A Cochrane review included 21 studies with a total of 2 082 subjects. The included trials mostly assessed the levonorgestrel-releasing intrauterine system (LNG IUS; Mirena®) that releases 20 µg/day of levonorgestrel. Comparisons were made with placebo, oral medical treatment, endometrial destruction techniques and hysterectomy.
Seven studies compared the LNG IUS with oral medical therapy: either norethisterone acetate (NET) administered over most of the menstrual cycle, medroxyprogesterone acetate (MPA) (administered for 10 days), the oral contraceptive pill, mefenamic acid or usual medical treatment where participants could choose the oral treatment that was most suitable. The LNG IUS was more effective than any other medical therapy at reducing heavy menstrual bleeding (HMB) as measured by the alkaline haematin method (percentage reduction in blood loss at end of study, from baseline 66.91, 95% CI 42.61 to 91.20; 2 studies, n=170; I²=81%) or by Pictorial Bleeding Assessment Chart (PBAC) scores (percentage reduction 55.05, 95% CI 27.83 to 82.28; 3 studies, n=335; I²=79%).The LNG IUS was also more effective improving quality of life and a greater number of women continued with their treatment at 2 years when compared with oral treatment. The direction of effect consistently favoured the LNG IUS. Minor adverse effects (such as pelvic pain, breast tenderness and ovarian cysts) were more common with the LNG IUS. In one study of 236 women the blood loss reduction at one year follow-up was in LNG IUS group 97 % measured by alkaline haematin method, 78-86 % measured by PBAC score and in balloon ablation group 88-97 % measured by PBAC score.
Ten studies compared the LNG IUS with endometrial destruction techniques: 3 with transcervical resection, one with rollerball ablation and 6 with thermal balloon ablation: Improvement in HMB within 12 months was similar (amenorrhoea, RR 1.21 95% CI 0.85 to 1.72; 8 trials, n=431). Evidence was inconsistent. Improvements in quality of life were experienced with both types of treatment. Minor adverse events were more common with the LNG IUS overall, but it appeared more cost effective compared to thermal ablation within a two-year time frame in one study.
The LNG IUS was not as successful at reducing HMB as hysterectomy in 3 trials (high quality evidence). However, the women in these studies reported improved quality of life, regardless of treatment. In spite of the high rate of surgical treatment in those having LNG IUS within 10 years, the LNG IUS was more cost effective than hysterectomy.
A Health Technology Assessment included 16 trials examining the effectiveness and cost-effectiveness of the 52-mg levonorgestrel-releasing intrauterine system (LNG IUS) as a treatment alternative for idiopathic heavy menstrual bleeding. The LNG IUS improved quality of life and reduced menstrual blood loss better than usual medical therapy. There was no evidence of a significant difference in these outcomes compared with the improvements offered by endometrial ablation or hysterectomy. Mild hormonal side effects were the most commonly reported. Results from the economic evaluation in 9-year time horizon showed the LNG-IUS was less costly and more effective providing higher quality-adjusted life years (incremental value of 0.05) compared with endometrial ablation.