Is norethisterone a lifestyle drug? Results of database analysis
BMJ 2000; 320 doi: https://doi.org/10.1136/bmj.320.7230.291 (Published 29 January 2000) Cite this as: BMJ 2000;320:291All rapid responses
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A holiday or summer peak in prescribing this drug, presumably to
postpone menstruation, could be also compatible with other explanations.
For example, a desire to have more or just to have sexual intercourse
during days’ rest. In these cases, I propose that norethisterone became a
“recreational drug”.
Competing interests: No competing interests
Shakespeare et al pose an interesting question regarding whether
norethisterone prescribed for delaying periods during holidays classifies
it as a lifestyle drug and whether this is an appropriate NHS cost (1).
The definition of lifestyle prescribing as 'a pharmaceutical product
characterised as improving quality of life rather than alleviating or
curing disease' suggests that the crucial distinction lies in whether
there is demonstrable pathology. Most clinicians would recognise that,
although in some clinical scenarios the diagnosis or exclusion of disease
is crucial, in many instances this is of less utility than establishing
the potential cost-benefit or improvement to quality of life achieved by
treatment. The reaction of many doctors to the limited list of patients
who the secretary of state initially deemed eligible for NHS prescription
of sildenafil provides an example of this. The use of aetiology rather
than clinical need as the basis of rationing was described as "a decision
that makes no sense on clinical, equity, or cost effectiveness grounds"
(2). Menstrual problems provide another instance where clinical findings
do not closely reflect the subjective experience of symptoms and measured
blood loss is of less importance to women than the overall impact of a
constellation of symptoms (3) Other examples would include back pain
where, in the majority of cases, pathology matches poorly with symptoms,
yet treatment is provided on the basis of clinical need or quality of
life.
Whether or not the NHS should fund 'lifestyle drugs' comes down to the
'rationing' or 'prioritisation' debate regarding what it is that the NHS
should strive to provide. If it is solely to combat disease while ignoring
quality of life issues then this is an impossible distinction in many
instances and would have implications for a great deal of the current work
of the NHS. More realistically, the debate should focus on quality of life
rather than disease versus non-disease. The key question which remains is
what taxpayers are prepared to fund.
References
1. Shakespeare S, Neve E, Hodder K. Is norethisterone a lifestyle
drug? Results of a database analysis. BMJ 2000; 320: 291-291.
2. Chisholm J. Viagra: a botched test case for rationing [editorial].
BMJ 1999;318: 273-274
3. O'Flynn N, Britten N. Menorrhagia in general practice - disease
or illness? Social Science and Medicine 2000; 651-661.
Miriam Santer
MRC Special Training Fellow
Department of General Practice,
University of Edinburgh,
20 West Richmond Street,
Edinburgh EH8 9DX
Competing interests: No competing interests
Shakespeare et al report a seasonal variation in prescribing of
noresthisterone, specifically holiday peaks compatible with the drug being
used to postpone menstruation, and point out that such usage, to enhance
quality of life rather than treat disease, would class it as a 'lifestyle'
drug. 1
This implies a belief that the extra women consuming the drug at holiday
times do not have symptoms warranting alleviation. But this does not
necessarily follow from their forgoing medication at other times of the
year. Indeed, there is evidence that many women endure menstrual problems
untreated for considerable intervals. 2
Decisions regarding treatment are made by balancing the gains (reduction
of symptoms and consequences) against the costs (side-effects of
treatment, prescription costs, acceptance of 'sick role'). In general
women prefer not to have to take medication for menstrual problems, 3 so
noresthisterone, with its well-known unpleasant side-effects, is likely to
be particularly unappealing. Although these 'costs' will not vary
seasonally, the potential 'gains' very certainly will. Removed from her
usual life and coping strategies, into the unknown of holiday environment,
a woman suffering menstrual disorder is likely to experience exacerbation
of its consequences (disability, pain, issues around sanitary protection,
extra laundry, constraints on activities). Similar considerations apply to
Christmas with its associated family expectations, when there can be
considerable additional demands on women, even if staying at home.
Therefore there are valid reasons for treatment uptake, and hence
prescribing, to vary seasonally, in response to a need to restore quality
of life in specific (holiday time) contexts.
It is regrettable that these very interesting data should have been
interpreted so readily, and solely, as indicative of 'lifestyle' drug use
1. This is reminiscent of past observations that in complaints affecting
only women, the illogical acceptance of psychogenic origin, in the absence
of evidence, and consequent tendency not to provide symptomatic relief,
was suggestive of prejudice. 4 The pattern reported by Shakespeare could
alternatively suggest seasonal changes in prescribing criteria, despite
unchanging 'demand'. Or that many women with year-long menstrual health
needs are driven to take up an intervention which at other times they find
unsatisfactory, only when faced by a seasonal challenge that further
diminishes quality of life. This would be an indictment of health care
for women with menstrual problems, but may arise from the confusing
clinical picture of presentation and referral for menstrual problems. 5
All possibilities require careful consideration.
