I was very pleased to see the article by Shapiro and colleagues[1]
that was recently published online in the Journal of Family Planning and
Reproductive Health Care but dismayed to see the emotional response from
epidemiologists.[2] This reanalysis of data from the so-called 'Million
Women' study[3] raises important clinical concerns about the original
strongly stated conclusions. I think it is essential that we see
co...
I was very pleased to see the article by Shapiro and colleagues[1]
that was recently published online in the Journal of Family Planning and
Reproductive Health Care but dismayed to see the emotional response from
epidemiologists.[2] This reanalysis of data from the so-called 'Million
Women' study[3] raises important clinical concerns about the original
strongly stated conclusions. I think it is essential that we see
continuing debate about these complex epidemiological studies, where
results are open to different interpretations.
Putting emotions aside, there are some problems with the original
analysis of the Million Women Study (MWS). This type of study cannot make
allowances for every possible bias, and as we are all aware 'big is not
necessarily better' when biases are present. The statistically significant
differences seen in the MWS are still very small, and potential biases
could considerably change the final statistics.
It is the traditional scientific way to have debate about the
findings of controversial studies, and, to me, it seems appropriate that
the epidemiologists should set aside emotion and address the legitimate
questions and criticisms of other scientists in the original journal to
which the article was submitted.
The epidemiologists have managed to raise fear among women in the
general community about use of hormone replacement preparations, yet these
therapies have an enormous impact on many aspects of wellbeing, such that
the benefit-risk ratio for most individual women is very positive. I would
really like to show the epidemiologists I know (who do not see any
patients) the dramatic impact that hormone replacement therapy (HRT) can
have on the quality of the lives of many menopausal women.
We should not forget that the much vaunted and highly criticised
Women's Health Initiative study showed a significant reduction in risk of
breast cancer for women using oestrogen-alone HRT.[4] I do not hear the epidemiologists trumpeting this!
Everything we do in this life carries risk. Please can we look
realistically at what are the many potential benefits of HRT and put them
in perspective with individual risk. Let the debate continue - without
emotion!
References
1. Shapiro S, Farmer RDT, Stevenson JC, Burger HG, 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;doi:10.1136/jfprhc-2011-100229.
2. Kmietowicz Z. Articles disputing link between HRT and breast cancer are
"ridiculous" BMJ 2012;344:e513.
3. Million Women Study Collaborators. Breast cancer and hormone
replacement therapy in the Million Women Study. Lancet 2003;362:419-427.
4. The Women's Health Initiative Steering Committee. Effects of conjugated
equine estrogen in postmenopausal women with hysterectomy: the Women's
Health Initiative randomized controlled trial. JAMA 2004;291:1701-1712.
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
wom...
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).
We read with interest the findings that 8% of HIV positive women may
have had their HIV diagnosed earlier if routine HIV testing were delivered
in termination of pregnancy (TOP) and colposcopy services.
We introduced routine, opt-out HIV testing in the termination service
in Homerton Hospital, London in April 2008[1] and in the colposcopy unit
of Homerton Hospital in September 2010.[2]
We read with interest the findings that 8% of HIV positive women may
have had their HIV diagnosed earlier if routine HIV testing were delivered
in termination of pregnancy (TOP) and colposcopy services.
We introduced routine, opt-out HIV testing in the termination service
in Homerton Hospital, London in April 2008[1] and in the colposcopy unit
of Homerton Hospital in September 2010.[2]
In 3 years, between 01/04/2008 and 31/03/2011, 4326 women had a TOP.
2599 (60%) had an HIV test 7 (0.3%) of whom were newly diagnosed with
HIV.
In the 6 months between 01/09/2010 and 28/02/2011 687 women had a
colposcopy of whom 518 (75%) accepted HIV testing. 14 were known to be HIV
positive. One new case of HIV was diagnosed. The overall prevalence of HIV
was 2% and the incidence of newly diagnosed HIV was 0.2%.
The incidence of newly diagnosed HIV was 0.3% in TOP and 0.2% in
colposcopy. In comparison with other established testing sites, the
incidence among women attending the genito-urinary medicine clinic in the
same period was 0.2% and 0.1% in the antenatal clinic.
These findings suggest that the introduction of routine HIV testing
is acceptable, with uptake of 60-75%. It is an effective method of
diagnosing HIV, with a prevalence of newly diagnosed HIV being 0.2-0.3%.
We support the authors' recommendations that HIV testing become standard
practice in the management of CIN2/3 and TOP.
