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Treatment of Menopause-Associated Vasomotor Symptoms: Position Statement of the North American Menopause Society

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Treatment of Menopause-Associated Vasomotor Symptoms: Position Statement of the North American Menopause Society Menopause: The Journal of The North American Menopause Society Vol. 11, No. 1, pp. 11-33 DOI: 10.1097/01.GME.0000108177.85442.71 © 2004 The North American Menopause Society ࠗϱ Text printed on acid-free paper. POSITION STATEMENT Treatment of menopause-associated vasomotor symptoms: position statement of The North American Menopause Society ABSTRACT Objective: To create an evidence-based position statement regarding the treatment of vasomotor symptoms associated with menopause. Design: The North American Menopause Society (NAMS) enlisted clinicians and researchers acknowledged to be experts in the field of menopause-associated vasomotor symptoms to review the evidence obtained from the medical literature and develop a document for final approval by the NAMS Board of Trustees. Results: For mild hot flashes, lifestyle-related strategies such as keeping the core body tempera- ture cool, participating in regular exercise, and using paced respiration have shown some efficacy without adverse effects. Among nonprescription remedies, clinical trial results are insufficient to either support or refute efficacy for soy foods and isoflavone supplements (from either soy or red clover), black cohosh, or vitamin E; however, no serious side effects have been associated with short-term use of these therapies. Single clinical trials have found no benefit for dong quai, evening primrose oil, ginseng, a Chinese herbal mixture, acupuncture, or magnet therapy. Few data support the efficacy of topical progesterone cream; safety concerns should be the same as for other proges- togen preparations. No clinical trials have been conducted on the use of licorice for hot flashes. Among nonhormonal prescription options, the antidepressants venlafaxine, paroxetine, and fluox- etine and the anticonvulsant gabapentin have demonstrated some efficacy for treating hot flashes and were well tolerated. Two antihypertensive agents, clonidine and methyldopa, have shown modest efficacy but with a relatively high rate of adverse effects. For moderate to severe hot flashes, systemic estrogen therapy, either alone (ET) or combined with progestogen (EPT) or in the form of estrogen-progestin oral contraceptives, has been shown to significantly reduce hot flash frequency and severity. Clinical trials have associated ET/EPT with adverse effects, including breast cancer, stroke, and thromboembolism. Several progestogens (both oral and intramuscular formulations) have shown efficacy in treating hot flashes, including women with a history of breast cancer, although no definitive data are available on long-term safety in these women. Conclusions: In women who need relief for mild vasomotor symptoms, NAMS recommends first considering lifestyle changes, either alone or combined with a nonprescription remedy, such as dietary isoflavones, black cohosh,RETIRED or vitamin E. Prescription systemic estrogen-containing prod- ucts remain the therapeutic standard for moderate to severe menopause-related hot flashes. Rec- ommended options for women with concerns or contraindications relating to estrogen-containing treatments include prescription progestogens, venlafaxine, paroxetine, fluoxetine, or gabapentin. Clinicians are advised to enlist women’s participation in decision making when weighing the ben- efits, harms, and scientific uncertainties of therapeutic options. Regardless of the management Received October 30, 2003. Charles L. Loprinzi, MD; and Nancy King Reame, MSN, PhD, FAAN. Edited, modified, and subsequently approved by the NAMS Board of The Board of Trustees of The North American Menopause Society Trustees in October 2003. (NAMS) developed this manuscript with assistance from an Editorial Board composed of Nanette F. Santoro, MD (Chair); Thomas B. Clark- Address correspondence and reprint requests to NAMS, PO Box 94527, son, DVM; Robert R. Freedman, PhD; Adriane J. Fugh-Berman, MD; Cleveland, OH 44101, USA. Menopause, Vol. 11, No. 1, 2004 11 NAMS POSITION STATEMENT strategy adopted, treatment should be periodically reassessed as menopause-related vasomotor symptoms will abate over time without any intervention in most women. Key Words: Menopause – Vasomotor symptoms – Hot flashes – Estrogen – Progestogen – Hor- mone therapy – Antidepressants – Isoflavones – Black cohosh – Vitamin E – Gabapentin. n response to the need to define standards of clini- cancer. Although their vasomotor symptoms may be cal practice in North America, The North Ameri- related to breast cancer treatment (eg, tamoxifen), it is can Menopause Society (NAMS) has created this reasonable to assume that the therapeutic results may Ievidence-based position