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Hormone therapy in postmenopausal women and risk of endometrial hyperplasia. 2009

Sue Furness, and Helen Roberts, and Jane Marjoribanks, and Anne Lethaby, and Martha Hickey, and Cindy Farquhar
Obstetrics & Gynaecology, University of Auckland , 85 Park Rd, Grafton , Private Bag 92019, Auckland, New Zealand. suefurness@gmail.com

BACKGROUND Declining circulating estrogen levels around the time of the menopause can induce unacceptable symptoms that affect the health and well being of women. Hormone therapy (both unopposed estrogen and estrogen/progestogen combinations) is an effective treatment for these symptoms, but is associated with risk of harms. Guidelines recommend that hormone therapy be given at the lowest effective dose and treatment should be reviewed regularly. The aim of this review is to identify the minimum dose(s) of progestogen required to be added to estrogen so that the rate of endometrial hyperplasia is not increased compared to placebo. OBJECTIVE The objective of this review is to assess which hormone therapy regimens provide effective protection against the development of endometrial hyperplasia and/or carcinoma. METHODS We searched the Cochrane Menstrual Disorders and Subfertility Group trials register (searched January 2008), The Cochrane Library (Issue 1, 2008), MEDLINE (1966 to May 2008), EMBASE (1980 to May 2008), Current Contents (1993 to May 2008), Biological Abstracts (1969 to 2008), Social Sciences Index (1980 to May 2008), PsycINFO (1972 to May 2008) and CINAHL (1982 to May 2008). Attempts were made to identify trials from citation lists of reviews and studies retrieved, and drug companies were contacted for unpublished data. METHODS Randomised comparisons of unopposed estrogen therapy, combined continuous estrogen-progestogen therapy and/or sequential estrogen-progestogen therapy with each other or placebo, administered over a minimum period of twelve months. Incidence of endometrial hyperplasia/carcinoma assessed by a biopsy at the end of treatment was a required outcome. Data on adherence to therapy, rates of additional interventions, and withdrawals due to adverse events were also extracted. METHODS In this substantive update, forty five studies were included. Odds ratios were calculated for dichotomous outcomes. The small numbers of studies in each comparison and the clinical heterogeneity precluded meta analysis for many outcomes. RESULTS Unopposed estrogen is associated with increased risk of endometrial hyperplasia at all doses, and durations of therapy between one and three years. For women with a uterus the risk of endometrial hyperplasia with hormone therapy comprising low dose estrogen continuously combined with a minimum of 1 mg norethisterone acetate or 1.5 mg medroxyprogesterone acetate is not significantly different from placebo (1mg NETA: OR=0.04 (0 to 2.8); 1.5mg MPA: no hyperplasia events). CONCLUSIONS Hormone therapy for postmenopausal women with an intact uterus should comprise both estrogen and progestogen to reduce the risk of endometrial hyperplasia.

