<h2>Practice points</h2><ul><li>Soy isoflavones may relieve menopausal symptoms, in particular vasomotor symptoms (VMS) however data is contradictory. Therapeutic effect may be achieved after 2 months of use</li><li>Black cohosh may effectively relieve menopause symptoms when taken continuously for 4–12 weeks </li><li>Omega-3 fatty acids from fish oil may decrease incidence of hot flushing and improve mood when taken for 8 weeks</li><li>Preliminary studies suggest St John’s wort may assist menopausal women with psychological symptoms after ~8 weeks of use</li></ul><h2>Description</h2><ul><li>The menopause refers to the final menstrual period and a woman is considered postmenopausal 12 months after her final menstrual period1</li><li>The average age of natural menopause is 51 years1</li><li>Menopause is associated with cessation of ovarian function and diminished oestradiol2</li><li>There are four main symptom categories: vasomotor (VMS) (hot flushes and night sweats), psychological, general physical, and urogenital/sexual. Symptoms last on average 4-5 years1,2</li><li>Hot flushes are the primary reason women seek medical attention,2 and 25% of women experience severe VMS1</li><li>Other health consequences of hormonal changes include metabolic, cardiovascular, skeletal and neurological2 </li></ul>

<h2>Management guidelines</h2><ul><li>Provide information and advice about normal menopausal changes and symptoms1</li><li>Recommend bone density measurement1 </li><li>Assess:2 <ul><li>Cardiovascular disease risk (blood pressure, lipids)</li><li> Diabetes risk (blood glucose)</li><li>Urogenital health</li><li>Cancer screening (breast check, PAP smear)</li></ul> </li><li> Anxiety and depression may be increased during the perimenopausal period. Consider mental health referral in those with symptoms of mood disorder1</li><li> Non-pharmacologic treatment (e.g. lifestyle changes), or pharmacologic treatment (non-hormonal and hormonal therapies) if lifestyle changes are not sufficiently effective1,2</li></ul>

