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t- ..
The levonorgesirel intrauterine system avoided hysterectomy in
women with excessive uterine bleeding
Lahteenrnaki P, Haukkamaa M,
Puolakka J, et al. Open randomised
study of use of levonorgestrel releasing intrauterine system as alternative
to hysterectomy- BMJ. 1998 Apr II;
316:1122-6.
Question
In women awaiting hysterectomy for
excessive uterine bleeding, can the
levonorgestrel intratsterine system be
used to avoid surgery?
Design
Randomised controlled trial with follow-up at 6 months. The levonorgestrel
device group was also evaluated at 12
months or at discontinuation.
Setting
Gynaecology departments of 3 hospitals in Finland.
Patients
56 women between 33 and 49 years of
age (mean age 42 y) scheduled to have
hysterectomy for excessive uterine
bleeding with or without dystnenorrhoea. Exclusion criteria were 1 fibroid
larger than 3 cm in diameter, > 3 uterinefibroidsdetected by ultrasonography,
or contraindications to the use of a
hormonal device.
Intervention
28 women were allocated to the levonorgestrel intrauterine system (Mirena)
and 28 to a control group. The device
was inserted into the uterine cavity
after menstruation. Patients in the
control group continued their existing medical treatment for excessive
bleeding.
Main outcome measures
Number of women cancelling then: decision to have hysterectomy and the degree of disturbance of their menstrual
bleeding or pain on general well-being,
work performance, physical activity,
sexual activity, and general leisuretime activity.
group (P < 0.001) (Table). Menstrual
disturbance scores at 6-month follow^
up favoured the levonorgestrel group
more than the control group for general well-being, work performance,1
physical activity, sex life, and leisuretime activity (P = 0.002 for sex life and..
P < 0.001 for all other variables). The.
beneficial effect was maintained for Ufj:
to 12 months in the levonorgestrel•;
group. Differences in the number o!
days of bleeding between the groups
did not reach statistical significance;.:.
For correspondence: Dr. P. Lahteenmiiki,
Leiras Oy, Pansiontie 47, P.O. Box 415, FEi
20101, Turku, Finland. FAX OU-358-%:
191-8288.
-:
Levonorgestrel
system
Control
group
RBI (95% CI)
64%
14%
350% (91 to 1065)
N.NT.
2 (1 to 4) .v;;
*Abbreviations defined in Glossary; RBI, NNT, and CI calculated from data in article:;.-.?.
Commentary
This study by Lahteenmaki and colleagues
provides high-quaiity evidence that the
levonorgestrel intrauterine system, when
used in women awaiting hysterectomy for
menorrhagia, is a very effective therapy.
Not only did die menstrual symptoms and
quality of life generally improve with treatment, but hysterectomies were avoided in
two thirds of women using the levonorgestrel intrauterine system.
Most clinicians treat excessive menstrual
blood loss in the absence of systemic or pelvic pathology (idiopathic menorrhagia) with
pharmacological therapies. Antifibrinolytics
and prostaglandin synthetase inhibitors reduce mean blood loss, but they often fail to
prevent hysterectomy. One report estimated
18
Therapeutics
that approximately 35% of women with idiopathic menorrhagia would subsequently
have a hysterectomy (1). This major surgical intervention has been a cause of concern
for patients, consumer groups, third-party
payers, and government agencies because of
possible overuse, inappropriate indications,
operative risks, and economic consequences.
Minimal-access surgical interventions, such
as endometrial resection and ablation, are
also alternatives to hysterectomy, but their
uptake has been limited.
The results cannot be generalised to all
women with idiopathic menorrhagia because the study population was taken from
surgical waiting lists. Until further research
addresses broader study groups, however,
;
Source of funding: Leiras Oy, Turku, Finlaid \
The levonorgestrel intrauterine system vs continuing current treatment
(control) at 6 months in women with excessive uterine bleeding*
Cancelling
hysterectomy
'
Conclusion
Use of the levonorgestrel intrauterinf':
system avoided hysterectomy in.:
women with excessive uterine bleeding;:
Main results
Analysis was by intention to treat.
More women in the levonorgestrel
group cancelled hysterectomy at 6
months than did those in the control
Outcome
(
•
j
.
,
it is plausible that the levonorgestrei i
uterine system could be a widely effe
treatment for menorrhagia. ThereMj':
women with idiopathic menorrhagia shots?::;;
be given the option to make an inform^:-:.;:
choice about the use of the ievonorgests& g
mtrautenne system, as many would [
to avoid surgery altogether.
-^
KhalidS.Kban,MBBSM
Birmingham Women's Ho^1^.,
Birmingham, England, (||:l
Reference
1. Liu DX Treatment of dysfunctional ui
bleeding. Amenorrhoea need not be an *gj
point. BMj. 1995;310:802.
""*'''
Evideme-Bosed Medicine
January/February 1
Downloaded from http://ebm.bmj.com/ on June 18, 2017 - Published by group.bmj.com
The levonorgestrel intrauterine system avoided
hysterectomy in women with excessive uterine
bleeding
Evid Based Med 1999 4: 18
doi: 10.1136/ebm.1999.4.18
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