BACKGROUND AND PURPOSE:

• Use of the levonorgestrel-releasing intrauterine system (LNG-IUS) can reduce menstrual blood loss by up to 90%
• Bofill Rodriguez et al. (Cochrane Systematic Review – Intervention, 2020) determined the effectiveness, patient acceptability, and safety of progestogen-releasing intrauterine systems to reduce heavy menstrual bleeding (HMB)

METHODS:

• Systematic review and meta-analysis
• Inclusion criteria
  • RCTs
  • Trials in women of reproductive age treated with LNG-IUS devices vs
    • No treatment | Placebo | Other medical/surgical therapy for HMB
• Study design and data analysis
  • Two authors independently extracted data, assessed risk of bias and determined certainty of evidence using GRADE criteria  

RESULTS:

• 25 RCTs were included | Combined total of 2511 women

LNG-IUS vs Other Medical Therapy

• Other therapies investigated were
  • Norethisterone acetate
  • Medroxyprogesterone acetate
  • Oral contraceptive pill
  • Mefenamic acid
  • Tranexamic acid
  • Usual medical treatment (patient choice of suitable oral treatment)
• The LNG-IUS may improve HMB, with lower menstrual blood loss using various bleeding assessment tools
  • The alkaline hematin method: Mean difference (MD) 66.91 mL (95% CI, 42.61 to 91.20; 2 studies, 170 women; low‐certainty evidence)
  • The Pictorial Bleeding Assessment Chart: MD 55.05 (95% CI 27.83 to 82.28; 3 studies, 335 women; low‐certainty evidence)
• Uncertain whether the LNG-IUS has any effect on women’s satisfaction up to one year
  • RR 1.28 (95% CI 1.01 to 1.63; 3 studies, 141 women; very low‐certainty evidence)
• The LNG‐IUS probably leads to slightly higher quality of life compared with other medical therapy using the following scales  
  • The SF‐36: MD 2.90 (95% CI, 0.06 to 5.74; 1 study: 571 women; moderate‐certainty evidence)
  • The Menorrhagia Multi-Attribute Scale: MD 13.40 (95% CI, 9.89 to 16.91; 1 trial, 571 women; moderate‐certainty evidence)
• Serious adverse events were similar between LNG-IUS and other medical therapies
  • RR 0.91 (95% CI 0.63 to 1.30; 1 study, 571 women; moderate‐certainty evidence)
• Compared to LNG-IUS, women using other medical therapy are probably more likely to
  • Withdraw from treatment for any reasons; RR 0.49 (95% CI, 0.39 to 0.60; 1 study, 571 women, moderate‐certainty evidence)
  • Experience treatment failure: RR 0.34 (95% CI 0.26 to 0.44; 6 studies, 535 women; moderate‐certainty evidence)

LNG‐IUS vs Endometrial Resection or Ablation (EA)

• Bleeding outcome results are inconsistent
  • Effect of LNG-IUS vs EA are probably similar when comparing rates for the following  
    • Amenorrhea | Hypomenorrhea | Eumenorrhea
  • Uncertain whether there is a difference in quality of life
• Women with the LNG-IUS are probably more likely to have any adverse event
  • RR 2.06 (95% CI, 1.44 to 2.94; 3 studies, 201 women; moderate‐certainty evidence)
• Women with the LNG‐IUS may experience more treatment failure (persistent HMB or requirement of additional treatment) at one year follow up
  • RR 1.78 (95% CI, 1.09 to 2.90; 5 studies, 320 women; low‐certainty evidence)
• Women with LNG-IUS may be more likely to require hysterectomy at one year follow up
  • RR 2.56 (95% CI 1.48 to 4.42; 3 studies, 400 women; low‐certainty evidence)

LNG‐IUS vs Hysterectomy

• Uncertain whether LNG_IUS had any effect on HMB compared with hysterectomy
  • Amenorrhea: RR 0.52 (95% CI, 0.39 to 0.70; 1 study, 75 women; very low‐certainty evidence)
• It is uncertain whether there is a difference between LNG-IUS and hysterectomy for the following
  • Satisfaction at five years
  • Quality of life via SF-36
• Women in the LNG‐IUS group may be more likely to have treatment failure requiring hysterectomy for HMB at 1‐year follow‐up
  • RR 48.18 (95% CI, 2.96 to 783.22; 1 study, 236 women; low‐certainty evidence)

CONCLUSION:

• LNG-IUS vs other medical therapies may improve heavy menstrual bleeding and quality of life
• Bleeding outcomes with LNG-IUS were similar to endometrial ablation although LNG-IUS may be associated with more adverse events
• This study yielded uncertain results when comparing LNG-IUS to hysterectomy

Learn More – Primary Sources:

Progestogen-releasing intrauterine systems for heavy menstrual bleeding

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