1. Shakespeare S, Neve E, Hodder K. Is norethisterone a lifestyle
drug? Results of a database analysis. BMJ 2000; 320: 291-291.
2. MORI Women's health in 1990. Research study conducted on behalf
of Parke-Davis Laboratories. 1990
3. Warner P. Preferences regarding treatments for period problems:
relationship to menstrual and demographic factors. Journal of
Psychosomatic Obstetrics and Gynaecology 1994; 15: 93-110.
4. Lennane KJ and Lennane RJ. Alleged psychogenic disorders in
women - a possible manifestation of sexual prejudice. New England Journal
of Medicine1973; 288: 288-292.
5. Warner P, Critchley HOD, Lumsden MA, Campbell-Brown M, Douglas A,
Murray G. Menorrhagia referral - but what is the menstrual health need?
BMJ submitted
Pamela Warner
Lecturer in Medical Statistics
Department of Community Health Sciences,
University of Edinburgh Medical School,
Teviot Place,
Edinburgh EH8 9AG
Competing interests: No competing interests
Dear Editor,
Heavens above,whatever next!Naughty Oxford
GPs have been caught out,prescribing norethisterone to delay periods,for
"lifestyle" purposes.(BMJ Vol.320
29 Jan.2000- dr.Judy Shakespeare et al.).Tut,tut,off to the correction
centre with the lot of them.
I wonder about some of the articles printed by the BMJ.You know the
sort I mean.Articles showing that depression is more common around the
menopause,or that starvation is bad for people.Dr. Shakespeare
reports,with wide-eyed horror,or dare one hope,tongue in cheek
humour,something that GPs have been doing for many years,as though it is
new and out of order.
In my defence,your honour,it was all those whinging women.As a mere
male I wouldn't want a period anytime,but they didn't want them during
exams,hang-gliding in Wales,or lying on a tropical beach.Seemed reasonable
to me.Norethisterone is safe,it seems well tolerated and it usually
works.They keep asking for more anyway.
Nowadays we're not supposed to let our patients enjoy life but,before
you pass sentence,what chance did I have.Me,a child of the Sixties,with
flowers in my hair (I did once have hair) and peace and love to all
men.I've prescribed the Pill for 25 years.If thats not a "lifestyle"
drug,what is? Doesn't the quality of life for my women patients have some
health benefits?
Of course,with NICE and CHIMP breathing down our necks we must do
better.Only Mr.Clinton can have fun and get away with it.Even that nice
Mr.Blair must pay for his "lifestyle"mistakes.Most women only want a delay
for a week or two,so 50 tabs is usually ample, leaving the NHS in
profit.Is that so wicked?But I'll go quietly to the retraining
centre.6mths off,locum expenses........could be
fun.
Dr.David F.Bird.
French Weir Health Centre,
Taunton,
Somerset TAI 1NW.
Competing interests: No competing interests
Dear Editor,
Shakespeare et al demonstrated a summer peak in prescribing in their
study1 on norethisterone prescribing. Their study did not seek to
determine the indication for these prescriptions so they had to surmise
that the summer peak was due to prescriptions for delaying menstruation
over the main holiday period.
Data from this practice suggest their interpretation is correct. From
a list of 6450 patients this practice issued 58 prescriptions for
norethisterone 5mg, between January 1998 and December 1999, to 43 women.
Our practice policy is to include an indication for all prescriptions; 27
of the 58 (47%) were for postponement of menstruation. The 20 women whose
indication was postponement of menstruation had a mean age of 35 (95%
confidence intervals 29-41). This appears surprisingly old, until one
considers that users of the combined oral contraceptive can avoid untimely
menstruation by omitting the gap between packets of their pill, the so-
called “bicycling”.
This adds another dimension to the debate over “lifestyle” drugs. If
postponing menstruation is a lifestyle issue (and by inference, one the
NHS should hesitate to offer) we must acknowledge that some women,
predominately the young, can achieve the desired effect through a non-
lifestyle drug.
Yours sincerely,
William Hamilton, general practitioner
Barnfield Hill Surgery, 12, Barnfield Hill, Exeter EX1 1SR.
e-mail barnfield.hill.research@which.net
Reference.
1. Shakespeare J, Neve E, Hodder K. Is norethisterone a lifestyle
drug? Results of database analysis. BMJ 2000;320:291.
Competing interests: No competing interests
When at medical school we were taught not to use the term menorrhagia
since it meant so many different things to different people.
In general practice I found many women complained of prolonged,
irregular or unpredictable periods, all of which could be helped with
norethisterone.
Following the publication of the Effective Health Care Bulletin in
1995 the prescription of norethisterone in general practice has been
widely criticised on the assumption that general practitioners were
treating heavy periods (menorrhagia). Instead it is likely that GPs are
using norethisterone effectively to give women control over the timing of
their menstruation as Shakespeare, Neve and Hodder suggest. Whether GPs
should improve their patients quality of life in this way is another
question.
