- Email: [email protected]
PROGESTAGEN USE IN POSTMENOPAUSAL WOMEN
1243 or ill-educated, guesses would surely be more efficient. There are strong possibilities of saving by examining the data that emerge and finding better and cheaper ways of meeting need. Outpatient services are an example. At £ 30 a visit, the annual total of almost 40 million outpatient visits costs some [1.2 billion. We know that there are variations in referral by general practitioners and that certain consultants tend to hold on to patients. We lack detail. A simple program could help explore this interface. Measures could then be taken to equalise standards of referral through a combination of peer review, closer cooperation between consultants and general practitioners, and educational initiatives. If a 20% reduction could be achieved, the saving would be 240 million. A study of care in the community that could be obtained from the program might also suggest new ways of defining problems and of dealing with them. If Korner data from patients seen on the District were integrated with the clinical record within the computer we could begin to explore possibilities. This is
educated,
Consensus Conference PROGESTAGEN USE IN POSTMENOPAUSAL WOMEN IN postmenopausal women, the risk of endometrial hyperstimulation with oestrogen-only therapy is now well recognised; as a result, combined treatments, in which a progestagen is given together with oestrogen, are being prescribed more frequently. There have lately been many published reports on combined therapies, but no forum has been specifically convened to identify avenues worthy of further research, to review areas of accord and disagreement, and to prepare guidelines for clinical management. Fifty-six participants, all actively engaged in research on the effects of progestagens on various end-organs and
invited to attend the First International on Conference Progestagen Use in Postmenopausal Women, held in Naples, Florida, in September. Presentations (many including unpublished data) and workshops occupied the first two days; the subsequent discussions covered pharmacokinetic, pharmacodynamic, biochemical, histological, clinical, and epidemiological aspects. On the third morning there was an open forum which was devoted to producing a consensus report and the following statements were agreed.
tissues,
were
Consensus
CONSENSUS REPORT
1. Basic science, clinical, and epidemiological studies have shown that progestagen treatment is efficacious and is indicated for opposing the effects of oestrogen on the endometrium. 2. These studies have shown that increasing the number of days of progestagen treatment, beyond 7-10 days each cycle/month, has a further beneficial suppressive effect on endometrial proliferation. Because of well-recognised symptoms and potentially adverse metabolic effects, it is important that the duration of progestagen administration should be individually tailored. 3. In
with a uterus who are totally progestagen it is reasonable to prescribe oestrogen therapy without the addition of progestagen provided that the patient is monitored carefully and made aware that this mode of treatment is a departure from standard practice. Because preliminary epidemiological data indicate that unopposed oestrogens can increase the risk of endometrial malignancy for many years after oestrogen-only some women
intolerant,
easily done. Similarly if we made a program to record and classify risk factors we could prepare a risk-profile of the community and devise and target preventive measures that might reduce expensive hospital care later. Prescribing data, too, could be examined in relation to morbidity; and the data could be used not only at practice level but also for a national system of post-marketing surveillance that would be considerably less costly to the pharmaceutical industry and more effective than other options. These are only a few of the possibilities. In general, we will know what we need to know about illness in the district and in the nation and how it is treated both in general practice and in the hospital. Saving money within the health service, both in reduction of cost and in spending more effectively, is most likely to be achieved if we know what is happening. Update Computers Ltd, 19-30 Alfred Place, London WC1E 7EA
ABRAHAM MARCUS
