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News and Announcements

This article is of the greatest importance for anyone interested in the question of HRT and breast cancer: it should be read in conjunction with my research paper [ABC Study] found further down this page.

 

2013 Dec;76(4):342-9. doi: 10.1016/j.maturitas.2013.08.002. Epub 2013 Sep 10.

 

Reduced breast cancer incidence in women treated with subcutaneous testosterone, or testosterone with anastrozole: a prospective, observational study.

 

OBJECTIVES:

There is evidence that androgens are breast protective and that testosterone therapy treats many symptoms of hormone deficiency in both pre and postmenopausal patients. However, unlike estrogen and progestins, there is a paucity of data regarding the incidence of breast cancer in women treated with testosterone therapy. This study was designed to investigate the incidence of breast cancer in women treated with subcutaneous testosterone therapy in the absence of systemic estrogen therapy.

STUDY DESIGN:

This is a 5-year interim analysis of a 10-year, prospective, observational, IRB approved study investigating the incidence of breast cancer in women presenting with symptoms of hormone deficiency treated with subcutaneous testosterone (T) implants or, T combined with the aromatase inhibitor anastrozole (A), i.e., T+A implants. Breast cancer incidence was compared with that of historical controls reported in the literature, age specific Surveillance Epidemiology and End Results (SEER) incidence rates, and a representative, similar age group of our patients used as a 'control' group. The effect of adherence to T therapy was also evaluated.

RESULTS:

Since March 2008, 1268 pre and post menopausal women have been enrolled in the study and eligible for analysis. As of March 2013, there have been 8 cases of invasive breast cancer diagnosed in 5642 person-years of follow up for an incidence of 142 cases per 100000 person-years, substantially less than the age-specific SEER incidence rates (293/100000), placebo arm of Women's Health Initiative Study (300/100000), never users of hormone therapy from the Million Women Study (325/100000) and our control group (390/100000). Unlike adherence to estrogen therapy, adherence to T therapy further decreased the incidence of breast cancer (73/100000).

CONCLUSION:

T and/or T+A, delivered subcutaneously as a pellet implant, reduced the incidence of breast cancer in pre and postmenopausal women. Evidence supports that breast cancer is preventable by maintaining a T to estrogen ratio in favor of T and, in particular, by the use of continuous T or, when indicated, T+A. This hormone therapy should be further investigated for the prevention and treatment of breast cancer.

 

KEYWORDS: Anastrozole; Breast cancer; Implants; Prevention; Testosterone

 

 

Ovarian dysfunction/premenstrual syndrome

It is of interest to me that this condition of ovarian dysfunction (PMS) attracts so little attention from my colleagues when it is so common and really disabling for the sufferer.  Perhaps they are experiencing the same frustration that I suffered in not understanding the problem and having no effective solution.  Well part of that has changed for me in that I can offer a solution without being entirely clear about the details of the cause.  The further speculation that is really exciting is the possibility that treating the condition may reduce the breast cancer rate in those women in their forties and fifties.  Read on.....

 

A proposed explanation of the ovarian dysfunction state, giving rise to the premenstrual syndrome.

 

The premenstrual syndrome and ovarian dysfunction is a subject that has defied clear explanation for many years and at least well antedating the efforts of Dr Katherine Dalton, who treated the condition in the 1950s in London.  That treatment was with progesterone that was subsequently shown to be ineffective in double-blind trials.  Nonetheless, Dr Dalton achieved a certain reputation, if not notoriety for her efforts and I think probably demonstrated the power of placebo response in attending to this vexed question.  The secret, of course, to detecting a placebo response is whether or not the treatment benefit extends beyond the six months that usually is the time within which the placebo effect expires.  Hence, naturopaths are wont to say that they administer “courses of treatment” and that when one “course of treatment” becomes ineffective, then they set up a second course of treatment and everybody benefits from the placebo results.

 

I used to hate dealing with premenstrual syndrome, simply because I didn’t understand it and I didn’t have a suitable treatment available for something I didn’t understand.  In due course, I took time out to consider the symptoms and clinical signs at my leisure and evolved what I termed a “model of understanding” of the condition on which I then instigated a treatment schedule.  My model of understanding was that the mid-cycle ovulation was either absent or impaired, so that luteinisation of the follicle does not occur effectively: and so the follicle simply keeps on growing and the oestradiol secretion level does not undergo the characteristic mid-cycle decline, as would be the case in a normal cycle: either that or there may be the development of multiple follicles again without luteinisation.  The oestrogen level, therefore, continues to climb through the menstrual month, until the end at which time the oestrogen levels may achieve toxic levels.  Since the length of the month is not regulated by ovulation, it can be a variable length, both short and long and because there is no luteinisation of the endometrium the blood loss can be very heavy and prolonged.  The excess oestrogen in the last seven to ten days of the month is characterised by a series of symptoms, which I will describe below. 

