The levonorgestrel intrauterine system: a simple and effective alternative for the management of menorrhagia?

Question What is the effectiveness of the levonorgestrel-releasing intrauterine system (IUS) compared with hysterectomy for the management of women with menorrhagia? Design: Randomised controlled trial, double-blind. Setting: Five university hospitals in Finland. Patients: Premenopausal women aged 35–49 years, with menorrhagia and no major gynaecological abnormalities were recruited to the study. Exclusion criteria were submucous fibroids, endometrial polyps, ovarian tumours or masses greater than 5 cm, cervical disease, urinary and bowel symptoms or pain resulting from large fibroids, lack of indication for hysterectomy, history of cancer, menopause, severe depression, metrorrhagia as a main complaint, previous treatment failure with levonorgestrel-releasing intrauterine system (IUS), severe acne, and uterine malformation. Interventions: 119 patients were allocated to the IUS group and 117 were allocated to the hysterectomy (any method) group. Hysteroscopy was performed before randomisation only if clinically indicated. Main outcome measures: Quality-of-life measures (including health-related, measured on a scale of 0–1 with the EuroQuol [EQ-5D] instrument), anxiety measures, resource use, menstrual blood loss, haematological indices. Main results: In the IUS group, 24 women (20%) had had a hysterectomy and 81 (68%) continued to use the system at 12 months. Of the women assigned to the hysterectomy group, 107 underwent the operation (5 cancelled before surgery and 5 withdrew from the study group). Health-related quality of life improved significantly in both the IUS and hysterectomy groups (change in EQ-5D, 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 the hysterectomy group had less pain than the IUS group at 12 months. Overall costs were about three times higher for the hysterectomy group than for the IUS group. Conclusion: 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 for treating this disorder. International hysterectomy rates vary considerably; by the age of 60 years, a third of women in the United States will have undergone a hysterectomy and menorrhagia is one of the most common indications. 1 Satisfaction rates with hysterectomy have been consistently reported as 95% or higher. 2 Quality-of-life measures have also been reported to improve following hysterectomy. 3 It is perceived as a permanent solution to the problem of menorrhagia. However, short-term complications following hysterectomy are not uncommon; recent studies report rates of moderately severe complications of 16% while in …