Hormone replacement therapy is the most effective treatment for menopause symptoms. Despite concerns regarding its long-term use, women often have concerns about stopping it.
The menopause is a natural part of female ageing and up to 75% of women experience menopause symptoms, most commonly vasomotor symptoms. Hot flushes and sweats usually resolve in 2-5 years, but studies on the duration of vasomotor symptoms have shown that over 10% of women with flushes will flush for more than 10 years, with some women continuing to flush into their 70s and beyond. It is possible that this group of women with persistent symptoms will continue to be symptomatic when trying to discontinue HRT. However only a minority of women will take hormone replacement therapy (HRT), even though this offers the greatest efficacy for symptom control. HRT is generally initiated in the perimenopause and most women will have discontinued it within five years.1
Why stop HRT?
The background risk of cardiovascular disease and breast cancer increases with age and there is concern that longer-term use of HRT in women, particularly over 60 years adds to this. The findings of the Women’s Health Initiative (WHI) Study and subsequently the Million Women Study raised concerns about the longer-term use particularly of combined oestrogen/progestogen HRT in regards to increasing breast cancer risk and the use of HRT in older women because of the associated risk of coronary heart disease and stroke.2
However HRT has the potential for improving cardiovascular disease (CVD) risk because of favourable effects on vascular function, cholesterol levels and glucose metabolism. The WHI study showed the risk of coronary heart disease (CHD) was greater in women starting HRT more than 10 years following menopause. This is possibly due to cardiovascular changes that had already occurred after the menopause and before HRT was started. There is evidence that HRT started within 10 years of the menopause may offer a degree of protection against CHD but women taking HRT beyond 60 years need to be aware of the possible increasing risks. The WHI study also showed that HRT started at any age increased stroke risk slightly and with the increasing background risk of strokes in ageing women, this adds to the concern about HRT use in women beyond 60 years.2
However women with severe and protracted symptoms may wish to take HRT in the longer term (more than five years) for quality of life reasons, and as a result they would still fulfill the criteria for HRT use as issuedby the Committee on Safety of Medicines. This advice was issued in response to the initial findings of the WHI study and is shown in Table 1.3 Additional recommendations were then published by the Medicines and Healthcare Products Regulatory Agency (MHRA) in 2007 (Table 2) that stated that the decision to prescribe HRT should be based on a thorough evaluation of the potential rises and benefits (including quality of life) of treatment, particularly in those older than 60 years who may have increased baseline risk of serious adverse events.4
It is important to note that the concerns about longer-term HRT use do not apply to young women taking HRT for premature ovarian failure and it is important for these younger women to continue HRT until their early 50s, the average age of the natural menopause, as recommended by the CSM.
How and when to stop HRT?
Approximately 75% of women who try to stop are able to stop HT without major difficulty.5A number of studies have shown that the return of symptoms is little different whether the HRT is stopped abruptly or tapered down gradually.5 However one retrospective survey, women that had tapered down their HRT gradually and concomitant alternative therapies had a return of fewer menopause symptoms than those women who stopped HRT abruptly.6 If a woman experiences significant menopause symptoms impacting her quality of life while reducing or after stopping HRT, she still fulfills the CSM criteria for continuing it. The International Menopause Society recommend that women should “try without HRT every few years” but acknowledge that in some women symptoms can last for many years, and that the lowest effective dose should be used.2 As menopause symptoms do improve with time, generally increasingly lower doses can be used for symptom control.
Vasomotor symptoms usually begin before periods stop and their severity peaks in the first year after the last period. Therefore it seems logical to wait until a woman is postmenopausal before attempting to reduce HRT. As many women start HRT in the perimenopause, it is impossible to predict when menstruation finally ceases.
However, eighty percent of women are postmenopausal by 54 years1 and most women can be changed onto a continuous combined HRT preparation at this stage, as it provides most effective endometrial protection2 and eliminates the need for a regular withdrawal bleed. Changing to a continuous combined regime is an opportunity for reducing the oestrogen dose, as part of the tapering down process. Anecdotally, older women need less oestrogen to control their symptoms and the continuous progestogen in these regimes may contribute to symptom control.1
However despite the advice from the MHRA to use the smallest possible dose for effective symptom control, increasingly lower doses of oestrogen products are limited and therefore reducing the frequency of dosing becomes inevitable. As menopause symptoms fluctuate in severity, if a woman is attempting to wean herself off HRT, it would seem sensible to leave several months between each reduction.
