Clinical question
Do levonorgestrel-releasing intrauterine systems (LNG-IUS) improve outcomes in patients with premenopausal heavy menstrual bleeding with benign cause?
Bottom line
Comparing LNG-IUS with other therapies (eg, oral contraceptives [OCs]), blood loss is reduced (by 82% vs 26%), more patients are satisfied (75% vs 60%), and more continue with treatment at 2 years (64% vs 38%).
Evidence
Results were statistically different unless indicated.
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A comprehensive systematic review included 9 RCTs comparing LNG-IUS (52 mg) with other treatments.1 Percentages presented here were calculated by the authors (J.P. and A.J.L.):
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Blood loss was reduced by about 82% with LNG-IUS versus 26% with control treatments (OCs or medroxyprogesterone acetate). Patient satisfaction at 1 year was 75% versus 60% with control treatments (OCs, norethisterone, or tranexamic acid with norethisterone). Treatment success (based on bleeding score and no other treatment needed) was 82% versus 43% in control groups. Breast tenderness (19% vs 6%) and ovarian cysts (4% vs 1%) were more common in LNG-IUS groups. Quality of life (QOL) usually did not differ and withdrawal rates owing to side effects did not differ. Rates of dysmenorrhea were not reported.
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In 1 RCT of women taking anticoagulants, the LNG-IUS group had lower mean bleeding scores at 6 months than the control group (156 vs 255; lower scores better), lower mean bleeding days per cycle (2 vs 7), and better hemoglobin levels (120 g/L vs 100 g/L).2
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A pragmatic RCT (N=571) compared an LNG-IUS group with a control group taking their choice of tranexamic acid, nonsteroidal anti-inflammatory drugs, OCs, or progesterone-only pills.3 At 2 years, there was a higher mean score on a menorrhagia QOL scale (0 to 100; lower scores worse, baseline 40) in the LNG-IUS group (81 vs 67 control) and higher proportions of participants remained on LNG-IUS (64% vs 38% control). At 5 years, there were no differences in menorrhagia QOL scores (both >80) or surgical intervention rates (about 20%); more continued with LNG-IUS than with other treatments (47% vs 15%).
Limitations: No studies examined other levonorgestrel doses. Most RCTs excluded patients with fibroids. Evidence was generally rated as low (bleeding) to moderate certainty (QOL), but very low for satisfaction.1
Context
With respect to bleeding, QOL, and patient satisfaction, LNG-IUS are likely at least as good as ablation.1
Indirect comparisons suggest proportions of patients who respond to various treatments (<80 mL of blood loss per menstrual cycle after 3 months) include the following: LNG-IUS 88%, OCs 63%, progestin-only OC pills 64%, tranexamic acid 48%, and placebo 18%.4
Blood-loss volume does not correlate with patient experience.6
Implementation
Heavy menstrual bleeding (measured objectively) is estimated to occur in 9% to 14% of women annually.1 It is generally diagnosed based on patients’ perceptions and becomes problematic when it affects QOL or causes conditions such as anemia.1 Intrauterine systems provide effective contraception and are approved for up to 5 years of use; it may be reasonable to use them for up to 6 years for contraception, but efficacy for heavy menstrual bleeding has not been studied beyond 5 years.7 Benefits of lower-dose LNG-IUS for heavy bleeding are unknown.1
Tools for Practice articles in CFP are adapted from peer-reviewed articles at http://www.toolsforpractice.ca and summarize practice-changing medical evidence for primary care. Coordinated by Dr G. Michael Allan and Dr Adrienne J. Lindblad, articles are developed by the Patients, Experience, Evidence, Research (PEER) team and supported by the College of Family Physicians of Canada and its Alberta, Ontario, and Saskatchewan Chapters. Feedback is welcome at toolsforpractice@cfpc.ca.
Footnotes
Competing interests
None declared
References
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- 7.Baragar I, Kirkwood J, Paige A, Potter J.. Can it stay or must it go? Extended use of intrauterine devices. Edmonton, AB: Alberta College of Family Physicians; 2022. Available from: https://gomainpro.ca/wp-content/uploads/tools-for-practice/1643999687_tfp308_iud.pdf. Accessed 2022 Dec 2. [Google Scholar]