Abstract
Idiopathic menorrhagia (IM) is an important clinical challenge. The levonorgestrel-releasing intrauterine system (LNG IUS) provides an effective treatment option as shown by multiple small clinical studies. In this analysis of combined data, we describe the time course of relative change in menstrual blood loss (MBL) from baseline up to 5years. The results of two different methods to assess MBL were merged. We pooled and analyzed five prospective, randomized clinical studies investigating the effect of the LNG IUS on IM in a total of 230 women. Four studies assessed MBL by using the pictorial blood loss assessment chart (PBAC) and one study used the alkaline hematin method. We gathered data on percentage change from baseline after 3 and 6months, and annually up to 5years. In addition we analyzed results on hemoglobin (Hb) and serum ferritin (S-Fe). MBL data was available after 3 and 6months from 165 and 152 patients, respectively, and after 1year from 51 patients. Long-term data up to 3 and 5years was available for 28 and 10 patients, respectively. Not all studies provided data for all time points. Median (interquartile range) MBL decreased from baseline by -84.5% (-93.3; -63.6%) after 3months, by -92.9% (-97.6; -81.1%) and by -93.8% (-98.8; -81.1%) after 6months and 1year, respectively (P<0.0001, all time points). After 2and 5years the decrease was more than 96%. In parallel, Hb and S-Fe increased significantly. The LNG IUS rapidly induced clinically and statistically significant long-term reductions in MBL, paralleled by increases in Hb and S-Fe levels.
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