Menopause & HRT

1. Menopause & HRT DR FULVA DAVE 29th November 2016

2. ‘Aging’ an unavoidable property of all living tissue.. - Charles Darwin

3. ‘They thought I was a hypochondriac. It’s taken me years to convince them that there was something else besides neurosis’ ‘I didn’t feel like a ‘real woman’. I felt inferior’ ‘I felt like a new person. I was reborn, even though they were brought on by tablets’ ‘Most people say; ‘At my age’, ‘I’m at the age’ and I think, ‘well, I’m not, not at all, I’m half the age’………………

4. Women’s one third of life in menopause • Women make up almost half (47%) the workforce in the UK – occupational health issue • 3.5 million women age 50 or over • Research at University of Nottingham in 2011 - majority felt they were little preparted for this ‘change of life’ - need for further advice & support - some considered working part-time/alternatives - Issue about temperature control at workplace, poor toilet facilities, lack of access to cold drinking water, uniform etc

5. Objectives • Refresh and strengthen the basics • NICE update • Clarify myths related to HRT

6. What is menopause? • Meno-pause (cessation of periods) • 12 months after last menstrual period • Average age in UK - 51 years • Perimenopause - symptoms + irregular periods (45-55 years) • Early menopause < 45 years (around 5%) • Premature menopause < 40 years (1%)

7. Menopause contd. • DO NOT use FSH test to diagnose menopause if on women using hormones • Consider using FSH test as a diagnostic test for menopause ONLY if: Age 40 - 45 years with menopausal symptoms including a change in menstrual cycle Age < 40 with a suspicion of early onset of menopause

8. Premature menopause • Aetiology • Elevated FSH levels > 30 IU/L (two samples 4-6 weeks apart) Fertility issues • Osteoporosis - Increased risk • Need HRT until 51 years • Refer for expert opinion

9. Symptoms & effects Hot flushes Osteoporosis • Night sweats Cardiovascular disease • Sleep disturbances Dementia • Joint pains, aches Degenerative/debilitating disease • Headaches Incontinence • Memory loss • Anxiety, depression • Vaginal dryness, low libido Oestrogen deficiency • Bloating • Increased urinary frequency

11. How does it affect? • Not everyone suffers with symptoms • 70% - vasomotor symptoms • Varies - familial, ethnicity • Duration : 6 months - 20 years • After 60, requirement for oestrogen reduced

12. What to do? • Awareness • Coping mechanisms (Diet, lifestyle, Exercises) • If severe, consider HRT

13. Diet, Exercise, Lifestyle • Greatest impact on women’s life • Balanced diet & optimum BMI • Weight bearing exercise, brisk walking • Smoking, alcohol, caffeine, excess salt & sugar

14. Hormone replacement therapy (HRT) Oestrogen (Main), Progestogens (Endometrial protection) and Testosterone (Rarely used) Truly effective to reduce symptoms and long term benefits for bones Women without uterusWomen with uterus - Oestrogen only - Oestrogen & Progesterone Still having periods or within 1 year of LMP Cyclical/Sequential More than one year of LMP or after 54 years Continuous combined

15. HRT contd. • Oestrogen preparationsProgesterone preparations • Ethinyl estradiol (synthetic) Norethisterone • Estradiol Levonorgesterol • Estriol Medroxyprogesterone acetate • Estrone Mirena IUS • Micronised Progesterone – • Utrogesterone (natural)

16. Doses & routes • Oral 0.5mg, 1mg, 2mg (once a day) • Patches 25, 37.5, 50, 75, 100 mcg (twice weekly) – below waist • Gel/Pessary/Cream • Progestogens - variable • Mirena (20mcg LNG/day) • Natural progestogen (utrogestan) 100 or 200mcg • Testosterone (gel, cream) Implants no longer available in UK

17. Side effects • Fluid retention • Headaches • Breast tenderness • Bloating • Nausea • Mood swings • PMS like symptoms

18. Contraindications • Oestrogen dependent malignant tumours - breast, endometrium • Undiagnosed vaginal bleeding • Current DVT/PE • Pregnancy

19. Controversies…..

21. Women’s Health Initiative (WHI)Million Women Study (MWS) - USA (1993-2002) - UK (1996 – 2003) - 16000 (50-79) - One million women attending NHS - Randomised HRT Vs placebo breast screening clinic over 50 years old - Increase in breast cancer, coronary - Screening women already high risk events, stroke, DVT in HRT group - Study methodology criticised - Study stopped early in 2002 - Oestrogen only increases risk of breast, - HRT in under 60 - Protective uterine and ovarian cancer - Risk is duration dependent, more risk - Combined more risk than oestrogen only with combined than oestrogen only