 

At the same time that the oestrogen production is excessive, the progesterone disappears entirely and so does the testosterone, both in terms of production and availability that is controlled by the oestrogen stimulation of the sex hormone binding globulin.  So the woman has oestrogen toxicity with progesterone and testosterone deficiency.  Replacement of progesterone, as I have already indicated, has historically been shown to be ineffective.  The use of the oral contraceptive pill, to some extent, can be effective, but adds more oestrogen to a situation that is already oestrogen replete.  Administration of testosterone, however, I believe, dampens the rate of follicular growth by direct suppression of the ovary and, at the same time, and most usefully, replaces that testosterone which has been lost and a deficiency that can be shown to be clearly symptomatic.  As the hormonal status returns to normal, the degree of bleeding is reduced, both in duration and in volume, and allows the woman to avoid the hysterectomy that is so often done for this condition on indications that are contrived and not truly causative.  It is all very well undertaking the hysterectomy to stop troublesome bleeding and pain, but the symptoms of ovarian dysfunction continue post-operatively.

 

The symptoms of the ovarian dysfunction and premenstrual syndrome, are those of abdominal bloating, swelling of the hands and feet, temporary weight gain and menstrual diuresis, menstrual headache, enlarged sore breasts, and significant mood upset.  The mood upset can be towards anger or tears or both.  The number of these symptoms that a woman may experience and express may not be a complete list of symptoms but may be some of them, with others absent.  For example, there seem to be some women who are subject, particularly, to fluid retention, in which they give evidence of swelling in the hands and feet, abdominal bloating and facial swelling.  Others have none of that at all and don’t even have a menstrual diuresis.  One woman at least had trembling with her cycle at the time of menstruation that was labelled as “orthostatic tremor”; she was also prone to anxiety.

 

At the same time, the symptoms of testosterone deficiency are quite pronounced and in the order of priority, as decided by the patients (not the doctors!), both male and female are as follows.  Mood upset to a variable status with tears and/or anger, loss of energy, poor stamina, impaired concentration, deteriorating memory, lack of decisiveness, enlargement and soreness of the breasts, loss of libido, loss of clitoridal sensitivity, dry and irritated vulval skin, dry facial skin, loss of muscle strength, and soreness in the neck and shoulders.  These are highly characteristic testosterone deficiency symptoms and the order of priority should be noted, particularly as most doctors perceive testosterone deficiency to be intimately, if not exclusively, related to the loss of sexual drive.  While this does occur, it is not by any means the most important symptom.

 

The glitch about this idea is that the pathology doesn’t support it.  Very frequently the testosterone levels are gratifyingly suppressed with a raised SHBG but the oestrogens are normal or low even when taken late in the cycle.  Maybe the excess oestrogen is not inevitably oestradiol that we conventionally measure.

 

What is worrying about the premenstrual syndrome is that recurrent stimulation of the breasts, to the point of soreness, and leads one on to wonder whether these women are being set up for the hormonal instigation of breast cancer.  These cancers in younger women are so characteristically in excessively stressed individuals leading a frenetic existence.  Who is more likely to develop ovarian dysfunction and yet so simply treated.

 

Certainly, in my publications and now others, I have shown in a modest manner that testosterone appears to reduce the breast cancer incidence to below normal.  This, I hasten to say, is very far from proven and is based simply on retrospective observational studies.  The reference to those studies is as follows.

 

http://menopause.com.au/files/ABC_Study.pdf

http://menopause.com.au/files/ABC_Study_Editorial.pdf

 

http://www.ncbi.nlm.nih.gov/pubmed/19453875

 

With the administration of testosterone in whatever dose that is required to be effective, the syndrome comes under control, the symptoms all but disappear and the cycle becomes regulated with a shorter, lighter bleed.  As the administered testosterone level begins to decline at the four months following implantation, the symptoms tend to start to recur; a further testosterone implant can then be administered and suppression of the ovarian dysfunction may continue.  At least in the untreated state the premenstrual syndrome may improve, as a woman travels through her late 40s, since during those years ovarian function may start to fail and with that failure there comes a failure of the ovarian dysfunction as well, with some amelioration of symptoms.  The woman becomes quite joyous at the prospect of becoming well again, only to be downcast when the menopause arrives and she may then be troubled with menopausal symptoms.

 

This condition is not insignificant, in that I meet women who have had the problem for 30 years, perhaps, and who have exhausted the doctors in their attempts to find a solution.  Whether it goes so far as for the woman to commit suicide, I am uncertain.  I am well aware that the woman suffering the premenstrual syndrome may be provoked into homicide, or at least attempted murder of her partner.  These were the sort of women that Katherine Dalton was defending in court when they became arraigned.

