Yet again scientists and epidemiologists are publicly debating the
controversies around the previously reported risks of HRT (hormone
replacement therapy). Is this further publicity deserved? The impact of
studies such as the Million Women Study (MWS)[1] and Women's Health
Initiative (WHI)[2] has been profound leading to significant reductions in
the use of HRT. This has understandably affected millions of menopausal
women globally who deserve to be fully informed of any doubts that may
exist concerning the studies and should be aware of the debate.[3-4]
Ever since these publications were published the headlines in the
popular press have been biased towards the 'bad news' messages, resulting
in our patients feeling confused and under pressure to stop HRT. Following
a recent web-based survey 70% of women who came off their HRT were below
the age of 50. More importantly had these women known what we know today,
45% would have stayed on treatment.[5]
Many patients have been advised by their doctors to stop HRT and in
some cases have had their prescriptions unilaterally withdrawn. These
women have sought additional, poorly researched products with unproven
safety and efficacy - often sold as food supplements to circumvent
regulatory authorities.
Which risk is greatest? Taking a treatment which has little evidence
of effectiveness or safety, or taking a product with the enormous research
base that applies to HRT? Do we really know the answer? Is there enough
information to allow carers or patients to be fully informed? We believe
that the risk, if any is small and it is the view of the British Menopause
Society (BMS) that, when used appropriately, any risks are outweighed by
the benefits for the majority of women.
We must not forget that at the centre of the current published
arguments there are millions of women who want to be properly informed
about whether they should be taking HRT. Further, there are likely to be
thousands of doctors and nurses who want to be more knowledgeable and
confident about prescribing HRT.
In recognition of the menopause having diverse consequences and in an
attempt to improve the provision of essential information for women, the
BMS has recently submitted recommendations to the Department of Health.
The key recommendation is that women should, around the time of the
menopause transition, have a formal assessment of their needs, including
advice concerning lifestyle, diet and individualised discussion of the
risks and benefits of any suitable hormonal therapies. The BMS also
suggested that whilst this would require additional resources, the
potential long-term health gains would make this consultation highly cost
effective in disease prevention terms.[6]
The two main areas that require addressing urgently are:
1) A robust understanding of the benefits and risks of HRT for
patients and carers.
Most women who have been taking HRT since the publication of WHI and
MWS will have been doing so having weighed up the pros and cons of
treatment. Many women, even if there were genuinely a small increased risk
of breast cancer, would accept this, if they could have a good quality of
life through relief of the debilitating symptoms that invariably affect
personal, social and wider quality of life.
The clear benefits in osteoporosis treatment and prevention have
recently been included in a recommendation from the National Osteoporosis
Society that recommends HRT for the treatment and prevention of
osteoporosis in women under 60.[7]
2) HRT is not a single drug as the press and our patients seem to
have derived from the publicity.
HRT is a comprehensive suite of preparations and delivery routes
produced by the pharmaceutical industry in response to women's needs over
more than 20 years of development, refinement and research. This research
continues, even though research funding is a fraction of what it once
was.[8]
Recently completed trials not only suggest that natural progesterone
may not affect the risk of breast cancer and have a neutral effect,[9] but
also that soon to be released small studies of lower dose, endogenous-type
hormone treatments given to recently menopausal women show great
promise.[10]
The BMS feels that the research must continue. As the female
population lives longer after the menopause we need to establish safe ways
to prevent disease and maintain a high quality of life. This requires a
trial to establish definitively the correct indications, patients and
hormones for optimal postmenopausal health.[11] We should harness the
wealth of knowledge from the debates around WHI and MWS to design this
study rather than watch the arguments from the sidelines.
The BMS is dedicated to advancing education in all matters relating
to the menopause and to the primary prevention of the burden of
preventable chronic disease.
Nick Panay, Chairman, British Menopause Society;
Consultant Gynaecologist, Queen Charlotte's and Chelsea & Westminster
Hospitals, Honorary Lecturer, Imperial College London, London, UK
Heather Currie, Medical Advisory Council Member, British Menopause Society;
Associate Specialist Gynaecologist, Dumfries and Galloway Royal Infirmary,
Dumfries, UK; Medical Director "Menopause Matters Ltd"
Edward Morris, Medical Advisory Council Member, British Menopause Society;
Consultant, Obstetrics & Gynaecology, Norfolk & Norwich University
Hospital, Norwich, UK
References
[1] Million Women Study Collaborators. Breast cancer and HRT in the
Million Women Study. Lancet 2003; 362: 419-427.
[2] Writing group for the Women's Health Initiative Investigators.
Risks and benefits of estrogen plus progestin in healthy postmenopausal
women: principal results from the Women's health initiative randomised
controlled trial JAMA 2002; 288(3): 321-333.
