Elsevier

The Lancet

Volume 357, Issue 9252, 27 January 2001, Pages 273-277
The Lancet

Early Report
Quality of life and cost-effectiveness of levonorgestrel-releasing intrauterine system versus hysterectomy for treatment of menorrhagia: a randomised trial

https://doi.org/10.1016/S0140-6736(00)03615-1Get rights and content

Summary

Background

Heavy menstrual blood loss is a common reason for women to seek medical care. The levonorgestrel-releasing intrauterine system (IUS) is an effective medical treatment for menorrhagia. We report a randomised comparison of this approach with hysterectomy in terms of the quality of life of women with menorrhagia and cost-effectiveness.

Methods

Of 598 women referred with menorrhagia to five university hospitals in Finland, 236 were eligible and agreed to take part. They were randomly assigned treatment with the levonorgestrel-releasing IUS (n=119) or hysterectomy (n=117). The amount of menstrual blood loss was objectively measured. The primary outcome measure was health-related quality of life at 12-month follow-up. Analyses were by intention to treat.

Findings

In the group assigned the levonorgestrel-releasing IUS, 24 (20%) women had had hysterectomy and 81 (68%) continued to use the system at 12 months. Of the women assigned to the hysterectomy group, 107 underwent the operation. Health-related quality of life improved significantly in both the IUS and hysterectomy groups (change 0·10 [95% CI 0·06–0·14] in both groups) as did other indices of psychological wellbeing. There were no significant differences between the treatment groups except that women with hysterectomy suffered less pain. Overall costs were about three times higher for the hysterectomy group than for the IUS group.

Interpretation

The significant improvement in health-related quality of life highlights the importance of treating menorrhagia. During the first year the levonorgestrel-releasing IUS was a cost-effective alternative to hysterectomy in treatment of this disorder.

Introduction

Excessive menstrual blood loss accounts for more than 10% of outpatient referrals to gynaecology consultants, and about half of the referred women will undergo hysterectomy within 5 years.1 Although hysterectomy is by definition more effective than other treatment modalities for menorrhagia, the associated morbidity and complication rates cannot be ignored.2, 3 The levonorgestrel-releasing intrauterine system (IUS) effectively reduces menstrual blood loss.4, 5 Crosignani and colleagues' randomised trial showed no significant differences in the quality of life between groups treated with the levonorgestrel-releasing IUS or by endometrial resection after 1 year of follow-up, as measured by the short form 36.6 However, the effectiveness of the levonorgestrel-releasing IUS has not been systematically compared with that of hysterectomy.

We undertook a randomised trial of the levonorgestrel-releasing IUS or hysterectomy in the treatment of menorrhagia. The outcome measures were health-related quality of life, other measures of psychological wellbeing (anxiety, depression, sexual function), and costs. We report the results after the first year of follow-up.

Section snippets

Participants

The women who took part in the study were referred by general practitioners or gynaecologists to one of the five university hospitals in Finland because of menorrhagia, between November, 1994, and November, 1997. Women who had no indication of predefined exclusion criteria when referred were assessed by medical history, physical examination, cervical smear, transvaginal ultrasonography, and endometrial biopsy. When clinically indicated, hysteroscopy was also done. The predefined exclusion

Study population

598 women were screened (figure 1). The 362 women ineligible or unwilling to take part did not differ from the study group in terms of age, employment status, or occupation. Of the 236 participants, 107 were enrolled in Helsinki, 44 in Kuopio, 22 in Oulu, 21 in Tampere, and 42 in Turku. Baseline characteristics of the participants are given in table 1.

Levonorgestrel-IUS group

Of the 119 women assigned to the levonorgestrel-releasing IUS group (figure 1), 117 attended the 6-month follow-up visit and 116 the 12-month

Discussion

Hysterectomy was successful in the treatment of menorrhagia in this study, but it was associated with several complications. The levonorgestrel-releasing IUS was also successful in decreasing menstrual blood loss in most women. However, about a third of devices were removed, and 20% of the women underwent hysterectomy during the first year of follow-up. Health-related quality of life and other measures of psychosocial wellbeing improved in both groups. At 12 months, there were no significant

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