 

Some of these women say that the problem started after the birth of their last child.  That is too common a history to be ignored but, as yet, I have no clear understanding of what event might have occurred in a final pregnancy to set the ovary off on its miscreant course.  A proven understanding of the original cause could be useful in contributing to a more complete understanding of the whole condition.  In some ways, I believe there is more that I don’t understand about the condition than I do understand but that status, I believe, is the mark of an educated woman.

 

Dr Rosemary A. JONES 

10th March, 2009

edited 22nd March 2013

second editing 16th January 2015

 

Improvement in scalp hair growth in androgen-deficient women treated with testosterone: a questionnaire study

<http://www.ncbi.nlm.nih.gov/pubmed/21967243>

In conclusion, our results suggest that the effect of androgens on scalp hair growth in women is complex. Loss of hair may occur in hyperandrogenic states, possibly due to similar genetically determined DHT-driven mechanisms as occur in male balding, although the only evidence of this in our study was the lack of improvement in hair thinning in women with high BMIs. However, androgen deficiency may also lead to thinning hair due to loss of a more general testosterone-dependent anabolic effect on hair growth. This observation needs to be confirmed but potentially opens the way for a new approach to the treatment of female hair loss.

 

Skin changes in relation to menopausal hormone deficiency and replacement of oestrogen

Women being the creatures we are, generally take a pride in our appearance.  This link refers to the scientific basis that there is a benefit of oestrogens (HRT) on skin and hair quality.  Read on...

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2685269/?report=classic

 

South Australian Ending Life With Dignity Bill has strong safeguards

And now as the Bill comes up for the vote, please look at this factual presentation

http://www.youtube.com/watch?v=0IB-_eAvV3k

 

The fiction of so-called assisted dying slippery slopes

And then, this is the second video recorded by Neil.  A very persuasive presentation.

http://www.youtube.com/watch?v=NdLxvRgh668

 

Even the best palliative care can't always help

Please view this interesting and compelling video compiled by one of our most eminent voluntary euthanasia activists, Neil Francis, past president of The World Federation of Right To Die Societies

http://www.youtube.com/watch?v=rC7N7OkAZTU

 

You might also consider clicking the "Like" button (if viewing on the YouTube native page).

That does require to be logged in with a Google account (e.g. gmail, chrome, google+, YouTube), for it to work, though. But, the more likes, the more compelling the message to pollies.

Thank you for your interest.  There will be a further two videos to come later.


 

Voluntary Euthanasia

Doctors for Voluntary Euthanasia Choice

Legalise voluntary euthanasia: a cause supported by the strongest of ethical arguments

Join this national medical group

Choose to be a co-signatory on letters and submissions to politicians and media

Visit..................................................................................................................................................drs4VEchoice.org


Medical News

June 6th  2012

The 2012 Hormone Therapy Position Statement of The North American Menopause Society

Abstract

Objective: This position statement aimed to update the evidence-based position statement published by The North American Menopause Society (NAMS) in 2010 regarding recommendations for hormone therapy (HT) for postmenopausal women. This updated position statement further distinguishes the emerging differences in the therapeutic benefit-risk ratio between estrogen therapy (ET) and combined estrogen-progestogen therapy (EPT) at various ages and time intervals since menopause onset.

Methods: An Advisory Panel of expert clinicians and researchers in the field of women’s health was enlisted to review the 2010 NAMS position statement, evaluate new evidence, and reach consensus on recommendations. The Panel’s recommendations were reviewed and approved by the NAMS Board of Trustees as an official NAMS position statement.

Results: Current evidence supports the use of HT for perimenopausal and postmenopausal women when the balance of potential benefits and risks is favorable for the individual woman. This position statement reviews the effects of ET and EPT on many aspects of women’s health and recognizes the greater safety profile associated with ET.

Conclusions: Recent data support the initiation of HT around the time of menopause to treat menopause-related symptoms and to prevent osteoporosis in women at high risk of fracture. The more favorable benefit-risk ratio for ET allows more flexibility in extending the duration of use compared with EPT, where the earlier appearance of increased breast cancer risk precludes a recommendation for use beyond 3 to 5 years.

 

Menopause:
March 2012 - Volume 19 - Issue 3 - p 257–271
doi: 10.1097/gme.0b013e31824b970a
Position Statement

 

May 22nd

This was such a good comment on the current status of HRT in the menopause that I couldn't resist reproducing it here.