[3] Shapiro S, Farmer RD, Stevenson JC, Burger H, Mueck AO. Does
hormone replacement therapy cause breast cancer? An application of causal
principles to three studies Part 4: The Million Women Study J Fam Plann
Reprod Health Care 2012. Jan 16 (ahead of print)
[4] Shapiro S, Farmer RD, Mueck AO, Seaman H, Stevenson JC. Does
hormone replacement therapy cause breast cancer? An application of causal
principles to three studies: part 2. The Women's Health Initiative:
estrogen plus progestogen. J Fam Plann Reprod Health Care 2011
Jul;37(3):165-172.
[5] Cumming GP, Currie HD, Panay N, Moncur R, Lee AJ. Stopping
hormone replacement
therapy: were women ill advised? Menopause Int 2011; 17(3): 82-87.
[6] British Menopause Society Council. Modernizing the NHS:
observations and recommendations from the British Menopause Society.
Menopause Int 2011 Jun;17(2):41-43.
[7] Bowring CE, Francis RM. National Osteoporosis Society's Position
Statement on hormone replacement therapy in the prevention and treatment
of osteoporosis. Menopause Int 2011; 17: 63-65.
[8] Panay N, Ylikorkala O, Archer DF, Rakov V, Gut R, Lang E. Ultra
low-dose estradiol and norethisterone acetate: Effective menopausal
symptom relief. Climacteric 2007; 10(2): 120-131.
[9] Fournier A, Fabre A, Mesrine S, Boutron-Ruault MC, Berrino F,
Clavel-Chapelon F. Use of different postmenopausal hormone therapies and
risk of histology- and hormone receptor-defined invasive breast cancer. J
Clin Oncol 2008; 26(8):1260-1268.
[10] Harman SM, Brinton EA, Cedars M, Lobo R, Manson JE, Merriam GR,
Miller VM, Naftolin F, Santoro N. KEEPS: The Kronos Early Estrogen
Prevention Study. Climacteric 2005 Mar;8(1):3-12.
[11] Panay N, Fenton A. Has the time for the definitive, randomized,
placebo-controlled HRT trial arrived? Climacteric 2011 Apr;14(2):195-196.
Conflict of Interest:
Nick Panay (NP), Eddie Morris (EM) and Heather Currie (HC) have received sponsorship for lectures and advisory work performed for pharmaceutical companies.
NP and HC have received educational grants for meetings and NP has received funding for pharmaceutical trials.
NP is co-editor in chief of Climacteric (International Menopause Society Journal) and EM/HC are co-editors in chief of Menopause International (British Menopause Society Journal).
Yet again scientists and epidemiologists are publicly debating the controversies around the previously reported risks of HRT (hormone replacement therapy). Is this further publicity deserved? The impact of studies such as the Million Women Study (MWS)[1] and Women's Health Initiative (WHI)[2] has been profound leading to significant reductions in the use of HRT. This has understandably affected millions of menopausal women globally who deserve to be fully informed of any doubts that may exist concerning the studies and should be aware of the debate.[3-4]
Ever since these publications were published the headlines in the popular press have been biased towards the 'bad news' messages, resulting in our patients feeling confused and under pressure to stop HRT. Following a recent web-based survey 70% of women who came off their HRT were below the age of 50. More importantly had these women known what we know today, 45% would have stayed on treatment.[5]
Many patients have been advised by their doctors to stop HRT and in some cases have had their prescriptions unilaterally withdrawn. These women have sought additional, poorly researched products with unproven safety and efficacy - often sold as food supplements to circumvent regulatory authorities.
Which risk is greatest? Taking a treatment which has little evidence of effectiveness or safety, or taking a product with the enormous research base that applies to HRT? Do we really know the answer? Is there enough information to allow carers or patients to be fully informed? We believe that the risk, if any is small and it is the view of the British Menopause Society (BMS) that, when used appropriately, any risks are outweighed by the benefits for the majority of women.
We must not forget that at the centre of the current published arguments there are millions of women who want to be properly informed about whether they should be taking HRT. Further, there are likely to be thousands of doctors and nurses who want to be more knowledgeable and confident about prescribing HRT.
In recognition of the menopause having diverse consequences and in an attempt to improve the provision of essential information for women, the BMS has recently submitted recommendations to the Department of Health. The key recommendation is that women should, around the time of the menopause transition, have a formal assessment of their needs, including advice concerning lifestyle, diet and individualised discussion of the risks and benefits of any suitable hormonal therapies. The BMS also suggested that whilst this would require additional resources, the potential long-term health gains would make this consultation highly cost effective in disease prevention terms.[6]
The two main areas that require addressing urgently are:
1) A robust understanding of the benefits and risks of HRT for patients and carers.
