OBJECTIVES: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 5 years. The results of two different methods to assess MBL were merged. METHODS: 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 6 months, and annually up to 5 years. In addition we analyzed results on hemoglobin (Hb) and serum ferritin (S-Fe). RESULTS:MBL data was available after 3 and 6 months from 165 and 152 patients, respectively, and after 1 year from 51 patients. Long-term data up to 3 and 5 years 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 3 months, by -92.9% (-97.6; -81.1%) and by -93.8% (-98.8; -81.1%) after 6 months and 1 year, respectively (P < 0.0001, all time points). After 2 and 5 years the decrease was more than 96%. In parallel, Hb and S-Fe increased significantly. CONCLUSION: The LNG IUS rapidly induced clinically and statistically significant long-term reductions in MBL, paralleled by increases in Hb and S-Fe levels.
RCT Entities:
OBJECTIVES: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 5 years. The results of two different methods to assess MBL were merged. METHODS: 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 6 months, and annually up to 5 years. In addition we analyzed results on hemoglobin (Hb) and serum ferritin (S-Fe). RESULTS:MBL data was available after 3 and 6 months from 165 and 152 patients, respectively, and after 1 year from 51 patients. Long-term data up to 3 and 5 years 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 3 months, by -92.9% (-97.6; -81.1%) and by -93.8% (-98.8; -81.1%) after 6 months and 1 year, respectively (P < 0.0001, all time points). After 2 and 5 years the decrease was more than 96%. In parallel, Hb and S-Fe increased significantly. CONCLUSION: The LNG IUS rapidly induced clinically and statistically significant long-term reductions in MBL, paralleled by increases in Hb and S-Fe levels.
Authors: Sabina Sanghera; Tracy Elizabeth Roberts; Pelham Barton; Emma Frew; Jane Daniels; Lee Middleton; Laura Gennard; Joe Kai; Janesh Kumar Gupta Journal: PLoS One Date: 2014-03-17 Impact factor: 3.240