is withdrawn, monitoring should be continued well into the post-treatment phase. 4. In some carefully monitored, prospective clinical trials it is ethical to include a study group of non-hysterectomised women receiving unopposed oestrogen (without progestagen). In this group, careful monitoring should be continued after termination of the trial. 5. All women should be made aware of the consequences of oestrogen-deficiency in the postmenopause; and should be offered the opportunity to receive oestrogen therapy. 6. It was proposed that, with informed consent, it would be ethical to include a placebo group (no hormonal treatment) in well-defined, prospective, clinical trials in which appropriate monitoring is carried out. If positive results are achieved during the trial before the proposed termination, then the trial should be discontinued immediately. Whilst this proposal received some support, it was also opposed and no consensus was reached. 7. The biochemical and histological data on the effects of progestagens on normal breast tissue are inconsistent; the epidemiological data are insufficient to suggest that progestagen addition in normal postmenopausal oestrogen-users reduces the risk of breast cancer. Thus, a consensus was reached that progestagens should not be used routinely in women without a uterus. 8. Progestagens, given alone, may be useful in the treatment of premenopausal and perimenopausal women with benign breast treatment
changes. 9. The available data indicate that the addition of progestagen to the oestrogen therapy does not influence the skeletal response provided that the oestrogen dose is adequate. Thus, progestagens should not be routinely prescribed to women who have had a hysterectomy and are taking oestrogens and who are seeking to prevent osteoporosis. 10. Short-term studies have shown that some progestagens, by themselves, are capable of reducing postmenopausal bone loss. However, there are no data on the long-term effects of progestagenonly treatment on bone mass, nor on fracture frequency. 11. Some progestagens, used alone, can reduce vasomotor
instability. 12. More information is urgently needed on the pharmacodynamics of progestagens. It is not clear whether certain progestagens have similar bioavailability irrespective of the route of administration (oral vs non-oral), or whether the route influences the biological response. 13. There is sufficient evidence to support a cardioprotective effect of oestrogen-only therapy in postmenopausal women. 14. Epidemiological evidence suggests that the cardioprotective effect of oestrogen is partly mediated by an alteration of lipid and
1244
lipoprotein metabolism. The importance of other mechanisms is unclear. Some progestagens in large doses may adversely affect lipid and lipoprotein metabolism and may partly negate this beneficial effect. There are insufficient data to know whether the other mechanisms of cardioprotection are affected by progestagens. 15. There are insufficient long-term histological and data to advocate the routine use of daily doses of epidemiological both progestagen and oestrogen (continuous-combined therapy). The long-term metabolic consequences of daily progestagen addition need to be determined. However, continuous-combined therapy may be an option. 16. Some progestagens in large doses cause adverse symptomatic and psychological changes; the lowest dose required for endometrial protection should be prescribed.
Occasional Book TIME IS POWER
LIKE many other issues in the contemporary world, the study of time has suffered from professional overspecialism. Sociologists, psychologists, and others have mostly left time to historians. But historians, so occupied with temporality as a context, have rarely paused to consider its meaning. This is the theme of The Rhythms of Society, edited by Michael Young and Tom Schuller.1 "We have become like Alice’s White Rabbit," say the editors in their introduction (somewhat unhappily subtitled Towards Chronosociology), the point about Alice’s White Rabbit being that he was always aware not of what time is but of what time it is. Innovative thinkers able to surmount disciplinary barriers have known better how critical a determinant time is of life in industrial society. Thus Piaget described children’s need to learn about time in the same way as they must comprehend space; Marx understood that power over time is what most people living and working in the capitalist world lack; and Freud saw that even the most apparently free among us may yet be slaves to an interior past. One of the editors of The Rhythms of Society, Michael Young, also has a reputation for innovative thought, having been responsible for such important developments as the Institute of Community Studies and Which magazine. This collection of essays represents his latest interest, which is as much with the way human beings interpret and use time as with the constraints imposed by biological rhythms of the human condition. The essays cover a wide range of areas and interests including time in economic development, timeconsciousness in the Middle Ages, and conflicts over time in the factory, and are well worth plundering for their capacity to reshape taken-for-granted assumptions and viewpoints. I recall in the mid-1970s conducting observations of doctors and patients in a large maternity hospital, and being very puzzled by the issue of time and time-keeping. Until, that is, I grasped the main tenet of Ronald Frankenberg’s chapter in this book, which is concerned with the "tragic temporal contradictions of biomedical practice". As Frankenberg puts it, medicine is a waiting culture. We need go no further than the very term patient. In my own hospital observations I was particularly struck by the new house officers’ habit of arriving on time for clinics, which contrasted with the consultants’ tendency to come late---or sometimes not at all. After a while the new recruits acquired consultant-like habits (while the patients went on waiting). Time is power, and power relations are expressed through