Management

<h2>Primary recommendations</h2><h2>SOY EXTRACT (containing isoflavones and/or other phytoestrogens)</h2>Mechanism of action<ul><li> Soy may selectively modulate and bind to oestrogen receptors, mimicking the effects of oestrogen in some tissues and antagonising the effects of oestrogen in others.3 Soy has a greater affinity with oestrogen β-receptors than β-receptors. β-receptors are found in the brain, bone and vascular epithelia, tissue in which soy isoflavones purportedly have activity4</li><li> May reduce VMS by acting on the vascular system without causing unwanted oestrogenic effects in other body systems3</li></ul>Research<ul><li> There is a considerable body of research on phytoestrogens in menopausal symptoms, in particular VMS.5,6 However, studies are conflicting which may be due to methodologic shortcomings and differences in phytoestrogen types and dosages5,6</li><li> A 2013 Cochrane review (43 RCTs; n=4364)3 that investigated phytoestrogens, including soy, for menopausal VMS was inconclusive. However 9 out of 11 trials that compared soy extracts to placebo, reported a reduction in the frequency or severity of hot flushes</li></ul>Studies using concentrates of genistein were more positive. In 4 placebo-controlled studies genistein extracts (30-60 mg/d) appeared to significantly reduce symptom frequency in women with moderate-to-severe hot flushes, although to a lesser extent to continuous hormone therapy (-24% vs. -30% respectively.)<ul><li>A 2015 systematic review and meta-analysis (15 high-quality RCTs; n=1753) reported that while phytoestrogens did not decrease the Kupperman index hot flush severity score compared to placebo, their use was associated with a reduction in hot flush frequency5</li><li>Soy isoflavone extracts have been compared to conventional oestrogen replacement in preliminary trials with favourable results in reducing menopausal symptoms and hot flushes6</li></ul>Dosage<ul><li>As a supplement typically found in tablet/capsule or in powder form</li><li>Soy foods contain variable amounts of isoflavones.4,6 May be difficult to obtain therapeutic dose from dietary sources alone</li><li> Dosage range: <ul><li>Soy protein: 20–60 g /d (providing 34–76 mg isoflavones)6</li><li>Soy isoflavone extract providing 50–120 mg/d isoflavones6</li><li>Genistein (soy isoflavone): 30–60 mg/d3</li></ul> </li></ul>Adverse effects<ul><li>May produce GI and menstrual complaints in certain individuals</li><li>Soy may act as a goitrogen affecting thyroid function, especially in those with iodine insufficiency</li></ul>Interactions7<ul><li>Warfarin: soy protein may decrease the anticoagulant effect</li><li>Thyroxine: soy may decrease blood levels of drug unless medications are separated by at least 2 hours</li><li>Tamoxifen: soy may have oestrogenic activity and may theoretically interfere with tamoxifen efficacy</li></ul><h2>BLACK COHOSH (Cimicifuga racemosa)</h2>Mechanism of actionNot fully understood:<ul><li> Does not contain natural oestrogens or exert significant oestrogenic activity. Some evidence suggests it acts as a selective oestrogen receptor modulator4</li><li> May reduce circulating levels of luteinizing hormone in menopausal women4</li><li> May have serotonergic, dopaminergic and opioid activity8</li></ul>ResearchStudies of black cohosh have yielded conflicting data, in part because of variations in herbal preparations and dosage, heterogeneity across studies, and methodological shortcomings9,10 <ul><li> A 2008 systematic review (6 DBRCTs; n=1112)10 concluded that evidence does not consistently demonstrate a beneficial effect; although 5 of the 6 trials had some positive outcomes, especially for reducing the severity of hot flushes. Effects may be greater in peri-menopausal women than postmenopausal women, particularly those with moderate to severe symptoms</li><li> A 2010 systematic review and meta-analysis (9 RCTs) found some black cohosh extracts may reduce symptoms of menopause, such as hot flushes.11 Five of the studies used combination products with various ingredients (including soy, red clover, St John’s wort, Vitex agnus-castus). Six trials found significant improvements. A combined estimate of 7 trials found black cohosh preparations improved VMS overall by 26% compared to placebo. Black cohosh with St John’s wort may improve menopausal symptoms to a greater extent than black cohosh alone</li><li>A 2012 Cochrane review (16 RCTs; n=2027) found no significant evidence to support the use of black cohosh in reducing the frequency of hot flushes and/or other menopausal symptoms in peri-menopausal or postmenopausal women but stated that there is adequate justification for conducting further studies in this area9</li></ul>Dosage<ul><li>Typically found in tablet/capsule form</li><li>Dosage ranges in trials with German products use standardised extract equivalent to 40-140 mg/day dried root and rhizome8</li><li>Doses typically used by Western herbalists range from 0.9-6 g/day dried root and rhizome8 </li></ul>Adverse effects<ul><li>Black cohosh is well tolerated, but may cause headache, GI disturbance and rashes4</li><li>May be linked to rare cases of idiosyncratic hepatic reactions4</li></ul>Interactions<ul><li>Chemotherapeutic drugs: may cause increased cytotoxicity of docetaxel and doxorubicin; decreased cytotoxicity of cisplatin7</li><li>A 2011 prospective observational study (n=50) in breast cancer patients taking tamoxifen found coadministration of black cohosh significantly decreased some menopausal symptoms including hot flushes, sweating, sleep problems, and anxiety12</li></ul>

Primary

<h2>Secondary recommendations</h2><h2>FISH OIL (omega-3)</h2>Studies (1 open, 2 RCTs) have found omega-3s may decrease the frequency of hot flushes and improve mood in menopausal women with psychological distress13,14,15<h2>ST JOHN’S WORT (Hypericum perforatum)</h2>There are mixed data on the efficacy of St John's Wort in relieving hot flushes with one RCT finding benefit at 8 weeks and a pilot study finding a non-significant trend in favour of St John's Wort.16,17 St John's Wort may significantly improve sleep and quality-of-life in peri-menopausal women at 12 weeks17

