The UK National Institute for Health and Care Excellence (NICE) has issued its first-ever guidance on menopause , which emphasizes that help and information are available to women suffering from symptoms and that a range of treatment options, such as hormone-replacement therapy (HRT) as well as nondrug treatments, can be discussed with their doctors.
The new guidelines were widely reported in the UK media, along with a variety of reactions.
NICE notes that menopause is a gradual process that occurs on average, at age 51 in UK women, and it estimates that 80% of women going through perimenopause/menopause suffer from common symptoms such as hot flashes and night sweats. Other debilitating symptoms include mood changes, sleep disturbances, joint and muscle pain, and headaches.
Together these symptoms, which last 4 years on average but can affect 10% of women for up to 12 years, "can severely affect a woman's life. Yet the effects of menopause are often not fully understood. As a result, women do not always get the help they need from their general practitioner [GP], nurse, practice, or hospital specialist to manage their symptoms effectively," NICE notes.
Published yesterday, the guidelines received unprecedented media coverage here in the United Kingdom, in particular with regard to the issue of whether or not women should take HRT. Since the results of the Women's Health Initiative studies more than 10 years ago, which showed no cardiovascular benefit but showed an increase in breast-cancer risk, there has been a big decline in the number of women taking HRT for menopausal symptoms in the United Kingdom.
Some newspaper reports of the new NICE guidelines included criticism from cancer experts, who said that the cancer risks associated with HRT are being downplayed by NICE and that the result of this new guideline might be to "rehabilitate" HRT without appreciation of the potential long-term harm. And there was condemnation that more than half of the members of the NICE panel that compiled the guidelines have ties to pharmaceutical companies that manufacture HRT products.
GPs Lack Confidence to Prescribe HRT
The guidelines steer doctors through how to diagnose menopause and advise women on the short- and longer-term treatment options for each symptom, including vasomotor and psychological symptoms, as well as urogenital atrophy.
As well as conventional menopause, the guidelines also focus on the "often-overlooked" needs of women aged under 40 experiencing premature menopause and women who have menopause triggered as a result of treatment for hormone-dependent cancer or gynecological conditions.
They also counsel doctors to explain to women who wish to try complementary therapies that "the quality, purity, and constituents of products may be unknown." Similarly, the "efficacy and safety of unregulated compounded bioidentical hormones are unknown," they add.
With regard to HRT, there are tables detailing risks for coronary heart disease, venous thromboembolism, stroke, breast cancer, and osteoporosis according to type of HRT and duration of use, including how that risk changes after stopping HRT.
The NICE guidelines recommend that doctors:
Offer women HRT for hot flushes and night sweats after discussing risks and benefits.
Consider HRT to ease low mood that occurs as a result of menopause and consider cognitive behavioral therapy to alleviate low mood or anxiety.
Explain that estrogen-only HRT has little or no increase in the risk of breast cancer, while HRT with estrogen and progestogen can be associated with an increase in the risk of breast cancer, but any increased risk reduces after stopping HRT. Specifically, it says there will be 17 more cases of breast cancer per 1000 menopausal women in current HRT users over 7.5 years (compared with no HRT).
Understand that HRT does not increase cardiovascular disease risk when started in women aged under 60 years and it does not affect the risk of dying from cardiovascular disease. Also ensure that women with cardiovascular risk factors are not automatically excluded from taking HRT.
Refer women to a menopause specialist if there's no improvement after trying treatments.
"For the past decade, some GPs have been worried about prescribing HRT, and women worried about taking it,"Dr Imogen Shaw, a GP with special interest in gynecology and one of the authors on the new guideline, said in a NICE press release issued yesterday.
"I hope that this new NICE guideline will empower women to talk to their GP or practice nurse about menopause and provide them with information on the range of options that could help. For health professionals, the guideline should boost their confidence in prescribing HRT, having fully discussed the woman's individual circumstances with her," she added.
Varied Reactions From Specialist Bodies
Reactions of specialist organizations to the new guidance varied.
In a statement provided to Medscape Medical News, Dr David Richmond, president of the Royal College of Obstetricians and Gynaecologists (RCOG), called the guidelines a "milestone" and said that, for some women, "menopausal symptoms can be extremely debilitating and dramatically impact upon their quality of life."
This guidance has been compiled by the leading experts in the field and represents a comprehensive review of all of the existing evidence, he added. "We hope that this guideline will not only support healthcare professionals but also provide women with the necessary information to empower them to make informed decisions about their choice of treatment."
Dr Heather Currie, chair of the British Menopause Society (BMS), added:"Our hope is that the guideline will play an important role in raising awareness of all menopausal symptoms, will encourage women to consider lifestyle changes to improve later health, and will clarify uncertainty around both prescribed and nonprescribed treatment options."
She acknowledged, however, that much further research is "needed."
Meanwhile, Valerie Beral, MBBS, director of the cancer epidemiology unit at Oxford University — who leads the Million Women study, which has linked HRT to breast and ovarian cancer — spoke to UK newspapers to stress that the risks of cancer are clear.
"About one million UK women are currently using hormones for the menopause," she told the Guardian. "Among them, about 10,000 extra breast cancers are estimated to occur in the next 10 years [40,000 in total, instead of 30,000 if the women had not used the hormones]. Also about 1000 extra ovarian cancers are estimated to occur among them in the next 10 years [6000 in total]."
"The link between cancer and hormone-replacement therapy is well established and is underpinned by a large body of evidence," Dr Julie Sharp, head of health information at Cancer Research UK, added in a statement provided to Medscape Medical News.
"Although it's an effective treatment for menopausal symptoms, we know that using HRT increases a woman's risk of developing breast, ovarian, and in some cases, womb cancer.
"It's vital that each woman has access to good-quality information about the benefits and risks of using HRT so that she can come to a decision that is right for her," she added.
Unlike Cancer Research UK, however, North American cancer groups have been much less vocal about the issue of HRT. The American Association for Cancer Research, the American Society of Clinical Oncology, and the American Cancer Society all told Medscape Medical News recently that they have no official position or recommendations about HRT.
Cancer Risk Is "Not Trivial"
Separately, Klim McPherson, MA, PhD, of Oxford University, an epidemiologist who has performed research into cancer and HRT, expressed concern that neither he nor Dr Beral were asked to participate in drawing up the new NICE guidance, calling the decision "ludicrous" in an interview with a UK tabloid newspaper, the Daily Mail .
"The guidelines are totally misleading. They give the impression that the cancer risk from HRT is trivial, and it is not," he added.
Dr McPherson added that he is also troubled by the fact that half of the 18 NICE panel members who drew up the guidance have financial ties to pharmaceutical companies marketing HRT.
NICE told Medscape Medical News in a statement that it recruits members to its guideline committees "through open, competitive advertising and appoints members from the [National Health Service] NHS, academia, and industry as well as lay members with an understanding of patient and public perspectives on healthcare issues.
"All of our guidance is also subject to public consultation, and we actively seek the views of healthcare professionals, patient groups, and national organizations independent of the guideline-development group, which effectively minimizes the risk of undue influence to any guideline.
"We have a clear and robust conflict-of-interest policy, which is applied throughout our recruitment process and publicly available on our website."
National Institute for Health and Care Excellence. Menopause: diagnosis and management. Guidelines
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Cite this: Menopause Therapy: 'Don't Suffer Silently,' Says UK NICE - Medscape - Nov 13, 2015.
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