18. More clinical data are urgently required. Because of the questionable validity of various animal models, results of animal studies should not be extrapolated to women. Academic Department of Obstetrics and Gynaecology, King’s College School of Medicine and Dentistry, London
MALCOLM WHITEHEAD
Divison of Reproductive
Endocrinology and Infertility, University of Southern California School of Medicine, Los Angeles, California
ROGERIO A. LOBO
time. This helps to explain the peculiar resistance to change of organisational structures within medicine-for instance, the routines inflicted on hospital inpatients, whereby people are woken up to be given sleeping pills and encouraged to eat breakfast in the middle of the night. A particularly sturdy example of this is the system of booking clinic appointments that ensures a constant excess supply of patients over the demand for them. Whenever change is suggested, which it has been frequently, various excuses are given, but the underlying reason is that the powerful must continually assert their power by keeping the powerless waiting. This, of course, is interestingly at odds with the evidence that psychological stress, of the sort occasioned by endless waiting, is bad for people’s health. Frankenberg observes that, within obstetrics and gynaecology, the doctor-patient hierarchy in time is conflated by that of gender. By obdurately menstruating, gestating, and lactating, women are "naturally" always a likely axis for cultural unease. The female body is a constant reminder that temporal meaning and constraints are set aside by nature as well as by culture. Emily Martinzhas suggested (and it would have been valuable to see this theme developed here) that one reason why medicine has needed to develop a technical vocabulary for naming women’s psychobiological disorders (viz, premenstrual syndrome, postpartum depression, the "menopausal" woman) is that the time structures of advanced industrialised societies are not advanced enough to take account of these special female rhythms. Social time is unadapted to female life-time. From the viewpoint of the obstetrician, the problem with pregnancy specifically is that it is self-limiting, whereas the obstetrical raison d’etre requires that limits be imposed on it. In line with this, a little publicised finding of Ann Cartwright’s survey of induction habits in Britain some years ago3 was that higher induction rates increased obstetricians’ job satisfaction. This is a thought-provoking book. It would be nice to see extracts from it pinned on hospital noticeboards--even though no one, probably, would have the time to read them. Thomas Coram Research 41 Brunswick Square, London WC1N 1AZ
Unit,
ANN OAKLEY
1. The
2.
Rhythms of Society. Edited by Michael Young and Tom Schuller London: Routledge (for the Association for the Social Study of Time). 1988. Pp ix & 233. £27.50. ISBN 0-4150255338 Martin E. The woman in the body a cultural analysis of reproduction. Boston Beacon,
3
Cartwright A. The dignity of labour? A study of childbearing and induction
1987.
Tavistock,
1979.
London.
educated,
Consensus Conference PROGESTAGEN USE IN POSTMENOPAUSAL WOMEN IN postmenopausal women, the risk of endometrial hyperstimulation with oestrogen-only therapy is now well recognised; as a result, combined treatments, in which a progestagen is given together with oestrogen, are being prescribed more frequently. There have lately been many published reports on combined therapies, but no forum has been specifically convened to identify avenues worthy of further research, to review areas of accord and disagreement, and to prepare guidelines for clinical management. Fifty-six participants, all actively engaged in research on the effects of progestagens on various end-organs and
invited to attend the First International on Conference Progestagen Use in Postmenopausal Women, held in Naples, Florida, in September. Presentations (many including unpublished data) and workshops occupied the first two days; the subsequent discussions covered pharmacokinetic, pharmacodynamic, biochemical, histological, clinical, and epidemiological aspects. On the third morning there was an open forum which was devoted to producing a consensus report and the following statements were agreed.