AHC Media / OB/GYN Clinical Alert / 2012 / OB/GYN Clinical Alert / Estrogen and Breast Cancer

Estrogen and Breast Cancer---------Abstract & Commentary

By Jeffrey T. Jensen, MD, MPH , Leon Speroff, Professor and Vice Chair for Research, Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, is Editor for OB/GYN Clinical Alert


Commentary

The great thing about the weather in Oregon in the spring is change. If you don't like it now, just wait 20 minutes and the rain, snow, and hail will change to brilliant sunshine and balmy temperatures. Although it often switches back, the days become progressively longer, brighter, and warmer. So goes the Women's Health Initiative Study, the large NICHD-funded evaluation of hormonal therapy in postmenopausal women. The initial news from the combined Prempro arm was devastating, and the shock affected the confidence of clinicians and women such that use of postmenopausal HRT declined precipitously and many symptomatic women found it difficult to obtain treatment. The combined treatment with conjugated estrogen and medroxyprogesterone acetate (MPA) increased the risk of breast cancer, and increased the risk of cardiovascular complications like coronary heart disease, venous thrombosis, and stroke.1 Over the years, much more has been learned. First, the results of the estrogen-only WHI studies differed from the combined therapy arm with respect to several clinically important outcomes; there was no overall impact on coronary heart disease with estrogen-only treatment and there was the trend toward a reduction in risk of invasive breast cancer in the estrogen-only arm.2 The decreased risk of invasive breast cancer persisted in a 2011 analysis of results from this study,3 and the present publication now provides more evidence showing that breast cancer mortality is also reduced. Taken together with similar favorable results evaluating cardiovascular effects with estrogen-only therapy, and in younger users of combined HRT, it seems that spring may be returning to hormonal therapy.

Given the fact that a steady diet of negative reporting has led many women and clinicians to view estrogen as a cancer-causing poison, the Anderson report is bound to cause confusion or, worse yet, to be ignored entirely. However, there is substantial basic research that suggests the true role of estrogen is a trophic hormone that positively affects growth of many tissues, including some cancers. More like a fertilizer than a toxin. You put fertilizer in the garden to support the growth of vegetables, accepting that it will improve the growth of weeds too. Natural estradiol should be viewed as a healthy organic fertilizer that helps the brain, bones, and many other tissues. While the data do not support that estrogens cause cancer, they will support the growth of these unwanted cells too; routine mammography is the way to identify these "weeds." The use of a progestogen complicates the picture in the breast. Using core needle biopsies, Murkes and colleagues found greater breast cell proliferation in postmenopausal women using oral conjugated estrogens and MPA than in those treated with transdermal estradiol and oral micronized progesterone.4 Since increasing numbers of women are reaching menopause with an intact uterus, we need to re-energize research to develop and market local progestogen delivery systems (like the LNG IUS) for postmenopausal use. Until then, off-label use of the LNG IUS should be considered.

Postmenopausal hormone therapy: an Endocrine Society scientific statement.

 

Santen RJ, Allred DC, Ardoin SP, Archer DF, Boyd N, Braunstein GD, Burger HG, Colditz GA, Davis SR, Gambacciani M, Gower BA, Henderson VW, Jarjour WN, Karas RH, Kleerekoper M, Lobo RA, Manson JE, Marsden J, Martin KA, Martin L, Pinkerton JV, Rubinow DR, Teede H, Thiboutot DM, Utian WH; Endocrine Society.

Division of Endocrinology and Metabolism, University of Virginia, Charlottesville, Virginia 22908, USA. RJS5Y@VIRGINIA.EDU

Abstract

OBJECTIVE: Our objective was to provide a scholarly review of the published literature on menopausal hormonal therapy (MHT), make scientifically valid assessments of the available data, and grade the level of evidence available for each clinically important endpoint.

PARTICIPANTS IN DEVELOPMENT OF SCIENTIFIC STATEMENT: The 12-member Scientific Statement Task Force of The Endocrine Society selected the leader of the statement development group (R.J.S.) and suggested experts with expertise in specific areas. In conjunction with the Task Force, lead authors (n = 25) and peer reviewers (n = 14) for each specific topic were selected. All discussions regarding content and grading of evidence occurred via teleconference or electronic and written correspondence. No funding was provided to any expert or peer reviewer, and all participants volunteered their time to prepare this Scientific Statement.

EVIDENCE: Each expert conducted extensive literature searches of case control, cohort, and randomized controlled trials as well as meta-analyses, Cochrane reviews, and Position Statements from other professional societies in order to compile and evaluate available evidence. No unpublished data were used to draw conclusions from the evidence.