statement on the treat- be applicable to naturally postmenopausal women, ment of menopause-associated vasomotor symptoms. even though the physiologic mechanisms can differ. Fi- nally, although the information is relevant internation- METHODOLGY ally, the focus is limited to therapies available in clini- cal practice in the United States and Canada. An Editorial Board composed of experts from both clinical practice and research was enlisted to review the OVERVIEW published data, compile supporting statements and conclusions, and reach consensus on which recommen- The symptoms of vasomotor instability associated dations to endorse. If the evidence was contradictory or with menopause are commonly termed hot flashes. Hot inadequate to form a conclusion, a consensus-based flashes are recurrent, transient episodes of flushing, opinion was established. (Practice parameter standards perspiration, and a sensation ranging from warmth to intense heat on the upper body and face, sometimes fol- related to NAMS position statements were described in 5 a previous editorial.1) lowed by chills. Hot flashes that occur with perspira- For this position statement, a search was conducted tion during sleep are termed night sweats. of the medical literature for clinical trials that presented The terms hot flash, hot flush, and vasomotor symp- data specific to the treatment of vasomotor symptoms toms are often used to describe the same phenomenon. using the database MEDLINE. Priority was given to NAMS defines vasomotor symptoms as a global term evidence from randomized, controlled clinical trials as that encompasses both hot flashes and night sweats. well as systematic reviews and meta-analyses of such NAMS prefers the term hot flash rather than hot flush. trials, using criteria described elsewhere for evaluating Hot flashes are considered one of the hallmark signs the evidence levels.2-4 Conclusions from other evi- of perimenopause. The exact cause of hot flashes has dence-based guidelines also were reviewed. The not been determined, although it seems that the chang- NAMS Board of Trustees was responsible for the final ing endogenous estrogen concentrations associated review and approval of this document. Updates to this with menopause may play a role. However, endog- position statement will be published as developments enous estrogen concentrations alone are not predictive in scientific research occur that substantially alter the of hot flash frequency or severity. conclusions. Most hot flashes are mild to moderate in intensity The overall objective of this position statement is to and typically stop over time without therapy, but the RETIREDexact timing cannot be predicted. Nevertheless, many provide a review of clinical data relating to treatment of peri- and postmenopausal vasomotor symptoms and to North American women experience hot flashes severe recommend the most effective treatments. Research of- enough to seek treatment. Although the available thera- ten does not distinguish between vasomotor symptoms pies do not “cure” hot flashes, they can provide signifi- resulting from spontaneous menopause and those from cant relief. induced menopause, although anecdotal reports sug- The main focus of this paper is on treatment options gest that induced menopause may result in more fre- for hot flash symptoms; however, it first presents some quent and/or severe symptoms. This position statement background information on epidemiologic, etiologic, will not specifically address vasomotor symptoms as- and physiologic characteristics. sociated with causes other than menopause, such as EPIDEMIOLOGIC CONSIDERATIONS hypogonadism, low serum gonadotropin levels, or gonadotropin-releasing hormone agonist therapy. Hot flashes are an early, readily apparent sign of ap- However, it will include research conducted among proaching menopause. A review5 found that the inci- peri- and postmenopausal women who have had breast dence of hot flashes typically increases during peri- 12 Menopause, Vol. 11, No. 1, 2004 NAMS POSITION STATEMENT menopause, reaches its highest rate during the first 2 compared with 32% of women without a history (odds years postmenopause, then declines over time. In a pro- ratio, 1.42; 95% CI, 1.04-1.93). spective, longitudinal study of 436 community-based Various lifestyle and social factors also seem to be US women aged 35 to 47,6 31% experienced hot related to hot flash frequency: flashes before noting any observable irregularity in • Warm ambient air temperatures increase a wom- menstrual cycles or changes in serum estrogen levels. an’s core body temperature and make her more Most women experience hot flashes for 6 months to likely to reach the sweating threshold. Cooler air 2 years, although some women have them for 10 years temperatures are associated with a lower incidence 5 or longer. A Swedish study found that about 9% of of hot flashes.19,20 7 72-year-old women have
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