tissues,
were
Consensus
CONSENSUS REPORT
1. Basic science, clinical, and epidemiological studies have shown that progestagen treatment is efficacious and is indicated for opposing the effects of oestrogen on the endometrium. 2. These studies have shown that increasing the number of days of progestagen treatment, beyond 7-10 days each cycle/month, has a further beneficial suppressive effect on endometrial proliferation. Because of well-recognised symptoms and potentially adverse metabolic effects, it is important that the duration of progestagen administration should be individually tailored. 3. In
with a uterus who are totally progestagen it is reasonable to prescribe oestrogen therapy without the addition of progestagen provided that the patient is monitored carefully and made aware that this mode of treatment is a departure from standard practice. Because preliminary epidemiological data indicate that unopposed oestrogens can increase the risk of endometrial malignancy for many years after oestrogen-only some women
intolerant,
easily done. Similarly if we made a program to record and classify risk factors we could prepare a risk-profile of the community and devise and target preventive measures that might reduce expensive hospital care later. Prescribing data, too, could be examined in relation to morbidity; and the data could be used not only at practice level but also for a national system of post-marketing surveillance that would be considerably less costly to the pharmaceutical industry and more effective than other options. These are only a few of the possibilities. In general, we will know what we need to know about illness in the district and in the nation and how it is treated both in general practice and in the hospital. Saving money within the health service, both in reduction of cost and in spending more effectively, is most likely to be achieved if we know what is happening. Update Computers Ltd, 19-30 Alfred Place, London WC1E 7EA
ABRAHAM MARCUS
is withdrawn, monitoring should be continued well into the post-treatment phase. 4. In some carefully monitored, prospective clinical trials it is ethical to include a study group of non-hysterectomised women receiving unopposed oestrogen (without progestagen). In this group, careful monitoring should be continued after termination of the trial. 5. All women should be made aware of the consequences of oestrogen-deficiency in the postmenopause; and should be offered the opportunity to receive oestrogen therapy. 6. It was proposed that, with informed consent, it would be ethical to include a placebo group (no hormonal treatment) in well-defined, prospective, clinical trials in which appropriate monitoring is carried out. If positive results are achieved during the trial before the proposed termination, then the trial should be discontinued immediately. Whilst this proposal received some support, it was also opposed and no consensus was reached. 7. The biochemical and histological data on the effects of progestagens on normal breast tissue are inconsistent; the epidemiological data are insufficient to suggest that progestagen addition in normal postmenopausal oestrogen-users reduces the risk of breast cancer. Thus, a consensus was reached that progestagens should not be used routinely in women without a uterus. 8. Progestagens, given alone, may be useful in the treatment of premenopausal and perimenopausal women with benign breast treatment
changes. 9. The available data indicate that the addition of progestagen to the oestrogen therapy does not influence the skeletal response provided that the oestrogen dose is adequate. Thus, progestagens should not be routinely prescribed to women who have had a hysterectomy and are taking oestrogens and who are seeking to prevent osteoporosis. 10. Short-term studies have shown that some progestagens, by themselves, are capable of reducing postmenopausal bone loss. However, there are no data on the long-term effects of progestagenonly treatment on bone mass, nor on fracture frequency. 11. Some progestagens, used alone, can reduce vasomotor
instability. 12. More information is urgently needed on the pharmacodynamics of progestagens. It is not clear whether certain progestagens have similar bioavailability irrespective of the route of administration (oral vs non-oral), or whether the route influences the biological response. 13. There is sufficient evidence to support a cardioprotective effect of oestrogen-only therapy in postmenopausal women. 14. Epidemiological evidence suggests that the cardioprotective effect of oestrogen is partly mediated by an alteration of lipid and
1244
lipoprotein metabolism. The importance of other mechanisms is unclear. Some progestagens in large doses may adversely affect lipid and lipoprotein metabolism and may partly negate this beneficial effect. There are insufficient data to know whether the other mechanisms of cardioprotection are affected by progestagens. 15. There are insufficient long-term histological and data to advocate the routine use of daily doses of epidemiological both progestagen and oestrogen (continuous-combined therapy). The long-term metabolic consequences of daily progestagen addition need to be determined. However, continuous-combined therapy may be an option. 16. Some progestagens in large doses cause adverse symptomatic and psychological changes; the lowest dose required for endometrial protection should be prescribed.