22. HRT - risks • Breast cancer risk -4 extra cases /1000 women after 5 years (This is less risk than smoking 10 cigs/day) 45/1000 – population risk 49/1000 – HRT (5 years) 51/1000 – HRT (10 years) Combined HRT more risk than with Oestrogen only Safe for receptor negative cancers SSRIs should not be offered to patients with breast cancer on tamoxifen Risk reduces after stopping HRT

23. HRT risks contd. • Ovarian cancer - No increased risk • Endometrial cancer - Adding progestogen decreases risk

24. HRT risks contd. • Venous thromboembolism • Risk of VTE is increased with oral HRT compared to baseline population risk • Risk of VTE associated with transdermal preparations given at the standard • therapeutic dose is no greater than the baseline population risk • Risk of VTE is greater in oral HRT compared with transdermal preparations • Patients with high risk of VTE (strong FH of VTE or hereditary thrombophilia) • refer to menopause specialist or haematologist for assessment before • considering HRT

25. HRT risks contd. • Risk of heart disease not increased if started between 50 and 59 • Stroke - not increased if started under 60. More risk with smoking and over weight • Weight gain - RCT no evidence • Osteoporosis - Useful more in Premature menopause, but not a first line for prevention • in older • Do not use HRT In Breast or Endometrial cancer, Stroke or DVT, Severe liver disease.

26. Review • At 3 months to assess efficacy and tolerability • Annually thereafter unless treatment becomes ineffective or side effects from HRT

27. Referral • Treatment does not improve their menopausal symptoms • Ongoing troublesome side effects • Menopausal symptoms & contraindication to HRT • Uncertainty about the most suitable treatment options

28. Criteria for ultrasound • Any bleeding after 6 months of continuous combined HRT even in low risk women • Bleeding after amenorrhoea has been established • Any bleeding in the first 6 months if any risk factors present

29. Alternative options • Tibolone(Livial) – oestrogenic, progestogenic & androgenic properties • SERM - Raloxifene • SSRI/SNRI - Venlafaxine/Fluoxetine/Paroxetine • Clonidine - not very effective • Complementary - soya, red clover, black cohosh, evening primrose, acupuncture, homeotherapy • Insufficient data for safety & effectiveness

30. Alternative options contd. • Bio-identical hormones - not enough evidence for safety • - same risk and benefit as traditional • - unregulated • Cognitive behavioural therapy

31. To summarise…. Premature menopause Totally safe until 51 years, then review Peri menopause and Post menopause Benefits Vs Risk (Individualised) Symptom control & long term benefits (Bones, Heart) Lowest effective dose Sooner the better Not advisable to start after 60 years

32. Do not use FSH test routinely to diagnose menopause • Contraception after last menstrual period – 2 years if < 50 years • 1 year if > 50 years • Consider referral to appropriate health professional expert for • complex cases

33. Where to refer?

34. Menopause clinic at QMC, NUH (every Thursday am) Miss Anita Juliana – RCOG & BMS accredited Menopause specialist Staff awareness session quarterly - NUH 14000+ workers 10500 women 4000 > 45 years old

35. Case discussion

36. Case study • 52 year old secondary school teacher • No relevant medical history • Always calm and organised • Recently irritable and struggling to cope with minor challenges • Exploited by school children of her weakness • Unable to sleep, asking GP for more sleeping tablets

37. How to approach? • Relevant history LMP 6/12 ago, before that 3/12 ago • Night sweats with severe chills sometimes, occasional day time flushes • Often wakes up then sweats • No interest in sex, often it hurts

38. She would like to try some HRT • Where in menopause transition is she? • What are the symptoms? • What is her main concern? • What is her risk profile?

39. What do we choose now? • Elleste duet 1mg Estradiol 1mg plus NET 1mg from day 17-28 NHS cost £9.72 for 3 months

40. Review in 3 months • Persistence of symptoms • Any new symptoms/side effects? • When do they occur in the cycle? • Bleeding pattern • BP • Review of risk analysis

41. 3 months later • Symptoms and sleep better in the first 2 weeks of the pack • Not so good and tearful when pill colour changes • Bleeding is fine • Would like to improve things

42. Modify treatment • Increase estrogen • Change progestogen preparation • Femoston 2:10 ( 17B estradiol 2mg plus 10mg dydrogesterone) • Cost £13.47 for 3 months

43. Additional resources • NICE guideline 2015 • British menopause society • www.menopausematters.co.uk • www.womens-health-concern.org.uk • www.menopause-health-concern.org.uk • www.daisynetwork.org.uk • TOG article by Dr Dave et al…!

44. Thank you