CONSENSUS PROCESS: A consensus was reached after several iterations. Each topic was considered separately, and a consensus was achieved as to content to be included and conclusions reached between the primary author and the peer reviewer specific to that topic. In a separate iteration, the quality of evidence was judged using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system in common use by The Endocrine Society for preparing clinical guidelines. The final iteration involved responses to four levels of additional review: 1) general comments offered by each of the 25 authors; 2) comments of the individual Task Force members; 3) critiques by the reviewers of the Journal of Clinical Endocrinology & Metabolism; and 4) suggestions offered by the Council and members of The Endocrine Society. The lead author compiled each individual topic into a coherent document and finalized the content for the final Statement. The writing process was analogous to preparation of a multiauthored textbook with input from individual authors and the textbook editors.

CONCLUSIONS: The major conclusions related to the overall benefits and risks of MHT expressed as the number of women per 1000 taking MHT for 5 yr who would experience benefit or harm. Primary areas of benefit included relief of hot flashes and symptoms of urogenital atrophy and prevention of fractures and diabetes. Risks included venothrombotic episodes, stroke, and cholecystitis. In the subgroup of women starting MHT between ages 50 and 59 or less than 10 yr after onset of menopause, congruent trends suggested additional benefit including reduction of overall mortality and coronary artery disease. In this subgroup, estrogen plus some progestogens increased the risk of breast cancer, whereas estrogen alone did not. Beneficial effects on colorectal and endometrial cancer and harmful effects on ovarian cancer occurred but affected only a small number of women. Data from the various Women's Health Initiative studies, which involved women of average age 63, cannot be appropriately applied to calculate risks and benefits of MHT in women starting shortly after menopause. At the present time, assessments of benefit and risk in these younger women are based on lower levels of evidence.

PMID: 20566620 [PubMed - indexed for MEDLINE]

 

July 14, 2009 (Bastille Day)

It has been a year since I last communicated with my readers who I know persist in their visits. I think you will find the additions,

  • A longitudinal study of bone density gender Tx EndoMeeting2.ppt;
  • An explanation of the ovarian dysfunction state.doc;
  • Rosie publish.jpg;

worthwhile and particularly the replacement of my airbrushed image that was originally fun but lost its sparkle with the passage of time.

I continue in practice and have no plans to retire as I continue to enjoy your company whether in person or in your cyberpresence. I do believe there are a number of aspects of my practice that are near to unique if not absolutely so; it has proved difficult to find a replacement or indeed a successor and so you are stuck with me for the present.

I have returned from the biennial conference of the World Professional Association for Transsexual Health in Oslo with a fresh determination to improve the standards of care in Transsexual Medicine. It was fascinating to sit for three days with 200 senior professionals considering the problems of Gender Dysphoria and contrasting mentally the ratbag headlines that can emanate from the tabloid press, thereby cheapening the issues of seriously distressed people.

While the data on bone density for individuals is over a ten year span it has been 25 years in the collection; this is a labour of love and I’m proud of it. It is reassuring news.

The article on PMS I think is of the greatest importance. It is far from proven but if I am on the right track, I may have discerned at least part of the origin of the disasters that befell the likes of Kylie Minogue.

Finally, if there is a subject that I have failed write about or written inadequately then perhaps you might care to e-mail me and I can remedy the deficiency.

Rosemary A Jones


 

A longitudinal study of bone density gender Tx EndoMeeting2.ppt;

An proposed explanation of the ovarian dysfunction state, giving rise to the premenstrual syndrome.


 

June 20, 2006

ANZCOG Male to female transsexualism - Word document

Male-to-female transsexualism: Laparoscopic pelvic floor repair of prolapsed neovagina

Australian and New Zealand Journal of Obstetrics and Gynaecology 2006; 46: pp254-260  

 


 

References will be supplied on request


 

May 18, 2005

Comment on WHI-May 2005

September 11, 2004

Today is the anniversary of the destruction of the World Trade Centre in New York and the loss of so many lives. It is then with great pleasure that I seek to redress the balance of such a bad memory with good news that has the capacity to save lives. My research into the effect of testosterone on breast cancer incidence has been published and the full text article is to be found on this website. In addition, Professor Gelfand has written in the same journal an editorial that is supportive of the findings.

The research findings do not prove that the addition of testosterone in women taking hormone therapy will reduce their breast cancer rate to normal, but rather is strongly suggestive that this may be the case. Proof of this contention will be difficult and expensive and will be a long time coming. In the meantime I am happy to work on the assumption that testosterone is effective in making HT safer and the woman taking oestrogen may feel reassured.

If my conclusions are correct, then there is no need to limit the duration of exposure to HT to five years as has been widely suggested.