Occasional Book TIME IS POWER
LIKE many other issues in the contemporary world, the study of time has suffered from professional overspecialism. Sociologists, psychologists, and others have mostly left time to historians. But historians, so occupied with temporality as a context, have rarely paused to consider its meaning. This is the theme of The Rhythms of Society, edited by Michael Young and Tom Schuller.1 "We have become like Alice’s White Rabbit," say the editors in their introduction (somewhat unhappily subtitled Towards Chronosociology), the point about Alice’s White Rabbit being that he was always aware not of what time is but of what time it is. Innovative thinkers able to surmount disciplinary barriers have known better how critical a determinant time is of life in industrial society. Thus Piaget described children’s need to learn about time in the same way as they must comprehend space; Marx understood that power over time is what most people living and working in the capitalist world lack; and Freud saw that even the most apparently free among us may yet be slaves to an interior past. One of the editors of The Rhythms of Society, Michael Young, also has a reputation for innovative thought, having been responsible for such important developments as the Institute of Community Studies and Which magazine. This collection of essays represents his latest interest, which is as much with the way human beings interpret and use time as with the constraints imposed by biological rhythms of the human condition. The essays cover a wide range of areas and interests including time in economic development, timeconsciousness in the Middle Ages, and conflicts over time in the factory, and are well worth plundering for their capacity to reshape taken-for-granted assumptions and viewpoints. I recall in the mid-1970s conducting observations of doctors and patients in a large maternity hospital, and being very puzzled by the issue of time and time-keeping. Until, that is, I grasped the main tenet of Ronald Frankenberg’s chapter in this book, which is concerned with the "tragic temporal contradictions of biomedical practice". As Frankenberg puts it, medicine is a waiting culture. We need go no further than the very term patient. In my own hospital observations I was particularly struck by the new house officers’ habit of arriving on time for clinics, which contrasted with the consultants’ tendency to come late---or sometimes not at all. After a while the new recruits acquired consultant-like habits (while the patients went on waiting). Time is power, and power relations are expressed through
18. More clinical data are urgently required. Because of the questionable validity of various animal models, results of animal studies should not be extrapolated to women. Academic Department of Obstetrics and Gynaecology, King’s College School of Medicine and Dentistry, London
MALCOLM WHITEHEAD
Divison of Reproductive
Endocrinology and Infertility, University of Southern California School of Medicine, Los Angeles, California
ROGERIO A. LOBO
time. This helps to explain the peculiar resistance to change of organisational structures within medicine-for instance, the routines inflicted on hospital inpatients, whereby people are woken up to be given sleeping pills and encouraged to eat breakfast in the middle of the night. A particularly sturdy example of this is the system of booking clinic appointments that ensures a constant excess supply of patients over the demand for them. Whenever change is suggested, which it has been frequently, various excuses are given, but the underlying reason is that the powerful must continually assert their power by keeping the powerless waiting. This, of course, is interestingly at odds with the evidence that psychological stress, of the sort occasioned by endless waiting, is bad for people’s health. Frankenberg observes that, within obstetrics and gynaecology, the doctor-patient hierarchy in time is conflated by that of gender. By obdurately menstruating, gestating, and lactating, women are "naturally" always a likely axis for cultural unease. The female body is a constant reminder that temporal meaning and constraints are set aside by nature as well as by culture. Emily Martinzhas suggested (and it would have been valuable to see this theme developed here) that one reason why medicine has needed to develop a technical vocabulary for naming women’s psychobiological disorders (viz, premenstrual syndrome, postpartum depression, the "menopausal" woman) is that the time structures of advanced industrialised societies are not advanced enough to take account of these special female rhythms. Social time is unadapted to female life-time. From the viewpoint of the obstetrician, the problem with pregnancy specifically is that it is self-limiting, whereas the obstetrical raison d’etre requires that limits be imposed on it. In line with this, a little publicised finding of Ann Cartwright’s survey of induction habits in Britain some years ago3 was that higher induction rates increased obstetricians’ job satisfaction. This is a thought-provoking book. It would be nice to see extracts from it pinned on hospital noticeboards--even though no one, probably, would have the time to read them. Thomas Coram Research 41 Brunswick Square, London WC1N 1AZ
Unit,
ANN OAKLEY
1. The
2.
Rhythms of Society. Edited by Michael Young and Tom Schuller London: Routledge (for the Association for the Social Study of Time). 1988. Pp ix & 233. £27.50. ISBN 0-4150255338 Martin E. The woman in the body a cultural analysis of reproduction. Boston Beacon,
3
Cartwright A. The dignity of labour? A study of childbearing and induction
1987.
Tavistock,
1979.
London.