Open Randomised Study of Use of Levonorgestrel Releasing Intrauterine System as Alternative to Hysterectomy

Objectives: To assess whether the levonorgestrel intrauterine system could provide a conservative alternative to hysterectomy in the treatment of excessive uterine bleeding. Design: Open randomised multicentre study with two parallel groups: a levonorgestrel intrauterine system group and a control g...

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Bibliographic Details
Published in:BMJ (Online) 1998-04, Vol.316 (7138), p.1122-1126
Main Authors: Lähteenmäki, Pekka, Haukkamaa, Maija, Puolakka, Jukka, Riikonen, Ulla, Sainio, Susanna, Suvisaari, Janne, Nilsson, Carl Gustaf
Format: Article
Language:English
Subjects:
Adult
Bleeding
Control groups
Drug Administration Routes
Female
Follow-Up Studies
Humans
Hysterectomy
Leiomyoma
Levonorgestrel - administration & dosage
Medical treatment
Menorrhagia
Metrorrhagia
Middle Aged
Physicians
Progesterone Congeners - administration & dosage
Quality of Life
Statistical median
Treatment Outcome
Uterine hemorrhage
Uterine Hemorrhage - drug therapy
Uterine Hemorrhage - surgery
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Summary:Objectives: To assess whether the levonorgestrel intrauterine system could provide a conservative alternative to hysterectomy in the treatment of excessive uterine bleeding. Design: Open randomised multicentre study with two parallel groups: a levonorgestrel intrauterine system group and a control group. Setting: Gynaecology departments of three hospitals in Finland. Subjects: Fifty six women aged 33-49 years scheduled to undergo hysterectomy for treatment of excessive uterine bleeding. Interventions: Women were randomised either to continue with their current medical treatment or to have a levonorgestrel intrauterine system inserted. Main outcome measure: Proportion of women cancelling their decision to undergo hysterectomy. Results: At 6 months, 64.3% (95% confidence interval 44.1 to 81.4%) of the women in the levonorgestrel intrauterine system group and 14.3% (4.0 to 32.7%) in the control group had cancelled their decision to undergo hysterectomy (P < 0.001). Conclusions: The use of the levonorgestrel intrauterine system is a good conservative alternative to hysterectomy in the treatment of menorrhagia and should be considered before hysterectomy or other invasive treatments.
ISSN:0959-8138
1756-1833
1468-5833
DOI:10.1136/bmj.316.7138.1122