One other finding should be noted and that is the apparent effect of progestogens. Progestogens are given to protect the woman against oestrogen induced uterine cancer. The evidence is increasing and supported in my research findings that while progestogens may protect against uterine cancer, they increase the risk of breast cancer. This adverse effect is through the direct stimulation of the breast and by interfering with the protective effect of testosterone. The answer to this dilemma apart from the obvious solution of hysterectomy is to place a Mirena* intrauterine system into the cavity of the uterus. This has the effect of bringing the progestogen into the organ where it is required rather than soaking the whole woman with the hormone.

Links to the article and editorial are,
Breast cancer incidence in postmenopausal women using testosterone in addition to usual hormone therapy

Menopause: The Journal of The North American Menopause Society
Vol. 11, No. 5, pp. 531-535

It might be wise to consider adding androgen to the estrogen or estrogen-progestin regimens in the appropriate patients

Menopause: The Journal of The North American Menopause Society
Vol. 11, No. 5, pp. 505-507

 

ABC Study (56kb) ABC Study Editorial (40kb)

 

 

September 11, 2003

Position Statement Rev 10/09/03
ABC Study Poster Final Revision

July 1, 2002

Testosterone Titbits

March 21, 2003

The data on the apparent beneficial effect of testosterone in reducing breast cancer in women on HRT has been accepted for presentation in America.  These data will be placed before the annual meeting of the Endocrine Society in Philadelphia in June this year.  I hope to be there in person to explain the outcome of the Study.

The title of the paper was:

Breast Cancer Incidence in Australian Women Using Testosterone in Addition to Estrogen Replacement.

 

March 13, 2003

It has been a busy six months as we dealt with the issues arising from the WHI Trial publication.  Happily the new knowledge arising from the trial has now been assimilated into practice and a new confidence is being restored to the use of Hormone Replacement, or as it has been renamed ‘Hormone Treatment’ (HT).

There are some new products that I would draw to your attention.  The MIRENA intrauterine system has now been placed on the PBS.  This is a useful progestogen bearing ‘IUCD’ that replaces the need to take progestogen by mouth and avoids thereby the common side effects of that medication.  It has the added benefit of being contraceptive and deals effectively with that worrying uncertainty of fertility in the perimenopausal years.

The IMPLANON device for contraception in the younger woman has risen in popularity to become ‘top of the pops’ and perhaps this is because of it’s convenience lasting for three years, being very cheap, and should enable most women to become free of menstrual bleeding.

Transdermal testosterones are in development and currently under trial.  These are both skin patches and oral sprays not to mention of course the skin creams that suit women looking for a ‘softer’ effect than implants.

 


September 2, 2002

Further Reflections on The Women's Health Initiative Trial Result

Essentially this trial was stopped because of the rise in the rates of breast cancer but at the same time, perhaps to some people’s surprise, the rates of coronary artery disease and stroke rose rather than fell. The initial and essential point to understand is, to ask oneself whether this was a primary preventive trial or a secondary preventive trial. All of the scientific and observational evidence in the past has pointed towards a protective effect of oestrogens in the development of cardiovascular disease. Following on the HERS Trial however, there may have emerged the understanding that the woman who already has cardiovascular disease may not be protected in quite the same way. The latter would have been an attempt at secondary prevention after the disease has become established, in contrast to the scientific evidence for primary prevention in a woman who has clean arteries. What type of study was this WHI Trial?

It is essential to look at the sort of woman who was recruited into this trial. It should be firstly understood that the average age at recruitment was 63 years and going up to the maximum age of recruitment of 79 years. These were not younger, immediately menopausal women but an older group of women in whom the expectation might be that they already had cardiovascular disease. There are other patient characteristics that would be of concern. 50.4% had previously smoked cigarettes, or were currently smoking. 69.5% were overweight in terms of a BMI of greater than 25, while 34.2% were morbidly obese with a BMI of greater than 30. 35.7% were under treatment for hypertension and 12.5% were under treatment for an elevation of their cholesterol. This was clearly not a healthy group of women. The trial therefore, was looking at a mix of primary and secondary prevention and therefore, should not be quoted as being authoritative in a purely primary preventative conclusion.

Returning for a moment to the question of breast cancer. The conclusion seems to have been made that these problems emerged after 5.2 years of exposure to oestrogen and progestogen. However, 26.1% were in fact current uses of oestrogen for up to ten years or longer and with a three month washout period before starting the trial. This duration of treatment in a quarter of the patients makes a mockery of recommendations that a five-year exposure is the only safe length of time for oestrogen exposure. In any event, since the publication of the Beral study, it has been our clear understanding that while the rates of breast cancer may rise; the mortality from the disease actually falls below that of untreated women.

There has been very little publicity given to the conclusion about the falling rates of hip fracture and a perhaps surprising degree of protection against bowel cancer.