Problems stopping HRT
Women that feel well on HRT are likely to be reluctant to stop, especially as it is not possible to predict who will experience a return of menopause symptoms. As HRT is generally the most effective treatment for menopause symptoms, women need to understand that other treatments may not be as effective. However some reduction in symptoms with alternative approaches will be helpful and may be sufficient for women wanting to avoid longer-term use of HRT.
Vasomotor symptoms and genitourinary atrophy are most frequently reported when discontinuing HRT.7 The onset of arthritic conditions such as rheumatoid arthritis and osteoarthritis often coincide with menopause and joint pain too is frequently problematic when discontinuing HRT.8 One study showed that some women also experienced a general reduction in quality of life and this too should to be considered.6
The decision to come off HRT needs to be made after consultation between the clinician and each individual woman. It seems sensible to counsel women about trigger factors that impact vasomotor symptoms, such as smoking, alcohol, caffeine, high body mass index, stress and anxiety, before altering the HRT dose. Making appropriate diet and life style changes may help reduce the severity of any returning symptoms.
Stress and anxiety are major well-known trigger factors for vasomotor symptoms, so allowing women some control over the timing and pace of tapering down the dose, depending on their life pressures and return of symptoms would also seem logical. Small trials on the effects of meditation, relaxation, controlled breathing and cognitive behavioural therapy show promise2 but more data is still needed. There is a plethora of over-the-counter therapies available for the control of vasomotor symptoms but none have been found to be consistently beneficial in the control of vasomotor symptoms. However, one recent double-blind placebo controlled study showed that isoflavones (80mg daily) significantly reduced vasomotor symptoms.9 There is also some anecdotal data on the use of magnetic therapy for the reduction of flushes and sweats. There is little evidence that exercise can help reduce vasomotor symptoms but should still be encouraged for its multiple other benefits.
Alternative prescribed medication for the control of vasomotor symptoms includes gabapentin (up to 300mg three times daily) and this was shown to be as effective as a low-dose oestrogen preparation. However it is an unlicensed use and women need to be warned of side effects and possible drug interactions. A number of antidepressants including venlafaxine, fluoxetine, paroxetine and citalopram have all be shown in randomised clinical trials to reduce vasomotor symptoms. In one study venlafaxine in a dose up to 75mg daily was equally effective as gabapentin but was better tolerated. Clonidine in doses of 50-75mcg twice daily offers another alternative for women with mild to moderate flushes and in turn is better tolerated than venlafaxine. Long-term efficacy with these agents has not been demonstrated.2
Forvaginal atrophy or urinary symptoms linked to the menopause, consider offering a local low dose vaginal oestrogen, starting as HRT is withdrawn, before atrophy becomes a significant problem. These products contain either low dose oestradiol or a weak oestrogen, oestrone. They have very limited systemic absorption but may take a number of months to be totally effective if a vaginal has become atrophied. Low dose vaginal oestrogen tablets are now licensed for indefinite use and women may continue them in the long term for control of urinary symptoms or vaginal dryness, without an effect on the endometrium.
Simple vaginal lubricants can improve discomfort during intercourse and non-hormonal preparations for vaginal atrophy are available on prescription. For women with continuing postmenopausal urinary problems, life style changes (such as weight reduction), bladder retraining, pelvic floor muscle training and alternative prescribed medication such as duloxetine may be appropriate.
There is limited information and research specifically on non-hormonal treatment of postmenopausal joint pain, despite this being a common problem.The National Institute for Health and Clinical Excellence (NICE) has produced guidance for the management of osteoarthritis.10 Accessing appropriate information on life style changes, exercise to improve fitness and to strengthen muscles and weight loss, if applicable, needs to be done on an individual basis and may offer sufficient symptom control. Over-the-counter alternatives such as glucosamine (with or without chondroitin), have some data to support their use for knee and back pain, however are contradicted for use in people with an allergy to shellfish and those taking warfarin.2 Othercomplementary therapies, homeopathy,11 massage and acupuncture have some limited data to support their use for postmenopausal joint pain.1
Longer term health risks in the postmenopause
The prevalence of heart disease, osteoarthritis and osteoporosis in women increases significantly at menopause and continues to increase thereafter. In addition to supporting a woman coming off HRT, there is also an opportunity to consider her long-term health risks.