References
1. Creighton S, Badham L, Stacey L, Reeves I. HIV testing in termination of pregnancy services. Sexually Transmitted Infection (pending)
2. Creighton S, Dhairyawan R, Millett D, Stacey L. Routine HIV testing in colposcopy. (submitted to Sexually Transmitted Infection)
The article on HIV testing in abortion clinics provides a compelling
argument for normalising HIV testing and making it part of our general
medical care.(1) Similar discussions regarding approaches to HIV testing
in low prevalence settings are ongoing in general practice.(2)(3)
We recently reviewed the recorded HIV status of patients from countries of
high HIV prevalence (>1%) in our practice in Portsmouth (an area with...
The article on HIV testing in abortion clinics provides a compelling
argument for normalising HIV testing and making it part of our general
medical care.(1) Similar discussions regarding approaches to HIV testing
in low prevalence settings are ongoing in general practice.(2)(3)
We recently reviewed the recorded HIV status of patients from countries of
high HIV prevalence (>1%) in our practice in Portsmouth (an area with
an HIV prevalence of less than 0.2%), identifying 124 patients born in sub-Saharan African countries.(4) Among these patients, there were a variety
of ages and ethnic groups. In 90% of these patients, no HIV status was
recorded.
We were then faced with a dilemma. Based on 2008 UK National Guidelines
for HIV testing, HIV testing should be routinely offered to people from
countries of high HIV prevalence.(5) However, no further guidance is
offered regarding what is meant by 'routine testing'; whether we should
attempt to contact this at-risk group of patients systematically and, if
so, how we should contact them?
Opportunistic testing is an option, but given that some of these patients
have not consulted for a number of years could mean that some time could
pass before there is an opportunity to discuss HIV testing with the
potential for delayed diagnosis. We have raised awareness regarding HIV
testing to our staff and patients and plan to re-audit to see whether
these changes have resulted in increased testing.
In addition to people known to be from a country of high HIV prevalence
(>1%), the guidelines outline seven other categories of patients in whom
HIV testing should be routinely offered, in low prevalence settings. The
recommendations for low prevalence settings appear sensible, but are
difficult to implement in the real world. It requires significant input in
terms of staff training to identify at-risk patients, and there are issues
of raising the subject of an HIV test during a consultation for a
different problem. In contrast, it is relatively easy to design services
providing universal screening. Although the cost-effectiveness of
universal testing in low prevalence settings is still to be established,
such a strategy is likely to be the most successful in identifying those
currently living with HIV and unaware of their infection.
References
1. Bates S. HIV testing in abortion clinics. J Fam Plann Reprod Health
Care. 2011;37(4):198-200.
2. Arkell P, Stewart E, Williams I. HIV: low prevalence is no excuse for
not testing. The British Journal of General Practice. 2011 Apr;61(585):244
-5.
3. Smith C. HIV: low prevalence is no excuse for not testing. The British
Journal of General Practice [Internet]. 2011 Jul [cited 2011 Nov
21];61(588):436. Available from:
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3123475&tool=pmcentrez&rendertype=abstract
4. Health Protection Authority. Diagnosed HIV prevalence by Strategic
Health Authority (SHA) and Primary Care Trust (PCT) in England, 2009
[Internet]. 2009. Available from:
http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1228207184991
5. British HIV Association. UK National Guidelines for HIV Testing 2008
[Internet]. 2008. Available from:
http://www.bhiva.org/documents/Guidelines/Testing/GlinesHIVTest08.pdf
I was very pleased to see the article by Shapiro and colleagues[1] that was recently published online in the Journal of Family Planning and Reproductive Health Care but dismayed to see the emotional response from epidemiologists.[2] This reanalysis of data from the so-called 'Million Women' study[3] raises important clinical concerns about the original strongly stated conclusions. I think it is essential that we see co...
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 wom...
We read with interest the findings that 8% of HIV positive women may have had their HIV diagnosed earlier if routine HIV testing were delivered in termination of pregnancy (TOP) and colposcopy services.
We introduced routine, opt-out HIV testing in the termination service in Homerton Hospital, London in April 2008[1] and in the colposcopy unit of Homerton Hospital in September 2010.[2]
In 3 years, betwee...
The article on HIV testing in abortion clinics provides a compelling argument for normalising HIV testing and making it part of our general medical care.(1) Similar discussions regarding approaches to HIV testing in low prevalence settings are ongoing in general practice.(2)(3) We recently reviewed the recorded HIV status of patients from countries of high HIV prevalence (>1%) in our practice in Portsmouth (an area with...
Pages