There are a number of worrying areas in terms of potential litigation vulnerability. There are as always the sins of omission and commission. Perhaps the breast cancer incidence will be of little consequence since I would assume that most practicing doctors would have already got that piece of information under their belt and carefully advise their patients accordingly. The question of the incidence of cardiovascular disease perhaps needs somewhat more careful evaluation than we have been accustomed to in the past. The essential thing here is to try to establish whether the asymptomatic woman already has diseased arteries and if not, what her risk for developing a problem may be.

What is of the greatest concern to me is the doctor who throws up his hands and declares that he is never going to prescribe hormones again. The problem here firstly, is that oestrogen has a very long 'washout' interval and during that time, the endometrium is open to unopposed stimulation with the risk of hyperplasia or even malignant change. I can imagine that many of these women are going to develop irregular bleeding, with evidence of hyperplasia, require hysteroscopy and D&C or even hysterectomy should they go on to develop a malignancy. In truth, the risk of malignancy is probably quite small and takes some years to develop. Nonetheless, there are going to be some rather unhappy women who may complain that they were not warned about this kind of problem when giving away hormones altogether, whether by their own choice or at the instigation of their physician. The important point here is that even if the woman ceases her oestrogen replacement, in the presence of a uterus she must continue the progestogen until all signs of withdrawal bleeding ceases.

On the contrary, a woman who is entirely healthy and has clean arteries and who is denied oestrogen replacement may also have grounds for complaint that her protection from cardiovascular disease has been withdrawn.

Most of my patients who are reasonably intelligent have worked out most of this for themselves and concluded whether to continue or to cease their hormones. Some of our patients however, are sufficiently intellectually challenged that they will find it impossible to grasp perhaps slightly difficult concepts. They are likely to say something like "I will leave it to you doctor" or " I do not care what you are saying, I am going to go off the hormones". Indeed, in the occasional patient the panic reaction is such that they are unable to listen to a reasoned explanation. This is an emotional reaction and needs to be handled with care, with the essential point being that the doctor needs to maintain a contact so that he can gain access to her reasoning when the panic reaction subsides.

Briefly, with reference to natural therapies, I have downloaded a copy of an excellent paper written by Dr Maida Taylor from San Francisco in which she discusses very clearly and in some detail this whole question. This is a very useful document at a time when our patients may be seeking some other form of relief other than the ‘synthetic doctor inspired’ recipe.

August 14, 2002

In the Breast Cancer Study, there were in fact only 7 cancers and not 8 as previously concluded (careful review found that one patient had been recorded twice). This compares to 12 cancers in a similar number of women in the general South Australian population or 14 if they were all taking oestrogen replacement without testosterone. These data are under intense scrutiny by my American colleagues working at the same institution (National Institute of Health, Bethesda, Maryland) whence the recent publication emanated that has given rise to so much anxiety about Hormone Replacement Therapy.

August 13, 2002

Dr. Jones will be speaking at the Adelaide Meridian, North Adelaide, on Wednesday August 21 from 6:00 - 7:30 pm, on behalf of "Fitness on the Park." Please call (08) 8267 1887 to book.

Statement of the education subcommittee of the Australasian Menopause Society on the first report of the Women's Health Initiative.

July 10, 2002

The news from the WHI Study about HRT is of some concern to women taking HRT. This will require full discussion with our patients. It should be noted that the full details are not yet published making it difficult to fully evaluate the conclusions drawn by the researchers. I hope to be able to read the publication by the next Menopause Meeting on the 24th July and be in a position to make some comments by that date. I would encourage you to attend that meeting.

July 1, 2002

Hormone Replacement and Breast Cancer

Prolapse Repair

February 4, 2002

Please see Contacts for doctors who are willing to consider Testosterone Therapy. I would be happy to include on this page the names and contact details of other like-minded practitioners.

February 4, 2002

"Testosterone and Breast Cancer" has been updated with new information.

October 24, 2001

Wednesday 24th October is the tenth anniversary of the first stapling laparoscopic hysterectomy that I undertook in South Australia. This 'red letter' day has gone largely unremarked and that is a shame since this procedure has been claimed by me to be the safest form of hysterectomy. This I have published as: . The lack of recognition is sad but maybe I will have to await the verdict of history. In the meantime, my reward is that of satisfied patients.

August 9, 2001

MORE ABOUT TESTOSTERONE AND BREAST CANCER

There has appeared in the medical press a most interesting piece of basic scientific work by Jian Zhou. This is published in The FASEB Journal. 2000;141725-1730. This laboratory research may lend some support to the concept that the use of testosterone in women using HRT may reduce their risk for breast cancer. I have extracted the following comment from Dr Zhou's conclusions in his paper.

