BACKGROUND AND PURPOSE:

• Beelen et al. (AJOG, 2020) compared the effectiveness of the levonorgestrel-releasing IUD with endometrial ablation in women with heavy menstrual bleeding

METHODS:

• Multicenter, randomized controlled, noninferiority trial
• Participants
  • Heavy menstrual bleeding and no intracavitary pathology
  • ≥34 years
  • Does not desire pregnancy
• Interventions
  • Levonorgestrel IUD (Mirena)
  • Endometrial ablation with a bipolar radiofrequency device (NovaSure)
• Statistical analysis
  • Blood loss based on Pictorial Blood Loss Assessment Chart (PBAC) score
  • 50 point difference in PBAC score considered clinically meaningful
  • Expert panel, using previous studies and clinical judgment difference, determined that “noninferiority of the LNG-IUS treatment would be shown if the upper limit of the 95% CI for the difference in PBAC score did not exceed the predetermined noninferiority margin of 25 points, with a corresponding P value of <.05”
• Primary outcome
  • Blood loss at 24 months
• Secondary outcomes
  • Reintervention rates
  • Patient satisfaction and quality of life
  • Sexual function

RESULTS:

• IUD group: 132 women | EA group: 138 women
• Mean PBAC score decreased substantially in both groups within the first 3 months
  • IUD group: 616.3 to 120.8
  • EA group: 630.0 to 59.2
• Women in the EA group had lower mean blood loss scores at 24 months
  • IUD group: 64.8 mean blood loss score
  • EA group: 14.2
  • Difference 50.5 points (95% CI, 4.3 to 96.7)
  • Upper limit of the 95% CI exceeds the noninferiority margin of 25 points | Noninferiority of the IUD was not demonstrated
• Women in the IUD group were at a higher risk of undergoing a surgical reintervention
  • IUD: 27% (34 women)
  • EA: 10% (14 women)
  • Relative risk 2.64 (95% CI, 1.49 to 4.68)
• There was no significant difference in patient satisfaction and quality of life between the groups

CONCLUSION:

• Women in both groups experienced a large decrease in menstrual blood loss after intervention
• EA did result in a greater decrease in blood loss over the levonorgestrel IUD (noninferiority was not demonstrated) and women who started with the IUD were more likely to need a surgical reintervention
• Quality of life scores were comparable between the two groups
• The authors conclude

The results of this study will enable physicians to provide women with clear information about multiple important outcomes after HMB treatment

For instance, the faster reduction in menstrual blood loss and lower chance of needing additional treatment of EA can be weighed against the less-invasive and reversible characteristics of the LNG-IUS

Learn More – Primary Sources:

Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding

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