Women with a history of vasomotor symptoms may be at particular risk andlimited data from the WHI study suggest that hot flushes were associated with cardiovascular disease.12 However life style modification has been shown to attenuate this risk. It may be prudent to offer women who started HRT for the treatment of vasomotor symptoms a CVD risk assessment and appropriate advice on diet, life style and exercise.
While HRT is protective against the hormone related postmenopausal bone loss and fracture risk, this protection is gradually lost after HRT is discontinued. An individual’s fracture risk can be estimated using the FRAX model, developed through the World Health Organisation and available online at www.sheffield.ac.uk/FRAX. For women at risk, alternative bone protective medication can the be initiated before HRT is discontinued. Ideally all women at the menopause or discontinuing HRT should be offered information on bone protection.
Alzheimer’s disease is twice as common in women than in men. Again diet and lifestyle factors are recommended to help reduce or delay the onset of Alzheimer’s disease, similar to those for cardiovascular and bone protection but we should also be encouraging women to stay mentally active by reading, writing, taking adult education courses, dancing, playing instruments or doing mental puzzles, together with socialising and generally pursuing hobbies and interests.
As the risks of continuing HRT in older women are not fully understood, there is concern about long-term use. However the risks and benefits of HRT use will vary between each woman and as a result it is not possible or appropriate to create an arbitrary limit of its use to apply to all women.
Discontinuing HRT needs to be achieved in a timely way. As quality of life is a criterion for its use it is important to encourage women to implement dietary and life style changes that may affect the return of menopause symptoms beforehand. Alternative treatment options and approaches should also be considered if symptoms return. As stress and anxiety are well-known trigger factors for vasomotor symptoms, allowing women some control about when HRT should be withdrawn seems prudent. As HRT is effective in preventing postmenopausal bone loss and there is evidence that it is cardioprotective if started around the time of the menopause, counseling women about the withdrawal of HRT provides a valuable opportunity to discuss lifestyle and dietary factors to promote healthy ageing and to encourage women to take responsibility for their long-term physical, mental and social health.
1. Rees M, Stevenson J, Hope S et al. Management of the Menopause, 5th edition. London: Royal Society of Medicine Press Ltd; 2009.
2. Sturdee DW and Pines A. Updated IMS recommendations on hormone replacement therapy and preventive strategies for midlife health. Climacteric. 2011;14:302-20.
3. Duff D. Further advice on the safety of HRT: risk: benefit unfavourable for first line use in prevention of osteoporosis. 2003. Available at: www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con019496.pdf. Accessed 9th January 2012.
4. Tilstone C, Ed.. Hormone-replacement therapy: updated advice.Drug Safety Update. MHRA; 2007. Available at: www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con2032233.pdf. Accessed 9th January 2012.
5. Lindh-Åstrand L, Bixo M, Hirschberg AL, et al. A randomized controlled study of taper-down or abrupt discontinuation of hormone therapy in women treated for vasomotor symptoms. Menopause. 2010;17(1):72-9.
6. Haskell S, Bean-Mayberry B, Gordon K. Discontinuing post-menopausal hormone therapy an observational study of tapering versus quitting cold turkey: is there a difference in recurrence of menopausal symptoms. Menopause. 2009;16(3):494-499.
7. Ness J, Aronow WS and Beck G. Menopausal symptoms after cessation of hormone replacement therapy. Maturitas. 2006;53(3):356-61.
8.Stevenson JC. A woman's journey through the reproductive, transitional and postmenopausal periods of life: Impact on cardiovascular and musculo-skeletal risk and the role of estrogen replacement. Maturitas.2011;70:197-205.
9. Lipovac M, Chedraui P, Gruenhut C et al. The effect of red clover isoflavone supplementation over vasomotor and menopausal symptoms in postmenopausal women. Gynecological Endocrinology. (Epub ahead of print).
10. National Institute for Health and Clincical Excellence (NICE). Osteoarthritis: The care and management of osteoarthritis in adults. London: NICE; 2008. Available at:http://publications.nice.org.uk/osteoarthritis-cg59
11.Thompson EA. Alternative and complementary therapies for the menopause: a homeopathic approach. Maturitas. 2010;66(4):350-4.
12. Pines A. Vasomotor symptoms and cardiovascular disease risk. Climacteric. 2011;14(5):535-6.
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