Current Controversy on Hormonal Therapy in .NET

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Epidemiologic studies indicate that current key predictors of HT use are: age at menopause (the younger the woman, the higher the probability she will require and be prescribed HT); type of menopause (surgical menopause is three times more likely to be hormonally treated); and education and socioeconomic level (women better educated and with higher socioeconomic background are more likely to require and use HT) (reviewed in [5]) Up to 75% of women with a premature, early, or natural menopause may complain of one or more impairing menopausal symptoms, affecting their quality of life, which may be alleviated or cured with appropriate HT [10 14,18 24] Unfortunately, the Women s Health Initiative (WHI) publication [9] and the following data analysis [15,16] led to concerns, fear, and distrust toward
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Hormonal Therapy after Menopause
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Table 271 Typical premenopausal and postmenopausal serum steroid hormone concentrations Steroid hormone Estradiol Testosterone Androstenedione DHEA DHEAS Reproductive age 100 150 400 1,900 5,000 3,000,000
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Typical serum level, pg/ml Natural menopause 10 15 290 1,000 2,000 1,000,000 Iatrogenic menopause 10 110 700 1,800 1,000,000
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DHEA, dehydroepiandrosterone; DHEAS, dehydroepiandrosterone sulfate Adapted from Lobo (1999) [2]
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Table 272 Terminology for peri- and postmenopausal therapy* ET: EPT: Progestogen: Systemic ET/EPT: Local ET: HT: Estrogen therapy Combined estrogen and progestogen therapy Encompassing both progesterone and progestin Preparations of ET or EPT that have a systemic, not solely vaginal, effect Preparations of ET that have a predominantly vaginal, not systemic, effect Hormone therapy (encompassing both ET and EPT) in asymptomatic women such as those in RCT (late therapy) Hormone replacement therapy, which includes administration of hormones to symptomatic estrogende cient women, in the late perimenopause or early postmenopause, such as those in observational studies Continuous combined estrogen-progestogen therapy (daily administration of both estrogen and progestogen) Continuous sequential estrogen-progestogen therapy (estrogen daily, with progestogen added on a set sequence)
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* Adapted from Sturdee & MacLennan (2003) [13], the North American Menopause Society Position statement [11], the European Menopause and Andropause Society position statement [12], and the International Menopause Society (IMS) Hormone Replacement Therapy: practical recommendations [14]
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HRT, in women and in physicians [5] WHI data exacerbated the worries previously raised by the Heart and Estrogen/Progestin Replacement Study (HERS I) [7] and HERS II [8] The Million Women Study (MWS) [17], in spite of its lower level of evidence (II2) compared to the WHI (I) and HERS I and HRS II (I), further increased concerns by the extensive neg-
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ative media coverage it generated Weaknesses and strength of the WHI have been discussed in previous papers [5,11 12,14,18,24,37] Critical data emerging from the WHI are discussed under the paragraphs Indications for HT and Risks of HT Fear was triggered by the inappropriate media reading of odds ratios A key practical recommendation,
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27 by Graziottin [23] focused on natural menopause and senium)
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when discussing risk and bene t with patients, is to distinguish absolute risk/bene t from relative risk/bene t, which is expressed as a percentage increase or decrease in absolute risk This means, for example, that the reported 26% increase in the relative risk of breast cancer in the WHI is actually an absolute excess of four breast cancers for 1000 women treated for ve years, or less than one excess case per 1000 women per year of treatment [14] The latter simple gures should be used In recognition of this communication and risk perception problem, the Council for International Organizations of Medical Sciences (CIOMS) task force released its report in 1998, providing a risk categorization to assist healthcare professionals and the public when interpreting risks (discussed in [11]) In this context, risks are considered as follows: <1/1000 = rare <1/10,000 = very rare The meanings of absolute risks of HT are reviewed in detail in recent position papers [10 12] Reactions to the ndings of the randomized controlled trials (RCTs) on the impact of HT on women s health have caused a signi cant drop in medical prescriptions They have dramatically illustrated the uncertainty and the emotional vulnerability of the medical profession regarding the usefulness and even the safety of HT [5] Authoritative position statements [10 12] and practical recommendations and guidelines [14,18 20] aimed at helping clinicians by clarifying the contradictory evidence emerging from the previous observational data vs the most recent RCTs, HERS I, HERS II, and WHI, have been published Their conclusions and the most relevant published data will be the base of the present chapter, aimed at helping the clinician in his/her daily practice with the increasing population of postmenopausal women Indeed, the negative domino effect of a symptomatic menopause may negatively affect the sexual well-being of the woman and the couple, unless appropriately treated (see the review of RCT on HT and sexuality by Alexander et al [21], the review of observational studies on menopause and sexuality by Dennerstein et al [22], the comprehensive clinical approach to FSD and HT discussed by both Graziottin and Basson [4] focused on premature menopause and sexuality, and
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