UI MeSH Term Description Entries
D011372 Progestins Compounds that interact with PROGESTERONE RECEPTORS in target tissues to bring about the effects similar to those of PROGESTERONE. Primary actions of progestins, including natural and synthetic steroids, are on the UTERUS and the MAMMARY GLAND in preparation for and in maintenance of PREGNANCY. Gestagenic Agent,Progestagen,Progestagenic Agent,Progestational Agent,Progestational Compound,Progestational Hormone,Progestogen,Progestogens,Gestagen,Gestagen Effect,Gestagen Effects,Gestagenic Agents,Gestagenic Effect,Gestagenic Effects,Gestagens,Progestagenic Agents,Progestagens,Progestational Agents,Progestational Compounds,Progestational Hormones,Progestin,Progestin Effect,Progestin Effects,Progestogen Effect,Progestogen Effects,Agent, Gestagenic,Agent, Progestagenic,Agent, Progestational,Compound, Progestational,Effect, Gestagen,Effect, Gestagenic,Effect, Progestin,Effect, Progestogen,Effects, Gestagen,Effects, Gestagenic,Effects, Progestin,Effects, Progestogen,Hormone, Progestational
D004714 Endometrial Hyperplasia Benign proliferation of the ENDOMETRIUM in the UTERUS. Endometrial hyperplasia is classified by its cytology and glandular tissue. There are simple, complex (adenomatous without atypia), and atypical hyperplasia representing also the ascending risk of becoming malignant. Atypical Endometrial Hyperplasia,Complex Endometrial Hyperplasia,Simple Endometrial Hyperplasia,Atypical Endometrial Hyperplasias,Complex Endometrial Hyperplasias,Endometrial Hyperplasia, Atypical,Endometrial Hyperplasia, Complex,Endometrial Hyperplasia, Simple,Endometrial Hyperplasias,Endometrial Hyperplasias, Atypical,Endometrial Hyperplasias, Complex,Endometrial Hyperplasias, Simple,Hyperplasia, Atypical Endometrial,Hyperplasia, Complex Endometrial,Hyperplasia, Endometrial,Hyperplasia, Simple Endometrial,Hyperplasias, Atypical Endometrial,Hyperplasias, Complex Endometrial,Hyperplasias, Endometrial,Hyperplasias, Simple Endometrial,Simple Endometrial Hyperplasias
D004967 Estrogens Compounds that interact with ESTROGEN RECEPTORS in target tissues to bring about the effects similar to those of ESTRADIOL. Estrogens stimulate the female reproductive organs, and the development of secondary female SEX CHARACTERISTICS. Estrogenic chemicals include natural, synthetic, steroidal, or non-steroidal compounds. Estrogen,Estrogen Effect,Estrogen Effects,Estrogen Receptor Agonists,Estrogenic Agents,Estrogenic Compounds,Estrogenic Effect,Estrogenic Effects,Agents, Estrogenic,Agonists, Estrogen Receptor,Compounds, Estrogenic,Effects, Estrogen,Effects, Estrogenic,Receptor Agonists, Estrogen
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014592 Uterine Hemorrhage Bleeding from blood vessels in the UTERUS, sometimes manifested as vaginal bleeding. Hemorrhage, Uterine,Vaginal Bleeding,Uterine Bleeding,Bleeding, Uterine,Bleeding, Vaginal,Bleedings, Vaginal,Uterine Bleedings,Uterine Hemorrhages,Vaginal Bleedings
D015914 Estrogen Replacement Therapy The use of hormonal agents with estrogen-like activity in postmenopausal or other estrogen-deficient women to alleviate effects of hormone deficiency, such as vasomotor symptoms, DYSPAREUNIA, and progressive development of OSTEOPOROSIS. This may also include the use of progestational agents in combination therapy. Hormone Replacement Therapy, Post-Menopausal,Postmenopausal Hormone Replacement Therapy,Replacement Therapy, Estrogen,Estrogen Progestin Combination Therapy,Estrogen Progestin Replacement Therapy,Estrogen Replacement,Replacement, Estrogen,Therapy, Estrogen Replacement,Estrogen Replacement Therapies,Estrogen Replacements,Hormone Replacement Therapy, Post Menopausal,Replacement Therapies, Estrogen,Replacements, Estrogen,Therapies, Estrogen Replacement
D016032 Randomized Controlled Trials as Topic Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table. Clinical Trials, Randomized,Controlled Clinical Trials, Randomized,Trials, Randomized Clinical
D016889 Endometrial Neoplasms Tumors or cancer of ENDOMETRIUM, the mucous lining of the UTERUS. These neoplasms can be benign or malignant. Their classification and grading are based on the various cell types and the percent of undifferentiated cells. Cancer of Endometrium,Endometrial Cancer,Endometrial Carcinoma,Cancer of the Endometrium,Carcinoma of Endometrium,Endometrium Cancer,Neoplasms, Endometrial,Cancer, Endometrial,Cancer, Endometrium,Cancers, Endometrial,Cancers, Endometrium,Carcinoma, Endometrial,Carcinomas, Endometrial,Endometrial Cancers,Endometrial Carcinomas,Endometrial Neoplasm,Endometrium Cancers,Endometrium Carcinoma,Endometrium Carcinomas,Neoplasm, Endometrial
D017698 Postmenopause The physiological period following the MENOPAUSE, the permanent cessation of the menstrual life. Post-Menopause,Post-menopausal Period,Postmenopausal Period,Period, Post-menopausal,Period, Postmenopausal,Post Menopause,Post menopausal Period,Post-Menopauses

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