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A randomized UK study of menorrhagia shows that the levonorgestrel intrauterine system (LNG-IUS) is more effective than standard medical treatment in reducing the adverse effect of the menstrual problem on women's quality of life.
A randomized UK study of menorrhagia shows that the levonorgestrel intrauterine system (LNG-IUS) is more effective than standard medical treatment in reducing the adverse effect of the menstrual problem on women’s quality of life.
The multicenter ECLIPSE (Effectiveness and Cost-Effectiveness of Levonorgestrel-Containing Intrauterine System in Primary Care against Standard Treatment for Menorrhagia) trial enrolled 571 women aged 25 to 50 years. All the participants presented to primary care physicians with complaints of menorrhagia during at least 3 consecutive menstrual cycles. Randomization was to the LNG-IUS or standard therapy for menorrhagia (tranexamic acid, mefenamic acid, combined estrogen-progestogen, or progesterone alone).
The goal of the research was to assess, over a 2-year period, patient-reported scores on the Menorrhagia Multi-Attribute Scale (MMAS), which measures the effect of menorrhagia on practical difficulties, social life, psychological health, physical health, work and daily routine, and family life and relationships. MMAS scores were assessed at 6, 12, and 24 months on a scale from 0 (severely affected) to 100 (not affected). The study had 90% power (P<0.05) to detect 0.3 SD differences in primary outcome at any given time.
From baseline to 6 months, MMAS scores in both groups improved, with mean increase of 32.7 points in the LNG-IUS group versus 21.4 in the usual-treatment group. The trend continued at 12 and 24 months, with more significant increases in the LNG-IUS group than the usual-treatment group (mean between-group difference, 13.4 points; 95% CI, 9.9 to 16.9; P<0.001). The LNG-IUS group had significantly greater improvements in all MMAS domains and in 7 of 8 quality-of-life domains. More women in the LNG-IUS group than in the group receiving usual treatment also were continuing their therapy at 2 years (64% vs 38%, P<0.001). No significant differences between groups were reported for rates of surgical intervention, sexual-activity scores, or serious adverse events.
The strengths of the trial, according to the researchers, included its large size, multicenter design, relatively low rates of loss to follow-up, 2-year assessment period, and focus on burden of menorrhagia.