EFFCTIVENESS OF LEVONORGESTREL INTRAUTERINE SYSTEM VERSUS NORETHISTERONE IN IDIOPATHIC HEAVY MENSTRUAL BLEEDING

Abstract

BACKGROUND: : Heavy Menstrual Bleeding (HMB) is defined as menstrual blood loss for more than 7 days and/or blood loss greater than 80 ml. Women having HMB who have no demonstrable organic pathology are diagnosed as having idiopathic heavy menstrual bleeding. Abnormal uterine bleeding is one of the commonest reasons for which women are referred to hospitals by general practitioners. This study was conducted to compare levonorgestrel intrauterine system and norethisterone in idiopathic heavy menstrual bleeding. 
METHODS: The study was carried out at the Department of Gynecology and Obstetrics, Fauji Foundation Hospital, Rawalpindi, Pakistan. A Randomized Controlled Trial (RCT) was chosen in order to achieve the above-mentioned objective. Duration of this study was 8 from December 26, 2014 to August 30, 2015. All women with idiopathic heavy menstrual bleeding presented at the Department of Gynecology and Obstetrics, were enrolled in the study. A computer generated table of random numbers was used to randomize the enrolled women into two study groups – Group A and Group B. In group A levonorgestrel intrauterine system was inserted and in group B oral norethisterone was given. Norethisterone tablet was prescribed at dose of 5 mg 3 times daily from day 1-21 over 6 cycles in group B. Once treatment started data were collected on the especially designed profroma by the principal investigator herself. Total number of pads used per cycle, hemoglobin level (g/dl) at presentation and total number of pads used per cycle, hemoglobin level (g/dl) and patient satisfaction n terms of whether they wanted to continue the treatment or wanted other option like hysterectomy) at 6 months were recorded. For follow up, patients contact number and address were noted.Data were entered and analyzed using SPSS version 20. 
RESULTS: : During the study period , a total of 110women with idiopathic heavy menstrual bleeding (55 in each study arm) presented at the Department of Gynecology and Obstetrics, Fauji Foundation Hospital, Rawalpindi, were enrolled. The mean (SD) age of women enrolled in levonorgestrel intrauterine system group was 41.1 (± 3.3) years while in norethisterone group, it was 41.0 (± 3.5) years. In levonorgestrel intrauterine system group, 21 (38%) women were less than 40 years of age, while in norethisterone group 16 (30%) women were less than 40 years of age. In levonorgestrel intrauterine system group 54 (98%) women were multigravida whereas in norethisterone group all 55 (100%) women were multigravida. The comparison of mean difference in various parameters from baseline to end of treatment between two study groups showed that women in levonorgestrel intrauterine system group had significantly less mean number of sanitary pads used/ cycle (p<0.0001), significantly lower mean blood loss (p<0.0001) and significantly mean higher hemoglobin level (p=0.018) compared to women in norethisterone group. Similarly, a significantly higher number of women in levonorgestrel intrauterine system group showed satisfaction with treatment than women in norethisterone group (p=0.007) at the end of treatment (after 6 months). 
CONCLUSION: In conclusion, our study shows that women who were given levonorgestrel releasing intrauterine system showed a significantly lower use of sanitary pads, significant lower volume of blood loss, significantly improvement in hemoglobin levels and a significantly higher percentage of them showed satisfaction with the treatment after 6 months of treatment compared to women who were given norethisterone treatment for the management of HMB. 
KEYWORDS:: Heavy Menstrual Bleeding, Levonorgestrel Releasing Intrauterine System, Norethisterone, Hemoglobin.