HRT has a consistent and favorable effect on bone density at all sites, and confers protection against fractures for the duration of treatment (Wells et al., 2002). This protection wears off rapidly after HRT use ceases (Banks et al., 2004). From a public health perspective, there are many risk factors for osteoporotic fractures apart from being postmenopausal that are amenable to physical, dietary, and non-hormonal therapies. In particular, HRT has no effect on physical fitness, which is highly associated with falls, the major cause of fractures (Uusi-Rasi et al., 2005).

In relation to coronary heart disease (CHD), women prior to menopause have lower rates than men, but after menopause their rates rise to rates similar to those of men. This and other observations led to the hypothesis that estrogen has a protective effect on the cardiovascular system of women. During the 1980s and early 1990s, there were many observational studies suggesting that there was a substantial reduction in CHD risk in women who took estrogens. A 1992 meta-analysis showed that there was one-third less fatal heart disease in postmenopausal women taking HRT than in women not taking HRT. Based upon these calculations, it was argued that taking HRT at a population level would be an effective intervention, with a net gain in lives saved. This was deemed so despite increased risk of death from breast or uterine cancers, because CHD is more common than those cancers (Barrett-Connor, 2003). These arguments had a significant effect upon bodies such as the American College of Physicians, the American College of Obstetrics and Gynecology, and the American Heart Association, who issued recommendations that all postmenopausal women should be offered HRT to prevent heart disease. Offering HRT became an accepted indicator used in assessing quality of medical practice, and not offering HRT was considered unethical (Barrett-Connor, 2003).

Some commentators at the time argued that the observational data were potentially biased, as women taking HRT tended to be white, educated, upper middle class, and lean, all of which would reduce their risk of CHD independent of taking HRT. The hypothesis needed to be tested by a large-scale randomized controlled trial (RCT) to eliminate potential biases in the observational studies. There had been one RCT of estrogen in a secondary prevention trial with participants with known CHD in the 1960s, with male participants. The estrogen arm of this trial was stopped early because estrogen-treated men had an increased rate of thromboembolic events and myocardial infarction (Barrett-Connor, 2003). Twenty-three years later, the first RCT to evaluate whether estrogen plus progestin therapy reduced the risk for CHD events in postmenopausal women with established coronary disease started. This was the Heart and Estrogen/Progestin

Replacement Study, known as HERS. Barrett-Connor provides a detailed description of these trials and commentary on their findings. In summary, HERS found no overall difference in the primary CHD outcomes between treated and nontreated groups, and there was excess mortality in the treated group in the first year of treatment. These results were unexpected, although consistent with the earlier trial in men and with emerging results from smaller trials. One of the main criticisms of these trials was that giving HRT to women with established CHD may be too late and that estrogen may be more effective for primary prevention.

The HERS trial was followed shortly after by a large primary prevention trial called the Women’s Health Initiative or WHI. The WHI trial compared three preventative strategies (HRT, diet, and calcium supplements) on disease outcomes in healthy postmenopausal women. This was a complex trial with multiple arms, one arm of which (combined HRT in women with intact uteruses) was stopped early due to excess breast cancers. Initial analysis showed that none of the excess risks or benefits was large (all fewer than 10 events per 10 000 women per year). Overall, the numbers of breast cancers, cardiovascular events, and pulmonary emboli in the hormone-treated groups exceeded the fractures prevented and decreased colonic cancers in those groups. The results of WHI, first published in the Journal of the American Medical Association in 2002 (Rossouw et al., 2002), received extensive media coverage, caused widespread confusion and anxiety among women currently taking HRT, and led to reported decreases in the numbers of women taking HRT (Hoffmann et al., 2005).

The debate about the meaning of these results continues. It has been argued that the WHI used the wrong estrogen and progestogen, used the wrong-aged women, had inadequate blinding, and had high rates of dropouts and that the results lacked generalizability. Klaiber et al. (2005), for example, in their review focus upon the effects of cohort age and the use of a combined continuous regimen of HRT to argue that the design flaws in the WHI led to adverse conclusions about HRT, and that further research with different hormonal regimens and younger women are required (Klaiber et al., 2005).

With our current state of knowledge, HRT is not recommended as a preventative therapy for osteoporosis or CHD, as the risks seem to outweigh the benefits. In addition, there are good public health reasons for advocating for population health approaches to the treatment of multifactorial diseases such as CHD and osteoporosis rather than using individual hormonal treatments. Finally, treatment with HRT can be expensive, not only in terms of the direct costs of the pharmaceutical agents, but also in terms of the associated costs of increased medical care, largely associated with breast and uterine diagnostic and treatment interventions. These costs fall after the first year of treatment but remain significant (Ohsfeldt et al., 2004).

Research Ethics And Menopause

Treating menopause is a multimillion dollar business in Western countries, although profits have fallen following publicity about the results of the WHI trial. As well as prescribed medications, many women take complementary or alternative therapies, also at significant cost. Much of the research evidence that we have about HRT, in particular the observational studies that suggested that HRT had cardio-protective effects, was generated in trials funded by pharmaceutical companies. In her 2004 critique of the pharmaceutical industry, Angell warns us ‘to question how reliable publications from industry-sponsored research really are’ (Angell, 2004, p. 113). With respect to the treatment of symptoms at menopause, the research agenda has been dominated by pharmaceutical interventions. There was significant lobbying of medical practitioners to promote HRT prior to the results of the HERS and WHI trials through activities such as continuing medical education funded by pharmaceutical companies and visits by pharmaceutical representatives.

Ideally, research agendas should be set in partnership with those who are affected by symptoms, include a range of treatment alternatives, and lead to research that provides practical information for women. At present this has not been achieved. It is hoped that research projects in progress will lead to greater clarity about the place of HRT and other symptom-relief measures for menopausal women.


Menopause, as a universal feature of female aging, provides a major opportunity for public health interventions aimed at improving women’s health. Many women require information and general advice about optimizing their health at this time, rather than pharmaceutical treatment with uncertain benefits and identifiable risks or complementary and alternative therapies of little proven benefit. There are high costs and potential health risks in adopting a pharmaceutical treatment model for menopause, and the opportunity for effective public health interventions may be lost. At present we lack sufficient information for women and their health providers to make informed decisions about the long-term use of HRT.


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