In summary, the present data show that addition of androgen to estrogen treatment reduces mammary epithelial proliferation and ER expression, suggesting that androgens may protect against breast cancer, by analogy with progesterone's protective effects on the uterus. Androgens have actually been used to treat breast cancer with some success in the past. If androgen is in fact protective, then conventional menopausal hormone replacement regimens may promote breast cancer risk both by increasing estrogens and decreasing endogenous androgens. Oral estrogen therapy reduces free androgen levels by stimulating increased hepatic production of sex hormone binding globulin, and by suppressing LH, which drives ovarian androgen production after menopause. These considerations suggest that balanced estrogen/androgen 'replacement' therapy may be beneficial to menopausal women.


 

March 16, 2001

LAPAROSCOPIC HYSTERECTOMY SAFEST SURGERY

I have published my final report on this technique in the journal, Gynaecological Endoscopy (December 2000- <2000: vol 9. pp.373-378>).

The article reports the rates of complications in the first 500 laparoscopic hysterectomies and concludes that as a surgical technique it compares favourably with coventional vaginal and abdominal hysterectomy. There is little doubt in my mind that it will become the operation of choice when hysterectomy becomes necessary. This conclusion applies not only to the safety of the procedure but also to the rapid recovery experienced. If you send me your email address, I would be happy to send you the full text of the article.

 




November 11, 2000

TESTOSTERONE AND BREAST CANCER

PLEASE NOTE THAT THIS INFORMATION IS NOT YET
'PEER REVIEWED' AND SHOULD BE READ WITH CAUTION

The A-Z of Testosterone Treatment (new)

The "ABC" Study - Testosterone Effect on Lipids, Bone Density and Breast Cancer Incidence (new)

I have made the observation over the years that breast tenderness caused by the use of oestrogen is reduced by the use of testosterone. The thought occurred as to whether this might be accompanied by a reduction in the incidence of breast cancer. In an attempt to investigate this I undertook a retrospective study of 512 patients receiving oestrogen and testosterone in the menopause over 12 years.

There were 8 cases of breast cancer recorded in my patients for the duration of the study. Reference to data taken from The Cancer Registry of South Australia would lead me to conclude that there would have been 12 cases of cancer in a comparable group of the general population. It is estimated that 39.5% of these women in the South Australia population were current consumers of oestrogen replacement and 60% were 'ever users'.

While there might appear to be a reduction in the risk to my treated patients, statistical analysis (life table analysis) does not, however, confirm that there is a demonstrable reduction of the incidence of cancer but simply that there is no increase in the cancer incidence.

Study patients: 10-year breast cancer free survival rate for patients in the trial was 97.41% with a 95% confidence interval of 95.53% to 99.29%.

    Comparative group: expected 10-year breast cancer free survival rate is 97.52%, almost identical to that actually observed

    Bone densities were observed to increase significantly,

 

 

 

 

 

 

Lumbar Spine 1-3 years % gain = +10.6% p=0.07 NS

Neck of Femur 1-3 years % gain = +6.4% p = 0.02

 

There was no adverse effect on the improvement in cholesterol status as would be anticipated from the use of oestrogen replacement.

 

Total cholesterol % reduction = -12.7% (approx)

LDL-c (damaging) % reduction = -19.8% (approx)

HDL-c (protective) % increase = +3.7% (approx)

 

It should be emphasised that retrospective data collection, such as this, is on the lowest rung of reliability in scientific study and statistical analysis. The purpose of the study was to draw attention to a possible benefit in using this hormone for menopausal patients electing to receive Hormone Replacement Therapy and to encourage a more formal and controlled study of the effect of testosterone in conjunction with oestrogen replacement.


September 7, 2000

There has just been launched a new product, Livial (Tibolone).

This is a new substance that has an oestrogenic, progestogenic and testosterone effect. This seems to be almost too good to be true but I have been watching the emergence of this agent (ORG OD 148) in the research literature over the past few years and it appears to be withstanding the rigorous scientific testing. It has earned a good reputation in its use overseas. I have yet to get personal experience in its use. It is yet another option that you might care to consider.




There has been a flood of enquiries about the new hormone patch that has been publicised on the television. This is the Estalis patch. It employs a delivery system for oestrogen identical to the Estraderm MX patch. What is new is that it can also deliver progestogen transdermally. Progestogen must be used in a woman who seeks HRT and still retains her uterus. Progestogens are poorly tolerated generally with a significant incidence of adverse side- effects. It is hoped that the new patch will permit the woman to avoid these problems while at the same time maintaining the protection from cancer of the uterus that is achieved by progestogen. The patch comes in different strengths and the progestogen can be taken 'continuous' or 'cyclic', depending on whether the woman wishes to avoid cyclic bleeding.