Secondary

<h2>Diet and lifestyle recommendations</h2><ul><li>Dietary phytoestrogens (such as from soy) may offer a protective role for bone density and may decrease VMS18</li><li>Methods of cooling (e.g. lightweight clothing, use of fans) may help manage VMS but will not reduce VMS or other symptoms2</li><li>Weight loss/healthy BMI may reduce VMS in overweight women2</li><li>Exercise may help but evidence is mixed. Increased physical activity may improve sleep and general wellbeing2</li><li>Relaxation techniques may provide relief of VMS. Slow, controlled, diaphragmatic breathing has been proven effective in clinical trials6</li><li>Mindfulness and cognitive behaviour therapy may reduce impact and severity of VMS1</li><li>Avoidance of smoking, and limiting alcohol and caffeine may benefit all women during the menopause1,2</li></ul>

Diet & lifestyle

<h2>References</h2>1. Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Management of the menopause. RANZCOG; 2014 2. Jane FM, Davis SR. A practitioner’s toolkit for managing the menopause. Climacteric 2014; 17(5):564-79. 3. Lethaby A1, Marjoribanks J, Kronenberg F, et al. Phytoestrogens for menopausal vasomotor symptoms. Cochrane Database Syst Rev 2013; (12):CD001395. 4. Braun L, Cohen M. Herbs &amp; Natural Supplements. 3rd ed. Chatswood: Elsevier; 2010.Chen MN, Lin CC, 5. Liu CF. Efficacy of phytoestrogens for menopausal symptoms: a meta-analysis and systematic review. Climacteric 2015; 18(2):260-9. 6. Natural Medicines database 2016. Soy professional monograph 7. Blackmores Institute Complementary Medicines Interaction Guide; 2016. 8. Bone K, Mills S. Principles and Practice of Phytotherapy 2nd ed. Churchill Livingstone 20139. Leach MJ, Moore V. Black cohosh (Cimicifuga spp.) for menopausal symptoms. Cochrane Database Syst Rev 2012; (9):CD007244. 10. Borrelli F, Ernst E. Black cohosh (Cimicifuga racemosa) for menopausal symptoms: a systematic review of its efficacy. Pharmacol Res 2008; 58(1):8-14. 11. Shams T, Setia MS, Hemmings R, et al. Efficacy of black cohosh-containing preparations on menopausal symptoms: a meta-analysis. Altern Ther Health Med 2010;16(1):36-44. 12. Rostock M, Fischer J, Mumm A, Saller R, Bartsch HH. Black cohosh (Cimicifuga racemosa) in tamoxifen-treated breast cancer patients with climacteric complaints - a prospective observational study. Gynecol Endocrinol. 2011 Oct;27(10):844-8. 13. Freeman MP1, Hibbeln JR, Silver M, et al. Omega-3 fatty acids for major depressive disorder associated with the menopausal transition: a preliminary open trial. Menopause 2011; 18(3):279-84. 14. Lucas M, Asselin G, Mérette C, et al. Ethyl-eicosapentaenoic acid for the treatment of psychological distress and depressive symptoms in middleaged women: a double-blind, placebo-controlled, randomized clinical trial. Am J Clin Nutr 2009; 89(2):641-51. 15. Lucas M, Asselin G, Mérette C, et al. Effects of ethyl eicosapentaenoic acid omega-3 fatty acid supplementation on hot fl ashes and quality of life among middle-aged women: a double-blind, placebo-controlled, randomized clinical trial. Menopause 2009; 16(2):357-66. 16. Abdali K, Khajehei M, Tabatabaee HR. Effect of St John’s wort on severity, frequency, and duration of hot fl ashes in premenopausal, perimenopausal and postmenopausal women: a randomized, double-blind, placebo-controlled study. Menopause 2010;17(2):326-31.17. Al-Akoum M, Maunsell E, Verreault R, et al. Effects of Hypericum perforatum (St. John’s wort) on hot flashes and quality of life in perimenopausal women: a randomized pilot trial. Menopause 2009; 16(2):307-14. 18. Ma DF, Qin LQ, Wang PY, et al. Soy isoflavone intake increases bone mineral density in the spine of menopausal women: meta-analysis of randomized controlled trials. Clin Nutr 2008;27(1):57-64

Menopause

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