Competing interests: No competing interests
EDITOR-
The summer peak in norethisterone prescribing so graphically demonstrated
by Shakespeare et al1 will be an unsurprising phenomenon to most GPs.
Whilst agreeing the evidence suggests that norethisterone is ineffective
in reducing menstrual loss in menorrhagia2, it is licensed and is
effective at delaying the onset of menstruation and regulating chaotic or
short menstrual cycles3.
To imply that use of norethisterone to postpone menstruation, which
may be a substantial proportion of current prescribing of the drug, is
inappropriate for the NHS, is in my opinion insulting to women.
Menstrual bleeding disorders are common and often not associated with
recognised abnormal pathology: dysfunctional uterine bleeding being an
acceptable diagnosis. Problem periods result in both physical and
psychological dis-ease.
In Southern Derbyshire, focus groups informed the development of our
guidelines for menstrual bleeding problems5. Women with problem periods
perceived that their symptoms were often disregarded by health
professionals. Positive outcomes desired from treatment were to have a
regular cycle, without restrictions on their social functioning and sex
lives.
In this era of patient-centred care, once serious pathology has been
excluded, many women choose to put-up with their problem periods most of
the time. However for a few weeks of the year they may decide to take a
period holiday.
Tranexamic acid used to treat menorrhagia for one year costs as much
as £100 while norethisterone to delay a period may cost only £53. It
could be argued that women who tolerate their symptoms for most of the
year but take a period holiday make efficient use of NHS resources.
Health is not merely the absence of disease, but a positive concept
of well-being5. Norethisterone used to delay a period is no more a
'lifestyle therapy' than other activities of the NHS aimed at promoting
health.
Gerry Bryant
specialist registrar in public health medicine
Leicestershire Health Authority, Leicester LE5 4QF
gerry.bryant@mail.leicester-ha.trent.nhs.uk
Ian Scott
consultant in obstetrics and gynaecology
Derby City General Hospital, Derby DE22 2NE
Anne Worrall
specialist registrar in public health medicine
Nottingham Health Authority, Nottingham NG1 6GN
1. Shakespeare J, Neve E, Hodder K. Is norethisterone a lifestyle
drug? Results of database analysis. BMJ 2000;320:291.
2. NHS Centre for Reviews and Dissemination. Effective health care:
Number 9. The management of menorrhagia. York: NHS Centre for Reviews
and Dissemination, 1995.
3. British National Formulary. BNF 38. London: BMA and RPS, 1999
4. Southern Derbyshire Health Authority. Clinical Guidelines in Southern
Derbyshire. The management of menstrual bleeding disorders. Derby: SDHA,
1997.
5. World Health Organisation. Constitution. Geneva: WHO, 1946.
Competing interests: No competing interests
Shakespeare et al question whether norethisterone should be
prescribed on the NHS to postpone menstruation. Summer peaks, they
conclude, suggest it is (mis)used for this purpose. They describe it as a
"lifestyle drug" in this context, this being "a pharmaceutical product
characterised as improving quality of life rather than alleviating or
curing disease."
By this token oral contraception (a far more widely prescribed form of
norethisterone) also is a "lifestyle drug" as it is taken to prevent a
physiological rather than a pathological process.
Oral contraception is exempt from a prescription charge to the patient, so
questioning the appropriateness of prescribing norethisterone on the NHS
must be on principle rather than on financial grounds.
David Carvel
MRCGP DRCOG
Competing interests: No competing interests
I may be a bloke but a lot of my patients are pretty keen not to have a period during their holidays- a well known time of stress. Our surgery computer reports that we have prescribed norethisterone to postpone menstruation 194 times since 1988 to 140 different women. And I shall continue doing so!...
Competing interests: No competing interests
"enjoy or delight drugs"
The described overuse of norethisterone in summer holidays could be
related, as Shakespeare et al. (BMJ 29 January) mentioned, to delay
menstruation during holidays. This desire to postpone the menstruation may
avoid some medical-related problems associated with menses, mainly painful
menstruation and dysmenorrhea, and pre-menstrual syndromes (dysphoric
disorders). Other causes could be more related to facilitate typical
activities done in vacation periods, as a decreasing the dependence to
hygienic measures associated to the menstruation or increasing the
possibility of sexual activity. Taking in to account that norethisterone
seems to be used to increase the enjoyment during holidays, why not to use
the term "enjoy or delight drugs". In addition, the knowledge of possible
similar peaks in the prescription of oral contraceptives during summer may
contribute to reinforce the proposed increase of "lifestyle drug" use
associated to holidays.
Magí Farré
Associate professor of Clinical Pharmacology
IMIM-UAB (Barcelona, Spain)
e-mail. mfarre@imim.es
I do not have any conflict of interest.
Competing interests: No competing interests