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Evidence summaries

Progestogen-Releasing Intrauterine Systems for Heavy Menstrual Bleeding

Levonorgestrel-releasing intrauterine device (LNG IUS) is effective for heavy menstrual bleeding reducing menstrual blood loss by 80-95 percentage. LNG IUS is more effective than drug therapy, and appears to be as effective as endometrial ablation. Level of evidence: "A"

Levonorgestrel-releasing intrauterine device is recommended for heavy menstrual bleeding as therapy of choice for patients who accept an intrauterine device.

A Cochrane review [Abstract] 1 included 25 studies with a total of 2 511 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.

Ten studies compared the LNG IUS with endometrial destruction techniques: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.

The LNG IUS was not as successful at reducing HMB as hysterectomy . However, the women in these studies reported improved quality of life, regardless of treatment.

Another Cochrane review[Abstract]3assessed interventions for heavy menstrual bleeding. For first line treatments, meta-analysis included 26 studies with 1770 participants. LNG-IUS resulted in a large reduction of menstrual blood loss (MBL; mean rank 2.4, MD 105.71 mL/cycle, 95% CI 201.10 to 10.33) and was the best option. Antifibrinolytic agents reduced MBL (mean rank 3.7, MD 80.32 mL/cycle, 95% CI 127.67 to 32.98); longcycle progestogen reduced MBL (mean rank 4.1, MD 76.93 mL/cycle, 95% CI 153.82 to -0.50), and NSAIDs slightly reduced MBL (mean rank 6.4, MD 40.67 mL/cycle, 84.61 to 3.27). For second line treatments, hysterectomy was the best and endometrial ablation the second best option.

A Health Technology Assessment 2 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.

References

  • Bofill Rodriguez M, Lethaby A, Jordan V. Progestogen-releasing intrauterine systems for heavy menstrual bleeding. Cochrane Database Syst Rev 2020;(6):CD002126. [PubMed]
  • Health Quality Ontario. Levonorgestrel-Releasing Intrauterine System (52 mg) for Idiopathic Heavy Menstrual Bleeding: A Health Technology Assessment. Ont Health Technol Assess Ser 2016;16(18):1-119. [PubMed]
  • Bofill Rodriguez M, Dias S, Jordan V et al. Interventions for heavy menstrual bleeding; overview of Cochrane reviews and network meta-analysis. Cochrane Database Syst Rev 2022;(5):CD013180. [PubMed]

Primary/Secondary Keywords