Most women who have been taking HRT since the publication of WHI and MWS will have been doing so having weighed up the pros and cons of treatment. Many women, even if there were genuinely a small increased risk of breast cancer, would accept this, if they could have a good quality of life through relief of the debilitating symptoms that invariably affect personal, social and wider quality of life.
The clear benefits in osteoporosis treatment and prevention have recently been included in a recommendation from the National Osteoporosis Society that recommends HRT for the treatment and prevention of osteoporosis in women under 60.[7]
2) HRT is not a single drug as the press and our patients seem to have derived from the publicity.
HRT is a comprehensive suite of preparations and delivery routes produced by the pharmaceutical industry in response to women's needs over more than 20 years of development, refinement and research. This research continues, even though research funding is a fraction of what it once was.[8]
Recently completed trials not only suggest that natural progesterone may not affect the risk of breast cancer and have a neutral effect,[9] but also that soon to be released small studies of lower dose, endogenous-type hormone treatments given to recently menopausal women show great promise.[10]
The BMS feels that the research must continue. As the female population lives longer after the menopause we need to establish safe ways to prevent disease and maintain a high quality of life. This requires a trial to establish definitively the correct indications, patients and hormones for optimal postmenopausal health.[11] We should harness the wealth of knowledge from the debates around WHI and MWS to design this study rather than watch the arguments from the sidelines.
The BMS is dedicated to advancing education in all matters relating to the menopause and to the primary prevention of the burden of preventable chronic disease.
Nick Panay, Chairman, British Menopause Society; Consultant Gynaecologist, Queen Charlotte's and Chelsea & Westminster Hospitals, Honorary Lecturer, Imperial College London, London, UK
Heather Currie, Medical Advisory Council Member, British Menopause Society; Associate Specialist Gynaecologist, Dumfries and Galloway Royal Infirmary, Dumfries, UK; Medical Director "Menopause Matters Ltd"
Edward Morris, Medical Advisory Council Member, British Menopause Society; Consultant, Obstetrics & Gynaecology, Norfolk & Norwich University Hospital, Norwich, UK
References
[1] Million Women Study Collaborators. Breast cancer and HRT in the Million Women Study. Lancet 2003; 362: 419-427.
[2] Writing group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's health initiative randomised controlled trial JAMA 2002; 288(3): 321-333.
[3] Shapiro S, Farmer RD, Stevenson JC, Burger H, Mueck AO. Does hormone replacement therapy cause breast cancer? An application of causal principles to three studies Part 4: The Million Women Study J Fam Plann Reprod Health Care 2012. Jan 16 (ahead of print)
[4] Shapiro S, Farmer RD, Mueck AO, Seaman H, Stevenson JC. Does hormone replacement therapy cause breast cancer? An application of causal principles to three studies: part 2. The Women's Health Initiative: estrogen plus progestogen. J Fam Plann Reprod Health Care 2011 Jul;37(3):165-172.
[5] Cumming GP, Currie HD, Panay N, Moncur R, Lee AJ. Stopping hormone replacement therapy: were women ill advised? Menopause Int 2011; 17(3): 82-87.
[6] British Menopause Society Council. Modernizing the NHS: observations and recommendations from the British Menopause Society. Menopause Int 2011 Jun;17(2):41-43.
[7] Bowring CE, Francis RM. National Osteoporosis Society's Position Statement on hormone replacement therapy in the prevention and treatment of osteoporosis. Menopause Int 2011; 17: 63-65.
[8] Panay N, Ylikorkala O, Archer DF, Rakov V, Gut R, Lang E. Ultra low-dose estradiol and norethisterone acetate: Effective menopausal symptom relief. Climacteric 2007; 10(2): 120-131.
[9] Fournier A, Fabre A, Mesrine S, Boutron-Ruault MC, Berrino F, Clavel-Chapelon F. Use of different postmenopausal hormone therapies and risk of histology- and hormone receptor-defined invasive breast cancer. J Clin Oncol 2008; 26(8):1260-1268.
[10] Harman SM, Brinton EA, Cedars M, Lobo R, Manson JE, Merriam GR, Miller VM, Naftolin F, Santoro N. KEEPS: The Kronos Early Estrogen Prevention Study. Climacteric 2005 Mar;8(1):3-12.
[11] Panay N, Fenton A. Has the time for the definitive, randomized, placebo-controlled HRT trial arrived? Climacteric 2011 Apr;14(2):195-196.
Conflict of Interest:
Nick Panay (NP), Eddie Morris (EM) and Heather Currie (HC) have received sponsorship for lectures and advisory work performed for pharmaceutical companies. NP and HC have received educational grants for meetings and NP has received funding for pharmaceutical trials. NP is co-editor in chief of Climacteric (International Menopause Society Journal) and EM/HC are co-editors in chief of Menopause International (British Menopause Society Journal).